#TBT: CER Collaborative & Environmental Trends

September 24, 2015

As part of our Throwback Thursday blog series, we’re taking a look at a topic that’s currently in the news and tagging it with previous research, videos or commentaries in a relevant way. As the saying goes, “what’s old is new again” – and we hope you enjoy our wonky twist on #TBT.

“Limiting one’s evidence scope is analogous to viewing an object with a single eye, narrowing the field of vision and minimizing the appreciation of depth,” explained NPC’s Chief Science Officer Robert Dubois, MD, PhD, and Vice President of Comparative Effectiveness Research (CER) Jennifer Graff, PharmD, in a 2013 Journal of Comparative Effectiveness Research “Methods to Policy” column. “By opening both eyes to the best available randomized and real-world evidence, we will improve our understanding of what treatments work and for whom,” they wrote.

CER, as they point out, can effectively broaden our understanding of how treatments work by answering certain health care questions and informing formulary decisions. However, little guidance exists on how to evaluate and use these new studies, creating a risk for two undesirable outcomes: new study data being misinterpreted or critical information not being used to inform formulary decision-making.

In 2012, the National Pharmaceutical Council (NPC) joined forces with the Academy of Managed Care Pharmacy (AMCP) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) to establish the CER Collaborative (and our #TBT pick of the day), an initiative designed to help identify optimal ways to assess evidence from CER studies.

Since its launch, the Collaborative has pinpointed good research practices to increase uniformity, clarity and transparency in how observational studies can help inform formulary decision-making. Online tools, training sessions and a continuing education certificate program, “CER in Decision-Making,” all developed by the Collaborative, educate decision-makers about how to assess individual CER studies, as well as how to synthesize the evidence from multiple studies designs.

NPC asked Dr. Graff, who leads the initiative at NPC, a few questions about the impetus of the Collaborative and what trends she’s noticed as the use of CER progresses.

What motivated these three organizations to partner for this cause?

Researchers were starting to generate more observational studies, but when it came to formulary decision-making, we found that only one in every three health plans was consistently using these types of studies to inform their decisions. Most formulary decision-makers didn’t have a process to assess the quality of the studies so NPC, AMCP, ISPOR and our respective members seized the opportunity to identify good research practices to help them.

How does considering a broader set of CER studies help decision-makers in their roles?

Payers and other decision-makers are increasingly focused on value. And to improve value, payers are focused on care coordination, quality of care, risk-sharing and the impact on the delivery system. To inform these questions, evidence on how treatments work in the real world is needed. Second, as new treatment alternatives become available, new study designs such as indirect treatment comparisons can help decision-makers compare products without head-to-head trial information in a systematic way. Other designs like modeling studies can help project the impact on health care quality and total cost beyond what is known at product launch. Having a systematic way to pull all of these studies together is helpful for decision-makers to share more transparently how decisions were made.

Are we seeing broader use of observational studies by formulary decision-makers?

We’ve learned that the availability of tools and participation in training increases the use these studies to inform formulary decisions. The training program learners have noted they have increased confidence in their ability to evaluate, interpret and apply the findings in their work. As one user noted during a training session, rather than ignoring a study that was a new study design, they now had the ability to evaluate the evidence and use it as part of their coverage determination.

Have CER studies become more consistent in their conduct?

Based on NPC’s most recent annual survey, 2015 CER and the Environment for Health Care Decision-Making, health care stakeholders remain optimistic that there is a growing movement toward widely-agreed upon standards for CER, which would definitely provide more consistency. Although we’re not there yet, 49 percent of the survey respondents acknowledged that there is at least a trend toward agreed upon standards—compared to only 24 percent who recognized a trend in 2011.

Learn more about the Collaborative and its online tools and resources. Already a member of the CER Collaborative? Join its LinkedIn group!

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