National Coverage Analysis (NCA) View Public Comments

Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer

Public Comments

Commenter Comment Information
Carter, J Jacques Title: Asst Professor of Medicine, Harvard Medical School
Organization: Medical Advisor, Prostate Health Education Network (PHEN)
Date: 04/29/2011
Comment:
I am in strong support of The Centers for Medicare and Medicaid Services (CMS) draft determination that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication under 1862(a)(1)(A) of the Social Security Act

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Donahue, Kerry Organization: CareToLive
Date: 04/29/2011
Comment:
Dear CMS,
Please consider first and foremost the men and the families who love them. These are the true beneficiaries of the Provenge Medicare coverage. To you they may be portrayed as points on a graph, but to us, each and every one of these men, matter greatly. We call them Dad, Grandpa, Son, Brother and Husband. During the approval and now coverage process, we have experienced moments of extreme joy and devastating heartbreak. The almost five year old continuing Provenge saga, ongoing

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Rudolph, Edward Title: retired
Date: 04/29/2011
Comment:
[PHI Redacted] However, it now is an anxious period because its life saving effectiveness can end any time. [PHI Redacted] died earlier this year after several years of chemo which effectively killed him. The thought that Provenge might be available through Medicare reduces my anxiety because not only has it been found to extend life beyond any other drug available but it does so with the least side effects. This means that if it extends life it also does so

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chambers, kenneth Date: 04/29/2011
Comment:
I feel that the evidence is sufficient to justify the use of this form of treatment. And should save many lives.
Collins, Ann Date: 04/29/2011
Comment:
[PHI Redacted] receives Medicare and it currently appears that he might soon need Provenge. Having it covered by Medicare would make a huge difference in his lifespan[PHI Redacted]. Please give us a new weapon in an eighteen year battle by approveing it for coverage by Medicare Thank you.
Love, J Date: 04/29/2011
Comment:
Please don't deny patients and families this option.
pawlosky, charles Date: 04/29/2011
Comment:
[PHI Redacted] I have first hand knowledge of the how prostate cancer effects the individual as well as all those who are close to him. Long tem recovery for those who have had the cancer move to other parts of the body is bleak indeed. I strongly support of Medicare access to FDA-approved prostate cancer treatments such as Provenge, a new immunotherapy treatment for advanced prostate cancer. Treatments such as these may be the only hope thousands of men may have to a

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Wick, Richard Date: 04/29/2011
Comment:
[PHI Redacted] I strongly support Provenge as a treatment for prolonging the lives of prostate cancer patients. I have closely followed, for quite some time, the endless delays and rigorous testing by the FDA and other government bodies. Now, with FDA approval, I implore you to complete the process please provide men suffering from prostate cancer to have this therapeutic option without severe financial concern. Medicare coverage will make it available to all those who need

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Saphire-Bernstein, Inger Title: Manaager of Regulation
Organization: American Urological Association
Date: 04/29/2011
Comment:

AUA Comment on Proposed Decision Memo on Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer

The American Urological Association (AUA), which represents 90 percent of the practicing urologists in the U.S, is pleased to comment on the Proposed Decision Memo on autologous cellular immunotherapy treatment of metastatic prostate cancer. The long-standing mission of the AUA is to promote the highest standards of clinical urological care through education,

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Frawley, Leo Date: 04/29/2011
Comment:
If one has hormone independent PCa there is little in the oncologists medical bag of tricks to extend life for any period of time. There are many hopeful options outside our boarders if one can afford them. [PHI Redacted]
Dennison, Robert Date: 04/29/2011
Comment:
I strongly urge that CMS approve ACI for treatment of metastatic prostate cancer. [PHI Redacted] CMS must recognize the role of its approval in the private insurance industry as well. CMS should approve ACI thereby opening the door to millions of prostate cancer survivors who can benefit when few other options exist.
Reilly, John Date: 04/29/2011
Comment:
Provenge will extend my life six months.I am 71 yrs. old.I support Provenge 100%. Thank You.
Dillon, Tom Date: 04/29/2011
Comment:
[PHI Redacted] I fully support your proposed policy recommendation regarding the availability of Provenge via Medicare for those metastatic patients whose lives could be extended by its use.
Green, Robin Date: 04/29/2011
Comment:
I support the proposal for Medicare to have access to Provenge.
Recktenwalt, Thomas Date: 04/29/2011
Comment:
[PHI Redacted] I urge you to approve it as a Medicare treatment. Thank You!
Askier, Paul Title: Steering committee member
Organization: Man to Man Warriors
Date: 04/29/2011
Comment:
The progress made in immunotherapy is the most exciting advance in the treatment of prostate cancer. Developing antibodies from our own blood is the natural way our bodies work to heal. [PHI Redacted]
Speer, David Date: 04/29/2011
Comment:
[PHI Redacted] It has now become hormone independent and this treatment is one of the few that holds promise for continued life. [PHI Redacted] Having this treatment covered by Medicare would further encourage insurance companies to include it in approved options.
Thompson, Robert J. Title: Mr.
Organization: N/A
Date: 04/29/2011
Comment:

I am shocked by the apparent acceptance of Provenge to reportedly delaydeath of Pca patients for about four months. This at a cost of $90,000. I belive that there should be a body of people (doctors) that can deny treatment payments from Medicare for this type expense.I understand that Medicare can not deny such payments.Too bad that Dendreon has invested Billions. I believe we as a nation must get real about making these sort of medical/health decisions. I do not think that in this case

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Kaighin, Karen Date: 04/29/2011
Comment:
Please support Medicare access to Provenge!
Scholz, Mark Title: Mark Scholz, MD
Organization: Prostate Oncology Specialists
Date: 04/29/2011
Comment:

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Blvd.
Baltimore, MD 21244
Re:Response to Draft National Coverage Decision for sipuleucel-T

Dear Dr. Jacques,

Our medical group, Prostate Oncology Specialists in Marina del Rey, CA, strongly supports the recently published National Coverage Determination for sipuleucel-T which concluded that sipuleucel-T is

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Berg, Sharon Title: Retired Federal Attorney
Date: 04/29/2011
Comment:
CMS should finalize its proposed coverage of sipuleucel-T ("Provenge") to follow the FDA label. As I am not a medical professional, I also urge the CMS to give full consideration to the proposals outlined by Drs. Higano et al., to provide more clarity to the treatment population. I also applaud CMS' proposal to permit local Medicare contractors to cover Provenge as evidence of its utility and efficacy for earlier stage prostate cancer is collected. On a separate note, I remain astonished at

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Meek, Clinton Organization: Us Too
Date: 04/29/2011
Comment:
Please support access to FDA approved cancer treatments, such as Provenge, for men fighting advanced prostate cancer.
Smith, Gary Date: 04/29/2011
Comment:
The fight against Prostate Cancer deserves every opportunity and advantae available. The use of Autologous Cellular Immunotherapy must be approved.
mok, Kent Title: Concerned Citizen
Date: 04/29/2011
Comment:
After reading some recent comments by practicing urologists and oncologists I found that some CMS local contractors are using clinical trial enrollment criteria to set up hurdles to deny access to Provenge from eligible late stage prostate cancer patients even if they meet FDA approved on label specifications. Please correct this mistake in your final decision. Thank you very much for your diligent work.
Raper, Andy Date: 04/29/2011
Comment:
[PHI Redacted] I support Provenge as a reasonable and necessary treatment for patients who have asymptomatic or minimally systematic castrate-resistant disease and are on Medicare.
Medical Decision Making, Foundation for Informed Organization: Foundation for Informed Medical Decision Making
Date: 04/29/2011
Comment:
Given that FDA has approved Provenge, it is appropriate that CMS approve payment for its use in patients for whom there is clear evidence of benefit. However, we would urge CMS to develop clear, unbiased patient information to accurately present the benefits and downsides of Provenge and to ensure that patients review that information with their clinicians before they receive the therapy. Patients have an absolute right to have a fully transparent and balanced understanding of the benefits

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barnosky, joyce Date: 04/29/2011
Comment:
I support Medicare coverage of Provenge both for on and off label.
hearne, laura Date: 04/29/2011
Comment:
FDA must support immunotherapies as an alternate to the treatment of all cancers. Chemical treatments offered by our pharmacutical industry for the last 50 years have proven to be both harmful and ineffective. Creating great income streams for the industy and little relief or improvement in the quality of life for cancer patients. We all know the definition of insanity- doing the same thing over and over and expecting a different outcome. Lets get some new offerings in the pipeline and offer

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Cornick, Michael Date: 04/29/2011
Comment:
[PHI Redacted] The combination of the two resulted in a PSA decline of over 99%. Thus, I strongly support Provenge.
Hillman, Philip Organization: PHEN
Date: 04/29/2011
Comment:

I support CMS assessment that the evidence is sufficient to conclude that the use of autologous cellular immunotherapy treatment improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.

I also recommend that the FDA take the necessary steps to insure access to Provenge for the men in need.

Fiore, Roy Title: Resource Coordinator
Organization: Scranton Counselling Center
Date: 04/29/2011
Comment:
Due to the lack of side effects, it works while you are sleeping, it does not ravage and destroy your body, CMS should cover and pay. In the long run it will cost less than chemo and restore lives.
Waterhouse, Robert Date: 04/29/2011
Comment:
I support the proposed final determination for use of Provenge for metastatic prostate cancer patients
Womack, Jerry Organization: PHEN (Prostate Health Education Network)
Date: 04/29/2011
Comment:
I strongly support The Centers for Medicare and Medicaid Services (CMS) draft determination.Some of the most needy clients are those eligible for Medicare and not having access to it would thus prove unfairness.
I recommend that the final national coverage determination removes any ambiguity between the clinical trial enrollment criteria and the FDA approved label to insure access to Provenge for the men in need.
Nebeker, David Date: 04/28/2011
Comment:
I concur and hope those in power will consider that someday they too will meet their maker and not do the bidding of BIG PHARMA. I've met the wife of a major company in America. Dreadful woman, very accustomed to have whatever she wants and quickly. [PHI Redacted] Regards.
Gould, Russell Organization: Wellness Place
Date: 04/28/2011
Comment:
The Centers for Medicare and Medicaid Services (CMS) proposes that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication under 1862(a)(1)(A) of the Social Security Act (the Act). I am the leader of four

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Ross, Duncan Title: Private Citizen
Date: 04/28/2011
Comment:

I fully support coverage of Provenge and other similar therapies for men with advanced disease.

Thank you

Duncan R. Ross

Spooner, James Date: 04/28/2011
Comment:
I think $90,000 for an additional 4 months of pain is an absurdity. Even without pain it would be the same. [PHI Redacted] Put your time and money into anti-angiogenesis.
Johnson, Kurt Date: 04/28/2011
Comment:
I support the coverage of Provenge and other similar Autologous Cellular Immunotherapies in treatment of metastatic prostate cancer. I understand the high cost is a concern, but only through use of treatments like this can we advance the state of current and new treatments of this deadly disease.
Bocchino, Carmella Title: EVP, Clinical Affairs and Strategic Planning
Organization: America's Health Insurance Plans (AHIP)
Date: 04/28/2011
Comment:

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Jacques:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) national coverage decision memo (NCD) for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer CAG-00422N).

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COON, NANETTE Date: 04/28/2011
Comment:

LETS GET PROVENGE FROM DENDREON GOING , LETS SAVE LIVES AND OPEN THE DOOR TO THE 21ST CENTURY OF HEALTH CARE . LOOKING FORWARD TO A NEW ERA . NANETTE COON

dyson, doris Date: 04/28/2011
Comment:

I am emailing in support of the preliminary ruling to support the proposed final determination for national coverage of Provenge as stated by CMS above. Please support people who are suffering from this disease.

Hutchins, Bill Date: 04/28/2011
Comment:

When compared to long term treatments (for those who have survived several years of Prostate cancer treatment, or those who likely will) Provenge will probably be an even more cost effective treatment.
I am hoping for this new possible alternative to a longer and better life.

Pugh, David Date: 04/28/2011
Comment:

I want to thank CMS for proposing a very reasonable on-label coverage category. The added caveat for leaving off-label coverage up to contractors was very welcome as well. I hope CMS will stick firmly to those proposals.

For anyone who has looked at Provenge closely, the larger beneficial prospects for treatment will come if, and I expect it will, when the evidence accumulates supporting Dr. Dan George's contention that the actual survival benefit for the 'tested' population

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Spear, USAF, Ret., Gen.and Mrs. Richard B Date: 04/28/2011
Comment:

My husband and I feel that Dendreon is the very best choice for Prostate Cancer available to the American people at this time, and pray it will be available as soon as is possible. Their product is a blessing to All men in need of this great new procedure. To be almost painless at the end of one's life, is a God-Given Gift that will be accepted with thanks. To be able to share more months and even more years with one's family is priceless.

Please provide the finacial needs for all,

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Kienow, Paul Date: 04/28/2011
Comment:
At this time there is very little hope for the prostate cancer patient once the cancer is able to grow without testosterone. I have watched several men die of prostate cancer once the cancer becomes hormone refractive, or grows in the absence of testosterone. This treatment seems to offer some hope that this need no longer be the case for hormone refractive prostate cancer. Please approve this for Medicare coverage.
Canty, Jim Title: retried
Organization: retired
Date: 04/28/2011
Comment:

I hope that CMS finalizes its NCA decision along the lines of the draft decision as soon after the comment period ends as possible.

Provenge gives hope to thousands of men that their lives may be extended without the misery of chemotherapy.

Fouts, David Date: 04/28/2011
Comment:
I feel that the use of Provenge for men that need to use it for there Prostate Cancer. Should be allowed to use it if they are on Medicare, or Medicaid. If Provenge stops or slows down the progression of Prostate Cancer. Why should men be penalized for being on these programs.
Thank you for your time.
David Fouts
Mok, Tiffany Date: 04/28/2011
Comment:
I endorse whole heartedly the suggestions by Dr.Higano and Dr. Frohlich to make the final decision clarify that local contractors are not to use trial criteria as barriers to qualified patients getting Provenge if they meet the FDA approved label. Thank you
Bogin, Ronald Date: 04/28/2011
Comment:
[PHI Redacted] I urge that Provenge be approved for all those covered by Medicare who would benefit from it.
Mak, Roti Date: 04/28/2011
Comment:
I would like to add that I strongly support the suggestion by Malecare Cancer Support,a non-profit group, who urged CMS to remove any 'ambiguity' between the clinical trial enrollment ctiteria and the FDA approved label to ensure access to Provenge. Thank you for your consideration and your hard work.
Marc-Aurele, Larry Date: 04/28/2011
Comment:
The most important thing that can be done against PC is to make Provenge available to ALL PC patients as a first-line treatment. Requiring men to give up testosterone or undergo life-altering surgery as a prerequisite defeats the potential of Provenge. Right now it is only given to men least likely to benefit from it. [PHI Redacted] Give these ideas some press. This is a travesty that needs to be rectified. Give Provenge to PC patients to PREVENT the illness from becoming

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Johnson, Kevin Title: Sr. Vice Pres., Government Relations & Advocacy
Organization: ZERO - The Project to End Prostate Cancer
Date: 04/28/2011
Comment:

As a leading national patient advocate organization for men in the United States, ZERO supports the proposed decision by CMS regarding coverage of autologous cellular immunotherapy treatment of metastatic prostate cancer.

We are encouraged by this decision as it represents an entirely new way of treating diseases in general, and cancer specifically. Not only will this new treatment represent hope for prostate cancer patients who have run out of options, but it will usher in a new

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Cainski, Nick Title: Mr.
Organization: FCWRD
Date: 04/28/2011
Comment:
Please continue providing coverage for Provenge, the FDA approved immunotherapy for prostate cancer. It is a non toxic, non invasive FDA approved treatment, safer and more effective than anything that has been previously approved.
Please provide coverage whenever a Doctor orders Provenge because it is necessary and lifesaving.
Thankyou
Brewster, John Organization: Telcordia
Date: 04/28/2011
Comment:
Your draft version was very well reasoned and a great starting point for late stage prostate cancer patients. Expect much greater benefit for patients who receive Provenge earlier in their disease progression but that is not yet proven. This therapy will potentially make prostate cancer a chronic condition instead of a death sentence because it can reduce the metasticies that kill the patients. Please let it go forward in the FDA approved indications so that all current and future PCA patients

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Lupton, Frank Date: 04/28/2011
Comment:
It is good news to know that Provenge is being considered for approval for Medicare coverage for persons[PHI Redacted] Please support it in every way possible. THANK YOU!
Mak, Roti Date: 04/28/2011
Comment:
This is a follow up comment. I strongly support the suggestion by Malecare Cancer Support, a non-profit group, who urged CMS to remove any 'ambiguity' between the clinical trial enrollment criteria and the FDA approved label to ensure access to Provenge. Your consideration is greatly appreciated.
McPhearson, Melvin M. Title: Support Group Facilittor
Organization: Man to Man / UsToo Support and Education Group
Date: 04/28/2011
Comment:
The importance and necessity of treating those on a fixed income is vitally important to the individuals, their families and to soceity as a whole. We have a humanitrian commitment to the elderly and to those who are less fortunate.
Bylander, Ernest Date: 04/28/2011
Comment:
I guess that Provenge is said to work only for 1/3 of the prostate cancer patients. And then for only 3 months. I talked to a former researcher from Dendreon who had little faith in the vaccine. Also at the DoD conference just held I talked to one of the session chairs who wondered about the NE Jour. of Med. article where the PSA continued to increase for patients said to have CaP in remission from the vaccine.
Matthews, Fred Date: 04/28/2011
Comment:
I very much support the CMS position to allow Provenge to be used in treating certain types of prostate cancer.
Nyhus, Douglas Date: 04/28/2011
Comment:
FDA - Approved prostate cancer treatments such as Provenge should be covered by Medicare and insurers. Prostate cancer patients deserve access to the most up to date treatment options.
Essex, Wayne Date: 04/28/2011
Comment:
Provenge is an important medication fpr the treatment of advanced prostate cancer. I hope it is approved fro Medicare patients.
Harvey, Robert Title: Co-Chairman
Organization: Us Too Group at Hackensack University Medical Center
Date: 04/28/2011
Comment:

I completely agree with the CMS proposed decision memo stating Provenge is reasonable and necessary for patients who have asympotomatic or minimally systematic castrate-resistant disease and are on Medicare.

Robert Harvey, Ph.D.
CHENG, ROBERT Date: 04/28/2011
Comment:
I strongly support the comments by Drs. Kantoff, ... and Small. These are the doctors who are most knowledgeable about Provenge and prostate cancers. Please adopt their suggestions.
Dantonio, Joanne Date: 04/28/2011
Comment:
I urge approval of Provenge thruogh the medicate system. It has shown to be critical in effective treatment of prostate cancer.
Johnson, H Mark Date: 04/28/2011
Comment:
[PHI Redacted] I am very much in favor of your support of the use of Provenge for advanced cancer. Thanks you for considering this treatment positively.
Wong, Willie Date: 04/28/2011
Comment:
This is my second post to show my 100% support for the excellent proposals advocated by doctors Higano, Kantoff, Petrylak, Schellhammer, and Small. Ladies and gentlemen please, please adopt their specifications to avoid any further confusion by local contractors in order to save as many loves as possible and extend their quality of living for those who are eligible and supported by earlier FDA approval. Thank you again for the hard work done.
Stokes, Rembert Organization: Roosevelt ICL
Date: 04/28/2011
Comment:
I would like to know from Provenge how many treatments would be required to cut the cost in half and then in half again.
Boyd, Donald Title: none
Organization: none
Date: 04/28/2011
Comment:
I think provenge should be approve by medicare. I know that given a choice I would treat prostate cancer with provenge rather than chemothearpy. The quality of life would be so much better. I also hope that cms would approve provenge for earlier use. Earlier use could show that our body could fight the cancer thus preventing other parts of our body being harmed by other treatments.
Mok, Kent Date: 04/28/2011
Comment:
I fully support CMS draft memo that Provenge is a reasonable and necessary treatment. I pray that you folks will maintain as such in your final decision. Thank you.
Massimino, Joseph Date: 04/28/2011
Comment:
Provenge should be made available, and readily accessible to those who are in need, and who's medical condition is justified. If a remedial solution is available for those who have tried other modalities, that have not worked, and a tried and tested solution is available, why not make this available?
Porter, Gary Date: 04/28/2011
Comment:
How can anyone justify the cost/benefit of this treatment. It will place an extreme burden on Medicare to pay for it. To extend ones life by a couple of months at the end of ones life is not the kind of QOL I wish to have.
Marcus, Jack David Title: Chapter Leader
Organization: US TOO New York
Date: 04/28/2011
Comment:
[PHI Redacted] I unequivocally support the proposed final determination for national coverage of Provenge as stated by CMS.
frankenberger, casey Date: 04/28/2011
Comment:
I support Medicare coverage of Provenge to treat prostate cancer and I endorse making the final decision clarify that local contractors are not to use trial criteria as barriers to men getting Provenge if they meet the FDA approved label.
Concepcion, M.D., F.A.C.S., Raoul Organization: Large Urology Group Practice Association (LUGPA)
Date: 04/28/2011
Comment:

Dr. Donald Berwick
Administrator
Centers for Medicare & Medicaid Services
Mail Stop 314G? 200 Independence Ave. S.W.?
Washington, D.C. 20201?
Donald.Berwick@CMS.hhs.gov

Dear Dr. Berwick:

The Large Urology Group Practice Association (LUGPA) was established in order to provide urologists practicing within large groups the best methodology to access resources, technology and management tools that will provide the best possible care for our

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Hine, William Title: just a regular guy
Organization: in a regular life
Date: 04/28/2011
Comment:
I write this in support of Provenge I am not here to complain about its cost, but rather to acknowledge its groundbreaking technology for treating men with this specific form of prostate cancer. Am I a medical expert...NO. Am I professional in the field of medicine...no. Do I have a bunch of initials after my name that apparently mean something to someone somewhere. NO Who am I? I am a small time investor in Dendreon with about as much a monetary investment as some of these experts who have

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vogt, Betty Title: Reistered Nurse
Organization: Winnipeg Health Science
Date: 04/28/2011
Comment:
I agree with the suggestion by Drs Kantoff and Frohlich to make the final decision clarify that local contractors are not to use trial criteria as barriers to men getting Provenge if they meet the FDA approved label. Thank-you. Betty Vogt
Whittaker, Thomas Organization: Association of Community Cancer Centers
Date: 04/28/2011
Comment:

April 28, 2011

BY ELECTRONIC DELIVERY

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Medicare Drug & Health Plan Contract Administration Group
Centers for Medicare & Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)

Dear Dr.

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dodge, corinne Date: 04/28/2011
Comment:
I endorse the suggestion by Drs. Kantoff and Frohlich
Kerpelman, Saul Date: 04/28/2011
Comment:
I am writing this brief addendum to my prior comments to add this--I endorse the suggestion by Dr. Frohlich and Dr. Kantoff that the final decision by CMS remove any ambiguity regarding using trial criteria as barriers to providing Provenge to men who need it. If local contractors are requiring that men meet trial criteria beyond the FDA approved label, this is certainly inappropriate and should be stopped by CMS.
Hunter, Donald Date: 04/28/2011
Comment:

Thank you for your initial response regarding approval of Provenge for on label and off label use when determined ,by physicians, to be reasonable and necessary.

As the father of three sons, and a family prone to having prostate cancer, I implore you to grant final approval for both on label and off label use of Provenge.

Bennett, Charles Date: 04/28/2011
Comment:
Provenge should be supported by the CMS and our government as it has been shown to improve life-expectancy and quality of life.
Wong, Benny Date: 04/28/2011
Comment:
I want to add another comment. I strongly urge CMS to ensure that local Medicare contractors do not add any additionalbarriers to access Provenge for eligible patients approved by FDA for on-label use. Thank you.
Kennedy, Mark Date: 04/28/2011
Comment:

Comment to CMS on Provenge National Coverage Determination:

This therapy is a critically important milestone in the treatment of prostate cancer for all men. It is especially important to the many men at high risk, many of whom are typically diagnosed at late stages of the disease.

The positive impact on survivability will be immeasurable. As such, I support the CMS current determination with regard to Provenge, and strongly urge CMS to make Provenge available to

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Risch, Alan Title: Pharmacist
Date: 04/28/2011
Comment:

I would strongly recommend that CMS approve Provenge for it's FDA approved use in prostate cancer. Not only is this drug a breakthrough treatment for this indication,but with it's limited side effects represents a new benign way to treat cancer.

