CMS Approves Medicare Coverage for New Alzheimer’s Drugs to Facilitate Research

New approved drugs for Alzheimer’s may be covered by Medicare if patients meet the conditions of showing cognitive decline and early onset of dementia, the Centers for Medicare & Medicaid Services (CMS) said Thursday.

Administrator Chiquita Brooks-LaSure shared the process for access and coverage by Medicare for such Alzheimer’s drugs that are currently pending approval by the Food and Drug Administration (FDA). Medicare will only cover the drugs in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare, CMS said in a press release.

Several drugs that slow the progression of Alzheimer’s disease are awaiting FDA’s so-called traditional approval – which means that the drugs have shown clinical benefits – and may become available for research and Medicare coverage in the coming months.

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“CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” Brooks-LaSure said. “If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered … I hope we see more private sector partners in this work making their own announcements soon.”

The results of a confirmatory trial of Leqembi, manufactured by the Japanese pharmaceutical company Eisai Co., will be discussed by the FDA on June 9, with a potential decision on traditional approval possible within weeks. Wider Medicare coverage would begin on the same day that the FDA grants traditional approval, CMS said.

CMS also shared that currently two Alzheimer’s drugs have received accelerated approval from the FDA, but no product has received traditional approval.

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In order for drugs with traditional FDA approval to be covered by Medicare, a physician and clinical team participate in the collection of evidence about how these drugs work in the real world, also known as a “registry.”

And so, to get Medicare coverage once these drugs receive FDA’s seal of approval, people will need to be enrolled in Medicare Part B, have a diagnosis of mild cognitive impairment or early dementia caused by Alzheimer’s disease, and also have a qualified physician participating in a registry. These conditions are in addition to any label requirements specified by the FDA.

Clinicians will be able to submit this evidence through a nationwide, CMS-facilitated portal. And researchers will then have access to the information to conduct future studies. CMS said that it is working with multiple organizations that are getting ready to open their own registries.

Information on other registries for Alzheimer’s drugs that become available in the coming weeks and months will be available at https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development.