Monday, May 26, 2008

A Foray into Avastin, Gliomas and Asking: At What Price?

News about Senator Kennedy’s brain tumor prompted the Disease Management Care Blog to think about the treatment options, with a special focus on bevacizumab a.k.a Avastin. The DMCB has special memories about this particular agent. Back in its earlier managed care days, this incredibly expensive treatment was source of great controversy between us medical directors and the network oncologists. Avastin was under “prior authorization” and without it, the drug was ‘non-approved.’ The oncologists wanted to use it for all kinds of different cancers involving all kinds of desperate patients. If ‘prior auth’ was not granted, patients and their physicians were free to appeal. And appeal. And appeal. The medical directors generally lost.

The topic of 'losing' may warrant a future blog post, but suffice it to say that the argument came down to the obligation of a health insurer to cover anything that is 'medically necessary.' Typical definitions of 'medical necessity' exclude treatments that are 'experimental.' New research involving a limited number of patients with initially promising results could be either experimental or medically necessary. What ended that tug of war, however, was the inevitable intrusion of a more compelling concept: hope is medically necessary.

But the DMCB digresses. Avastin is a biologically manufactured complex protein (an antibody) that binds to another protein that regulates the formation of new blood vessels. Many cancers are thought to grow in part due to their ability to create new “feeder” vessels, and this agent blocks that, causing tumor starvation. It’s typically not given as a single treatment, but as part of a “cocktail” with other drugs. It was originally approved by the U.S. Food and Drug Administration in February of 2004 when a prospective clinical trial involving metastatic colon cancer patients showed Avastin increased survival from 15.6 to 20.3 months. It’s since been approved by the FDA for most types of lung cancer and for metastatic breast cancer. Avastin is NOT approved by the FDA for treatment of brain cancer gliomas, but it is widely used ‘off-label’ for a variety of kinds of cancers.

Gliomas are one of those 'off label' cancers Research in one series of 23 patients with a recurrence of their cancer after standard treatment showed Avastin (plus another agent called irinotecan) led to 'six month progression free survival' rate of 46% and a 6 month survival of 77%. Other studies in 30-50 patients have shown similar results. This was enough to prompt the widely respected National Comprehensive Cancer Network to place Avastin in their approved guidelines as 'salvage' therapy for gliomas that have come back. Aetna will cover it for gliomas also.

Why is Avastin a source of such pain for health insurers? According to this analysis, the Medicare reimbursement for Avastin is about $57 per 10 mg. Recall gold is about $300 per oz. Avastin is over $160,000 per oz. A treatment course involving several doses over several months can cost up to $90,000. To get further perspective, note that the cost for Avastin is over $340,000 per year of life gained, and contrast it with this well written $129,000 article in Time. Yes, it's only money, but health insurers have a role assessing the real value of the services they cover on behalf of their enrollees.

Far be it from the DMCB to ‘price’ a living human being, but $90K is a lot of money for progression free or disease free survival that is typically measured in months. That’s true whether health insurers want to keep that money as a return on equity for their investors - or to make not-for-profit health insurance (where I worked) as affordable as possible.

No comments: