capitol hill report: AAN MONITORING LECANEMAB FOR ALZHEIMER’S DISEASE

December 12, 2022

Latest Advocacy News

• The Medical Marijuana and Cannabidiol Research Expansion Act was signed into law on December 2. Read the two letters the AAN signed onto earlier this year urging the passage of the bill.

• AAN sent a letter to House and Senate leadership reiterating the Academy’s top advocacy priorities for the end of the year, which include protecting the health care workforce, ensuring continued access to telehealth, streamlining the Medicare prior authorization process, and investing in medical research and veterans.

• The Academy joined several other organizations in support of the inclusion of the SURS Extension Act (H.R. 6576) in a year-end legislative package. The legislation extends an important technical assistance program known as the Quality Payment Program—Small, Underserved, and Rural Support, which provides support to practices who participate in Medicare value-based payment initiatives.

• The Centers for Medicare & Medicaid Services released a proposed rule on December 6 to address challenges with prior authorization (PA). The rule would advance interoperability and improve the PA process by requiring Medicare and Medicare Advantage plans to adopt electronic PA, respond to PA requests in specific timeframes, require public reporting on the use of PA, and much more. This rule will have a significant impact on provider and patient experience and should help in the Academy’s efforts to get the Improving Seniors Timely Access to Care Act signed into law. The Academy will submit comments on this proposed rule in the new year.

Issue in Focus

Alzheimer’s experts from around the world met in San Francisco for the 15^th annual Clinical Trials on Alzheimer’s Disease conference. While a variety of sponsors presented results from their clinical trials, it was Eisai’s presentation of their Phase 3 CLARITY AD trial for their monoclonal antibody directed against amyloid for the treatment of Alzheimer’s disease (AD), lecanemab, that generated the most excitement. Experts presented an article published in the New England Journal of Medicine that found that lecanemab was able to meet primary endpoints demonstrating statistically significant clearance of amyloid plaque as well as a 27-percent reduction in cognitive decline over 18 months as measured by the Clinical Dementia Rating―Sum of Boxes.

The FDA is scheduled to make its accelerated approval decision on lecanemab on or before January 6, 2023. Should the therapy be approved, it would immediately fall under the National Coverage Determination (NCD) finalized earlier this year in response to the approval, and the surrounding controversy, of aducanumab last year. That NCD stipulated that all therapies in the same class as aducanumab would only be covered by Medicare under a mechanism known as Coverage with Evidence Development which only allows for coverage in the context of a randomized controlled trial.

Eisai, the Alzheimer’s Association, and many other stakeholders are already making the case for lecanemab to be removed from the constraints of the NCD so that the estimated 1.2 million patients with early AD or mild cognitive impairment can access this therapy as soon as possible.

The AAN has been heavily involved in this space since prior to the approval of aducanumab in May 2021 and has already begun outreach to CMS and other key stakeholders in order to best represent our members’ interests as these new therapies emerge.

What We're Reading

• CMS proposes new prior authorization requirements for payers, including MA plans (HealthcareDive)
• Stop hospital consolidations to lower health care prices for all Americans (The Hill)
• Employers Use Patient Assistance Programs to Offset Their Own Costs (KHN)