This new treatment represents the best of American Science and demonstrates why people all over the world come here for treatment and look to us for breakthrough medicines. History will record all those individuals that enable this

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Kirk, Thomas Title: President & CEO
Organization: Us TOO International PCESN
Date: 04/28/2011
Comment:

Frankly, many of us were concerned and fearful this day would not come. It is with excitement that I add my voice and express my support for the CMS proposed decision that states Provenge improves health outcomes for men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer and is reasonable and necessary.

Many of us from Us TOO as well as numerous others attended and shared our comments at the MEDCAC meeting. In addition, nearly 4,000 people

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Mueller, Joan Organization: California Prostate Cancer Coalition
Date: 04/28/2011
Comment:
I support the funding for Provenge. [PHI Redacted] died from prostate cancer almost 9 years ago and would have met the criteria for treatment with Provenge. I'm only sorry it wasn't available for him and can only hope that it will be available for others. Thank you.
Scott, Congressman David Title: Member of Congress
Date: 04/28/2011
Comment:

Dear Doctor Berwick,

As a Representative of the state of Georgia, I would like to congratulate CMS on their recent decision to support patients of advanced prostate cancer by covering Provenge. Since my days as a state senator, I've been committed to making sure that citizens in the state of Georgia have proper access to lifesaving cancer medications and Provenge represents the forefront of new personalized medications that will dominate the rest of the century and change the way

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Craig, Charles Title: President
Organization: Georgia Bio
Date: 04/28/2011
Comment:
Georgia Bio promotes patient access to innovative life-saving therapies created by bioscience companies, such as Dendreon. I encourage the CMS to support use of Dendreon’s immunotherapy treatment as approved by the FDA and directed by the FDA label; and urge CMS not to restrict any patient access.
Bell, Dale Date: 04/28/2011
Comment:
I strongly support "The Centers for Medicare and Medicaid Services (CMS) proposes that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication under 1862(a)(1)(A) of the Social Security Act (the Act).

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Mitteldorf, LCSW, Darryl Title: Executive Director
Organization: Malecare Cancer Support
Date: 04/28/2011
Comment:
Malecare Cancer Support is the largest volunteer prostate cancer support and advocacy national nonprofit in the United States. Our program for men diagnosed with late stage or advanced prostate cancer helps thousands of men and their families.
In support of these men, I endorse The Centers for Medicare and Medicaid Services (CMS) draft determination that the evidence is adequate to conclude that PROVENGE improves health outcomes. It seems appropriate that the final national coverage

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callion, w Date: 04/28/2011
Comment:

this treatement needs to be approved ASAP by CMS!!

Save lives!!

Graff, Joyce Title: Executive Director
Organization: VHL Family Alliance
Date: 04/28/2011
Comment:

I strongly support The Centers for Medicare and Medicaid Services (CMS) draft determination that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication under 1862(a)(1)(A) of the Social Security Act

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Todd, Laurel L. Title: Managing Director, Reimbursement and Health Policy
Organization: Biotechnology Industry Organization
Date: 04/27/2011
Comment:

April 28, 2011

BY ELECTRONIC DELIVERY

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)

Dear Dr. Jacques:

The Biotechnology Industry Organization (BIO) appreciates this

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Seldeen, William Title: Attorney
Organization: None
Date: 04/27/2011
Comment:
I agree with the determination that Sipuleucel-T is reasonable and necessary for patients on the FDA label, and support the decision to give the MACs coverage discretion for off-label use, which is not currently supported by clinical evidence. This is a ground-breaking, life-saving improvement in the treatment of metastatic prostate cancer, and should available to all patients who will benefit.
singh, Bhupinder Date: 04/27/2011
Comment:

Please approve Provenge. This is way overdue.

Thanks

Hardenbrook, Gary Date: 04/27/2011
Comment:
[PHI Redacted] I urge a favorable action regarding coverage of this life-saving medication.
Blumberg, Joseph Title: Executive Director
Organization: Men's Health and Wellness Center
Date: 04/27/2011
Comment:
[PHI Redacted] I have become increasingly aware of the options, especially for men who are refractory and suffering the serious consequences of this disease in it's more advanced stages. A treatment like Provenge offers us the chance to live longer with a better quality of life. To deny men this option would be a travesty. We suffer the same statistics as women with breast cancer, yet there are never enough research dollars for our cause...the cause of men's health. We are

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Dreyer-Goldman, Erik Date: 04/26/2011
Comment:
Provenge is a prove and effective treatment for late stage metastatic prostate cancer. Continued R &D of this treatment by Dendreon represents a positive push to help men throughout the USA and ultimately the world. National coverage would allow this treatment to become available to many who might not otherwise have the resources available to pay for the treatment in its entirety. I strongly urge CMS for approval.
Jacques, David Title: Engineer
Date: 04/26/2011
Comment:
I have witnessed [PHI Redacted] in their battles with prostate cancer. All three have experienced significant negative quality of life issues due to current cancer treatments. Sadly, one of them is no longer with us. [PHI Redacted] Provenge is the most effective treatment ever discovered for on label use. However, beyond its effectiveness and efficacy, the most beneficial feature is its minimal side effect profile. Provenge provides the best quality of life

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Wong, Cindy Date: 04/26/2011
Comment:
This is a follow up post. I strongly support the adoption of standards proposed by Drs.Higano,Kantoff,Petrylak,Schellhammer and Small. These reasonable and sensible proposals should be valued highly by CMS. THANK YOU.
Wilson, Charlotte Date: 04/26/2011
Comment:
I am writing in support of CMS's coverage of provenge for the treatment of late stage prostate cancer. Provenge represents a new paradigm in fighting cancer and must be supported if the "war on cancer" is to be taken seriously. The cost is on par with or cheaper than toxic chemo. Keep the door open for early stage prostate cancer patients too. Thank you!
Man, Joseph Date: 04/26/2011
Comment:
Excellent comments on 4-25-11 by Dr. Shore of Atlantic Urology Clinics with first hand experience and observations of administering Provenge to late stage prostate cancer patients. I strongly urge you ladies and gentlemen of CMS to pay special attention to this moving article and carry out his suggestions in your June decision. Thank you for your consideration.
Corman, Stephen Title: Mr.
Organization: National Alliance of State Prostate Cancer Coaltions
Date: 04/26/2011
Comment:
[PHI Redacted] I urge CMS to approve national coverage for this treatment. [PHI Redacted] I would like to see any and all barriers removed. I run a prostate cancer support group and many of my patients have been looking forward to full approval for a long time now. Once somebody is eligible for this treatment, there is no place else to turn.
Li, Sally Date: 04/26/2011
Comment:
I felt there is a need to commend the marvelous work by Dr.Petrylak and his colleagues on 4-22-11. I thank you the fact based hard work your staff has done and I wish your agency would weigh heavily on their opinion.
McCraw, Fred Title: Retired Telecommunications Executive
Organization: United Telecommunications/ Sprint
Date: 04/26/2011
Comment:
I intended to provide a history of the Prostate Cancer death of a friend by taxotere. [PHI Redacted] Because of FDA Denial of Provenge in May 2007, my friend sought access to this life-extending treatment through a Phase III Clinical Trial known as "IMPACT." Sadly, he was randomized to the Placebo Arm of the Trial and, in the end, was never able to receive even the cross-over "salvage Provenge" that could have added additional quality time and longevity to his highly

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Ellingson, Jean Date: 04/26/2011
Comment:

At some point CMS, as will all of us, will have to face the question: When is the cost of a treatment, for what small benefit it provides, not worth the price we will have to pay in the form of cuts to other more beneficial services or loss of coverage entirely? If not $100,000 for four months of additional survival, will it be at $1,000,000 for one month? $100,000 will pay for the medical costs of Medicaid benefits for about 24 Minnesotans for a year. Even more concerning will be the

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McNeil, Ryan Date: 04/26/2011
Comment:
I would like to add my support for coverage of Provenge in treating prostate cancer. Prostate cancer has struck my family and it is clear that we need better treatments to fight this horrible disease. I would also support giving Provenge earlier in the treatment cycle.
SCOTT, JOHN J. Title: Mr.
Organization: none
Date: 04/26/2011
Comment:
I again applaud you for your preliminary approval to grants coverage of PROVENGE. You are aware of the importance to keep open promising lines of investigation and treatment of various types of cancer. The platform used by DENDREON shows promise of extending treatment into other areas of the disease, specifically bladder cancer. Further, it seems probable that use of PROVENGE in earlier stages of prostate cancer may prove highly efficacious.
Curry Hill, Claudia Title: Operations Director
Organization: Prostate Conditions Education Council
Date: 04/26/2011
Comment:
I applaud the draft determination finding that the evidence is adequate to conclude that the use of sipuleucel-T improves health outcomes for men with asymptomatic or minimally symptomatic prostate cancer. I further recommend that the final national coverage determination removes any limitations between the clinical trial enrollment criteria and the FDA approved label to insure access to Provenge for all the men who could benefit from it.
Hayward, Fredric Date: 04/26/2011
Comment:
I think this coverage should be added. It is clear to me that, if anything comparable, were being considered for breast cancer, it would be covered, and men deserve no less for prostate cancer. Thank you.
Williams, Larry Date: 04/26/2011
Comment:
I am writing to thank you for your determination to allow Medicare to cover Provenge as a treatment for advanced Prostate Cancer. I have a history of prostate cancer in my family and know that the current treatment for the advanced stages of prostate cancer (chemo) is a horrible choice to have to make. I have seen chemo save [PHI Redacted] life for a short time, only to ravage him in his dying days. I can assure you, the amount of hospitalization [PHI

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Kilbourn, Max Organization: C & M ENTERPRISES
Date: 04/26/2011
Comment:
This information needs to go out!
thomas, r. Date: 04/26/2011
Comment:
The sick people with problems that Dendreon's Provenge has been proven to help desperatly need this medicine. Please continue the approval process. Thank you
jacobson, Joel Date: 04/26/2011
Comment:
I'm a [PHI Redacted] old born in the USA & have been here all my life. Having grown up & lived here, I can't even imagine men of this country being denied insurance coverage enabling them to avail themselves of this FDA approved drug for a killer cancer. It is beyond my ability to comprehend. This fantastic treatment has been proven in the sickest of men to be more efficacious & substantially less toxic than any alternative. The only FDA approved alternative is so

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Eaker, Seth Date: 04/26/2011
Comment:
Provenge is a proven, effective treatment for late stage metastatic prostate cancer. Further, the continued research and development of this treatment by Dendreon represents a positive push to help men throughout the USA and ultimately the world. National coverage would allow this treatment to become available to many who might not otherwise have the resources available to pay for the treatment in its entirety. As someone who has known many men with prostate cancer and its incredibly

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Gordon, Dinah Date: 04/25/2011
Comment:
Please support the coverage of Provenge via Medicare and help change the world. Life is too short as it is; please give new meaning and hope to thousands!!
Mittman, Samuel Date: 04/25/2011
Comment:
[PHI Redacted] When science providees a new treatment, to deny payment for that treatment amounts to a death sentense for many men. Please seriously consider this matter as it is life and death for many of us.
Kiser, Dale Date: 04/25/2011
Comment:
I am pleased that CMS will provide for access to Provenge. I only ask that CMS institute controls that prevent outrageous pricing by the manufacturer as has been done by Pfizer with Lipitor and KV Pharaceutical with Makena. Zostavax (shingles vaccine) is another example of a drug that has been priced too high in addition to being placed in a high tier.
Frohlich, MD, Mark W. Title: Chief Medical Officer
Organization: Dendreon Corporation
Date: 04/25/2011
Comment:

April 25, 2011

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

Re: Comments on Proposed Decision Memo for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)

Dear Dr. Jacques,

On behalf of Dendreon Corporation (Dendreon), I applaud the Centers for Medicare & Medicaid

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Crosby, Barbara Date: 04/25/2011
Comment:
I'm a member of WAPC and feel very strong about this new treatment. Men of color are dying young because the lack of adequate treatment or treatment received too late. [PHI Redacted] is a survivor because of early intervention. Lost a friend at the age of 47 to prostate cancer.
maloney, daniel Date: 04/25/2011
Comment:
Thank you once again for the diligence you have undertaken on behalf of prostate cancer sufferers. Your thoroughness and efficient handling, and subsequent recommendation for approval of Provenge, is a very positive social, medical, and economically sound decision
Man, Maggie Date: 04/25/2011
Comment:
Really appreciate your hard work and come to the conclusion that Provenge is a reasonable and necessary treatment for late stage prostate cancer. Keep up the good work for June. Thanks a lot.
Wong, Willie Date: 04/25/2011
Comment:
I am so happy when CMS announced initial on-label coverage for late stage prostate cancer patients have been waiting for a humane and non invasive treatment.
Please keep this to be your final decision and thank you again.
wilton, daniel Title: Esq.
Organization: Law Office
Date: 04/25/2011
Comment:
Thanks for the opportunity to make this comment.[PHI Redacted] However, I do have a family member and several friends recently diagnosed with PC. And it is with these folks in mind that I urge the Center for Medicare/Medicaid Services to finally lift the ambiguity that veils and hinders the adoption and availability of the Provenge treatment protocol. I have for too, too long followed the development and approval process of Provenge and need, like the public at large to at

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Hiley, Howard Date: 04/25/2011
Comment:
I support the decision by CMS to provide coverage for Provenge. I also believe that this treatment is reasonable, necessary, and hope that it represents the leading edge of more personalized medicines.
Vogt, Elizabeth Title: Registered Nurse
Date: 04/25/2011
Comment:
I strongly support a positive recommendation for CMS to provide medicare coverage for provenge, a prostate cancer immunotherapy. The other alternative of chemo therapy which has been used for years, has so many more side effects and is much more costly when you tally up the chemo, the medication and the treament for the side effects, not withstanding the lack of quality of life. Please allow prostate cancer patients to have an alternate choice when dealing with this dreadful disease of

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Shore,MD,FACS,CPI, Neal Title: Medical Directoe/Managing Partner
Organization: Atlantic Urology Clinics
Date: 04/25/2011
Comment:

Dr. Donald Berwick
Administrator
Centers for Medicare & Medicaid Services
Mail Stop 314G?
200 Independence Ave. SW
Washington, DC 20201?
Donald.Berwick@CMS.hhs.gov

Dear Dr. Berwick,

I want to express my earnest belief and support for CMS’ draft memo which endorses full on-label coverage of the therapy known as Provenge, noting that this novel biologic is assuredly “reasonable and necessary” for men with advanced prostate cancer.

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S, V Date: 04/25/2011
Comment:
Cellular Immunotherapy Treatment of Metastatic Prostate Cancer, also known as "Provenge".....I can't believe we are still WAITing for, yet another Gov Agency, to move at a snails pace on ok'ing the BEST Treatment ever for Patients in such a desparate condition......the FDA set-back other ACI treatment going on 4 years already. A mulitude has died waiting for their hope. Approve Payment of Provenge Candidates ! It needs to be given as early as possible, to work its best. Provenge will keep our

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Sarandan, Sandra Date: 04/25/2011
Comment:
It is imperative that Provenge be approved for this disabling and potentially fatal stage of prostate cancer without further restrictions. It is the only therapy that shows improved quality and length of life for men with this diagnosis. Prostate cancer also affects those who love and care for these men and can lessen the stress associated with this care.
Hallin, George Title: Retired
Date: 04/25/2011
Comment:
I strongly support a positive recommendation for CMS to provide Medicare coverage for Provenge a prostate cancer immunotherapy. [PHI Redacted] died of prostate cancer as well as [PHI Redacted]. [PHI Redacted] has been sucessfully treated for prostate cancer but we live in constant fear that it may return. You can see why my family is so supportive of Provenge. I have been following the Provenge story since January of 2004 and strongly believe

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Dixon, E James Date: 04/25/2011
Comment:
It is imperative that provenge be universally available to the victims of advanced prostate cancer. More than 28,000 lives are lost to this disease in the US every year, and the premature loss of these men far exceeds the cost of treatment with provenge.
Keyes,Jr, Jerome Title: Retired
Organization: Duke '57 Alumnae Association
Date: 04/25/2011
Comment:
I just lost [PHI Redacted] to prostate cancer. Two other close friends have been diagnosed with PC. With CMS concurrence, these two men may benefit from Provenge. The three of us and many more are counting on you to help them combat PC.
Gunn, Ido.a Date: 04/25/2011
Comment:
I support the efforts to bring this drug to Prostate Cancer Patients. [PHI Redacted] the thought of any drug or therapy that could extend the life or quality of life of an individual suffering from Prostate Cancer should be investigates. Thank You. Idola Gunn
Hoff, Bert Title: President
Organization: MenWeb
Date: 04/25/2011
Comment:
I am delighted that you are taking this step, for treating prostate cancer. It will help a lot of men ... and the women who love them.
Lebowitz, Wendy Title: Dr. Wendy A. Lebowitz
Organization: Malecare.org, Women Against Prostate Cancer, Interfaith Med. Ctr
Date: 04/25/2011
Comment:
Comment to CMS on Provenge National Coverage Determination: I am a hospital based clinical psychologist; I also work as a volunteer with cancer patients and their families. [PHI Redacted] On his behalf, on mine, on behalf of the nonprofits working so hard on supportive, educative and advocacy activities, including Malecare and Women Against Prostate Cancer, I strongly support CMS’ draft determination that the evidence is adequate to conclude that the use of autologous

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Brinkerhoff, Jim Date: 04/25/2011
Comment:
I have not had prostate cancer, but many of my friends have.
It's devastating.
This immunotherapy should be available.
AJB
Barnett, Barry Title: Coordinator of Federal Programs
Organization: MA Dept. of Elementary and Secondary Education
Date: 04/25/2011
Comment:
I support the inclusion of Provenge to covered treatment protocols. The prevalance of prostate cancer, and the limited number of exisitng options for treatment make the expansion of choices for affected men critical.
Wright, Lindsay Date: 04/25/2011
Comment:
The FDA approved a first of its kind immunotherapy to treat prostate cancer. Provenge is exciting because of the way it fights cancer. Side effects minimal if any and a remarkable median survival. It has been brought up in a previous comment that the age of men who would be eligible for Provenge are at the late stage of their life and would it then be worth it. Absolutely worth it! We cannot predict the lifespan of specific individuals or how much more they can contribute to society. This

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Lederer, Robert Title: M.D.-Retired
Date: 04/25/2011
Comment:

*Men fighting advanced prostate cancer must have available all the tools we know that extend their life. Currently, there are only three of these tools available, one of which is Provenge. *

*There is no excuse that any man who falls within the population that the evidence has clearly demonstrated will experience life extension should not have Provenge available through Medicaid or Medicare.*

*It is clear from the Centers for Medicare and Medicaid Services (CMS) draft

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miller, nathan Date: 04/25/2011
Comment:
[PHI Redacted] i know how important the use of autologous cellular immunotherapy treatment is.Provenge should be fully covered under the Social Security Act and rules shoud be written to be clear that any man meeting the qualifications be provided the required coverage. We must use all treatments we have at our disposal to treat this disease that affects hundreds of thousand of US citizens
Remache, Joseph Title: Bilingual Health Educator / Outreach Worker
Organization: Morton Comprehensive Health Services
Date: 04/25/2011
Comment:
Interesting!
Morrow, Theresa Organization: Women Against Prostate Cancer
Date: 04/25/2011
Comment:

Speaking on behalf of myself and Women Against Prostate Cancer, a national nonprofit dedicated to providing support and resources to the women who love prostate cancer patients, I strongly support CMS’ draft determination that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T ; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone

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Boudreau, Paul Title: President
Organization: Morris County Chamber of Commerce
Date: 04/25/2011
Comment:
We are excited about the progress Dendreon has made in ramping up its Provenge manufacturing facility in Morris County, NJ, and we applaud the decision of CMS to cover therapy for men with advanced prostate cancer. It is crucial that the final NCD policy does not place additional barriers in front of patients who fit the FDA indication and NCCN guidelines. Patients should have a clear and understandable path to qualifying for treatment.
Gardner, Mary Catherine Date: 04/25/2011
Comment:
I urge that Provenge be fully covered under the Social Security Act and that the rules be written to be clear that any man meeting the qualifications be provided the required coverage through Medicaid or Medicare.
wallace, rick Date: 04/25/2011
Comment:
There is no excuse that any man who falls within the population that the evidence has clearly demonstrated will experience life extension should not have Provenge available through Medicaid or Medicare. [PHI Redacted] strongly feel all eligible men should be provided the treatment. The cost compares favorably to lengthy & brutal chemo.
Bechtold, Paul Date: 04/25/2011
Comment:

Men fighting advanced prostate cancer must have available all the tools we know that extend their life. Currently, there are only three of these tools available, one of which is Provenge.

There is no excuse that any man who falls within the population that the evidence has clearly demonstrated will experience life extension should not have Provenge available through Medicaid or Medicare.

It is clear from the Centers for Medicare and Medicaid Services (CMS) draft

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Balis, Philip Date: 04/25/2011
Comment:
[PHI Redacted] we should have available all the tools that can extend our lives. Currently, there are only three of these tools available, one of which is Provenge. There is no excuse that any man who falls within the population that the evidence has clearly demonstrated will experience life extension should not have Provenge available through Medicaid or Medicare. It is clear from the Centers for Medicare and Medicaid Services (CMS) draft determination that the evidence is

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Helmsen, Eric Date: 04/25/2011
Comment:
I support Medicare coverage of Provenge both for on label and off label use. Provenge has proven to be effective via FDA approved trials and should be available to all eligible recipients for on-lable use, minimally
Stanley, Michael Date: 04/25/2011
Comment:
[PHI Redacted] I call upon Medicare to reimburse for Provenge for all men across this nation who might benefit from it. Thank you.
Griffin, Douglas Date: 04/24/2011
Comment:

I agree with the CMS's careful and thorough analysis which resulted in the interim determination released March 30. Autologous Cellular Immunotherapy has survival benefits which far exceed existing cancer treatments, while also offering substantial quality of life benefits due to its insignificant side effects.

Furthermore, this technology is a groundbreaking one, and as more information is learned from a larger population of users insights will likely be gleaned which will

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Karbowicz, Sean Organization: RegenceRx
Date: 04/24/2011
Comment:

RegenceRx conducts independent analyses of medications. Our evidence-based clinical review has concluded that the evidence supporting sipuleucel-T (Provenge) is unreliable, the impact it will have on patients is uncertain, and its treatment value is questionable.

The evidence for sipuleucel-T (Provenge) in the first-line salvage treatment of asymptomatic (or minimally symptomatic) metastatic hormone resistant prostate cancer is unreliable due to major flaws in the design and

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McMurray, III, Stonewall J. Title: senior citizen
Organization: none; we're cats needing to be herded.
Date: 04/24/2011
Comment:
[PHI Redacted] I have many contemporaries who have been so diagnosed, and have even lost a few to it. If the subject treatment extends life or eases life for those experiencing a remission but still suffering the consequences of an earlier bout with prostate cancer, then it makes sense for you to approve full payment for it. I urge you to approve the proposal before you.
Wong, Cindy Date: 04/24/2011
Comment:
I am thrilled to see a revolutionary treatment for late stage prostate cancer finally recognized by you ladies and gentlemen at CMS to be reasonable and necessary. Please keep the same decision to give full on label reimbursement and off label by local contractor discretion. Thanks a lot.
Li, Sally Date: 04/24/2011
Comment:
Thank you for the hard work which lead to the initial approval of Provenge for late stage prostate cancer. I strongly support the full approval in June. Thanks again.
Singh, Ajit Date: 04/24/2011
Comment:
[PHI Redacted] I request CMS to approve the Provenge. Thanks, Ajit Singh
Mahal, Sandeep Date: 04/24/2011
Comment:

Please approve the coverage of Provenge. This is the safest Immunotherapy out there and will lead to now discoveries in the immunotherapy field.

Regards,

Sandeep Kaur
Mahal, Jaspal Date: 04/24/2011
Comment:

Please continue providing coverage for Provenge. This is the future. Please do not get swaed by the Chemo Cartel.

Thanks You
Ghazey, Robert Date: 04/24/2011
Comment:

Thanks to CMS for its well-considered draft opinion regarding provenge. I believe that health care is one area in which additional jobs are being created. The development of advances in medicine is a critical element of this job creation. It is also an important aspect of world leadership by the United States in scientific matters. The dawn of the age of cancer immunotherapies holds great promise for the fight against this dreadful disease. I hope that the CMS final decision will

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Marchand, David Date: 04/24/2011
Comment:

This comment is relative to the proposal to approve reimbursement for treatment of hormone refractory prostate cancer with Provenge.

I do not believe that the indicated improvement in lifespan (median 4 months) is worth the cost.

