The pharmaceutical industry is ready to pressure Medicare and demand the agency reverse its restrictive coverage plan for new Alzheimer’s treatments like Aduhelm.
The big picture: Doctors, researchers and health policy experts praised Medicare’s proposal as a way to get more data to prove whether Aduhelm works, but with billions of dollars and many other similar Alzheimer’s drugs on the line, the industry is prepared for war.
Where things stand: Now that CMS proposed limiting coverage of Aduhelm to patients who enroll in a randomized, controlled clinical trial, the public has 30 days to submit comments.
What to watch: An all-out lobbying blitz that pushes Medicare to scrap its plan and allow full coverage of the $28,000-per-year drug.
- Biogen and Eisai, which co-developed Aduhelm, have already signaled strong opposition.
- “I can’t believe that the final [coverage decision] will be similar than the draft,” Biogen CEO Michel Vounatsos told Wall Street yesterday. He also threatened to cut more jobs if the proposal didn’t change.
- A top Biogen executive “pledged to flood CMS with comments,” according to an internal company email obtained by Zach Brennan of Endpoints News.
- PhRMA — whose board is chaired by David Ricks, CEO of Eli Lilly, which has an Alzheimer’s drug in trials — said in a statement that Medicare “is writing off an entire class of medicines.”
Between the lines: This is just the tip of the iceberg since the decision affects other experimental Alzheimer’s drugs in addition to Aduhelm.
- Companies facing Medicare restrictions or pay cuts often use the public comment period to inundate the agency with their messaging, with the hope of changing the outcome.
- Patient advocacy groups, including those with financial ties, also signaled they would participate in the fight.
- “We’re gonna use every means at our disposal to try and turn this decision around,” said George Vradenburg, co-founder of UsAgainstAlzheimer’s.
The other side: Independent experts say Medicare’s proposal is a compromise based on the known science.
- Mark Miller, a former top Medicare official who is now at Arnold Ventures, said he would have rejected coverage of Aduhelm based on how the existing clinical trials didn’t prove the drug improved patients’ cognitive function.
- “[CMS officials] are being generous,” bioethicist and health policy expert Zeke Emanuel said. “You’ve got something unproven, and you’ve gotta conduct a trial to prove it, and you’re getting help from the government to do that. What could be better? Stop complaining.”