Alzheimer's disease medicine

Why Medicare finalizes its restrictions on new Alzheimer’s drug, despite pressure from drugmakers?

WASHINGTON – Medicare on Thursday finalized its plan to restrict coverage of the controversial, expensive Alzheimer’s drug Aduhelm for patients participating in clinical trials.

The decision markers the end of an intense pressure campaign from drug makers and some patient groups, who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. Since clinical trials usually take place outside major medical centers, the decision would mean that some interested patients would not be able to access the drug. However, Medicare does not explicitly require that patients be treated in hospital-based clinics as in the initial proposal.

Alzheimers disease
Alzheimer’s disease

The impact of the decision extends beyond Biogen, the maker of Alzheimer’s drug, as well. The coverage decision is not specific to Aduhelm, and applies to all drugs in the class, including an upcoming treatment that Eli Lilly has begun submitting for FDA approval. But in a major change from the initial proposal, Medicare officials created a sort of shortcut path for drugs that, unlike Aduhelm, demonstrate clinical benefit before being approved for patients. Medicare would cover those drugs for a wider group of patients.

They will still need to collect some data, but the study’s potential design is much more flexible a significant win for Eli Lilly.

“This long-term route is to be agile and responsive to any new drugs in this class that are in the pipeline and demonstrate clinical benefit,” Lee Fleischer, Medicare’s chief medical officer, told reporters.

Since the Food and Drug Administration approved Aduhelm last summer, with doctors and scientists questioning whether it really works, government surveillance has begun to investigate whether the FDA has followed the proper process to approve it. has followed, and policy experts have questioned whether it is effective enough to justify its hefty cost. 

Medicare officials also increased premiums for the entire program to anticipate a potential influx of patients taking the expensive drug. But the new restrictions mean the drug will put less financial burden on the Medicare program. Health Secretary Javier Becerra said he plans to make a decision soon about whether to reduce Medicare premiums for older adults following Medicare’s coverage decision for Aduhelm.

Alzheimer’s drug aduhelm’s limited coverage policy is unprecedented, as Medicare almost always covers drugs if the FDA approves them. Aduhelm has been different because the agency approved the treatment without the guarantee that patients would actually see slow cognitive decline. Following STAT’s report that Biogen had an extensive back-channel relationship with the FDA, the drug’s approval process has been the subject of several investigations.

Alzheimer’s drug aduhelm coverage decision highlights a strong power struggle between Medicare and the FDA over Americans’ access to Aduhelm, but Medicare officials made a major concession to the FDA. The structure and set-up of clinical trials being sought by Medicare will not be overseen by Medicare itself, but by the FDA or the National Institutes of Health.

Medicare will also limit the number of people who can receive the drug who have cognitive impairment or mild forms of dementia, and who have amyloid plaques, designed to target the protein Aduhelm in their brain. The patient population is narrower than the drug approved for treatment by the FDA, because the FDA did not require evidence of amyloid plaques.  In a change from the initial proposal, Medicare opted to allow patients with other medical conditions, such as Down syndrome, to participate in the trials as well.

The narrow coverage policy is a major blow to Biogen, which had hoped that access to the Medicare patient market could bolster the drug’s short sales.

The controversial tool Medicare used to cover Aduhelm is called “Coverage with Evidence Development.” It’s possible Biogen or other drugmakers could sue Medicare by arguing Medicare doesn’t have a legal authority to prove that companies’ drugs benefit patients, said Sean Tunis, a principal at Rubix Health who helped develop the CED process during his tenure at the Centers for Medicare and Medicaid Services.

“In some ways, the CED process has not been challenged in any way before, because it was not for anyone’s benefit,” Tunis said. Typically, CED devices have been used to regulate the coverage of new indications of drugs or devices that would not have been covered otherwise.

“Biogen is carefully considering its options and will provide updates as the company evaluates the business impact of this decision,” the company said in a written statement.
While many Americans with Alzheimer’s disease are also Medicare beneficiaries, the decision could have broader implications, as most major insurers follow the federal government’s lead in setting their policies to cover the drugs.

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