Marking the first FDA approval of an Alzheimer's disease
treatment in nearly 20 years, the federal agency on June 7 gave accelerated
approval to Biogen Inc. and Eisai Co., Ltd.'s Aduhelm (aducanumab-avwa).
Controversial approval:
- Aduhelm's two Phase III trials showed contradictory
results regarding efficacy. Moreover, patients reported temporary swelling
in areas of the brain that caused symptoms such as headache, confusion and
nausea, and an adverse reaction. The Institute for Clinical and Economic
Review in a draft evidence report concluded that the evidence
was "insufficient" to determine the net health benefit of
Aduhelm.
Medical benefit coverage:
- Aduhelm is infused once every four weeks and therefore
likely to be covered under the medical benefit. Biogen has said it expects
about 80% of potential Aduhelm patients to be covered through Medicare
Part B, which would easily double the $37 billion Medicare already spends
on Part B drugs annually if Biogen's estimates are correct that roughly 1 to 2
million Americans would qualify for treatment.
Implications for Medicare:
- "New generations of drugs are increasingly tied to
diagnostic monitoring. In this case, patients may be required to undergo
Magnetic Resonance Imaging (MRI) to determine disease progression,"
observes Jay Jackson, a principal at Avalere Health. And MRI is a
currently covered diagnostic for Alzheimer's patients, he notes.
"While most Medicare beneficiaries have some form of secondary
insurance…out-of-pocket expenses for both for those patients without such
secondary coverage could create barriers to access."
- For MCOs, the drug and related imaging presents a
"major incremental cost" to Medicare and could trigger the
"significant cost" threshold in Medicare, suggested analysts
from Evercore ISI in a June 7 research note.
- Since MA plan bids were due on June 7, it's too late
for Aduhelm's approval to be factored into their 2022 capitation rates and
it's unclear at this time what CMS will do for the 2023 capitation rates,
suggests Brad Piper, a principal and consulting actuary with Milliman.
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