PARC report: a perspective on the state of clinical pharmacogenomics testing

Jennifer Eichmeyer 1, Sara Rogers 2, Christine M Formea 3 4, Jyothsna Giri 4, J Shawn Jones 5, Erica Schnettler 6, Tara Schmidlen 7, Emily Glogowski 8, Raluca N Kurz 9

Affiliations

PMID: 32635876
DOI: 10.2217/pgs-2019-0193

Abstract

In this Perspective, the authors discuss the state of pharmacogenomics testing addressing a number of advances, challenges and barriers, including legal ramifications, changes to the regulatory landscape, coverage of testing and the implications of direct-to-consumer genetic testing on the provision of care to patients. Patient attitudes toward pharmacogenomics testing and associated costs will play an increasingly important role in test acquisition and subsequent utilization in a clinical setting. Additional key steps needed include: further research trials demonstrating clinical utility and cost-effectiveness of pharmacogenetic testing, evidence review to better integrate genomic information into clinical practice guidelines in target therapeutic areas to help providers identify patients that may benefit from pharmacogenetic testing and engagement with payers to create a path to reimbursement for pharmacogenetic tests that currently have sufficient evidence of clinical utility. Increased adoption of testing by payers and improved reimbursement practices will be needed to overcome barriers, especially as the healthcare landscape continues to shift toward a system of value-based care.

Keywords: direct-to-consumer testing; genetic testing; liability; malpractice; patient access; payers; personalized medicine; pharmacogenetics; pharmacogenomics; reimbursement.