Aprepitant for Chemotherapy-Induced Emesis

I strongly support the use of aprepitant being expanded to include its use in combination with dexamethasone and a 5-HT3 antagonist in patients receiving chemotherapy agents/regimens that are currently considered to be moderately emetogenic, as well as for future chemotherapy agents classified as highly or moderately emetogenic using the Hesketh emetogenic classification system or listed in at least two published evidence-based guidelines. I also support the use of the term 'NK-1 antagonist' to be used instead of 'aprepitant' in the NCD. Additionally, CMS should consider parenteral formulations of NK1-antagonists, dexamethasone and 5HT3-antagonists be covered as part of the NCD to ensure that patients who are not suitable for oral therapies (such as those who cannot swallow due to their disease or radiation therapy; those who are unable to tolerate oral therapies; or those with allergies to inactive ingredients found in the oral formulations) have access to adequate CINV prevention.

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April 19, 2012

Louis Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards & Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Aprepitant for Chemotherapy-Induced Emesis (CAG-00248R)

Dear Dr. Jacques:

On behalf of the Hematology/Oncology Pharmacy Association (HOPA), I would like to express our support for your proposed decision of the reconsideration of the National Coverage Determination (NCD) for Aprepitant (Emend®) for Chemotherapy-Induced Emesis.

HOPA is a nonprofit professional organization launched in 2004 to help hematology and oncology pharmacy practitioners and their associates provide quality cancer care. HOPA’s membership is predominantly oncology pharmacists, but also includes pharmacy interns, residents, nurses, technicians, researchers, and administrators specializing in hematology/oncology practice. The roles of our membership span from direct patient care, to education, to research. HOPA represents approximately 2,000 members working in hundreds of hospitals, clinics, outpatient oncology practices, home health practices, community pharmacies, and other healthcare settings.

As you know, the initial aprepitant NCD became effective in 2005, and since that time the Food and Drug Administration has expanded aprepitant’s approved indications to include moderately emetogenic anticancer chemotherapy agents. Additionally, the emetogenic potential ratings of cancer chemotherapy medications have also been updated, adding new anticancer medications and standards of care for individuals receiving anticancer chemotherapy treatment. To provide the most appropriate care for our Medicare patients receiving anticancer chemotherapy, it is necessary to consider incorporating these updated materials into the current aprepitant NCD.

HOPA supports the Centers for Medicare and Medicaid Services (CMS) proposed decision for aprepitant. While the memo did not address all 7 proposed changes, it does represent a significant increase in coverage when aprepitant is used in combination with an all–oral antiemetic regimen in patients receiving moderately emetogenic chemotherapy (MEC). We also agree that the term NK-1 antagonists should be used in the manual to describe the class of drugs that would be covered in the NCD as opposed to the drug name aprepitant. Finally, HOPA recommends that CMS consider parenteral formulations of NK1-antagonists, dexamethasone and 5HT3-antagonists be covered as part of the NCD to ensure that patients who are not suitable for oral therapies (such as those who cannot swallow due to their disease or radiation therapy; those who are unable to tolerate oral therapies; or those with allergies to inactive ingredients found in the oral formulations) have access to adequate CINV prevention.

We appreciate the opportunity to submit this letter. HOPA stands ready to work with you and CMS as you finalize the development of a revised NCD for Aprepitant for Chemotherapy-Induced Emesis. If you have any questions about our letter, please feel free to contact me or HOPA’s Health Policy Associate, Jeremy Scott (202/230-5197, jeremy.scott@dbr.com).

Sincerely,

Niesha Griffith, MS RPh FASHP
President
Hematology/Oncology Pharmacy Association

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I am writing to strongly support the proposals to expand the NCD for aprepitant (Cag-00248). I feel strongly that this current proposal use the term "neurokinin-1 (NK-1) antagonist" instead of "aprepitant" to enable our patients to receive this class of drug in combination with an steroid and an 5-HT3 antagonist for moderately or highly emetogenic chemotherapy regimens. Access to this agent should be by class of drug (NK-1 antagonist), independent of route of administration.

