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 The U.S. Food and Drug Administration approved the drug, called
Aduhelm, based on limited evidence that it might slow a decline in
cognitive function in people with the memory-robbing disease.
Some prominent doctors, hospitals and health insurers have
criticized the FDA decision and said they will not offer the drug.
The agency itself has invited an outside investigation into its
decision-making process.
Other leading institutions, including in Michigan, Florida and Rhode
Island, were eager to make the therapy available to patients in the
hope it will provide a benefit, but told Reuters this week they are
proceeding slowly while Medicare determines how it will cover
Aduhelm, initially priced at about $56,000 per year.
Medicare has launched a nine-month process to set standardized
national terms for Aduhelm coverage that may seek to limit its use.
For now, the government health plan is processing claims for the
drug on a case-by-case basis. The first centers to use the drug as a
commercial product said those claims have not yet been paid.
"Medicare does this very, very rarely for drugs and issues these
coverage restrictions, again, very rarely," said Dr. Aaron
Kesselheim of Brigham and Women’s Hospital during an online
interview presented jointly by The Forum at the Harvard T.H. Chan
School of Public Health and Reuters. Kesselheim resigned as a member
of the FDA advisory panel that reviewed Biogen's drug after the
agency chose not to follow it recommendation against approval.
The slow uptake raises questions about the potential for 2021 sales
for the treatment ahead of Biogen’s second-quarter earnings report
on Thursday.
'BEING VERY CAUTIOUS'
The Michigan Institute for Neurological Disorders (MIND) said it has
only treated one patient with Aduhelm.
Sonda Rossman, head of disease state initiatives, therapeutics, and
clinical research at MIND, said the institute is testing more
patients for Aduhelm eligibility, but is "being very cautious" about
financial, as well as medical, risks.
Florida's First Choice Neurology and Butler Hospital's Memory and
Aging Program in Providence, Rhode Island, have treated three
patients each. Butler's program is run by Dr. Steven Salloway, an
Aduhelm supporter who has called the drug's approval "a turning
point in Alzheimer’s research."
The Mayo Clinic, which has partnered with Biogen to provide clinical
testing to diagnose whether someone is eligible for the new
medication, said it is still reviewing whether to offer Aduhelm to
its own patients.
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The FDA approved Aduhelm for patients who test positive for a
component of amyloid brain plaques, but later narrowed that to just
those in the early stages of the disease - the group tested in
clinical trials.
UCLA Health System said none of its providers have asked to use
Aduhelm, with many awaiting additional data before making a final
decision.
Biogen declined to comment on the number of centers using its drug,
but said it expects the rollout to be gradual.
MEDICARE LIMITS
Because Alzheimer's is an age-related disease, around 85% of people
eligible for Aduhelm are covered by Medicare, which could incur a
$29 billion annual spending increase, according to Kaiser Family
Foundation.
Experts say Medicare could seek to lower the therapy's cost to
taxpayers by limiting access to the treatment, linking coverage to
real-world evidence of patient outcomes, or setting a fixed payment
that combines drug reimbursement with other costs related to the
treatment.
"Given the potential budgetary impact, it could be that things are
departing from normal," said Dan Ollendorf, of the Center for the
Evaluation of Value and Risk in Health at Tufts University Medical
Center in Boston.
Tufts and others have called for Medicare to go beyond a national
coverage determination and institute a policy known as coverage with
evidence development.
Under such a program, data on Aduhelm's real-world effectiveness and
safety would be compiled in a Medicare patient registry, quickly
providing new data to analyze.
Medicare could also institute a stricter "demonstration project" for
Aduhelm that would pay for the drug's use at a limited number of
medical centers and for a fixed amount that bundles in costs for
scans, follow-up and to monitor for side effects.
While Medicare is prevented by law from negotiating drug prices,
this type of approach could limit reimbursement to hospitals,
possibly at an amount below Aduhelm's list price. That could put
pressure on Biogen to cut the price if it wants Aduhelm to be used,
said Raymond James analyst Chris Meekins.
(Reporting By Deena Beasley; Editing by Caroline Humer and Bill
Berkrot)
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