THE ROAD AHEAD: ARE U.S. PAYER POLICIES KEEPING PACE WITH RAPID INNOVATION IN ALZHEIMER'S DISEASE DIAGNOSTIC TESTING?
Author(s)
Yamina Rajput, M.Sc1, Sophie Roth, MSc2, Matt DeNave, MBA1;
1Roche Diagnostics Corp, Indianapolis, IN, USA, 2Roche Diagnostics International, Rotkreuz ZG, Switzerland
1Roche Diagnostics Corp, Indianapolis, IN, USA, 2Roche Diagnostics International, Rotkreuz ZG, Switzerland
OBJECTIVES: The recent FDA approval of blood-based biomarkers (BBBMs) for Alzheimer's Disease (AD) marks a major scientific advancement in diagnostic testing. Given the importance of this innovative technology for earlier AD diagnosis and clinical management, our objective was to evaluate whether payer policies have evolved to cover BBBMs, ensuring continued patient access and seamless continuity of care.
METHODS: We analyzed Alzheimer's Disease-Modifying Therapy (DMT) medical policies from 25 U.S. payers (published 01/01/2024-12/31/2025). Commercial and Medicare Advantage (MA) policies were evaluated separately to account for distinct regulatory frameworks: Commercial payers exercise autonomy, while MA plans must adhere to CMS statutory requirements (unavailable MA policies were assumed consistent with the DMT NCD). We assessed payer willingness to incorporate BBBMs to confirm amyloid pathology, comparing this against the inclusion of Cerebrospinal Fluid (CSF) testing and Positron Emission Tomography (PET)
RESULTS: Medicare Advantage plans (n=50): 74% did not mandate a specific test for amyloid confirmation within their DMT policies. When specified, clinical criteria included PET (26%), CSF (22%), and BBBMs (4%). Commercial plans (n=48): 19% (9/48) excluded DMT coverage entirely. Among those offering DMT coverage (n=39), amyloid confirmation requirements were highly prescriptive: 77% (30/39) required PET and 74% (29/39) required CSF. Only 23% (9/39) of covering plans allowed flexibility in testing modality, and BBBMs were rarely included (5%; 2/39).
CONCLUSIONS: BBBM testing offers an affordable, scalable alternative to complex neuroimaging and lumbar punctures for early AD diagnosis. However, there is a disconnect between diagnostic innovation and payer policies, with low rates of BBBM coverage. Commercial policies remain restrictive by mandating PET or CSF testing, whereas MA policies are predominantly silent regarding testing modality. Improving access and adoption of BBBMs will likely require additional clinical utility evidence and formal integration into appropriate use recommendations, and the CMS AD Registry.
METHODS: We analyzed Alzheimer's Disease-Modifying Therapy (DMT) medical policies from 25 U.S. payers (published 01/01/2024-12/31/2025). Commercial and Medicare Advantage (MA) policies were evaluated separately to account for distinct regulatory frameworks: Commercial payers exercise autonomy, while MA plans must adhere to CMS statutory requirements (unavailable MA policies were assumed consistent with the DMT NCD). We assessed payer willingness to incorporate BBBMs to confirm amyloid pathology, comparing this against the inclusion of Cerebrospinal Fluid (CSF) testing and Positron Emission Tomography (PET)
RESULTS: Medicare Advantage plans (n=50): 74% did not mandate a specific test for amyloid confirmation within their DMT policies. When specified, clinical criteria included PET (26%), CSF (22%), and BBBMs (4%). Commercial plans (n=48): 19% (9/48) excluded DMT coverage entirely. Among those offering DMT coverage (n=39), amyloid confirmation requirements were highly prescriptive: 77% (30/39) required PET and 74% (29/39) required CSF. Only 23% (9/39) of covering plans allowed flexibility in testing modality, and BBBMs were rarely included (5%; 2/39).
CONCLUSIONS: BBBM testing offers an affordable, scalable alternative to complex neuroimaging and lumbar punctures for early AD diagnosis. However, there is a disconnect between diagnostic innovation and payer policies, with low rates of BBBM coverage. Commercial policies remain restrictive by mandating PET or CSF testing, whereas MA policies are predominantly silent regarding testing modality. Improving access and adoption of BBBMs will likely require additional clinical utility evidence and formal integration into appropriate use recommendations, and the CMS AD Registry.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
MT11
Topic
Medical Technologies
Disease
SDC: Neurological Disorders, STA: Personalized & Precision Medicine