These proposals will allow us to provide the most appropriate care for our Medicare patients receiving anticancer chemotherapy. It is necessary to consider incorporating these updated materials into the current aprepitant NCD. Nausea and vomiting are side effects most commonly affecting our patients receiving chemotherapy. This may be debilitating to our patients and could lead to further complications if not controlled appropriately. This newest class of anti-emetics, the neurokinin-1 (NK-1) antagonists, has been very beneficial to our patients receiving highly and moderately emetogenic chemotherapy agents and regimens.

Thank you for the opportunity to comment on a decision that will impact the cancer patients that we care for.

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Merck appreciates the opportunity to provide comments on the proposed Decision Memorandum. CMS has specifically asked for comment on the following:

“In order to maintain an open and transparent process, we are seeking comments on our proposal. We are particularly interested in comments on whether the term “NK-1 antagonists” should be used in the manual to describe the class of drugs that would be covered in the NCD as opposed to the term “aprepitant” which is currently the sole NK-1 antagonist component of the three drug antiemetic regimen."

The proposed Decision Memo accurately and succinctly describes the use of the NK-1 antagonist aprepitant in combination with a 5HT3 antagonist and a steroid for prevention of CINV. The proposed Decision Memo also describes the use of the available 5HT3 antagonists and notes from the guidelines of ASCO, NCCN, and MASCC that not all 5HT3 antagonists are equal in efficacy, duration of effect, and toxicity when used for prevention of CINV.

Clinical and investigative research has documented a variety of chemical compounds that are termed “NK-1 antagonists” because of their ability to bind to the NK-1 receptors located in various parts of the central nervous system and non-central nervous system tissue. These investigational NK-1 antagonists appear to have a variety of clinically useful effects highly dependent on the particular antagonist. At the current time, a selection of NK-1 antagonists are under study, as documented on www.clinicaltrials.gov, for prevention of CINV, PONV, tinnitus & hearing loss, post-traumatic stress disorder, urge urinary incontinence, overactive bladder, alcohol craving, irritable bowel syndrome, and cannabis withdrawal & dependence. In addition, additional medical literature are replete with additional studies of NK-1 antagonists for anxiolytic effects, pain, osteoarthritis pain, motion sickness, migraines, psychiatric disorders, and the inhibition of cyclophosphamide-induced damage in the rat and ferret bladder. The current list of investigations of NK-1 antagonists supports the fact that not all NK-1 antagonists are equal in efficacy or with identical potential indications.

Recently, an NK-1 antagonist casopitant was investigated for the prevention of CINV and PONV, but was withdrawn from further consideration due to safety signals. Two other NK-1 antagonists are currently under investigation on www.clinicaltrials.gov for prevention of CINV and/or PONV. One of the two is a fixed dose oral combination of an NK-1 antagonist and a 5HT3 antagonist, and thus not equivalent to an NK-1 antagonist.

In summary, “aprepitant” should be retained in the proposed “Decision Memo”. It is the only NK-1 antagonist approved for the prevention of CINV at this time, until additional compounds under investigation are fully assessed and approved by regulatory agencies for the prevention of CINV.

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I am writing to strongly support the CMS proposals to expand the NCD for aprepitant (Cag-00248). I feel strongly that this current proposal use the term "neurokinin-1 (NK-1) antagonist" instead of "aprepitant" to enable our patients to receive this class of drug in combination with an steroid and an 5-HT3 antagonist for moderately or highly emetogenic chemotherapy regimens. Access to this agent should be by class of drug (NK-1 antagonist), independent of route of administration.

These proposals will allow us to provide the most appropriate care for our Medicare patients receiving anticancer chemotherapy. It is necessary to consider incorporating these updated materials into the current aprepitant NCD. Nausea and vomiting are side effects most commonly affecting our patients receiving chemotherapy. This may be debilitating to our patients and could lead to further complications if not controlled appropriately. This newest class of antiemetics, the neurokinin-1 (NK-1) antagonists, has been very beneficial to our patients receiving highly and moderately emetogenic chemotherapy agents and regimens.

Thank you for the opportunity to comment on a decision that will impact the cancer patients that we care for.

