OBJECTIVES: Post-Brexit, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) pursued different reliance/work-sharing routes. This study investigates new active substances (NASs) approved by MHRA through three pathways: European Commission Decision Reliance Procedure (ECDRP), Access Consortium (Access), and Project Orbis (Orbis), and assesses the impact of these routes on Health Technology Assessment (HTA) review times and outcomes by England's National Institute for Health and Care Excellence (NICE) and Scotland's Scottish Medicines Consortium (SMC).

METHODS: Data was extracted from MHRA reports, NICE guidance, and SMC advice from NASs approved by MHRA between 01-Jan-2021 to 31-Dec-2022 through ECDRP, Access, or Orbis. Time to recommendation was calculated as FDA approval to HTA recommendation, and HTA review times as time from HTA submission to recommendation. HTA recommendations were classified as positive, positive with restrictions, and negative.

RESULTS: We identified 47 HTA assessments (59.6% [28/47] from NICE, 40.4% [19/47] from SMC), involving 31 unique NASs in total. The ECDRP route constituted 66.0% of all HTA assessments, followed by Orbis (12.8%) and Access (8.5%). The route of 12.8% of assessments was unclear. The mean (SD) time to recommendation was 482 days (230) for ECDRP, 256 (79) for Access, and 516 (222) for Orbis products. No difference was observed for the time to recommendation (p=0.074) or HTA review time (p=0.6) between pathways. HTA review times from SMC were significantly faster compared to NICE (p<0.001). HTA recommendations were generally evenly distributed across all pathways, with ECDRP, Access and Orbis products receiving 48%, 50%, and 67% of positive recommendations, respectively.

CONCLUSIONS: The current post-Brexit regulatory landscape in the UK predominantly relies on the ECDRP. The contrast between NICE and SMC review times can relate to their different review processes. HTA recommendations were generally distributed evenly across all pathways, suggesting the reliance route does not impact HTA outcomes.