The fate of the drug for breast cancer has been closely watched by patients, oncologists, women’s health advocates, health-care policymakers, politicians and the pharmaceutical industry. The case has triggered strong reactions from advocates of easier access to new treatments and from critics fearing health-care rationing. It is also being seen as one of the most visible medical examples of scientific evidence winning out over an animated public outcry. Ultimately, clinical trials failed to support the drug’s early promise for breast cancer treatment.
“I think we all wanted Avastin to succeed, but the reality is that these studies did not bear out that hope,” said Natalie Compagni Portis, who represented patients on the panel.
If the FDA revokes Avastin’s approval for treatment of breast cancer, the drug would remain available for other cancers, enabling doctors to prescribe it “off-label” for breast cancer patients. But the decision would probably prompt insurers to stop paying for the drug — which costs about $88,000 a year per patient — for breast cancer treatment. . Breast cancer patients also would lose eligibility for a program sponsored by the drugmaker, Genentech, that caps the annual cost at about $57,000 for women making less than $100,000 a year.
“A terrible tragedy has occurred,” said Frank Burroughs of the Abigail Alliance for Better Access to Developmental Drugs, which is among the groups that has been pressing the FDA to maintain Avastin’s approval on the grounds that it benefits some patients.
But the decision was praised by others, including several leading breast cancer advocacy groups and experts who said it was important for the agency to base its decisions on the scientific evidence, not emotional appeals, especially when lives are at stake and controlling health-care costs is so crucial to the nation’s economy.
“Now we must focus attention and resources on drugs that will truly make a difference for women suffering from breast cancer. Avastin does not,” said Fran Visco of the National Breast Cancer Coalition.
“I think it’s great that they are willing to make a tough call,” said H. Gilbert Welch of the Dartmouth Institute for Health Policy and Clinical Practice.
The FDA is not supposed to acknowledge cost in drug approvals, and officials have stressed that the price was irrelevant. But coming amid a continuing national debate over President Obama’s health-care overhaul, the fight about Avastin has become entangled in the politically sensitive struggle over medical spending and effectiveness.