One regional Medicare provider has decided to continue to cover Avastin, a breast cancer drug, reversing their decision from last week’s announcement to refuse coverage.
Questions about coverage of the pricey drug were sparked by the Food and Drug Administration (FDA)’s12-1 ruling in July to revoke approval of the drug for use to treat breast cancer. Genentech, the manufacturer of the drug, is appealing the decision.
A spokesperson for Medicare contractor Palmetto GB, a subsidiary of Blue Cross Blue Shield of South Carolina, reported in the New York Times that Palmetto “has suspended consideration of changes in its reimbursement policy for Avastin as a treatment for breast cancer” while the appeal process continues.
Last week, in a notice posted on its website, Palmetto GB, a regional company that determines Medicare coverage for South Carolina, Ohio, West Virginia, California, Nevada and Hawaii had said that it would stop paying for the use of Avastin for breast cancer treatment as of Jan. 29. That notice was updated this week to state it will “continue coverage of Avastin under current policy.”
In July, the F.D.A. decided to revoke approval of Avastin, also called bevacizumab, because the F.D.A. said follow up studies had found the drug was not effective and had dangerous side effects.
In 2008, the expensive drug was a part of the F.D.A.’s accelerated approval program, according to the FDA’s website. The approval was based on a trial of patients who had not received chemotherapy for mestatic breast cancer.
“Under the accelerated approval program, a drug may be approved based on clinical data that suggest the drug has a meaningful clinical benefit, with more information being needed to confirm this. The program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted.”
According to the F.D.A., follow-up trial results submitted by Genentech only showed a small effect on “progression-free survival.”
The F.D.A.’s decision to revoke approval for use of the drug for breast cancer treatment will not affect its approval for use for treating other cancers.