The objective of this study was to evaluate the effect of pharmacogenetics-guided treatment on patients diagnosed with depression and/or anxiety, in a diverse set of clinical settings, as compared to the standard of care. The trial design followed a prospective, randomized, subject- and rater-blinded approach enrolling 685 patients from clinical providers specializing in Psychiatry, Internal Medicine, Obstetrics & Gynecology, and Family Medicine. The NeuroIDgenetix test uses a genetic variant panel of ten genes, along with concomitant medications, to make medication management recommendations based on gene-drug and drug-drug interactions for over 40 medications used in the treatment of depression and anxiety. Pharmacogenetic testing was performed at the initial screening visit and baseline patient assessments were determined using the 17-item Hamilton Rating Scale for Depression (HAM-D17) and the Hamilton Rating Scale for Anxiety (HAM-A). Following enrollment and randomization, pharmacogenetic results for subjects assigned to the experimental group were provided to physicians to guide treatment selection, while control subjects were treated according to the usual standard of care. HAM-D17 and HAM-A assessments were collected at 4 weeks, 8 weeks, and 12 weeks after baseline to assess the efficacy of therapeutic selection. In patients diagnosed with depression, response rates (p = 0.001; OR: 4.72 [1.93-11.52]) and remission rates (p = 0.02; OR: 3.54 [1.27-9.88]) were significantly higher in the pharmacogenetics-guided group as compared to the control group at 12 weeks. In addition, patients in the experimental group diagnosed with anxiety showed a meaningful improvement in HAM-A scores at both 8 and 12 weeks (p = 0.02 and 0.02, respectively), along with higher response rates (p = 0.04; OR: 1.76 [1.03-2.99]). From these results, we conclude that pharmacogenetic-guided medication selection significantly improves outcomes of patients diagnosed with depression or anxiety, in a variety of healthcare settings.

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Funding for this analysis was provided by AltheaDx, which is the manufacturer of the IDgenetix test. AltheaDx personnel assisted in the study design, data collection, and review of the manuscript. Maciel and Garces are employed by AltheaDx. Groessl has received funding as a consultant from American Specialty Health.

The burden of depression significantly impacts the patient, the health care system, and society, at large. Medication management guided by pharmacogenetics has been shown to increase therapeutic efficacy and improve symptoms in patients diagnosed with depression, but limited data are available on the cost savings of pharmacogenetic-guided interventions outside of psychiatric clinical specialties. Our study utilizes published health care costs and clinical patient outcome data to model the economic impact of pharmacogenetic-guided treatment for depression in a variety of clinical settings. Assuming a test cost of USD$2,000 for pharmacogenetic testing, the model predicts a savings of USD$3,962 annually per patient with pharmacogenetic-guided medication management.

ClinicalTrials.gov Identifier: NCT02411123​​.

This report shows the presence of low-risk HPVs (HPV 6 and 11) associated to malignant tumors in a frequency higher than usually observed. The data raise questions about which are the circumstances which may favor low-risk HPV related oncogenesis.

Background The response to therapeutics varies widely in patients with depression and anxiety, making selection of an optimal treatment choice challenging. IDgenetix Ò , a novel pharmacogenomic test, has been shown to improve outcomes by predicting the likelihood of response to different psychotherapeutic medications. Objective The objective of this study was to estimate the cost effectiveness of implementing a novel pharmacogenomic test (IDgenetix Ò ) to guide treatment choices in patients with depression and/or anxiety compared with treatment as usual from the US societal perspective. Methods We developed a discrete event simulation to compare clinical events, quality-adjusted life-years, and costs of the two treatment strategies. Target patients had a Hamilton Rating Scale for Depression Score C 20 and/or a Hamilton Rating Scale for Anxiety score C 18 at baseline. Remission, response, and no response were simulated based on the observed rates in the IDgenetix Ò randomized controlled trial. Quality-adjusted life-years and direct and indirect costs attributable to depression and anxiety were estimated and compared over a 3-year time horizon. We conducted extensive deterministic and probabilistic sensitivity analyses to assess the robustness of the results. Results The model predicted cumulative remission rates of 78 and 66% in IDgenetix Ò and treatment as usual groups, respectively. Estimated discounted quality-adjusted lifeyears were 2.09 and 1.94 per patient for IDgenetix Ò and treatment as usual, respectively, which resulted in 0.15 incremental quality-adjusted life-years (95% credible interval 0.04-0.28). The total costs after accounting for a US$2000 test cost were US$14,124 for IDgenetix Ò compared with US$14,659 for treatment as usual, suggesting a US$535 (95% credible interval -2902 to 1692) cost saving per patient in the IDgenetix Ò group. Incremental quality-adjusted life-year gain (0.49) and cost savings (US$6800) were substantially larger in patients with severe depression (Hamilton Rating Scale for Depression score C 25). Conclusion Using the IDgenetix Ò test to guide the treatment of patients with depression and anxiety may be a dominant strategy, as it improves quality-adjusted lifeyears and decreases overall costs over a 3-year time horizon.Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40273-017-0587-0) contains supplementary material, which is available to authorized users.

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