Despite FDA's Rejection of Avastin for Breast Cancer, Medicare Will Continue Coverage

On Wed., June 29, 2011, the FDA(U.S. Food & Drug Administration), unanimously rejected the drug Avastin for the treatment of breast cancer by a vote of 6-0, saying it was not safe or clinically beneficial for treating the disease, disregarding the cries of many breast cancer survivors, who said it saved their lives.

On Thur., the following day, a spokesman for the CMS(Center for Medicare & Medicaid) said it will continue to provide coverage for the use of Avastin for breast cancer, regardless of the FDA findings. He went on to say that the drug will still be on the market, doctors will keep prescribing it, and we will continue to pay for it's use- a victory for those breast cancer patients who are using it, to say the least.

Patients who are or were on the drug testified during a 2 day hearing that the drug Avastin, saved their lives and they feared they would lose their insurance coverage if the FDA rejects the the drug for the treatment of breast cancer. Avastin costs it's patients about $18,000 a month to use.

This FDA decision came as a big blow to Roche, the manufacturer of Avastin, as well as the thousands of patients who insisted that the medicine saved their lives. Roche stands to lose nearly a billion dollars out of a total of 6 billion in Avastin revenue if it's use is ultimately revoked for breast cancer treatment.

Avastin won U.S. clearance in 2008 based on a study showing the drug stalled breast cancer growth by 5.5 months when used in conjunction with chemotherapy. Later studies, according to the FDA, showed it only had a 1 to 3 month delay in breast cancer growth and some it's side effects were devastating.

Based on Avastin's side effects and the fact that it would take at least 3.5 years to get new trial results meant the FDA couldn't continue to back it's use in the interim. No matter what they looked at, the advisers to the FDA said there was nothing that they could see as a benefit in the drug that makes them feel comfortable about exposing a lot of patients to it's risks.

As of now, Medicare patients using the drug Avastin for treatment of breast cancer can rest assured their prescriptions will continue to be covered. We all know things can change in the blink of an eye though, but hopefully this won't be one of them, at least until another solution is found for the treatment of this horrible disease.

Source: Reuters.com