Abstract
The National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) make recommendations to inform public reimbursement of healthcare technologies based on their clinical- and cost-effectiveness in England and Scotland, respectively. Some companies choose not to make a submission resulting in a terminated appraisal and non-reimbursement. This research aims to systematically analyse all NICE and SMC terminated appraisals. NICE single technology appraisals (STAs) and SMC advice were screened (01/01/2006-20/03/2018) and the recommendations, indications, and dates were extracted. All statistical tests were conducted using Pearson’s Chi square tests. 11% (37/342) of NICE STAs, and 19% (232/1248) of SMC advice resulted in terminated appraisals. For both NICE and the SMC, the proportion of non-submissions was numerically higher for oncology drugs vs. non-oncology drugs (NICE: 14% (24/174) vs. 8% (13/168), p=0.104; SMC: 22% (62/279) vs. 18% (170/969), p=0.069). There is a clear significant increase in the proportion of SMC advice with a non-submission outcome since the referendum outcome announcement (23 June 2016) versus those beforehand (30% (58/191) vs. 17% (174/1057), p<0.001), but no comparable trend for NICE (11% (12/114) vs. 11% (25/228), p=1), potentially reflecting the much longer timelines for NICE appraisals versus the SMC. For a significant minority of new health technologies (particularly oncology therapies), companies chose not to submit for public reimbursement in England and Scotland and this trend may be further increasing over time. This likely reflects NICE’s and SMC’s stringent evidentiary requirements for robustly demonstrating clinical- and cost-effectiveness, and that other countries formally and informally reference NICE and SMC decision-making. As ‘Brexit’ approaches, the potential prospect of a divergent UK regulatory/marketing authorization process could act as an additional hurdle that further deters companies from submitting for reimbursement and accentuates this trend.
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