Cost-Effectiveness of Access Expansion to Treatment of Hepatitis C Virus Infection Through Primary Care Providers.

BACKGROUND & AIMS: Chronic hepatitis C virus (HCV) infection is a major burden on individuals and health care systems. The Extension for Community Healthcare Outcomes (Project ECHO) enables primary care providers to deliver best-practice care for complex conditions to underserved populations. The US Congress passed the ECHO Act in late 2016, requiring the Department of Health and Human Services to investigate the model. We performed a cost-effectiveness analysis to assess diagnosis and treatment of HCV infection in a primary care patient panel with and without the implementation of Project ECHO. METHODS: We used Markov models to simulate disease progression, quality of life, and life expectancy among individuals with HCV infection and for the general population. Data from the University of New Mexico's ECHO operation for HCV show an increase in treatment rates. Corresponding increases in survival, quality-adjusted life years (QALYs), costs, and resulting budget impact between ECHO and non-ECHO patients with HCV were then compared. RESULTS: Project ECHO increased costs and QALYs. The incremental cost-effectiveness ratio of ECHO was $10,351 per QALY compared with the status quo; >99.9% of iterations fell below the willingness-to-pay threshold of $100,000 per QALY. We were unable to confirm whether the increase in rates of treatment associated with Project ECHO were due to increased or more targeted screening, higher adherence, or access to treatment. Our sensitivity analyses show that the results are largely independent of the cause. Budget impact analysis shows payers would have to invest an additional $339.54 million over a 5-year period to increase treatment by 4446 patients, per 1 million covered lives. CONCLUSION: Using a simulated primary care patient panel, we showed that Project ECHO is a cost-effective way to find and treat patients with HCV infection at scale using existing primary care providers. This approach could substantially reduce the burden of chronic HCV infection in the United States, but high budgetary costs suggest that incremental rollout of ECHO may be best.

Multicenter Feasibility Study of Tumor Molecular Profiling to Inform Therapeutic Decisions in Advanced Pediatric Solid Tumors: The Individualized Cancer Therapy (iCat) Study.

IMPORTANCE: Pediatric cancers represent a unique case with respect to cancer genomics and precision medicine, as the mutation frequency is low, and targeted therapies are less available. Consequently, it is unknown whether clinical sequencing can be of benefit. OBJECTIVE: To assess the feasibility of identifying actionable alterations and making individualized cancer therapy (iCat) recommendations in pediatric patients with extracranial solid tumors. DESIGN, SETTING, AND PARTICIPANTS: Clinical sequencing study at 4 academic medical centers enrolling patients between September 5, 2012, and November 19, 2013, with 1 year of clinical follow-up. Participants were 30 years or younger with high-risk, recurrent, or refractory extracranial solid tumors. The data analysis was performed October 28, 2014. INTERVENTIONS: Tumor profiling performed on archived clinically acquired specimens consisted of mutation detection by a Sequenom assay or targeted next-generation sequencing and copy number assessment by array comparative genomic hybridization. Results were reviewed by a multidisciplinary expert panel, and iCat recommendations were made if an actionable alteration was present, and an appropriate drug was available. MAIN OUTCOMES AND MEASURES: Feasibility was assessed using a 2-stage design based on the proportion of patients with recommendations. RESULTS: Of 100 participants (60 male; median [range] age, 13.4 [0.8-29.8] years), profiling was technically successful in 89 (89% [95% CI, 83%-95%]). Median (range) follow-up was 6.8 (2.0-23.6) months. Overall, 31 (31% [95% CI, 23%-41%]) patients received an iCat recommendation and 3 received matched therapy. The most common actionable alterations leading to an iCat recommendation were cancer-associated signaling pathway gene mutations (n = 10) and copy number alterations in MYC/MYCN (n = 6) and cell cycle genes (n = 11). Additional alterations with implications for clinical care but not resulting in iCat recommendations were identified, including mutations indicating the possible presence of a cancer predisposition syndrome and translocations suggesting a change in diagnosis. In total, 43 (43% [95% CI, 33%-53%]) participants had results with potential clinical significance. CONCLUSIONS AND RELEVANCE: A multi-institution clinical genomics study in pediatric oncology is feasible and a substantial proportion of relapsed or refractory pediatric solid tumors have actionable alterations. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01853345.

Primary care, depression, and anxiety: exploring somatic and emotional predictors of mental health status in adolescents.

INTRODUCTION: A growing body of research points to regular, comprehensive mental health screening in primary care practices as an effective tool, but a thorough and efficient approach is not yet widely used. The purpose of this report is to describe the pattern of mental health-related concerns, protective and social risk factors reported by adolescents during routine well-child visits in primary care settings, and their occurrence among teens that screen positive for either depression or anxiety with brief validated measures. METHODS: A personal digital assistant-based questionnaire was administered as part of clinical care to adolescents 11 to 18 years old (N = 2184) attending preventive well-child visits in 13 pediatric and family medicine primary care practices in a northern New England practice-based research network over 18 months (2008 to 2009). Depressive and anxiety-related symptoms were assessed using the 2-question versions of the Patient Health Questionnaire and Generalized Anxiety Disorder scale, respectively. Analyses determined the role that the protective and social risk factors played in determining who screens positive for depression and anxiety. RESULTS: In the fully adjusted model, risk factors that were significant (P < .05) predictors for a positive screen of depression included substance use (adjusted odds ratio [AOR], 2.05); stress (AOR, 3.59); anger (AOR, 1.94); and worries about family alcohol and drug use (AOR, 2.69). Among protective factors, that is, those that reduce the risk of depression, age (AOR, 0.87 for younger patients); having parents who listen (AOR, 0.34); and having more assets (AOR, 0.65) were significant. Significant predictors of screening positive for anxiety included substance use (AOR, 1.97); stress (AOR, 6.10); anger (AOR, 2.31); trouble sleeping (AOR, 1.75), and the sex of the adolescent (AOR, 1.87 for girls). Although having parents who listen was still a significant protective factor for anxiety (AOR, 2.26), other assets were not significant. CONCLUSIONS: Comprehensive primary care mental health screening that considers both anxiety and depression while including strength-based and psychosocial support questions is a helpful adjunct to clinical practices and has been done routinely by using an electronic tool at the point of care. Because certain common somatic and emotional concerns can precede depression and anxiety, routine screening for these issues along with depression and anxiety screening is suggested.