Objectives: In 2017, NICE introduced a fast-track process for highly cost-effective technologies; in April-2018, NICE introduced process changes to simplify and accelerate appraisals without compromising scientific rigour. NICE now aims to publish guidance within 90-days of marketing authorisation (MA) for most new medicines, in one Committee meeting. This research evaluates whether NICE’s process changes have delivered on these objectives.

Methods: NICE’s website was searched for publicly-available appraisal documents published between May-2017 and May-2020. Details of the technology, indication, process followed, timelines, number of appraisal consultation documents (ACDs) published, and recommendations were extracted for each appraisal. Appraisal timelines were compared against European MA dates (excluding resubmissions).

Results: Data were extracted for 215 medicines from 185 appraisals (155 under the pre-April-2018 process; 30 post). The median time between MA and final technology appraisal guidance (TAG) publication was 300 days (336 pre-April-2018 and 207 post). The median time between submission and TAG was 287 days pre-April-2018 and 272 post. Pre-April-2018, 4% of guidance was published within 90-days of MA and 16% within 180-days, versus 7% and 37% post, respectively. The proportion of appraisals where no ACD was published (i.e. straight to final guidance) was 19% pre-April-2018 and 40% post. Oncology medicines (n=121) benefitted most from process changes, with median MA-to-TAG timelines of 292 days pre-April-2018 and 184 days post, versus 371 days pre-April-2018 and 324 post for non-oncology medicines (n=94). Only 5/215 medicines had been appraised through the fast-track process since being introduced.

Conclusions: Recent NICE process changes have sped-up access to medicines in England and Wales by ~4 months, relative to MA. However, guidance is published within 90-days of MA in <10% of cases, most appraisals still require more than one Committee meeting, and the fast-track process remains underutilised. Further process refinements could help to ensure timely patient access for new medicines.