A field of study that looks at how a person's genotype may affect their response to a drug. The GeneSight Psychotropic test uses a patient's unique genetic profile to guide doctors in choosing medications. At 6 weeks, Winner et al29 saw similarly greater improvement on the HAMD-17 score in the guided group (35.4% improvement vs. 18.5% improvement in the unguided group, P = .04). Based on very low quality evidence (Table 10), the findings were inconsistent as to whether GeneSight-guided care improved therapeutic decisions compared with usual care (Table 9). How does this work? insurance companies cover this type of testing. For example, if testing indicates that your body metabolizes a drug too slowly, the drug might build up in your body and increase the likelihood of side effects. GeneSight Analgesic GeneSight ADHD SureGene Test Pain Medication DNA Insights . The authors also observed a difference among patients in the unguided care group who were prescribed red-bin medications compared with those who received yellow- or green-bin medications. Table 6 summarizes the effect on measures of depression among patients who received guided care compared with those who did not (at end-of-study follow-up). A dozen studies focusing on patients with depressive disorders have reported outcomes from using commercially available gene test panels to guide antidepressant choice. The authors asked clinicians to rate their level of satisfaction, and to estimate their patients' level of satisfaction (Table 12). FOIA A large proportion of the Ontario population lives with a diagnosed mental illness. However, it is uncertain whether guided treatment using GeneSight is effective compared with unguided treatment (usual care). official website and that any information you provide is encrypted that determine how quickly a drug is processed, or metabolized, in your body or How many average folks know what is a gene variant, an extensive metabolizer, or a receptor? Primary outcomes of interest were prevention of suicide, remission of depression symptoms, response to depression therapy, depression score, and quality of life. On the other hand, if testing suggests that the drug would leave your body quickly, it may not have a chance to work properly or would require a dose that is larger than normal. Patients with depressive symptoms who had the GeneSight test to help guide the choice of their medication responded better to treatment and their mood improved compared with patients who did not have the test. Health Reports. Analysts and patients were blinded to their treatment group allocation, Psychiatric patients diagnosed with anxiety, depressive disorders, bipolar disorders, or other psychotic disorders, and prescribed one of the 26 antidepressant or antipsychotic medications covered by GeneSight at the time. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Of these, six were pharmacokineticmembers of the cytochrome P450 family of liver enzymes, which play an important role in overall drug metabolism. The answer is, "Not many." Is it important? It is ordered and reviewed by physicians but may be more expensive than whole genome sequencing. A new test called "GeneSight" developed by the company Assurex assesses an individual's genetic profile to determine how a particular antidepressant may affect their metabolic processing as well as response to FDA-approved drugs utilized to treat depression. HHS Vulnerability Disclosure, Help You and your doctor can. (3980795), limit 64 to english language [Limit not valid in CDSR,DARE; records were retained] (3106), We are very confident that the true prognosis (probability of future events) lies close to that of the estimate, We are moderately confident that the true prognosis (probability of future events) is likely to be close to the estimate, but there is a possibility that it is substantially different, Our confidence in the estimate is limited: the true prognosis (probability of future events) may be substantially different from the estimate, We have very little confidence in the estimate: the true prognosis (probability of future events) is likely to be substantially different from the estimate. In Ontario, there is no standard method for pharmacogenomic testing at present. Listing of a code in this policy does not imply that the service described by the code is a covered or non -covered health service. Total remission is the primary goal when treating patients with depression, as advised by the experts consulted for this review. In these studies, too, the tests failed to show value on their key measures of efficacy. In the spring of 2016, we solicited expert consultation on the appropriate use of pharmacogenomic testing to support psychotropic medication selection. And the few genes used in the current commercial test panels do not appear to be the key genes determining risk or response. Winner JG, Carhart JM, Altar CA, Allen JD, Dechairo BM. The https:// ensures that you are connecting to the Health Alerts from Harvard Medical School. Results for Differences Across Patient Phenotypes Identified With Single Genotyping vs. Combinatorial Genomic Testing (GeneSight)a, Databases searched: All Ovid MEDLINE, Embase, PsycINFO, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, CRD Health Technology Assessment Database, Cochrane Central Register of Controlled Trials, and NHS Economic Evaluation Database, Database: EBM Reviews - Cochrane Central Register of Controlled Trials , EBM Reviews - Cochrane Database of Systematic Reviews <2005 to February 19, 2016>, EBM Reviews - Database of Abstracts of Reviews of Effects <1st Quarter 2016>, EBM Reviews - Health Technology Assessment <1st Quarter 2016>, EBM Reviews - NHS Economic Evaluation Database <1st Quarter 2016>, Embase <1980 to 2016 Week 08>, All Ovid MEDLINE(R) <1946 to Present>, PsycINFO <1967 to February Week 2 2016>, Our first consideration was study design; we started with the assumption that randomized controlled trials are high quality, whereas observational studies are low quality. the contents by NLM or the National Institutes of Health. So the choice in drug is pushed to pathways where the patient would have normal metabolism. We used a fixed-effects model where there was low between-study heterogeneity based on the interventions and populations described, an I2 30%, or both.25 Where fixed-effects models were inappropriate, we applied a random-effects model. Three depression scores were used across the included studies. While the drug still may be useful for you, lower doses may be appropriate. Where pooling of data was not appropriate after considering study design, inclusion criteria, and other sources of heterogeneity between individual studies, we summarized data narratively in evidence tables. Each medication has its own evidence profile, but the quality of the evidence supporting green-, yellow-, or red-bin classifications in GeneSight is not clear in the current version of the GeneSight report as clinicians would not know the strength of