OBJECTIVES: England and Scotland have separate health technology assessment (HTA) programs, with process differences sometimes leading to divergent recommendations. The objective of this research was to characterise trends and reasons for differences in National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) submission outcomes.

METHODS: All publicly-available technology appraisal advice was extracted from the NICE and SMC websites from January-2010 to January-2018. Superseded, suspended, terminated, and non-submissions were excluded. Submission outcomes including restrictions, cost-effectiveness assessments, and evidence critique were recorded for all products assessed by both agencies. Concordance was assessed using Cohen’s kappa and reasons for divergence were explored.

RESULTS: A total of 371 NICE and 576 SMC decisions were extracted. Overall outcomes for NICE were 51% recommended, 29% restricted, and 20% not recommended; outcomes for SMC were 43% recommended, 35% restricted, and 22% not recommended. Additionally, there were 154 non-submissions to SMC and 38 to NICE. 129 treatments had been appraised by both agencies across 174 indications, with the same decision reached in 65% of cases (n=113) and a different decision reached in the remaining 35% (n=61; Cohen’s kappa=0.40, indicating fair-to-moderate agreement). Most differences related to the nature of acceptance (i.e., recommended by one agency while restricted by the other); however, there were 17 instances of products recommended/restricted by NICE being rejected by SMC, while 2 submissions recommended/restricted by SMC were rejected by NICE. Reasons for variation included differing judgements of cost-effectiveness, decision-modifiers such as differing end-of-life criteria, and subgroup restrictions.

CONCLUSIONS: NICE and SMC decision-making aligns in around two-thirds of cases, but divergence can result from differing assessment criteria and processes. Further, many products are appraised by one agency but not the other, potentially leading to heath inequalities between England and Scotland. There may be more need for consistency between NICE and SMC in terms of decision-making.