The modest benefit observed with Avastin together with the substantial adverse reactions observed in breast cancer trials to date fail to provide a favorable risk-benefit profile to support continued marketing of Avastin for a first-line metastatic breast cancer indication. It is the conclusion of OND that the breast cancer indication for Avastin be withdrawn.
The drug remains approved for various colon, kidney, brain and lung cancers.
The WSJ’s editorial reaction was harsh, calling the decision ”reprehensible” and a “tragedy for desperately ill women.”
The reprehensible tragedy is that the WSJ would write this editorial. Some facts:
- The decision doesn’t pull Avastin from the market. Genetech can still sell it for anyone with a prescription from their doctor.
- The decision doesn’t prohibit physicians from prescribing Avastin for breast cancer. If your doctor thinks it can help, they can still prescribe it off-label.
- The decision doesn’t affect reimbursement from Medicare, Medicaid or any private health plan. Avastin is still listed in the drug compendia and HHS hasn’t identified it as “not medically appropriate”, which means that Medicare reimbursement continues under Section 1861(t)(2) of the SSA (for traditional Medicare) and Section 1860D-2(e) (for Part D). The WSJ is flat out wrong on this. No death panels, unless you’re a transplant patient on Arizona Medicaid.
The primary result of this FDA recommendation – if it withstands the political attack on science – will be a hearing in which Genentech can dispute the FDA’s analysis. If the FDA prevails, Genentech will have to change the label and from that point forward cannot market Avastin off-label for metastatic breast cancer.
Marketing a $88,000 drug on an unproven hope of a cure? That’s what I call a tragedy for desperately ill women.