Coverage Policy and Use Beyond the FDA-Approved Label

Author: William T. McGivney PhD
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The issue of insurance coverage for the use of drugs and biologics in cancer care for indications beyond Food and Drug Administration (FDA)-approved labeling is one that has been important to the oncology community since interferon was approved for use in hairy cell leukemia in the late 1980s. Today, the research pipelines of the pharmaceutical and biotech industries are replete with innovative and promising agents to treat solid tumors and hematologic malignancies and for supportive care. The approval and use of these important new therapies usually come with significant price tags in addition to improved therapeutic indices. Recent articles1,2 focus on the added cost created by integrating new agents into existing regimens. Thus, introducing new agents into practice coincides with a resurgent and growing concern about the rate that health care expenditures rise in both the public and private sectors, with particular emphasis in the Medicare program. This commentary provides historical perspective on the issue of payment for uses beyond the FDA label, describes the issue within the context of today's environment, discusses related issues that may impact access to improved therapies, and describes the NCCN's response. The introduction of interferon in the 1980s focused the attention of payors on an already common practice in oncology. This biologic agent was approved for the aforementioned ``orphan'' indication but was quickly also studied and used in patients with a range of solid tumor types and hematologic malignancies. Insurers morphing into managed care companies began to assert their new orientation and managed to...

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William T. McGivney, PhD, is the Chief Executive Officer of the National Comprehensive Cancer Network and a recognized expert in coverage policy and drug and device regulatory policy. Before joining the NCCN in 1997, Dr. McGivney directed the Division of Health Care Technology at the American Medical Association and worked for Aetna Health Plans as Vice President for Clinical and Coverage Policy. Awarded the FDA Commissioner's Medal of Appreciation in 1989, Dr. McGivney has served on numerous national boards and committees. He earned his PhD at the University of North Carolina at Chapel Hill and completed a postdoctoral fellowship in the Department of Psychiatry at the Harvard Medical School.

  • 1.

    Schrag D. The price tag on progress: Chemotherapy for colorectal cancer. N Engl J Med 2004;351:317-319.

  • 2.

    Berenson A. Cancer drugs offer hope, but at a huge expense. The New York Times, July 12, 2005.

  • 3.

    Harris G. US weighs not paying for all uses of some drugs. The New York Times, January 30, 2004.

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