The nation’s largest private health insurer, UnitedHealthcare, announced August 1 that 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.
The positive coverage decision was good news for makers of the multi-gene panel tests, including Myriad Genetics. Its GeneSight Psychotropic was one of 10 tests for a range of conditions taken off of the company’s “unproven and not medically necessary panels” list.
“We’re very excited that the nation’s largest private health insurer has issued a positive policy decision supporting the advance of precision medicine in mental health,” said Ron Rogers, spokesperson for Myriad in an emailed statement. “Today’s decision is validation of the need for pharmacogenomic testing in mental health and is a recognition of the important role that genetics plays in medication response.”
UnitedHealthcare’s 10-page policy announcement details the scientific evidence for its support of guiding treatment decisions in psychiatric disorders using multi-gene panels.
“Up to 42 percent of variance in therapy response for major depressive disorders (MDD) can be explained by genetic variation, which has led to the development of pharmacogenetic tests to inform the use of certain psychiatric medications. Prospective randomized clinical trials have been performed to validate the clinical validity and utility of a number of pharmacogenetics (PGx) multi-gene panels,” the new policy reads.
UnitedHealthcare’s policy specifies that the use of pharmacogenetic multi-gene panels to guide therapy decisions is proven and medically necessary for antidepressants and antipsychotics medication when the following criteria are met:
- The individual has a diagnosis of major depressive disorder or anxiety; and
- 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
Depression is the leading cause of disability worldwide according to the World Health Organization. An estimated 17.3 million (7.1 percent) adults in the United States had at least one major depressive episode in 2017, according to the National Institutes of Mental Health. Treatment resistant depression is especially difficult for patients and their families as well as a significant financial cost to the U.S. healthcare system.
UnitedHealthcare cited, among others, the GUIDED study as support for its new coverage decision regarding antidepressants. The study was published in the 4 January 2019 issue of the Journal of Psychiatric Research. It included more than 1,100 patients with depression and is the largest of its kind to date. The study showed that, individuals in the GeneSight cohort had a 50 percent higher rate of remission at week 8, a 30 percent higher rate of response and 11 percent greater improvement in symptoms compared to those in a treatment-as-usual group. (Remission is the goal of treatment according to the American Psychiatric Association.)
Previous studies also show that UnitedHealthcare’s new policy makes good economic sense. Using GeneSight resulted in a $6,050 per patient savings in first-year healthcare costs compared to treatment-as-usual for patients with depression, according to a 2018 study published in Personalized Medicine. “Additional health economic studies of GeneSight demonstrated that when test was used to guide care there was a four-fold decrease in disability claims and 16 fewer medical absence days,” according to a statement released by Myriad at the time the study was published.
While the focus of UnitedHealthcare’s recent policy revision was testing for mental health disorders, the company removed 10 multi-gene panel tests from its list of “unproven and not medically necessary panels.” These included panels for pain management, cardiac risk and narcotic risk in addition to the ones for anti-depressants and anitpsychotics. It also specified that using multi-gene panels to evaluate drug-metabolizer status “is unproven and not medically necessary” due to “insufficient evidence of efficacy.”