Abarelix for the Treatment of Prostate Cancer

CMS NCA document | source_status=Closed | review_type=New | public_comment_open=False | document_id=CAG-00238N

The Centers for Medicare & Medicaid Services (CMS) has made the following determinations regarding the use of abarelix in the treatment of patients with prostate cancer. 1) Consistent with the specifications of the FDA labeling, the evidence is adequate to conclude that abarelix is reasonable and necessary as a palliative treatment in patients with advanced symptomatic prostate cancer in whom gonadotropin-releasing hormone (GnRH) agonist therapy is not appropriate, who decline surgical castration, and who present with one of the following: (a) risk of neurological compromise due to metastases, (b) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (c) severe bone pain from skeletal metastases persisting on narcotic analgesia. Also consistent with the FDA labeling, the following additional conditions for coverage must be met to ensure that abarelix is used only in patients for whom the drug is indicated: The patient has been evaluated and the drug has been prescribed by a physician who has attested to the following qualifications and accepted the following responsibilities, and on that basis, has enrolled in the post-marketing risk management program established by the drug manufacturer. The physician has attested willingness and ability to: Diagnose and manage advanced symptomatic prostate cancer; Diagnose and treat allergic reactions, including anaphylaxis; Have access to medication and equipment necessary to treat allergic reactions, including anaphylaxis; Have patients observed for development of allergic reactions for 30 minutes; following each administration of abarelix; Understand the risks and benefits of palliative treatment with abarelix; Educate the patients on the risks and benefits of palliative treatment with abarelix; Report serious adverse events as soon as possible to the manufacturer or the FDA. 2) The evidence is not adequate to conclude that abarelix is reasonable and necessary for indications other than that specified above. All other uses of abarelix therefore are not covered. In light of the concern regarding safety risks of abarelix, off-label uses that may appear in listed statutory drug compendia on which Medicare and its contractors rely to make coverage determinations will remain non-covered unless CMS extends coverage through a reconsideration of this NCD.