Medicare For The First Time To Cover Combinatorial Genetic Testing To Guide Individualized Selection Of Depression Medications

MASON, Ohio, Oct. 30, 2014 /PRNewswire/ -- The promise of genetic testing to guide more effective treatment for millions of older and disabled Americans suffering from depression has shifted from a futuristic vision to a practical reality.

Assurex Health today announced that Medicare has issued a Local Coverage Determination (LCD) that will provide coverage for GeneSight® Psychotropic, the first combinatorial pharmacogenomic test to help guide medication decisions for depression.  Prior to GeneSight, no psychiatric pharmacogenomic test has achieved a favorable coverage decision from Medicare. There is no out-of-pocket cost to Medicare Part B patients.  

"Medicare's decision is a milestone in helping improve the care of the millions of older Americans and others with depression," said Assurex Health CEO Virginia C. Drosos. "Healthcare providers now have a simpler, faster way to help ensure their patients are prescribed the right medication sooner, so they can get better faster and begin to reclaim their lives."

Medicare is a federal program that provides health insurance to more than 52 million Americans, age 65 and older and those with disabilities.  According to the Geriatric Mental Health Foundation, nearly 15 percent of those older than 65, and almost half of nursing home residents have depression.  

"This is an important step forward for personalized medicine and a forward-looking appraisal by Medicare with regard to better diagnosis and treatment planning for mental health conditions," according to Bruce Quinn, M.D., Ph.D., a national expert on Medicare policy and former medical director for the California Part B program. Quinn is senior health policy advisor at FoleyHoag LLP.

GeneSight Psychotropic is a clinically proven test based on combinatorial pharmacogenomics (CPGx™) --the study of how variations in multiple genes influence an individual's response to medications -- as well as evidence-based medicine and clinical pharmacology. 

"This positive coverage decision validates the proven clinical benefit of the GeneSight Psychotropic assay for Medicare patients.  We also believe that a more consistent and transparent approach to reimbursement will help to further drive innovation in the rapidly growing molecular diagnostics field," Drosos said.

Seniors May Have Unique Risks
More than 90 percent of individuals aged 65 years or older take one or more medications per week, and more than 40 percent used five or more different medications per week.[i]  Additionally, seniors are at greater risk of experiencing medication adverse effects compared to younger populations.[ii] 

"GeneSight has made an enormous difference for many patients, helping free them of depression and anxiety for the first time in years," said Allan A. Anderson, M.D., a specialist in geriatric psychiatry and past President of the American Association of Geriatric Psychiatry.  "In my experience, mood disorders in the older patient are more difficult to treat with inappropriate treatment leading to more emergency department visits and more psychiatric hospitalizations. It is a relief to my patients and their families to know that a medication decision is more likely to be the right one, right away."

GeneSight Lowers Health Care Costs, Improves Response
Multiple peer-reviewed clinical studies have demonstrated both the efficacy and utility of GeneSight. Compared with the current standard of care, patients whose treatment was guided by GeneSight experienced a 70 percent greater improvement in depressive symptoms.[iii] In addition, patients with depression whose treatment was guided by GeneSight experienced double the likelihood of remission and double the odds of response compared with treatment as usual.[iv,v] Studies have shown incorporating GeneSight when evaluating medication decisions for patients with depression can reduce annual health care costs per patient by over $2,500, potentially resulting in millions of dollars in taxpayer savings.[vi]

Based upon each patient's unique genetics, the GeneSight Psychotropic test report places FDA-approved medications for depression and other mental health conditions into three color-coded categories: "Use as Directed" in green, "Use with Caution" in yellow, or "Use with Increased Caution and with More Frequent Monitoring" in red. The report alerts healthcare providers to the implications of the genetic information as it relates to dosage, pharmacology, and FDA-approved package insert information.  

Growing Acceptance of GeneSight 
Medicare's coverage of the GeneSight Psychotropic test points to its growing acceptance by insurers, and follows a recent announcement by the U.S. Department of Veterans Affairs (VA), America's largest integrated health care system with more than 1,400 sites of care, serving almost nine million veterans each year.

"Prescribing a medication regimen that is more likely to succeed because it is tailored to an individual patient's genetic profile can help healthcare providers better manage each patient's disorder and improve clinical outcomes," said Bryan M. Dechairo, Ph.D., Senior Vice President, Medical Affairs & Clinical Development at Assurex Health. "Now aging and disabled Americans - in addition to veterans and many patients already covered by commercial insurance plans - can benefit from tailored precision medical care for mental health."

About Assurex Health 
Assurex Health is a personalized medicine company providing industry-leading treatment decision support to clinicians for behavioral health conditions. Assurex Health's proprietary technology is based on combinatorial pharmacogenomics (CPGx ^TM) – the study of the genetic factors that influence an individual's response to medications – as well as evidence-based medicine and clinical pharmacology.  Assurex Health has licensed patented technology from Mayo Clinic and Cincinnati Children's Hospital Medical Center who remain technology contributors. For more information, visit www.assurexhealth.com.

About GeneSight
GeneSight helps health care providers make more precise treatment decisions based on how a patient's unique genetic makeup affects their individual response to 38 FDA-approved medications for depression, posttraumatic stress disorder (PTSD), bipolar disorder, schizophrenia and/or other mental health conditions.  GeneSight is the only neuropsychiatric combinatorial pharmacogenomic test validated in multiple, peer-reviewed, published clinical studies. GeneSight analyzes over 785,000 permutations of an individual's genes and available medications, and presents the results in an easy to read, actionable color-coded report available 36 hours after Assurex Health receives a patient's cheek swab. Many commercial and government insurance plans, including Medicare and the U.S. Department of Veterans Affairs, reimburse all or part of the cost of GeneSight. Assurex Health also offers financial assistance programs for patients who qualify.  Learn more at www.genesight.com.

[i] Gurwitz JH, et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003 Mar;289(9):1107-16. [PMID: 12622580].

[ii] Beers MH, et al. Explicit criteria for determining potentially inappropriate medication use by the elderly: an update. Arch Intern Med. 1997 July;157:1531-36. [PMID: 9236554].

[iii]  Hall-Flavin DK, et al. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenet Genomics. 2013 Oct;23(10):535-48. [PMID: 24018772].

[iv]  Hall-Flavin DK, et al. Using a pharmacogenomic algorithm to guide the treatment of depression. Transl Psychiatry. 2012 Oct 16;2:e172. [PMID: 23047243].

[v] Winner JG, et al. A prospective, randomized double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder. Discov Med. 2013 Nov;16(89):219-27. [PMID: 24229738].

[vi] Winner JG, et al. Psychiatric pharmacogenomics predicts health resource utilization of outpatients with anxiety and depression. Transl Psychiatry. 2013 Mar 19;3:e242. [PMID: 23511609].

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