Presentation (CTI)

OBJECTIVES: Health technology assessment (HTA) agencies face growing pressure to evaluate more new active substances (NASs). England and Scotland have introduced streamlined HTA (sHTA) mechanisms for lower-risk submissions in established therapeutic classes where alternatives exist, replacing full appraisals with lighter-touch reviews. Both require similar clinical effectiveness, but their cost criteria differ: NICE’s Proportionate Approach requires the medicine to cost the same or less, excluding higher-priced products; SMC’s Abbreviated Submission accepts either equivalent/lower cost or limited net budget impact. We assessed whether sHTA is fit for purpose by comparing uptake, review times, and outcomes versus standard reviews.
METHODS: Data were extracted from the 1st HTA reports of NASs published by NICE and SMC between 1 January 2022 and 31 December 2025. Key metrics included pathway type (standard versus streamlined), median HTA review time (days), and HTA outcome, categorised as optimal (positive, positive with restrictions or multiple) versus non-optimal (negative).
RESULTS: 116 reviews were identified from NICE and 104 from SMC. NICE’s Proportionate Approach was used in 2.6% of reviews (n=3), compared to 11.5% for SMC’s Abbreviated Submission (n=12). Both pathways showed shorter median review times than standard reviews (195 vs 315 days in England (p=0.014); 95 vs 214 days in Scotland (p<0.001)) and a 100% optimal recommendation rate (3/3 NICE; 12/12 SMC), versus 89.4% and 73.9% for standard NICE and SMC reviews, respectively.
CONCLUSIONS: Both pathways delivered faster evaluations while achieving 100% optimal recommendation rates. This rate likely reflects eligibility criteria deliberately selecting low-risk, low-budget-impact medicines. The lower NICE uptake is consistent with a narrower route that excludes medicines priced above class comparators, though its more recent adoption may also contribute. This may affect whether sHTA can meaningfully increase appraisal capacity within the NASs pipeline. As submission volumes rise, sHTA offers a mechanism to protect timely patient access and reserve committee capacity for complex appraisals.