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Transparency in Evidence Evaluation and Formulary Decision-Making

Conceptual Development to Real-World Implementation

Although the type of evidence required to make health coverage decisions is well-documented, how the evidence is evaluated and translated into formulary decision-making is not. As a result, decisions about treatment access are often unpredictable to patients, providers and biopharmaceutical manufacturers.

This study, “Transparency in Evidence Evaluation and Formulary Decision-Making,” discusses efforts to increase the clarity, consistency, and transparency of how evidence is applied by payers during the formulary decision-making process. During the project, the new approach was evaluated in a pharmacy and therapeutics setting.

The project, conducted with Cerner Research and other research experts, and sponsored in part by Pfizer Inc, was completed in three phases. First, an expert panel created an evidence assessment tool based on the core elements of formulary decision-making: safety, efficacy, cost and certainty of evidence. Next, the evidence assessment tool was validated by surveying a larger group of medical and pharmacy directors. Finally, the tool was piloted in a real-world pharmacy and therapeutics (P&T) environment.

Survey responses from the validation process with medical and pharmacy directors indicated that the tool could increase clarity, consistency and transparency in formulary decision-making. In the hypothetical scenarios tested using the tool, increased product access was associated with greater efficacy, more evidence certainty, fewer safety concerns and lower costs.

However, the tool did not hold up during real-world pilot testing. Participants in the pilot-testing portion of the project indicated that the tool did not capture the dynamic and complex variables involved in the formulary decision-making process, and therefore would not be suitable for more sophisticated organizations.

NPC also hosted a webinar about the research, along with a discussion about how payers are evaluating evidence, on September 10.

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