Potential Impact on Medicare Part B Premium

July 7, 2023: Today, the federal Food and Drug Administration. (FDA) granted full approval to the Alzheimer’s drug called Leqembi and manufactured jointly by Cambridge-based Biogen and the Japanese drug manufacturer Eisai that also has offices/labs in that city.

At the outset, it’s important to emphasize that Leqembi is not a “cure-all” of Alzheimer’s for everyone. Its use has been approved only for people with early forms of Alzheimer’s, meaning those with mild cognitive impairment or mild dementia who have been confirmed to have amyloid plaques in their brains. According to experts in this field. that group constitutes about a sixth of the more than 6 million nationally who are currently diagnosed with Alzheimer’s.

Officials point out that even for those who may benefit from the drug, it’s not a cure. In an 18-month clinical trial, Leqembi was. shown to slow declines in cognitive ability and function by 27%. Simply put, it slows down the disease’s progression.

Also today, the Centers for Medicare and Medicaid Services (CMS) announced that it will now expand coverage of Leqembi broadening access for up to an estimated million people with early forms of the disease. Leqembi’s cost is prohibitive at a whopping $26,500 annually.

But the coverage does come with some qualifications. Medicare will cover the approved drug when a physician and clinical team participate in the collection of evidence about how the drug works in the real world, also known as a registry. This information, collected by the registry, will help gauge the usefulness of the medication for Medicare enrollees.

Providers will be able to submit the evidence through a CMS-facilitated portal, which will be free to use. CMS released more details of its plan to cover new Alzheimer’s drugs in late June. According to the agency, it is working with a number of organizations that are preparing to open their own registries. Clinicians will be able to choose which registry to participate in.

While today’s positive actions by FDA and CMS are understandably welcome news for Medicare retirees who are suffering from the  early stages of Alzheimer’s, they raise questions on their potential impact on the Medicare Part B premium. According to Association President Frank Valeri, “We’re naturally concerned after our experience just two years ago with another Alzheimer’s drug manufactured by Biogen called Aduhelm.”

In 2021, Biogen had received FDA approval for Aduhelm. In order to set aside reserves to pay for the drug’s cost, originally estimated at $56,000 annually and later reduced in half, CMS made exorbitant hikes in Medicare ‘s 2022 Part B premiums that Mass Retirees strongly opposed.

Eventually, CMS severely restricted Aduhelm’s usage for Medicare enrollees. As a result, CMS adjusted its premiums for the current (2023) year. Biogen has since shifted its resources away from Aduhelm and to Leqembi.

“That brings us to where we’re at right now and uncertain over the potential impact on 2024 Part B premiums that will be announced later this year,” continues Valeri. “Be assured that we’ll be closely monitoring developments on this issue.

“We’ll be updating our members here, in our Voice, weekly emails and videos, as well as on our Hotline. Please stay tuned for more.”

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