Medicare will pay for Alzheimer's treatments

Medicare will pay for fully approved Alzheimer’s disease therapies for patients whose doctors submit data about their treatment to a national registry, the agency that oversees the program said Thursday.

The decision is in line with previous guidance from the agency, the Centers for Medicare and Medicaid Services. And while CMS framed its plan as a way to ensure the availability of Alzheimer’s drugs, it maintained the registry requirement, which drug makers and advocates opposed.

In response to the announcement, the Alzheimers Association, which has received some funding from drug companies, has renewed its criticism of the registry requirement.

We continue to believe that the registry as a hedge condition is an unnecessary barrier, the advocacy group said in a statement. Records should not be a requirement for coverage of an FDA-approved treatment.

Last year, CMS instituted tight coverage restrictions on a new class of Alzheimer’s therapies known as amyloid antibodies due to concerns about the cost and effectiveness of Biogen’s drug Aduhelm (ticker: BIIB) and Eisai (ESAIY) which was the first in its class to receive accelerated approval from the Food and Drug Administration.

Advertising – Scroll to continue

Medicare generally refused to pay for Aduhelm. Now, a more effective drug from the same companies, known as Leqembi, is on track to gain full approval in July. An FDA advisory panel is scheduled to consider trials for the drug next week.

CMS Administrator Chiquita Brooks-LaSure said Thursday that if a drug like Leqembi receives full approval, Medicare will pay for it for patients with mild cognitive impairment or early dementia caused by Alzheimer’s.

If the FDA grants traditional approval, CMS is ready to ensure that anyone with Medicare Part B who meets the criteria is covered, Brooks-LaSure said.

Advertising – Scroll to continue

The agency said, however, that doctors prescribing the drugs will need to collect evidence about the treatment to be submitted to a CMS registry. That requirement is generally consistent with what CMS has been saying for months.

Pharmaceutical company executives, including Eli Lilly chief scientific and medical officer Dr. Daniel Skovronsky and Biogen CEO Christopher Viehbacher have been vocal critics of the registries, which the companies fear could limit access to the drug if doctors are unwilling to go through the registry process.

And on Thursday, Lilly pointed out that logs remained a problem. Lilly is developing its own drug of the same type.

Advertising – Scroll to continue

We strongly believe that requiring patient enrollments in registries will continue to pose unnecessary barriers and contradicts CMS’s promise of broad coverage to all Medicare beneficiaries, the company said in a statement Thursday.

Eisai said CMS has not yet provided enough details about the registry for the company to say how it might affect access to Leqembi.

Eisai looks forward to CMS releasing details that we hope confirm claims previously made by CMS and Administrator LaSure about the broad access to this class of Alzheimer’s disease therapies and the easy-to-use format for the registries, the company said. in his statement.

Biogen has taken a similar tone. While we’re encouraged to see CMS’s intent to expand access to these therapies, more details are needed to understand the implications of the proposed registries, the company said Thursday.

Advertising – Scroll to continue

For pharmaceutical companies, the commercial future of drugs is at stake. Virtually all Alzheimer’s disease patients in the United States are enrolled in Medicare, so Medicares coverage policies will determine revenue for the class of drugs. While analysts once saw huge blockbuster potential in the drugs, Aduhelm’s experience has dampened expectations.

In midday trading on Thursday, Biogen shares rose 2.8% and Eisais’ U.S. depositary receipt rose 2.3%.

Advertising – Scroll to continue

An analyst on Thursday saw the CMS announcement as positive news for Alzheimer’s drugmakers. In a note, William Blair analyst Myles Minter wrote that the records won’t stop doctors from prescribing the drug. We don’t think registries at the specialty centers where Leqembi is likely to be initially administered won’t be a substantial barrier, Minter said. Doctors will still follow patients closely, he said, given the known safety risks of the drugs.

We view today’s CMS statement as a tailwind for payback for the anti-amyloid class, he wrote.

Details of exactly what the registries will require were not included in Thursday’s statement. CMS said it will facilitate a portal through which doctors can submit registry data. He said he is working with a number of organizations preparing to open their registries. I hope to see more private sector partners in this work making their own announcements soon, Brooks-LaSure said.

Email Josh Nathan-Kazis at

#Medicare #pay #Alzheimers #treatments

By admin

Leave a Reply

Your email address will not be published. Required fields are marked *