The FDA has withdrawn approval for the use of Avastin to treat advanced terminal breast cancer as a life extender. I wrote about this earlier, when the FDA decision was preliminary, suggesting that the benefit of the doubt should probably be given to keeping the drug approved. I stated at the time that the FDA should be solely about efficacy—in this case whether it extends life—and not cost benefit, which is not the agency’s role.
Now, the final decision has been made to withdraw approval. From everything I have read, I think the benefits of the doubt fall in the other direction—based on general lack of efficacy and very serious side effects. That being so, this seems the right call.
And yet, Medicare and private insurance companies will still pay for it. NYT columnist Joe Nocera asks why. From “Why Doesn’t No Mean No?”
The strangest reaction, though, has come from the nation’s health insurers and the administrators of Medicare. Despite the clear evidence of Avastin’s lack of efficacy in treating breast cancer, they have mostly agreed to continue paying whenever doctors prescribe it “off label” for breast cancer patients. Avastin, by the way, costs nearly $90,000 a year. The reason they are doing so is obvious: the science notwithstanding, no company wants to be cast as so heartless that it would deprive a seriously ill cancer patient of a drug that might offer hope, however slim. In October, when The Times reported that California Blue Shield would no longer pay for Avastin as a breast cancer therapy, the company was immediately inundated with calls from elected officials, reporters and patient advocates. Although the furor appeared to be orchestrated by Genentech’s lobbyists, the insurance company quickly put out a statement making it clear that it would, in certain cases, continue to pay for Avastin.
Yes, and that kind of charge is generally led by pro single payer liberals—who ironically, say that rationing—that is, denying coverage for efficacious treatments based on cost or quality of life judgmentalism—is a must if government is the payer.
I don’t understand why “off label” prescribing is permitted at all. When a drug is prescribed for something for which it has not been tested, it seems to me that constitutes unethical human experimentation. That point aside, I think Nocera is right: There should be no obligation for any payer to fund treatments that are not FDA approved.
What about the UK’s NICE’s recent refusal to allow payment for a new cancer drug, Wesley? You criticized that decision. Indeed I did, but that was because NICE refused to permit an efficacious drug to be approved based on costs. That’s a different kettle of fish. If the FDA made this Avastin decision based on cost rather than efficacy, it would be rationing like NICE, and my opinion would change.
At a deeper level, the problem Nocera dances around deals with contemporary culture’s overriding drive of avoiding difficulty, judgmentalism, hurt feelings, and suffering at any and all costs. Sometimes that blade cuts left and sometimes, right. But it is the ultimate source of many societal problems afflicting the West in health care and issues far beyond.
