Medicare & FDA not on the same page

February 19th, 2009 | Sources: NY Times

New rules promulgated last November obligate Medicare to pay for expensive cancer drugs in hundreds of situations where the drugs are not approved by the FDA.

rubhereI'llgrant3wishesMedicare now covers Eli Lilly’s Gemzar for 16 different cancers for example. The FDA approves the $5,000 per month drug for four.

And Genentech’s Avastin, which can cost twice that, will now be covered by Medicare for use in cancers of the ovary, brain and kidney. The FDA has approved no such thing.

The windfall is the result of Medicare’s new plan to delegate coverage decisions to a set of reference guides.  If one guide recommends it, Medicare pays unless another guide specifically says you’ve got to be crazy.

Medicare didn’t seem to mind that scientists it retained to study the guides found they “cited very little of the available evidence,” or that they varied markedly in their recommendations according to Amy Abernethy, a Duke oncologist who headed an investigation on the matter. Abernathy’s report is due out shortly.

And guess what? The editors of the guides have financial ties to Big Pharma!

One guide is produced by the National Comprehensive Cancer Network, for example. The Network routinely retains experts on the dole from drug companies.

Then there’s the American Hospital Formulary guide, compiled by the American Society of Health-System Pharmacists.

Last year, the Society inked a deal with a “Foundation” which  accepts $50,000 application fees in return for assuring the applicant’s favorite oncology drug gets reviewed by the guide within 90 days.

No word on whether applicants get their money back if the guide rejects their proposal.

Oncologists generally support the new rules. They know it takes years for the FDA to act. Take thalidomide for example. It had become central to the treatment for multiple myeloma years before receiving FDA approval for that purpose.

And for rare cancers, drug companies don’t have a financial incentive to run the gauntlet of an FDA approval process, so patients go without. The FDA has approved only 2 drugs for the treatment of brain cancer, for example.

That may be true, but why not demand better evidence and clean up the conflicts of interest?

Medicare is providing “carte blanche in treatment for cancers,” Consumer’s Union health policy analyst Steven Findlay told the Times.  “It makes it easier to give drug after drug, and keep the fantasy alive” added Andrew Berchuck, the director of gynecologic oncology at Duke.


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