The Centers for Medicare and Medicaid Services (CMS) said Medicare will continue paying for Avastin for the treatment of metastatic breast cancer, despite a Food and Drug Administration (FDA) panel’s recommendation to withdraw the drug’s approval for that use.
“The FDA decision, when it comes, does not affect CMS,” Don McLeod, a CMS spokesman, told Reuters. “The drug will still be on the market, doctors will still be prescribing it, and we will continue to pay for it.” Many private health insurance companies typically follow Medicare’s lead.
Without coverage, the drug, manufactured by Genentech, costs about $2,000 to $3,000 per dose, adding up to about $8,000 a month — or nearly $90,000 per year — which would put it out of reach for many of the 17,500 breast cancer patients in the U.S. who currently use it. The CMS decision may ease many of those women’s fears. Further, as Reuters reported:
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.
On Wednesday an FDA advisory panel recommended revoking approval of Avastin for advanced breast cancer, finding unanimously that the drug did not extend life and exposed women to serious, potentially fatal side effects, including high blood pressure, heart attack, heart failure, internal bleeding, perforated organs and even swelling of the brain. According to clinical trial data, about 1% of women who take the drug die from it.
The panel’s vote came at the end of an emotional two-day hearing, during which breast-cancer survivors whose lives have been extended on Avastin pleaded with the panel not to withdraw its approval. Their testimony clashed, sometimes heatedly, with scientists who favored removing the breast-cancer label.
Although the data show that the drug does not help women on average, some experts think it may help extend life in a small group of “super-responders.” Reported Melinda Henneberger on Healthland:
Beth DuPree, a Pennsylvania breast cancer doctor who as a surgeon does not prescribe Avastin but does have patients who are on it … said she has had patients get a couple of extra years of life as a result of Avastin since it was provisionally approved — pending further clinical-trial data — for patients with late-stage breast cancer in 2008. Since then, Roche has failed to prove that it sufficiently extends or improves the quality of life for women with terminal breast cancer. Yet, for some reason, it does seem to help a minority of patients. “I had one woman who got to watch her child go from 12 to 14″ because of Avastin, DuPree said. Is that a big deal? If you’re that woman or her child, of course, that’s not even a serious question.
Nancy Haunty, a 41-year-old who showed the panel a photo of herself climbing Mount Adams in Washington State last year, said she has been symptom-free for the entire 21 months she’s been on the drug. Crystal Hanna, a 35-year-old mom from Parkersburg, W. Va., said all she’d gotten out of being on it so far is the chance to see her child baptized, to travel with her family to Disney World, and to attend her brother’s wedding. “Every moment is important to us,” she told the panel, adding that if the FDA does withdraw its approval for use by women with late-stage cancer,” my insurance won’t pay and I can’t afford it.”
The final decision on Avastin now rests with FDA Commissioner Margaret Hamburg. Either way, the drug will remain on the market for the treatment of lung, colon, kidney and brain cancers, and can still be prescribed off-label to breast-cancer patients.