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National Coverage Determination (NCD) for Abarelix for the Treatment of Prostate Cancer (110.19)

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Benefit Category
Incident to a physician's professional Service
Inpatient Hospital Services

Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A.      General

An estimated 230,000 new cases of prostate cancer occurred in the United States during 2004. Treatment options vary once the disease is diagnosed depending on age, stage of the cancer, and other individual medical conditions. Surgery (e.g., radical prostatectomy) or radiation is typically used for early-stage disease. Hormonal therapy, chemotherapy, and radiation (or combinations of these treatments) are used for more advanced disease. Prostate cancer is androgen-dependent. In recent years, hormonal therapy has evolved from orchiectomy and estrogens to the use of synthetic drugs known as gonadotropin-releasing hormone (GnRH) agonists or analogues. GnRH agonists include drugs such as leuprolide (LupronTM) and goserelin (ZoladexTM). In contrast with GnRH agonists, newer compounds such as abarelix (PlenaxisTM) are thought to be devoid of agonist activity and to lack an initial androgen-stimulating effect and are thus considered GnRH receptor antagonists. Abarelix has been proposed as a substitute for GnRH agonists with and without anti-androgens in the treatment of patients with advanced prostate cancer for whom a surge in androgen blood levels may pose a risk of worsening symptoms (“clinical flare.”)

Indications and Limitations of Coverage

B.      Nationally Covered Indications

Effective for services performed on or after March 15, 2005, the Centers for Medicare & Medicaid Services (CMS) make the following determinations regarding the use of abarelix in the treatment of patients with prostate cancer:

The evidence is adequate to conclude that abarelix is reasonable and necessary as a palliative treatment in patients with advanced symptomatic prostate cancer: (1) in whom GnRH agonist therapy is not appropriate; (2) who decline surgical castration; and (3) who present with one of the following:

  • risk of neurological compromise due to metastases,
  • ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or,
  • severe bone pain from skeletal metastases persisting on narcotic analgesia.

The following additional conditions for coverage must be met in accordance with the Food and Drug Administration (FDA) labeling requirements to ensure that abarelix is used only in patients for whom the drug is indicated:

  • The patient has been evaluated by, 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.
  • Physicians have 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 patients on the risks and benefits of palliative treatment with abarelix; and,
    • Report serious adverse events as soon as possible to the manufacturer and/or the FDA.

C.      Nationally Non-Covered Indications

Effective March 15, 2005, CMS determines that 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 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 Medicare Administrative Contractors rely to make coverage determinations will remain non-covered unless CMS extends coverage through a reconsideration of this National Coverage Determination (NCD).

D.      Other


Claims Processing Instructions
Transmittal Number


Revision History

04/2005 - Covered for use as palliative treatment in patients with advanced symptomatic prostate cancer. Effective date 3/15/2005. Implementation date 5/25/2005. (TN 34) (CR 3775)

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.