What Is a Highly Specialised Technology (HST)? The Revised NICE HST Criteria in Practice

OBJECTIVES: The National Institute for Health and Care Excellence (NICE) updated their criteria for the HST Program in February 2022: (1) disease prevalence <1:50,000; (2) <300 treatment-eligible patients in England; (3) disease significantly impacts length/quality of life; and (4) no satisfactory treatment options exist or technology offers significant benefit over existing treatment. Judgements on the eligibility of technologies for the HST Program are naturally subjective, and NICE states that these criteria were designed to facilitate consistent and predictable decision-making. This research aims to explore NICE’s application of the revised HST criteria.

METHODS: The NICE website was searched for ongoing and published technology appraisals (TAs) and HSTs with invitations to participate post-February 2022. Published HST checklists were identified and reviewed to determine how NICE evaluated candidate technologies against the HST criteria.

RESULTS: Eleven published HST checklists were identified; of these, only one appraisal was subsequently routed to HST having met all four criteria. Criterion 1 was satisfied by 6/11 appraisals and criterion 2 by a different set of 6/11 appraisals. In most appraisals (10/11), NICE based their decisions for criterion 1 on the prevalence of the full population with the broad disease, instead of the licensed indication. 5/11 appraisals did not meet criterion 3; of these, impacts on length/quality of life were considered significant for only a proportion of the population (2/5 appraisals) or were deemed unclear/not significant (3/5 appraisals). 3/11 appraisals met criterion 4; there were considered to be no satisfactory treatments available for all three conditions. 0/11 interventions were considered to offer significant additional benefit over existing treatments.

CONCLUSIONS: Clarifying the HST criteria wording and providing greater detail on what may be considered ‘sufficient’ evidence may improve predictability in decision-making, allowing manufacturers to better assess the suitability of their treatments for HST, thereby offering efficiencies to all stakeholders.