A Randomized Controlled Trial Driving Clinical Utility for the Treatment of Depression and Anxiety
Enhanced Therapeutic Efficacy
Source: Bradley, et al. https://www.ncbi.nlm.nih.gov/pubmed/28992526
Study Design Intro:
This 12-week study evaluated if pharmacogenetics can help guide therapeutic decisions for patients diagnosed with depression and/or anxiety disorders and improve patient outcomes by maximizing drug efficacy.
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. Study participants were randomized by disease and severity and allocated in 1:1 ratio to the experimental (PGx guided) or the control group (standard of care).
Patient assessments were determined using the HAM-D17 and HAM-A rating scales.
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]).
Cost-effectiveness of PGx Test to Guide Treatment for Major Depressive Disorder
A Markov state-transitions probability model was built to analyze the cost-effectiveness of IDgenetix® testing v. standard of care for MDD patients in general practice and psychiatric care settings. This analysis included moderate to severe MDD patients who were new to treatment and who were failing treatment.Read More
The primary advantage of pharmacogenetic testing is to find an effective treatment sooner, therefore reducing potential side effects, potential suicides, increasing the quality of life (QOL), and reducing medical costs.
This analysis model found that the total cost over three years was less for moderate to severe MDD patients whose clinicians had received IDgenetix testing compared to those who received standard of care ($44,697 v $47,295, respectively)View Source
Estimating Cost Savings of Pharmacogenetic Testing for Depression in Real-World
This study utilizes published health care costs and clinical patient outcome data to model economic impact of pharmacogenetic-guided treatment for depression in a variety of clinical settings.Read More
The cost data was generated using the data from Bradley et al in an analysis model published by Greenberg et al in 2015, which is a comprehensive overall cost of depression and the additional economic burdens MDD patients deal in addition to their MDD diagnosis (i.e. costs of non-depression mental health, costs of non-mental health medical services, costs of medical services and prescriptions (depression and non-depression services and prescriptions), costs of missed productivity)
Our model showed a potential annual cost savings of USD$3,962 per patient tested with NeuroIDgenetix®.View Source
Economic Evaluation of Implementing a Novel Pharmacogenomics Test (IDgenetix®) to Guide Treatment of Patients with Depression
The purpose of this study was to estimate the cost effectiveness of IDgenetix-guided treatment choices in patients with depression and/or anxiety compared to patients treated with standard of care (SOC).Read More
The purpose of this study was to estimate the cost effectiveness of IDgenetix-guided treatment choices in patients with depression and/or anxiety compared to patients treated with standard of care (SOC).
A discrete event simulation was created to compare clinical events, quality-adjusted life-years, and costs of the two treatment strategies in patients with moderate to severe depression and/or anxiety. Data for this model came from Bradley et al clinical study.
The results from this simulation predicted IDgenetix-treated patients would experience a cumulative remission rate of 78% compared to 66% in SOC patients, an estimated discounted quality-adjusted life-years of 2.09 (IDgenetix-treated) and 1.94 (SOC) per patient, and an estimated USD$535 cost savings per IDgenetix-treated patient (USD$14,124 total costs for IDgenetix-treated patients v USD$14,659 for SOC patients).View Source
CYP2D6 Copy Number Distribution in
the US Population
The cytochrome P450 superfamily of genes is well understood for their role in drug metabolism, with CYP2D6 being the most extensively studied. Although many CYP2D6 variants have been identified that contribute to variability in enzymatic function, the gene is also known to have stably inherited gene deletion and duplication events. In this report, we provide CYP2D6 copy number variation (CNV) data on the single most comprehensive US population data set reported to date.Read More
In a set of over 30,000 deidentified clinical samples, 12.6% had a CNV of the CYP2D6 gene.
The distribution of ethnicity among the self-reported samples closely mirrors the results of the 2010 US census, suggesting the CYP2D6 CNV frequency data obtained in this study is reflective of the relative diversity of the US population.
African Americans showed a significantly reduced frequency of the expected 2 copies of CYP2D6 (p < 0.01).
22% of African Americans were shown to possess more or less than two copies of CYP2D6 as compared to only 11-13% of other ethnicities (p<0.01).
Approximately 70% of patients with zero copies of CYP2D6 are on at least one drug metabolized by that gene.
The combined prevalence of CYP2D6 CNVs, along with their relative contributions to deleterious PM and UM phenotypes, underscores the importance of determining CYP2D6 CNV in the clinical practice of pharmacogenomics.
Beoris M, Amos Wilson J, Garces JA, and Lukowiak AA. CYP2D6 copy number distribution in the US population. Pharmacogenetics and Genomics. 2016; 26(2): 96-99.View Source
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