ISPOR’s Initiative on US Value Assessment Frameworks was created to inform the shift towards a value-driven health care system by promoting the development and application of high-quality, unbiased value assessment frameworks. A number of value frameworks have been developed as the US health care system has begun to move toward a value-driven approach. Emerging frameworks, however, are widely diverse in their approaches, and this inconsistency can lead to variable evaluations of treatments. A need therefore exists for a set of standards that are robust, transparent, methodologically sound, and that involve the input of all key stakeholders to guide the development of value assessment frameworks for health care decision making.
ISPOR’s Chief Executive Officer Nancy S. Berg and Chief Science Officer Richard J. Willke, PhD opened the meeting by providing a brief overview of the Initiative and setting the context for the goals and format of the Stakeholder Conference. The Initiative was designed to engage key health care stakeholders throughout the process. The Stakeholder Conference was specifically intended to be an opportunity to gain input, recommendations, and advice on the Initiative’s draft scope of work from the Stakeholder Advisory Panel, a Framework Developer Panel, and the broader stakeholder community.
Mark B. McClellan, MD, PhD, Director, Duke Robert J. Margolis, Center for Health Policy was the keynote speaker for the event. Dr. McClellan commended ISPOR on the Initiative, noting that the effort was relevant, timely, and necessary to move toward value-based pricing in health care. He emphasized that value frameworks, when properly structured and executed, can be used to not only to inform health care decision making at the patient level, but also serve as a basis for clinical guidelines, pricing and coverage decisions, and value-based payment models.
Special Task Force co-chair, Peter J. Neumann, ScD, Director, Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center; Professor of Medicine, Tufts University School of Medicine, provided an overview of the five major US value frameworks currently available, including frameworks from the Institute for Clinical and Economic Review, Memorial Sloan Kettering, American Society for Clinical Oncology, National Comprehensive Center Network, and the American College of Cardiology/American Heart Association. He noted that value frameworks, driven by the private market in the US, are being developed in response to a real need. Dr. Neumann emphasized the challenges inherent in developing value frameworks, but noted that we should welcome their development and stressed the need to discuss issues related to their design and use. Special Task Force co-chair, Lou P. Garrison, Jr, PhD, Professor, University of Washington School of Pharmacy and ISPOR President provided an overview of the draft scope of work for the Initiative’s Special Task Force. Dr. Garrison also reviewed survey results on the Initiative showing that the Stakeholder Advisory Panel strongly agreed with the overall aim and focus of the Special Task Force.
Jalpa A. Doshi, PhD, Associate Professor, Perelman School of Medicine, University of Pennsylvania chaired the Stakeholder Panel comments on the Initiative’s draft scope of work. Randy Burkholder, Vice President of Policy and Research, Pharmaceutical Research and Manufacturers of America expressed PhRMA’s support for high-quality, patient-centered value assessments as well as its agenda to move toward a value-driven health care system. Eleanor Perfetto, RPh, PhD, Senior Vice President, National Health Council (NHC), providing the patient perspective, reviewed the NHC’s Patient-Centered Value Model Rubric and urged the Special Task Force to make direct patient input a high priority for inclusion in value frameworks. Edmund Pezalla, MD, MPH, (retiring) Vice President, National Medical Director, Aetna, offered the payer’s perspective, indicating that value assessment frameworks can provide a common language and allow us to move ahead with a rational discussion of costs and benefits. Dr. Pezalla also noted that the balance of health care costs and benefits, “depends on who you are and where you sit.” Susan A. Cantrell, RPh, CAE, Chief Executive Officer, Academy of Managed Care Pharmacy, stressed that transparency, adaptability, and usability of the economic models are key to improving the utility and relevance of value frameworks. Audience input was robust, including suggestions for the Special Task Force to get more direct patient input, consider curative therapies, include patient-payer discussions, develop patient-provider decision making tools, evaluate tradeoffs in value attributes, explore sources of patient-centered data, and address the uncertainties of relating randomized clinical trial results to real-world patients.
Dr. Neumann chaired the Framework Developer Panel comments on the Initiative’s scope of work. Daniel A. Ollendorf, PhD, Chief Science Officer, Institute for Clinical and Economic Review (ICER), reported on the ICER Value Assessment Framework as well as stakeholder feedback received from their open call for comments. Roger Longman, MA, Chief Executive Officer, Real Endpoints, demonstrated, his company’s web-based, interactive platform for multi-criteria decision analysis. RxScorecard™ has been licensed by DrugAbacus, one of the value assessment frameworks recently created by Dr. Peter B. Bach, Director, Center for Health Policy and Outcomes, at Memorial Sloan-Kettering, to help users determine appropriate value for cancer drugs. Lowell E. Schnipper, MD, Theodore W. and Evelyn G. Berenson Professor, Medicine, Harvard Medical School, and American Society of Clinical Oncology (ASCO), reviewed the ASCO Value Framework and how it integrated clinical benefit into its net health benefit measure. He discussed the use of value frameworks in both shared decision making and in broader health policy decisions. Daniel B. Mark, MD, MPH, Professor of Medicine, Duke Clinical Research Institute and American College of Cardiology (ACC), reviewed the ACC/American Heart Association value framework and discussed the need for quality health economic studies on which to base value assessments, despite the frequent lack of quality, randomized clinical trial evidence to inform decision making, and clinical guidelines. Audience input included statements regarding the importance of solving long- versus short-term economic considerations, ensuring transparency in the assessment process, the need for clear definitions of value, concerns about budget impact being considered a value measure, and defining how assessments deal with future non-medical costs incurred due to increased survival rates.
Information on the ISPOR Initiative on US Value Assessment Frameworks can be found here. Opportunities to contribute to the Initiative can be found here. Additional information, including a participant list for the Initiative that includes the Steering Committee, Expert Advisory Board, Special Task Force, and Stakeholder Advisory Board can be found here.
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Meeting Link: ISPOR Initiative on US Value Assessment Frameworks Stakeholder Conference
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