NICE have published nine HST guidance, all with positive recommendations, a median of 20 months (range 7-38) after European MA. An additional 11 HST guidance are in development with MAs for a median of 14 months (range: 0-53) with six having draft guidance issued, all being "not recommended". Of the 20 HSTs with NICE guidance published/in-development, 16, 14, 8, 6, 2, and 6 were assessed by HAS, G-BA, NCPE, SMC, TLV, and ZIN, respectively. Of these, 22/30 (73%) and 7/22 (32%) of assessments made by clinical-effectiveness and cost-effectiveness HTA bodies received positive outcomes, respectively, with median delays between European MA and positive appraisal outcomes of 7 and 37 months, respectively. Conclusions: Although NICE HST appraisals have more positive recommendations and have faster time to recommendations following European MA than other costeffectiveness HTA bodies, time to positive recommendation is still substantially delayed compared to clinical-effectiveness HTA bodies. In 2018, a new SMC appraisal framework was introduced, whereby ultra-orphan therapies would be made available for $3-years while additional evidence is collected pending a final SMC appraisal. This could potentially prove a more suitable best-practice model.
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