House GOPs: FDA Considered Cost in Avastin Withdrawal for Breast Cancer

Blogs and traditional sources are abuzz with the news that the FDA is considering the withdrawal of Avastin's indication for breast cancer. The agency, in what may be a harsh, but necessary decision, concluded that Roche's monoclonal antibody—which is otherwise approved for the treatment of colon cancer, non-small cell lung cancer, glioblastoma, and metastatic kidney cancer—"has not been shown to be safe and effective for [breast cancer]."

The FDA based its looming rescission on the postmarketing results of 4 clinical studies, which showed that Avastin does not prolong overall survival or slow disease progression to an extent that outweighs drug-related risks (like hemorrhage, organ perforation, and MI). The agency evidently reached its conclusion after agreeing with input from an oncology advisory committee (which voted, 12-1, in July of this year to pull the breast-cancer indication).*

For now, Genentech (Roche's subsidiary) has not agreed to voluntarily pull the drug. Confusing the US regulatory decision is the fact that the European Medicines Agency affirmed the utility of Avastin in metastatic breast cancer (with paclitaxel). Genentech will evidently accept the FDA's invitation for a Notice of Opportunity for a [Public] Hearing, according to a company press release. In the meantime, the drug will retain its breast-cancer indication in the United States.

There are others who also oppose the FDA's decision on Avastin, including patient advocates, US breast-cancer experts (who observe that subgroups of patients clearly respond remarkably to the drug), and House Republicans. The political charge is that the FDA is considering cost—not merely efficacy and safety—in its decision to withdraw Avastin for breast cancer. Two statements jump out in a joint press release.

Reps. Gingrey, Myrick, Pitts and Upton are gravely concerned that the FDA is putting economics ahead of proper courses of treatment and that today's announcement is the first step towards government rationing of health care.

And

Allowing the FDA to factor in the cost of a drug when determining whether that drug should be approved is the first big step towards government rationing.

If this is true (that the FDA considered the cost of Avastin in its approval process),** the government would be overstepping its legislated bounds. It's not the FDA's legal job or purview to consider what the free market can or should bear (despite the rising costs of health care). That issue should be left up to the free market. Perhaps House Republicans are creating a diverting issue by raising drug cost in the case of Avastin withdrawal, but it is an issue worth exploring (by further probing the FDA's review process of Avastin).

According to the AP and other sources, Avastin costs about $8000 a month, but Roche caps the annual price at $57,000. The drug brings in about $1 billion from use in breast-cancer patients (which is a fraction of overall Avastin revenue). According to the NY Post (I know), agency officials deny that their decision is based on cost. 

Of course, individuals with breast cancer could still receive Avastin off-label, if the FDA's withdrawal sticks; however, insurance coverage for the indication may be jeopardized as a consequence. That's the point and fear of Avastin advocates and patients.  

* In a July analyst call, Avastin director Stefan Frings reportedly complained openly about the biased makeup of the advisory panel and the FDA's statistical methods.

** Although I've found no evidence that the FDA considered the cost of Avastin in the process of making its latest decision.