Jan 11 (Reuters) - The U.S. government Medicare program on
Tuesday said it plans to cover Alzheimer's treatments including
Biogen Inc's Aduhelm but will require patients to be
enrolled in a clinical trial, limiting access to the treatment
more than many expected.
Biogen shares were down 7.3% at $224 in extended trading on
Tuesday. Shares of Biogen's Japanese partner Eisai Co Ltd
slid 2.6% in Tokyo.
The decision from the U.S. Centers for Medicare and Medicaid
Services (CMS), the health agency that runs Medicare, could
change as it seeks comment from companies and patients. A final
decision is due on April 11.
The final CMS coverage terms are expected to apply to all
drugs in the class, including experimental medications in
development by Eli Lilly & Co, Roche Holding AG
Patient advocacy group UsAgainstAlzheimers chairman George
Vradenburg said he was angry Medicare placed conditions on the
use of the drugs that were more limiting than the regulator, the
Food and Drug Administration, put on Aduhelm, and that the
Medicare decision applied to any amyloid drug.
The government's health service was "at war with itself," he
"The FDA has approved this drug and now Medicare has
disapproved the drug," Vradenburg said.
The FDA approved the drug in June last year despite its
11-member committee of outside experts voting nearly unanimously
in November 2020 that the drug should not be approved, citing
inconclusive evidence the drug was effective.
Many experts have questioned the FDA's rationale for
Aduhelm's approval without more definitive proof of benefit, and
doctors have held back on prescribing it.
"The wholesale rejection of this product by payers and
health systems around the country is notable but not shocking,
given how little evidence the manufacturer produced at the time
of its FDA approval," said Dr. Caleb Alexander, a professor with
the Johns Hopkins Center for Drug Safety and Effectiveness, in
Baltimore. Alexander was a member of the FDA advisory panel that
voted not to approve the drug.
Demand for an Alzheimer's treatment, he said, "should fuel
our investments in drug development, not a lowering of standards
that Americans rely upon to know whether their drugs are safe
The unusual move to require clinical trials for recipients
of the already approved drug comes after a six-month process in
which CMS had been working on a national coverage policy for the
The decision to require the trial "will exclude almost all
patients who may benefit," Biogen said in a statement.
The requirements "can take months to years to initiate," it
said, and promised to urge the agency to align its coverage
policy with the populations that have been studied in previous
"We believe Alzheimer's patients should have access
consistent with other therapies with FDA accelerated approval,"
Sales so far have been weak and Biogen last month cut the
medication's list price by about half to $28,200 per year.
Cowen analyst Eric Assaraf said in a research note the
decision to restrict coverage to clinical trial participants was
more restrictive than he had expected, noting the agency could
have simply required Biogen to maintain a registry of patients
that documented responses to the drug. He said CMS may change
its stance in the final decision.
Aduhelm's high price also has raised concerns over the toll
it might take on the Medicare program, the U.S. government
health plan for people age 65 and over. Because Alzheimer's is
an age-related disease, around 85% of people who might use the
medicine are in the government plan.
With the proposed decision, the cost will shift to patients,
"Unless you are a very wealthy person, you are not going to
get access to the drug," he added.
Aduhelm, given as a monthly infusion, is a monoclonal
antibody designed to remove a type of brain plaque associated
with Alzheimer's Disease. Patients need to be monitored for
potential side effects including brain swelling.
(Reporting By Deena Beasley, in Los Angeles, Julie Steenhuysen
in Chicago and Leroy Leo in Bengaluru;
Editing by Caroline Humer, Bill Berkrot, Devika Syamnath, Peter
Henderson and Lincoln Feast.)