Wait until further studies show a cost of less than $100,000 per year of life extension before approval.

Angotta, M.A., M.F.T., Chad Date: 04/24/2011
Comment:

Men fighting advanced prostate cancer must have available all the tools we know that extend their life. Currently, there are only three of these tools available, one of which is Provenge.

There is no excuse that any man who falls within the population that the evidence has clearly demonstrated will experience life extension should not have Provenge available through Medicaid or Medicare.

It is clear from the Centers for Medicare and Medicaid Services (CMS) draft

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Kleinot, Ph.D., Michael Date: 04/24/2011
Comment:
I am writing in support of CMS approval of Provenge for treatment of prostate cancer. In harnessing the body's immune system to recognize and attack cancer cells, Provenge represents an important advance in oncology. The success of Provenge will pave the way for immune system-based approaches to treatment of other cancers. This new treatment paradigm will eventually save both lives and dollars. As I understand it, Provenge is currently not more expensive than the alternative treatments,

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Range, Bob Date: 04/24/2011
Comment:

This is just to add an additional comment to my previous observation. I’ve lived almost 78 years and experienced unfathomable times and amazing progress enjoyed by large segments of humanity. From this perspective, one can sometimes become a somewhat detached observer of the world around as it unfolds from day to day. As I step back and study the issues before CMS with respect to the Provenge matter, I try to evaluate and understand the positions of the several respondents who have

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Apple, H F (Pete) Title: none
Organization: none
Date: 04/24/2011
Comment:

Men fighting advanced prostate cancer must have available all the tools we know that extend their life. Currently, there are only three of these tools available, one of which is Provenge.

There is no excuse that any man who falls within the population that the evidence has clearly demonstrated will experience life extension should not have Provenge available through Medicaid or Medicare.

It is clear from the Centers for Medicare and Medicaid Services (CMS) draft

More

Bradley, James Date: 04/24/2011
Comment:
please approve provenge for treatment of metastatic prostate cancer.
Ferdinand, Gary Title: Homeowner and Senior
Organization: None-personal views.
Date: 04/24/2011
Comment:
I believe this break though treatment is absolutely vital to the thousands of older men with little to no other recourse with their advanced, metastatic disease. Please approve it for coverage without delay. Thank you so much!
crowley, gerald Date: 04/24/2011
Comment:

Men fighting advanced prostate cancer must have available all the tools we know that extend their life. Currently, there are only three of these tools available, one of which is Provenge.

There is no excuse that any man who falls within the population that the evidence has clearly demonstrated will experience life extension should not have Provenge available through Medicaid or Medicare.

It is clear from the Centers for Medicare and Medicaid Services (CMS) draft

More

Nowak, Joel Title: Director for Advocacy & Advanced Prostate Cancer P
Organization: Malecare
Date: 04/24/2011
Comment:

Men fighting advanced prostate cancer must have available all the tools we know that extend their life. Currently, there are only three of these tools available, one of which is Provenge.

There is no excuse that any man who falls within the population that will experience life extension should not have Provenge available through Medicaid or Medicare.

It is clear from the Centers for Medicare and Medicaid Services (CMS) draft determination that the evidence is

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Lam, Paul Date: 04/23/2011
Comment:
These are excellent thoughts and comments on 4/22 by doctors Higano,Kantoff,Petrylak,Sschellhammer and Small. Ladies and gentlemen please heed their advice in your June final decision to save as many late stage prostate cancer men as possible. Thank you for your consideration.
Chow, Kathleen Date: 04/23/2011
Comment:
I am so impressed with the well thoughtout post of Dr. Eric Small and signed also by other oncologists I am asking CMS to adopt their suggestions in full force. Thank you.
Lau, Jessica Date: 04/23/2011
Comment:
I am giving my full support to the comments made on 4/22/11 by Dr.Higano,Dr.Kantoff,Dr.Petrylak,Dr.Sshellhammer and Dr. Small. These experts nailed it when they stated that some prostate cancer patients were denied coverage because some local contractors were confused by the broad language which wind up hurting some eligible patients. Please follow these doctors' advice. Thank you.
Adams, Tara M Date: 04/23/2011
Comment:
[PHI Redacted] both died of prostate cancer. The hardest part came when [PHI Redacted] was on chemo. I applaud your action and hope that no man will ever go through what [PHI Redacted] went through.
mackay, stacey Date: 04/23/2011
Comment:
I applaud Medicare for approving coverage for Provenge and for having the foresight to open the possibility for off label coverage as well. Though not a urologist, I am a physician. The alternatives to chemotherapy must be pursued vigorously. The long term view that Medicare has taken with this stance will open further possibilities for care which is more humane, more effective and of cost benefit to the individual and the population as a whole. Thank you.
Blaisdell, E. A. Title: Dr.
Date: 04/23/2011
Comment:
I strongly urge CMS to support the coverage of Provenge for both on and off label use. Its attack on prostate cancer is a breakthrough in treatment that does not have the horrendous side effects of radiation and chemotherapy. Provenge provides a 40% three-year survival benefit. Additionally, it has the potential to significantly extend life if it is given in the initial stages of the disease before one's immune system is greatly compromised.
Hills, Greg Date: 04/23/2011
Comment:
Please approve coverage for Provenge. It's simply more effective than current chemo treatments, and is safer with fewer side effects. Please consider off-label use or make it easy to obtain off-label use as more ad-hoc data becomes available after treatment becomes widespread. Provenge is a turning point in the treatment of cancer and will hopefully lead to better treatement for prostate and other cancers. Your approval will help.
Poage, Wendy Title: President
Organization: Prostate Conditions Education Council
Date: 04/22/2011
Comment:
I applaud the draft determination finding that the evidence is adequate to conclude that the use of sipuleucel-T improves health outcomes for men with asymptomatic or minimally symptomatic prostate cancer. I further recommend that the final national coverage determination removes any limitations between the clinical trial enrollment criteria and the FDA approved label to insure access to Provenge for all the men who could benefit from it.
Schellhammer, MD, FACS, Paul F. Title: Professor of Urology
Organization: Eastern Virginia Medical School
Date: 04/22/2011
Comment:

April 22, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memo for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)

Dear Dr. Jacques,

As physicians who treat patients with advanced prostate cancer, we were pleased to read the Center for Medicare and

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Small, MD, Eric J. Title: Chief, Division of Hematology and Oncology
Organization: UCSF Helen Diller Family Comprehensive Cancer Center
Date: 04/22/2011
Comment:

April 22, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memo for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)

Dear Dr. Jacques,

As physicians who treat patients with advanced prostate cancer, we were pleased to read the Center for Medicare and

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Higano, MD, Celestia S. Title: Professor of Medicine, Medical Oncology Division
Organization: University of Washington School of Medicine
Date: 04/22/2011
Comment:

April 22, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memo for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)

Dear Dr. Jacques,

As physicians who treat patients with advanced prostate cancer, we were pleased to read the Center for Medicare and

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Kantoff, MD, Philip W. Title: Chief, Division of Solid Tumor Oncology
Organization: Dana-Farber Cancer Institute, Harvard Med. School
Date: 04/22/2011
Comment:

April 22, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memo for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)

Dear Dr. Jacques,

As physicians who treat patients with advanced prostate cancer, we were pleased to read the Center for Medicare and

More

Petrylak, MD, Daniel P. Title: Professor of Medicine
Organization: Columbia University Medical Center
Date: 04/22/2011
Comment:

April 22, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memo for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)

Dear Dr. Jacques,

As physicians who treat patients with advanced prostate cancer, we were pleased to read the Center for Medicare and

More

Johnson, Bryan Date: 04/22/2011
Comment:

I would like to register my strong support for the Medicare coverage of Provenge. This treatment is the best thing to ever happen for men suffering from prostate cancer.
I appreciate the wording of your preliminary ruling concerning off label use. I think that Provenge used in earlier stages of prostate cancer will prove even more effective.

Thank you.
Huynh, Charlie Date: 04/22/2011
Comment:

I fully support the CMS's decision to have Medicare reimburse Provenge for FDA on-label indications and want to thank the men and women at CMS who put the time and effort to carefully come to this decision. I hope that the CMS will also consider reimbursement of Provenge for off-label indications as well.

I wanted to reiterate my original comment that Provenge is positive in terms of economics and for the benefit of humanity as a whole. Economically, the use of Provenge will

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Hartnett, David Title: Vice President, Bioscience Industry
Organization: Metro Atlanta Chamber of Commerce - Economic Development
Date: 04/22/2011
Comment:

I am writing in support of CMS coverage of Provenge, as this autologous cellular therapy has been one of the major breakthroughs in the treatment of prostate cancer. We are enthusiastic about the FDA approval of this drug and fully support the presence of Dendreon’s state-of-the-art manufacturing facility in Metro Atlanta.

We value the efforts and success of Dendreon and therefore believe it is imperative that CMS cover this therapy to the FDA label indication to prevent

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Scheerer, P Philip Title: physician (M.D.)
Organization: na - retired
Date: 04/22/2011
Comment:
I am a retired heme-onc M.D. While investigating the subject of cancer immunotherapy in early 2007, I ran across the October 2006 Urology issue article regarding Provenge. I concluded at that time that the positive results reported most likely were not due to chance. I was pleased when the FDA consultant panel recommended approval in early 2007, only to be shocked when the FDA decided otherwise. I consider it a crime to have withheld Provenge from men with terminal illness and no good

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Wong, Fiona Date: 04/22/2011
Comment:
This is a follow up comment to my last post. Some people(doctors included) have misconceptions about the 4.1 month median survival rate. As a matter of fact some prostate cancer patients who have received provenge live years longer. Please keep your positive initial draft as your policy. Thank you very much.
Henry, Jack Organization: Private Citizen with military service in Vietnam.
Date: 04/22/2011
Comment:
I have two close friends who have Prostate Cancer and are over 65, eligible for Provenge. I am also quite aware from reading websites and FDA documents that Provenge as a autologous cellular immunotherapy is an innovative and effective way to treat late stage Prostate Cancer. [PHI Redacted] I know that Taxotere, the alternative to Provenge, has terrible side effects and less effective than Provenge. While it costs about $40,000 for a full treatment, the total costs of

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Lam, Maggie Date: 04/22/2011
Comment:
Dendreon received FDA approval for Provenge ?based on the results of years of clinical ?trials...results which proved the efficacy of ?the treatment and which were INDISPUTABLE.??Why now the confusion being created by the CMS ?review? ?The short sighted, short term view would be to ?deny these men access to this treatment and to ?continue to burden our society with the heavy ?dollar cost of chemo and the emotional cost of ?bereavement.??Open minded and forward looking, men and women ?with

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Man, Joseph Date: 04/22/2011
Comment:

Dendreon received FDA approval for Provenge which proved the efficacy of ?the treatment and which were INDISPUTABLE. Dying men have patiently waited for this ?treatment to be made available. Many are no ?longer alive today as a result of past delays in ?getting Provenge to market.??Moreover from a cost perspective there is again ?misleading information. The $93k is NOT an ?annual cost. It is a one time cost for the ?treatment and most CERTAINLY compares favorably ?to the chemo options AND

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Guiltinan, Anne Date: 04/22/2011
Comment:
I am writing in support of the CMS recommendation to reimburse for Provenge as a treatment option for prostate cancer for on label use, as well as leaving open the possibility for appropriate future use of the treatment in appropriate off label scenarios. I strongly believe the evidence overwhelmingly shows that Provenge prolongs the life of many of those receiving the treatment quite substantially, and that it does so with the absolute minimum side effects and with little or no negative

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Wilczynski, David Date: 04/22/2011
Comment:

This ground breaking treatment needs to be available to all qualified prostate cancer patients and be approved for full reimbursement.Remember that one day you or someone in your family may have prostate cancer diagnosis and trust me when I say the alternative poison chemotherapy is worse to tolerate than the cancer itself.Provenge has virtually NO adverse side effects and when you consider the price remember chemotherapy requires significant and expensive follow up therapies just to manage

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Lazarski, Leila Date: 04/22/2011
Comment:
I would like to express my support for the approval of Provenge for prostrate cancer. [PHI Redacted] died of prostrate cancer two years ago. Had he had the advantage of this treatment, he may have been able to enjoy a longer life and been able to see his latest grandchild born.
Wells, Rodney Date: 04/22/2011
Comment:

First, thank you for your diligent work which led to the decision of tentative approval of Provenge which is extending lives right now due to your hard work and solid judgement.

I fully and whole-heartedly support the full approval of Provenge.

There are detractors who speak against Provenge on the grounds of money - although chemo and treatment related to it's side effects combine to cost taxpayers more with inferior results - but as we all know, the patients are

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Ember, Joe Date: 04/22/2011
Comment:
I support the draft NCD for Provenge and ask that you to adopt it as the final NCD. Somewhat lost in the general discussion about Provenge is the horrendous side-effect profile of chemotherapy like Taxotere. [PHI Redacted] Provenge is a landmark achievement in the scientific march toward ending the scourge of cancer. I dispute that it would only help a bunch of old folks already on death's doorstep. But even if it is so characterized, I believe that only indicates it should be

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Williams, Scott Title: Vice President
Organization: Men's Health Network
Date: 04/22/2011
Comment:

On behalf of Men’s Health Network (MHN), we commend CMS for following the science around Provenge as well as providing for broad on-label access in the Proposed Decision Memo. CMS needs to be clear that this decision supports coverage according to the FDA label and that local Medicare contractors should not be adding unnecessary barriers for men who desperately need this therapy. The final National Coverage Determination should make certain that men with metastatic, castrate-resistant

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Lam, Shou Yung Date: 04/21/2011
Comment:
Thank you for agency's decision to provide national coverage for provenge to older prostate cancer patients. It is such a more humane choice compared to other alternatives. Thank you again.
Lam, Paul Date: 04/21/2011
Comment:
Ladies and Gentlemen, I am so glad that you have reached a favorable decision to provide provenge coverage to old folks like me. I consider such coverage is tax dollar well spend because peovenge offers a qualiry of life that is unmatched by other alternatives. Thank you very much.
moore, richard Date: 04/21/2011
Comment:

First I have to state I believe this CMS NCD was a much too long and drawn out process: effective medicines should reach people sooner not later. That said I do want to commend your preliminary determination. I believe it is a wise, even-handed, reasonable decision. And I believe leaving off label use up to the doctor and patient was both humanly compassionate and scientifically thoughtful. Considering Provenge has better survival- a wonderful 4.1 month median survival benefit rarely

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Diego, Manuel Date: 04/21/2011
Comment:

I would like to commend the CMS for issuing a favorable Proposed Decision Memo on Sipuleucel-T (Provenge) Autologous Cellular Immunotherapy Treatment for Metastatic Prostate Cancer. Medicare patients suffering from Prostate Cancer deserve improved treatment options beyond the traditional chemotherapeutic drugs that inflict harmful side effects to the patient. In contrast, Provenge is a safe, effective, clinically proven, FDA approved, breakthrough treatment that activates and trains the

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Martin, Gerri Date: 04/21/2011
Comment:
Comment to CMS on Provenge National Coverage Determination:
I strongly support The Centers for Medicare and Medicaid Services (CMS) draft determination that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries
Chow, Alfred Date: 04/21/2011
Comment:
I am writing to respond to Mr.Stephen Jencks'comment on 4/19/2011 in which he stated that 'this treatment can have quite SIGNIFICANT side effects, may actually do more harm.' Ladies and gentlemen, do I miss something? A great majority of commentators here are praising provenge because of its mild side effects profile. It is sad that Mr.Jencks who once worked for the same medicare service can have such misunderstanding and misconception of the treatment I applaud the current CMS staff found

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Swift, Orin Date: 04/21/2011
Comment:
[PHI Redacted] I fully support the Medicare coverage of Provenge or a generic of it. Prostate cancer survivors have been wanting for significant breakthroughs in treating this form of cancer. Immunotherapy is such a breakthrough and needs to be supported. Your support of covering this medication under medicare will help many extend their lives, save medicare costs of expensive chemotherapy and its related care of side effects, and pave the way for improved immunotherapy

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Heitman, Mark Title: n/a
Organization: n/a
Date: 04/21/2011
Comment:

I support Medicare coverage of Provenge for on-label and off-label use.

Provenge provides a safe, innovative, and efficacious treatment for prostate cancer sufferers. In sharp contrast, the only other treatment alternative—Taxotere—almost always has a deleterious impact on the quality of life of the patient.

As a middle-aged male with a history of prostate cancer in my family, I would hope that Provenge would be available to me as a treatment option should the need

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Chau, Freddy Date: 04/21/2011
Comment:
My prayor has been answered when you ladies and gentlemen decided to cover provenge for prostate cancer patients. For such a humane treatment it is tax dollar well spent. Thank you.
Robinson, William Title: Founder/Director
Organization: Black Men's Health Initiative
Date: 04/21/2011
Comment:

Please support the efforts of the Centers for Medicare and Medicaid Services (CMS) to use autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® to improve health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer.

As a facilitator of prostate health and cancer prevention programs for Black men, there is a need for lost cost treatment options for men that are at

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Gatz, David Date: 04/21/2011
Comment:
I believe that the recent proposal by CMS to allow coverage of Sipuleucel-T based on the FDA-approved label is the correct decision. I also applaud the allowance of off-label usage at the discretion of local contractors. A paradigm shift in the treatment of cancer patients has been long awaited. May this therapy pave the way to future discoveries. I for one am tired of the patient suffering and the loss in quality of life under the current treatments available. Thank you.
Powers, Pat Title: nonw
Organization: nonw
Date: 04/20/2011
Comment:
I strongly support and endorse CMS approval of Provenge, and I encourage its approval and reimbursement for both on label and off label usage. It is by far the best treatment for prostate cancer and lacks the debilitating side effects of tax, radiation or chemo therapies.
Many patients have survived for years as a result of Provenge with an excellent quality of life. Its early usage will provide even more spectacular benefit for longer HIGH-QUALITY life.
Greenwood, Sharon Date: 04/20/2011
Comment:
I support the CMS coverage of Provenge. For the sake of those men who are in need of this product, please continue to pay for it. I would go as far as asking that it be paid for off label use, as it appears to benefit early stage cancer.
Bassford, Elizabeth Date: 04/20/2011
Comment:
I can't believe CMS is doing this all over again....asking for comments. Did you not get enough comments the first time around. I personally know 3 men under 60 who have had prostate cancer. Provenge could well be a lifesaver for them.
Enough is enough....CMS, it is time to rule the way you recently said you would....cover Provenge.
Cornell, Amy Date: 04/20/2011
Comment:

It's been long enough. My family needs this!! Put politics and "investing" on the back burner for once please. Give [PHI Redacted] a chance. Cover Provenge!!!!!!

arnold, jared Date: 04/20/2011
Comment:
I support PHEN's Dr. Farrington's position on providing coverage for Provenge. Many thousand african american men suffer from this disease and deserve an opportunity to receive this treatment. Many of these men simply cannot take chemotherapy and those that can often suffer from severe side-effects. This treatment should not be only for those wealthy enough to afford it. Thank you
Brewer, Robert Date: 04/20/2011
Comment:
I an in support of reimbursement for Provenge for both on and off label use.
Mok, Tiffany Date: 04/20/2011
Comment:
I am writing to offer my strong support for your agency's initial decision to cover provenge for older men with prostate cancer. It is such a humane treatment that pc patients have been waiting for years. Please also keep this as your decision. Thank you.
Adge, Stan Date: 04/20/2011
Comment:
Men suffering from prostate cancer need your help! They need you, CMS, to take the steps necessary to approve Provenge for on and off label use. Please, do it NOW!!!
Wilson, Susan Date: 04/20/2011
Comment:
I support full Medicare coverage of Provenge both for on label and off label use. The science and data behind Provenge does not lie.
Grant, John Date: 04/20/2011
Comment:

I would like to recommend that CMS finalize their very balanced preliminary decision on Provenge.

This treatment is supported by science/statistics and is a novel approach to fighting cancer that could in the future be the primary method to treat cancer — not just prostate cancer but many different types of cancers. Think how odd this approach must look at first glance: a personalized activation of a patient's own immune system (outside of the patient's body no less) to

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Wong, Benny Date: 04/20/2011
Comment:
I fully support your conclusion that Provenge is a reasonable and necessary treatment for prostate cancer. Please adopt the same conclusion in your final decision. Thank you. Sincerely.
Wayne, Isadore Title: Co-Founder
Organization: The Empowerment Network,LLC.
Date: 04/20/2011
Comment:
I agreed with “The Centers for Medicare and Medicaid Serv ices (CMS) proposes that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication under 1862(a)(1)(A) of the Social Security Act (the

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Jamison, Alma Date: 04/20/2011
Comment:

I have one more thought in that I encourage your financial support for PROVENGE to treat prostate cancer in men. It's the right thing to do for men who are dying and in need. To make financial support of no concern, you only need discontinue financial support for poisonous Taxotere as a treatment for this condition. I also suspect that a surplus of funds will result as a consequence of this decision.
Sincerely,
Alma S. Jamison

mann, eric Date: 04/20/2011
Comment:

The world needs access to something besides lethal chemicals to fight cancer! Apparently the FDA agreed when it approved Provenge. Please approve medicare payment for this most needed therapy!

Thank you.
Gillick, Muriel Title: Professor of Population Medicine
Organization: Harvard Medical School
Date: 04/20/2011
Comment:

I am writing to encourage CMS to limit coverage for Sipuleucil-T to to those patients shown in the published studies to clearly benefit from this treatment, to require patient copayments, to ensure appropriate informed consent, and to require evidence development.

  1. The patients enrolled in the research studies that underlie the NCD had the following characteristics, all of which must be present for the drug to be covered by CMS:
    1. The patient is able to

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Mak, Betty Date: 04/20/2011
Comment:
I am writing to show my support for this novel agent, Provenge, to treat prostate cancer patients. A favorable final decision will encourage more innovation using our own immune system to treat cancers instead of poisons. Thank you for a wise decision.
Mak, Roti Date: 04/20/2011
Comment:
Provenge is a revolutionary treatment for prostate cancer patients, characterized by benign side effects and quality of life that cannot be claimed by other treatments. I strongly urge you ladies and gentlemen to give it national coverage in your final decision. Thank you.
Farrington, Thomas Title: President
Organization: Prostate Health Education Network, Inc.
Date: 04/20/2011
Comment:

I strongly support The Centers for Medicare and Medicaid Services (CMS) draft determination that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication under 1862(a)(1)(A) of the Social Security Act

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Chau, Rex Date: 04/20/2011
Comment:
I strongly support the CMS initial draft to provide coverage for prostate cancer patients because Provenge is such a benign treatment and offers quality of life after treatment. Ladies and gentlemen, I salute for the wise decision and please keep this as your final decision. Thank you.
Freddy, Chau Date: 04/20/2011
Comment:
My prayor has been answered when you folks decided to provide national coverage to late stage prostate cancer patients. Provenge is a paradigm change in the ways to treat p.c. with its absolutely mild side effects. The media even reported that some patients even went to play golf soon after treatmen. That is amazing! Please keep it as your final policy. Thank you.
Anon, Shamblinthru Date: 04/20/2011
Comment:
Most Respectfully:
In rebuke of Dr Joanne Lynn's statement, Prostate Cancer is NOT a "__condition__ that mostly afflicts persons in advanced years"

From 1998 to 2002, the median age at diagnosis was 68 years. The percentages of people diagnosed with prostate cancer based on age were as follows:

  • 0.5 percent between 35 and 44
  • 8.3 percent between 45 and 54
  • 26.9 percent between 55 and 64
  • 37.0 percent between 65 and 74
  • 22.6 percent

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  • Quinn, John Date: 04/20/2011
    Comment:
    This comment is in response to the comment of Joanne Lynne of CMS. Joanne Lynne's death panel-esque comments regarding Provenge reek of sour grapes that her "just let the elderly die" position was shot down, and the draft decision will cover the cost of Provenge. As has been pointed out many times, there is no minimum age at which a man can contract prostate cancer. Men suffering this malady are not all old men that have outlived their usefulness to society as Ms. Lynne suggests. Many men live

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    Orr, Bob Date: 04/20/2011
    Comment:
    Men suffering from prostate cancer need CMS to approve Provenge for on and off label use. This is a good thing!!!!
    Richardson, Sean Date: 04/19/2011
    Comment:
    Men suffering from prostate cancer need your help! They need you, CMS, to take the steps necessary to approved Provenge for on and off label use. Please, do it NOW!!!
    Ellard, Scott Date: 04/19/2011
    Comment:

    CMS/Medicare support for Provenge is fundamental to improving both the outcomes and the cost of cancer treatment in this country and around the world. Such a revolutionary change in treatment vs current alternatives must be supported and encouraged. This is not just a question of prostate cancer, but all cancers. The possibility of training ones own immune system to fight these horrible and costly conditions must be allowed to evolve and continue to be researched and

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    Reeves, James Organization: Retired
    Date: 04/19/2011
    Comment:

    I am writing to encourage the full coverage of Provenge for the treatment of metastatic prostate cancer. By full I mean to include off label coverage.