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I am writing to strongly support the following proposals to expand the NCD for aprepitant (Cag-00248):

1. Expand the use of aprepitant in combination with dexamethasone and a 5-HT3 antagonist to include the patient population receiving anticancer chemotherapeutic agents currently considered "moderately emetogenic" (MEC), including alemtuzumab, azacitidine, bendamustine, carboplatin, clofarabine, cyclophosphamide, cytarabine, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, and oxaliplatin.

2. Expand coverage of aprepitant in combination with dexamethasone and a 5-HT3 antagonist for use with future chemotherapy agents classified as HEC or MEC using the Hesketh emetogenic classification system or listed in at least two published evidence-based guidelines such as ASCO, ESMO, NCCN or MASCC.

I feel strongly that this current proposal use the term "neurokinin-1 (NK-1) antagonist" instead of "aprepitant" to enable our patients to receive this class of drug in combination with an steroid and an 5-HT3 antagonist for moderately or highly emetogenic chemotherapy regimens. Access to this agent should be by class of drug (NK-1 antagonist), independent of route of administration.

These proposals will allow us to provide the most appropriate care for our Medicare patients receiving anticancer chemotherapy. It is necessary to consider incorporating these updated materials into the current aprepitant NCD. Nausea and vomiting are side effects most commonly affecting our patients receiving chemotherapy. This may be debilitating to our patients and could lead to further complications if not controlled appropriately. This newest class of antiemetics, the neurokinin-1 (NK-1) antagonists, has been very beneficial to our patients receiving highly and moderately emetogenic chemotherapy agents and regimens.

Thank you for the opportunity to comment on a decision that will impact the cancer patients that we care for.

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I feel strongly that the use of aprepitant should be expanded to include its use in combination with dexamethasone and a 5-HT3 antagonist in patients receiving chemotherapy agents/regimens that are currently considered to be moderately emetogenic, as well as for future chemotherapy agents classified as highly or moderately emetogenic using the Hesketh emetogenic classification system or listed in at least two published evidence-based guidelines.

In addition, I strongly suggest using the term 'NK-1 antagonist' be used instead of 'aprepitant' in the NCD.

Thank you.

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As a practicing clinical oncology pharmacist, and a pharmacy educator, I am writing in support of the following 2 proposals:

1.Expand the use of aprepitant in combination with dexamethasone and a 5-HT3 antagonist to include the patient population receiving anticancer chemotherapeutic agents currently considered "moderately emetogenic" (MEC), including alemtuzumab, azacitidine, bendamustine, carboplatin, clofarabine, cyclophosphamide, cytarabine, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, and oxaliplatin.

2.Expand coverage of aprepitant in combination with dexamethasone and a 5-HT3 antagonist for use with future chemotherapy agents classified as HEC or MEC using the Hesketh emetogenic classification system or listed in at least two published evidence-based guidelines such as ASCO, ESMO, NCCN or MASCC.

I also recommend that the term "NK-1 antagonist" be used instead of "aprepitant" in the proposal so that either aprepitant or fosaprepitant would be reimbursed when used in combination with an oral steroid and an oral 5HT3 antagonistfor MEC or HEC.

Thankyou, Deborah A. Hass, Pharm.D, BCOP, BCPS

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As an oncology health care practitioner, I feel it is important to change the wording from aprepitant to NK-1 antagonists to open up the possibilities for other agents in the future as well as the intravenous salt fosaprepitant.

Working daily with a population that is fighting for life, required to pay many large copays and then to have to deal with restrictions on what drugs are available due to wording is an additional burden to the patients. Working in an outpatient setting the availability of the intravenous preparation gives us the advantage to guarantee the patient receives the medication and we are doing the utmost to give them good care. Many of our patients are unable to afford the oral drug or try and "save" by only taking 1 of the 3 capsules of the oral TriPak. This is actually decreasing the effectiveness of the regimen, in the end costing the patient and the system more money than being able to give the IV agent upfront.

As our population in cancer care increases we find that the differences of the studied population for certain drugs or regimens and classification of highly emetogenic or moderately emetogenic does not hold true for everyone. I feel it is important for cancer care to be able to move forward by giving the health care providers working with the patients the ability to make the decision of what is necessary and appropriate for that patient. Guidelines and research are great tools to us as health care practitioners. But we know working daily with the patients that not everyone fits into a neat little box.We need the ability to utilize these agents interchangeably for HEC or MEC.

