BY SALLY C. PIPES – During the healthcare debate, few charges were more controversial than the one that government would decide who lives and who dies by rationing medical care. But based on a recent government healthcare ruling, it looks as if that accusation wasn’t such an exaggeration.
In late December, the Food and Drug Administration (FDA) moved to rescind the approval of a miracle drug that currently represents the last, best hope for women with metastatic breast cancer.
Each year 17,500 women are treated with Avastin, a late-stage breast cancer drug that restricts blood flow to tumors, slowing their growth, shrinking them, sometimes even eliminating them. The drug typically extends a patient’s life for a few months, but some “super responders” can go on living for years.
Unfortunately, Avastin treatments for breast cancer can cost upwards of $90,000 a year. The government vociferously denies it, but almost no one in the medical community believes the FDA’s unprecedented decision to revoke Avastin’s approval for the treatment of breast cancer only was completely unrelated to cost.
In making recommendations, the FDA’s Oncologic Drugs Advisory Committee (ODAC) is supposed to consider only clinical evidence. Yet one of its members — University of Nebraska oncologist Jean Grem — admitted she was cognizant of the drug’s hefty price tag.
Women suffering from breast cancer have just one last shot at keeping Avastin a viable treatment option: Roche, the pharmaceutical company that makes Avastin, has begun the appeal process on the FDA’s decision. The FDA’s final ruling could come as soon as February.
While the appeal is underway, most insurers — including Medicare — will continue to cover Avastin. It appears that Medicare, though, is eager for a pretext to stop footing the bill for the drug. On January 6, Palmetto GBA, one of the companies that determines regional Medicare coverage, posted a notice on its website stating that coverage of Avastin would cease to be offered to new breast cancer patients as of January 29.
Palmetto GBA’s decision was quickly reversed because the FDA had given prior assurances that Medicare would continue to pay for the drug during the appeal process. If Palmetto hadn’t changed course, though, breast cancer patients on Medicare in California, Hawaii, Nevada, Ohio, South Carolina, and West Virginia would have been out of luck.
It’s clear that government insurance programs such as Medicare and Medicaid will no longer cover Avastin If the FDA’s ruling stands.
So far, the government remains nearly alone in its belief that Avastin is not a legitimate breast cancer treatment. Both the Susan G. Komen Foundation and the Ovarian Cancer National Alliance have been publicly urging the FDA not to revoke its approval.
The National Comprehensive Cancer Network (NCCN), a nonprofit alliance of oncologists that produces treatment standards recognized in more than 100 countries, still supports the drug as a breast cancer treatment. NCCN’s support of the drug has thankfully convinced a few insurers, such as Wellpoint, to continue paying for Avastin at least for the time being.
The government drug rationing that begins with Avastin isn’t going to stop with Avastin. Dr. Donald Berwick, the Obama administration’s controversial recess appointee heading up the Centers for Medicare and Medicaid Services (CMS), has said that “it’s not a question of whether or not we will ration health care,” but “whether we will ration with our eyes open.”
Government drug rationing also threatens to have a dangerous impact on medical innovation. The reason Avastin is expensive is that Genentech, the division of Roche that developed it, spent $2.3 billion to research and develop the drug. If the government can arbitrarily decide not to pay for a drug based on its cost rather than its clinical effectiveness, pharmaceutical companies will be a lot less willing to spend billions developing the next cutting-edge, life-saving medicine.
The FDA has one last chance to demonstrate government rationing isn’t the new order in American healthcare. It can overturn its Avastin decision on appeal. Cancer treatments should be decided between patients and doctors, not government bureaucrats.
Sally C. Pipes is President, CEO, and Taube Fellow in Health Care Studies at the Pacific Research Institute. Her latest book, The Truth About Obamacare (Regnery 2010), was just released.
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