CMS Coverage Lift on PET Beta Amyloid Imaging Impact on mAb Treatment and Beneficiary Out-Of-Pocket Spending

OBJECTIVES: In October 2023, CMS lifted the National Coverage Determination (NCD) 220.6.20, removing the lifetime limit on PET beta amyloid imaging. This change is crucial for early Alzheimer's disease (AD) detection, treatment evaluation, and cost coverage for beneficiaries treated with anti-amyloid monoclonal antibodies (mAbs). Our study examines the impacted beneficiary population, focusing on their demographics, healthcare utilization, and out-of-pocket spending.

METHODS: This study analyzed the 100% Medicare fee-for-service research identifiable files (RIFs) from January 2021 to June 2023. Patients were selected if they received beta amyloid PET testing and/or anti-amyloid mAbs infusion within the study period. Descriptive statistics were done for demographic information, enrollees who underwent PET beta amyloid imaging, anti-amyloid mAbs treatment, and those who received both.

RESULTS: This study included 12,310 unique beneficiaries with PET beta amyloid imaging and/or anti-amyloid mAbs treatment claims. The mean age for the population was 74.3 with the majority being male (52%) and white (82). 88% of the paid claims were linked to PET imaging (n=11,933) while 12% were anti-amyloid mAbs infusions (n=1,608). Looking at paid claims only, 66% of enrollees had evidence of 1 PET scan with an average OOP payment of $203, 17% had between 2 and 5 scans and an average OOP payment of $358, and less than 1% of enrollees had 6 or more scans with an average OOP of $1,472. Very few beneficiaries (<1%, n=48), have both paid anti-amyloid mAbs and PET claims. Those who have evidence of both treatments have substantially higher average OOP of $4,363.

CONCLUSIONS: AD impacts approximately 6.5 million Americans. This CMS coverage update should improve access to amyloid PET scans for diagnosis and monitoring, increase rates and evaluation of new anti-amyloid mAbs treatments, and lead to a multifaceted approach to lowering OOP beneficiary cost for the early AD population.