CMS proposes narrowly covering controversial Alzheimer's drug Aduhelm for patients in clinical trials

Aduhelm's manufacturer Biogen generated controversy when it launched the Alzheimer's disease drug at $56,000 despite lingering questions over its effectiveness. (Biogen)

The Biden administration is proposing to have Medicare cover the controversial Alzheimer’s disease medication Aduhelm, but only for patients in relevant clinical trials.

The Centers for Medicare & Medicaid Services (CMS) released Tuesday a proposed national coverage determination for Medicare to cover drugs that target amyloid for the treatment of mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer's dementia. However, the decision only extends to patients that are in a qualifying clinical trial.

Currently, there is only one drug approved by the FDA in the class: Biogen’s Aduhelm, which was approved last year despite concerns over the drug’s efficacy.

“CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders,” said CMS Administrator Chiquita Brooks-LaSure in a statement.

RELATED: JPM 2022: Amid underwhelming Aduhelm launch, Biogen supports limited Medicare coverage, exec says

The Food and Drug Administration approved Aduhelm last year despite concerns from agency advisers over the drug’s efficacy.

Some large hospital systems such as Mayo Clinic and Cleveland Clinic have decided against prescribing the drug due to lingering concerns on its effectiveness.

CMS gave a nod to those concerns in its statement Tuesday.

"This proposed National Coverage Determination is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment, there is also the potential for harm to patients," said Lee Fleisher, M.D., CMS' chief medical officer.

Aduhelm also generated controversy with the high launch price of $56,000 for the drug, a price it halved late last year due to the blowback.

Biogen slammed the decision in a statement, saying it will “significantly limit patient access to an FDA-approved treatment.”

The drugmaker added that such coverage determinations can also take “months to years to initiate and hundreds of Alzheimer’s patients — the majority of whom are Medicare beneficiaries — are progressing each day from mild to moderate disease stages, where treatment may no longer be an option.”

Tamara Syrek Jensen, director of the Coverage and Analysis Group at CMS Center for Clinical Standards and Quality, said on a call with reporters that it is “unusual” for CMS to propose coverage with an evidence determination, but the agency believes it is appropriate for the Medicare population to make the decision.

“We felt that as you know that our obligation is to ensure that we look at and approve treatments that are shown to have benefits and those benefits outweigh the harms,” Fleisher added on the call.

The agency is holding a 30-day public comment period and will announce its final decision by April 11.

After the agency reaches a final decision on the national coverage determination, CMS will approve clinical trials that meet certain criteria, including patient diversity and representation of the Medicare population with Alzheimer's. The agency will also approve any trials supported by the National Institutes of Health.

"Medicare patients participating in these trials would be eligible to receive coverage of the drug, related services, and other routine costs, which may include PET scans if required by a clinical trial protocol," CMS said in a release.