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Prostate Cancer Drug Plenaxis Gets Medicare Coverage

March 22, 2005

The Centers for Medicare & Medicaid Services issued a final decision memorandum extending Medicare coverage to Praecis Pharmaceuticals' prostate cancer drug Plenaxis.

Approved by the FDA in November 2003, Plenaxis (abarelix) is a gonadotropin-releasing hormone (GnRH) agonist that lowers the rate of tumor growth by inhibiting testosterone production.

The CMS determined that evidence is adequate to conclude that abarelix is reasonable and necessary as a palliative treatment in patients with advanced symptomatic prostate cancer in whom GnRH agonist therapy is not appropriate. To qualify for coverage, Medicare beneficiaries must present one of the following conditions:

Risk of neurological compromise from metastases;

Ureteral or bladder outlet obstruction from local encroachment or metastatic disease; or Severe bone pain from skeletal metastases persisting on narcotic analgesia.

To view the final coverage decision, go to http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=129 (http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=129).