The fallout continues from the FDA's decision to pull Avastin's breast cancer approval. Starting Jan. 29, a Medicare coverage contractor will stop paying for the drug when it is used in breast cancer patients, the New York Times reports. It's the first official repercussion from the FDA's ruling that Avastin's benefits to breast cancer patients were too small to outweigh the risks.
The decision covers patients in South Carolina, Ohio, West Virginia, California, Nevada and Hawaii, Roche's Genentech told the NYT, and applies to patients who start treatment Jan. 29 or later. Women whose treatment has already begun--or who will start before that date--will still be covered, the company said. The Medicare contractor's choice contradicts previous assurances that reimbursement wouldn't be changed until the drugmaker had its chance to appeal.
Patients and politicians are likely to intensify their attacks on the FDA, even though some patient advocacy groups concurred with the agency's decision. Opponents are hyping the Avastin ruling as "rationing" and likening the agency to a "death panel," accusing FDA of putting cost before public health. Genentech maintains that Avastin data is "robust" and that it should be an option for breast cancer patients.
But as the FDA's oncology chief told the Wall Street Journal, the agency wasn't just acting on clinical data that showed a limited benefit from Avastin. It also had warned Genentech that its data supporting Avastin's breast cancer use was lacking. The drug won the indication on the fast track, which required follow-up study.
The data includes a key study called E2100, which the company said shows Avastin delays tumor growth in advanced breast cancer for five months. Independent reviews drew different conclusions from Genentech's study investigators, Richard Pazdur told the WSJ. "There were always issues with this trial [and] problems," Pazdur said. Follow-up studies found "nowhere near five months" of tumor delay. He says anecdotal reports of Avastin's benefit could stem from the drug it's paired with, namely Taxol. Genetech is appealing.
- get more from the NYT
- see the WSJ interview