Are Medicare director Don Berwick and the Obama administration delaying or denying patients access to medical innovations? That's a question the Senate's Finance Committee should ask Berwick, who heads up the Center for Medicare and Medicaid Services (CMS), when he testifies November 17.
The timing couldn't be better. Medicare won't pay for Provenge, the first cancer vaccine, since it was approved in April. It's waiting for the Medicare Coverage Advisory Committee (MEDCAC) -- also meeting on the 17th -- to decide whether the Food and Drug Administration, the National Cancer Institute, and cancer experts are right in supporting Provenge use for prostate cancer patients.
MEDCAC was established in 1998 so CMS could ask leading scientists and doctors to recommend what information should be collected to determine the best use of new technologies. But recently MEDCAC has -- under CMS direction -- begun evaluating whether innovations are cost-effective.
In November 2008 Medicare bureaucrats asked MEDCAC: At current Medicare prices, how confident are you that CTC has a similar ratio of cost per LYS (Life Years Saved) as optical colonoscopy? In 2009 CMS asked MEDCAC: What are the desirable measures of the cost-effectiveness of screening genetic tests for the prevention or early detection of illness or disability? By 2010 CMS was simply asking MEDCAC whether CMS should cover new technologies unless there was evidence of its cost and clinical effectiveness from long and expensive studies. As one speaker at a MEDCAC hearing about genetic tests noted, "if clinical outcomes as defined… become a requirement for reimbursement, it will reduce investment in new genetic tests and the market introduction of these tests, and ultimately their use. "
That's the goal. But given Provenge's high profile, asking about its cost-effectiveness would be controversial. Since the one-time treatment runs about $90,000, CMS thought it could ask if Provenge was effective without mentioning cost. Hence, Dr. Louis Jacques, the director of the Coverage and Analysis Group at Medicare, told Forbes: "We've been getting questions from people," says Jacques. "'Well, what's up with Provenge? Is it a drug? Is it a biologic? Is it something else? Does it really work? It has been interesting to look at the evidence around it."
Does it really work?!
Maybe Dr. Jacques didn't get the memo about the FDA approving Provenge. The FDA said Provenge "substantially improved survival to patients with a fatal disease. The risks… are minor relative to the benefit of improved survival." Or perhaps he didn't see the May 6 National Cancer Institute statement asserting: "The field of cancer immunotherapy received an important boost last week with the FDA's approval" of Provenge. On May 29 the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium added Provenge to its list of standard therapies. On June 15 Aetna said it would cover Provenge.
Federal law requires that CMS cover any cancer drug approved by the FDA or NCCN compendium therapy. Instead, on June 30, an anonymous individual requested that CMS hold a MEDCAD hearing on Provenge before it covered the drug. CMS immediately accepted the query from the secretive party. Perhaps the Finance Committee can find out who that was.
MEDCAC will render its decision based on a just released evaluation of the FDA data conducted by the Agency for Health Research and Quality (AHRQ). AHRQ tried to pretend it wasn't second-guessing the FDA and the NIH. In October, the report name was changed on AHRQ's website from "The Efficacy and Safety of Sipuleucel T" (Provenge) to "The Outcomes of Sipuleucel T." The reviewers determined the FDA data used to approve Provenge was "adequate" but not entirely convincing. You might wonder: What expertise in prostate cancer did the authors use to draw to that conclusion? The answer is none unless you count nursing, a master's degree in statistics, or a PhD in sociology. Apparently CMS believes AHRQ's collective wisdom towers over the oncology expertise of the FDA, NCI, and NCCN.
The AHRQ report understates the impact of Provenge on survival. First, it begrudges the fact that many patients receiving chemotherapy after taking Provenge live longer. It focuses on the median survival benefit of 4.5 months (which tells you the midpoint of patient survival but not how many patients lived longer and for how long). Then it raises doubts about safety. And finally the study glosses over the finding that terminal prostate cancer patients who received Provenge were 40 percent more likely to be alive in three years than those who did not receive it. The AHRQ report is ideology masquerading as medical facts. The routine and expanding using of AHRQ to guide life or death decisions undermines the legitimacy of real science.
MEDCAC meets this week but CMS can take months to decide. This callous and possibly illegal process reflects Berwick's stated belief that only a centralized entity should decide what's best for us. People with prostate cancer have died and will die waiting. If that's not a death panel, I don't know what is.
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