Making health care coverage decisions for patient populations requires having the right evidence and information in hand. And payers, in particular, want to understand how treatments work in the real-world—insights that are often gleaned from comparative effectiveness research (CER) and other types of real-world studies. Given the increase in the use of data and number of CER studies, it can be challenging to sort through which studies are high-quality and should be used in health care decision-making.
A feature article in this month's Value and Outcomes Spotlight highlights the importance of CER and details the CER Collaborative Initiative, a joint effort by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the Academy of Managed Care Pharmacy (AMCP) and the National Pharmaceutical Council (NPC) to assist health care decision-makers in assessing and synthesizing these studies. As a relatively young field, there is a limited number of accepted principles for the interpretation of CER, and the quality of the studies can vary. Both of these factors can limit the usefulness of these studies, particularly for drug formulary and population health decision-makers. In fact, “only about 1 in 3 plans were consistently using observational research, and most didn’t have a process to assess the quality of these studies,” explained Jennifer Graff, PharmD, vice president of comparative effectiveness research at NPC.
That’s where the CER Collaborative comes in. Its goal is to provide greater uniformity and transparency in the use and evaluation of CER information for coverage and health care decision-making by providing user-friendly resources to help users navigate through the various types of study methods used to generate information for evidence-based health care decision-making. To help health care stakeholders understand when and how CER can be useful, the Collaborative developed an online, easy-to-use, free toolkit that enables users to 1) assess the relevance and credibility of individual CER studies and 2) evaluate the results from multiple studies in a more consistent and transparent manner to inform coverage or policy recommendations.
The assessment part of the toolkit consists of interactive questionnaires that can be used to systematically evaluate modeling, observational and network meta-analysis/indirect treatment comparison studies, and includes related educational modules for health care coverage decision-makers on how to use the assessment toolkit. The assessment tool serves as a guide to determine whether a study is relevant to the setting and credible enough to include in the formulary decision-making process, offers an educational platform to improve users’ study assessment skills and was designed to allow users to read and easily utilize CER studies.
These tools have been shown to improve decision-makers’ confidence abilities and ultimate use of CER after participating in the training program. However, the CER Collaborative assessment tools and CER Certificate Program may also assist researchers in their study design process, helping them understand how their research will be evaluated by decision-makers. By participating in the educational and training opportunities provided by the CER Collaborative, researchers will be aware of the measures end users will employ to determine a study’s value, accessibility and quality. Several organizations have already adopted or cited the tool and several thousand users have used the tools provided by the CER Collaborative. For example, the AMCP Format for Formulary Submissions 4.0 references the Collaborative tools; students participating in the AMCP Foundation Pharmacy and Therapeutics Competition utilize the tools to assess the evidence and develop formulary recommendations; and the Food and Drug Administration cited the Collaborative’s approach when drug and device manufacturers share health care economic information with payers, formulary committees and other entities.
With the right tools and training, the promise of CER can help health plans and payers ensure that their coverage and reimbursement includes the treatments that work best for their members and provider networks. For more information on the CER Collaborative Initiative and other CER training opportunities, visit the CER Collaborative Initiative or the CER Certificate training program website.
Note: The CER Continuing Education Certificate Course is no longer being offered as of July 2018. For further information, please contact firstname.lastname@example.org.