CER Collaborative: Providing the Tools for Better Formulary Decisions

National Pharmaceutical Council Chief Science Officer Robert Dubois, MD, PhD, and Director of Comparative Effectiveness Research Jennifer Graff, PharmD, recently co-authored a column in the Journal of Comparative Effectiveness Research, "Understanding What Works--Evaluating the Evidence with Both Eyes Open," on the potential of both randomized and non-randomized evidence to inform formulary decisions.

National Pharmaceutical Council Chief Science Officer Robert Dubois, MD, PhD, and Director of Comparative Effectiveness Research Jennifer Graff, PharmD, recently co-authored a column in the Journal of Comparative Effectiveness Research, "Understanding What Works--Evaluating the Evidence with Both Eyes Open," on the potential of both randomized and non-randomized evidence to inform formulary decisions.

The article addresses the pitfalls of solely considering data from only a portion of the evidence available and the insights that can be gained from non-randomized or observational studies to assess treatments in usual care settings. Based on the recognition of the role of non-randomized studies in providing important comparative effectiveness research (CER), a collaboration called the CER Collaborative Initiative was formed among NPC, the Academy of Managed Care Pharmacy (AMCP) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and their respective memberships.

In their column, Drs. Dubois and Graff outline the CER Collaborative's work on adapting real-world evidence to formulary decision-making, including:

  • creating processes and tools for evaluating study relevance and quality;
  • developing an approach to consider both randomized and non-randomized studies; and
  • preparing training materials for professionals who apply CER to formulary decisions.

In order to evaluate CER studies more effectively, the collaborative created online assessments that score the credibility and relevance of several study designs, such as prospective observational, retrospective observational, indirect comparisons, and modeling. The collaborative also adapted a framework and developed guidelines and web-based tools outlining best practices for considering the entire range of evidence (e.g., both randomized and real-world studies) as part of formulary decision-making. To maximize the impact of its new resources, the collaborative developed training programs that help decision-makers evaluate data and use the new web-based tools.

The CER Collaborative also will lead an educational symposium, "Assessing the Evidence for Better Patient Care: Synthesizing the Body of Evidence--A Tool for Formulary Decision-Making," at the International Society for Pharmacoeconomics and Outcomes Research 18th Annual International Meeting on May 19 at 5:15 pm. In addition, members from the CER Collaborative will share their work to assess the relevance and credibility studies during a plenary session, “Assessing the Evidence for the Health Care Decision Maker," at ISPOR on May 22 at 9:45 am.

Watch Dr. Graff discuss the CER Collaborative's work: