WASHINGTON Medicare will continue paying for Roche Holding's drug Avastin for breast cancer, regardless of what health regulators decide about the medicine's future, a spokesman said on Thursday.
The statement from the U.S. healthcare program could mitigate concerns that patients using the drug would lose insurance coverage should the U.S. Food and Drug Administration revoke approval for its use in breast cancer.
An FDA panel recommended on Wednesday that Avastin no longer be used to treat the disease because it has not proven safe or clinically beneficial in large trials. FDA Commissioner Margaret Hamburg is expected to make a final decision later this year.
Doctors can still prescribe Avastin if the FDA revokes approval, but the move would influence recommendations by physician and insurance groups over whether to pay for it.
"The FDA decision, when it comes, does not affect CMS," Don McLeod, a spokesman for the Centers for Medicare and Medicaid (CMS), said on Thursday.
"The drug will still be on the market, doctors will still be prescribing it, and we will continue to pay for it," he said, adding that CMS often pays for off-label uses of drugs.
The Medicare statement could also influence private insurers. A WellPoint Inc spokeswoman said on Thursday it would not drop support for patients already taking Avastin and is unlikely to disrupt coverage for new patients.
Patient groups say Avastin has saved lives even if the effect does not show up in broader sets of data. They pleaded with the FDA to keep its breast cancer label. Some 17,000 U.S. patients take Avastin, which costs about $8,000 a month.
"CMS essentially stands between (patients) and death, that's how we perceive it," said Terry Kelley, who formed the group Freedom of Access to Medicines and organized the protest outside the FDA building on the first day of hearings.
If the FDA pulls approval for Avastin in breast cancer, it could prompt a review of industry guidelines from groups like the National Comprehensive Cancer Network, which represents leading cancer treatment centers.
NCCN has so far not strayed from its earlier guideline, approving use of Avastin with the chemotherapy drug paclitaxel for some patients. CMS often takes its cue from such groups. Insurance companies, in turn, generally take into account CMS decisions to help determine coverage.
Roche's U.S. unit Genentech, for its part, plans to continue providing Avastin for free to women without insurance or whose insurance drops Avastin coverage, a unit spokesman said. The free medicine comes through Genentech's patient access program for women who make less than $100,000 a year, he said.
Using Avastin for metastatic breast cancer costs about $88,000 a year, based on people taking it for approximately 11.3 months, Roche said.
Genentech has limited the annual cost of Avastin to $58,000 for patients taking it for any FDA-approved indication. But if breast cancer loses that indication in FDA's final ruling, the cost limit offer would also have to end, Genentech said.
Genentech said global Avastin sales for Roche in 2010 were $6.2 billion, while U.S. sales of Avastin in 2010 were approximately $3.1 billion. It said 2010 U.S. sales of Avastin for breast cancer were about $750 million.
The Swiss drugmaker is now poised to carry out another trial of Avastin in a bid to prove it does significantly extend the time women live without their disease getting worse.
(Editing by Derek Caney, Robert MacMillan, Gary Hill)