Transparency in evidence evaluation and formulary decision-making: From conceptual development to real-world implementation

摘要

Objective: Establishing a better understanding of the relationship between evidence evaluation and formulary decision-making has important implications for patients, payers, and providers. The goal of our study was to develop and test a structured approach to evidence evaluation to increase clarity, consistency, and transparency in formulary decision-making. Study Design: The study comprised three phases. First, an expert panel identified key constructs to formulary decision- making and created an evidence-assessment tool. Second, with the use of a balanced incomplete block design, the tool was validated by a large group of decision-makers. Third, the tool was pilot-tested in a real-world P&T committee environment. Methods: An expert panel identified key factors associated with formulary access by rating the level of access that they would give a drug in various hypothetical scenarios. These findings were used to formulate an evidence-assessment tool that was externally validated by surveying a larger sample of decision-makers. Last, the tool was pilot-tested in a real-world environment where P&T committees used it to review new drugs. Results: Survey responses indicated that a structured approach in the formulary decision-making process could yield greater clarity, consistency, and transparency in decisionmaking; however, pilot-testing of the structured tool in a realworld P&T committee environment highlighted some of the limitations of our structured approach. Conclusion: Although a structured approach to formulary decision-making is beneficial for patients, health care providers, and other stakeholders, this benefit was not realized in a realworld environment. A method to improve clarity, consistency, and transparency is still needed.