Medicare Broadens Coverage of Cancer Drugs.. Melanoma..Jim Breitfeller

Medicare Broadens Coverage of Cancer Drugs

As Reported by The New York Times. 2009 Jan 26

As of November 2008, Medicare now covers cancer drugs prescribed for off-label uses not indicated by the Food and Drug Administration (FDA). This new policy continues to stir the controversy waged by proponents of the move, who say it helps patients receive the most up-to-date care and furthers research, and opponents, who cite cost and patients’ potential exposure to adverse effects from treatments that may not provide any benefit. There is no provision in the new policy for monitoring outcomes from off-label uses. How much the new policy will increase Medicare’s spending on cancer drugs above the $2.4 billion it spent in 2007 is difficult to know, because Medicare canceled a cost analysis of the changes. Gemzar (gemcitabine) and Avastin (bevacizumab) are 2 of the drugs that will receive expanded coverage. In 2007, Medicare rejected nearly all claims for off-label use of bevacizumab for ovarian cancer.

Medicare asserts that the new policy responds to oncologists’ criticisms that it has been too slow in the past in recognizing off-label uses of drugs that show clinical promise. The American Society of Clinical Oncology applauds the new rules. Oncologists have needed the flexibility to prescribe cancer drugs off label, singly or in combination, because FDA drug approvals can take years. The off-label use of thalidomide for multiple myeloma is a case example. Rules for coverage limiting patients to only a few drugs could deprive them of a life-saving treatment. Sometimes numerous drug trials are necessary before they find a treatment to which they respond.

Medicare relies on 3 compendia as reference guides in deciding which off-label uses of cancer drugs to cover. It will review its choice of compendia every year. The contents of the compendia wield considerable power in decision making under the new policy: as long as 1 of the 3 compendia recommends a particular cancer treatment, Medicare is obligated to pay for it.

Conflicts of interest related to ties between the compendia developers and the pharmaceutical industry are being examined in a report to be delivered to Medicare soon. Some experts contributing to the National Comprehensive Cancer Network (NCCN) guidelines, which Medicare uses, have ties to drug companies. Similarly, the American Hospital Formulary compendium, which Medicare consults, used to be published by a nonprofit group. It now operates through the Foundation for Evidence-Based Medicine, to which a drug company can pay a $50,000 fee to have its drug reviewed for inclusion in the compendium. Less than one-third of such reviews result in a recommendation, however.

Medicare officials acknowledge that various issues that still need to be resolved, but they stand behind their choice of compendia.


Jimmy B