    Often, by the time a person receives the full barrage of treatment on his way to hormone-resistant prostate cancer, several hundred thousands of dollars are spent. Biopsy, surgery, radiation, hormone therapy, and chemotherapy, are all expensive. The use of Provenge and other such treatment could dramatically improve outcomes

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    Benedict, Megan Date: 04/19/2011
    Comment:
    I strongly support Medicare coverage of Provenge for both on-label and off-label use. Who would say "no" to a ground-breaking new treatment for cancer with so few side effects? Should my husband or sons ever need it, I certainly hope Provenge will be widely available.
    Flores, Melvin Date: 04/19/2011
    Comment:
    I support Medicare coverage for the immunotherapy called Provenge both for as well as off label use. This is the way that cancer will be treated in the future. It works very well- better than anything that's available to doctors today. Provenge has sufficiently proven itself already. Our government needs to stop with it's continued barriers to this wonder drug and just accept it and support its use by the men that need it.
    Babu, Balaji Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Feigelman, Theodor Date: 04/19/2011
    Comment:
    I am a physician who practices Internal Medicine. I have taken care of men with what was formerly end-stage metastatic hormone resistant prostate cancer. This is a devestating illness. Anything which might replace the suffering of available chemotheraputic treatments should be supported. I believe that CMS-Medicare should support full (on AND off-label) use of Provenge.
    Lutz, Don Date: 04/19/2011
    Comment:
    Provenge needs to be covered by Medicare. Live is precious and needs to be extended. This is a great discovery. I want it available for my father and myself or my son's - should the need arise in the future.
    Ruley, Gerald Organization: Individual
    Date: 04/19/2011
    Comment:
    The advance of medicine has entered a new phase with the approval by the FDA of Provenge. This drug provides a patient, who is basically out of viable options, to receive a truly potentially life saving treatment. The amazing thing about this new drug is the almost total absence of negative side-effects. I know Prostate Cancer Patients who refuse Chemotherapy due to the horrible side-effects. I sincerely recommend and hope that you will approve coverage of this drug in all areas of the United

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    Reay, Al Date: 04/19/2011
    Comment:
    Having had two very close relatives live through the tortuous pain and side effects of chemo treatment for their prostate cancer, it is hard to understand why this review is even taking place. Provenge vastly outperforms the current standard of care, Taxotere, while maintaining a much higher quality of life. And, although cost is not allowed to be taken into consideration, you should know that Provenge is cheaper than Taxotere when taking into account all the costs associated with Taxotere

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    wang, wilson Date: 04/19/2011
    Comment:
    This treatment was legally approved by FDA's very own vigorous trials for on-label use. Therefore it is reasonable and necessary. CMS should approve its national coverage for on-label use.
    Arnold, Cheryl Date: 04/19/2011
    Comment:
    As a cancer and chemotherapy survivor[PHI Redacted] cancer. [PHI Redacted] experience with chemo to treat breast cancer was difficult and scary. I hope more therapies are developed using this technology to treat other forms of cancer. Thank you
    Fang, Tilden Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    U, Raj Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Shropshire, Tyler Date: 04/19/2011
    Comment:

    Provenge represents a new paradigm in treating prostate cancer that is the most efficacious therapy EVER for treatment of this virulent disease. Not only is Provenge the most efficacious treatment, but it comes with the fewest number of side effects. It is an understatement to say that the future of this therapeutic platform is bright both for earlier stage prostate cancer as well as cancer in other organs of the body. To deny coverage of this groundbreaking treatment based on a one-time

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    Lum, Daniel Date: 04/19/2011
    Comment:
    I sure support Medicare coverage of Provenge both for on label and off label use.
    Barela, Jayne Date: 04/19/2011
    Comment:
    I fully support Medicare coverage of Provenge for men with advanced prostate cancer.
    I have followed the Provenge saga for almost 10 years, first as the family member of an individual struggling with prostate cancer and later as an investor in the science of autologous cellular immunotherapy. It seems surreal that it has taken ten long years to make this novel life-extending treatment available to the men who need it. Please finalize your decision in favor of Provenge and allow men to

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    Ohlund, Dennis Date: 04/19/2011
    Comment:

    Provenge works.

    Provenge is safer than the alternatives.

    Provenge is actually cheaper than the alternatives.

    What's NOT to like about Provenge?

    Jencks, Stephen Title: Consultant in Healthcare Safety & Quality
    Organization: self-employed
    Date: 04/19/2011
    Comment:

    I am deeply concerned that the proposed decision would cover Provenge for ALL patients with castration-resistant metastatic disease when the trials excluded all patients with an ECOG status of 2 or higher and all patients with lung, brain, or liver metastases. It seems very possible that this treatment, which can have quite significant side effects, may actually do more harm than good for such patients, and there is certainly no evidence of effectiveness for these groups.

    I am

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    Worden, Daniel Date: 04/19/2011
    Comment:
    Thank you for approving Provenge for payment. I believe this new treatment for cancer is a breakthrough; not only for prostate cancer but other cancers as well. Two years ago I had to watch [PHI Redacted] fight for her life, without success, as she faced pancreatic cancer. We searched for every available treatment option, but only found chemo, which was a horrible experience. If only Dendreon's cassette technology for immune therapy had been approved years ago for prostate

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    Mathew, Paul Title: Associate Professor
    Organization: Tufts Medical Center
    Date: 04/19/2011
    Comment:

    I am an oncologist dedicated to the care of men with prostate cancer.

    My concern with this agent is that I cannot explain the major (4-month) survival benefit observed in the Phase III trial based on what was actually observed among treated patients. Almost none of the patients had tumors that shrank, remained stable or grew slower when treated with Sipuleucel-T when compared to the placebo arm and almost none had PSA declines at any time.

    This kind of discordance

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    P, Rick Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use. Provenge is not only a groundbreaking prostate cancer vaccine but also the first-ever FDA-approved therapeutic cancer vaccine. The knowledge gained and to be gained with further research will result in other, perhaps more advanced, cancer treatments with Provenge being the archetype of this new treatment paradigm for better health and longer survival. Provenge is the future delivered today.
    Nonnenmacher, Francis Title: dmd
    Date: 04/19/2011
    Comment:
    Provenge needs to be approved and covered by CMS now.There presently is no other TX for prostate CA that mimics it's 4.1 month survival. Is it perfect...... No , but no tx\drug is. It is a stepping stone in our quest to find a cure for this dreaded disease .
    Park, Charles Date: 04/19/2011
    Comment:
    I applaud the CMS draft decision to cover Provenge for on-label population. There has been only 3 times in the history of oncology drugs where a drug has shown to extend survival by 4 months or more. Therefore, Provenge is a strikingly effective drug for extension of survival with minimal side effects. It fits the description of reasonable and necessary perfectly.
    Repasky, John Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Solan, MT Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Navarrete, Juan Date: 04/19/2011
    Comment:
    I support expanded coverage for this treatment!
    I understand that Cancer research is done on the latest stage patients, those most advanced in the progression of their disease, and would emplore allowing this treatment approach to be available to those men at the earliest stage of hormone failure. Earlier Even! In those patients trialed (the sickest) three year survival was on the order of three to one favoring the treatment group! Physicians need to have this in their

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    Hinsvark, Vernon Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    It is my judgement that the "net realized cost" for Provenge will prove far less costly than the current "chemo" treatments and their additional costs for the terrible side effects they produce, including pain and hospitalization.
    Thank you for moving forward
    Kindly allow Provenge to be used and reimbursed for on label as well as off label use.
    Liang, Leonard Date: 04/19/2011
    Comment:

    I am a urologic surgeon and a fellowship trained transplant surgeon. I fully support CMS coverage of Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (00422N). This is a revolutionary treatment using a patient's own immune cells to specifically target and attack prostate cancer. Castrate Resistant Metastatic prostate cancer is a terminal disease. Thus, this treatment which has been proven to significantly extend survival with mild side effects is a significant

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    Rasmussen, Dale Date: 04/19/2011
    Comment:
    Thank you for moving the process of Medicare Coverage forward for Provenge. I only wish Provenge had been available a couple of years ago. It possibly could have saved my family a lot of pain and grief. Hopefully you will make a quick decision for reimbursement both on and off label use.
    Wang, Jessica Title: Lawyer
    Date: 04/19/2011
    Comment:

    I would like to express my strong support on CMS' preliminary decision to allow on-label use coverage of Provenge.

    The immutherapy is the future of cancer treatment. Our country needs to take brave steps to encourage innovation.

    The 4-month medium survival is quite misleading. In fact, it means half of the patients under Provenge would survive more than 4 months, or even years, than the placebo group. CMS should not deny the hope for about half of the patients.

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    wick, charles Date: 04/19/2011
    Comment:
    I was astounded by the comment from Dr Lynn, apparently an employee of CMS, which displayed a chilling ignorance of the medicine upon which Provenge is based, of the statistical record justifying its approval, and most appalling, her betrayal of a curious approval for euthanasia that should be entirely absent from someone in her position.
    Just why Provenge, this exciting and hopeful new paradigm for the treatment of cancer, attracts so many ill informed and biased opponents is something

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    Krautter, George Date: 04/19/2011
    Comment:
    Kudos to the CMS for correctly determining Provenge coverage is appropriate. But more importantly, proposing that the regional offices can determine if coverage is reasonable for cases of earlier stages of disease is insightful! This is the best way to confirm what is expected, healthier patients will produce a more robust immune response and favorable outcome, where metastatic progression is delayed or suppressed entirely. If such is the case, significant quality of life benefits to

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    Mantarakis, P Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use. If one considers the cost of oncologists and chemotherapy, then the cost of Provenge is very favorable. And the quality of life is vastly improved with Provenge.
    Castro, Justiniano Title: MD
    Organization: UPR School of Medicine
    Date: 04/19/2011
    Comment:
    Provenge is the first immunotherapy directed treatments that demonstrate activity and improvement in the overall survival for patients with prostate cancer. Although the administration of the treatment is complex, it is reasonable alternative to considerate in a small population of prostate cancer patients. As a physician my position is to strongly support the inclusion and cover of this unique treatment.I will suggest to request to the company to provide special training for the proper use of

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    Dietch, James Title: Dr.
    Date: 04/19/2011
    Comment:
    I am a physician and [PHI Redacted] (with surgery and radiation). I have followed the Provenge "saga" for many years, excited about the prospects for this new therapy. The data are compelling. The FDA dragged their feet on this remarkable drug for too long, yet finally approved it. I really don't understand why there is any question about CMS coverage. I am not one to believe easily in conspiracy theories, but it seems that there are individuals dedicated to preventing

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    jones, william Date: 04/19/2011
    Comment:
    [PHI Redacted] I support Medicare coverage of Provenge both for on label and off label use.
    K., P. Title: Dr.
    Organization: Private
    Date: 04/19/2011
    Comment:

    Below are some comments on Dr. Joanne Lynn’s comments posted on 4/16/2011:

    1. In scientific drug testing, the entry protocol of a well-controlled randomized blinded trial must be precisely defined to ensure that patients are as similar as possible between the two arms of the trial. Thus, aside from the definition of a disease or disease stage to be treated, the entry protocol of a trial would often include or exclude certain additional patient characteristics. The FDA was well

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    Lau, Jessica Date: 04/19/2011
    Comment:
    I am very happy that you folks decided to give coverage to older men with prostate cancer. I have a [PHI Redacted] who may need Peovenge down the road and they don't want chemo because it is so devasting. Thanks a lot for your favorable decision.
    Kuziola, Bruce Date: 04/19/2011
    Comment:
    The first thought that came to mind after reading Dr. Lynn's comments was "Death Panels". Her focus on cost is myopic when all costs of the current SOC (chemo) are considered. It is likely that Provenge will reduce total costs to the Medicare system in addition to improving the quality of life of its patients. I encourage the CMS to issue a final decision consistent with the current draft decision.
    Wong, Fiona Date: 04/19/2011
    Comment:
    Provenge is a treatment of prostate cancer that offers a choice of no burning,cutting or poisoning of our body. Instead it triggers our own immune system to fight off cancer cells. Your positive initial draft for a national coverage is wise and cheered by men with prostate cancer. Thank you very much.
    Sapire, PhD, Dennis Date: 04/19/2011
    Comment:

    Dr. Lynne is way off with her Provenge comments!

    I support aspects of Dr. Lynne's writings about palliative and end of life concerns; but her approach to Provenge makes no sense.

    Provenge is not only life extending (with retention of full quality of life - like coaching little league for years after treatment) but it is not a last line of treatment. Taxotere and possibly abiraterone and others will follow Provenge treatment.

    A hospice is to end of life

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    Price, Dennis Date: 04/19/2011
    Comment:

    This is a ground breaking treatment for prostate cancer, it helps patients live longer without the terrible side effects of chemo, and must be approved.

    Provenge will become the standard treatment for prostate cancer against which all other drugs/treatments will be compared. It is the least damaging of all "chemo" treatments for this terrible disease and may actually give better results by being given earlier rather than later in the progression of the cancer.

    Many

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    Chow, Kathleen Date: 04/19/2011
    Comment:
    I strongly support your decision to set up a national coverage policy for Provenge for older men with prostate cancer. Provenge provide very mild side effects with no hospital costs associated with it,thus saving a lot more money vs other treatments that require hospitalization. Thank you with the good work.
    Shakarji, Craig Date: 04/19/2011
    Comment:

    I support the recommended national coverage decision draft

    The coverage of Provenge makes sense when compared benefits, costs, and side effects are compared with conventional treatments (especially when full treatment and subsequent costs are included).

    Gesink, Donald Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Clift, James Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Haberstroh, John Title: retired
    Date: 04/19/2011
    Comment:

    Thank you CMS for your well-reasoned draft proposal on Provenge. Please formalize this proposal in your final decision on CMS coverage.

    We are in a fiscal environment where Medicare and Medicare must be prudent in their health care expenditures. However, it would be a mistake to curtail the use of a revolutionary approach to prostate cancer that advances beyond the "burn or poison" treatments of radiation or chemo and offers patients superior treatment with little side effect. In

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    Scott, Warren Date: 04/19/2011
    Comment:
    Greetings and thank you for the opportunity to voice my opinion regarding Provenge. I first became aware of this treatment when desperately researching options for my prostate cancer afficted [PHI Redacted]. Dendreon was just initiating their trial enrollment, but, alas, [PHI Redacted] onocologist was just to busy to look into it. What a shame, as he was a perfect candidate. In any event, he eventually died from chemotherapy induced complications. But now,

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    Cheng, Shulan Date: 04/19/2011
    Comment:

    As a retired scientist who have worked 30 years in biotech research in universities and private pharmaceutical companies, I know research to find cancer cure is a slow process. Now Provenge is a truly break-through treatment for prostate cancer. It utilize patients' immune system to fight the disease. Unlike chemotherapies which use toxic chemicals to kill the cancer cells as well as the healthy cells and cause miserable side effects, Provenge prolongs life and gives patients good life

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    Lynne, Joseph Date: 04/19/2011
    Comment:

    I believe my friend Saul Kerpelman said it best regarding Dr. Joanne Lynn -

    First, I realize this is a public comment period and employees of CMS are part of the public, but I must say it smacks of impropriety for a CMS doc to be airing opinions in this forum. If CMS is considering the appropriate thing to do behind closed doors—as the regulations seem to contemplate—it seems inappropriate for less than all of those involved in the decision-making process to be

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    Labeaume, Louison Date: 04/19/2011
    Comment:
    [PHI Redacted] died of prostate cancer and [PHI Redacted] are followed by urologists for high PSAs. Prostate cancer has been in our lives for years and so far, the only available treatment was potentially worst than prostate cancer itself. Please make sure Provenge will be available to us if we ever need it. Thank you.
    Pintner, Steven Date: 04/19/2011
    Comment:
    If making significant progress in the "War on Cancer" is a serious goal then a safe, efficacious, innovative treatment such as Provenge must be allowed to reach the patients. I am in favor of CMS reimbursement for Provenge, allowing doctors to use their best judgement as to which patients could benefit from it. This immunotherapy has been shown to be more effective than chemotherapy. The side effects for Provenge are mild, not debilitating as with chemo. The cost of one course of Provenge

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    Harthcock, Thomas Date: 04/19/2011
    Comment:
    Thank you for your recent draft concerning the national coverage determination for Provenge. This is drug gives hope for prostate cancer patients including [PHI Redacted] who was recently diagnosed with the disease. Please consider coverage for both on and off label usage. Thank you
    Barnosky, Lisa Date: 04/19/2011
    Comment:

    I support Medicare coverage of Provenge both for on and off label.
    I feel Dr. Lynn's post seems biased because it seems to me to be based upon age discrimination—which seems especially strange for a doctor working for CMS and thus Medicare, which is charged with improving the health and lives of older patients. Perhaps this is a remnant of her background in palliative care for the dying, but I must say that my reading her attitude of "just let them die without pain" evoked

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    Pearce, Elizabeth Date: 04/19/2011
    Comment:

    I have been following the cancer immunotherapy field for years. I would like to see the practice of treating prostate cancer move towards using Provenge, but testing for upregulation in CD-54 after the second treatment and not continuing the treatment if there is no increase in CD-54 or an otherwise measured response from the immune system.

    I want to see a balance between encouraging innovation (which stimulates the economy, exports and job creation) and discouraging the overuse

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    Richards, Gary Date: 04/19/2011
    Comment:

    I support Medicare coverage of Provenge both for on label and off label use.

    With prostate cancer the most common malignancy in American men and the second leading cause of deaths from cancer, this FDA approved life extending breakthrough treatment should be an available choice to all men.

    Mansager, Scott Date: 04/19/2011
    Comment:

    I'm encouraged that CMS has not ruled out off label use for Provenge. The trials that were approved by the FDA targeted men with hormone refractory prostate cancer (androgen independent). These men were very sick and even with their compromised immune systems Provenge extended survival by 4.1 months median and increased 3 year survival by 40%. These numbers are even more impressive once you take into consideration that crossovers were allowed in these trials. There is some statistical

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    Carson, H.C. Organization: United States Taxpayer
    Date: 04/19/2011
    Comment:
    It would be hard to imagine a treatment that has been more rigidly tested than Provenge. Never the less, it has passed these tests and the grades just keep getting better and better with added examination. Many men who might well still be enjoying life have died waiting for this modern marvel to come to them. I hope that CMS does not add it's name to the long list of villains who have worked against this treatment. Time will congratulate and applaud you for the vision to make Provenge

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    Hotujec, Timothy Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use. [PHI Redacted] I have two friends that have used the provenge treatment and both are still alive!
    richardson, paul Title: SIR
    Organization: Citizen of the United States
    Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use. The discovery, research and development of this efficacious vaccine reminds me of the story of anaesthesia. The pain and suffering of soldiers during the civil war could have been alleviated but for a little foresight. Provenge is the tip of the iceberg and will stimulate a humongus search for more and better vaccines.
    Bulger, John Date: 04/19/2011
    Comment:
    I am writing in strong support of the CMS decision to cover Provenge for men with late stage prostate cancer. I further urge you to keep the door open to off label use as there is compelling evidence that this immunotherapy is even more effective in earlier disease stages. Thank you.
    mann, eric Date: 04/19/2011
    Comment:
    Bravo to CMS for finally putting the obvious politics aside and giving prostate cancer sufferers HOPE. Why CMS has no problem paying for expensive and dangerous chemo but is giving Provenge a hard time is beyond me. Cost is NOT a valid or legal consideration. Approving payment for this unique and groundbreaking therapy is the ONLY viable and REASONABLE choice.
    Moonda, Faroq Title: MD
    Date: 04/19/2011
    Comment:
    If CMS really has to question if provenge should be approved....you should just close shop and go home. There are only a couple of cancer drugs out there that have a better efficacy or a cleaner side effect profile than Provenge. If you don't reimburse for provenge then you should stop reimbursement for all cancer drugs...Period. The CMS was established to help the American public that is not able to help themselves..So please Do What You are Supposed to Do. Approve Provenge Reimbursement NOW.
    Deckert, Don Title: Bodily Injury Claims Specialist
    Organization: Insurance
    Date: 04/19/2011
    Comment:
    I support medicare coverage of Provenge both for on label and off label use. Please approve it now!
    Warner, Gerald Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Miller, Vicky Date: 04/19/2011
    Comment:
    I am in total support of Nedicare coverage for Provenge for both on label and off. How can you NOT cover this treatment?? To think that a person could have a treatment for cancer that doesn't kill off his whole body while killing the cancer is a something I would hope you all would want! You would if it were you!!!
    Give Dendreon the chance to do something that no big pharma CAN do - lenghthen lives without all the pain and side effects - both short and long term.
    Hile, Toni Date: 04/19/2011
    Comment:

    I support Medicare coverage of Provenge both for on label and off label use.

    It's a great drug that extends life. It should be covered.

    Broadland, Troy Date: 04/19/2011
    Comment:
    Please move forword and allow the use of Provenge for on and off label uses. This treatment is long awaited and desperatly needed for Metastatic Prostate Cancer Patients. Provenge is a far superior treatment over "chemo" is both extending life and relatively minor side side affects. This is just the beginning in the great fight agaist cancer!!!
    Kerpelman, Saul Date: 04/19/2011
    Comment:

    I feel like I have to respond to the recent negative comment by Dr. Lynn.

    First, I realize this is a public comment period and employees of CMS are part of the public, but I must say it smacks of impropriety for a CMS doc to be airing opinions in this forum. If CMS is considering the appropriate thing to do behind closed doors—as the regulations seem to contemplate—it seems inappropriate for less than all of those involved in the decision-making process to be publicly

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    Wallace, Randy Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use
    Davis, Jerry Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Whitman, Barry Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge for both on-label and off-label usage. I believe Provenge has a great potential for actually reducing the cost of care for prostate cancer, which is a growing concern given a population which is experiencing expanding life expectancy.
    greenwald, jeffrey Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    cumiskey, chuck Organization: Yes
    Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use. Please make it happen!
    Cope, Michael Date: 04/19/2011
    Comment:
    I strongly support the approval and coverage of Medicare for Provenge for on-label and off-label use in the fight against prostate cancer. Having witnessed the scourge of cancer up close as well as the debilitating impact of existing therapies upon patients, I cannot see any ethical reason to not allow and support the use of this therapy.
    Warnke, Wesley Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Futcher, Bruce Title: Professor
    Organization: Stony Brook University
    Date: 04/19/2011
    Comment:
    I support coverage of Provenge by Medicare/Medicaid for on-label use. Even considering the costs, the benefits are substantial. It is possible that the benefits were under-estimated in the trial (because the control arm received frozen Provenge, which may be of benefit). Finally, like any new mode of therapy, the efficacy of the therapy may increase with experience.
    Cross, Gary Date: 04/19/2011
    Comment:

    After following this for over 4 years now, it is my opinion that Provenge should be covered by Medicare for on label as well as off label use.

    It should be left up to the patient and the doctor!

    Conant, Steve Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    O'Brien, Dan Title: Pres
    Organization: Plaza Properties
    Date: 04/19/2011
    Comment:
    I urge you to make Provenge available for both on label and off label use.
    Balsamo, Gian Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Wick, Stanley Date: 04/19/2011
    Comment:
    It is imperative that Provenge be fully supported by The Centers for Medicare and Medicaid Services. This breakthrough treatment will help thousands of men with late stage prostate cancer. As time goes on I am sure it will become very clear that Provenge 1.0 will be just the first of many Autologous Cellular Immunotherapy Treatments which will greatly improve the lives of those who suffer with this terrible disease.
    Hamilton, Barbara Date: 04/19/2011
    Comment:
    Provenge is a breakthrough in cancer treatment type. It should be covered by Medicare both for on label and off label use, so that earlier use/combination use can be developed.
    Burns, Ronald Title: Associate Pastor
    Organization: New Covenant Christian Church
    Date: 04/19/2011
    Comment:

    I strongly urge the CMS to support the use of Provenge for use as the doctors see fit - both on label and off label use.

    As a pastor, I have seen the ravages of cancer as well as the ravages of cancer treatments.

    This treatment has very mild side effects and helps the patient live with dignity and freedom. Besides all that - it works quite effectively!

