Federal officials are wrestling with a decision that could go a
long way toward determining the future of the controversial new Alzheimer’s
drug, Aduhelm, and whether significant numbers of patients use it.
اضافة اعلان
In January, Medicare, the federal health insurance program for
people 65 and older, plans to issue a preliminary decision on whether it will
cover the expensive medication. The Food and Drug Administration’s approval of
Aduhelm in June has drawn fierce criticism because clinical trials showed the
drug had significant safety risks and unclear benefit to patients.
Roughly 80% of potential Aduhelm patients are old enough to
receive Medicare, making the program’s coverage decision crucial. Private
insurers often follow Medicare’s lead.
Medicare almost always pays for Food and Drug
Administration-approved drugs, at least for the medical conditions designated
on their label, health policy experts said. But with Aduhelm, Medicare
officials have undertaken a monthslong review that could result in no coverage,
full coverage or limited coverage.
“It’s truly unprecedented,” said James Chambers, a researcher at
the Center for the Evaluation of Value and Risk in Health at Tufts Medical
Center in Boston.
Chiquita Brooks-LaSure, administrator of the Centers for
Medicare & Medicaid Services, declined to discuss the deliberations. “It’s
a process our coverage team goes through,” she said. “We will let the
scientists continue their work.”
Aduhelm, made by Biogen, is a monoclonal antibody also known by
its scientific name, aducanumab. Patients receive it in monthly infusions and
also require regular MRI scans to monitor for potentially dangerous side
effects, including brain swelling and bleeding.
Last week, after weak sales, Biogen slashed Aduhelm’s price to
$28,200 a year from $56,000.
In a statement, Michel Vounatsos, Biogen’s CEO, said, “It is a
critical time for the Alzheimer’s disease community as the Centers for Medicare
& Medicaid Services (CMS) is considering the possibility of coverage of not
only Aduhelm, but also this entire new class of Alzheimer’s disease therapies.
We hope our actions today will facilitate patient access to these innovative
Alzheimer’s treatments.”
The new price is still much higher than many analysts have said
is warranted.
The total cost to Medicare would depend on the terms it sets and
how many patients decide to use Aduhelm. About 1.5 million Americans may be
eligible because they have mild Alzheimer’s-related dementia.
“While it of course depends on Aduhelm’s utilization, it seems
that even at $28,000 a year, Aduhelm would still be one of Medicare’s biggest
drug expenses,” Chambers said.
Before Biogen’s price cut, Medicare’s actuarial division, acting
without knowing what the coverage decision would be, imposed one of the
biggest-ever increases in Medicare Part B premiums for 2022, partly driven by
the possibility of Aduhelm coverage.
Medicare’s review comes as Aduhelm faces criticism and hurdles
around the world.
Reviewers at the European Union’s drug regulator, the European
Medicines Agency, recommended against approving the drug, a decision that
Biogen is requesting be reexamined. Leading Canadian Alzheimer’s research
organizations earlier said that approving Aduhelm in Canada “cannot be justified.”
Large U.S. medical systems, including Cleveland Clinic, Mount
Sinai Health System, Mass General Brigham and the Department of Veterans
Affairs have declined to offer Aduhelm.
The American Academy of Neurology said recently that if Aduhelm
was covered by Medicare, which typically pays 80% of a drug’s price, “many
beneficiaries would pay thousands of dollars of out-of-pocket costs for a drug
with substantial risks and without proven clinical benefit.”
During the evaluation process, Medicare officials have met with
stakeholders, including supporters of coverage, like Biogen and the Alzheimer’s
Association, a leading patient group.
“We have been engaging with CMS towards the goal of providing
access in a way that is sustainable for Medicare beneficiaries and the health
care system,” Biogen said in a statement.
Medicare officials have also met with those that oppose coverage
or want it sharply narrowed, like the American Geriatrics Society and the Blue
Cross Blue Shield Association, which, during a public comment period this past
summer, wrote, “We feel strongly that aducanumab does not meet the statutory
coverage standard of ‘reasonable and necessary’ as the current evidence
highlights numerous safety risks and uncertain clinical benefits.”
In approving Aduhelm, the FDA acknowledged that there was
insufficient evidence that it would help patients but greenlighted it under a
program called “accelerated approval,” which allows authorization of unproven
drugs for serious diseases with few treatment options if the drug affects a
biological mechanism in a way considered “reasonably likely to predict clinical
benefit.”
As its justification, the agency cited Aduhelm’s reduction of a
protein, amyloid, that forms plaques in the brains of people with Alzheimer’s.
But many Alzheimer’s specialists say that extensive research has shown little
evidence that reducing amyloid slows cognitive decline.
In evaluating Aduhelm, Medicare officials are supposed to decide
if it is a “reasonable and necessary” treatment, a phrase that usually “means
adequate evidence of improved health outcomes,” said Dr. Sean Tunis, a former
official with CMS who is now a senior fellow at the Tufts center.
“If you go strictly by what the language is, this doesn’t meet
Medicare’s ‘reasonable and necessary’ criteria because the FDA themselves says
there’s no direct evidence of improved cognition,” said Tunis, who also works
as a consultant, including advising Biogen, before Aduhelm was approved, about
Medicare’s various options for coverage. He added that the FDA’s requirement
that Biogen conduct another trial (which will take years while Aduhelm is
available to patients) “implies that the cognitive benefits have not yet been
shown.”
If Medicare coverage for Aduhelm is denied, Tunis said, “to my
knowledge, it will be the first time ever that CMS has declined to pay for a
drug that was approved by the FDA for its on-label indication.”
The high-stakes coverage decision, expected to be finalized by
mid-April after a public comment period, has drawn impassioned and detailed
opinions, reflected in comments posted on the CMS website.
“Please, please, please, do not cover this medicine,” implored
Dr. James Castle, an Illinois neurologist who treats Alzheimer’s patients.
“Send a strong and clear message to the pharmaceutical industry that they need
to show proof of both efficacy and safety before releasing their medicines on
the market.”
Posts supporting coverage include comments from people who have
consulted for Biogen, like Dr. Jeffrey Cummings, a research professor in the
department of brain health at the University of Nevada, Las Vegas. He wrote
that the drug “prolongs the mental life of our declining patients,” adding,
“Medicare should unequivocally support coverage for aducanumab, and they should
do it as soon as possible.”
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