Medicare, in a separate issue, says it will cover costs of Provenge, an expensive treatment for advanced prostate cancer.
“We frequently cover off-label uses and have not been asked to stop paying for this one,” Don McLeod, a spokesman for Medicare, tells WebMD, referring to Avastin. “The label change will not affect our coverage.”
"Off-label" refers to prescribing a drug for a condition that is not specifically approved by the FDA.
Medicare and the FDA “are different agencies” and operate “under a different statute,” he tells WebMD. “We are looking at the evidence. It is not automatic.”
Decisions by Medicare and FDA Panel
Medicare, known formally as the Centers for Medicare and Medicaid Services or CMS, issued its “final decision” to cover Provenge on June 30, saying the drug “improves health outcomes” for certain men with advanced prostate cancer.
That announcement followed a June 29 decision by an FDA panel recommending that Avastin no longer be sold as a treatment for breast cancer.
The two cases had nothing to do with each other, McLeod tells WebMD, and it was “just coincidental” that the FDA panel’s recommendation against Avastin came one day before Medicare said Provenge would be covered.
“It would be incorrect to say that a decision has been made on coverage of Avastin,” McLeod says in an email. “So far, to this point, FDA’s actions have not affected CMS’s payment for Avastin. We are aware of the recent advisory committee vote as part of FDA’s ongoing review. As the situation evolves we will continue to evaluate and consider our options.”
Though the FDA panel said Avastin should no longer be sold as a breast cancer treatment, a final decision on whether to suspend marketing will be made later in the year by FDA Commissioner Margaret A. Hamburg, MD.
Cost of Provenge and Avastin
Provenge, made by Dendreon Corp., is estimated to cost about $93,000 per patient.