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Illustration: Aïda Amer/Axios

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."

Go deeper

Jan 10, 2022 - Health

Insurers to cover costs for at-home COVID tests starting Saturday

COVID-19 rapid at-home test kits rest on a table at a free distribution event for those who received vaccination shots or booster shots on Jan. 7 in Los Angeles. Photo: Mario Tama via Getty Images

Health insurers will be required to cover costs for over-the-counter, at-home COVID tests starting this Saturday, the Health and Human Services Department announced Monday.

Why it matters: Under President Biden's strategy to expand access to free COVID testing, insurers will either cover costs upfront or reimburse people after they submit claims.

Thousands without power as "hazardous" winter storm lashes East Coast

Satellite imagery of the Northeastern U.S. taken by NOAA on Jan. 17. Photo: NOAA

A major winter storm was lashing much of the East Coast on Sunday, causing widespread power outages and disrupting travel over the holiday weekend.

The latest: The Weather Prediction Center said in a storm summary Monday that winter storm warnings are still in effect for portions of the Central Appalachians, Ohio Valley, interior Mid-Atlantic, and Northeast, while portions of the Central Appalachians and coastal New England are under high wind warnings.

Colleyville Rabbi credits survival to active-shooter training

Rabbi Charlie Cytron-Walker, one of the people taken hostage in a synagogue outside Fort Worth on Saturday, said in an interview with CBS Monday that he initially took in the man because he thought he needed shelter.

The big picture: Cytron-Walker said he spoke to the hostage taker, identified by the FBI as 44-year-old British national Malik Faisal Akram, for several minutes and made him tea before Akram took the rabbi and three other people hostage during Shabbat services for around 11 hours in Colleyville, Texas.

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