Testimony on New Alzheimer’s Drugs Continues the AAN’s Legacy of Advocacy

In this issue, we look back at 75 years of AAN advocacy for neurologists and their patients. From its inception, the Academy was almost immediately working its way through the corridors of power in Washington, DC, as President A.B. Baker, MD, FAAN, and President Elect Pearce Bailey, MD, FAAN, pushed for the creation in 1950 of what we know today as the National Institute of Neurological Disorders and Stroke.

Fast forward to the Rayburn House Office Building on July 18, 2023. The AAN was invited to testify before the House Energy and Commerce Committee hearing on “Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology.” Representing your Academy and more than six million Americans living with Alzheimer’s disease, their caretakers, and the neurologists who treat them was our President Elect Natalia S. Rost, MD, MPH, FAAN, FAHA. Dr. Rost addressed new monoclonal antibody therapies recently approved for the treatment of early Alzheimer’s disease, particularly how the recent Food and Drug Administration approval for lecanemab and the National Coverage Determination (NCD) by the Centers for Medicare & Medicaid Services impact Medicare patients’ access to this drug.

“The AAN has been engaged on issues surrounding monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease for more than two years,” said Dr. Rost in her opening statement. “The goal of the AAN’s advocacy has always been to ensure appropriate access to these new therapies for patients in need. Shortly after the accelerated approval of aducanumab in the summer of 2021, the Academy participated in the National Coverage Analysis initiated by CMS to investigate appropriate coverage for aducanumab for the Medicare population. The AAN submitted comments and met with the Coverage Analysis Group at CMS to contribute to that analysis and was ultimately proud to have been cited extensively throughout the resulting NCD. Many of the AAN’s recommendations relating to study protocol requirements, care-team design, and loosening of site-of-service limitations were ultimately incorporated into the final NCD. However, there was one key disagreement the AAN had with the proposed NCD.”

Dr. Rost went on to explain the AAN’s concerns that the NCD for this “first-in-class” agent is being applied to the entire class of monoclonal antibodies (mAbs) directed against amyloid for the treatment of AD, even as multiple therapies are in various stages of the approval process that work through the same mechanism but for which the full body of evidence is not currently publicly available. “The AAN is concerned that results from trials in progress for upcoming therapies may demonstrate evidence of meaningful clinical benefits that will not warrant the same restrictions as proposed in this NCD.”

She told the committee that the AAN had asked CMS for an "off-ramp" to be created within this NCD that would allow for a therapy demonstrating safety and effectiveness to be reconsidered in a nimble and effective way without the need to restart the NCA/NCD process.

“Unfortunately, the AAN’s concerns have ultimately come to pass,” Dr. Rost continued. “CMS’ decision to implement a class-wide determination and the lack of a nimble process to update the NCD as evidence emerges for impacted products and subpopulations has necessitated a need for further reconsideration of the existing coverage policy.”

Dr. Rost explained that, working with the subject matter experts and leadership, the AAN has identified a subset of patients for whom there is conclusive peer-reviewed evidence available demonstrating the safety and effectiveness of lecanemab and recommends those patients be removed from the Coverage with Evidence Development (CED) requirements to ensure access outside of the existing study requirement. “Not only would this relieve these patients from any burdens associated with study participation, but it would also create the clear ‘offramp’ that is needed to ensure that CED is not indefinite, nor required of all Medicare beneficiaries, regardless of available evidence. As evidence is gathered on other patient populations, these criteria could be adjusted efficiently to broaden access.”

As she deftly fielded questions from the committee representatives on both sides of the aisle about such concerns as criteria for clinical trials for lecanemab and access to diagnostics, Dr. Rost mentioned the AAN by name numerous times and drove her message home on the need to increase the neurology workforce. Her comments prompted a couple of the lawmakers to mention they have family who grapple with brain diseases, illustrating how connecting with personal stories can help shape political outcomes.

Dr. Rost’s invited testimony continues efforts of the AAN to advocate for access to safe and effective treatments with Congress and federal agencies such as the CMS and the Food and Drug Administration. We have endeavored to keep members informed of these developments and their impact on their patients, such as the Academy’s 2022 Evidence in Focus document summarizes the level of evidence regarding aducanumab for patients with Alzheimer’s disease and reviews clinical considerations about its use, as well as a more recent document published July 26 in Neurology®―"Antiamyloid Monoclonal Antibody Therapy for Alzheimer Disease: Emerging Issues in Neurology"―which reviewed available information on lecanemab, aducanumab, and donanemab.

Even though there were several physicians and two pharmacists on the House Energy and Commerce Committee listening to Dr. Rost’s testimony, we know that only neurologists can accurately and effectively represent neurology and the unique nature of the many brain diseases we treat and the patients who live with them. Through years of effective representation by member leaders and staff, we have earned the respect of Congress as trusted authorities in this arena. Your participation in contacting your lawmakers when you receive Action Alert emails reinforces our expertise and our responsibilities to our patients—their constituents.

On September 22, we will hold our next Legislative Summit in Washington, following on the heels of our second annual Brain Health Summit. You will hear more about both events in the weeks following and how the AAN continues to champion our profession on behalf of our patients. Just as it has done for 75 years! 

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October

Carlayne E. Jackson, MD, FAAN President, AAN cjackson@aan.com @CarlayneJackson on Twitter