National Coverage Analysis (NCA) Tracking Sheet

Abarelix for the Treatment of Prostate Cancer

CAG-00238N

Issue

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.

National Coverage Determinations

Benefit Category

Incident to a physician's professional Service
Inpatient Hospital Services

Requestor Information

Requestor Name Requestor Letter
Praecis Pharmaceuticals Incorporated View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
06/22/2004
Expected NCA Completion Date
03/18/2005
Public Comment Period
06/22/2004 - 07/22/2004
Proposed Decision Memo Due Date
Proposed Decision Memo Released
12/17/2004
Proposed Decision Memo Public Comment Period
12/17/2004 - 01/17/2005
Decision Memo Released
03/15/2005
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Elizabeth Truong
Lead Medical Officers
Carlos Cano, MD

Medicare Benefit Category Determination Date

Actions Taken

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.