CER Has Implications for Stakeholders

Tampa—The growing availability of new research methods poses challenges and opportunities for today’s formulary decision-makers. Little guidance exists on how to evaluate these new studies, creating a risk for 2 undesirable outcomes: (1) new study data being misinterpreted; or (2) critical information not being used to inform decision-making. To address those challenges, members of the Comparative Effectiveness Research (CER) Collaborative, which include AMCP, the International Society of Pharmacoeconomics and Outcomes Research, and the National Pharmaceutical Council, developed a series of questionnaires to guide decision-makers in reviewing studies.

The CER Collaborative also developed an online toolkit incorporating the 3 questionnaires to guide decision-makers as they assess and incorporate CER studies with other types of evidence for coverage and reimbursement decisions. The CER Collaborative’s online toolkit has 2 main components:

•   Assessing the Evidence: An Individual Study—3 articles and an online tool help users determine whether a study is relevant and credible enough to include in the formulary decision-making process. The tool helps decision-makers’ assessment using different types of research studies, including prospective and retrospective observational studies, indirect treatment comparisons or network meta-analyses, and modeling studies

•   Synthesizing a Body of Evidence: Multiple Studies—Formulary decisions require rigorous evaluation of the body of evidence, which may include different study designs, each with strengths and limitations. The online guided review of the evidence empowers the decision-makers with the tools to consistently and transparently assess the comparative benefits and risks of therapies and the corresponding certainty of evidence

During a session at the AMCP meeting, a panel of experts discussed how the toolkit is being used in pharmacy and therapeutics (P&T) committees, academia, and the pharmaceutical industry.

P&T Committees

Daniel Allen, PharmD, clinical pharmacist consultant, OmedaRx, opened the session with a discussion about opportunities for P&T committees and drug evaluation units to consider CER data as part of their formulary decision-making process. He explained how pharmacy benefit manager, OmedaRx, implemented the Institute for Clinical and Economic Review (ICER) evidence rating matrix for its clients.

The ICER matrix presents a framework for evaluating the comparative benefits and risks of therapies in a consistent, transparent system leading to an evidence rating that can guide coverage and formulary placement decisions. For OmedaRx, the ICER process include 4 steps: (1) estimate the certainty in the overall clinical data (eg, high, moderate, or low certainty); (2) estimate the magnitude of net-health benefit (eg, negative, comparable, incremental, or substantial health benefit); (3) identify the “point estimate” on the ICER matrix; and (4) make safety modification to point estimate (ie, track record with proven advantages over active comparator). When determining which studies to include within the relevant scope of the body of evidence, ICER recommends the PICO (population, intervention, comparator, and outcome) framework be applied.

Important activities to consider while implementing the ICER evidence synthesis method into the formulary decision process include extensive staff training, in-service for P&T committees over multiple meetings, and continuous quality improvement.

Dr. Allen noted several points to consider when using the ICER matrix. He said most reviews involve 2 comparisons—against placebo and against existing therapies. New therapies often lack direct comparative trials. Also, the process is always subject to peer review. “We challenge each other on our assessment of the evidence, our assessment of the standard of care, and our assessment of the safety profile,” he said.

He concluded that successful clinical evidence synthesis is dependent on rigorous clinical evaluation. Agreed upon, uniform grading and synthesis guidelines are important for maintaining quality across multiple reviewers. He also stressed the importance of never allowing the quantification guidelines to override professional judgment.

Academia

Eleanor Perfetto, PhD, MS, professor, University of Maryland School of Pharmacy, continued the session by providing the academia perspective on the importance of inculcating an understanding of CER into drug information courses and drug evaluation courses in schools and colleges of pharmacy.

The University of Maryland School of Pharmacy is a school that implemented CER into its Epidemiology and Medical Evidence course, which is a requirement for second year pharmacy students. The benefits of this approach included a new way of teaching epidemiology and how to read the literature. It was also a highly-structured approach, in that students were directed which CER tool to use for assigments.

In the future, Dr. Perfetto said that an understanding of CER and the methods used in CER can be incorporated into a school of pharmacy curriculum in various ways. For example, CER could be included throughout the curriculum, as part of coursework and practical rotations, or as part of specific courses that address research methods and assessment of the literature.

Pharmaceutical Industry

Helen Sherman, PharmD, vice president, Solid Benefits Guidance, concluded the session with a focus on CER and the pharmaceutical industry. She said pharmaceutical health outcomes research departments could incorporate CER guidleines into pre- and post-marketing study design recommendations. She said it is important for the pharmaceutical industry to “ensure that research meets good practice priciples through eyes of the healthcare decision-makers.” These principles should be considered when designing the research, finalizing publications, and communicating evidence to decision-makers.