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I strongly support this NCD and applaud CMS in taking the step to provide quality care to cancer patients.

I would encourage CMS to change the working to NK1 antagonists instead of aprepitant to cover all of the drugs in the class.

Given the the single dose of IV fosaprepitant is cheaper than the oral doses of aprepitant and equally effective, I would also strongly recommend that CMS reimburse both the IV and oral formulations reimbursed and allow the providers to use the doseage form that clinically is best for the patient.

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In the current proposed new language for the updated NCD on oral EMEND, section A states that “The oral three-drug regimen of aprepitant, a 5HT3 antagonist, and dexamethasone is reasonable and necessary for beneficiaries receiving moderately emetogenic chemotherapy immediately before and within 48 hours after the administration of the anticancer treatment. Many pharmacies interpret this language, “immediately before the administration of their chemotherapy,” to mean that patients may not pick up their prescription for oral EMEND until the day they are to receive their treatment. This creates a hardship for many patients because they face logistical challenges such as not having enough time to pick up the drug on the same day they are receiving treatment or lack of transportation. Often their treatment is at 8:00 in the morning and they cannot pick up their prescription at the pharmacy on the same day. I would request the following language added to the NCD: “patients may pick up their doses of oral EMEND up to 72 hours in advance of receiving therapy." This would clarify the issue on when a patient may pick up their prescription of oral EMEND and not require that they must do it on the same day they receive therapy. This is important because some patients start therapy early in the morning before pharmacies are open, some drive long distances to the location where they receive therapy, others do not have access to transportation to a pharmacy and then on to a cancer center same day, and occasionally pharmacies are out of stock of the medication and allowing pick up in advance allows a window for the pharmacy to have the product. Having a defined window so that patients can pick up their oral pre meds up to 3 days in advance will lead to improved compliance. Thank you.

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Aprepitant is an extremely useful tool in our efforts to prevent and manage CINV. Expansion of Medicare coverage to include MEC and HEC is consistent with current clinical practice guidelines. At our institution, pharamacists assess patient risk factors for CINV including the emetogenicity of the regimen, as well as gender, history of motion sickness, and alcohol consumption. We prescribe initial anti-emetics based on this risk assessment, then continuously monitor outcomes and make adjustments. Our outcomes are very favorable, supported by the variety of medications we can offer our patients. This inlcudes aprepitant as an NK-1 antagonist, in combination with a 5HT2 antagonist and dexamethasone. I applaud Medicare's decision to re-evaluate coverage for this important medication in the prevention and treatment of CINV.

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I fully endorse expansion of coverage for the anti-emetic drug aprepitant. This agent significantly improves control of nausea & vomiting in patients undergoing both moderately & highly emetogenic chemotherapy. As a practicing oncology pharmacist for over 20 years, I recall the days before aprepitant or even before 5HT3 antagonists when highly or even moderately emetogenic chemotherapy could only be given on an inpatient basis due to intractable N&V. Thus this agent is not only efficacious but cost effective as well. [PHI Redacted] received moderately emetogenic chemotherapy almost 4 years ago for breast cancer (included doxorubicin and cyclophosphamide). During her four cycles of AC, she only took one prochlorperazine tablet after her first cycle for mild nausea - no surprise that she received optimal anti-emetic prophylaxis with aprepitant + 5HT3antagonist+dexamethasone. She was able to eat normally during the entirety of her treatment thus the impact on her ability to fight her disease and maintain her strength from a nutrition standpoint was huge. In summary, from both a professional as well as a personal standpoint, coverage of aprepitant (and the IV version fosaprepitant) is immensely important to improving the QOL and easing suffering for patients undergoing moderately to highly emetogenic chemotherapy.

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The National Comprehensive Cancer Network (NCCN), an alliance of twenty-three of the world’s leading cancer centers, welcomes the opportunity to provide comment on the Proposed Decision Memo for Aprepitant for Chemotherapy-Induced Emesis (CAG-00248R).

