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National Coverage Analysis (NCA) Tracking Sheet for Abarelix for the Treatment of Prostate Cancer (CAG-00238N)

Abarelix for injectable suspension is a gonadotropin-releasing hormone (GnRH) antagonist that treats advanced, symptomatic prostrate cancer in men. Plenaxis works by blocking the body's ability to produce testosterone, the hormone that enables most prostate cancers to grow in men. Plenaxis is approved by the Food and Drug Administration (FDA) to treat advanced, symptomatic prostate cancer in men who cannot have or refuse other treatments for prostate cancer, such as other hormone treatments or surgery to remove the testicles.  Because of risks of serious allergic reactions, Abarelix is only available through a program run by the manufacturer, called the Plenaxis PLUS program (Plenaxis User Safety Program), to ensure that it is used safely by doctors with the right skills to administer and monitor the drug. The manufacturer, Praecis, has requested a national coverage determination to define the appropriate coverage indication, coverage in certain defined trials, and specific noncoverage for other indications.

Incident to a physician's professional Service
Inpatient Hospital Services
Requestor Name(s)Praecis Pharmaceuticals Incorporated
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated06/22/2004
Expected NCA Completion Date03/18/2005
Public Comment Period06/22/2004 - 07/22/2004
Proposed Decision Memo Released12/17/2004
Proposed Decision Memo Public Comment Period: 12/17/2004 - 01/17/2005 
Decision Memo Released03/15/2005
Comments for this NCA:View Public Comments
Lead Analyst(s)
  • Elizabeth Truong
Lead Medical Officer(s)
  • Carlos Cano, MD

June 22, 2004

CMS accepts Praecis’ request for a national coverage determination.

Praecis’ request and recommendations for coverage [PDF, 202KB] are available for review and comment.

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 13, 2004

Comments [PDF, 13KB] from the 30-day public comment period are now available for viewing.

December 17, 2004

The proposed decision memorandum is now available for public comment. Instructions for submitting comments are available at http://www.cms.hhs.gov/coverage/8h.asp

March 15, 2005

The final decision memorandum is posted and can be reviewed at http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=129.
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