(Washington, DC, March 24, 2014)—Three peer-reviewed articles published in Value in Health offer important guidance to aid formulary decision-makers in evaluating certain types of comparative effectiveness research (CER) studies. The articles, developed by CER Collaborative members Academy of Managed Care Pharmacy (AMCP), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the National Pharmaceutical Council (NPC), describe how to assess the credibility and relevance of individual research studies for making coverage and reimbursement decisions.
Members of the CER Collaborative recognized that the growing availability of new research methods poses challenges and opportunities for today’s formulary decision-makers. There is little guidance 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 decision-making.
To address those challenges, the CER Collaborative developed a series of questionnaires to guide decision-makers in reviewing studies, which are outlined in the following articles:
- A Questionnaire to Assess the Relevance and Credibility of Observational Studies to Inform Health Care Decision Making: An ISPOR-AMCP-NPC Good Practice Task Force Report
- Indirect Treatment Comparison/Network Meta-Analysis Study Questionnaire to Assess Relevance and Credibility to Inform Health Care Decision Making: An ISPOR-AMCP-NPC Good Practice Task Force Report
- Questionnaire to Assess Relevance and Credibility of Modeling Studies for Informing Health Care Decision Making: An ISPOR-AMCP-NPC Good Practice Task Force Report
These articles were published in the March/April issue (Vol.17 Iss.2) of Value in Health, ISPOR’s official peer-reviewed journal.
An online toolkit (www.cercollaborative.org) incorporating the three questionnaires also assists decision-makers as they assess and incorporate CER studies with other types of evidence for coverage and reimbursement decisions.
“The rapid introduction of new medicines, especially specialty drugs, makes it imperative that formulary decision-makers evaluating comparative effectiveness have the right tools to reach the most reliable results,” said AMCP CEO Edith A. Rosato, RPh, IOM. “The potential to improve health outcomes and health care affordability is enormous.”
The CER Collaborative’s online toolkit has two main components:
- Assessing the Evidence: An Individual Study—Three 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 online tool helps decision-makers make that assessment for four types of research studies: 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.
Both components of the toolkit provide abundant links to background information and include user “helper” questions, tangible examples, frequently asked questions and glossaries. The CER Collaborative also will be discussing the toolkit at AMCP’s Annual Meeting on Thursday, April 3, 2014 from 2:45 pm–4:00 pm. Incorporating Comparative Effectiveness Research Knowledge and Tools into Practice: Three Perspectives will discuss how the tool is being used in pharmacy and therapeutics (P&T) committees, academia, and the pharmaceutical industry.
“These reports and online tools serve as a platform to assist the health care decision-making community in the use of observational, modeling, and indirect treatment comparison studies in their deliberations. The goal of this collaborative effort is to educate both the producers (researchers) and users (health care decision-makers) of health care evidence.” said Marilyn Dix Smith, RPh, PhD, Founding Executive Director, ISPOR.
“Understanding how treatments work in the real world is an important but complex task. Collaborative dialogues across all stakeholders help to ensure that meaningful and usable research is generated to guide decision-making,” said Dan Leonard, NPC President.
About the Academy of Managed Care Pharmacy (AMCP)
The Academy of Managed Care Pharmacy is a national professional association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to improve health care for all. The Academy's nearly 7,000 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit. www.amcp.org.
About the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) promotes the science of pharmacoeconomics (health economics) and outcomes research (the scientific discipline that evaluates the effect of health care interventions on patient well-being including clinical, economic, and patient-centered outcomes) and facilitates the translation of this research into useful information for health care decision makers to increase the efficiency, effectiveness, and fairness of health care to improve health. For more information, please see: www.ispor.org and follow ISPOR on Twitter: @ISPORorg.
About the National Pharmaceutical Council (NPC)
The National Pharmaceutical Council is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. Founded in 1953 and supported by the nation’s major research-based pharmaceutical companies, NPC focuses on research development, information dissemination, and education on the critical issues of evidence, innovation and the value of medicines for patients. For more information visit www.npcnow.org and follow NPC on Twitter @npcnow.