Avastin and Off-label Use: What's a Payer to Do?
This article was originally published in RPM Report
Executive Summary
FDA's Rejection of Avastin for Late Stage Breast Cancer Provides An Opening to Grapple with Off-Label Use of Approved Medicines
You may also be interested in...
Avastin and FDA/CMS Coordination: Genentech's Safe Strategy to Save Medicare Coverage
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.
FDA's Avastin Breast Cancer Withdrawal Sets New Standard, Deters Drug Development
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].
The Avastin Docket: Few Comments, But Lots of Questions About Implications
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.