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National Coverage Analysis (NCA) Tracking Sheet for Aprepitant for Chemotherapy-Induced Emesis (CAG-00248N)

Aprepitant is an orally administered neurokinin 1 (NK1) antagonist with favorable effects in both acute and delayed phases of chemotherapy-induced emesis. The Food and Drug Administration (FDA) approved aprepitant under the trade name Emend®. The Centers for Medicare and Medicaid Services (CMS) has internally generated a national coverage determination to determine if aprepitant is full replacement for other covered treatment(s) for chemotherapy-induced emesis. If aprepitant is determined to be full replacement, the CMS will then describe the circumstances where it is reasonable and necessary for Medicare beneficiaries.

Oral Antiemetic Drugs
Requestor Name(s)CMS internally generated request
Formal Request Accepted and Review Initiated07/06/2004
Expected NCA Completion Date04/01/2005
Public Comment Period07/06/2004 - 08/06/2004
Proposed Decision Memo Released01/06/2005
Proposed Decision Memo Public Comment Period: 01/06/2005 - 02/04/2005 
Decision Memo Released04/04/2005
Comments for this NCA:View Public Comments
Lead Analyst(s)
  • Karen Rinker, MS
Lead Medical Officer(s)
  • James A. Rollins, MD, PhD, MSHA

July 6, 2004

NCD opened.

The initial 30-day public comment period begins with this acceptance date, and ends after 30 calendar days.  CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under consideration as well as comments on the appropriate benefit categories to which the technology should be assigned.

August 18, 2004

Comments [PDF, 832KB] from the first 30-day public comment period are now available for viewing.

January 6, 2005

CMS is posting its proposed decision memorandum  on the use of aprepitant for chemotherapy induced emesis. We are soliciting public comments on this proposed decision.

In addition, we are aware that aprepitant may likely have other uses beyond those consistent with the part B proposed benefit category determination. Beginning January 1, 2006 aprepitant for these other uses will be covered under Medicare Part D, the new prescription drug benefit created by the Medicare Modernization Act of 2003 (MMA). As a result, aprepitant would be covered under part B for the indications specified in the proposed NCD and under part D for others. Based on the NCD guidelines, it will then be up to the provider to determine whether aprepitant is prescribed under part B or part D. Part D indications may likely represent the largest proportion of the use of aprepitant by Medicare beneficiaries.

April 4, 2005

The final decision memorandum  is posted.
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