Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/ Case Summary:  The enrollee requested reimbursement for a gene test. She has a history of bipolar depression and has experienced panic attacks, anxiety and episodes of mania. She has been treated with lithium, BuSpar, Seroquel and Abilify, but she experienced side effects and anxiety despite the medications. Her provider ordered genetic testing in order to determine the correct medication and dosage for the enrollees condition. The enrollee reports that since the testing and medication adjustments she feels she has achieved long-term stabilization of her condition. Pharmacogenetic testing, also called pharmacogenomics, or pharmacogenetics, was developed to evaluate a persons potential response to drug therapy based on their genetic makeup. It is sometimes recommended for those who appear to be refractory to their drug regimen. According to current literature, pharmacogenetic testing is not standard of care, as the goal of individualized therapy based upon pharmacogenetic testing has yet to be realized. Despite the promise of a growing body of research relating to pharmacogenetics and its impact on drug response, the literature indicates the use of these tests is not widespread. The current literature at this time does not support the specific testing provided to this enrollee has been proven to be beneficial. Researchers reviewed a clinical study assessing the efficacy of pharmacogenomic testing for major depressive disorder. The studies were non-randomized and open-label. While the studies showed promise for the clinical utility of pharmacogenomic testing, improved health outcomes have not yet been demonstrated or supported with replicated evidence. Researchers note the evidence supporting the use of these panels has significant limitations. Many of the commonly analyzed genetic variants do not demonstrate independent associations with treatment response or clinical outcome across multiple, large studies. Research is lacking comparing clinical outcomes between enrollees who are treated based on pharmacogenomic evidence and those treated by standard trial-and-error approaches. Current studies are small, limited by design and analysis flaws, funded by industry, and have yet to be replicated. A safety communication warning against the use of many pharmacogenomic tests was published indicating the link between DNA variations and antidepressant efficacy has never been established. The organization further notes that changes to medication regimens should not be initiated based on results from genetic testing procedures. The organization notes such changes to medications could lead to serious health consequences.Final Result: Three of the three reviewers determined that the requested services are not likely to have been more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in psychiatry and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.