Medicare will pay for fully approved Alzheimer’s disease therapies for patients whose doctors submit data on their treatment to a nationwide registry, the agency that oversees the program said on 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 availability of Alzheimer’s drugs,” it retained the registry requirement, which drugmakers and advocates have opposed.
In response to the announcement, the Alzheimer’s Association, which has received some funding from drugmakers, renewed its criticism of the registry requirement.
“We continue to believe that registry as a condition of coverage is an unnecessary barrier,” the advocacy group said in a statement. “Registries should not be a requirement for coverage of a FDA-approved treatment.”
Last year, CMS instituted strict limitations on coverage of a new class of Alzhiemer’s therapies, known as anti-amyloid antibodies, because of concerns about the cost and effectiveness of Aduhelm, the
Biogen
(ticker: BIIB) and
Eisai
(ESAIY) drug that was the first in its category to gain accelerated approval from the Food and Drug Administration.
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 committee is scheduled to consider the evidence for the drug next week.
CMS’s administrator, Chiquita Brooks-LaSure, said Thursday that if a drug like Leqembi receives full approval, Medicare will pay for it for patients who have mild cognitive impairment or early dementia caused by Alzheimer’s.
“If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered,” Brooks-LaSure said.
The agency said, however, that doctors prescribing the drugs will need to collect evidence about the treatment to submit to a CMS registry. That requirement is generally consistent with what CMS has said for months.
Executives for drug companies, including Eli Lilly chief scientific and medical officer Dr. Daniel Skovronsky and Biogen CEO Christopher Viehbacher, have been vocally critical of the registries, which the companies worry could limit access to the drug if doctors are unwilling to go through the registry process.
And on Thursday, Lilly emphasized that the registries remained an issue. Lilly is developing its own drug of the same type.
“We strongly believe that mandating patient enrollment in registries will continue to pose unnecessary barriers and contradicts CMS’ promise of broad coverage to all Medicare beneficiaries,” he company said in a statement Thursday.
Eisai said CMS had not yet offered enough details about the registry for the company to say how it might impact Leqembi access.
“Eisai looks forward to CMS releasing details that we hope confirm statements previously made by CMS and Administrator LaSure about broad access to this class of Alzheimer’s disease therapies and easy-to-use format for registries,” the company said in its statement.
Biogen struck a similar tone. “While we are encouraged to see CMS’ intention to broaden access to these therapies, more details are needed to understand the implications of the proposed registries,” the company said Thursday.
For the drugmakers, the commercial future of the drugs are at stake. Virtually all Alzheimer’s disease patients in the U.S. are enrolled in Medicare, so Medicare’s coverage policies will determine the revenue for the class of drugs. While analysts once saw enormous blockbuster potential in the drugs, the Aduhelm experience has dampened expectations.
In midday trading Thursday, Biogen shares were up 2.8% and Eisai’s American depositary receipt was up 2.3%.
One analyst on Thursday saw the CMS announcement as positive news for the Alzheimer’s drugmakers. In a note, William Blair analyst Myles Minter wrote that the registries won’t keep doctors from prescribing the drug. “We believe that registries at specialist centers where Leqembi is likely to be initially administered won’t be a substantial hurdle,” Minter said. Doctors will be tracking patients closely anyway, he said, given the drug’s known safety risks.
“We view today’s CMS statement as a reimbursement tailwind for the anti-amyloid class,” he wrote.
Details of exactly what the registries will require weren’t included in the Thursday statement. CMS said that it will facilitate a portal through which physicians can submit registry data. It said it is working with a number of organizations preparing to open their own registries. “I hope we see more private sector partners in this work making their own announcements soon,” Brooks-LaSure said.
Write to Josh Nathan-Kazis at [email protected]
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