National Coverage Analysis (NCA) View Public Comments

Aprepitant for Chemotherapy-Induced Emesis

Public Comments

Commenter Comment Information
Pruemer, Jane Title: Oncology Clinical Pharmacy Specialist
Organization: University of Cincinnati Medical Center
Date: 02/04/2005
Comment:

As an oncology pharmacy specialist, I have seen the benefits of aprepitant in preventing the nausea and vomiting seen with cisplatin-based chemotherapy regimens. Due to the fact that elderly patients often have only Medicare coverage, they have a hard time affording this important therapy. Many times patients are admitted to the hospital for uncontrolled, refractory nausea and vomiting, and this costs the Medicare system much more money than paying for the 3-day aprepitant regimen

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Gershon, Barry Title: Director, Public Policy and Advocacy
Organization: GlaxoSmithKline
Date: 02/04/2005
Comment:

GlaxoSmithKline appreciates the opportunity to comment on the recent National Coverage Analysis (CAG-00248N) that would extend Medicare Part B coverage to aprepitant, an oral anti-emetic under certain circumstances. The product would only be covered for patients who

  • Are receiving anti-cancer chemotherapeutic agents defined as level 5 on Hesketh’s classification system of acute emetogenicity of anti-cancer chemotherapeutic agents, and

  • Have demonstrated

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  • Smith, Nancy Title: RNC, OCN Chemotherapy Charge Nurse
    Date: 02/04/2005
    Comment:

    I want to voice my opinion that I strongly believe that any patient who receives chemotherapy should be able to receive Emend antiemetic. Coverage should not be limited to patients who have failed on other antiemetic regimens. I am an oncology nurse and I know first hand how nauseating chemotherapy can be for patients and no one can predict how a patient will tolerate any chemo drug. Please, do not restrict this wonderful drug, Emend. Patients need it desperately. It WORKS!

    Nancy Smith

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    Stovall, Ellen Organization: Cancer Leadership Council
    Date: 02/03/2005
    Comment:

    The undersigned patient advocates, providers and cancer research organizations appreciate the recent decision by the Centers for Medicare & Medicaid Services (CMS) to cover a new class of oral anti-emetic drugs under Part B of Medicare as part of a “full replacement” regimen instead of intravenous anti-emetic therapy. This decision by CMS is a fitting complement to your recent initiation of a demonstration project to measure and assess quality of life during cancer

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    Stovall, Ellen Title: President & Chief Executive Officer
    Organization: National Coalition for Cancer Survivorship (NCCS)
    Date: 02/03/2005
    Comment:

    The National Coalition for Cancer Survivorship, which represents survivors of all forms of cancer, applauds the decision by the Centers for Medicare & Medicaid Services (CMS) to cover a new class of oral anti-emetic as part of a “full replacement” oral regimen under §1861(s)(2)(T) of the Social Security Act. This decision by CMS underscores your agency’s commitment to quality of life for cancer patients, as reflected in the initiation of the new demonstration

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    Hoverman, Russell Title: Vice President
    Organization: Texas Oncology, P.A.
    Date: 02/03/2005
    Comment:

    We have added aprepitant to our antiemetic guidelines which I shall submit as a separate attachment. Its use is reasonable in high risk patients or in those who have had difficulty with platinum containing regimens.

    Attachment
    Oholendt, Michael Title: Clinical Pharmacy Specialist, Heme/Onc/BMT
    Organization: Center for Cell and Gene Therapy, Baylor College of Medicine/ Methodist Hospital
    Date: 02/01/2005
    Comment:

    Aprepitant quietly crept into the oncology armamentarium for CINV and proven to be rather understated. CINV is a serious issue for patients undergoing emetogenic chemotherapy. Kudos to CMS for agreeing to cover the oral aprepitant therapy, but caution in restricting to "failures" (cycle 1 protection is critical to subseqent CINV control) or restrictions in "only oral premeds, including 5HT3's" (always exceptions to the rule, including IV palonosetron). NCCN guidelines (revised) are

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    McCarthy, James Title: Oncology Pharmacy Manager
    Organization: Montefiore Medical Center
    Date: 01/31/2005
    Comment:

    Aprepitant is more effective in the treatment of CINV for highly emetogenic drugs, when used in combination with other anti-emetic drugs. CMS coverage of the drug will improve patient outcomes by reducing the incidence of nausea and vomiting. This proposal will have a positive benefit for this patient population.

    Person, Linda Title: Advanced Practice Nurse, Ambulatory Services
    Organization: USC/Norris Cancer Hospital
    Date: 01/27/2005
    Comment:

    As the CNS in the outpatient areas I have seen Aprepitant used successfully in a variety of patients who are receiving emetogenic chemotherapy regimens. The reduced nausea allows more and more patients to complete therapy on time and at the ordered dose. This supportive drug is essential for patients who are at an increased risk for CINV or those who have failed other antiemetic regimens. The oral preparation is easily managed.

