A spokesman for the Centers for Medicare and Medicaid Services said the agency would continue to pay for Avastin for breast cancer, even if the Food and Drug Administration revoked the drug’s approval as a treatment for that disease.
“The label change will not affect our coverage,” the spokesman, Don McLeod, said.
An advisory committee to the F.D.A. voted unanimously Wednesday in favor of rescinding the breast cancer approval, saying the latest evidence suggested the drug was not effective. The final decision will be made by the F.D.A. commissioner, Dr. Margaret A. Hamburg, after a public comment period ends on July 28.
Avastin would retain approval for other cancers so doctors could still use it off label for breast cancer. But some women fear that insurers will no longer pay for the drug, putting the medicine, which costs about $88,000 a year, out of reach for most women.
Mr. McLeod’s statement could allay those concerns, at least for women covered by Medicare. He said that Medicare commonly paid for off-label use of cancer drugs.
Still, Mr. McLeod said that while there were no plans for one right now, he could not totally rule out that Medicare might one day undertake a national coverage determination to decide whether to pay for Avastin. That process would take at least a year and involve public input.
Such a national coverage determination was undertaken for Provenge, which costs $93,000 for a complete course of treatment.
The final decision, issued Thursday, said the evidence was adequate to conclude that Provenge “improves health outcomes for Medicare beneficiaries” and was therefore “reasonable and necessary” for their treatment.
The result confirmed a preliminary decision announced three months ago.
The decision applies to men who meet the criteria in the drug’s label, meaning the cancer has spread beyond the prostate gland, it is no longer controlled by hormone therapy and the men have few or no symptoms.
The national coverage determination drew outcries from some men with prostate cancer, investors in Dendreon and critics of health care reform, who said the government was singling out the drug because of its cost and was on its way to rationing health care. Similar accusations about rationing greeted the F.D.A.’s proposal to remove the breast cancer approval for Avastin.
Both Medicare and the F.D.A. said the costs of the drugs were not a factor in their deliberations.
Private insurance companies must also decide whether to continue paying for Avastin as a breast cancer treatment.
WellPoint said it would review the medical necessity after the F.D.A. makes its final determination.
Cigna and the Health Care Service Corporation, which operates Blue Cross and Blue Shield plans in Illinois, Texas, Oklahoma and New Mexico, both said they would evaluate their coverage positions after the F.D.A. made a final decision.
UnitedHealthcare said its chemotherapy coverage decisions were based on a reference published by the National Comprehensive Cancer Network. That reference lists Avastin as a valid treatment for breast cancer.
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