DEAL OR NO DEAL: THE EVOLVING USE OF COMMERCIAL ACCESS MECHANISMS IN NICE TECHNOLOGY APPRAISALS

Author(s)

David Aitken, MBiochem, Mark Orchard, BSc, Sophie Fox-Gmuer, MSc.
Cogentia Healthcare Consulting, Cambridge, United Kingdom.
OBJECTIVES: Commercial arrangements are an increasingly important tool for companies seeking to demonstrate cost-effectiveness and strengthen their value proposition during NICE appraisals. This research quantifies the proportion of NICE appraisals incorporating a commercial arrangement and characterises how their use has evolved over time.
METHODS: A review of the NICE website was conducted in May 2026 to identify technology appraisals containing a commercial arrangement. Appraisals that were terminated, superseded, non-recommended, or recommended only in research were excluded. No date restrictions were applied.
RESULTS: Of the 933 appraisals identified, 719 met the inclusion criteria. Within this subset, 428 (60%) included a simple patient access scheme (PAS), 113 (16%) a commercial access agreement (CAA), and 15 (2%) a complex PAS. Formally introduced under the Pharmaceutical Price Regulation Scheme, simple PAS adoption grew gradually between 2009 and 2015 and has remained consistently high since 2016. In contrast, CAAs were almost entirely absent before 2016 but have grown steadily following the launch of the Cancer Drugs Fund and, subsequently, the Innovative Medicines Fund as managed access routes, for which a commercial agreement is a prerequisite. Of the 15 complex PAS agreements, nine involved free stock, three a dose cap, and the remaining three comprised an outcomes-based agreement, a single fixed price, and a response scheme. Overall, commercial arrangements now feature in the vast majority of positive NICE recommendations (86% in 2025).
CONCLUSIONS: Commercial arrangements have become a routine feature of NICE appraisals. Early arrangements centred on complex PAS, before simple PAS discounts became the dominant mechanism; more recently, CAAs have grown rapidly, though their use remains far below that of simple PAS. Since 2015, most appraisals have featured a commercial arrangement, and manufacturers should now treat them as a core component of their NICE submission strategy.

Conference/Value in Health Info

2026-11, ISPOR Europe 2026, Vienna, Austria

Value in Health, Volume 29, Issue 12S

Code

HPR157

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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