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.
