Medicare's limits on Aduhelm coverage sparks questions about future drugs

• Those patients must also have mild rather than advanced symptoms of the disease and show evidence of a build-up of amyloid plaques in the brain, which is one of the hallmarks of the disease.
• The class of drugs Aduhelm is part of will be subject to similar conditions unless they're approved through the FDA's traditional drug approval pathway.

"There is potential for promise with this treatment. However, there's not yet enough evidence of clinical benefit to say it is reasonable and necessary for people with Medicare," said CMS chief medical officer Lee Fleisher in a call with reporters.

Catch up quick: Aduhelm received "conditional" approval from the FDA in June with the requirement that further trials show the drug slows cognitive decline and is safe.

• As the first Alzheimer's drug to win approval in about 20 years, it spurred excitement and an intense advocacy push from Alzheimer's patient groups. But it has been widely panned within the medical community over unproven clinical benefits, serious side effects and $28,000 annual price tag.
• That put it at the center of an intense lobbying battle in recent months, as well as congressional debates over the FDA's "accelerated approval" process.

What they're saying: "The big question will be 'Is this really just CMS talking about one class or is CMS going to expand this out and consider this for accelerated approval for other drugs?" Chris Meekins, a former HHS official who is now an analyst at Raymond James, told Axios.

• "I continue to believe this is a special case and this won't become a broader policy for drugs that receive accelerated approval," he said.

Yes, but: Others say there are more far-reaching precedents.

• "One of the implications of it is: What is the order for getting approval for a drug?" Mark Miller, a former top Medicare official who is now at Arnold Ventures, told Axios.
• "Are we asking manufacturers to produce their evidence in order to get FDA approval and ultimately CMS coverage? Or are we starting to relax our evidence standards? This should be the exception," he said.

The other side: "This unprecedented CMS decision effectively denies all Medicare beneficiaries access to Aduhelm," Biogen said in a statement. "These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas."

• George Vradenburg, chairman of patient group UsAgainstAlzheimer's called the decision "devastating" for Alzheimer's patients, but also said it set a precedent that could apply to other drugs like cancer or HIV.
• "The precedent they're setting is that Medicare beneficiaries cannot have access to any drug unless it is proven in a phase 3 clinical trial to produce a clear clinical benefit," he said. "That means every accelerated approval ... is not going to be covered until there is a demonstrated clinical benefit for those drugs."

What to watch: This decision will limit the overall number of patients who will likely access the drug.

• That could mean a previously announced premium hike linked to the cost of the drug could come back down.