    Off label use is important to me because it very well might be beneficial to use this treatment in earlier

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    Poor, Sandra Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    There is no doubt that Provenge works and is a much kinder treatment.
    Gilbert, Greg Date: 04/19/2011
    Comment:

    I fully support CMS approving the use of Provenge for men suffering from late stage prostate cancer as well as earlier use of Provenge for the men with an earlier stage of this horrific decease.

    Provenge has gone through four different PIII trials and has been reviewed extensively by the FDA for it's effectiveness. Plan and simple, it works!

    When a 'drug' helps built one's own body fight this crumpling decease without the horrendous side affect of chemo AND adds

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    dodge, corinne Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    McLain, James M. Date: 04/19/2011
    Comment:

    Gentlemen and ladies of CMS:

    Provenge represents a paragigm shift in the treatment of late stage prostate cancer and it is available now, today. The use of Provenge at earlier stages of prostate cancer could lead to remarkable extension of life. In the future, the technology and process might very well be used to address other types of cancers. I support Medicare coverage of Provenge both for on label and off label use.

    James M. McLain

    Martinson, David Date: 04/19/2011
    Comment:
    I fully support Medicare coverage of Provenge for both on label and off label use. I believe the earlier the usage of Provenge commences, the longer the life of the recipeint and the less cost faced by Medicare for additional kinds of treatments.
    Mamin, Jean-Pierre Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Katz, Alan Title: Professor of Genetics
    Organization: Ilinois State University
    Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Nelson, Brian Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Hape, Patrick Date: 04/19/2011
    Comment:
    Thank you for your support of provenge. A personalized medicine such as provenge that doesn't have any of the nasty side effects like chemo is finally a step in the right direction in the fight against cancer. Having the use of our immune system to fight cancer will only work better if used earlier, because it takes longer to ramp up. The survival advantage of provenge was shown to have a median survival advantage of 14.2 months when not competing against a lesser version of itself. While

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    kappes, greg Title: pharmacist
    Date: 04/19/2011
    Comment:
    I support the treatment of PC with Provenge. This is the tip of the iceberg in the future and rational treatment of malignancies. The sooner the better and the outcomes will reflect
    Bujanowski, Edward Date: 04/19/2011
    Comment:
    I Believe in the potential of this procedure as it is the next generation of treatment of prostrate cancer.I want this available for on and off label use because I believe this is the treatment of the future. Technology marches on. Burn the buggy whips!!
    Cannon, Andrew Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Mass, Arnold Title: Citizen
    Organization: un-affiliated
    Date: 04/19/2011
    Comment:
    Damage has been done by the needless delays brought about by Corporate "gamesmanship".I am delighted to see that CMS has seen the light and has moved forward. It is never easy to thwart. the hands that feed you especially when those hands pay a large part of your budget.It is my judgement that the "net realized cost" for Provenge will prove far less costly than the current "chemo" treatments and their additional costs for the terrible side -effects they produce,including pain and

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    Grant, Mike Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Gannon, Charles Title: CHARLES S GANNON, MD
    Date: 04/19/2011
    Comment:
    When one considers the combination of patient tolerability, effectiveness of the drug to prolong life, and the ultimate cost to the patient, government and insurance companies, there is nothing else out there that can compete with Provenge for on-label, and probably for off-label, treatment of prostate cancer.
    Johnson, Ron Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Gustafson, Walt Date: 04/19/2011
    Comment:
    I believe Medicare should cover prostate cancer treatment using Provenge for both on and off label usage.
    Buchan, Robert Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge both for on label and off label use.
    Abernathy, John Date: 04/19/2011
    Comment:
    It is time to move forward with this treatment, we have been patiently waiting for years, all this has just been delaying the future, for the patients, and the chemo industry, protection of that industry is due to be stopped now.....
    Heuring, Doug Date: 04/19/2011
    Comment:

    I support Medicare coverage of Provenge both for on label and off label use.

    I work in 250-bed hospital and see men all the time with Prostate cancer. We need a drug with little side effects and and great survival benefit.

    we need other drugs besides chemo as its side effects make most of these men not even want to consider it.

    so i ask agian please support Medicare coverage of Provenge both for on label and off label use.

    Doug
    Adams, Lee Date: 04/19/2011
    Comment:

    I am writing in SUPPORT of CMS coverage for Dendreon's Provenge. I believe CMS should cover Provenge 100% for both on AND OFF label use. Citizens of the U.S. deserve such leading edge medical breakthroughs for the 21st century. Considering the side effects of Provenge relative to chemotherapy the costs of Provenge is less than the comprehensive costs attributed to chemotherapy.

    The chemo industry and captured doctors will be the entities that fight tooth and nail against Provenge

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    Nobles, Kevin Date: 04/19/2011
    Comment:
    I am in support of Medicare coverage for Provenge. This revolutionary has been proven to extend the life of people taking the drug without the horrible side effects of chemotherapy. Coverage should be extended in order to allow those suffering with prostate cancer to have another medical alternative.
    malne, dan Date: 04/19/2011
    Comment:
    I strongly support Medicare coverage of Provenge both for on label and off label use. I applaud your diligence in examining the medical and economic benefits of this protocol, especially during difficult economic times
    Simon, Chuck Date: 04/19/2011
    Comment:
    I would like to state my support for Medicare coverage of Provenge for both on label and off label use.
    Shrims, Shrimps Date: 04/19/2011
    Comment:
    I support Medicare coverage of Provenge for on label and off label use.
    Brennan Jr., Vernon Date: 04/19/2011
    Comment:
    Provenge must be covered by Medicare.
    Kostas, Constantine Title: Dr.
    Organization: MMS
    Date: 04/18/2011
    Comment:

    Provenge,studied and reported as prolonging usefull life and greater survival than any other medication to treat androgen deprived patients with metastatic prostatic cancer, ought to have the opportunity to have the potential benefits if they choose.
    Consider that this choice is no different than that faceing thee potential liver or heart transplant patient, whose life is prolonged by by having surgery to replace the ailing organ. We are not talking about cure here, only

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    Hise, Justin Date: 04/18/2011
    Comment:
    Prostate cancer is a horrible disease that needed a better treatment. Provenge is a miracle that every man should have in the fight against prostate cancer. To use our own immune system to fight the cancer is a huge breakthrough. It is my hope that we use Provenge earlier in the cycle. The minimal side effects that don't require additional treatments will most likely save money. If you have on one hand Chemo and Radiation killing everything or Provenge boosting the cells to fight the cancer

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    Logue, Dan Date: 04/18/2011
    Comment:

    Please support the use of Provenge. Do not further the conspiracy against a treatment that will be an important step in finally conquering cancer. This treatment has become a case study in how government agencies and financial markets should not work.

    Simply look at the percentage of patients with long term survival. This is enough evidence to support using this treatment and to support finding new uses for this treatment.

    Holloway, Kelly Title: Mr.
    Date: 04/18/2011
    Comment:
    Provenge was approved for use by the FDA. Provenge fights prostate cancer without the many horrific side-effects of chemotherapy. It is glaringly apparent that Medicare should cover the use of Provenge.
    Melsoni, Mara Date: 04/18/2011
    Comment:
    Not only do I support the national coverage decision draft, I cannot imagine Provenge being brought to market after FDA approval and NOT being nationally covered by Medicare. Patients (those who have lived long enough) have waited patiently for this breakthrough treatment to become available. Now Medicare patients are waiting patiently for definitive coverage. Thank you.
    zarouri, mourad Date: 04/18/2011
    Comment:

    I am not sure Dr. Joan Lynne should even be allowed to post a comment being a CMS employee, but in a way I am glad since it gives me the opportunity to respond.
    Joan main concerns were the effectiveness and cost of Provenge.
    Effectiveness: Provenge had to go through multiple trials and a high statistical bar for effectiveness set by the FDA. It passed with flying colors. I’d like Joan to stand up and tell the close to 30% of patients still alive 3 years after receiving

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    Rostock MD, Robert Organization: Geisinger Clinic
    Date: 04/18/2011
    Comment:

    I wish to directly respond to Joanne Lynn Md's comments.

    First, There is an obvious bias in this doctors thinking and analysis. She obviously does not practice clinical medicine for prostate cancer. Her work has focused on end of life isues and terminal care. While I applaud her accomplishments the simple fact is that those patients receiving provenge are far from death's door.
    I would challenge some of her claims:

    First she states that "Most actual patients would not

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    Goker, Turguy Title: Research & Development Manager
    Organization: Quantum Corp
    Date: 04/18/2011
    Comment:
    Back when I was a young guy, I truly did not pay attention to any of these since the PC and I were too far apart in my stupid and ignorant mind. We all will get old and this is a bus stop in our life that no one can avoid unless they die prematurely. Biotechnical Technical achievement such as Provenge is very crucial to humanity and must be supported in fullness. Now I am nearing the age where PC starts to be important consideration and I monitor all advances in cancer research with full

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    Benedict, Roger Date: 04/18/2011
    Comment:
    I strongly support payment by Medicare for treatment of this cancer with Provenge. [PHI Redacted] died of prostate cancer and would have been a candidate for Provenge had it been available to him in time.
    Lambert, Michael Organization: Self employed
    Date: 04/18/2011
    Comment:
    Please continue the authorization for health care providers to proscribe provenge where deemed appropiate. It is safe, effective and the quality of life of the recepient is enhanced in comparison to any other alternative. Cancer is a devastating disease and provenge has taken a step forward towards combating the malady in a unique,humane way.
    Hall, Andrew Date: 04/18/2011
    Comment:

    I’m writing to express my support and gratitude for the CMS’s recent national coverage decision draft with respect to Dendreon’s prostate cancer treatment Provenge.

    As I’ve stated in a previous comment (7/8/2010), I’ve seen firsthand the frequently ravishing effects that chemotherapy has had on friends and family afflicted by various cancers, and have followed the Provenge story since the results of the Impact Study were first released.

    With its clearly significant

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    Kearney, Mike Title: Spokesperson
    Organization: CareToLive, a not for profit corporation
    Date: 04/18/2011
    Comment:

    Please cover Provenge. I have read some comments written by ignorant people who spew misinformation about how long the patients survive and their quality of life after treatment. The facts are that there are some patients who have been living for years after taking Provenge. I have heard stories of men being treated on a Tuesday and they are out on the golf course by the weekend. The quality of life is so much better than the alternative toxic treatments plus there are no expensive hospital

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    Dreyer, Gary Date: 04/18/2011
    Comment:
    Provenge works per the FDA. The median survival of 4.1 months is deceptively conservative as it was compared against a frozen version of itself, so it likely works even better than advertised. If it could be given earlier, it may turn prostate cancer in to a manageable disease. When compared to the overall cost of chemo therapy, with all it's associated treatments to counter-act the effects of chemo, it is relatively equivalent in cost. When one considers the quality of life issues, provenge

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    Fidler, Kim Date: 04/18/2011
    Comment:

    As a wife, mother and concerned citizen I applaud the decision of CMS to cover Provenge through Medicare. This life-extending treatment is a safe alternative to current treatments which are so awful that many men choose to die rather than suffer the side-effects.

    These extra months/years you allow us with our loved ones are priceless. To allow a father or grandfather at a child's graduation, their presence at the birth of a child or grandchild, their loving eyes present to

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    Melvin, Lawrence Date: 04/18/2011
    Comment:
    I would like to express my support for Provenge's (Sipuleucel-t)full coverage by CMS for its full on label usage. For the thousands of men suffering from prostate cancer there are few, if any, options. Provenge provides life extending benefit with an unparalleled safety and quality of life profile.
    Nulsen, Rita Date: 04/18/2011
    Comment:

    Just as so many Americans have, I too have lost loved ones to painful deaths due to cancer. Mindful of this, I respectfully urge CMS to approve Provenge and withdraw the NCA now.

    Dendreon has provided us with a stellar moment in the war agains cancer with its autologous cellular immunotherapy (PROVENGE). Provenge boosts an individual's own immune system to fight cancer cells. No poisonous chemo required!

    America has waited a long time for an advance in the cancer

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    Fedorko, Maryann Date: 04/18/2011
    Comment:
    I agree with CMS' position that Provenge is a necessary treatment for Medicare beneficiaries with prostate cancer.
    Gulla, Bill Title: President
    Organization: WRG Consulting Group
    Date: 04/18/2011
    Comment:
    I agree with the CMS’ determination that Provenge is a reasonable and necessary treatment for Medicare patients for late stage prostate cancer. I further agree that off label use should be a consideration on a case-by-case basis. CMS actions demonstrate a caring, thoughtful, and perceptible approach in review of this matter.
    Garnick, Daniel Title: Assoc. Director for Regional Economics (retired)
    Organization: BEA, US DOC
    Date: 04/18/2011
    Comment:

    This paradigm provides for an highly valuable treatment shown to extend men's lives from 4+ months to several years. It has been shown that if the man's immune system has not been completely destroyed.. it will function again, after PROVENGE is given - the way it formerly did, and will stop the proliferation of the cancer cells.

    Hopefully, PROVENGE will be allowed to be used EARLIER - "before" a person's Immune System has been majorly compromised. This treatment is more

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    rednor, jeffrey Date: 04/18/2011
    Comment:
    as a physician, i am so please that cms has seen the remarkable help this therapy offers our patients. the ability to offer the therapy as earlier stages through off label requirements will give greater longevity to our patients as well.
    Wolfsberg, James Date: 04/18/2011
    Comment:

    I am posting my unconditional support for the CMS decision to cover Provenge for men with cancer. There is no question that this is the right decision and it opens the dcor to the use of immunotherapy for all types of cancer.

    The data is conclusive that Provenge is beneficial to cancer patients and that Medicare needs to not only cover "on label" reimbursement, but encourage "off-label" usage as well. The use of the body's own immune system to battle cancer is clearly a

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    Acker, Lawrence Date: 04/18/2011
    Comment:
    The FDA and other federal agencies must understand to open up their eyes and ears to new and inventive ways to treat cancer. We can no longer try to deal with symptoms only and learn to harness the power of the immune system to create new ways to heal from within. I was saddened and more angry when the FDA denied this novel therapy when there appear to be little to no negative side effects. I believe there were conflicts of interest that the FDA would prefer to hide behind in voting down

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    Schneider, Lindy Date: 04/18/2011
    Comment:

    To the Committee ...

    I have been praying for YEARS - for the type of treatment that PROVENGE offers to Cancer victims!! I lost [PHI Redacted] to this HIDEOUS disease - and had to watch them suffer and die earlier, because of the destruction of their immune systems, and horrendous and barbaric side effects of the TOXIC Chemo and Radiation that was forced on them!!

    Why does a patient who is suffering, then have to be TORTURED ??

    This new

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    Baranoski, Daniel Date: 04/18/2011
    Comment:
    I firmly agree with the CMS' finding that Provenge is a reasonable and necessary treatment for Medicare patients with certain types of prostrate cancer. I congratulate CMS' on their carfeul and independent position allowing local providers to use such treatments on a case by case basis for the care and betterment of their patients.
    Han, Seung Date: 04/17/2011
    Comment:
    Is it possible to receive it before the end stage prostate cancer over chemotherapy? I woudl think it would be more humane and less money spent on a long run. I would definatly prefer immunotherapy over chemotherapy if I ever get prostate cancer in future.
    Laden, Robert Title: President
    Organization: CE, Inc.
    Date: 04/17/2011
    Comment:
    It is without doubt that the Centers for Medicare and Medicaid should fully back this treatment for prostate cancer. It is a revolutionary new therapy that gives patients a longer life, without the horrible side effects that go along with the alternative chemotherapy.
    It is very disturbing to know that this treatment which because of the way clinical trials to approval are set up is not available to patients at earlier stages of prostate cancer. To set up such a clinical trial would

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    F., Tony Date: 04/17/2011
    Comment:

    I urge CMS to approve Provenge for coverage; it has proven itself to the high standards of the FDA; received FDA's approval and compares favorably (if not better) with the the TOTAL cost of the sole chemo treatment.

    I am a life-long taxpayer; my government made a contract with me decades ago to provide medical care in my retirement years.

    I am a covered Medicare recipient; my family has a history of prostate cancer and there are 4 brothers at risk today.

    The

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    Powers, John Date: 04/17/2011
    Comment:
    Having the immune system trained to attack cancer is very exciting indeed. I hope this technology can one day be used to treat other cancers as well.
    Thank you
    John Powers
    Uradnik, John Date: 04/17/2011
    Comment:
    Living in a 55 & 0ver Mobile home park in Florida for six months yearly and having contact with many friends there who have been treated for Prostate cancer, I am happy to hear of Provenge as a treatment for their cancer if the situation warrants it.
    Robbins, Maura Date: 04/17/2011
    Comment:
    Covering Provenge for prostate cancer patients is the best thing CMS has done lately. If the FDA/CMS powers that be can accelerate the process to approve coverage for patients at an earlier state in the disease, they will save so many more men from the miserable effects of this disease in addition to millions upon millions of dollars in medical costs.
    Limpert, John Date: 04/17/2011
    Comment:
    [PHI Redacted] It seems like Provenge is far better than chemo and opens the door to improved treatments for all kinds of cancers.
    Simma, Fred Date: 04/17/2011
    Comment:

    I strongly support the recommended national coverage decision draft regarding the prostate cancer vaccine Provenge by Dendreon. I follow Provenge development and believe that this is a real breakthrough. Do the right thing and many ofter similar drugs will follow. Many men who currently have no other option (chemo is not an option for many of them) are desperately waiting. Please do the right thing and provide whatever approvals are required to help these men.

    Thank

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    Devoy, C. Patrick Date: 04/17/2011
    Comment:
    I am so pleased with your desicion regarding Provenge. I have a friend who was a trial particapant and is still with us today over 3 years later. Thank You
    Ducotey, Richard Date: 04/17/2011
    Comment:
    [PHI Redacted] died of cancer. Thank you for approving reimbursement for Provenge. This is the beginning of a great revolution in the humanitarian treatment of cancer (as opposed to the horiffic chemo treatment.)
    Barone, Al Date: 04/17/2011
    Comment:
    Provenge represents a major breakthrough in cancer treatment. It is critical that healthcare move away from a chemotherapy approach to a new model that utilizes the bodies immune system. Medicare must look to the future with the approval of new treatments such as Provenge for the treatment of prostate cancer.
    PURCHASE, GREGORY Date: 04/17/2011
    Comment:
    I believe that Provenge is a transformational addition to the arsenal of prostate cancer treatments, and I consider it mandatory that reimbursement be approved. Thank you for allowing public input on this important matter.
    Muniz, Tim Organization: Retired
    Date: 04/16/2011
    Comment:
    I support full Medicare coverage of the drug Provenge. This is a miraculous treatment and will greatly improve and extend the lives of thousands of Americans. Thank you for your kind consideration of this email.
    Tim Muniz
    McGrath, Bonnie Date: 04/16/2011
    Comment:
    As the [PHI Redacted] of a prostate cancer victim, I wish Provenge to be readily available. It is safe and effective, it is much less traumatic than its alternative, and the patient has a much better quality of life.
    SAMUEL, JOSEPH Date: 04/16/2011
    Comment:
    IT IS IMPORTANT THAT YOU DO NOT CHANGE YOUR ORIGINAL TEMPORARY APPROVAL OF PROVENGE
    Cook, Donald Date: 04/16/2011
    Comment:
    I would like to add my enthusiastic support for Provenge by Dendreon. I have followed the trials of this revolutionary process for many years and look forward to the promising future of immunotherapy for prostate as well as other cancers.
    Doherty, Jim Title: Dr.
    Date: 04/16/2011
    Comment:

    I am a health economist with 15 years of pharma- industry experience submitting reimbursement dossiers to health insurance authorities in America, England, Scotland, Germany, France, Japan and South Korea. So I speak with some authority with regards to worldwide insurance reimbursement standards, whether they be cost-effectiveness, comparative-effectiveness or 'reasonable and necessary' standards.

    First of all, with regards to the elephant in the room i.e. cost. I can say with

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    CAMPOS, ANTHONY Title: PRESIDENT
    Organization: STOCKTON THRIFT CAR SALES
    Date: 04/16/2011
    Comment:
    A story I've been following is Provenge, A major breakthrough in the treatment of Prostate cancer.. Lets not drop the ball on this by letting politcs get in the way of a breakthrough treatment. The experts have all spoken on this issue. Lets not ignore them.
    Glode, MD, L. Michael Organization: uchsc
    Date: 04/16/2011
    Comment:
    The treatment of prostate cancer patients with novel approaches remains a challenge. Immunotherapy is but one of several new, admittedly expensive approaches. While it is critical for CMS and our health care system to implement cost containment measures, evaluations of cost-effectiveness, and clinical guidelines for best care, this treatment is comparable to many other expensive cancer treatments with limited efficacy. Under no circumstances should prostate cancer be treated differently than

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    Lynn, Joanne Date: 04/16/2011
    Comment:

    April 9, 2011

    To: CAG, re Administrative File CAG-00422N

    From: Joanne Lynn, MD, MA, MS, DrJoanneLynn@gmail.com

    Re: Proposed National Coverage Determination for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer

    I am writing to encourage the National Coverage Determination for Sipuleucil-T to be much more constrained than the current proposal envisions by making the following adjustments:

    1. All of the potentially

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    Smith, Barbara Date: 04/16/2011
    Comment:
    I am writing in support of the CMS payment for the DNDN Provenge treatment approval. [PHI Redacted] and had Prostate cancer surgery nearly 40 years ago when there were few options, certainly nothing with so little side effects. If Provenge had been available to him, his many years of dealing with the after-effects of the treatment he had would be so different and require so much less care. I have followed the development of Provenge since it became public and pray that Dads,

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    Thiede, Kendall Date: 04/16/2011
    Comment:
    I think it is wonderful that the CMS has decided to cover Provenge. This treatment is revolutionary and will help many people.
    Welter, Jeff Date: 04/16/2011
    Comment:
    I am strongly in favor of CMS supporting the use and reimbursement of Provenge. The median increase in survival by 4.1 months is dramatic in that less than a handful of cancer treatment breakthroughs have ever achieved this length of survival increase. Even more important to me is the almost 40% better chance of survival at 3 years for treatment with Provenge versus placebo. I lost a relative to prostate cancer. He was able to see his 2 sons get married- the last one from a wheel chair. He did

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    Farrar, Kenneth Date: 04/16/2011
    Comment:
    I support Medicare coverage for Provenge. Provenge is the first FDA-approved treatment that utilizes the body's immune system to fight cancer. Provenge is a revolutionary new treatment for prostate cancer. If Provenge is given the chance to succeed, the technology behind Provenge will likely lead to successful new treatments for other cancers in the future.
    Myers, Warren Date: 04/16/2011
    Comment:
    I support and urge CMS to approve the decision for Medicare to provide reimbursement for Provenge and any autologus cellular immunotherapy treatment in the future. It's time to lay Chemo to rest.
    slomiany, ray Date: 04/16/2011
    Comment:
    Creating Medical Assets.
    For the sickest of patients, a 4.1 month median increase in life span and a 38% increase in survival at 3 years are the results after treatment with Provenge. These are not the total improvements to be had for the cost of treatment. The larger argument of cost of treatment should include what happens after the patent expires, and what contribution a drug makes to developing the next improved generation.
    My friend has a heart condition for which he takes 5

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    Wagner, Susan Date: 04/16/2011
    Comment:
    [PHI Redacted] could have used this drug...it came just a little too late. Please make it available to as many patients as possbile.
    Hamilton, Sam Date: 04/15/2011
    Comment:
    Please make official your plans to approve the payment for Provenge treatment of prostrate cancer.
    Those who suffer from this disease look to Provenge as being a way to extend their lives without all the horrible side effects of chemotherapy. Their hope is also that allowed earlier use of Provenge may even cure the prostate cancer.
    Mahamood, Salman Date: 04/15/2011
    Comment:
    This is a big step forward in Cancer treatment. We need more drugs like Provenge.
    marchese, frank Date: 04/15/2011
    Comment:
    I fully support the cms decision for provenge, also would hope and encourage off label use for this indication.
    Teitelbaum, Marshall Date: 04/15/2011
    Comment:
    I am thrilled to finally see a breakthrough type of treatment for a major and frequent cancer type become available. I'd love to see further immunotherapy options become available at earlier treatment junctures and for other cancer types, but this amazing breakthrough should help further research into a new frontier, and hopefully one that allows more effective and more tolerable treatment for the suffering.
    Albin, Jessy Date: 04/15/2011
    Comment:
    This treatment is proved to be very effective by using all forms of testing mandated by the FDA which has given approval. The CMS policy has always been to provide coverage for FDA approved treatments. One fails to understand why CMS should change the policy now. Provenge saves lives. Is that not good enough for CMS coverage? I support a favorable decision.
    Bonn, Leonard Title: retired gentleman
    Date: 04/15/2011
    Comment:
    [PHI Redacted] I have seen too many of my friends family, and shipmates suffer and die from prostate cancer. The hope that Autologous Cellular Immunotherapy Treatment provides men with pc as contrasted to the otherwise almost hopeless future leads me to vigerously support the CMC decision to approve reimbursement
    Brown, Brian Date: 04/15/2011
    Comment:

    I am writing to support the decision to cover Provenge.

