PHP364 - HOW TO USE RWE TO OPTIMIZE P&R OF NEW HEALTH TECHNOLOGIES

Abstract

Utilizing real world evidence (RWE) of disease burden and performance of technologies in clinical practice settings is increasingly a focus of the healthcare industry. However, the willingness and ability to use RWE in reimbursement decision-making varies significantly. This research aims to classify major national payers into archetypes based on their use of RWE in decision-making. Publically-available information on payer processes were screened from the relevant websites for UK (NICE), Germany (G-BA), France (HAS), Sweden (TLV), Australia (PBAC), Canada (CADTH) and Italy (AIFA) alongside a targeted search of appraisal outcomes for how RWE has been used. RWE has been used by payers to quantify the unmet need (all), support economic modelling (NICE, TLV, PBAC, CADTH) and/or validate the clinical benefit of a new technology. Some markets have regular HTA re-assessments (HAS) or produce time-limited outcomes (G-BA and NICE[CDF]) where local RWE on clinical benefits can be submitted. Reimbursement can also be linked to patient outcomes using RWE (AIFA [Onco registry], NICE [complex PASs] and PBAC [Managed Entry Schemes]). Few specific examples were identified where RWE directly supported favourable P&R outcomes. No RWE had been used in G-BA assessments, no HAS re-assessments using RWE had increased its ASMR, no drugs have completed the CDF [NICE] and MES [PBAC] processes, and a recent report of AIFA performance-based reimbursement concluded it only produced drug budget savings of 3%. Evidence of RWE directly supporting favorable reimbursement is limited to date. However, payer systems are evolving to better facilitate this. Utilizing RWE to support optimal reimbursement will necessitate a global evidence generation strategy as well as specific local implementation tactics to navigate local requirements. However, archetyping payers by RWE demands can enable a better-focused evidence generation strategy to optimize commercial success.