The pharmaceutical industry is set to pressure Medicare and demand that the agency reverse its restrictive coverage plan for new Alzheimer’s treatments like EduHelm.
big picture: Doctors, researchers and health policy experts praised Medicare’s proposal as a way to get more data to prove whether EduHelm works, but with billions of dollars and many other similar Alzheimer’s drugs on the line, The industry is ready for war.
Where things stand: Now that CMS has proposed limiting coverage of EduHelm to patients who enroll in a randomized, controlled clinical trial, the public has 30 days. submit comments,
what to watch: An all-out lobbying blitz that pushes Medicare to eliminate its plan and allow full coverage of the drug for $28,000 per year.
- Biogen and Christian, who co-developed Eduhelm, have already indicated Strong opposition,
- “I can’t believe the final [coverage decision] Will be similar to the draft,” Biogen CEO Michelle Vonatsos told Wall Street yesterday. He also threatened more job cuts If the offer didn’t change.
- According to an internal company email obtained by, a top Biogen executive “pledged to fill the CMS with comments”. Zach Brennan of Endpoints News,
- PhRMA — whose board is chaired by David Ricks, CEO of Eli Lilly, which has an Alzheimer’s drug in trial — said in a statement that Medicare is “prescribing a whole class of drugs.”
Between the lines: This is only the tip of the iceberg as the decision affects experimental Alzheimer’s drugs other than EduHelm.
- Companies facing Medicare restrictions or pay cuts often use the public comment period to impress the agency with their message, with the hope of turning the results around.
- Patient advocacy groups, including those with financial ties, also indicated they would participate in the fight.
- “We are going to use every means at our disposal to try and change this decision,” said UsAgainstAlzheimer’s co-founder Georg Vradenberg.
Second aspect: Independent experts say the Medicare proposal is a compromise based on known science.
- Mark Miller, a former top Medicare official now at Arnold Ventures, said he may have dismissed EduHelm’s coverage on the grounds of how current clinical trials have shown the drug to improve patients’ cognitive function. did not do.
- ,[CMS officials] Being generous,” said bioethicist and health policy expert Zeke Emanuel. “You have something unproven, and you have to do a test to prove it, and you’re getting help from the government to do that. What could be better than this? stop complaining.”