    Good work. Men need this treatment.

    poonati, apparao Date: 04/15/2011
    Comment:
    pts need proveng to extend survial and qulity of life
    Wuepper, William Title: Citizen
    Date: 04/15/2011
    Comment:
    I would like to add my voice to those who support the Dendreon Provenge therapy. Having had two members of my family die from cancers, I welcome another option to fight cancer. I remember [PHI Redacted] after a chemo session laying on the couch, bucket close at hand. Or [PHI Redacted], received so much radiation that her tongue lacked flexibility. I must say that the quality of life in those conditions is not that great. Maybe some day you too will be faced

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    cook, s Date: 04/15/2011
    Comment:
    Thank you for your decision to finally recommend Provenge for national coverage. The treatment is effective and almost as important, HUMANE. Suffering men have been waiting for decades for a compassionate treatment for prostate cancer. CMS needs to be at least as compassionate and issue the written recommendation without further delay. Our husbands, brothers, uncles, sons and nephews are counting on you. Don't let them down. Thank you.
    Drury, Noel Title: M.D.
    Date: 04/15/2011
    Comment:
    May CMS completely fund this most essential new weapon in the fight against the scourge of prostate cancer! Many thanks if you do!
    Beridze, Revaz Title: DDS
    Organization: Tower Dental Associates P.C.
    Date: 04/15/2011
    Comment:
    Autologous Cellular Immunotherapy (ACI) is a revolutionary technology which will create new practices to fight different types of cancer.
    I applaud the draft descision to fully reimburse for autologous active cellular immunotherapy (Provenge) use.
    I am looking forward to a positive final NCD in June, allowing for the use of Provenge in both on and off label treatment. Thank you for giving these men something to count on, while they wait and hope for a cure.
    Johnson, RN, Kathleen Date: 04/15/2011
    Comment:
    I wholeheartedly support the recommended national coverage decision draft guidelines. My husband and my father may be in need of this breakthrough treatment one day. We are on the cusp of a new era in cancer treatment. Few side effects, one course of treatment required, the body's immune system trained to fight cancer. We live in amazing times. My family learned this week that [PHI Redacted] has developed lung cancer and due to her frail condition, can only receive

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    Dakik, Alon Organization: Self
    Date: 04/15/2011
    Comment:
    Provenge should be available to all those in need of it. Hopefully, off label to early prostate cancer patients in hope to avoid further damage to their health. Provenge will actually save money and free up critically needed hospitals and staff. Chemo is expensive, requires hospital stays, nurses, and repeat visits with severe side affects. It is in the best interest for this nation to start supporting that create products such as Provenge. Support them so that they will continue creating

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    Ferfon, Michael Date: 04/15/2011
    Comment:

    Extremely happy for the men in my family and the country now that such an advancement in medical science will be available going forward.

    Probably one of the most significant medical break-throughs to arrive on the scene in years. The data supporting Provenge's effectiveness is such a clear hit especially in light of the fact that Provenge had to compete with itself for much of the survival curves highlighted in the Ph III trials as a good portion of the placebo group for

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    Rennell, Jeffrey Date: 04/15/2011
    Comment:
    Please cover Provenge. The general public does not understand how awful chemo can be and all the added cost it takes to treat the unwanted side effects. Besides the fact that Provenge works better than Chemo. Thank you for your time.
    Angiolillo, James Title: CPA
    Organization: Angiolillo & Associates
    Date: 04/15/2011
    Comment:
    We have waited much too long for a viable alternative to treating prostate cancer......Provenge is a wonderful option to consider for men with prostate cancer....the side effects alone are soo minute compared to chemo that all men should have the choice. Imagine if the vacccine for polio was not approved..........
    Udziela, Joseph Date: 04/15/2011
    Comment:
    I am very thankful that Medicare has decided to cover Provenge.
    zehrer, paul Date: 04/15/2011
    Comment:

    I fully support Medicare covering Provenge costs for the treatment of Metastatic Prostate Cancer. I have read the science and see this as a very beneficial breakthrough in treatment, well worth our tax dollars compared to alternative treatments currently on the market and paid for through Medicare. In addition, I would hope CMS is forward thinking in allowing the broadest application for this treatment.

    Thank you,
    Paul Zehrer
    Kerpelman, Donna Date: 04/15/2011
    Comment:

    I am very happy the draft decision supports coverage of Provenge. Please cover off label, as well as on label. It is very likely that it will help earlier stage men even more, since they have healthier immune systems. In the long run we will actually save money.

    Men with prostate cancer need this treatment.

    Please make sure it is available to them!

    Donges, Charles Date: 04/15/2011
    Comment:
    Please allow coverage of Provenge for patients with Prostate Cancer. It is a major advance in treatment for patients, and avoids nasty chemotherapy side effects and cost. Comparative data show Provenge to be no more expensive then a year of older chemo regimens that are very burdensome to patients and their families. Keep in mind also that the median survival advantage was over 4 months, not the average. Big difference.Thank you.
    small, terry Title: mr.
    Organization: n/a
    Date: 04/15/2011
    Comment:
    I am glad to see that people now have a choice in treatment for prostate cancer other than chemo. luckely I don't have it yet myself (knock on wood) but [PHI Redacted] died of it. please keep it avalible for people. thank you.
    Caruso, Kevin Date: 04/15/2011
    Comment:

    Thank you for the positive determination that Provenge is a reasonable and necessary treatment for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.

    I would also like to implore CMS to start a NCD to reverse the coverage of Taxotere in the on-label Provenge patient population as a first-line therapy. Only if Provenge has been administered or an Oncologist/Urologist deems it necessary should the US taxpayer be

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    Deaton, William Date: 04/15/2011
    Comment:

    I am very encouraged by your draft National Coverage Determination Letter regarding coverage of the label indications for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer also known as Provenge. Provenge provides a needed alternative to chemotherapy in treatment of their disease.

    I have a friend who is battling prostate cancer at this time. The availability of Provenge may be too late in coming for him. But it will provide a welcome tool in a fight

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    Jamison, Alma Date: 04/15/2011
    Comment:

    I have been following the PROVENGE story for years and I just want to say:

    Please-o-please pay for this PROVENGE treatment for prostate cancer.

    Sincerely,
    A. Jamison
    Hamilton, Carol Date: 04/15/2011
    Comment:
    I have followed the advance of Provenge through the phase 2 and 3 trials. I am aware of the cost for treatment and the quality of life issues involved in the only other treatment options. I believe for science to move forward in cancer treatment that Provenge must be covered by all insurance - medicare and private. I wholeheartedly support this coverage.
    Pfumfel, Hendrik Organization: Had to pick Alaska to be able to post, but I´m from Germany
    Date: 04/15/2011
    Comment:
    Dear CMS-Team Thank you for making the right decision by providing Medicare-Insurance for Provenge with your decision in March. Your decision to reimburse Provenge gives desperate patients new and much needed hope that they will have the ability to get Provenge soon. In addition, I would like to thank you because I think your decision is critical in lending further testimony to reasonable necessity of men.Your decision may pave the way for a more efficient as well as expeditious path to

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    LANCE, DENISE Date: 04/13/2011
    Comment:
    Thank you for the decision in favor of Provenge. The FDA has agreed with Dendreon that Provenge is safe and effective. This is an important treatment in the fight against cancer. As someone who has witnessed the effects of chemotherapy it is encouraging to know that future cancer sufferers may be spared some of it's devastating side effects. Please confirm coverage in your final draft. And once again, thank you.
    Granahan, John Title: CEO
    Organization: BayMarnie
    Date: 04/13/2011
    Comment:
    After reviewing all available information on Provenge, I have had personal experience with family members who would have benefited from Provenge.I recommend that the proposed decision for CMS coverage be finalized as soon as possible. Thank you for your consideration.
    Kassabian, Vahan Title: Research Director
    Organization: Georgia Urology
    Date: 04/11/2011
    Comment:
    As a former investigator for Dendreon and current infuser of Provenge, I congratulate CMS on the recent decision to cover this novel therapy for men with advanced prostate cancer. I fully support the use of Provenge as it is approved by the FDA and hope that CMS will be clear in their final NCD policy to make sure that men with metastatic, castrate resisitant prosate cancer are able to receive Provenge per its FDA approved indication.
    Requests for additional information beyond the obvious

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    Lindley, Donald Date: 04/11/2011
    Comment:
    Please expand the use of Dendreon's PROVENGE to as wide a patient population as possible. Thank you.
    Hess, Herbert Date: 04/11/2011
    Comment:
    Just a note about medicare coverage for Provenge. I think it is important that medicare covers Provenge in both the late stages of prostate cancer and in the early stages. It seems logical that if it is helpful in the late stages, it would also be helpful in the early stages.
    irwin, s Date: 04/10/2011
    Comment:
    i support the NCD to cover provenge
    Becker, Peter Date: 04/09/2011
    Comment:

    Dear Sir/Madame: I'm a retired army officer and a New York attorney. I invest in ground breaking bio-technology and the future of our great nation. I shall only comment briefly on the need for CMS to provide coverage for Provenge.

    The evidence is overwhelming that Provenge is safe and effective for the treatment of advanced prostate cancer. The FDA has approved the use of Provenge for the treatment of men with advanced prostate cancer.

    Provenge has a clearly

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    Cunningham, Bill Date: 04/09/2011
    Comment:
    I was very happy to read the draft memo on the proposed Provenge coverage. You have now given tremendous hope to some very sick men who, prior to this announcement, must have felt like they were being held in limbo, in their quest for relief from the curse that had been beset upon them. Especially heartening was the idea that "off-label" use of Provenge was NOT prohibitted. I believe this is the only way we will be able to find out how well Provenge can work in earlier stage PCa, since any

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    Roberts, Andrew Date: 04/08/2011
    Comment:
    I applaud CMS and all medical professionals involved in this review for their unbiased analysis of this groundbreaking treatment for prostate cancer. For years our only treatment for cancer was cut the cancer (along with otherwise healthy cells) out, poison the body with radiation or chemotherapy and hope that the cancer would die before the rest of the body, or slow the cancer’s growth by altering the hormone balances of the patient. We have now discovered much better way to battle the

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    Rafter, Peter Date: 04/07/2011
    Comment:

    I applaud the FDA for their belated approval of Dendreon's groundbreaking cancer immunotherapy, Provenge.
    Provenge (sipuleucel-T)was approved by the FDA in early Spring 2010 to treat men with Hormone Refractory Prostate Cancer. The trial data revealed a median survival advantage of a robust 4.1 months.

    In the long history of cancer research, no cancer treatment other than Provenge, has such mild side-effects, e.g. flu-like symptoms lasting @2-3 days, of which, only some

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    Reese, Michael Date: 04/07/2011
    Comment:
    As a physician [PHI Redacted] I am appalled that cms just approved Provenge to treat advanced prostate ca. The $93,000 price tag will give patients approximately 4 Months of extended life.This could be the reason that our medical care is on the brink of failure.We cannot continue to give this costly care to everyone, it is not rationing care but being rational about what care we provide.
    Krelle, Dana Date: 04/07/2011
    Comment:

    I would like to see at a minimum the proposed decision be adopted as it covers what the Trial targets have targetted, while leaving the door open for coverage of earlier use. Common sense would say that a treatment that trains the immune system would have increasing effect (and lower lifetime overall medical expense) the earlier it is used. Thus unlike standard chemo, Provenge has both a medical and an overall cost benefit; I urge CMS to allow early use to be covered.

    I also

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    Nieh, Hwa-Tung Date: 04/06/2011
    Comment:
    I strongly support the decision to fully reimburse the autologous active cellular immunotherapy (Provenge) use. It affords peace of mind for old-aged people like me, knowing that Provenge is effective and causes only very mild side effects. Compared with sufferings caused by chemotherapy, immunotherapy with Provenge is simply wonderful. Provenge is a path breaker. Hopefully, immunotherapies for other cancers will soon follow.
    Husic, Bill Date: 04/06/2011
    Comment:

    Initial public opinions submitted to CMS were overwhelmingly positive for Medicare to cover Provenge. During CMS meeting, expert testimonies were provided and again, overwhelmingly positive to cover Provenge. The CMS panel votes were consistent with the public opinion/experts and were overwhelmingly positive.

    Made complete sense that CMS' March 30 release to cover Provenge was consistent with public opinion, expert testimonies and CMS panel votes. I support a final CMS

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    McQuarrie, Claude Date: 04/06/2011
    Comment:
    I applaud the draft descision to fully reimburse for autologous active cellular immunotherapy (Provenge) use. Use of this drug will afford meaningful life extension with good quality of life for prostate cancer patients. Compared to other drugs in prostate and other cancers, the benefit of Provenge use is substantial, while the side effect profile is slight. Cost, when compared to the direct and indirect costs of Taxotere use, is favorable. Not to be overlooked is the fact that widespread

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    Bastien, Jorden Date: 04/06/2011
    Comment:
    Thank you for making a positive decision concerning Dendreon's Provenge and clearing a path for possible off label use. Dendreon has shown and the FDA has confirmed that Provenge is both safe, effective, and increases the standard of living. When you compare Provenge to all the alternative treatments including Taxotere it is definitely the best choice for the patient. CMS please continue to help fight Prostate Cancer by making Provenge available to all in need!
    Erickson-Rulf, Pauline Date: 04/06/2011
    Comment:
    CMS's decision to grant Provenge full Medicare coverage for the treatment of late-stage prostate cancer has been applauded by many, and I join the chorus. You made the right decision. Dendreon's immunotherapy is a breakthrough in the fight against cancer and hopefully will lead to an improved and more humane treatment of other forms of cancer in the near future. The cost of Provenge, especially when compared to chemo with all its horrible side effects and hospital stays, is reasonable and

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    Lee, Michael Date: 04/06/2011
    Comment:
    I would like to express my strong support for the CMS draft decision regarding Provenge for the treatment of prostate cancer. As a retired family medicine physician I have seen the suffering due to this disease and experienced the frustration of not being able to give much hope to those in the late stage of hormone resistant metastatic disease. I'm very impressed with the studies that show a 3 year survival rate increase of 40% for those treated with Provenge. It is commendable that the CMS

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    Severson, Terry Date: 04/06/2011
    Comment:

    My family has a history of dealing with prostate cancer. I believe Provenge has the potential to become the new standard of care for prostate cancer.

    Using England's National Institute for Clinical and Health Excellence, or NICE criteria for cost-effectiveness, the ANNUAL COST of Taxotere+side-effects cost is approximately equal to the LIFETIME COST of Provenge + side-effects.

    Every effort should be made to make Provenge an available and accessible option for prostate

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    Barnosky, David Date: 04/06/2011
    Comment:
    I am absolutely 100 percent for the reimbursment of Provenge. This is something people need and should of had a long time ago. Other treatments are not as affective and are costing just as much.
    Mazzola, Joseph Date: 04/06/2011
    Comment:

    As a healthcare advocate and senior(70+)it seems to me that overall benefits to the health of senior citizens would be enhanced greatly by approving the process of autologous cellular immunotherapy for prostate cancer.

    I concur with Representative John Conyers(D-Michigan)in his letter to recent Cancer Institute committee that most cancer research in the last twenty years has not accomplished intended goals of direction, commitment and cooperation of these various organizations to

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    Marzan, Peter Date: 04/06/2011
    Comment:

    CMS must cover all on-label treatment for men with prostate cancer who chose treatment with Provenge. The chemo options are harmful and expensive when considering added treatments to address side effects. Use of Provenge facilitates a reasonable and very necessary treatment option for a large unmet meed among men who would otherwise die from their disease.
    The proposed coverage released March 31 needs to remain in tact.
    thank you,

    Peter Marzan
    Kendall, Mike Date: 04/06/2011
    Comment:
    The science behind Provenge provides a true paradigm shift in the treatment of cancer. Enabling our own bodies to fight this God Awful disease with better outcomes and less side effects than Chemotherapy is remarkable. Allowing this technology to help those suffering from Prostate Cancer and enabling the scientists at the company to work towards helping those with other types of cancers should be expedited. What if this technology, used earlier in the fight against cancer, eliminates the

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    McGrath, Peter Date: 04/05/2011
    Comment:
    [PHI Redacted] I wish that Dendreon Corporation's Provenge be covered by Medicare. This treatment has a better quality of life result than other treatments. Thank you.
    Hessel, Brad Date: 04/05/2011
    Comment:
    I write to congratulate you all on an excellent job on the draft coverage decision for provenge. This is such a better way to go than chemo both in terms of effectiveness and quality of life! I hope that immunotherapies for other cancers besides prostate will follow in the fullness of time.
    Holly, Alan Date: 04/05/2011
    Comment:
    Thank you for your positive response to the coverage of Provenge. I have witnessed the devastation to an individual suffering from prostate cancer and the impact on the family. That there is now a therapy with few side effects and which has proven to prolong useful life is fantastic. This is something for which we have all wished and prayed. CMS's findings and support of Provenge is a god send for individuals, families and the world. Thank you, again, and we all look forward to the final

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    Donohoe, James Date: 04/05/2011
    Comment:
    I applaud your recommendation of coverage of sipuleucel-T for asymptomatic or minimally symptomatic metastatic hormone refractory prostate cancer, in the Proposed Decision Memo CAG-00422N. Sipuleucel-T is clearly an effective treatment for prostate cancer, without the devastating side-effects of chemotherapy. I believe sipuleucel-T is just the first step in the application of immunotherapies to fight cancer. We need to support novel therapies such as sipuleucel-T, as long as they are safe

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    Johnson, Ben Title: Director of Pharmacy Services
    Organization: Union Pacific Railroad Employes Health Systems
    Date: 04/05/2011
    Comment:
    I whole heartedly agree with the decision that CMS is making on this medication. It is a very expensive treatment option with a small incremental increase in life expetancy. If the clinical data does not support that it is beneficial with other prostate cancer types, then it should not be approved in those members. I am also supportive of high copayments or coinsurance for this medication. The families should shoulder a significant portion of the expense of this medication.
    Martin, Phillip Date: 04/05/2011
    Comment:
    Please approve this breakthrough procedure for men with almost no other options. Statistically significant survival rates indicate that Provenge is an effective treatment for the devastating condition of late stage prostate cancer. Benign side effects are a plus, as is the whole concept of unleashing the patients own immune system to fight the disease.
    I have studied the results a lot, and would definitely choose Provenge for myself as the best solution if I had Hormone resistant late

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    Robb, Nancy Organization: N/A
    Date: 04/05/2011
    Comment:
    Given the added value of receiving this therapy (~4 months of added life), I am hoping that, at a minimum, this therapy has a coinsurance amount that will make recipients really think about which option they choose. I will be on Medicare in a few years and feel that if we do not start looking at the cost/value proposition of some of these therapies, we will be putting the future care of our children and grandchildren at risk. Cover the therapy, give people a choice but people need to have a

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    Swauger, Ernest Title: Commander, USN (Ret)
    Date: 04/05/2011
    Comment:
    [PHI Redacted] When/if my time comes to deal with this curse, I want every tool possible to fight with. This includes my own immune system. I implore you to approve this treatment, Provenge, and hopefully the treatments to follow using this revolutionary technology to save lives and improve quality of life. Chemo has its place, but Provenge is much better. May God grant you wisdom in your decision.
    Holmes, PE, Bruce Title: Director
    Organization: Holmes Enterprises
    Date: 04/05/2011
    Comment:
    I have been following Dendreon's saga of approval for a number of years and watched [PHI Redacted] (who at 17 enlisted in the Marines and landed on Iwo Jima) die a horrible death due to unnecessary delays in approving this immunotherapy. Your proposed approval is most welcome and ..........it is pretty obvious that if this worked with old men who were about to die and probably had weakened immune systems, it will work better in earlier stages of the cancer. Get going on this,

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    White, Barron Date: 04/05/2011
    Comment:

    This proceedure has been proven safe.

    It has been proven effective.

    There is potential for cures of certain types of cancer.

    The payment needs to be approved ASAP!

    Frankie, Brian Date: 04/04/2011
    Comment:
    I believe the proposed NCD covers the issues surrounding Provenge coverage very well. Clearly, Provenge is both reasonable and necessary for men suffering late stage prostate cancer. It also has great potential for treatment of earlier stages of PCa. The side effect profile is incredibly mild compared to current standard of care. Finally, this is the first approved autologous immunotherapy, and a wonderful breakthrough for medicine with tremendous potential for expansion to help alleviate

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    Ali, Yusuf Date: 04/04/2011
    Comment:
    Thanks for concluding your recommendation supporting the coverage of Provenge. Your support will assist many in need of this once in a life time medical break through to prolong life after all else has failed. Thank you.
    Treves, Jean francois and Ursula Date: 04/04/2011
    Comment:

    We believe it is vitally important that you give this treatment your support for the widest coverage. The scientific data are ever more encouraging, and patients who, at the end of their illness, count on this treatment for a chance to live, are waiting while their providers hesitate in prescribing it while they are awaiting CMS's decision.

    Thank you for your consideration.

    LAMBERT, MICHAEL Organization: SELF
    Date: 04/04/2011
    Comment:
    I STONGLY REQUEST YOU FOLLOW THE RECOMMENDATION TO COVER THE PAYMENT FOR PATIENTS DESIGNATED BY A PHYSICIAN TO RECEIVE PROVENGE. IT IS SAFE, EFFECTIVE AND FAR MORE HUMANE A COURSE OF TREATMENT THAN CHEMO. IT HAS BEN SUBJECTED TO THE SCRUTINY OF EVERY NEEDED AGENCY AND APPROVED.
    Bell, Alfred Date: 04/04/2011
    Comment:
    Dear CMS:
    Provenge is a revolutionary first in kind treatment for Prostate Cancer. It has been shown to be effective in large trials but further use will pinpoint those men who will benefit most from the vaccine. Since this disease is prevalent in older men, it is vital that Medicare coverage be granted so that future generations can share the benefits of this breakthrough treatment.
    Thank you for your consideration.
    schuette, jerry Date: 04/04/2011
    Comment:
    I have been following Dendreon for over 6 years,I im so very pleased that thier technology has advanced to where it is today, although not a cure for cancer it is a major step toward a cure.When we can extend lives with less side effects than chemo/radiation we are on the right path.Having lost [PHI Redacted] 3 years ago to cancer,i pray that some day we can win this BATTLE.Thanks
    Cav, Joe Date: 04/04/2011
    Comment:
    The only way to get new game changing therapies developed is to support them. I agree the price looks expensive but look at the cost of getting this to market. Look at the innunotherapies tyhat have failed.
    The price of these drugs (that the cure does not kill you) will come down in 10 yrs.
    Chemo is bullsh#t if you think about quality of life.
    Meyers, Andy Date: 04/04/2011
    Comment:

    Dear CMS,

    I hope your final determination will be in support of Provenge at least for "on label" use I feel Provenge should be the standard of care for patients with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer.

    Your decision regarding "off-label" use was fair. You could have proposed national non-coverage of off-label use but didn't.

    There is an argument in logic that Provenge will works even

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    Kuziola, Bruce Date: 04/04/2011
    Comment:
    I support the draft decision of CMS to cover Provenge for the following reasons:
    * The median survival benefit of Provenge is almost twice the benefit of the current standard of care (Taxotere),
    * The side effects of Provenge are minimal compared with the current SOC resulting in a much better quality of life,
    * The cost of Provenge is comparable, or better than the total cost of the current SOC when the costs of treating the side effects are taken into consideration.
    As a

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    Cohen, Theodore Date: 04/04/2011
    Comment:
    I concur in CMS’ determination that Provenge is a reasonable and necessary treatment for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer (CRPC). Further, I applaud the farsighted position taken by the Center that allows local carriers, on a case-by-case basis, to consider other possible off-label, non-covered uses of the treatment. Your actions in this matter demonstrate a caring, thoughtful, and manifestly

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    Buntin, William Date: 04/04/2011
    Comment:
    ntlemen, I would like to express my sincere hope that you will allow Provenge to be added to the approved list of drugs that you will cover for senior citizens like myself. I have a friend who is an oncologist that is battling prostrate cancer. He is trying to get in the program but so far he is not yet elgible. If I should someday be in his shoes I hope that will be given the option to use Provenge early. I have watched too many friends and relatives suffer thru the chemotherapy process

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    Lee, Mark Date: 04/04/2011
    Comment:
    I support the decision to cover Provenge for men with late stage prostate cancer. I also support the decision to leave the off-label coverage open. Eventually this type of treatment will become well-understood and a standard of care. When this happens cancer will become a disease we die with, not from. Probably not for us, but for our children or grandchildren. We have to start now and therapies like Provenge are the future.
    Gurnani, Haresh Date: 04/04/2011
    Comment:

    I welcome the draft decision by CMS that deems use of Provenge as "reasonable and necessary."

