by Carrie Pallardy
Since the FDA greenlit the Alzheimer’s drug Aduhelm (aducanumab)
in July under the accelerated approval program, concerns over the drug’s
hefty price tag and effectiveness have been mounting. Now, the drug’s
manufacturer, Biogen Inc., has cut the price approximately in half. One expert
tells AIS Health that the move may cause private insurers to view the drug more
favorably, but they’re still likely to impose coverage restrictions on it. And
a health plan trade group signaled that it isn’t impressed by the price cut.
Low Uptake Prompts Price Drop
- Biogen announced that effective Jan. 1, 2022, the yearly
cost of Aduhelm will be $28,200, down from $56,000.
- The price cut news comes on the heels of a regulatory
blow for Aduhelm. On Dec. 17, the European Medicines Agency (EMA) released
a refusal of marketing authorization recommendation
for the drug.
- But the furor surrounding Aduhelm isn’t solely about
price. “The clinical evidence that the FDA relied upon when approving the
drug had various limitations, and the findings of the two clinical studies
were conflicting,” James Chambers, Ph.D., MPharm., an associate professor
at the Tufts Medical Center Institute for Clinical Research and Health
Policy Studies, tells AIS Health.
CMS Weighs Its Decision
- Aduhelm also faces an upcoming coverage decision by
CMS. While product cost does not strictly play a role in CMS’s national
coverage determinations (NCDs), it could have an impact. A final decision
memorandum for the NCD from CMS is expected in April 2022.
- “Some of my research suggests that for treatments with
larger budget impacts, CMS may scrutinize the clinical data more closely,”
Chambers says.
- Medicare Part B premiums are set to rise substantially next year, and CMS
said one reason for the large increase is the need for “additional
contingency reserves due to the uncertainty regarding the potential use
of” Aduhelm by Medicare beneficiaries.
Private Coverage Could Hinge on CMS
- If the drug receives a positive coverage decision from
CMS, private payers could follow.
- “While it is unclear how private plans will react
following CMS’s NCD, they would likely look more favorably on the drug if
it had a lower price but will likely still impose coverage restrictions,”
Chambers says.
- The Alliance of Community Health Plans, meanwhile,
appears not to be impressed with the drug’s price cut.
- “Biogen’s recent price change does not alter the fact
that, besides being outrageously priced, Aduhelm is an unproven,
potentially dangerous drug — a drug Medicare simply should not cover,” the
trade group said in a Dec. 22 blog post.
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