As the original requestor of the reconsideration, we are pleased with the proposed coverage expansion to include moderately emetic chemotherapy. While we understand the inability to address the other requests asked for under this reconsideration, we look forward to an opportunity to address the additional concerns listed below.

Additional requests:

• Expand the current NCD acceptable list of 5-HT3 antagonists for use with aprepitant and dexamethasone to include palonosetron.
• Allow use of therapeutically equivalent doses of any available 5-HT3 antagonist, dexamethasone, and aprepitant formulations (oral, transdermal, intravenous).
• Allow for oral dexamethasone taken by the patient at home during the time period of chemotherapy administration.
• Allow for the intravenous administration of dexamethasone in place of oral dexamethasone.
• Allow for aprepitant in combination with 5-HT3 antagonists in patients shown to be dexamethasone (corticosteroid) intolerant or if the physician wishes to avoid dexamethasone (corticosteroids) because the patient is a diabetic.

The Proposed Decision Memo asks for comments on whether the term “NK-1 antagonists” should be used in the CMS User Manual to describe the class of drugs that would be covered in the NCD as opposed to the term “aprepitant”. NCCN cannot support using the term “NK-1 antagonists” in place of aprepitant in the respective NCD. We feel that the determination of clinical appropriateness should be made based on both efficacy and toxicity data respective to the individual agent, and not a class of agents. Just as any intervention found in the NCCN Clinical Practice Guidelines, any new NK-1 antagonists to come to market will need to be evaluated based on clinical data before NCCN can support its use.

We thank you in advance for your attention to these comments. Please do not hesitate to contact Jessica DeMartino, PhD, Manager of Health Policy Programs with any clarifying questions or comments.

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I support following proprosal:

CMS has made the following 2 proposals to expand the NCD for aprepitant:

1. Expand the use of aprepitant in combination with dexamethasone and a 5-HT3 antagonist to include the patient population receiving anticancer chemotherapeutic agents currently considered "moderately emetogenic" (MEC), including alemtuzumab, azacitidine, bendamustine, carboplatin, clofarabine, cyclophosphamide, cytarabine, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, and oxaliplatin.
2. Expand coverage of aprepitant in combination with dexamethasone and a 5-HT3 antagonist for use with future chemotherapy agents classified as HEC or MEC using the Hesketh emetogenic classification system or listed in at least two published evidence-based guidelines such as ASCO, ESMO, NCCN or MASCC.

I also recommend that the term "NK-1 antagonist" be used instead of "aprepitant" in the proposal so that either aprepitant or fosaprepitant would be reimbursed when used in combination with an oral steroid and an oral 5HT3 antagonistfor MEC or HEC.

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I am in favor of this proposed expansion for the use of NK-1 antagonists.

I am also in favor of the use of the term 'NK-1 antagonists' instead of just aprepitant. Another option, fosaprepitant is an injectable NK-1 antagosist that is very effective and can be used to improve compliance with anti-emetic therapy for these patients. Expanding to all NK-1 antagonists will be very beneficial for patients and for caregivers to give our cancer patients the best, most effective care possible.

Robert A. Dowd, PharmD, BCOP

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Eisai Inc. (Eisai) appreciates the opportunity to submit comments on the Proposed Decision Memo for Aprepitant for Chemotherapy-Induced Emesis (CAG-00248R). Eisai is the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Headquartered in Woodcliff Lake, New Jersey, Eisai is a research-based bio-pharmaceutical company that has developed therapies for the treatment of a wide range of conditions, including obesity, Alzheimer’s Disease, epilepsy, gastrointestinal disorders, prevention of deep vein thrombosis, and cancer. Eisai was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s worldwide human health care (hhc) mission is to give first thought to patients and their families and to increasing the benefits health care provides. Satisfying unmet medical needs exemplifies this mission.

