Jason T. Hurwitz

Is Real-World Evidence Used in P&T Monographs and Therapeutic Class Reviews?

BACKGROUND Payers are faced with making coverage and reimbursement decisions based on the best available evidence. Often these decisions apply to patient populations, provider networks, and care settings not typically studied in clinical trials. Treatment effectiveness evidence is increasingly available from electronic health records, registries, and administrative claims. However, little is known about when and what types of real-world evidence (RWE) studies inform pharmacy and therapeutic (P&T) committee decisions. OBJECTIVE To evaluate evidence sources cited in P&T committee monographs and therapeutic class reviews and assess the design features and quality of cited RWE studies. METHODS A convenience sample of representatives from pharmacy benefit management, health system, and health plan organizations provided recent P&T monographs and therapeutic class reviews (or references from such documents). Two investigators examined and grouped references into major categories (published studies, unpublished studies, and other/unknown) and multiple subcategories (e.g., product label, clinical trials, RWE, systematic reviews). Cited comparative RWE was reviewed to assess design features (e.g., population, data source, comparators) and quality using the Good ReseArch for Comparative Effectiveness (GRACE) Checklist. RESULTS Investigators evaluated 565 references cited in 27 monographs/therapeutic class reviews from 6 managed care organizations. Therapeutic class reviews mostly cited published clinical trials (35.3%, 155/439), while single-product monographs relied most on manufacturer-supplied information (42.1%, 53/126). Published RWE comprised 4.8% (21/439) of therapeutic class review references, and none (0/126) of the monograph references. Of the 21 RWE studies, 12 were comparative and assessed patient care settings and outcomes typically not included in clinical trials (community ambulatory settings [10], long-term safety [8]). RWE studies most frequently were based on registry data (6), conducted in the United States (6), and funded by the pharmaceutical industry (5). GRACE Checklist ratings suggested the data and methods of these comparative RWE studies were of high quality. CONCLUSIONS RWE was infrequently cited in P&T materials, even among therapeutic class reviews where RWE is more readily available. Although few P&T materials cited RWE, the comparative RWE studies were generally high quality. More research is needed to understand when and what types of real-world studies can more routinely inform coverage and reimbursement decisions. DISCLOSURES This project was funded by the National Pharmaceutical Council. Hurwitz, Brown, Peters, and Malone have nothing to disclose. Graff is employed by the National Pharmaceutical Council Part of this study was presented as a poster presentation at the AMCP Managed Care & Specialty Pharmacy 2016 Annual Meeting; April 19-22, 2016; San Francisco, CA. Study concept and design were primarily contributed by Malone and Graff, along with Hurwitz and Brown. All authors participated in data collection, and data interpretation was performed by Malone, Hurwitz, and Graff, with assistance from Brown and Peters. The manuscript was written primarily by Hurwitz and Malone, along with Graff, Brown, and Peters, and revised by Malone, Brown, Peters, Hurwitz, and Graff.

Real-World Evidence: Useful in the Real World of US Payer Decision Making? How? When? And What Studies?

OBJECTIVES To examine how real-world evidence (RWE) is currently perceived and used in managed care environments, especially to inform pharmacy and therapeutic (P&T) committee decisions, to assess which study factors (e.g., data, design, and funding source) contribute to RWE utility in decisions, and to identify barriers to consideration of RWE studies in P&T decision making. METHODS We conducted focus groups/telephone-based interviews and surveys to understand perceptions of RWE and assess awareness, quality, and relevance of two high-profile examples of published RWE studies. A purposive sample comprised 4 physicians, 15 pharmacists, and 1 researcher representing 18 US health plans and health system organizations. RESULTS Participants reported that RWE was generally used, or useful, to inform safety monitoring, utilization management, and cost analysis, but less so to guide P&T decisions. Participants were not aware of the two sample RWE studies but considered both studies to be valuable. Relevant research questions and outcomes, transparent methods, study quality, and timely results contribute to the utility of published RWE. Perceived organizational barriers to the use of published RWE included lack of skill, training, and timely study results. CONCLUSIONS Payers recognize the value of RWE, but use of such studies to inform P&T decisions varies from organization to organization and is limited. Relevance to payers, timeliness, and transparent methods were key concerns with RWE. Participants recognized the need for continuing education on evaluating and using RWE to better understand the study methods, findings, and applicability to their organizations.

Integrative medicine primary care: assessing the practice model through patients’ experiences

BackgroundThe University of Arizona Integrative Health Center (UAIHC) was an innovative integrative medicine (IM) adult primary care clinic in Phoenix, Arizona. UAIHC used a hybrid payment model to deliver comprehensive healthcare that includes conventional and complementary medical treatments.MethodsFidelity measures were collected to evaluate how well the IM care delivery process matched ideals for IM. Patient experiences are presented here. Patients visiting UAIHC on 1 of 10 randomly selected days between September 2013 and February 2015 were surveyed. Patients were asked about their experience with: holistic care; promotion of health, self-care, and well-being; relationship and communication with practitioners; and overall satisfaction.ResultsEighty-three patients completed surveys. Based on patient-reported experiences, UAIHC delivered IM care as defined by the practice model.ConclusionsPatients received holistic care, established positive caring relationships with providers who promoted their self-care and well-being, and reported high overall satisfaction with UAIHC.