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.
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.