Session (CTI)

In this Forum we will discuss the final recommendations from the ISPOR Statistical Evaluation of Surrogate Endpoints for HTA Decision Making Good Practices Task Force, which will be linked to the recent international HTA recommendations published by NICE on surrogate endpoints in cost-effectiveness analysis. The audience will gain a deeper understanding of statistical methods for clinical and economic value demonstration when surrogate endpoints are employed for licensing purposes. Despite the existence of guidelines on surrogate endpoints published by many HTA agencies, few HTA submissions explicitly present evidence supporting the translation of the treatment effect on the surrogate endpoints to the treatment effect on the target outcomes for clinical value and economic value demonstration. Dr Ciani will introduce the session (6 min). Dr. Bujkiewicz will discuss final recommendations related to statistical approaches available for surrogate endpoint evaluation, including considerations for predictions, associated uncertainty and emerging novel tools to tackle less optimal data scenarios to support decision making (12 minutes). Dr. Ouwens will discuss final recommendations around surrogacy and health economic modelling distinguishing partitioned survival analysis, state transition modeling and patient level simulations (12 min). Ms. Garrett will discuss implementation of the recommendations and compare the recommendations of the ISPOR taskforce to the recommendations of the HTA agencies report (12 minutes).Dr Ciani will open the Q&A session on these recommendations. The workshop ends with a poll on topics that deserve further exploration in future guidance (10 min).This informative workshop is designed for researchers, payers, regulators, and technology assessors, as well as for those working in the pharmaceutical industry or those interested in HTA and market access of health technologies.