In the proposed decision memorandum, the Centers for Medicare & Medicaid Services (CMS) requests comments on “whether the term ‘NK-1 antagonists’ should be used in the National Coverage Determination (NCD) Manual to describe the class of drugs that would be covered in the NCD as opposed to the term ‘aprepitant’ which is currently the sole NK-1 antagonist component of the three drug antiemetic regimen.” Eisai supports the replacement of the term “aprepitant” with “NK-1 antagonists” for several reasons. First, use of the term “NK-1 antagonists” is consistent with CMS’s use of “5HT₃ antagonist” rather than specific drug names to identify the therapies covered under the NCD. All available oral 5HT₃ antagonists are indicated for chemotherapy induced nausea and vomiting (CINV) and are all described in the NCD at the class level. All of the NK-1 antagonists currently in development are seeking indications for CINV and therefore, if approved, they should also be described in the NCD at the class level.

Second, given that a number of other NK-1 antagonists are currently in development, replacing the term “aprepitant” with “NK-1 antagonists” now would eliminate the need for CMS to revise the NCD later when such products become commercially available. CMS can reduce the administrative burden associated with reconsidering this NCD by referring to the NK-1 antagonist class of drugs rather than a single product in the final decision.

Third, applying the NCD to the class of NK-1 antagonists now will allow physicians and beneficiaries to choose appropriate new therapies in that class as they enter the market. By issuing the NCD to refer to the class of drugs, instead of a single product, CMS will provide physicians with more latitude to prescribe the medication that they deem best for the beneficiary when other therapies in that class become available. Use of this terminology also will ensure that beneficiaries can choose their treatment option based on their physicians’ clinical judgment instead of concerns about Medicare coverage.

Thank you for your consideration of these comments. We look forward to continuing to work with CMS to ensure that Medicare beneficiaries have access to the therapies they need. Please feel free to contact Stephen McMillan at (202) 347-7526, or stephen_mcmillan@eisai.com if you have any questions or if we can be of further assistance.

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In regards to the NCD for aprepitant, I would like to propose the use of 'NK-1 antagonist' vs. the use of the specific drug 'aprepitant' in the language of this document. This would prohibit future conflicts and confusion to appropriate interpretation of the approved language. Consider in the future, the potential development of alternative drugs within this class. I would like to be able to apply the class data vs. only the specific drug recommendations when devising antiemetic plans. Thank you.

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I support following proprosal:

CMS has made the following 2 proposals to expand the NCD for aprepitant:

1. Expand the use of aprepitant in combination with dexamethasone and a 5-HT3 antagonist to include the patient population receiving anticancer chemotherapeutic agents currently considered "moderately emetogenic" (MEC), including alemtuzumab, azacitidine, bendamustine, carboplatin, clofarabine, cyclophosphamide, cytarabine, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, and oxaliplatin.
2. Expand coverage of aprepitant in combination with dexamethasone and a 5-HT3 antagonist for use with future chemotherapy agents classified as HEC or MEC using the Hesketh emetogenic classification system or listed in at least two published evidence-based guidelines such as ASCO, ESMO, NCCN or MASCC.

I also recommend that the term "NK-1 antagonist" be used instead of "aprepitant" in the proposal so that either aprepitant or fosaprepitant would be reimbursed when used in combination with an oral steroid and an oral 5HT3 antagonistfor MEC or HEC.

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I am an oncology pharmacist and I strongly support the use of "NK1 antagonists" for this indication verses just "aprepitant". I work in an outpatient setting and we have huge struggles getting patients to fill oral aprepitant prior to their start of chemotherapy cycles. Having the ability to use the IV formulation of fosaprepitant is very important for our practice. Cancer patients already have many oral copays (pain meds, chronic meds, etc.) & 99% of our patients fall into the 'doughnut' hole for coverage during treatment. They are then unable to afford antiemetics orally & many end up in the hospital for retractable CINV.

In addition, I support this class of drugs use for both highly emetogenic and moderately emetogenic chemotherapy. This class of drugs are a huge additional to the antiemetic management of cancer patients. We need the ability to utilize these per guideline recommendations.

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I am a pharmacist in a hematology and oncology clinic. I support the approval of this NCA. I also would support the recommendation to use the term "NK-1 antagonists" instead of aprepitant alone. This drug alone has caused much confusion due to oral aprepitant and intravenous fosaprepitant. Also, new NK-1 antagonists are in various stages of clinical trials. Over the last several years, I have seen countless patients benefit from advances in the treatment of chemotherapy induced nausea and vomiting. Nausea continues to be a very large concern of patients undergoing chemotherapy. Please make this new rule flexible enough to accomodate cancer patients undergoing chemotherapy. There are many good and consistent guidelines from a number of organizations that recommend the use of NK-1 antagonists with HT3 antagonists and a steroid. The evolution of aprepitant to fosaprepitant has been a rough journey already in regards to the varying coverages of these products. Please make it easier for the appropriate patients to receive these products.