    Mehta, Marjaana Title: Oncology Nurse Practitioner
    Organization: University Medical Center of Southern Nevada
    Date: 01/27/2005
    Comment:

    I have seen wonderful results with Emend in my patients receiving chemotherapy. I absolutely support reimbursement for Emend by Medicare. However, I do not think that such restrictions should be placed. I disagree with approval for patients who have failed prior anti-emetics. The key is prevention of chemotherapy-induced nausea/vomiting. I also believe it should apply to all moderately or highly emetogenic chemotherapy.

    Johnson, M.D., David Title: President
    Organization: American Society of Clinical Oncology
    Date: 01/27/2005
    Comment:

    On behalf of its more than 20,000 members involved in cancer treatment and research, the American Society of Clinical Oncology (ASCO) commends the Centers for Medicare & Medicaid Services (CMS) for its ongoing efforts to modernize coverage of therapies integral to quality cancer care. Specifically, ASCO strongly endorses the CMS proposal to cover aprepitant, the first substance P/NK1 receptor antagonist, in combination with other oral anti-emetics as a full replacement for intravenous

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    Howard, Kay Title: Pharmacist
    Organization: University Physicians (Upstate Medical University Hospital)
    Date: 01/27/2005
    Comment:

    I am a Pharmacist in the outpatient Oncology setting. I feel that it is important that Emend (Aprepitant) be allowed for any oncology patient that is currently or about to begin treatments for Moderate to Highly emetogenic therapies as defined by Heskith scale. To reserve for only Highly emetogenic chemotherapies alone is doing these other patients a disservice. We are here to not only provide these poisons to people but to also help ensure that they have a good quality of life

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    Browne, Roy Date: 01/26/2005
    Comment:

    Apprepitant should be covered by medicare as many patients will benefit from using it. It really helps patients who are receiving highly emetogenic chemotherapy.

    Turowski, Bob Title: M.B.A., R. Ph.
    Organization: The James Cancer Hospital and Richard J. Solove Research Institute
    Date: 01/26/2005
    Comment:

    I agree that aprepitant is best used prophylactically, along with a 5-HT3 antagonist and dexamethasone, as opposed to as a rescue agent. The recommendation to use aprepitant before the first chemotherapy treatment if the regimen is considered a level 5 emetogenic regimen according to the Hesketh method is appropriate. Also, it is appropriate to allow the addition of aprepitant to a 5-HT3 antagonist and dexamethasone in less emetogenic regimens, including regimens not incorporating

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    DARNELL, ROBERT Title: Nursing Supervisor
    Organization: The Cleo Craig Memorial Cancer and Research Clinic
    Date: 01/25/2005
    Comment:

    Emend is a wonderful drug and should be approved by Medicare. However, you need to allow the patient to take the IV form of a 5ht-3 because if they don't have prescription coverage, and have to pay 20% out of pocket for the oral 5ht-3 and Aprepitant (emend), you're talking about $75.00 that they will pay. As an oncology nurse, I can tell you that these little old folks can't do it. They are barely getting by. PLEASE don't make this mistake. Robert Darnell RN, OCN

    Hyland, Sharon Title: Nurse Practitioner
    Organization: James P Wilmot Cancer Center, Rochester, NY
    Date: 01/25/2005
    Comment:

    As a Nurse Practitioner working in Breast Service I would recommend consideration of giving Emend with Dexamethasone on the first course of Adriamycin/Cytoxan because of the high incidence of debilitating delayed nausea and vomiting.

    Viale, Pamela Date: 01/24/2005
    Comment:

    As a nurse practitioner caring for patients receiving chemotherapy, I am responsible for helping to alleviate the symptoms that can occur with the chemo drugs themselves. By far, one of the worst symptoms is nausea and vomiting, and aprepitant has made a remarkable inroad in helping to minimize this dreaded side effect. Any assistance that we can get to help make it easier for our patients to receive the most appropriate therapies, both chemotherapy and for side effect management (or

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    Miller, Bonnie Title: R,N,
    Date: 01/23/2005
    Comment:

    I strongly believe that Medicare coverage should not be limited to patients who have failed on other antiemetic regimens and Medicare coverage should follow national guidelines for antiemetic therapy.

    kedziera, pamela Title: Clinical Manager
    Organization: Fox Chase Cancer Center
    Date: 01/21/2005
    Comment:

