The UK early access to medicines scheme: uptake, approvals, and reimbursement.

Objectives: The UK Early Access to Medicines Scheme (EAMS), launched in 2014, enables pre-license access to medicines for areas of high unmet medical need. This study aimed to evaluate the outcomes of the scheme by analyzing subsequent marketing authorization (MA), health technology assessment (HTA), and commissioning decisions.

Methods: We conducted a retrospective analysis of all completed EAMS programs from 2014 to April 2025, reviewing MA, HTA, and commissioning outcomes.

Results: Fifty-one EAMS programs were completed, over half in oncology. Median times from Scientific Opinion (SO) to MA, and reimbursement outcomes in England and Scotland were 4.3 (Q1: 2.6 and Q3: 7.3), 14.5 (Q1: 9.4 and Q3: 20.9), and 15.0 months (Q1: 11.4 and Q3: 18.1), respectively. Of 48 products appraised by the National Institute for Health and Care Excellence (NICE) or National Health Service (NHS) England, 50 percent received positive recommendations, 44 percent were optimized, and 6 percent were rejected. Of 45 products appraised by the Scottish Medicines Consortium or NHS Scotland, 73 percent were positive, 18 percent optimized, and 9 percent rejected. EAMS was qualitatively referenced in 48 percent of NICE appraisals and quantitatively in 18 percent.

Conclusions: Compared to non-EAMS products, those entering the scheme achieve faster MA and HTA timelines and higher regulatory success. However, EAMS is referenced quantitatively in less than a fifth of NICE appraisals, and fewer than half of Promising Innovative Medicine designations progress to a full SO. Administrative burdens, data demands, and liability concerns may limit uptake; addressing these barriers could enhance the scheme's impact.