    Treatment of cancer needs newer technologies and Provenge represents an important first step in that direction. To harness the body's own immune system to fight cancer is an important paradigm shift. There exists the possibility that early use of Provenge may provide even better benefits for prostate cancer patients. Without approval and widespread use of Provenge, we may never know the

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    Small, Steven Date: 04/04/2011
    Comment:
    [PHI Redacted] being a fan of Dendreons efforts to fight prostate disease it is obvious that PROVENGE is as close to a miricle cancer treatment as we are likely to get any time soon. We must have access to provenge as needed to fight advanced prostate cancer. This treatment is helping many patients to extend a usefull life by years not just months. I sincerely hope that any man who needs it and qualifies for provenge will find it available in every region and state in the

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    Rafanelli, Vincent Title: Partner
    Date: 04/04/2011
    Comment:
    I have followed DNDN and the Provenge trials for 10 years- [PHI Redacted] I have always considered Provenge a fantastic alternative [PHI Redacted]. I have read most of the statistical analysis for the trials, and I believe strongly that the effectiveness of Provenge has been under stated due to the fact that all of the trials allowed cross overs. I also believe that the earlier use of Provenge, which will have to be based upon additional trials, may be even

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    Thomas, Bob Date: 04/04/2011
    Comment:
    I believe the decision to cover Provenge was the appropriate action. We've already learned too much about how the unintended actions of many responses against US medical and biotech research companies has started to cause America to lose its strategic advantage in medicine and may even be a threat to national security. Yes, Provenge is a change in the way we treat Cancer. Then again, Penicillin was also a change in the way we treated the virus and infection. It was a good change. I believe

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    newman, fred Date: 04/04/2011
    Comment:

    I am writing in support of CMS providing coverage and reimbursement for medicare patients who are prescribed by their physicians to receive the Dendreon drug Provenge.

    As it has been determined to be both effective in prolonging life and has a favorable safety profile its cost is reasonable when compared to alternative available treatments

    Greenwood, John Date: 04/04/2011
    Comment:
    I would like to go on record as being in favor of paying for Provenge as outlined in your draft report. The men that need this treatment have few other options and this product has been shown to not only lengthen their lives, but does so with little side effects.
    Nagelvoort, Bernard Date: 04/04/2011
    Comment:
    I hereby proclaim my support for the Medicare coverage of Provenge as described in the preliminary recommendation. Approval of Provenge by the FDA opens the door for treatment of late stage prostate cancer with a superior survival benefit and a dramatically improved quality of life compared with the present alternative.
    sears, ralph Title: president
    Organization: S&S CONCRETE CONTRACXTORS
    Date: 04/04/2011
    Comment:
    Provenge: I want to thank all of you for approving this coverage. This is a new age and the coverage adheres to the schooling and knowledge in medical science and advancement of other cures with this decission.
    Mauritz, Daniel Date: 04/04/2011
    Comment:

    Please....Please provide coverage for Provenge.
    Prior to the FDA approving Provenge I had several of my close friends pass away due to Prostate Cancer. I think they might still be out fishing with me if they would have been able to get Provenge when they needed it.

    I now have several more friends and one relative who will be needing Provenge so I hope that the product is available and that it will be affordable for them to use it.

    miller, george Date: 04/04/2011
    Comment:
    please provide us with this alternative to chemo
    some family members of mine and friends have suffered enough from chemo's poison, please give us the opportunity to chose provenge for the right to live our lives happy and peacefully without side effects.
    genualdi, andrew Date: 04/04/2011
    Comment:
    The important point is to lessen the suffering of men with prostate cancer and secondly their families. If Provenge can do this and it has been already been proven, do the right thing allow these men the chance to spend more quality of life days alive.
    Enough lives have been lost, men would still be with their loved ones if only enacted sooner. Shame on all who delayed this vital therapy!
    DILENA, GEORGE Title: ROW inspector
    Organization: work for charlotte county
    Date: 04/04/2011
    Comment:
    TO cms, i would like to thank you for allowing men on medicare to recieve provenge. [PHI Redacted] died of prostrate cancer and i wish this treatment was available for him .I hope I don't get prostrate cancer but if I do I hope to recieve this treament.thankyou from all men,GOD BLESS YOU GEORGE DILENA
    Lee, John Title: Mr.
    Organization: self
    Date: 04/04/2011
    Comment:
    The draft CMS report was a good start; however, the final report should realize the importance to provide for Provenge treatment of PC before the late stage of sickness as indicated by on-label usage.
    bennett, patrick Title: Physician
    Organization: self employed and retired US Army
    Date: 04/04/2011
    Comment:

    I am a retired US Army physician.

    My patient population largely includes other US military retireees and perhaps the single most encouraging development in my practice is the development of Provenge.

    Please, please, please do NOT smother or further hamper the "deployment" of the next new paradigm in medical evolution. The men I am taking care of, and their families, are longing for Provenge to become readily available.

    Palamides, Timothy Date: 04/04/2011
    Comment:
    The CMS is to be applauded in its decision to reimburse the Medicare beneficiaries for such an innovative approach as autologous cellular immunotherapy in the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer. Thank you for the courage to accept this new technology for on-label coverage and recognize the potential benefit of off-label use in the future. Cost seems to a consideration, yet factoring the “quality of life” for the patients whose

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    Range, Bob Date: 04/04/2011
    Comment:
    This is to voice unequivocal support for a final decision by CMS that is consistent with the proposed decision memorandum issued March 30, 2011 for PROVENGE (sipuleucel-T). The strong, well reasoned position taken therein will act to advance medical care and scientific knowledge. It will provide the option of a potentially favorable extension of life treatment, without quality degradation, to men who would otherwise have few attractive treatment options.
    Waldecker, Don Date: 04/04/2011
    Comment:
    Thank you for CMS interim support of Provenge.
    Provenge represents a cancer-care breakthrough which many doctors believe will be even more effective than demonstrated to date.
    I urge support of off-label use so more PC victims can benefit from this most humane treatment.
    Shinerock, Robert Date: 04/04/2011
    Comment:
    Being of an age where Prostate Cancer is a possibility
    I urge you to support the use of Provenge as the best hope of those in the life threatening stage of this disease. Thank You, Robert Shinerock
    Bradley, Lucas Date: 04/04/2011
    Comment:
    Thank you for the preliminary decision to extend coverage for on-label indications. I urge for the use of off-label coverage as well, as Provenge will surely be an invaluable / successful regimen the earlier a diagnosed patient has access. The total cost savings in the long-term with this remarkable treatment are easily identifiable and are surely a fiscally prudent use of limited resources.
    Williams, Larry Date: 04/04/2011
    Comment:
    What would you, in your heart, choose if you had prostate cancer? We have all known people that have had cancer and were treated with chemo and we know what quality of life was like. Given the stringent testing of the FDA and the success of Provenge (with minimal side effects) the honest choice would be VERY EASY to make. Thank you for your initial coverage of this true blessing to suffering men.
    Lohmann MD FACS, George Date: 04/04/2011
    Comment:
    In regards to Provenge, as a practicing surgical specialist for over 35 years, I can say that this is as close to a miracle as anything in treatment of malignancies has come. The overall cost, despite what may appear high initially, is actually much lower that current chemo RX with all of it's concomitant side effects, morbidity and mortality and subsequent hospitalizations for same. Our government should be jumping all over this treatment, not only because of the near lack of side effects,

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    Vander Veen, Ronald Title: Retired Teacher
    Organization: San Jose State University, San Jose, California
    Date: 04/04/2011
    Comment:
    I applaud your endorsement of Provenge for advanced prostate cancer. Hopefully it will open the door for additional breakthroughs and eliminate the need for chemotherapy with its harsh side effects. Hopefully earlier treatment will result in even greater efficacy.
    Cronin PhD., Ciaran N. Date: 04/04/2011
    Comment:

    Dear Sir/Madam

    It is fantastic that CMS is recommending reimbursement for Provenge treatment. In my opinion, as a research scientist of over 30 years, with current emphasis in oncology drug discovery, I view Provenge as a breakthrough paradigm in cancer treatment. It's superior efficacy and benign side-effects profile over the current standard of care, Taxotere, is dramatic, and incredibly encouraging when one considers the advanced stage of the study population. I look forward to a

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    McCarthy, Daniel Date: 04/04/2011
    Comment:
    I fully support the CMS decision to cover Provenge as per label and to allow the regional CMS administrators to allow broader use of the product. Provenge is the cutting edge of a new paradigm for treating cancers of all types. It seems likely to me that future research will show that earlier use (e.g. before the cancer becomes castration-resistant) will result in far better outcomes at a far lower overall cost than current standards of care. [PHI Redacted] I can only hope

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    Traveler, Thomas Date: 04/04/2011
    Comment:

    Provenge took over ten years to development and for late stage Prostate Cancer patients it has proven to extend life with minimal side affects compared to chemotherapy.
    Given the fact that immunotherapy works best when given early I humble request that the FDA and CMS allow a wide birth and favorable label requirements to allow experimental usage in earlier stages of Prostate cancer. Earlier usage will allow Doctors to uncover all the potential that Provenge has to offer. The side

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    Adair, Douglas Date: 04/04/2011
    Comment:

    Provenge is the new standard of care.

    A first in kind treatment - PC patients are truly fortunate to have this option.

    It is time to draw a line under this unnecessary debate.

    The results presented to the FDA were indisputable and approval was given.

    Immunotherapy is the future for cancer treatment and a true way forward to lessen the burden on healthcare through the expensive costs of treating the horrendous side effects of cheno-therapy.

    The

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    Lee, Man Date: 04/04/2011
    Comment:

    I would like to congratulate CMS for their draft decision in providing coverage for Provenge. Provenge is a significant scientific breakthrough in cancer treatment based on years of research and clinical studies where overall survival is clearly demonstrated.

    Men with advanced prostrate cancer can now have a better option than chemotherapy. This approval will paved the way for more treatment options in the future.

    Thank you again and I look forward to the final

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    Lu, Chen-xi Date: 04/04/2011
    Comment:
    You have my full support for such a novel revolutionary treatment of Metastatic Prostate Cancer. I think this is the direction of where cancer treatment is going. What better ways to treat cancer than using our own body defense against it? This is the future. [PHI Redacted] went through cancer treament and I have personally seen the effect of chemo have done to him. I was so glad it wasn't metastic cancer as I can't imagine what it would be like to go through conventional

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    Bailey, Dr Steve Date: 04/04/2011
    Comment:
    I fully support providing Provenge to the public under CMS. This allows for equal access to all strata of our socio-economic population and provides the opportunity to extend life to all citizens.
    Walker, Robert Organization: retired
    Date: 04/04/2011
    Comment:
    I am writing this in support of Dendreon's provenge. [PHI Redacted] I believe that Medicare should cover this in full as the treatment does work as proven and the long term costs to medidare will be ultimatly much lower. It will allow the man to get back into society and be productive. You may contact me it need be. Thank you, Rob Walker
    Owens, Arthur Date: 04/04/2011
    Comment:
    I support the proposed determination regarding Provenge, and I urge that the final determination preserve the ability of patients to have access to treatment using Provenge. I am convinced that Provenge represents an important advance in treatment and that it should be covered by Medicare. It is important to recognize that patients with advanced prostate cancer have a need for the better treatment option that Provenge represents.
    newman, victor Title: President
    Organization: Mandala Books
    Date: 04/04/2011
    Comment:
    I applaud CMS's decision to cover PROVENGE for treatment of Prostate cancer. This treatment which allows the support of one's immune system to fight a disease which has ravaged men ever since Science has extended longevity, is nothing short of visionary. Thank you for allowing nature to prevail over the destruction of Chemotherapy. Sincerely, victor newman
    Elliott, Dan Date: 04/04/2011
    Comment:
    While I believe the CMS Review was unnecessary, the outcome was correct. Provenge will "SAVE" money in the long run.....and did I mention, "SAVE" lives too.
    wick, charles Date: 04/04/2011
    Comment:
    I was very gratified to see the CMS memo recommending coverage of Provenge, including flexibility in off-label use. This exciting,new therapy, carrying few side effects, should be available to doctors in the broadest possible way.
    Only by actual use by treating physicians can the full usefulness of Provenge be determined and refined.
    In comparison with other therapies for this cancer Provenge has no reasonable alternative, has fewer side effects and as a result should in the end be

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    Vestal, Ray Organization: Concerned Taxpayer
    Date: 04/04/2011
    Comment:
    CMS should be applauded for their positive decision for full coverage of Provenge. Even more so, CMS should be praised for their forward thinking about the possible off-label use of Provenge. This decision really shows progressive thinking about the use of new cancer treatments.
    Giboney, Thomas Title: retired & investor
    Date: 04/04/2011
    Comment:
    The Science is proven: Provenge has demonstrated almost a 40% three year survival advantage over what was formerly standard of care chemotherapy. Financially, Provenge is cheaper than the _total_ costs of chemothearpy. As DNDN expands its idustrial base, costs will go DOWN! [PHI Redacted] died of cancer w/ extensive chemo. Provenge is the start of the end of chemo. I will not die by chemo. Secondly, when DNDN begins work on breast cancer, any real or alleged shenanigans of FDA

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    Petersen, Jeanne Title: Tax Payer
    Date: 04/04/2011
    Comment:
    CMS has come to the correct conclusion. The road for Provenge's approval was long and many men have waited while suffering the wretched pain of prostate cancer. To my dismay many men did not make it. I have seen first hand the last months of a victim of this disease and cannot wipe those memories from my thoughts. Isn't it interesting that so many choose NOT to take chemo knowing that pain and difficulty lie ahead?
    Provenge is just the beginning and a real step towards the cure for cancer.
    Caricato, Nicholas Date: 04/04/2011
    Comment:

    Dear CMS,

    I would like to applaud you for your recent support of the draft decision in favor of coverage for Provenge. This new technology is destined to change the way we fight cancer. As the good friend of a late stage Prostrate cancer victim, I can tell you first hand that your brave efforts are making a positive difference in peoples lives and you should be very proud of yourselves. Thank you very much and god bless you.

    Winter, Rolland Organization: This Is a personal comment
    Date: 04/04/2011
    Comment:

    It is utterly impossible to understand the huge delays in approving the Provenge technology and the reimbursement of this procedure. Now we wait even another 90 days for a 'final' determination - absurd. You bureaucrats should be forced to visit a prostate cancer ward for one hour for every day you put off approving payment for this disease-ending, life-saving, wonder treatment. Shame!

    Rolland D. Winter
    Williams, Ray Date: 04/04/2011
    Comment:

    Provenge is breakthrough technology setting a new standard of care in the treatment of Prostate Cancer. Truly a Godsend for those suffering from prostate cancer. Side effects are minimal compared to chemotherapy.

    Thank you.
    Blackburn, S. J. Title: none
    Organization: none
    Date: 04/04/2011
    Comment:

    I want to thank you for confirming coverage of Provenge for treatment of late stage prostate cancer.
    We had a neighbor who died while waiting to receive it and another neighbor is on the list. After looking at Docetaxel and the horrible side effects, there is really no choice for these men.

    Please, in your final draft, confirm the coverage of Provenge as listed in the tentative draft just released. Thank you.

    Tolle, Dave Date: 04/04/2011
    Comment:
    Your preliminary report is on target, and I hope your final decision agrees with it: Provenge is beneficial and reasonable for its indicated use, and as more information is gathered in the coming months and years, its applicability may broaden to include earlier use, as well as other types of prostate cancer.
    Ross, George Date: 04/04/2011
    Comment:

    Members of the CMS panel, I would like to take this time to thank you for releasing the draft proposal recommending that PROVENGE be fully reimbursed for its on-label use and possibly off label use if the physician deems it worth while. You've made a tremendously wise decision in the on going battle of CANCER period.

    With Regards

    George Ross

    Kearney, Rory Title: President
    Organization: Care To Live
    Date: 04/04/2011
    Comment:

    I am president of Care To Live, the not for profit organization that fought long and hard, along with the Abigail Alliance, for the approval of Provenge.

    Now that we have met our goal, and Provenge is FINALLY approved, it is so very important that we encourage treatment with Provenge, as it is a major shift in the way cancer is attacked. Instead of losing the war, we finally have a chance of "winning", by utilizing this smarter, safer, more sensible way to attack the

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    Nestler, Scott Date: 04/03/2011
    Comment:
    I applaud CMS for proposing that Provenge be covered for men covered by Medicare and Medicaid. The FDA has already approved Provenge as an effective immunotherapy for cancer; it now needs to be available to all men who can benefit from it -- not just those with deep pockets. I hope that the Final Decision memo matches what is in the Proposed Decision memo. It is the right thing to do to prolong life (and the quality of life) for those suffering from prostate cancer.
    gottesman, joe Title: scientist
    Date: 04/03/2011
    Comment:
    To little to late for many patients. CMS/FDA are giving me flashback of Galileo Galilei.
    Schreiber, Karl Date: 04/03/2011
    Comment:

    Dear Sir or Madam:

    I am glad that you are recommending reimbursement for “on label” use of Provenge.

    Please consider partial reimbursement for “off label” earlier use. It is important that you get involved with immunotherapy at earlier stages of disease to verify that, as many Doctors have suggested, immunotherapy should work even better the sooner it is given.

    By offering partial reimbursement to earlier users and requiring follow-up for life, you can

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    Clark, Daniel Date: 04/03/2011
    Comment:
    A new drug/therapy such as Dendreon's Provenge is an important addition to the fight against prostate cancer. The quality of life differences between Provenge and chemotherapy are immense and it remains to be seen what the full range of efficacy is for this new cancer therapy. We know what chemo and other more invasive treatments can and cannot do. It is now important to allow this new therapy a chance to prove the extent of its effectiveness both in late stage and early stage prostate cancer

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    Varghese, PhD, Tom Title: President & CEO
    Organization: Cybioms Corporation
    Date: 04/03/2011
    Comment:
    The use of Dendreon's Provenge is the only last hope for many Prostate Cancer patients. It is the responsibility of the US Government not to stand in the way of such life or death decision for its citizens. CMS must approve the use of Provenge without any more delay and without any more influence from the anti-provenge lobby that has been in existence over the last so many years.
    Hudkins, Bruce Date: 04/03/2011
    Comment:

    I am writing in strong support of Provenge vis a vis the language in the recent CMS draft position. I think that this will ultimately prove to be an important milestone in the fight against prostate cancer.

    Bruce Hudkins, MD
    arnold, leslie Date: 04/03/2011
    Comment:
    I applaud the CMS recommendation to provide coverage for Provenge. This is an exciting advancement in our war on cancer. Having watched [PHI Redacted] suffer through chemotherapy I truly believe this treatment has opened the door to less toxic and more effective treatments. I strongly urge CMS to provide coverage for this cutting edge treatment. Thank you
    leachman, sheldon Date: 04/03/2011
    Comment:

    Thank you for your decision to include Provenge as a covered therapy in the treatment of late stage Prostate Cancer. That was the right thing to do.

    One day, I expect to thank you again for expanding coverage of Provenge to other applications and therapies, including early stage Prostate Cancer.

    I and others pay that day comes soon.

    Sheldon Leachman
    chow, alfred Title: taxpayer
    Date: 04/03/2011
    Comment:
    Really appreciate your agency spending so much time and effort to study the issues and finally deciding to provide Provenge coverage to PC patients. Thank you.
    chow, karen Date: 04/03/2011
    Comment:
    Thank you for providing national coverage of Provenge to prostage cancer patients.
    Hollander, Howard Date: 04/03/2011
    Comment:
    Provenge needs to be available to those in need including those with off label uses.
    bowden, phillip Date: 04/03/2011
    Comment:

    Please approve Provenge. It has been proven to be effective, and is much better than chemo alternatives. Many men would choose to not get treatment if chemo was the only choice. Any off-label flexibility would be greatly appreciated, as this is a breakthrough treatment from which many prostate cancer sufferers could benefit.

    thank you

    Scott, Ardeis Title: MD
    Date: 04/03/2011
    Comment:

    It is a huge advancement in the medical community and the cancer treatment sector to allow national reimbursement for Provenge.

    This vaccine provides a revolutionary approach to the treatment of cancer and has been withheld from widespread public use for a shamefully long period of time. We are discussing the number two killer of men from cancer in the United States.

    Provenge is a proven treatment which not only extends life expectancy but provides a quality of life

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    Bielen, Alex Date: 04/02/2011
    Comment:
    To a certain extent the FOIA documents obtained through the efforts of Care To Live go a long way in demystifying the necessity to define and consolidate coverage under an NCD. The working draft decision expresses a compassionate understanding for the pressing present need for this next generation therapeutic.
    Should future evidence demonstrate improvement in patient outcomes leaving off label coverage open to the discretion of local contractors signals a welcome hope that earlier

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    Timlin, E Date: 04/02/2011
    Comment:
    Dendreon's breakthrough prostate cancer treatment Provenge may well be curative, and most certainly prolongs high quality life years, particularly when the debilitating effects of traditional chemotherapy are considered. I believe the study data speaks for itself, regarding efficacy, and the patients consider this far better than the alternatives, in terms of quality and extension of quality life. I wholeheartedly support CMS intention to provide coverage.
    Odell, Brenda Title: Concerned Citizen
    Date: 04/02/2011
    Comment:
    I would just like to say THANKS for the wisdom exercised in the CMS rough draft reference the above title, and I hope it is reinforced in the final decision 6/30/11. Based on the science, I could not imagine that you would have done otherwise for this revolutionary paradigm in the treatment for prostate cancer. I am quite aware that the median results quoted are almost always misinterpreted by the media, but I KNOW THE DIFFERENCE between median and mean. The public has been greatly misled

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    Bartz, Manfred Title: R&D Engineering Manager
    Organization: Philips Healthcare
    Date: 04/02/2011
    Comment:
    Provenge is a breakthrough treatment that is one of the most effective cancer therapies on the market today with minimal side effects. Follow on studies indicate that it is likely much more effective at prolonging life than originally indicated because many in the placebo control group later progressed to receive Frovenge, a frozen, but less potent version of Provenge. Hence the treated group was competing and being compared with a control group that was receiving a delayed benefit from the

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    pateracki, alan Date: 04/02/2011
    Comment:
    It's hard to understand how, after all this time, that there is still a question as to whether or not Provenge works and that it most deinitely should be approved for CMS coverage. It's proven to work by the stingent standards of the FDA. What are my other choices should I be stricken by PC. God forbid! Some chemo drug which will knock the stuffing out of me and what ever life I still have left in me? No thankyou. Time to step into the new age of cancer treatment and get out of the stone

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    Huynh, Charlie Date: 04/02/2011
    Comment:

    The decision to fully support and allow CMS coverage/reimbursement for Sipuleucel-T (aka Provenge) used for FDA approved on-label indications is the correct one in my opinion.

    In the short term, the cost of Provenge when one looks at the overall picture is actually less than Chemotherapy treatments (Taxotere) for Prostate cancer because of the number of Chemo treatments needed and other medical costs due to the bad side effects of Chemotherapy. Provenge also is a much more

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    Belloto, Tim Date: 04/02/2011
    Comment:

    I applaud that CMS will be covering Provenge for men with advance prostate cancer, and that CMS is leaving off label use open to the local sub contractors. This is an important treatment in the fight against cancer.

    As a taxpayer I pay into the Medicare/Medicaid fund on a regular basis. I expect that when I reach the age to be covered, that I can continue to see that I am covered for all treatments approved by the FDA, and that I and my doctor can decide what is best for me.

