OBJECTIVES: All current guidance for technologies assessed under NICE’s HST pathway contain positive reimbursement recommendations. However, for some technologies reimbursement is restricted to a smaller population than market authorisation, or is subject to a relatively complex commercial agreement (e.g., managed access agreement [MAA], patient access scheme [PAS]). This review was conducted to identify factors associated with reimbursement restrictions.

METHODS: Data from publicly available HST guidance documents (up to May 2022) were extracted to a data collection form. Qualitative language analysis was used to identify trends between technology and assessment attributes, and reimbursement restrictions.

RESULTS: 19 unique HST appraisals, excluding one reassessment, were analysed. Reimbursement was granted in restricted populations in 8 (42%) appraisals; 7 technologies (37%) were subject to complex commercial agreements (5 MAA; 2 PAS). A higher proportion of technologies with reimbursement in restricted populations were subject to complex commercial agreements versus those without population restrictions (63% vs 18%). Over time, a lower proportion of appraisals included complex commercial agreements (pre-2017, 80%; 2018 onwards, 21%).

Fewer technologies that the committee concluded were innovative were subject to population restrictions compared with technologies not considered innovative (50% vs 82%, respectively). Innovation status did not appear to be associated with complexity of commercial agreements issued. Other technology and assessment attributes, including QALY weightings, discount rates, and quality of life impact were analysed, but no associations with reimbursement restrictions were identified.

CONCLUSIONS: Many HST appraisals recommend reimbursement subject to population restrictions or a complex commercial agreement. There was a trend towards fewer complex commercial agreements over time, which may reflect changes to the HST process in 2017 or more recent preference for simpler, discount-based agreements. Innovation was identified as a factor associated with fewer population restrictions. However, there remains uncertainty around how other technology attributes are associated with the committee’s reimbursement decision making.