So where are we at in the entire Avastin saga? On the surface things may look quite bad but in reality, matters are on target to turn out rather well.
Things look bad because of the four 6-0 decisions made by the Oncologic Drug Advisory Board (ODAC) against Avastin at the FDA hearing on June 29, 2011. As FAMEDS had warned before the hearing, ODAC was nothing but a Kangaroo court whose members had made up their minds prior to the hearing.
Lest we think the FDA and ODAC, "got away with it", think again. Because of the brazen actions taken against Avastin, Congress is very likely to insist on major changes to future FDA advisory boards. These changes will come as a direct result of the Avastin debacle, where only six of the 13 ODAC members even showed for the June hearing. The reform of ODAC and other FDA advisory boards is tied to renewal of the Prescription Drug User Fee Act (PDUFA), which throws off a lot of revenue to the FDA from the drug companies. The FDA wants this act reauthorized in 2012 and but will only see this occur with major changes to ODAC, the selection of ODAC members, etc. This reform comes too late for the Avastin decision but it will benefit all those affected by future hearings regarding other drugs. Please review the link below that recapped the first meeting of the House Energy and Commerce Subcommittee on Health regarding reauthorizing PDUFA. Several Congresspersons questioned the FDA at this hearing about the Avastin decision after we asked FAMEDS supporters to write them about this issue:
Health Subcommittee Examines FDA Regulatory Process
Scroll down to the 48:10 mark for one example: FDA 2012 Budget Request
FAMEDS followed the strategy of creating sufficient noise against the FDA in the belief that this would dissuade the Centers for Medicare and Medicaid Services (CMS) from following the same route. This appears to have worked. Even though there are no final rulings, FAMEDS believes that Avastin will continue to be available for those current Avastin patients who are either currently covered by Medicare or who will become eligible in the future.
The next question is this: what about those women taking Avastin who are not covered by Medicare and who are unlikely to be eligible any time soon? These are the patients, primarily younger, currently using private insurance. FAMEDS believes that the majority of these patients will continue to be covered by their private insurers, many of whom follow the NCCN guidelines. The National Comprehensive Cancer Network (NCCN) voted again recently 24-0 to retain Avastin for use with Taxol (a chemotherapy) for treating women with metastatic breast cancer. See this link directly below.
NCCN experts recommend bevacizumab for treating metastatic breast cancer
There are likely to be some private insurers who balk at Avastin coverage for women with MBC; these companies are not known for their benevolence. FAMEDS stands ready to publicly pressure these "outlier" insurers if that is required and we will seek your help to create this pressure. Furthermore, FAMEDS believes that for the small percentage of patients covered neither by CMS nor by private insurance that Genentech, the manufacturer of Avastin, should step up and cover these women on a compassionate use basis. In summary, while this is all speculation, FAMEDS believes that all current patients using Avastin for MBC will continue to receive the drug and will be covered by insurance or the donation of Avastin. It is our collective duty to make sure that this becomes reality.
The bigger question is what happens to the women who are not current Avastin patients but whose oncologists wish to prescribe this drug in future? Here the picture is less bright and even more speculative. At best CMS and some private insurers might still provide coverage for the use of Avastin with a few selected chemotherapies, such as Taxol, which have shown the best results with Avastin. The worst-case scenario is that future patients will be covered neither by CMS nor by private insurance. FAMEDS is cautiously optimistic that CMS will provide coverage for some limited use possibly with other restrictions in place. As Genentech has committed to further trials of Avastin with Taxol, usage may be tied in some way to the results of these future trials.
August 4th was the deadline for submitting public comments to the FDA's docket. As with most soap operas, the Avastin saga featured some last minute drama when Genentech submitted a so-called "middle ground" option to the FDA for their consideration, on the last day for submissions. Among other requests, Genentech asked for special exemptions for triple negative and her2-negative breast cancer patients. These patients have few options for treatment, as they do not respond to most drugs on the market. See:
FDA/CDER Final Post-Hearing Submission, August 4, 2011
for more information on the Genentech proposal.
Post-Hearing Submission of Genentech, Inc. In Support of Maintaining the Accelerated Approval of AVASTIN® (Bevacizumab) in Combination with Paclitaxel for the First-Line Treatment of HER2-Negative Metastatic Breast Cancer Click here to view PDF
This has created a further dilemma for FDA Commissioner Margaret Hamburg, who will soon make the final decision on Avastin. There has been much speculation that she will rule on August 15, 2011 or thereabouts but FAMEDS does not think this likely. For the FDA to process this most recent request by Genentech as well as all the other public comments submitted will take at least through September and possibly into October.
The pressure on Dr. Hamburg is enormous and this is likely to be her biggest decision as head of the FDA. On the one hand, if she overrules the decision of Avastin, she will incur the wrath of her staff and undermine their current modus operandi. On the other hand, we have the Avastin patients and their advocates, the NCCN, many oncologists, and some members of Congress who will not take kindly to a negative decision on Avastin.
As the FDA and CMS are both part of Health and Human Services (HHS) and as all heads are political appointees, the decision is likely to take political realities into account. With the 2012 elections on the horizon, the President does not need another election issue on his plate, with charges of rationing, death panels, etc. FAMEDS believes that the Secretary of HHS, Kathleen Sibelius, will broker a deal between CMS and the FDA, if she has not done so already. The deal will be essentially this: the FDA will continue its negative stance against Avastin when Commissioner Hamburg rules but the political fallout will be limited by CMS's coverage of patients. It is possible that Dr. Hamburg will surprise us with some limited exemptions (such as grandfathering in current patients) for Avastin but FAMEDS is not overly optimistic based on the FDA's consistent stance against Avastin.
However, depending on CMS's continued coverage of Avastin, Commissioner Hamburg's much anticipated decision may be of little practical importance. Follow the money, which right now needs to come from CMS, the private insurers and Genentech.
While we await the outcome of this epic battle, we thank you, the loyal supporters of FAMEDS, for your continued support of these brave women. If FAMEDS is correct in its speculation as to the outcome, this will only have been possible because of the public outcry over this matter.
FAMEDS will publish any new information from the FDA or CMS as soon as it becomes available.