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 new research published in the Journal of Managed Care & Specialty Pharmacy. Unlike clinical trials, which typically assess whether treatments can work in optimal care settings, RWE provides complementary information about how treatments works in care settings and patient populations more similar to those for which payers need to make decisions.
This new 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/organizations. When these studies were cited, they were found to be of high quality based on validated checklists for reviewing RWE quality.
What is RWE and why is it important? Understanding how treatments work in the real world is an important and complex task to guide care in real-world, clinical practice environments. Every day, data are generated as patients and consumers engage with the health care system. These data are collected via billing claims, electronic health records, patient registries and/or personal health devices. Through the use of careful methods and analytics, these data can be transformed into evidence to address specific issues that cannot or are impractical to be captured by controlled clinical trials. For example, RWE studies are often used to monitor treatment safety, track health epidemic outbreaks, determine treatment effectiveness in the real world or tailor care programs for particular patients or care settings.
Why isn’t RWE used consistently? According to the recently published research and related NPC studies, there are many reasons why RWE is not regularly used. First, 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.
Second, some experts believe treatment decisions should only use the best evidence from clinical trials rather than best available evidence, which may include RWE due to concerns about the validity of the studies. However, others experts have noted that differences in study results are not due to the use of RWE data nor the study design alone. In fact, many of the payer and clinical practice guideline groups recommend consideration of best available evidence, such as RWE, to inform coverage and care pathways.
Third, 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 to improve staff capabilities and confidence to apply these studies.
Finally, 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 who participated in the study may not adequately reflect information cited in all reviews or by a larger number of health plans.
What’s next for RWE? As more clinically rich information from health records is available, payers and health systems can better assess how treatments work in the real world. In fact, health plans are increasingly using data from the real world to inform process improvements and to offer targeted interventions or care programs to patients who can benefit the most. Understanding which treatments work best for whom requires the best available evidence, not less information, to guide our complex health care system.