Is Real World Evidence Used in P&T Monographs and Therapeutic Class Reviews?


Payers infrequently used real-world evidence (RWE), or information on how treatments work in the real world, to guide their medication coverage and reimbursement decisions, according to research published in the Journal of Managed Care & Specialty Pharmacy.

The study, conducted by researchers at the University of Arizona College of Pharmacy and the National Pharmaceutical Council, examined the information cited in 27 reviews of single products or therapeutic classes to inform pharmacy and therapeutic (P&T) committee recommendations at six health plans. Among 565 references cited, RWE studies comprised only 4 percent of all references and were included by only two of the six health plans. When these studies were used, they were found to be of high quality based on validated checklists for reviewing RWE quality.

Despite the greater availability of RWE, payers most commonly utilize clinical studies and biopharmaceutical manufacturer-generated evidence. Researchers suggested several reasons for the lower use of RWE:

  • Initial coverage and reimbursement decisions are made when a product is newly approved and just enters the market; at that point in time, information about how a treatment works in the real world may be limited or not yet available. Yet even when payers conducted reviews of all treatments used to treat a condition and real-world information is readily available, RWE studies were infrequently cited.
  • Some experts believe treatment decisions should only use the best evidence from clinical trials rather than best available evidence, even if the best available evidence is found to be of high quality and validity. Many payer and clinical practice guideline groups recommend consideration of best available evidence, such as RWE, to inform coverage and care pathways.
  • Payers may be limited by the staff or time needed to review all best available information. However, tools and training like those provided by the Comparative Effectiveness Research (CER) Collaborative may help improve staff capabilities and confidence to apply these studies.
  • The sample of single product reviews (e.g., a product to treat epilepsy) and class reviews (e.g., all treatments for diabetes) provided by the six organizations that participated in the study may not adequately reflect information cited in all reviews or by a larger number of health plans.

The research offers a stronger understanding as to how payers are actually using RWE, but additional research is needed to understand when and what types of RWE can inform coverage and reimbursement decisions in a more consistent manner.