Government

Medicare cancer patients win battle over off-label coverage

Legislative changes mean patients and independent reviewers can cite medical literature when defending off-label, non-compendia drug uses.

By Chris Silva — Posted May 4, 2009

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Cancer patient Judith M. Layzer says she has been in a life-or-death battle for more than two years not only with her illness but also with Medicare. Last month she scored a victory in the latter fight.

Layzer, a 68-year-old retired widow in New York City, has been treating her granulosa cell tumor with daily doses of Cetrotide (cetrorelix acetate) for more than nine years. More traditional treatments were not working, and she and her doctor became convinced that the off-label use of the drug offered the best chance of keeping the cancer in check.

The problem started when Layzer enrolled in Medicare's drug benefit in 2006. Not only was her prescribed use of Cetrotide absent from the drug's labeling, but it also could not be found in any of the three drug compendia that serve as medical reference guides for the use of Part D medications. So the Medicare drug plan said it was barred by federal law from covering the medication unless the labeling or the compendia were changed. An administrative law judge and the Medicare Appeals Council members reviewing the case agreed that the drug should be covered but concluded that their hands were also tied.

Because the hormone treatment costs upwards of $35,000 per month, Layzer could not afford to pay for it without help.

The situation started changing last July, when the Medicare Improvements for Patients and Providers Act clarified that the program can reference research in approved peer-reviewed literature when determining whether an off-label, non-compendia use is medically accepted. Under the clarified policy, an independent reviewer on April 20 approved Layzer's appeal and ordered that Part D cover her Cetrotide therapy.

The rationale: a recent article published in Gynecologic Oncology showed that the drug was effective in treating cancer with minimal toxicity.

A new precedent for cancer patients

The decision has given Layzer hope. She said she's gotten by so far on the generosity of her former employer's insurance company, which has been paying for 75% of her treatment. The ruling by the independent review board, however, has given her more stability and peace of mind.

The Medicare Rights Center, a nonprofit organization in Washington that assists seniors and people with disabilities, said the development goes far beyond one patient's case.

"This victory is important for Mrs. Layzer and all cancer patients," said Paul Precht, the center's director of policy and communications. "It is also a sign for policymakers on Capitol Hill and in the Obama administration that coverage decisions on these types of drug treatments can, and should, be made case by case on the basis of sound evidence vetted through the peer-review process."

The decision is a welcome one to experts who think relying on drug compendia alone to determine off-label coverage is going to leave some vulnerable patients out of luck.

"The value of basing coverage on peer-reviewed literature is that it is a source of information that is available much sooner than the compendia, which are only updated periodically," said Michael Miller, MD, president of HealthPolCom Consulting, a health policy, analysis and communications firm in Cambridge, Mass.

For some rarer cancers, such important data might never make it into the compendia, Dr. Miller said. "Thus, those patients unfortunate enough to have unusual malignancies could be permanently prevented from receiving the best treatments."

The Centers for Medicare & Medicaid Services said it does not comment on decisions from independent review entities, nor would it respond to criticism of the drug compendia.

The fight is not over. When initial appeals failed, the Medicare Rights Center in late 2007 sued the Dept. of Health and Human Services on behalf of Layzer and another patient, in an effort to challenge Medicare's interpretation of the off-label restrictions. That suit is still pending.

The legislative clarification of the Medicare statute, which took effect Jan. 1, still does not apply to non-cancer therapies, though the HHS secretary could approve additional compendia that list more off-label drug uses.

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ADDITIONAL INFORMATION

A new option for cancer patients

Medicare may now cover the off-label use of a cancer drug if:

  • The drug has been approved by the FDA.

AND

Such use is supported by one or more citations in one or more of the following compendia:

  • American Hospital Formulary Service-Drug Information.
  • U.S. Pharmacopoeia-Drug Information.
  • DRUGDEX Information System.
  • Any other authoritative compendia identified by HHS.

OR

  • The prescription drug plan involved determines that such use is medically accepted based on supportive clinical evidence in peer-reviewed medical literature appearing in publications approved by the HHS secretary.

Source: The Medicare Improvements for Patients and Providers Act of 2008

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