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.
McLeod tells WebMD that Medicare will cover Provenge for certain indications.
Avastin, made by California-based Genentech, costs about $88,000 a year.
Some people have expressed concern that Medicare might stop covering Avastin due to the June 29 recommendation by the FDA panel. But McLeod tells WebMD that those fears are not justified, at least not yet, because Medicare plans to keep paying for Avastin.
CMS Administrator Donald Berwick, MD, says in CMS’s news release on Provenge that Medicare “is dedicated to assuring that these [prostate cancer] patients can seek the treatments they need in accordance with their wishes.”
Medicare, in a lengthy “final” statement, says it will not pay for all possible uses of Provenge and will reimburse only costs for uses that closely match the drug’s labeling.
CMS’s Patrick Conway, MD, MSc, says in the news release that Medicare “is covering Provenge nationally only for those indications supported by evidence and consistent with the FDA label.”
Conway, chief medical officer of CMS and director of its office of clinical standards and quality, says individual patients “should discuss the risks and benefits with their physician” before making a decision to use Provenge.
Medicare’s statement says that because evidence is sufficient to conclude that Provenge improves the health outcomes of some prostate cancer patients, it was “reasonable and necessary” to make it available for their treatment.