With precision medicine gaining momentum as a guiding approach to healthcare practice and treatments, early pharmacogenomic testing in the consumer market is laying some of the foundation for use in psychiatry. To further inform, a recent CMS local coverage determination (LCD) proposal for combinatorial pharmacogenomics limited coverage presents a roundup of findings
It is estimated that over 50% of the variance of antidepressant response and tolerability is genetically controlled. And the societal direct and indirect cost of psychiatric disorders is widely understood.
For patients with major depressive disorder (MDD), pharmacogenomic testing provides additional insight about how well the person metabolizes certain drugs and the likelihood of the person experiencing side effects from particular medications. Some doctors would like to see pharmacogenomic testing become routine.
Pharmacogenomic testing is especially important to psychiatry because it offers objective data in a field that otherwise relies on subjective evaluation, says Michael Genovese, MD, JD, Medical Director of the Officer Safety and Wellness Committee of the FBI National Academy Associates. "In psychiatry, we need more tools in our toolbox," says Genovese.
A clinical psychiatrist, addiction specialist, and the Chief Medical Officer of Acadia Healthcare, Genovese also says he is frequently asked by clinicians how they should decide when to utilize pharmacogenomic testing.
An early adopter of pharmacogenomic testing, Michael Genovese, MD, JD (above), focuses on the psychiatry specialty. Genovese is involved with adoption and improvement of pharmacogenomics programs across Acadia Healthcare's network of 589 behavioral healthcare facilities. (Photo source: LinkedIn.)
Pharmacogenomics in Psychiatry: Early Adoption Insights
Genovese is an early adopter of pharmacogenomics technology, having used it since roughly 2012 as an attending physician at NYU Winthrop University Hospital and later in private practice. As CMO of Acadia Healthcare, Genovese is involved with adoption and improvement of pharmacogenomics programs across the company's network of 589 behavioral healthcare facilities with approximately 18,000 beds in 40 states, the United Kingdom, and Puerto Rico.
"The decision is different for everybody," Genovese says. For example, some physicians offer the test to all patients, while others are more conservative. "They might not use it right away if someone comes to their care because their psychiatrist moved, and they're doing perfectly well on whatever medication they're on."
Acadia Healthcare offers the laboratory developed pharmacogenomic test GeneSight, provided by genomics company Myriad Genetics Inc., at several of their facilities.
Since 2012, reimbursement policies for precision psychiatry have become more informed by research, such as that recently published in The Journal of Clinical Psychiatry, which found that GeneSight test results led to statistically significant improvement in remission, response, and symptoms for patients with depression compared to those receiving treatment as usual (TAU). The improvements in all clinical outcomes continued throughout the six-month follow-up period, researchers note. In particular, the rate of remission--which is the goal of treatment, according to the American Psychiatric Association--nearly doubled from week eight to week 24, according to the study.
New Reimbursement and Coverage Developments for Pharmacogenomic Testing in Psychiatry
According to Myriad, the GeneSight test is covered by UnitedHealthcare Medicare; CareFirst (a Blue Cross and Blue Shield affiliate); and the insurance network for the grocery chain Kroger. Also, a large pharmacy benefit manager (PBM) recently added GeneSight, and one of the PBM's member companies has decided to make the test available to its employees. This Dark Daily article explains more.
The coverage rationale provided in UnitedHealthcare's reimbursement policy states that "the use of pharmacogenetic multi-gene panels to guide therapy decisions is proven and medically necessary for antidepressants and antipsychotics medication when the individual has a diagnosis of major depressive disorder or anxiety, the individual has failed at least one prior medication to treat their condition, and the multi-gene panel has no more than 15 relevant genes."
More recent coverage information can also be found in the Centers for Medicare and Medicaid Services (CMS) proposed Local Coverage Determination (LCD) guidance on five combinatorial pharmacogenomics tests for which outcome data has been published. The comment period ended in late November 2019.
GeneSight is one of several other proprietary genotyping kits and algorithms to guide MDD treatment and that are explained in the LCD draft. Others reviewed include CNSDose, Genecept, NeuroIDgenetix, and Neuropharmagen. The information in the LCD is important for clinical laboratories, psychiatrists, and hospital and health system leaders who are interested in monitoring outcomes and reimbursement trends in pharmacogenomic testing.
More Informed Medication Decision Making Instead of Just Throwing Darts?
Pharmacogenomic test results simply provide information--to be considered with the clinical history--for clinicians to take into consideration when making prescribing decisions. The aim is to reduce the guesswork in selecting medications in various classes. "Instead of just throwing darts at a dartboard, we can start with something that's genetically concordant," Genovese says.
To understand the complexity of drug metabolism, there has been growing interest in using pharmacogenomics to improve medication selection for those struggling with difficult-to-treat forms of MDD. Additional research into pharmacogenomics in psychiatry is ongoing, with the promise to improve the science and technology surrounding genetic tests and their implications. "What I hope is that people continue to use and research it to glean information about even more mechanisms in action and how our DNA affects that," Genovese says. "I would like to see it so widely recognized as being valuable that it becomes just like routine labs for people."
-Debra A. Shute