    Nausea and vomiting are always unpleasant. For an individual with cancer who is struggling to maintain their physical health as well as their quality of life, the control of these symptoms is critical. Aprepitant has made a difference for the cancer patient. I support approving this drug coverage with some changes. I would ask you to review the FDA approval. Coverage should be approved for all individuals who are getting moderately to severely emetigenic cancer therapy. The route of

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    McClay, Edward Title: Director, San Diego Melanoma Research Center
    Organization: San Diego Cancer Center
    Date: 01/21/2005
    Comment:

    I would respectfully submit that the current requirement for patients receiving Level 4/5 chemotherapy to fail anti-emetic medication before we can prescribe Aprepitant incurs an undo burden on patients. These regimens by definition are highly emetogenic and are associated with a high failure rate. Of importance, is the fact that the first emetic experience with chemotherapy sets the tone with regards to subsequent treatments. Therefore it is important to make the first treatment

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    Wallace, Paul Title: PharmD, Oncology Clinical Specialist
    Organization: Tacoma General Hospital
    Date: 01/20/2005
    Comment:

    I strongly support the proposed coverage of Emend in the outpatient setting. It is extremely effective for prevention of acute/delayed nausea as previously demonstrated in trials and in postmarketing experience. I would like to see it used as first-line, rather than have a patient "fail" before they would be covered.

    Oster, Martin Title: Associate Professor of Clinical Medicine
    Organization: Columbia University Medical Center
    Date: 01/20/2005
    Comment:

    As a busy clinical oncologist since 1976, I have seen a continued improvement in controlling and minimizing chemotherapy-induced emesis over the past 28 years. Emend has been a major step forward in dealing with this difficult aspect of oncology care. Making it easier for our patients to take advantage of Emend is appreciated by all oncologists and their patients!

    Seifter, Eric Title: Associate Professor
    Organization: Johns Hopkins Hospital
    Date: 01/19/2005
    Comment:

    I am an associate professor of medicine and oncology at Johns Hopkins. I find aprepitant VERY helpful for patients with severe nausea from chemotherapy in combination (not in place of) other anti-emetics. The available literature and editorials in the Journal of Clinical Oncology support this approach. I would urge coverage of this oral anti-emetic in combination with other anti-emetics.

    Yowell, Sally Title: Clinical Oncology Pharmacist
    Organization: Duke University Medical Center
    Date: 01/19/2005
    Comment:

    I applaud CMS for adding coverage of aprepitant for CINV. However, I would encourage the removal of requiring patients to experience nausea and vomiting before allowing its use in the highly emetogenic setting. All the data supports the benefit of adding this drug up front to patients receiving highly emetogenic chemotherapy. In addition, the data supports the importance of controlling CINV with inital cycles of chemotherapy. To allow patients to suffer when an effective therapy is

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    Schwartzberg, M.D., Lee Title: Medical Director
    Organization: The West Clinic
    Date: 01/19/2005
    Comment:

    We have been using Emend in our clinic for the past 18 months. It has made a huge difference in the lives of our patients. The largest hurdle that we deal with daily is the cost of the medication. A majority of the private insurance companies are covering Emend; however , we still have our Medicare patients that cannot benefit from the advances in controlling both the nausea and vomiting. Emend has increased the quality of life for a large number of patients receiving highly emetic

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    Ostrow, Dr. Stanley Date: 01/18/2005
    Comment:

    Emend is highly effective and is very necessary for patients getting Emetogenic chemo (a medication that induces nausea). Emend should be used first line to prevent people from getting sick instead of waiting until after. Emend is a major advance compared to older anti-nausea medications. I believe Emend represents significant advances in the quality of life for cancer patients getting chemotherapy. Thank you.
    Sincerely,
    Stanley Ostrow, M.D., FACP

    Silberstein, Peter Title: Division Chief Hematology/Oncology
    Organization: Creighton University Medical Center
    Date: 01/16/2005
    Comment:

    I am an medical oncologist. Aprepitant is very useful for chemotherapy induced emesis for patients who are receiving highly emetogenic chemotherapy. It is effective in reducing delayed nausea and vomiting. It has a unique mechanism of action. It should be given with Decadron and a 5HT3 Antagonist. I think that medicare should cover this medication. If patient don't take Aprepitant and then they have to receive additional IV fluids, or be admitted to the hospital then it would be more

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    Escudier, Susan Date: 01/14/2005
    Comment:

    This is an important drug for the cancer patient and has made a huge difference in quality of life, ability to work, etc by reducing nausea and vomiting after chemotherapy.

    Lindley, Celeste Date: 01/14/2005
    Comment:

    I strongly support the decision to reimburse for Emend however patents should not have to fail prior antiemetic therapy in order to receive Emend. The literature clearly shows that cycle 1 protection is critical to subseqent CINV control. Please remove this restriction.

