Genetics in Medicine Publication by TRANSPERS Analyzes Private Payer Coverage Policies for ApoE Genetic Testing for Late-Onset Alzheimer’s Disease

In the article Private payer coverage policies for ApoE-e4 genetic testing by Arias et al, the authors evaluated the potential impact of Alzheimer’s disease field advancements on ApoE genetic testing coverage decisions. As the field advances, ApoE testing may have an important clinical role, particularly considering that disease-modifying therapies are under evaluation by the Food and Drug Administration (FDA). If the FDA approves a therapy, payers may be motivated to reevaluate their existing coverage policies.

Efforts to identify disease-modifying therapy for Alzheimer’s disease are tightly linked to understanding the etiology of the disease, the underlying pathology, and risk factors – including genetic risk factors. ApoE-e4 (ApoE) status is the most significant genetic risk factor for late-onset Alzheimer’s disease. Clinical access to ApoE genetic testing for predictive or diagnostic testing related to Alzheimer’s disease is determined, in part, by payers’ coverage policies. Yet, there is a gap in understanding private payers’ policies and their rationale for their coverage policies regarding ApoE genetic testing. This study in Genetics in Medicine, is the first to examine private payers’ coverage policies that apply to ApoE genetic testing for late-onset Alzheimer’s disease.

TRANSPERS collaborators analyzed the eight largest private payers’ coverage policies for ApoE genetic testing, examined the rationales, and described supporting evidence referenced by policies. They found that current payers’ coverage policies reflect standards that discourage ApoE genetic testing due to a lack of clinical utility. The primary policy rationales included genotyping would not affect patient management and lack of data sufficient to support genetic testing. While private payer coverage policies are consistent with the current professional guidelines and standards, emerging developments in the field may offer new clinical benefits of ApoE genotyping. This study is the first of work aiming to evaluate the relationship between payer coverage and access to genetic and biomarker testing in neurodegenerative conditions.

This study was led by Jalayne Arias JD, MA, (UCSF Memory and Aging Center) and TRANSPERS (UCSF Center for Translational and Policy Research) founding director Kathryn A. Phillips, PhD, with Michael Douglas, MS, and Ana Tyler JD, MA. TRANSPERS is located in the Department of Clinical Pharmacy at UCSF and is affiliated with the Philip R. Lee Institute for Health Policy Studies.