If FDA withdraws approval of Avastin for breast cancer, insurers could stop covering it

A Food and Drug Administration panel's decision this week to reject the drug Avastin for treatment for breast cancer could mean insurance companies would stop covering its costs for patients who depended on it.

CIGNA, for example, covers only FDA-approved medications, a company spokeswoman said.

"Avastin is currently an FDA-approved drug to treat breast cancer and as such is covered by CIGNA," she said. "We will wait until the FDA reaches a decision before considering any coverage impact."

Avastin is the world's best-selling cancer drug, generating about $7 billion in sales for Roche Inc., which is based in Basel, Switzerland, but has operations in Nutley and Branchburg, N.J. Genentech, in San Francisco, is the subsidiary that makes Avastin. Breast cancer treatments accounted for about $1 billion of the sales.

Avastin is approved for colon, lung, kidney, and brain cancer. The FDA panel that met Tuesday and Wednesday dealt only with the drug's safety and effectiveness in treating breast cancer. The six-member panel voted unanimously to withdraw approval of the drug for that purpose.

The advisory panel said five studies had not shown enough benefit to justify the risks. FDA Commissioner Margaret Hamburg has final say, but usually follows the recommendation of such panels. There was no word on when she will make a decision.

"We are very disappointed by the committee's recommendation and hope the commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options," said Hal Barron, Roche's chief medical officer and head of global product development, in a statement.

There are breast cancer patients on both sides of the Avastin debate, which went beyond scientific evidence. Health-care costs are part of fiscal arguments in Washington. Avastin's monthly cost is about $7,300.

Even if Hamburg agrees with the panel, doctors will be free to prescribe Avastin for breast cancer patients "off-label," but there could be less certainty about whether public or private insurers would pay for it.

The FDA evaluates drugs and medical devices. Medicare is the biggest government agency when it comes to paying for patient care, and Medicare spokesman Don McLeod said the FDA action would have no immediate effect on reimbursement.

"If it's still on the market and doctors are still prescribing it, we will continue to pay for it," he said. "We often cover off-label uses of [Medicare] Part B drugs."

McLeod declined to comment when asked if it made sense for the government to reimburse for drugs not approved by the FDA. Sometimes Medicare follows FDA labels. Medicare said Thursday that it would cover Provenge, a prostate cancer drug, "only for those indications supported by evidence and consistent with the FDA label," said Patrick Conway, who guides the agency's office of clinical standards.

Aetna, CIGNA, and UnitedHealthcare, three of the biggest private insurers, base some coverage decisions on guidelines established by the National Comprehensive Cancer Network, a Fort Washington-based not-for-profit alliance of 21 of the leading cancer centers.

Aetna's James Cross said in a statement: "The National Comprehensive Cancer Network guidelines continue to support Avastin's use for the breast cancer indication. We will continue to monitor any changes in the NCCN guidelines, research published in peer-reviewed medical literature and other sources, and will review and update our policies as needed."

UnitedHealthcare also said it would "continue to follow the NCCN guidelines regarding Avastin."

at 215-854-4506 or dsell@phillynews.com.