In July, the FDA is expected to make a decision on lecanemab (Leqembi), an antiamyloid therapy previously approved under the accelerated approval pathway, for a potential traditional approval for early-stage Alzheimer disease.
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According to a new announcement, the Centers for Medicare & Medicaid Services (CMS) plans to provide coverage for therapies designed to slow the progression of Alzheimer disease (AD) that have received traditional approval. The announcement comes months after the agency doubled down on its April 2022 decision to restrict the coverage of FDA-approved antiamyloid therapies to treat the neurodegenerative disease.1
"Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and caregivers in a way that almost no other illness does. CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease," Chiquita Brooks-LaSure, MPP, the administrator of CMS, said in a statement.1 "If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered. I’m pleased to make this announcement today as part of CMS’ mission to help improve the lives of Americans we serve. I hope we see more private sector partners in this work making their own announcements soon."
Earlier this year, in January, the FDA approved lecanemab (Leqembi; Eisai) for the treatment of patients with early-stage AD under the accelerated approval pathway, joining aducanumab (Aduhelm; Biogen) as the only antiamyloid therapies in its class. Shortly after, Eisai filed for traditional approval of the agent, using the phase 3 Clarity AD study (NCT03887455) as the confirmatory study.2 A few weeks before its expected PDUFA date of July 6, 2023, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will discuss the results of the trial to see if they warrant a traditional approval. That meeting is slated for June 9, 2023.
Under CMS’ current coverage policy, if the FDA grants traditional approval to other drugs in this class, they would be eligible for broader coverage. To get Medicare coverage, individuals will need to be enrolled in Medicare Part B, have a diagnosis of mild cognitive impairment or early dementia caused by AD, and have a qualified physician participating in a registry with an appropriate clinical team and follow up care.
CMS plans to provide coverage for Alzheimer disease therapies that receive traditional approval, expanding access for Medicare beneficiaries.
Medicare Part B enrollees with mild cognitive impairment or early dementia caused by AD may be eligible for coverage.
The requirement for clinicians to participate in a registry as a condition of coverage is a concern for the Alzheimer's Association.
The Alzheimer’s Association, which filed a formal request to remove the requirements for these approved therapies in December 2022, believes the registry as a condition of coverage is “an unnecessary barrier.” In an announcement it issued today, the organization stated that, “Registries are important tools to gather much needed real-world evidence to transform and improve patient care. But, registries should not be a requirement for coverage of a FDA-approved treatment. We look forward to learning more details from CMS and we are hopeful for the future of health care access for our constituents. However, we remain concerned that the requirement of clinicians to register and enter data will create unnecessary hurdles."3
The organization continued, "In its announcement CMS said it will have a nationwide CMS-facilitated portal and other future registries may also qualify. Additional information about the data submission, registry requirements and details about how patients and physicians can enroll is still needed."
For context, in April 2022, CMS published its final decision memo on its national coverage analysis for the class of monoclonal antibodies as treatments of AD, restricting the coverage of these products to 2 scenarios. The first provided coverage for approved agents that show change in surrogate end points in randomized controlled trials conducted under an investigational new drug application, while the second provided coverage in CMS-approved prospective comparative studies. Study data for CMS-approved prospective comparative studies must also be collected in a registry.