FDA’s Decision On Avastin Will Set the Standard

Later this month, the Food and Drug Administration will issue a ruling that will be a major test of the credibility of promises the Obama administration has made about the future of Medicare under health reform.

At a Senate Finance Committee hearing in November, the new chief of Medicare and Medicaid, Dr. Donald Berwick, offered broad reassurances about access to treatment under the new law: “The law explicitly protects the guaranteed Medicare benefits on which so many seniors and individuals with disabilities rely. It will not cut these guaranteed benefits, nor will it ration care.”

It sounded definitive, but is it really? Or will officials try to offset the price of extending coverage to the uninsured through underhanded restrictions on access to expensive treatments for seniors and others on public programs?

On Dec. 17, the FDA is set to decide the fate of an important cancer-fighting drug, Avastin. Used in conjunction with chemotherapy, Avastin is a breakthrough biologic medication that restricts blood flow to tumors.

First approved by the FDA in 2004 for treatment of advanced colon cancer, doctors and researchers also found the drug effective in slowing the growth of other tumors, including breast cancer. Avastin is not a cure, but it has been shown to reduce and even stave off the spread of cancer-causing cells.

The FDA granted Avastin its first temporary approval as a breast cancer treatment in 2007, after researchers showed that patients on a regimen that included the drug lived a median of two to three months longer than those on a regimen without it.

Though these results matter hugely to patients and their families, some in the medical community — the FDA-appointed Oncologic Drugs Advisory Committee (ODAC), for example — have been fighting to overturn Avastin’s approval. In July of this year, the ODAC raised the stakes by formally recommending to the FDA that it revoke Avastin’s approval.

Why? ODAC members cite concerns about relative effectiveness, but it’s hard to believe that another consideration isn’t weighing into their advocacy. Avastin, like many cutting-edge drugs, is expensive. Very expensive. As much as $100,000 a year with hospital and doctor markups.

Fortunately for patients. FDA approval as a breast cancer treatment means Medicare and private insurance covers most of the approximately $8,000 monthly cost. (Some seniors also have supplemental insurance to cover the fraction Medicare doesn’t pay). If the FDA revokes approval, however, breast cancer patients will face a no-win decision: find a way to finance the annual cost out-of-pocket, or do without a promising treatment.

For women already enduring the physical and financial burdens of advanced breast cancer, the last thing they need is a choice between ruinous expense or forgoing treatment.

Patients with colorectal, lung, renal and brain cancers will still have access to Avastin through Medicare, but breast cancer patients would not — except, of course, those who have an extra $100,000 dollars stashed away for a rainy day.

An FDA decision against Avastin for breast cancer could also jeopardize future innovation in the pharmaceutical industry. Genentech, the company that makes Avastin, has said it and partner Roche spent some $2.25 billion to develop the drug. If the FDA sends a message that its approval process is no longer cost-blind, it won’t be long before big pharma reevaluates its list of priorities.

It’s easy to say that Avastin is expensive. But what about the lives that won’t be saved or whose quality won’t be improved as a result of drugs that aren’t developed? How much are they worth? Already, increased FDA oversight in the field of genetics has begun to worry experts that governmental interference will lead to slower lab-to-patient timelines for new treatments as well as higher barriers to research funding.

For those who personally stand to be affected by the FDA’s decision later this month, the most important point in this debate — that Avastin prolongs and improves patients’ lives — is too often overlooked. Forty thousand American women die each year from breast cancer. Avastin is a treatment that might not reduce that number, but it does improve the quality of life for many during their last months.

Dr. Berwick promised that the law won’t let Medicare ration care to control costs. This month comes the first test of whether the FDA is on board with that promise or is going to allow its approval process to become an instrument for stealth rationing of care.

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

Scroll to Top