The Centers for Medicare and Medicaid Services will keep the status quo for now regarding Medicare Part B coverage for Roche/Genentech’s Avastin (bevacizumab) in metastatic breast cancer despite the Food and Drug Administration’s decision to formally withdraw approval for the indication, according to a CMS spokesman.
"Medicare will continue to cover Avastin. CMS will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies," the spokesman said in an e-mail. The FDA announced its final conclusion Nov. 18, maintaining that the safety risks associated with Avastin are not outweighed by any benefit in metastatic breast cancer (MBC).
But it also means there is a chance that local Medicare contractors may decide to deny coverage for the patients whose claims they manage now that the indication is officially off label. Administrative claims contractors are allowed to use their discretion in coverage decisions when CMS has no formal national reimbursement policy in place.
Last January, one of the largest contractors, Palmetto GBA, moved to drop coverage for Avastin in MBC but then quickly reversed itself, stating it would await a final decision by FDA before acting. At the time, Palmetto said it would continue to review relevant clinical trials and literature on the effectiveness of the drug in breast cancer and, if it determines a coverage policy change is warranted, would initiate a formal notice-and-comment process before any final decision is made.
Medicare contractors, like other payers, typically rely on medical policy guidelines in cases where a treatment is off label. One of the more influential sets of guidelines, the National Comprehensive Cancer Network Clinical Practice Guidelines for Oncology, recently reaffirmed its support for the treatment of Avastin in MBC.
The guidelines recommend that "bevacizumab in combination with paclitaxel is an appropriate therapeutic option for metastatic breast cancer with the evidence designation 2A," which means that "based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate."
In the private sector, a small but growing number of regional plans previously announced plans to drop coverage for Avastin in MBC, including Blue Shield of California.
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This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are owned by Elsevier.