In 2008, the Food and Drug Administration conditionally approved Avastin, a drug taken by women who have late-stage breast cancer. According to the Wall Street Journal, Avastin didn't lengthen patients' overall survival time, but it did slow tumor growth. What this means is that dying patients get a few extra months of quality time with family and friends. A small percentage were cured. Permanent approval of Avastin relied on additional studies focused on "Progression-free survival." The additional studies did not meet the FDA's endpoint of overall survival, despite extending patients lives by 5 and a half months compared to the alternative treatment. The FDA was not impressed, and moved to revoke Avastin's approval for breast cancer last year. A hearing is scheduled for next week to determine the fate of the use of Avastin in breast cancer.
This reminded me of the U.K. National Health Service (NHS). Within the NHS is the "National Institute for Health and Clinical Evidence (NICE). NICE notes that "With the rapid advances in modern medicine, most people accept the fact that no publicly funded health care system, including NHS, can not possibly pay for every medical treatment." So, who decides who get treatment in the UK? It's a beancounter. NICE does an tidy calculation called the Quality-Adjusted Life Years (QALY). This calculation compares quality of life on standard treatment to the quality of life on the new treatment multiplied by any extra months or years of survival. Then they decide if the cost of that extra survival is too high.
Back in the U.S. we have Dr. Donald Berwick. Obama appointed him to be the Administrator of the Center for Medicare and Medicaid Services (CMS). CMS makes "coverage determinations" on what drugs will be covered by these programs. The problem is that Dr. Berwick is a big fan of the NHS, and NICE in particular.
There is no question that Avastin is expensive. The Journal said it best in saying "The expected value of treatment for any given patient—the abstract "median"—seems small, so a private health plan may understandably balk at paying such a tab. But cost-effectiveness calculation isn't the FDA's job, and in fact the law forbids the agency from considering anything but a product's safety and effectiveness while it's evaluated." Sadly, Dr. Berwick may have the final say on whether Medicare/Medicaid pay for Avastin for breast cancer patients.
If Obama and Senate Democrats would deal with our deficits and our National Debt, we wouldn't have to put a price on a breast cancer patient. Let's not bet NICE.