The GeneSight test address an unmet need that mental health leaders have wanted for years: a way to avoid the "try until it fails" approach in selecting anti-depressants.
Myriad Genetics on Wednesday announced plans to acquire Assurex Health, makers of a market-leading test that helps physicians pick the right drug for patients with hard-to-treat depression.
“Assurex provides Myriad access to GeneSight, one of the fastest-growing new diagnostic tests ever in a multi-billion global markets, and builds upon Myriad’s commitment to expand into neuroscience,” said Myriad President and CEO Mark C. Capone.
The $225 million acquisition calls for up to $185 million in “performance-based incentives” and marks Myriad’s advance into diagnostics for some of the most vexing and costly conditions for payers. Assurex has revenues of $60 million for fiscal year 2016, according to Myriad.
Assurex’s GeneSight test can pinpoint the correct choice among 55 antidepressants that cover 95% of the prescriptions for depression, bipolar disorder, anxiety, and schizophrenia. Genetic material is collected through a simple cheek swab and sent to a laboratory for analysis, with results returned in days. Assays are based on data from pharmacodynamics and pharmacokinetic genes, according to Myriad spokesman Ron Rogers.
The test addresses an umet need that leaders in the mental health field have sought for decades. Historically, psychiatrists and primary care physicians alike typically try anti-depressants until they fail before moving on to another option.
In materials presented for an investor’s call, Myriad noted that physicians other than psychiatrists provide much of the nation’s treatment for depression; the company reported that 79% of the non-psychiatrists who have used the test followed its recommendations, and saved more than twice the amount of money as psychiatrists.
This is consistent with findings of studies in collaborative care, which show that when depression is treated in a primary care setting, patients offer suffer from “clinical inertia,” in which the wrong medication is used, or the dose is never increased.
Poor medication decisions in depression can be harmful for patients and payers alike. Patients who fail to respond to therapy continue to suffer symptoms, and some need hospitalization. Major depressive disorder (MDD) contributes to other comorbidities, disability, and high healthcare costs. A 2012 review by Ronald C. Kessler, PhD, noted that the MDD is the 4th leading cause of disability worldwide, and estimates put the annual lost economic value in the United States between $30 billion and $15 billion.1
When patients with refractory depression take the wrong therapy, it can make them less responsive to replacement treatments. Thus, taking a personalized medicine approach to MDD makes sense not only clinically, but also from a cost-effectiveness standpoint. Thomas Insel, MD, then-director of the National Institutes of Mental Health, told attendees at the 2014 meeting of the American Psychiatric Association that without better diagnostics, it would be hard to bend the cost curve in mental health care.
“We need to develop better diagnostics and disseminate them,” he said at the time. “The path to better mental health services is through science.” Since then, Insel has joined Google’s Alphabet venture, which seeks to deploy data to find better healthcare solutions.
The challenge, of course, is getting payers to cover the test. Information released with Wednesday’s call said that a Medicare local coverage determination (LCD) covers treatment resistant depression in patients seen by a psychiatrist, and that Horizon Blue Cross Blue Shield of New Jersey is the first private insurer to pay for the test. The information stated that contracted pricing is less than $2000 per test, with an average of $400.
Myriad sees GeneSight as a good companion for a separate test under development, myPath Bipolar, which uses a patient’s genetic material to help physicians distinguish between MDD and bipolar disorder. These conditions can be hard to distinguish, with devastating consequences. Treating patients with bipolar disorder with some MDD medications can trigger manic episodes, as noted during a session at the US Psychiatric and Mental Health Congress in 2014.
1. Kessler RC. The costs of depression. Psychiatr Clin North Am. 2012; 35(1):1-14.