Originally published June 27.
NEW YORK (GenomeWeb) – Doctors for the US Department of Veterans Affairs can now order Assurex Health's GeneSight Psychotropic test to help them make more personalized treatment decisions for patients with depression, post-traumatic stress disorder, schizophrenia, and other mental health conditions.
However, ordering physicians will have to show "medical necessity" to order the test and have it be reimbursed by the VA, which means that the patient will have to fit the VA's criteria showing that he or she isn't responding well to prescribed treatments and needs additional guidance with pharmacogenetic testing.
Assurex earlier this week announced that the VA has approved a Federal Supply Schedule contract that will allow the firm to provide its GeneSight Psychotropic test to doctors nationwide immediately through June 2019.
"While the VA has made great strides in the way it treats invisible wounds of war, the steady persistence of this problem demonstrates the need for more action,” said Senator Rob Portman (R-Ohio) said in a recent statement lauding the contract providing access to GeneSight for veterans. "Our brave men and women who have served in uniform deserve a comprehensive and effective approach to mental health in civilian life, and this is a positive step in the right direction."
Separately, the contract with the VA comes as the Centers for Medicare & Medicaid Services issued a draft local coverage determination (LCD) for GeneSight under its MolDx program for patients with refractory depression (see related story, in this issue). The move suggests growing acceptance of genetic testing for personalizing treatments for mental health conditions.
GeneSight Psychotropic analyzes genes that have been shown in studies to affect a person's response to antidepressant and antipsychotic treatments. The test gauges a panel of pharmacokinetic genes from the CYP450 family and pharmacodynamic genes implicated in the serotonin system.
Assurex has now proven the clinical validity and utility of its test in multiple studies. One study published last year by Hall-Flavin et al. in Pharmacogenetics and Genomics reported that patients with major depression whose treatment choices were informed by GeneSight results had higher response rates and remission rates compared to the group who had treatments given based on standard methods.
A RAND Center for Military Health Policy Research study reported in 2008 found that at least 20 percent of Iraq and Afghanistan vets have PTSD or depression or both. The same study estimated that a PTSD-stricken veteran's care costs 3.5 times more than a veteran without the disorder. Treating one PTSD patient can cost more than $8,000 per year.
Meanwhile, outside of the VA, caring for patients with depression, particularly those who have become unresponsive to certain types of drugs, can add between $106 billion and $118 billion in costs due to increasing healthcare utilization, increasing crime, and decreasing work place productivity. Assurex has conducted analyses to gauge whether GeneSight, by guiding more precise decisions about therapy, can help trim the cost of caring for veterans with mental health conditions. The company estimates that genetically-guided treatment decisions could reduce health care costs by 38 percent.
"All clinicians treating vets with depression, PTSD, or other mental illnesses can now order GeneSight to help them select a genetically concordant medication for their patient which is more likely to reduce symptoms and less likely to cause side effects," Gina Drosos, Assurex president, told PGx Reporter. Drosos also explained that the testing would especially be appropriate for vets who are not responding well to their medication or have suffered side effects that made them less likely to adhere to their prescription regimen.
The VA did not respond to an interview request ahead of press time to discuss its criteria for "medical necessity" for GeneSight.
However, CMS' draft LCD criteria provide some insights into the context in which payors are willing to cover the test. "This LCD provides limited coverage for the GeneSight Psychotropic gene panel," CMS states. "GeneSight testing may only be ordered by licensed psychiatrists contemplating an alteration in neuropsychiatric medication for patients diagnosed with major depressive disorder (in accordance with DSM IV/V criteria) who are suffering with refractory moderate to severe depression (as defined by the 17-item Hamilton Rating Scale for Depression (HAM-D17) score of 14 or greater) after at least one prior neuropsychiatric medication failure."
While the draft LCD from CMS presents a significant opportunity for Assurex's business, the reimbursement environment for the molecular diagnostics industry has been challenging in recent years. Payors, including those in the government, focused on reducing healthcare spending, have made moves recently to cut payment for lab tests. For example, Tricare, the healthcare program of the Defense Health Agency that provides benefits to military personnel, their families, and retirees, stopped reimbursing for more than 100 lab-developed tests last January. The DHA recently launched a demonstration project under which the DoD will evaluate lab tests for coverage.
That DHA demonstration project will not impact access to the GeneSight test offered to military veterans through the FSS contract, Assurex said.
The VA's integrated healthcare system, fitted with electronic medical records and the ability to longitudinally follow patients, should be ideally suited for genomics research and, ultimately, for implementation of personalized medicine and genetic testing. In 2011, the VA launched a project to study the genetic underpinnings of various illnesses in a million veterans. As of late last year, the project had enrolled 200,000 people and the VA has inked deals with genetic testing firms to genotype 100,000 veterans and sequence the exomes of a smaller cohort.
However, the study data from MVP and the results of genetic tests applied to the day-to-day care of veterans are stored in two different systems. Information from veterans' medical care is stored in an EMR system, called VistA, which links 152 hospitals and around 1,000 outpatient clinics that provide veterans care. Through this system, veterans can access parts of their record and provide information on their medical and family history through a secure portal, called My HealtheVet.
However, based on the experience of one researcher, the VistA system is capable of storing only some types of genetic testing data. Last year, Gholson Lyon from Cold Spring Harbor Laboratory's Stanley Institute for Cognitive Genomics described in the open access journal PeerJ how, after whole-genome sequencing a 37-year old veteran with obsessive compulsive disorder, he and his colleagues identified a number of genetic variants implicated with mental illness in the literature.
Although Lyon and his team informed the patient of the key genetic findings from their research, VA officials were unable to incorporate this information into the patient's VistA EMR record. "We hope to eventually incorporate his genetic data into his electronic health record if and when the VistA health information system is upgraded to allow entry of such data," the study authors wrote in the published paper.
When veterans receive the GeneSight test, doctors will learn the genetic markers their patients harbor that will make them more likely to respond well to certain psychotropic drugs or place them at risk of experiencing ill-effects when certain combinations of therapies are prescribed. This information will be critical to store in patients' EMRs for it to be useful in their care, particularly in emergency situations.
"We are working with the VA to provide this information directly into their EMR system so it is available to all clinicians who are treating them," Drosos said. "We have that capability but haven’t yet worked through all of the details with the VA. However, discussions between us to address this need have already begun."
In launching the test in the VA system, Assurex is putting resources behind educating doctors about the availability of GeneSight. The company has a GeneSight field team who will raise awareness of the test among VA providers. Assurex's medical science liaisons and experts will provide education and clinical support, while a customer service team will help physicians' office staff implement test protocols. Assurex is also reaching out to doctors through webinars and direct mail, and working with support groups and blogs to spread the word about GeneSight to veterans and their families.
The Veterans Health Administration operates 1,400 care sites and serves 9 million veterans each year. The contract for GeneSight was awarded by the VA, but doctors serving other federal agencies, such as the Department of Defense, Bureau of Indian Affairs, and Bureau of Prisons will also have access to the test.