National Pharmaceutical Council Remains Engaged With the Institute for Clinical and Economic Review, Continuing Constructive Dialogue to Improve Value Assessment Frameworks

(Washington, DC, September 8, 2016)—The National Pharmaceutical Council (NPC) Board of Directors has agreed to renew the health policy research organization’s annual membership in the Institute for Clinical and Economic Review (ICER). By choosing to stay engaged, the NPC Board hopes to positively impact the evolution of a broad ecosystem of value assessments in the United States, of which ICER is a part.

NPC’s continued engagement with ICER does not imply endorsement of its value assessment process or its conclusions. Rather, it signifies our Board’s commitment to the critical dialogue necessary to ensure that future value assessments account for all stakeholder perspectives and use appropriate methods—leading to the development of high-quality, meaningful tools that help patients, physicians, payers and others make informed, clinically appropriate decisions.

Earlier this year, NPC developed a set of guiding practices that can serve as a guidepost for framework developers. NPC will continue to use these guiding practices as a way to measure and evaluate ICER’s—and other frameworks’—capabilities to achieve a more holistic view of what value looks like to the patient. Establishing and adhering to guiding practices can help ensure that value assessment frameworks are effective tools for advancing patient care and achieving better clinical, economic and humanistic outcomes, rather than well-intentioned but flawed tools that impede such progress.

Despite agreeing to renew the membership, the NPC Board has expressed significant concern about the transparency and methodology of ICER’s approach to value assessment. More work remains to be done before ICER—or other frameworks—are ready for widespread adoption and use by stakeholders. Since one framework cannot meet the needs of all stakeholders, we look forward to continuing to have constructive dialogues with all developers to evolve value frameworks in a thoughtful, inclusive and patient-centered way.

ICER will be hosting a meeting later this month to discuss changes to its framework, informed by recommendations that NPC and other stakeholders will be submitting to ICER by September 12.

Given NPC’s expertise and focus on research methods, we have provided feedback about the framework via previous public comments and meetings, and will submit additional comments this week. Our comments will focus on multiple areas of concern with the existing ICER framework, including, but not limited to focusing on the need for:

• Full transparency and reproducibility of economic models
• Formal inclusion of patient-centered factors into the framework so they can be meaningfully considered in the value assessment
• A reevaluation of the appropriateness and approach to budget impact assessment and its relevance in calculating value-based price benchmarks
• Elimination of the “alarm bell” threshold, which does not involve a comprehensive consideration of the health care system, does not consider societal values, and does not adequately measure affordability

NPC believes that addressing these concerns are necessary steps to appropriately improve ICER’s current framework.

About the National Pharmaceutical Council

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.

NPC also will bring together health care stakeholders on September 29 in Washington, DC, for a conference, “Assessing Value: Promise and Pitfalls,” to explore value assessment frameworks. View the agenda and register for the conference on NPC’s website.