By Deena Beasley and Julie Steenhuysen
(Reuters) – U.S. Medicare plans withdraw from strict restrictions on new Alzheimer’s drugs as evidence emerges in the coming weeks that clearing amyloid brain plaques will help patients, Eli Lilly and Co say company officials told Reuters.
Lilly expects to announce trial results of its experimental amyloid-targeting drug donanemab by the end of June. Additional research data from partners Eisai Co., Ltd. and Biogen Co., Ltd. on the competing drug Recambi are expected to be announced in the coming months.
Leqembi received accelerated approval from the US Food and Drug Administration earlier this year, with a full approval decision expected by July.
Derek Assay, Lilly’s senior vice president of government strategy and federal accounting, said in an interview, “They (Medicare), like all other FDA-approved drugs, have what we call full coverage. Lilly has never spoken publicly about her Medicare coverage optimism before.
Currently, Medicare, the government health insurance for Americans 65 and older, offers anti-amyloid drugs approved under the FDA’s less rigorous expedited review if the patient is enrolled in a clinical trial. Pay only for The class of drugs that receive conventional FDA approval (which may eventually include her Leqembi and donanemab) are eligible contingent on participating in registries that track patients and their treatments.
Such “evidence development compensation” requirements are rare and have historically been used by Medicare to evaluate medical devices.
Industry groups and patient advocacy groups such as the Alzheimer’s Association say the supposed policy keeps patients out and calls for less coverage limits.
Medicare is estimated to cover 85% of eligible Americans for the drug, so investors are watching closely how the restrictions affect sales. Leqembi costs $26,500 annually.
Medicare’s current plans “could lead to some compensation, but the compensation is delayed and unfair,” said Assay, adding that many underserved patient populations, including minorities, will be affected. restricts access to
Eisai said Medicare will soon have a “substantial amount” of new data on donanemab and a complete data set on Eisai and Biogen’s Rekembi.
Asay said he believes both Lilly and Eisai/Biogen have enough evidence to address FDA questions that could open the door to wider coverage. Lilly is also participating in discussions with the US Centers for Medicare & Medicaid Services (CMS).
Lilly shares rose 2.8%, or $10.42, to $385.23 on Friday’s close. This is according to his SVB Securities analyst David Risinger, due to his Asay’s encouraging comments on upcoming earnings.
Medicare’s severe restrictions, mainly in response to previous Alzheimer’s treatments by Eisai, Biogen and Aduhelm, won early approval in 2021, but there was little evidence that it slowed cognitive decline.
In an emailed comment, a spokesperson for CMS said the agency is committed to being responsive as it reviews its coverage in the light of new evidence related to clinical benefit. It disputes claims that the policy will deny access to treatment for underserved patient populations. The plan calls for a diverse study cohort, the spokesperson said.
3 questions
Under its scope framework, CMS seeks answers to three key questions: Do these agents meaningfully improve patient health outcomes in broader community practice, such as slowing cognitive decline? Do the benefits outweigh the risks? How do benefits and harms change over time?
Eisai estimates that 100,000 US patients will be targeted with Leqembi in its first three years on the market and has said it is confident it can provide those answers.
Lilly’s Asay says: “I’m sure he can fully answer these three questions as well.”
Other products facing similar CMS limitations are in decline.
Amyvid, Lilly’s Alzheimer’s imaging agent that can detect amyloid plaques on PET scans, has been the subject of CMS’ evidence development program for 10 years.
Under this policy, diagnostics are available only by enrolling in a Medicare-approved registry, and reimbursement is limited to one scan in a lifetime.
Initial registrations did not recruit enough minorities. A second project, which started two years ago, has yet to register a single site in 18 states, Asay said.
“It shuts out many patients, especially those in minorities and rural areas,” said Dr. Maria Carrillo, chief scientific officer of the Alzheimer’s Association.
(Reporting by Deena Beasley, Los Angeles and Julie Steenhuysen, Chicago; Editing by Caroline Humer and Bill Berkrot)