    Rittenberg, Cynthia Title: Executive Director
    Organization: Multinational Association of Supportive Care in Cancer
    Date: 01/14/2005
    Comment:

    As an oncology clinical nurse specialist involved in initial trials of aprepitant and now as a speaker to nurses throughout the US about chemotherapy-induced nausea and vomiting (CINV), I want to emphasize the importance of adding UP FRONT aprepitant for prevention of CINV in those receiving highly emetogenic chemotherapy. By up front, I mean before a patient receives their first dose - not waiting until after a problem develops. All studies indicate that CINV becomes a much more

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    Kozlovski, PharmD, Anna Title: Oncology Clinical Pharmacist
    Organization: Our Lady of Mercy Medical Center Onc/Hem Deptartment
    Date: 01/14/2005
    Comment:

    Emend is an anti-emetic that has been very effective for patients getting highly emetogenic chemo regimens as well as patients that failed on standard therapy. We've been using Emend throughout last year and have seen tremedous results. Like with any new drugs, Emend is not inexpensive and hospitals, like ours, are very cost conscious. I, as the oncology clinical pharmacist at this institution, would greatly advocate for Emend being covered by Medicare, in the in and outpatient settings. It

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    mcewuen, sylvia Title: Clinical Trials Nurse/Data Manager
    Organization: Clinical Trials Research Unit
    Date: 01/14/2005
    Comment:

    This drug should be approved by Medicare for use in the first cycle of any chemotherapy known to be highly likely to cause nausea/vomiting. Patients should not have to endure nausea/vomiting because they are waiting to see if other antinausea drugs work.

    Chesbro, Byron Title: M.D.
    Organization: Texas Oncology
    Date: 01/14/2005
    Comment:

    As a medical oncologist, I applaud the decision to provide coverage for the use of aprepitant in those patients receiving highly or moderately emetogenic regimens who experience delayed nausea and vomiting. The treatment of cancer often involves negotiating a narrow path between efficacy and toxicity. Measures which diminish side effects such as nausea offer an immediate and appreciated improvement in quality of life. Aprepitant serves this goal in a significant number of our

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    Johnson RN, CNS, AOCN, Sandy Title: RN, CNS, AOCN
    Organization: Coborn Cancer Center
    Date: 01/13/2005
    Comment:

    I work within a busy cancer center. For the past 25 years I have been an oncology nurse. I have witnessed many improvements in the way we treat patients and in our ability to extend life for cancer patients. One of the most significant changes in treatment has been in the prevention and treatment of nausea and vomiting. The NCCN clinical practice guidelines for managing Chemotherapy Induced Nausea and Vomiting recommends the use of Emend as first line treatment for patients

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    Mills, Cheryl Organization: St. Luke's Regional Medical Center
    Date: 01/13/2005
    Comment:

    I am a Nurse Practitoner working in a busy outptient oncology clinic. I often see patients who have failed standard antiemetic regimins and thus become volume depleted. Usually this then involves a few days of IV hydration and rescue medications.

    Thus far, I have seen excellent results when these patients have had aprepitant added to their antiemetics on cycle two. I have not yet had a failure of therapyy requiring additional trips to clinic and/or volume repletion.

    Panackova, Silvie Date: 01/12/2005
    Comment:

    Emend has been a breakthrough medication for many patients going through highly emetogenic chemotherapy regimens. I have seen many personal testimonials from patients who have greatly benefited from this drug. Medicare patients who did not do well on standard 5HT3 antagonist and other anti-emetics were grateful for Emend. Emend should definitely be given on the first cycle of highly emetogenic therapy to prevent any chances of breakthrough emesis and decreasing quality of life. Please

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    Morton, RN, OCN, Paula Title: RN, OCN
    Organization: South Florida Center for Gynecologic Oncology
    Date: 01/11/2005
    Comment:

    Our practice regularly uses aprepitant in combination with other pre- and post-chemotherapy medications for the PREVENTION of CINV for highly and moderately ematogenic chemotherapy drugs. In almost all of our patients (98%), they report NO nausea post-chemo. We have anecdotal evidence that this is due largely to the use of aprepitant in our premedication regimine. When patients who used aprepitant in the past, forgot, or for other reasons, did not take it with subsequent chemo

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    Berger, Michael Organization: The James Cancer Hospital
    Date: 01/09/2005
    Comment:

    This is an outstanding decision which will immensely benefit a subpopulation of patients who have failed standard anti-emetics. Our outpatient oncology clinic has struggled to obtain / provide this drug for our patients up until now. Hopefully, this will allow us to provide aprepitant in our clinic, and other insurers will follow Medicare's example and be more willing to reimburse for this product.