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. 2013 Aug;38(8):465-83.

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

Bonnie B Dean, Kelly J Ko, Jennifer S Graff, A Russell Localio, Rolin Wade, Robert W Dubois

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

Bonnie B Dean et al. P T. 2013 Aug.

Abstract

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 decision-making; however, pilot-testing of the structured tool in a real-world 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 real-world environment. A method to improve clarity, consistency, and transparency is still needed.

Keywords: access; decision-making; evidence; formulary.

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Figures

Figure 1
Figure 1
Example of an evidence-assessment tool.
Figure 1
Figure 1
Example of an evidence-assessment tool.
Figure 2
Figure 2
Evidence-assessment tool evaluation following pilot-testing. P&T committee members were asked about their experience with the tool and how strongly they agreed with the statements listed above on a scale of 1 to 9 (1 = Strongly disagree, 9 = Strongly agree). NPC = National Pharmaceutical Council.
Figure 3
Figure 3
Ten-item evaluation to be completed by P&T committee members. (1 = Strongly disagree; 5 = Neutral; 9 = Strongly agree.)
See this image and copyright information in PMC

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