Decision-Making in NICE, SMC, and NCPE: Assessing Time From Regulatory Approval to HTA Decision Outcome

OBJECTIVES: Health Technology Assessments (HTA) on new medicines are conducted in Ireland by the National Centre for Pharmacoeconomics (NCPE) and in the UK by the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). This research aims to evaluate the variations in time from market authorisation (MA) to the publication of HTA outcome across the three assessment agencies in Ireland and the UK.

METHODS: Regulatory approval data and HTA outcomes from publicly available sources including the NCPE, SMC, NICE, European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) websites were collated in Excel®. A sample of 48 medicines with a HTA submitted to all three assessment agencies (NCPE, NICE and SMC) were identified between 2022 and 2024 and selected to assess the time to HTA outcome from original MA. For NICE and SMC, where the MA predates the MHRA conversion, the original EMA authorisation date is utilised.

RESULTS: The average time to HTA outcome from original MA was 1247.3 days for NICE, 1252.1 days for SMC, and 1652.3 days for NCPE. The proportions of outcomes below 1247.3 days were 46.94% (NCPE), 61.22% (NICE) and 55.10% (SMC). Similar cyclical patterns were observed for NCPE and SMC, which differed from NICE.

CONCLUSIONS: Time to HTA outcome from original MA in Ireland is significantly longer than that of the UK, taking on average 4.5 years in Ireland compared to 3.4 years in the UK. The results for NICE are longer than expected, due to the utilisation of original MA for medicines. Potential factors further influencing these results include the mandatory NCPE Rapid Review (RR) submission, the ability for NICE processes to commence pre-regulatory approval, and the different regulatory bodies between the jurisdictions as of 2021. Further analyses will include more data and MA extensions, where appropriate.