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I support the current proposal to recommend the use of NK-1 antagonists in combination with an oral steroid and oral 5HT3 antagonist for both moderately and highly emetogenic chemotherapy. As an oncology pharmacist that works with cancer patients daily this change will dramatically improve the quality of our patients’ lives during chemotherapy treatment. I also strongly support the use of NK-1 antagonists rather than “aprepitant”. This terminology would then support the use of all agents in this drug therapy class.

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I support the CMS proposal as stated. Furthermore, "NK-1 antagonists” should be used in the manual to describe the class of drugs that would be covered in the NCD as opposed to the term “aprepitant”. This would make it clear that EITHER Aprepitant or Fosaprepitant, in combination with an oral steroid and an oral 5HT3 antagonist, would be reimbursed for MEC or HEC.

Furthermore, for patients at risk of chemotherapy induced nausea and vomiting (CINV), I encourage CMS to please re-consider adding additional verbiage to the NCD manual which will exclude NK-1 antagonists, all 5HT-3 serotonin antagonists and dexamethasone from the "failure of oral medication first" stipulation as found in chapter 15 section 50.2 of the CMS Medicare Benefit Policy manual. This exclusion would allow physicians to select the most appropriate route of administration for NK-1 antagonists, steroids or 5HT3 antagonists for patients at risk for CINV

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Speaking and acting within ALL, ALL INCLUSIVE, my capacities, ALL INCLUSIVE, INCLUDING AND ESPECIALLY as the respective SOLE, PRO BONO Administrator of the Delois Albert Brassell Estate (D-U-N-S Number 831823948, active CAGE Code 5PAZ8), Robert James Brassell Estate (D-U-N-S Number 962019514, active CAGE Code 64WJ9), Annie Bell/Belle Albert Estate (United States EIN 27-6382218), Trudie Brassell Estate (United States EIN 90-6214502), Len Albert Estate (United States EIN 35-6822992), Charles Dennis Bronson Estate (United States EIN 46-6603164), George Albert Estate (United States EIN 35-6822993), Walter Francis McCarthy Estate (United States EIN 46-6128556), Robert Brassell Sr. Estate (United States EIN 32-6241103), John Aikman Estate (United States EIN 46-6229304), Dorothy M. Aikman Estate (United States EIN 46-6229582), Annie May Brassell Estate (United States EIN 45-7027079), Vernell Albert Estate (United States EIN 35-6822994), Julius Blackshear Estate (United States EIN 30-6337223), Rena Rothschild Estate (United States EIN 46-6609293), Arnold Michael Rothschild Estate (United States EIN 46-6606239), Arthur F. Rothschild Estate (United States EIN 46-6553791), Mary Moroney Estate (United States EIN 46-6579890), Veronica M. Moroney Estate (United States EIN 46-6576898), Melvin Blaine Rothschild Estate (United States EIN 46-6549605), Robert C. Rothschild Estate (United States EIN 46-6551214), Gustave Robert Rothschild Estate (United States EIN 46-6557440), Elisabeth Maria Rothschild Estate (United States EIN 46-6590684), Mary Moroney Sr. Estate (United States EIN 46-6582955), Jane Aikman Carbis Estate (United States EIN 46-6597056), Lois Washington Cobb Estate (United States EIN 38-7056893), Herbert Hirsh Rothschild, Jr., Estate (United States EIN 46-6600121), Michael Joseph Jackson Estate (United States EIN 46-6160053), Thomas J. Moroney Estate (United States EIN 27-6382172) and Alfred William Schrammar Estate (United States EIN 46-6594472), ALL INCLUSIVE: Expand the coverage as stated within the Decision Memo as soon as independently-verified/confirmed as medically ethical, safe and practicable as possible. Thank you.

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