    Whalen, Terrance Date: 04/02/2011
    Comment:
    I recommend approval provenge for medicare coverage. Of the currently available treatments, this drug provides the best life extending results while also showing the least negative effects. The cost of the medication is not only within the range of similarly priced chemotherapeutic treatments, but represents a comparatively lower cost due to the extremely limited supportive care needed to mitigate side effects. Note that it is a one-time treatment, unlike other treatments that may look less

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    Hise, Dale Date: 04/02/2011
    Comment:
    This country needs to imbrace new treatments for fighting cancer and Provenge is that treatment. It gives men with advanced prostate cancer a much better fight. To witness this disease and its current treatments literally decay the body is unforgettable. Thank you CMS for your positive review and my only hope is that Provenge could be used for earlier stage cancer as well. We will find that by extending life without the additional expense of treating the side effects will ultimately save this

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    Wilson, Bob Date: 04/02/2011
    Comment:
    I am appalled to read some dissenting views from the preliminary CMS decision by doctors who don't even know the difference from median and average survival benefits and who believe Provenge should not be Medicare reimbursed because it is non-curative (of course no other treatment for advanced prostate is either). One has to wonder what other agendas are operative. Provenge has demonstrated almost a 40% three year survival advantage over what was formerly standard of care chemotherapy. And

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    Mork, Claire Title: individual
    Date: 04/02/2011
    Comment:
    I support the CMS decision to pay for Provenge therapy for men with late stage prostate cancer. It is a major break through in the treatment of a deadly cancer and offers new hope for the many prostrate cancer patients and their families.
    Paladin, David Date: 04/02/2011
    Comment:

    To: Louis B. Jacques, MD
    Director, Coverage and Analysis Group

    Tamara Syrek Jensen, JD
    Deputy Director, Coverage and Analysis Group

    James Rollins, MD, MSHA, PhD.
    Director, Division of Items and Devices

    Leslye K. Fitterman, Ph.D.
    Lead Analyst and Epidemiologist, Division of Items and Devices

    Lori Paserchia, MD
    Medical Officer, Division of Medical and Surgical Services

    Eileen Pencek, RN, BSN, MBA
    Analyst, Division

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    oesting, heather Title: president
    Organization: abilita, inc.
    Date: 04/01/2011
    Comment:

    i strongly urge you to give full approval to provenge. this drug represents the currently available maximum effect balanced by the minimum negative efect in the treatment of prostate cancer. the cost of the medication is not only within the range of similarly priced chemotherapeutic treatments, but represents a comparatively lower cost due to the extremely limited supportive care needed to mitigate side effects. provene is, indeed, a reasonable and necessary weapon in the armamentarium

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    Tjie Khauw, Tan Title: Mr
    Date: 04/01/2011
    Comment:
    I had a family friend who died of PC after going through chemotherapy in Singapore, I can guarantee this well loved person would choose Provenge had this noble treatment been available to him. I hope Dendreon can bring this first ever immunotherapy noble treatment to Asia much sooner. This treatment by Provenge that prime up person's immune system to fight cancer is God sent, it is both effective and with very tolerable flue like symptoms, it should and will be embraced by the world over.

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    Cornell, David Date: 04/01/2011
    Comment:
    I am a college professor and lacrosse coach who has followed this "story" for many years following multiple family/friends suffering from cancer and in particular, prostate cancer. Provenge must be covered!!!! This decision is too important to too many lives. Provenge has the potential to be the foundation for which all individuals/families will look upon in dealing with this horrific disease. This is what we've been searching for to fight....hope!!!
    Thank You,
    David Cornell
    hise, andrea Date: 04/01/2011
    Comment:
    Prostate cancer is a horrible disease and the current treatments such as hormone, chemo, radiation have so many side affects that the patient usually requires much more treatments. Provenge will save the government money because there are hardly any side affects. Our scientist have discovered how to use our own immune system to help with this fight. Life is precious and if we can do what we can to help slow this disease by an FDA approved therapy imagine what we could accomplish if we could

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    lee, bsn,rn, anatoinette Title: RN, BSN
    Organization: private pratice
    Date: 04/01/2011
    Comment:
    I warmly applaud you for your converage of Provenge for metastastic prostate cancer.
    What could be better than this new immunotherapy?
    Chemotherapy is passe'for this disease, with its terrible side effects.
    Physicians should realize that the extension of survival can be much longer than the median 4 months that is stated. You have to read the whole trial to get this.
    Schmidt, Phillip Date: 04/01/2011
    Comment:
    I am extremely pleased that this treatment is now going to be available to people who need it instead of just those who are able to pay for it. It has great potential, and no bad side effects -- and it extended the lives of 30% who took it by a year or even more than a whole year. Further, it is a one sequence treatment and does not require continuous treatments as chemo does. It is in the final analysis CHEAPER than the traditional chemo when ALL of the chemo-related expenses are factored

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    Albert, Joe Date: 04/01/2011
    Comment:
    This treatment for prostate cancer is truely remarkable in theclife extension with little or no side effects. The cost is quite comparable to chemo when you consider the treatment for the attendent side effects as well as quality of life issues.
    Klotz, Lee Date: 04/01/2011
    Comment:

    I applaud the Centers for Medicare and Medicaid Services for their draft decision to cover Dendreon's Provenge. This is the beginning of a new age of cancer care that will provide patients with more effective, more humane, and more affordable treatments.

    Media confusion about the cost of the treatment and its effectiveness is discouraging. Only three treatments in the last two decades have extended life to this degree.

    Arguments that claim that Provenge is too

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    gauntt, lore Date: 04/01/2011
    Comment:
    It is so important to cover provenge for the patients that suffer from this horrible disease. Unless you have been through the effects of Chemotherapy and the devastation it does to the body PROVENGE will actually SAVE the government money because you won't have to pay the additional cost of keeping the patient comfortable and treating the havocs it puts on the body. Our scientist in this country have found a breakthrough for patients with prostate cancer and approval by the FDA is further

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    Petroff M.D., Dennis Title: M.D. private practice
    Date: 04/01/2011
    Comment:
    I strongly support your memo to approve payment for Provenge and urge you to issue a similar positive final determination as soon as possible.
    Madden MD, Robert Date: 04/01/2011
    Comment:
    I am an Internal Medicine physician. I have a personal family history of cancer and I would have specialized in oncology except for the fact that standard chemo offered very little to these pts.(Most of them die without benifit.) A few exceptions being Lymphomas and Leukemias.I am very excited by these new biologic treatments monoclonal antibodies and targeted cancer therapies.
    As Many of us know Standard Chemotherapy is also very expensive and it is embarrising how very little it has

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    Murphy, Jerome Title: Retired
    Date: 04/01/2011
    Comment:
    Thank you for the decision in favor of Provenge it is truly a step in the right direction. For years I listened to Oncologist tell those in there final day of life that "Chemo" would offer a quality of life. The quality of life they spoke of left patients bed ridden and or hospitalized because of the side effects of the treament and left the family feeling guilty about the decision not to mention the cost. Going forward the off label use might even prove to be a cure for early diagnosis. Thank

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    Hankins, Richard Title: RN
    Date: 04/01/2011
    Comment:
    I sincerely thank you for your recent recommendation to pay for the Provenge therapy. I have followed the path of Provenge for many years. It appears to be a new paridigm treatment that addresses not only survival, but overall quality of life. My own personal experience with Prostate cancer was [PHI Redacted], whom upon the return of the disease , lived an agonizing year. Constant pain, morphine solution and astounding weight loss. A man who had worked in a factory as a

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    Albin, Sacharia Date: 04/01/2011
    Comment:
    Provenge is the only treatment approved by FDA after all possible questions on efficacy were answered. The side effects and cost of Provenge are nothing compared those from alternative treatments like chemo. Provenge should be covered by medicare on this ground alone.
    Vachira, Vitoon Date: 04/01/2011
    Comment:
    For many years I've been following Dendreon Corp. because of their fantastic product: Provenge. [PHI Redacted] I've seen personally what chemo therapy have done to them both. There has to be a better more humane way to treat cancer and we have it now in Provenge. Thank you for paving the way for the medicare to better science and better alternative to cancer. This is the future and this is just the beginning. I urge all of the at CMS to finalize the decision to cover this

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    Williams, Ford Date: 04/01/2011
    Comment:
    The original trial for this treatment called 9901 had 127 men with advanced prostate cancer. They had their chemical castration and yet, the cancer came back. The trial was given a census of 2/3s in the treatment arm and 1/3 in the placebo arm. Crossovers were allowed when their disease advanced with metastases or pain with their bones or both. They were given frozen Provenge. The results is a 4 month Median statistic of longer life than the placebo. This isn't quite right. Almost all

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    Liao, Yihong Date: 04/01/2011
    Comment:

    I am here giving my total support for the CMS decision to cover Provenge for men with late stage prostate cancer. There is no doubt that this is the correct decision—legally, morally, financially—by every relevant measure.

    Further, I have reason to expect that Provenge used in earlier stage disease will work even better.

    Cleland, Robert Date: 04/01/2011
    Comment:
    Please do the right thing and approve the use of Provenge for the immunotherapeutic treatment of Metastatic Prostate Cancer. Provenge is becoming the standard of care for this ravaging disease and is proven to be significantly superior to chemotherapy in terms of toxicity and efficacy, as well as in quality of life issues.
    Hollingsworth, Kevin Title: Manufacturers Representative
    Organization: Leisure Sales
    Date: 04/01/2011
    Comment:
    I am commenting to state my total support of the CMS decision earlier this week for coverage of Provenge Treatment for men suffering from Late Stage Prostrate Cancer (PCa). I'm also somewhat encouraged by the language used towards the treatment or use of Provenge for earlier stages as well. While I understand that coverage of Off-Label use may not currently have any governing rules in order to be covered and it's been left entirely up to the sub-contractors, it's my belief that the use of

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    Alan, Michael Date: 04/01/2011
    Comment:

    I’m sure in the end we’ll all benefit from these small steps taken by companies like DNDN. I know it cost them billions to get this approved.

    However it is beyond my belief that this treatment is going to cost the tax payers $93,000 and only prolong life for +/- 4 months. In my opinion the end doesn’t justify the means here. This voodoo witchery needs to stop.

    It is time for Mr. Public to confront the inevitable that eventually we all are going to die. We shouldn’t

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    Hubbard, Kim Organization: Individual
    Date: 04/01/2011
    Comment:
    I have been following Dendreon for years due to having a personal interest. [PHI Redacted] died of prostate cancer and I have two grown sons that I worry about. [PHI Redacted] was diagnosed with prostate cancer and went through a round of radiation after which he went into submission for 5 years. The cancer returned and his only option was chemotherapy. To this day I believe it was the chemo that killed him. It poisoned his body to the point that he no longer

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    Malloy, Mike Date: 04/01/2011
    Comment:
    First let me express my disgust at the self-centered comments made by physicians in other areas of specialty who object to this product because it takes some of the pie called Medicare which they voraciously. Worse yet are urologists who would rather condem their patients to toxic chemotherapy that destroys the quality of life of men in thier last days on earth. Why would any physician want to increase the 3 year survival rate in their patients by 40% if it wasn't economically advantageous to

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    Klein, H.J. Date: 04/01/2011
    Comment:
    On behalf of the European men with late stage prostate cancer I salute you. By covering Provenge in the USA you speed up the decision making process regarding Provenge in Europe. That is why everyone will remember your name.
    Drevs, Ronald Title: Retired Medical Professional
    Date: 04/01/2011
    Comment:

    Doctors against Provenge reimbursement are not fully informed.
    Legally Medicare must cover treatments for the Medicare population that are "reasonable and necessary". There can rationally be no questioning whether Provenge is reasonable and necessary for men with late stage prostate cancer. It is a true breakthrough in cancer treatment—harnessing the patient's immune system to fight the cancer, while producing very minimal side effects. Provenge has produced the greatest survival

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    Wilson, Steven Date: 04/01/2011
    Comment:
    I congratulate CMS for concluding that Medicare should provide on label coverage of provenge for the treatment of metastatic prostate cancer. This treatment provides a significant survival advantage and negligible side effects when compared to toxic chemo alternatives at a comparable cost. I hope that regional MACs are provided the freedom to allow off label usage of this treatment in earlier stage prostate cancer, as I believe it will be even more effective in those patients.
    Fischer, M Date: 04/01/2011
    Comment:
    I applaud your decision to cover sipuleucel-T as the evidence in support of the effectivness of this treatment has stood up to intense scutiny, perhaps of a level that has not been seen before. This action of support for sipuleucel-T will not only provide a welcomed treatment, it will open the doors for opportunities to examine effectiveness at earlier stages in the disease. Such foresight on your part is to be congratulated.
    Rostock MD, Robert Title: Attending Physician
    Organization: Geisinger Clinic
    Date: 04/01/2011
    Comment:
    I found the recent NCA document about provenge very fair and comprehensive. I have never before seen an FDA approved drug go through so much scrutiny and generate so much controversey. CMS has done a fine job in addressing those issues. My only concern is the time it takes to complete the process.
    I fully support the use of provenge as approved by the FDA. Prostate cancer is the main focus of my practice. I have seen many patients die from this disease. Provenge represents a

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    Balsamo, Dom Date: 04/01/2011
    Comment:

    CMS - You have made the most appropriate decision possible with regards to both scientific standards and moral standards.

    You'll read many a comments from people who lament about the pricing of Provenge. Please continue to see through these comments for what they are. They are simply investors who tried to bet against your review.

    Anyone with a knowledge of the science, a loved one who has suffered from cancer, or any compassion at all understands the need for

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    CHENG, ROBERT Date: 04/01/2011
    Comment:
    I support National Coverage Analyses (NCAs) decision to cover Provenge for men with late stage prostate cancer. I also praise NCA's decision to leave the off-label coverage to the contractors of CMS. I strongly believe that Medicare would save money by treating patients with prostate cancer at the early stage instead of late stage. I believe money and lives would be saved by covering Provenge use, nation-wide, in earlier stage of prostate cancer.
    Zaczyk, Mike Date: 04/01/2011
    Comment:
    Thank you very much for deciding to cover Provenge. Patients should have choices other than expensive and painful chemotherapy (which ultimately costs more than this treatment due to all the awful side effects). Men have suffered too long with no alternatives. Thank you!
    Antonich, Steven Title: Farming
    Organization: na
    Date: 04/01/2011
    Comment:

    To CMS,

    I want to thanks CMS for voting to reimburse for Provenge. By this action you have opened the door on research into immunotherapy's for other forms of cancer. We are now assured that there will indeed be a new treatment paradigm that is beginning to take the place of the cut, burn and poison as new insights into cancer immunotherapy are learned.

    What better treatment can be had than to have a treatment that teaches our own immune system to recognize cancer

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    Erickson, PhD, Stephen Date: 04/01/2011
    Comment:
    Thank you for your clear and considered decision. I have followed the trials and the commentary surrounding them for nearly a decade. You have obviously thought the matter through in a very judicious manner. Of course there will always be critics of any decision. Calculating the cost of alternative chemo therapies, and recognizing what is probably the understated survival benefit shown by Provenge, you are showing the way forward and benefiting us all.
    Battaglia, Stephen Title: Retired
    Date: 04/01/2011
    Comment:
    I hope that you will approve this breakthrough method of treating late stage prostate cancer and will consider the effectiveness for earler stage prostate cancer also. Having had [PHI Redacted] go through breast cancer at relatively early ages, one at 25 (now 41) and one recently at 39 (now 40)and seeing the suffering of one of them going through taxotere, hospitizations, emergency visits to her doctor, immune system boosters causing severe pain, loss of hair, sickness,

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    Quinn, John Date: 04/01/2011
    Comment:
    Provenge truly is a miracle treatment. Its median life extension is almost double that of the current standard of care for the same indication, Taxotere, while delivering no practical side effects compared to the harsh, standard of life reducing side effects of chemo. As Provenge is tried in men with healthier immune systems who knows how great its benefit will show to be. Hopefully, this is just the first of many immunotherapies that addresses this terrible disease.
    O'Donnell, Joseph W. Date: 04/01/2011
    Comment:
    I was quite pleased to read your recently released draft comments on Provenge label approval(s). It is apparant to me that Provenge's ability to extend the quality of life of late stage prostate cancer victims creates a compelling value proposition versus other more costly treatments that carry with them, significant negative side affects that mitigate "quality of Life". In all prpbability, although as yet statistically unproven, it would seem to me that getting this treatment earlier will

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    Saunders, V. Date: 04/01/2011
    Comment:
    This comment period will be another "free for all" of uneducated biased, negative, opines. The media has painted a very distorted picture of the merits of Provenge. Back in '07 when [PHI Redacted] was a candidate for Provenge it was denied him by not being approved then. By today, hundreds of thousands of men with adv. PC have died, just like [PHI Redacted] did....the truth is that a third of these Provenge recipients have gone on to live many YEARS ! Half the

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    Varozza, Jack Date: 04/01/2011
    Comment:
    The recent CMS draft memo on Provenge was a 100% the right decision with regards to on and off label use. My family has been involved the medical field for 4 generations and we support this decision completely. Provenge is as close to a miracle drug for prostate cancer patients as one could get. Giving a grave prostate cancer patient 40% chance of being alive after 3 years is amazing and most importantly the quality of life is there. I watched [PHI Redacted] get ravaged by

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    Adams, Lee Date: 04/01/2011
    Comment:

    I am commenting in response to the excellent decision by CMS regarding Dendreon's Provenge. Provenge has produced the greatest survival benefit ever for this disease, and the results have been reported in the New England Journal of Medicine. Since by definition of "median" half the studied men lived more than an extra 4.1 months, a much more telling measure is the three year survival rate. The three year survival rate for men treated with Provenge improved by a whopping 40%. It should also

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    Sage, Larry Organization: none
    Date: 04/01/2011
    Comment:
    Yes, of course! fund Provenge. We finally have a proven method of fighting cancer and it's no more expensive than the overall cost of previous treatmends that don't have nearly the potential for further development and that impose their own, nearly lethal, brand of suffering on patients.
    Fassett, Frances Date: 04/01/2011
    Comment:
    The arguments here against Provenge treatment for Prostate Cancer are probably financially motivated. A threat to one's income is frightening. I wonder how many oncologists are afraid of losing their goose that lays those golden eggs - no chemotherapy, no ongoing money stream. Check those conflicts of interest, CMS. We don't really know how much longer Provenge patients will live - because so many of them are still alive!
    Pietroski, Scott Date: 04/01/2011
    Comment:

    The dawn of a new era in the fight against cancer has finally arrived. Provenge is the first therapy of its kind that actually treats the patient with their own body! I know of no other cancer treatment that can say the same.

    You hear of all the bad things that the FDA and Medicare do. Finally there is something to be proud of!

    Thank you for allowing the use of this long awaited treatment.

    Wick, Brad Date: 04/01/2011
    Comment:
    Thank you for making the right recommendation to cover Provenge for treatment of metastatic prostate cancer patients. This is an exciting treatment that has proven to be very successful in prolonging the lives of men while preserving their quality of life. As has been shown in trials, over 30% of men on Provenge were still alive after 3 years! Prostate cancer has severely impacted my family in many ways and I hope that the final decision at the end of June is to fully cover on-label usage

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    Roman, Chuck Date: 04/01/2011
    Comment:
    Thank you for your recent review and summary recommendations for the use of Provenge. Please continue with your formal/final recommendations and provide this unique treatment modality. Provenge is a much needed option from the toxic treatment of Chemotherapy. Hopefully in my lifetime the immune based treatment will change the way Cancer and perhaps other diseases will be treated and perhaps cured. Thank you for taking the necessary steps in establishing this paradigm shift in medicine.
    Ackerman, Michael Date: 04/01/2011
    Comment:

    We need to approve payment for Provenge so that as many men as possible can recieve the therapy. The data on these men can be used to determine which sub-group benefits more from the drug. This will, in the long run, reduce the amount of Medicare dollars spent on fighting this disease.

    Thank you!!!

    tabano, richard Date: 04/01/2011
    Comment:
    Provenge is a tremendous breakthru in the treatment of Prostate Cancer and also possible cure for this type of cancer and hopefully others.It should be allowed for on label and off label use.
    Hornish, Greg Date: 04/01/2011
    Comment:
    I support the decision for CMS to cover Provenge for men with prostate cancer. I am so excited to see that we have finally found a breakthrough type cancer treatment that that has minimal side effects and is reasonably priced compared to other traditional chemo treatments.
    Maness, GUY Title: Manager
    Date: 04/01/2011
    Comment:
    I agree with the current stated NCA decision on Autologous Cellular Immunotherapy Treatment of Metastatic PC. This will help all the men in this indication with another viable option with much less side effects and better chances of longevity.
    Lightner, Ruth Title: Concerned Taxpayer
    Date: 04/01/2011
    Comment:
    Given the controversy regarding the true efiicacy of this therapy as well as the significant cost, it is imperative that actual clinical results under real-world conditions be monitored and measured. CMS should require follow-up clinical studies validating the results and a follow-up evaluation of continued coverage. For these same reasons, CMS should not approve payment for off-label indications. THank you for your consideration.
    Goodenough, Donald Date: 04/01/2011
    Comment:
    I strongly support the CMS findings and policy regarding Provenge. [PHI Redacted] I have followed Provenge's journey for the past six years and feel the most logical explanation of how it works is that it attacks the smaller metastases first and therefore prolongs life. So, I believe the quicker a patient can receive Provenge after a prostectomy, the more likely a cure or at least a managed control can be accomplished. Also, the minimal side-effects makes a huge difference.

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    Blaisdell, Judith Title: retired occupational therapist
    Organization: VAMC
    Date: 04/01/2011
    Comment:
    Thank you for supporting this new advancement in the treatment of prostate cancer.
    Blaisdell, Ernest Title: Emeritus Professor of Mathematics
    Organization: Elizabethtown College
    Date: 04/01/2011
    Comment:
    Thank you for making a positive decision concerning Dendreon's new revolutionary treatment for prostate cancer. Many thousands of victims of this dreaded disease will now benefit from your action. Moreover, this new treatment, Provenge, may ultimately lead to a cure for some forms of cancer.
    Kerpelman, Saul Date: 04/01/2011
    Comment:

    I am commenting to state my total support for the CMS decision to cover Provenge for men with late stage prostate cancer. There is absolutely no question that this is the correct decision—legally, morally, financially—by every relevant measure.

    Legally Medicare must cover treatments for the Medicare population that are "reasonable and necessary". There can rationally be no questioning whether Provenge is reasonable and necessary for men with late stage prostate

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    Koers, Randal Date: 04/01/2011
    Comment:
    Great forward looking policy for a first in kind treatment that may spearhead large positive changes in cancer treatment. Congratulations.
    Dalton, Kevin Organization: Dalton Education, LLC
    Date: 04/01/2011
    Comment:

    This therapy, which is not a drug, signals a new approach to treating cancer patients. In clinical trials it has shown significant survival results over placebo and standard of care Tx.

    A 40% increase in 3 year survival is only one of the results. It should also be remembered that the trial group, because of ethical considerations, was comprised of only very sick patients. Meaning, that more work needs to be done with a healthier trial group to see if the effects of Provenge

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    Johnson, Gloria Title: RN
    Date: 04/01/2011
    Comment:
    Thank you for your compassionate and reasonable response to coverage for Provenge for treatment of metastatic prostate cancer and leaving open the possibility of coverage for off-label usage. Many of us believe that earlier usage of Provenge could be key in better response and potentially a cure. As a registered nurse and advocate for patients, we appreciate another weapon in the war on cancer.
    Sapire, PhD, Dennis Date: 04/01/2011
    Comment:
    Thank you, thank you for your decision to cover Provenge. [PHI Redacted] it is very reassuring to know that it will be covered bt Medicare. As far as I can tell, it represents a momentous breakthrough in cancer treatment and especially in quality of life during treatment.
    Miller, Israel Date: 04/01/2011
    Comment:
    It is beyond belief that the drug is going to cost $23,000 per treatment and only prolong life for +/- 4 months. It is time for the US public to confront the inevitable. We all die and we don't have to drain the coffers in our efforts to stay alive for an extra week or even 16 weeks. It's time to stop the drug companies from over charging (yes, they spent 1.2 billion to develop the drug but they don't need to make it back in one year as predicted they will. If they over charge, as in this

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    Niedelman, Adam Date: 03/31/2011
    Comment:

    I cannot begin to describe my visceral reaction to the news that Medicare is choosing to cover a $93,000 non-curative treatment that MAY exend life by 4 months. Given Medicare's actions in cutting reimbursement to physicians for proven, life prolonging testing and services (with a fraction of the cost) over the past few years, the decision is even more appalling.

    As I go to work tomorrow at my medical practice, worried about our financial solvency because of Medicare's recent

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    silverstein, steven Organization: inland northwest urology
    Date: 03/31/2011
    Comment:

    Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (sipuleucel-T)

    I am a board certified urologist, practicing in private practice since 1981, now retired.

    I have followed the sipuleucel-T testing. In my opinion, this is not an effective and certainly not cost effective treatment option for prostate cancer. there is sparse objective data with no psa benefit, the outcome of a three month survivial benefit is not truley clinically helpful to an

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