UK Market Access: The Evolving Scope of NICE and NHSE Specialised Commissioning

ABSTRACT

Objectives: Medicines are currently commissioned in England via Clinical Commissioning Groups (CCGs, following NICE appraisals) or national-level specialised services (that support people with rare, complex conditions) where commissioning is governed by NHS England (NHSE, who issue Clinical Commissioning Policies [CCPs] where there is a need, and no relevant NICE guidance exists). Under the 2019 Voluntary Scheme for Branded Medicines and Pricing and Access (VPAS), NICE committed to appraise all New Active Substances and significant new therapeutic indications by April 2020, except where there is a clear rationale not to do so. This research evaluates how the scope of NICE’s and NHSE’s CCP evaluations have evolved. Methods: Technologies considered under NICE Topic Selection or subject to NHSE CCP were identified from their respective websites and key information extracted (01-Jan-2015–21-Dec-2021). Results: 1,157 topics were considered, an average of 165/year (range112[2021]–251[2018]). 80% were prioritised for potential NICE guidance, 15% not prioritised, 2% routed to specialised commissioning, and 3% to other programmes/processes. From 2019, 90% of topics were prioritised versus 74% pre-2019 whereas topics routed to specialised commissioning fell from 2.4% to 0.2%. 216 health technologies have been the subject of NHSE CCPs, 49% were for medicines (76% of which were routinely commissioned), at a mean of 11.7/year (range1[2014]–23[2016]). The most common rationale for a medicine’s CCP was for off-label use (48%), followed by HIV indications (9%, not reviewed by NICE at that time). Conclusions: Since the 2019 VPAS, a greater proportion of (but by no means all) topics have been prioritised for potential NICE guidance and far fewer routed to specialised commissioning. However, NHSE CCPs are still developed for off-label/license considerations and medicines receiving routine licence extensions. Limitations of our analysis include the effects of the COVID-19 pandemic and any changes to Horizon Scanning, which may have acted as confounders.