Wednesday, January 5, 2022

Aduhelm Price Cut May Not Sway Private Payers’ View of Drug

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.

From Radar on Drug Benefits

No comments:

Post a Comment