Stakeholders find that step therapy should be evidence-based, flexible, and transparent: assessing appropriateness using a consensus approach.

BACKGROUND: Step therapy, one approach to utilization management, is used by health plans to ensure safe and clinically appropriate care while managing cost. Several patient and provider groups have each developed principles to guide the appropriate use of step therapy; however, no comprehensive multistakeholder informed set of criteria exist. OBJECTIVE: To assess multistakeholder consensus on criteria for the development and implementation of step therapy for pharmaceutical therapies. Stakeholders were asked to (a) assess the appropriateness of step therapy as a utilization management tool; (b) rate specific criteria across 5 domains (development, implementation, communication, appeals, and evaluation) of step therapy; and (c) categorize these criteria as standards or best practices. METHODS: We conducted a multiphase project culminating in a roundtable of experts representing patient, provider, plan, pharmacy, policy, and ethical perspectives. We first reviewed guiding principles, position statements, and legislative activity to draft criteria regarding step therapy protocol development, implementation, communication, and evaluation. To assess consensus across a convenience sample of experts, we employed an iterative 4-step modified Delphi method. Panelists were asked to (a) rate the overall appropriateness of step therapy, (b) rate the appropriateness of specific criteria, and (c) identify each as a standard or best practice. Appropriateness was rated from 1-9 and categorized in terciles (1-3: not appropriate, 4-6: neither, 7-9: appropriate) to assess quantitative agreement, disagreement, and indeterminate agreement. RESULTS: After the second round of voting, roundtable panelists (n = 16) disagreed on the appropriateness of step therapy for utilization management (50% appropriate, 31.25% neither, and 18.75% inappropriate). Agreement was achieved on 21 criteria across 5 themes (clinical criteria as the foundation for protocol development, implementation of protocols, transparency and communication of processes, navigation of the appeals process, and evaluation of health and administrative impact). Fourteen and seven criteria were categorized as standards and best practices, respectively. CONCLUSIONS: The stakeholders in this panel differed in their assessments of the appropriateness of step therapy but agreed regarding how these protocols should be developed, implemented, communicated, and evaluated. Most criteria were rated as standards that can be used by stakeholders when developing, implementing, and assessing step therapy processes today. DISCLOSURES: This study was funded by the National Pharmaceutical Council. Karmarkar was a fellow at the National Pharmaceutical Council and Duke-Margolis Center for Health Policy at the time this study was conducted. Dubois and Graff are employees of the National Pharmaceutical Council. This work was previously presented as a virtual poster during the AMCP 2020 eLearning Days, April 21-24, 2020.

Creation and maintenance of a table for assessment of evolving evidence for COVID-19-related treatments.

PURPOSE: This report describes the development and maintenance of a table to present an assessment of evidence for treatments used in patients with coronavirus disease 2019 (COVID-19). SUMMARY: AHFS Drug Information (AHFS DI) (American Society of Health-System Pharmacists, Bethesda, MD) is ASHP's evidence-based drug compendium that contains drug monographs written for pharmacists and other healthcare professionals. The professional editorial and analytical staff of pharmacists critically evaluate published evidence to develop drug monographs for AHFS DI. In response to the global COVID-19 pandemic, these skills were applied to assess emerging evidence for COVID-19-related treatments, and the information was compiled into a new resource for pharmacists and other healthcare professionals to use at the point of care. A list of therapies was developed and prioritized based on review of scientific and public discussions on the use of these therapies in patients with COVID-19; certain therapies used for supportive care and therapies that might theoretically be harmful to patients with COVID-19 also were considered for inclusion. Potential treatments were identified, and the evidence for use in patients with COVID-19 was assessed and summarized in a table format. Information presented for each therapy included the rationale for use, summaries of clinical trials or experience, trial registry numbers, and dosage regimens. Comments on safety and efficacy, including limitations of available data, were presented along with recommendations from recognized authorities. The editorial team continued to add new therapies to the table and update existing entries as new evidence emerged. CONCLUSION: A comprehensive table that summarized available evidence for potential treatments for patients with COVID-19 was developed. The table format enabled the drug information editorial staff to provide ongoing updates as new information emerged during the pandemic.

Students' perceptions of biostatistics following integration into an evidence-based medicine course series.

BACKGROUND AND PURPOSE: Student pharmacists are expected to demonstrate an understanding of commonly employed statistical tests. This study describes the integration of biostatistics in an evidence-based medicine course series using a learner-centered model tailored to students' needs and interests. EDUCATIONAL ACTIVITY AND SETTING: This course series included thirteen two-hour biostatistics sessions focused on interpreting results and critiquing statistical methods. Three lab sessions were also included, which focused on producing summary reports from clinical data. Journal club presentations were the key method of assessing knowledge. A survey to evaluate students' perceptions of the course and their level of confidence in applying biostatistical concepts was administered twice to measure change over time within two student cohorts. FINDINGS: Results of the survey showed that a significantly higher proportion of students agreed they understood the analyses covered in class (97% vs. 44%, p < 0.001) and felt more confident interpreting results (82% vs. 41%, p < 0.001) in their third year compared to the second year. Students who agreed that they learned important skills for future practice had a significantly higher mean exam score (82.5% vs. 76.2%, p = 0.001). SUMMARY: The results indicate an improvement in the students' perceptions over time with regards to knowledge and usefulness of the course content. Although, integrating biostatistics in a literature-evaluation course is common, this is the first study that evaluated teaching it in more than one semester beyond inclusion in assessment rubrics.