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Genomind Adds Utility Evidence for Mental Illness PGx Test in Bid to Increase Payor Acceptance

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NEW YORK (GenomeWeb) – A recently published study has demonstrated the ability of Genomind's Genecept pharmacogenetic test to reduce utilization of healthcare services and related costs among patients with mental illness, adding further clinical utility evidence that the company hopes will sway payors and drive adoption among psychiatrists.

The Genecept assay analyzes a patient's saliva sample, gauges pharmacokinetic and pharmacodynamic variants in 18 genes, and uses an algorithm to recommend treatments or a class of drugs to which the patient is likely to respond. Genomind launched the 18-gene panel two years ago, expanding an earlier version of the PGx test that analyzed variants in 10 genes.

PGx tests for personalizing psychiatric treatments have been around for more than a decade, and in that time doctors have slowly warmed to the use of these tools in patient care, while payors have been harder to sway. The King of Prussia, Pennsylvania-based company has raised funds twice over the last five years — $5 million in 2014 and $6 million in 2015 — with the aim of growing its pipeline of products and adoption of its lead test Genecept. 

Following the 2015 financing round, Genomind had specifically said it planned to use the funds to conduct multisite randomized trials for Genecept, and develop a new, expanded test offering. While a randomized study investigating Genecept's clinical utility is underway in patients with major depressive disorder, the company has continued to build on the clinical utility data underlying the test.

Earlier this month, a study published in Depression and Anxiety used health claims data from Aetna to compare health services utilization by psychiatry patients tested on the earlier version of the Genecept assay against those who didn’t receive such testing. Researchers led by Roy Perlis from Harvard Medical School and Guido Imbens from Stanford University conducted a propensity-score matched, case-controlled study involving around 800 patients with mood or anxiety disorders who, between January 2012 and December 2015, were tested on Genecept to identify the drug they're most likely to benefit from, and more than 2,700 controls.

Perlis et al. reported that PGx-tested patients experienced 40 percent fewer emergency room visits for any reason, and 58 percent fewer hospitalizations for any reason compared to the control group. When researchers dug into the data adjusting for various factors, they reported that psychiatric emergency room visits were around 2.5 times more common in the control group. PGx-tested individuals had significantly fewer outpatient visits when researchers performed adjusted, model-based analysis, though not in unadjusted bivariate analysis.

Genomind CMO David Krause noted that it's important that the researchers looked at hospitalizations and emergency room visits not just for psychiatric reasons but for any reason. "There is abundant literature that improvement in mental health affects all aspects of wellbeing and quality of life," he said, highlighting a 2015 study, which found that patients tested on Genecept to guide use of psychotropic medications, reported significant improvements not only in depression and anxiety symptoms, but also their quality-of-life. 

"The authors of the present study anticipated, correctly as it turns out, that improvement in mood disorders could affect all-cause spending," Krause said.

Although mood disorder-related hospitalizations or the number of prescribed psychotropic prescriptions didn't differ between the two groups, overall, six-month utilization costs were around $1,200 less in the PGx-tested group based on unadjusted comparisons, and around $1,900 less in adjusted modeling. The cost analyses, however, did not include the price of the test, which Genomind estimates to be approximately $750 for contracted health plans.

The broad finding from this study that Genecept is cost-effective corroborates another retrospective study from 2014. That study by Fagerness et al. found that the PGx test made psychiatric patients more adherent to their drugs, which increased pharmacy costs initially, but lowered outpatient costs over time as patients were more adherent to their medications. 

Researchers found that over a four-month period, patients in the genetically guided cohort had higher pharmacy costs, averaging $886 per PGx-tested patients, compared to $222 for controls. However, over a four-month follow-up period, there was a 9.5 percent, or about $562, per-patient reduction in total medical costs compared to controls. 

That study, involving researchers from Genomind and elsewhere and funded by the company, was smaller, but essentially asked the same questions as the latest evaluation. According to Krause, the present study — involving researchers from Harvard Medical School, Stanford University, and Healthagen, an Aetna subsidiary, and paid for by Genomind — is better designed and expands on the findings of the earlier evaluation, and is therefore generalizable to the covered populations of other payors.

However, Genecept presently is not covered by Aetna and is out of network with the majority of payors. "We're hopeful that this data will be used to convince Aetna and other payors that [Genecept] is cost effective when used appropriately," Krause said.

When it comes to PGx testing for mental health conditions, psychiatrists have not been an easy group to convince of the value of genetic information to guide treatment choice. It's common for patients on psychiatric medications to have to try different drugs and doses before they find the regimen that works for them. While patients are on the drugs that aren't helping them, they might experience more treatment-related adverse events and have to come into the doctor for more care.

Ideally, PGx testing is supposed to cut down the trial-and-error prescribing and save money by getting patients the drugs to which they're most likely to respond. While a number of studies to date have shown that PGx testing does improve outcomes and costs, even with the aid of genetic testing, choosing the right psychiatric medications and doses can be a complex endeavor.

"The universe of psychiatry in the US is divided about pharmacogenetic testing," acknowledged Krause. Based on his own interactions in the field, he believes that around a third of psychiatrists are enthusiastic about using PGx testing, a third are skeptical of such testing, and the rest have yet to be convinced.

"I think the universe is swinging toward more [psychiatrists] being convinced," he said. "But, I think it's incumbent upon us to develop the types of evidence to convince people that this is an assay that really helps people and saves lives." 

To date, doctors who order the test do so most readily for patients with mood disorders, like major depression, particularly those who have failed one or two prior therapies. Doctors also order testing for patients with generalized anxiety disorder, bipolar disorder, and attention deficit hyperactivity disorder.

To date, around 8,000 clinicians have ordered the test for more than 150,000 patients, and around 80 percent ordering the test for the first time reorder it. Test orders have been increasing in recent months, according to Genomind, and April was the company's biggest sales month on record.

According to Krause, Genomind is expecting test volume to increase by 30 percent to 35 percent over 2017, in line with growth seen in prior years. The company also provides a consultation service at no additional cost, which includes Genomind's psycho-pharmacologists answering physician's questions. Krause noted that the company has done around 4,000 consultations over the last three years and has conducted 62 percent more consultations in the first quarter of 2018 compared to the year-ago period.

He noted that test adoption is growing in step with the psychiatric community's increasing awareness of the utility of PGx testing, as well the expanding list of FDA-approved drugs with dosing modification or safety information based on genetic biomarkers.

While the present study adds to the clinical utility evidence for Genecept, the ultimate demonstration of the test's impact will come from a 370-patient randomized-controlled trial that is slated to report results later this year or early next year. Several other companies in the psychiatric PGx-testing space have already conducted RCT, with the goal of swaying payors.

Most recently, Myriad Genetics reported results from a RCT involving 1,100 patients with moderate to severe depression, which showed that individuals tested on its GeneSight PGx test were 50 percent more likely to achieve remission and 30 percent more likely to show a treatment response compared to those in the control group. Based on this data, Myriad CEO Mark Capone said the company has netted a new commercial coverage decision from an unnamed "top-20 payor in the Mid-Atlantic region." 

In case-control studies like this latest one involving Genecept, one can never entirely exclude the risk of bias, Krause said, even though the propensity matching technique, developed by Stanford's Imbens, aims to eliminate the biases as much as possible.

"A study like this study, that looked at many different dimensions of healthcare utilization would be quite difficult to conduct in the real world," he said. "Randomized-controlled trials are still the gold standard, but they're expensive, time-consuming, and costly. Some of the payors will definitely want RCTs."

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