the evidence behind what moves a medication from green bin- to another status. Psychotherapy alone or in combination with antidepressant medication. Abbreviations: HAMD-17, 17-item Hamilton Rating Scale for Depression; QIDS-C16, 16-item Quick Inventory of Depressive Symptomatology, clinician rating. Advertisements Medicare typically covers genetic tests only when a beneficiary has signs or symptoms that can be further clarified by diagnostic testing. change the doses or types of medications based on guideline recommendations, or seek a consultation with an expert. One study by the manufacturers found that non-psychiatrist primary care physicians followed the recommendations of GeneSight more closely than psychiatrists, but this study did not demonstrate whether this difference had an impact on patient outcomes, so it did not meet the inclusion criteria for this review.30 Similarly, GeneSight has been proposed for use in patients with mood disorders, anxiety, or schizophrenia, but the three studies that reported results for our primary outcomes of interest limited their populations to patients with major depressive disorder, excluding patients with anxiety alone without depression, patients with bipolar disorder, or schizophrenia. Genes determine some of our risk for depression and some of our response to treatment. Our intent at Health Quality Ontario is to continuously improve the quality of health care in this province regardless of who you are or where you live. Using a pharmacogenomic algorithm to guide the treatment of depression. Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for the management of major depressive disorder in adults III. testing known as pharmacogenomics looks for changes or variations in genes We obtained the full texts of these articles for further assessment. Genomind is a prescription genetic testing company for mental health treatment that usually must be ordered through a physician. Does Medicare cover pharmacogenetic testing 2021? After removing duplicates, we reviewed titles and abstracts to identify potentially relevant articles. In the meantime, there are many good and effective actions to take if treatment is not working well. Table 2 summarizes the study designs and conclusions of the included studies. Taken together, these factors limit the generalizability of the body of evidence. By the end of the studies, most patients were taking green-bin or yellow-bin medications, and few were taking red-bin medications. Ultra (or fast) metabolizers are less likely to experience side effects that lead to discontinuing the medication, but they may need a higher dosage to achieve a noticeable benefit.6, Genome-wide association studies have attributed as much as 42% of the variation in response to antidepressants to individual genetic differences, and other studies have demonstrated correlations with ethnicity and ancestral variations.1012 It is believed that prescribing clinicians who know a patient's genetic predisposition could better target therapies, reduce the risk of adverse effects, and minimize the use of the health care system, services, and costs.13, More and more medications include pharmacogenomic biomarker information in their product labelling.14 The most common information related to psychotropic medications is a warning about dosage for poor metabolizers known to be associated with the CYP2D6 and CYP2C19 enzymes; for example, patients classified as poor metabolizers for CYP2C19 should receive a starting dose of citalopram at 60% of the dose for a typical metabolizer.14, As research in this area continues to evolve, the evidence is improving around some single genes to predict how effective a drug will be for an individual. Against this background, experts with no financial interest in genetic testing have repeatedly recommended that genetic tests should not be used in choosing treatments for depression (see here and here). What do experts say about using gene tests to determine treatment for depression? The .gov means its official. Patients were then followed for 1 year using administrative data, Differences between rates of medication discontinuation before and after the start of study, Mean time to discontinuation of the initial medication from the start of study, Difference in mean number of medications per patient at the end of the study compared with the beginning, Mean number of psychiatric medications per patient at end of study, Increase in average number of medications taken from baseline to end of follow-up, Proportion of patients taking a green-bin medication at end of study, Proportion of patients taking a yellow-bin medication at end of study, Proportion of patients taking a red-bin medication at end of study, Absolute increase in percentage points of the proportion of patients taking a green-bin medication compared with baseline, Proportion of patients taking a red-bin medication who changed their medication by end of study, Proportion of patients taking a red-bin medication at baseline, Change in proportion of patients taking a green-bin medication from start of study to end of study, Change in proportion of patients taking a yellow-bin medication from start of study to end of study, Change in proportion of patients taking a red-bin medication from start of study to end of study, Physician perception of patient satisfaction; proportion rated as having very high perceived satisfaction, Physician confidence in choice of medication, Depression below a predefined threshold: HAMD-17 <8, QIDS-C16 <5 or PHQ-9 <5, At least 50% reduction in depression scores based on HAMD-17, QIDS-C16, or PHQ-9, % reduction in score (improvement in depression) HAMD-17, Inconsistent measurement outcome resulted in either no significant difference or observed difference in favour of guided therapy, Grading of Recommendations Assessment, Development, and Evaluation, 17-item Hamilton Rating Scale for Depression, Population, intervention, comparison, outcome and time, Pharmaceutical and Medical Devices Agency, Japan, 16-item Quick Inventory of Depression Symptomatology, clinician rating. Currently, there is no scientific evidence that gene tests are needed or would be helpful as part of those assessments. Baltimore, (MD): Centers Medicare Services [updated 2015 Aug; cited 2016 Jun 1]. Overall, these findings were based on evidence of low to very low quality and because of this, the effect of the GeneSight test on patient outcomes is uncertain. As a service to our readers, Harvard Health Publishing provides access to our library of archived content. According to guidelines from the Centers for Medicare & Medicaid Services, GeneSight may be ordered only by psychiatrists for patients diagnosed with major depressive disorder whose symptoms are refractory after at least one prior neuropsychiatric medication and who continue to experience moderate to severe depression as defined by the Hamilton Rating Scale for Depression.22. The site is secure. 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