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Alzheimer’s Treatment Policy Will Restrict Access For Most People

After years of failed trials, we appear to be on the verge of a breakthrough in Alzheimer’s treatment. Lecanemab, an experimental monoclonal antibody treatment made by Biogen and Eisai, reduced cognitive decline by 27% compared with a placebo in a Phase III trial. While the FDA will apparently decide on accelerated approval for the medicine in early January, getting access to the treatment may not be easy.

In a new analysis, Joe Grogan, a senior fellow at the USC Schaeffer Center and former White House domestic policy council director, explains how the Center for Medicare and Medicaid Services’ (CMS’s) current coverage policy for this new class of medicines will severely restrict access to new treatments and discourage innovation.

Grogan looked at five states where Aduhelm, another monoclonal antibody treatment for Alzheimer’s granted FDA accelerated approval, is covered by Medicare in specific clinical trials. In essence, access to Aduhelm – and by extension, access to future treatments approved in this class – is very limited outside of major cities.

The discussion of Ohio provides some insight into the problem:

Residents of Cincinnati must travel two hours to reach Columbus, though one Ohioan had to travel much further. He had moved from Nevada and was participating in the trial through a location in Las Vegas. He found Aduhelm so valuable that he was willing to travel to Las Vegas twice a month. When he was off the treatment, he was liable to believe he was still working, expecting clients to appear in his house, believing he was late for speaking engagements, and attempting to leave the house in the middle of the night in his pajamas or attempting to enter his neighbors’ homes on accident. His wife expressed frustration with CMS’s decision, highlighting the challenges with merely getting into a trial, including numerous tests and qualification criteria that need to be satisfied. She fears her husband will need to be hospitalized or institutionalized without treatment. While the Ohio State University Medical Center hosted a Phase III trial for Aduhelm, there are currently no trial sites for the medicine in the state. The nearest one is in Tennessee.

The situation is similar in Texas, Georgia, Pennsylvania, and California, the other states analyzed, where people must travel long distances to participate in trials to have the treatment covered by Medicare. Additionally, 27 states lack a clinical trial site for Aduhelm, meaning people living there would have to travel across state lines to access treatment. These hurdles are too great to overcome for many people who need treatment, particularly those in underserved communities.

Grogan’s analysis also highlights the impact CMS policy is having on innovation:

Additionally, it is important to remember that CMS sets the tone for other payers and providers in the healthcare system. Following the agency’s lead, United Healthcare, the nation’s largest private insurer, issued a coverage policy nearly identical to that issued by the agency. This further restricts the ability of patients who could stand to benefit from the treatment to be able to afford its costs. Similarly, several major hospital systems including the Cleveland Clinic and Mount Sinai have declined to provide the medicine to patients, though these moves preempted Medicare’s coverage determination.

Grogan ultimately recommends that CMS reconsider its coverage policy to ensure widespread access to lecanemab and other new treatments that receive FDA approval. You can read the full analysis here.