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Biogen Alzheimer’s Drug to Get Medicare Look at Effectiveness

July 12, 2021, 10:38 PM

The Biden administration is undertaking an analysis of Biogen’s new Alzheimer’s drug to determine whether it needs a national coverage policy under Medicare.

It’s the first indication from the Centers for Medicare & Medicaid Services that the drug will be scrutinized. Medicare is expected to bear the bulk of the cost of the drug’s use in patients.

The Food and Drug Administration approved aducanumab last month, sparking outcry in the medical community that there wasn’t sufficient evidence to show the drug worked.

The FDA gave accelerated approval to aducanumab, which has a brand name of Aduhelm. It’s a monoclonal antibody that may help reduce the buildup in the brain of amyloid beta plaque, a key indicator of Alzheimer’s disease.

A first-of-its-kind treatment, Aduhelm, made by Biogen Inc., is the first new Alzheimer’s treatment approved by the FDA since 2003.

On Monday, the CMS opened a national coverage determination to see if Aduhelm, “as well as any future monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease,” should be covered nationally by Medicare, an agency press release said.

A proposed national coverage determination is expected to be posted within six months and a final decision within nine months.

Effectiveness Matters

While the CMS “does not consider the cost of the treatment in the analysis,” the benefits the new treatment offers to Medicare enrollees will be a major consideration for the agency and members of Congress concerned about Medicare’s growing prescription drug costs.

The FDA’s interim commissioner, Janet Woodcock, recently requested the Office of Inspector General review the FDA’s approval of Aduhelm, after concerns were raised by members of Congress about potential improper contact between the agency and company officials before the decision to fast track the drug.

The agency will also host two public listening sessions in July to get public input about its efforts.

“Alzheimer’s is a devastating illness that has touched the lives of millions of American families and as CMS opens our National Coverage Determination analysis, we invite interested stakeholders to participate,” said a statement from CMS Administrator Chiquita Brooks-LaSure. “We want to consider Medicare coverage of new treatments very carefully in light of the evidence available. That’s why our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease.”

Researchers tested Aduhelm’s efficacy in three studies involving 3,482 patients, the FDA said. Patients receiving the treatment had “significant dose-and time-dependent reduction of amyloid beta plaque,” the FDA reported.

Currently, coverage determinations for Aduhelm are being made at the local level by Medicare Administrative Contractors. Coverage decisions by the CMS are “based on careful analysis of the evidence and benefits a given therapy provides to Medicare beneficiaries,” the agency said.

To contact the reporter on this story: Tony Pugh in Washington at tpugh@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Karl Hardy at khardy@bloomberglaw.com