Pharmacogenomic (PGx) Testing Acceptance Growing

Consumerism and transparency in healthcare have been trending for the last few years but will take on added significance in 2020 as costs for consumers show no signs of slowing down.

Aspects of market change, like pharmacogenomic (PGx) testing, has become increasingly incorporated into medical plan coverage through State Insurance Commission approved plan offerings. Allowing more use of testing for targeting appropriate drug use has gained acceptance along with paying for related services that will create delivery system efficiencies along with cost savings.

Harnessing technology to aid in managing health care costs remains a standard strategy. In 2018, the FDA issued a safety communication warning consumers and health care professionals about pharmacogenetic tests being marketed directly to consumers or offered through health care providers that claim to predict how a patient will respond to specific medications.

The FDA then reached out to several firms marketing pharmacogenetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication’s effects has not been established.

Most firms addressed the FDA’s concerns at the time and continue to remove specific medication names from their labeling, including promotional material and patient test reports. The FDA is increasingly concerned about the effect that pharmacogenetic testing companies marketing may have on patient medication adherence and switching.

The Personalized Medicine Coalition (PMC), representing innovators, scientists, patients, providers and payers, has taken the lead in representing genetic testing firms, and is expected to work with the FDA on this issue.

Meanwhile, the FDA approved 23andMe’s Personal Genomic Service (PGS) Pharmacogenetic Reports. This marks the first direct-to-consumer test for pharmacogenetics of enzyme variants that may affect the way patients break down medications.

Also, UnitedHealthcare (UHC) announced an updated policy on pharmacogenetic (PGx) testing. It will cover testing that will allow physicians to match their patients to anti-depressants most likely to work for them based on their genetic profiles. The new coverage policy, which also includes multi-gene panel testing for antipsychotic medications, goes into effect on October 1, 2019.

Clearly, pharmacogenetic (PGx) testing and regulations governing its use will continue to emerge as an important issue in healthcare in the future.