AMCP Helps Launch New Online Tool to Evaluate Observational Studies for Formulary Coverage Decisions

Health care decision makers have a powerful new tool for evaluating data in support of formulary decision making. AMCP, along with International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the National Pharmaceutical Council (NPC), have unveiled an online toolkit that lets users assess the evidence behind the many observational and outcomes studies that accompany medications on the market today.

The user-friendly website, “Assessing the Evidence for Health Care Decision Makers,” provides an interactive questionnaire that drills down on questions of whether a study’s: (a) population, intervention and outcomes are relevant to the setting/decision in question, and (b) the design, data, and analysis are credible enough to include in the overall body of evidence.

Among other applications, the tool may be used by pharmacy and therapeutics committees when evaluating available comparative effectiveness data on a medication.

“This is a major new resource that we expect will be widely used by managed care pharmacy practitioners and other health care professionals working in many settings,” says Edith A. Rosato, RPh, IOM, Chief Executive Officer of the Academy. “This is one more example of how the Academy is helping to improve the quality and efficiency of health today and in the future.”

The tool walks users through a series of web-based questionnaires that drill down on items to consider when interpreting the evidence in the study. Part 2 of the tool, expected to launch in July, will help the user appraise the evidence when multiple study methods are being used.

No summary score is provided for the overall questionnaire or for the domains of relevance and credibility. This was an explicit choice in the design of these questionnaires, since individuals may place greater or lesser weight on the response to any individual question.

The website will help decision makers determine the quality of a study, and decide if it’s applicable to the question at hand, explains Bernadette Eichelberger, AMCP’s Director of Pharmacy Affairs, who is overseeing the Academy’s efforts in the project.

“Part of the purpose of this tool is to grow expertise among pharmacists in evaluating the scientific literature, especially literature that is comparing one drug to another,” she says. She expects the tool will be incorporated in managed care pharmacy training and residency programs.

The toolkit is the most visible product to date of the three-year old Comparative Effectiveness Research (CER) Collaborative, which brought together stakeholders from three key sectors: managed care pharmacy, researchers and manufacturers. The goal of the Collaborative is to provide greater uniformity and transparency in the design and use of observational studies for more robust health care decisions.

The CER Collaborative also aims to enhance the usefulness of CER in improving patient outcomes. The group is working to provide guidance and practical tools to help pharmacy and therapeutic committee members appraise CER studies, and provide guidance to industry on what kinds of evidence payers want to see and how the evidence will be considered in decision making.

 “Much work went into the development of this tool, and the ongoing efforts of bringing CER into the practice of health care,” says Rosato. “We owe a debt of gratitude to the many volunteers from AMCP,  ISPOR and NPC who are engaged in this important endeavor.”

For more information and to access the tool, visit https://healthstudyassessment.org/.