Private payer coverage policies for ApoE-e4 genetic testing

Genetics in Medicine (2021)Cite this article

Abstract

Purpose

ApoE-e4 has a well-established connection to late-onset Alzheimer disease (AD) and is available clinically. Yet, there have been no analyses of payer coverage policies for ApoE. Our objective was to analyze private payer coverage policies for ApoE genetic testing, examine the rationales, and describe supporting evidence referenced by policies.

Methods

We searched for policies from the eight largest private payers (by member numbers) covering ApoE testing for late-onset AD. We implemented content analysis methods to evaluate policies for coverage decisions and rationales.

Results

Seven payers had policies with positions on ApoE testing. Five explicitly state they do not cover ApoE and two apply generic preauthorization criteria. Rationales supporting coverage decisions include: reference to guidelines or national standards, inadequate data supporting testing, characterizing testing as investigational, or that testing would not alter patients’ clinical management.

Conclusion

Seven of the eight largest private payers’ coverage policies reflect standards that discourage ApoE testing due to a lack of clinical utility. As the field advances, ApoE testing may have an important clinical role, particularly considering that disease-modifying therapies are under evaluation by the US Food and Drug Administration. These types of field advancements may not be consistent with private payers’ policies and may cause payers to reevaluate existing coverage policies.

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Data availability

The data reported in this paper were collected through publicly available resources. Therefore, the authors did not deposit these data into another repository. Requests for tools or frameworks used in our analysis will be considered on a case-by-case basis.

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Acknowledgements

Work reported in this publication was covered through funding from the National Cancer Institute (NCI)/National Human Genome Research Institute (U01 HG009599) and NCI (R01 CA221870). J.J.A. and A.M.T. have also been funded by the National Institute on Aging (NIA) (NIA-K01-AG057796).

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Affiliations

  1. Department of Neurology, University of California, San Francisco, San Francisco, CA, USA

    Jalayne J. Arias JD, MA & Ana M. Tyler JD, MA

  2. Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), University of California, San Francisco, San Francisco, CA, USA

    Michael P. Douglas MS & Kathryn A. Phillips PhD

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  1. Jalayne J. Arias JD, MA
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  2. Ana M. Tyler JD, MA
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Contributions

Conceptualization: J.J.A., M.P.D., K.A.P. Data curation: M.P.D. Formal analysis: J.J.A., M.P.D., A.M.T. Funding acquisition: K.A.P. Methodology: J.J.A, M.P.D., K.A.P. Validation: J.J.A., M.P.D., A.M.T. Visualization: J.J.A., A.M.T. Writing—original draft: J.J.A., M.P.D., A.M.T. Writing—review and editing: J.J.A, M.P.D., K.A.P., A.M.T.

Corresponding author

Correspondence to Jalayne J. Arias JD, MA.

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Competing interests

Competing interests have been reviewed by the University of California–San Francisco. K.A.P. receives consulting income from Illumina, Inc. M.P.D. receives consulting income from Illumina, Inc. The other authors declare no competing interests.

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Arias, J.J., Tyler, A.M., Douglas, M.P. et al. Private payer coverage policies for ApoE-e4 genetic testing. Genet Med (2021). https://doi.org/10.1038/s41436-020-01042-4

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