Alzheimer's disease blood-based biomarker testing: A stakeholder-informed assessment of coverage considerations

Abstract

BackgroundRecently published clinical studies suggest that blood-based biomarker tests (BBMTs) for Alzheimer's disease (AD) provide value, but in the U.S., neither public nor private payers currently cover these tests.ObjectiveTo describe considerations for payer coverage of AD BBMTs that would need to be addressed to facilitate timely diagnosis and equitable patient access if clinical utility is demonstrated.MethodsWe performed a targeted literature review to characterize predictable coverage barriers for BBMTs and inform the development of an interview guide. We conducted semi-structured interviews with clinicians, researchers, test developers, and a patient advocate and former payer (N = 12) to assess the barriers and refine the proposed key considerations for obtaining payer coverage.ResultsStakeholders noted that payers will require evidence of clinical validity and utility of BBMTs as part of their coverage determinations contingent on the specific indication for testing, with insufficient evidence for screening applications currently. Stakeholders also agreed that there are evidence gaps for use of BBMTs in patients from ethnic and racial minority communities that must be addressed. Given the shortage of memory specialists, stakeholders noted that limiting testing coverage authorization to specialists could be harmful to patients, particularly the underserved. Interviewees also agreed that patients with mild cognitive impairment or early-stage AD could benefit from earlier diagnosis to avoid progressing to moderate disease and limiting eligibility for new disease-modifying therapies.ConclusionsIf BBMTs meet criteria for clinical utility, anticipating and planning for coverage and reimbursement before widespread implementation will be critical to ensuring broad, equitable access to BBMTs.

Keywords: Alzheimer's disease; clinical utility; diagnostics; health equity; payer coverage.