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 In a preliminary proposal last month, the U.S. Centers for Medicaid
and Medicare Services (CMS), which runs the government health plan
for people age 65 and older, said it would cover Biogen's Aduhelm,
and similar Alzheimer's treatments in development, only for patients
enrolled in approved clinical trials.
Biogen said in an open letter published on Thursday that questions
around the efficacy of new Alzheimer's treatments will be best
answered with real-world data collected from broad use of drugs like
Aduhelm. The company is hoping for much broader patient access for
Aduhelm than the proposal would allow if enacted.
"Biogen is committed to generating data from real world usage and
with coverage, Alzheimer’s disease patients will be able seek
treatment instead of being restricted to enrolling in randomized
controlled trials where they may receive a placebo or be limited by
other coverage criteria," Maha Radhakrishnan, Biogen's chief medical
officer said in a statement.
In its letter, Biogen proposed generating such data demonstrating
Aduhelm's effectiveness by creating a focused registry to measure
outcomes from the treatment, as well as a new clinical data network
to allow institutions around the world to share Alzheimer's data and
analysis.
It also said it would conduct studies of Medicare claims for Aduhelm
to better understand the treatment's use patterns in different
regions and demographic groups.
Alzheimer's patient groups, disappointed by Medicare's plan to
sharply limit coverage for Aduhelm and similar drugs, are planning
publicity and lobbying campaigns to protest a proposal they say
could delay their use for 10 years.
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 CMS' plan would severely limit the number of
patients receiving the treatment, undercutting
the Food and Drug Administration's accelerated
approval of Aduhelm for patients in the early
stages of the memory-robbing condition.
The public disagreement over the drug's use is unusual for the
agencies, both part of the U.S. Department of Health and Human
Services.
The FDA's controversial June decision was the first approval of a
new Alzheimer's drug in nearly two decades. But it came against the
recommendation of its own panel of outside expert advisers.
It relied on evidence that the drug can reduce amyloid brain
plaques, a likely contributor to Alzheimer's, rather than proof that
it slows progression of the disease.
Aduhelm's cost has raised concerns over the toll it might take on
the Medicare program. Because Alzheimer's is an age-related disease,
around 85% of people who might use the medicine are in the
government plan.
The Medicare agency could alter its plan before it is finalized in
April.
(Reporting by Carl O'Donnell; Editing by Bill Berkrot)
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