Avastin and Off-label Use: What's a Payer to Do?
This article was originally published in RPM Report
FDA's Rejection of Avastin for Late Stage Breast Cancer Provides An Opening to Grapple with Off-Label Use of Approved Medicines
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FDA’s June Avastin hearing featured a number of points of clear disconnect between the sponsor, the agency, and other stakeholders debating the role of the therapy for metastatic breast cancer. Perhaps the biggest: the most important issue may depend on a completely different agency, CMS.
The public docket on FDA’s reconsideration of the approval of Avastin for breast cancer has only gathered a few dozen responses. Those submissions overwhelming favor retaining the indication, but also raise some broader questions about the standards for accelerated approval in oncology.
FDA’s proposal to withdraw the approval of Avastin for MBC is based on a new standard for the efficacy showing that a therapy must make in first-line MBC. The Agency previously -- and appropriately -- followed a more flexible approach based on data showing a medicine’s effect on PFS [progression-free survival] or other disease progression endpoints, together with data on OS [overall survival].