OBJECTIVES: The NICE methods review has proposed ways to provide faster, fairer access to medicines in the UK. This research aimed to establish the current status quo to monitor the impact of these changes moving forward. Particularly, given the differing published positive recommendation rates (EFPIA report: 67%; NICE’s website: 83%).

METHODS: Data was collected from 384 appraisals between July 2016 and May 2022 to enable calculation of an overall recommendation rate, observe how this has changed over time and identify any trends across variables extracted.

RESULTS: The analysis identified a positive recommendation rate of 76.3% (293/384) which was between that of the EFPIA and NICE figures (acknowledging analyses were conducted over different time periods). Of note, we observed the number of terminated appraisals (which were not included in NICE’s analysis), have been increasing, from 4% (2/50) in 2018 to 23% (20/87) in 2021. Of the 31 appraisals terminated in 2020/21, >63% of these received marketing authorisation within 12 months of termination, indicating these cannot be attributed to NICE clearing out-dated appraisals. However, 28.26% (13/46) of all combination therapies appraisals have been terminated, highlighting such appraisals have increasingly led to companies not submitting. Inconsistencies were observed in time to guidance by NICE committees, but more so with evidence assessment groups (EAGs), with the median time from marketing authorisation to reimbursement ranging from 314-414 days and 245-516 days, respectively.

CONCLUSIONS: This analysis has provided a baseline to allow monitoring of the impact of new access initiatives in the UK. However, it has also demonstrated the importance within metrics of incorporating all appraisal outcomes, including terminated appraisals. With the UK currently ranked 7^th in Europe for total availability of approved medicine (2017-2020) in the most recent EFPIA Waiting to Access Innovative Therapies (WAIT) report, holistically monitoring future trends is imperative.