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National Coverage Determination (NCD)

Abarelix for the Treatment of Prostate Cancer

110.19

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Tracking Information

Publication Number
100-3
Manual Section Number
110.19
Manual Section Title
Abarelix for the Treatment of Prostate Cancer
Version Number
1
Effective Date of this Version
03/15/2005
Ending Effective Date of this Version
01/01/2021
Implementation Date
05/25/2005
Implementation QR Modifier Date

Description Information

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


Please 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 (Lupron™) and goserelin (Zoladex™). In contrast with GnRH agonists, newer compounds such as abarelix (Plenaxis™) 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

N/A
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
34
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R34NCD.pdf
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)
Other

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.

Coding Analyses for Labs (CALs)

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

Additional Information

Other Versions
Title Version Effective Between
Abarelix for the Treatment of Prostate Cancer - RETIRED 3 04/10/2023 - 01/01/2021 View
Abarelix for the Treatment of Prostate Cancer 2 01/01/2021 - 01/01/2021 View
Abarelix for the Treatment of Prostate Cancer 1 03/15/2005 - 01/01/2021 You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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