The Avastin and breast cancer story is now familiar. The news is that Genentech went back to the FDA offering some ideas on how to keep it on the market for breast cancer. Approved conditionally by FDA for metastatic breast cancer (it is approved for other cancers) an expert committee voted to pull the drug off the market JUST for this indication. What this means is that Avastin will be available for physicians to use as they choose, but Genentech won't be able to promote it, and there will be serious restrictions on reimbursment (it costs $80,000/yr), which maybe removed alltogether.
Using standard statistical methods- the drug should be deemed ineffective for treating metastatic breast cancer. On the other hand, anecdotal evidence suggests that the occasional patient benefits dramatically. This has also become a political issues, with many claiming that the FDA shouldn't over-regulate and show flexibility when dealing with end-stage disease. What would an FDA worker do if faced with metastatic breast cancer- would she choose Avastin+paclitaxel (after other options were exhausted)? My bet is yes.
The Solution? Leave it on the market, but have Genentech lower the price just for this indication, given its questionable efficacy for large number of subjects. I know that the FDA doesn't control pricing (which is the way it should be), but there should be a common sense solution that allows for the facts as we understand them. I also know that Pharma companies hate to have different prices for the same product, so maybe the reimbursement agencies (medicare and private insurers) should agree with Genentech to a lower price, irrespective of what the FDA decides.
Just a thought, probably almost impossible to implement.
