National Pharmaceutical Council Studies New Formulary Decision-Making Tool

Washington, DC, August 19, 2013—A National Pharmaceutical Council (NPC) study published in the peer-reviewed journal Pharmacy and Therapeutics details new work in developing, testing and piloting a more structured approach to formulary decision-making.

The 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.

“Right now, there is a bit of a ‘black box’ around the formulary decision-making process,” said Robert Dubois, MD, PhD, NPC’s chief science officer and an author of the study. “As a result, decisions about treatment access are often unpredictable to patients, providers and biopharmaceutical manufacturers. We sought to identify ways to clarify the process.”

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.

“The results of this study show that we need to pursue other approaches for promoting a process that ensures all stakeholders know the ‘ingredients’ that go into decision-making and how evidence is applied,” said Jennifer Graff, PharmD, NPC director of comparative effectiveness research and a study author. “While our results show that this may not be the right approach for consistently translating evidence into decision-making, we have made progress in terms of supporting better approaches to evaluating the evidence. For groups with less rigorous or structured processes for conducting reviews, this may be a good starting point.”

In addition to its previous research on how payers assess evidence, NPC is continuing to explore ways to enhance the processes used to evaluate evidence. In particular, NPC is working with the Academy of Managed Care Pharmacy (AMCP) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on a joint project called the CER Collaborative Initiative to provide greater uniformity and transparency in the evaluation and use of evidence for coverage and health care decision-making. The CER Collaborative is developing a user-friendly toolkit and training materials to help increase decision-makers’ awareness, understanding, and confidence in their abilities to critically appraise individual studies and synthesize the evidence from a variety of study methods to guide formulary decisions.

NPC also will host a webinar about the research, along with a discussion about how payers are evaluating evidence, on September 10 at 1 p.m. ET. Registration is available on NPC's website.

About the National Pharmaceutical Council
The National Pharmaceutical Council is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. Founded in 1953 and supported by the nation’s major research-based pharmaceutical companies, NPC focuses on research development, information dissemination, and education on the critical issues of evidence, innovation and the value of medicines for patients. For more information, visit www.npcnow.org and follow NPC on Twitter @npcnow.

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