Consistent Decision-Making by NICE's TSOP Highlights Product Innovation as Critical for HST Routing Success

OBJECTIVES: This study aims to analyse the key determining criteria for HST/STA routing decisions from publicly available HST checklists.

METHODS: Publicly available NICE HST checklists were reviewed and assessed against final routing outcomes/status. Duration of appraisal process was also evaluated. Researchers then analysed the findings to interpret key patterns in decision-making against the four HST criteria.

RESULTS: As of June 2024, we identified 13 published HST checklists publicly available on the NICE website. Of these 13, we found that only 5 ultimately became HST, 6 routed to STA and 2 STAs were suspended. Checklist evaluation showed that, on average, HST criteria were ‘met’ 9/13 times (69%). The last criterion (regarding benefit over existing treatment options) was split between ‘met’ 7/13 times (54%) and ‘not met’ 6/13 times (46%). Criteria stratification, based on HST/STA outcome, showed that HST appraisals met all four criteria. However, for the six STA-routed appraisals, criteria decisions were deemed ‘met’ or (at the other extreme) ‘unmet’ in equal measure (n=11 times), with only two ‘partially met’ and four ‘unclear’ decisions made. Lastly, evaluation of time to reimbursement shows that, on average, HST's take longer than STA's (1.5 years more) to achieve final reimbursement.

CONCLUSIONS: Our findings suggest that rare disease products only achieve HST routing when all criteria are met. Markedly, the last criterion (benefit over existing treatment options) was unmet 5/6 times (83%) for technologies that failed to qualify for HST according to TSOP. This signals that product innovation is a key determinator for successful HST routing. Moreover, criteria assessment decisions are generally polar extreme, indicating consistent decision-making by TSOP against HST checklist criteria.