ISSUE: Extensive work has been conducted over the past 10 years designing frameworks to capture more comprehensive elements of value for new medicines. The ISPOR Value Flower and the 2^nd Panel on Cost-Effectiveness in Health and Medicine remain seminal works; since then, there have been multiple efforts focusing broadly and in specific therapeutic areas. While each has advanced science, by following the recommendations of ISPOR and 2^nd Panel they focus on incorporating elements into cost-effectiveness and are not routinely implemented in assessments of new medicines. Decision-makers, particularly payers/HTA, still primarily rely on traditional elements of value (CEA, net cost) when assessing innovation. Novel assessments are needed to reward development of medicines that bring more holistic value and incentivise patient access to these medicines.

This panel will debate the need for a framework that includes patient- and system-focused value elements, process for implementation with decision makers, and for which medicines. Panellists will also debate the importance of manufacturers adopting a robust, structured, and strategic evidence prioritisation and generation process to support novel value elements, and of payers modifying their quantitative and qualitative assessments as part of their deliberative processes.

OVERVIEW: The moderator will present an overview (10 minutes) of the value elements currently included by key HTAs (ICER, G-BA, HAS, NICE). Panellists will present their arguments for the additional elements of value that should be considered when assessing new medicines and barriers to capturing evidence required to support additional value elements (15 minutes). The moderator will challenge the panelists to defend the elements needed to a part of a holistic framework that comprehensively captures economic, societal and patient value and a process for ensuring effective implementation (10 minutes). The audience will be engaged in a discussion of the need, value, and applicability of this new framework, and polled regarding further enhancements (25 minutes).