The FDA, Avastin and Medicare

The FDA's expert panel says that Avastin is usually very effective against breast cancer and they can't endorse its use for that purpose.  Medicare says, not to worry, we'll pay for it. Huh? Isn't this the same Medicare that looked at whether or not it would reimburse for Provenge for nearly 1 year?  And that's for a drug that does meet its claims as far as I can tell.

I don't get it.  Presumably, Medicare was balking at Proveng's price tag ($93,000) and questioned cost-effectiveness before making its begrudging decision to provide coverage.  Now, we have an FDA panel of "experts" telling us that Avastin (and its $88,000 price tag) doesn't work too well for breast cancer patients and Medicare says we'll pay for its off-label use. It's spokesman says, "We often pay for off-label use of drugs, but not always."  So why this time for a drug that apparently doesn't work too often?

The Pharmalot blog suggests it is tradition.  That Medicare usually will cover indications for a drug - on or off-label - that are listed in compendia.  In this case, Avastin is listed as a breast cancer choice by the National Comprehensive Cancer Network (NCCN). Interestingly, 8 of the 33 members who consitute the NCCN breast cancer panel have ties to Avastin's creators Roche/Genentech.

So for now, it looks like Avastin whether recommended by the FDA's expert panel or not, will still be prescribed by physician's off-label when they feel it is appropriate and that Medicare will pick up the tab. Medicare does say that it will keep the situation under review as it evolves and "will consider its options".  See Pharmalot and In the Pipeline.

Posted by Bruce Lehr July 1st 2011.

 

 

Comments

[Blue Cross Medicare plans]

Excellent blog. I am a bit torn between agreeing and contesting it though. Breast cancer patients claims that taking the medicine can add 5 months to their life and that is a really long time for someone who is clinging for life and on the other hand officials claim that it is very expensive and doesn't work. Who is really telling the truth here?