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 The development underscores the division among doctors about whether
the $56,000-a-year drug helps patients and how uncertainty about
reimbursement from Medicare, the U.S. government health plan for
people over age 65, has held back prescriptions and sales. Aduhelm,
which is given as a monthly infusion, was approved by the U.S. Food
and Drug Administration in June even though one of Biogen's two
large clinical trials failed to show a benefit for patients
diagnosed with the incurable mind-wasting disease.
In order to expedite treatment, Biogen has begun to provide
Florida's First Choice Neurology with free-of-charge Aduhelm,
according to Dr. Jeffrey Gelblum, a neurologist at the center's
Aventura, Florida, operations.
"We have been using the Biogen access program - it is almost like a
sample program - to get patients started," he told Reuters.
Biogen has said it has a number of plans in place to support patient
access, but did not give further details.
Pharmaceutical companies can provide free medications through
patient assistance programs, "however we have never heard of that
for an injectable, infused drug," Steven Lucio, vice president at
Vizient Inc, which works with about half of U.S. hospitals to buy
drugs, said in an email.
James Chambers, a researcher at the Center for the Evaluation of
Value and Risk in Health at Tufts Medical Center in Boston, said
providing free medications is a common strategy drugmakers use to
boost patient prescription numbers.
HOSPITALS SLOW TO USE
A number of hospitals, as well as the Veterans Health Administration
https://www.reuters.com/
business/healthcare-pharmaceuticals/us-veterans-health-administration-turns-down-biogen-alzheimers-drug-2021-08-11,
have said there is not enough evidence to justify widespread use of
Aduhelm. Several commercial insurers
https://www.reuters.com/
business/healthcare-pharmaceuticals/biogen-alzheimers-drug-hits-roadblocks-with-some-hospitals-insurers-2021-07-15,
including UnitedHealth Group Inc, the largest private insurer
offering Medicare Advantage coverage to seniors, have said they are
waiting for further direction from Medicare before covering the
drug.
"Mainly because of the uncertainty around insurance coverage ...
most doctors and systems are in a holding pattern," said Dr. Anton
Porsteinsson, director of the University of Rochester Alzheimer's
Disease Care, Research and Education Program, which is only using
Aduhelm, also known as aducanumab, on patients enrolled in clinical
trials.
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 A recent survey of 78
neurologists conducted by Morgan Stanley found
that half were willing to prescribe Aduhelm, but
nearly two-thirds don't think the FDA should
have approved the drug. Just eight of the
surveyed neurologists had prescribed Aduhelm and
six of their Medicare claims had been paid as of
early August. Florida's First
Choice has so far infused more than 30 patients with Aduhelm, but
only the first doses for two patients were billed to Medicare -
their second doses, and first doses for the others, were provided at
no cost by Biogen, Dr. Gelblum said.
He said the clinic has been reimbursed by Medicare for the infusion
component of claims, but not for the medication itself, although he
expects that to happen within the next couple of weeks.
Because Alzheimer's is an age-related disease, around 85% of people
eligible for Aduhelm are covered by Medicare, which recently
launched https://www.reuters.com/
business/healthcare-pharmaceuticals/us-starts-review-national-medicare-coverage-policy-biogens-aduhelm-2021-07-12
a nine-month process to determine standardized national coverage
terms for the drug.
For now, the government health plan is processing Aduhelm claims on
a case-by-case basis.
In addition to the medication itself, costs of administering Aduhelm
include diagnostic testing for Alzheimer's and monitoring for side
effects such as dangerous brain swelling.
Experts say Medicare could seek to lower
https://www.reuters.com/
business/healthcare-pharmaceuticals/biogen-alzheimers-drug-slow-take-off-us-medicare-wrestles-with-coverage-2021-07-21
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.
Aduhelm, developed in partnership with Japan's Eisai Co Ltd, comes
in two vial sizes of 300 milligrams (mg) and 170 mg. Patients are
started out on a low dose, which is increased over time to the full
dose of 10 mg per kg of a patient's weight.
Sales of the drug are forecast to total $81 million this year, $1.3
billion next year and $5.8 billion by 2026, according to Wall Street
analysts polled by Refinitiv.
(Reporting by Deena Beasley; editing by Caroline Humer and Jonathan
Oatis)
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