Analysis of early access to cancer medicines in the United Kingdom following incorporation of the FDA-coordinated pathway, Project Orbis.

e23043 Background: After its withdrawal from the European Union, the United Kingdom (UK) transitioned to international regulatory collaboration via Project Orbis; an FDA-coordinated framework for concurrent oncology medicines review. While the Medicines and Healthcare products Regulatory Agency (MHRA) grants approval, nationwide patient access depends on reimbursement from the National Institute for Health and Care Excellence (NICE). Additionally, manufacturers may voluntarily apply for the Early Access to Medicines Scheme (EAMS); providing a pre-license "bridge" that grants access until regulatory determination. This study evaluates the impact on patient access as the UK shifts toward international regulatory work-sharing. Methods: A retrospective analysis compared two cancer medicine approval cohorts (n = 30 EAMS 2015-2025; n = 24 Project Orbis 2021-2025). Human impact was modelled by applying clinical trial Overall Survival (OS) gains to the duration of the access window (EAMS) or reimbursement gap (Orbis), weighted by monthly patient enrollment (High: 40; Medium: 15; Low: 5). For drugs with immature survival data, an EAMS-derived benchmark (4.2 months) used for imputation. For EAMS, a Net Access Gap was calculated by subtracting the pre-license access window from the standard reimbursement delay. Results: The annual volume of new oncology EAMS has decreased from a peak of 11 initiations in 2021 to 4 in 2022, 1 in 2023, and no initiations in 2024–2025. Median regulatory lag from FDA to UK approval was 163 days (IQR: 144) for EAMS drugs vs. 192 days (IQR: 94) for Project Orbis. The median reimbursement lag (MHRA to NICE) was 243.5 days (IQR: 310.25; n = 28) with EAMS medicines compared to 269 days (IQR: 500; n = 18) for Project Orbis. After accounting for the pre-license access window, the EAMS Net Access Gap was 127 days (IQR: 261.5). We estimate that pre-license access (EAMS) provided an estimated gain of 1,189.7 Quality-Adjusted Life-Years (QALYs). Utilizing the historical median EAMS window (120.5 days) as a benchmark, the opportunity cost of not utilizing a pre-license bridge for the Orbis cohort is 1,171.3 Life-Years (819.9 QALYs). Conclusions: FDA-coordinated pathways have become integral to UK cancer medicine approval, yet rapid regulatory approval can make pre-licensing schemes like EAMS less feasible to establish. Because the EAMS "bridge" that once mitigated reimbursement delays has diminished, the net duration patients spend without access has increased. For global stakeholders, this data suggests that regulatory acceleration alone is insufficient; without synchronized reimbursement, accelerated pathways may unintentionally result in a net reduction of the early access window once available to patients.