OBJECTIVES: Following Brexit, the MHRA has become the standalone regulator for medicines in the UK (except Northern Ireland). To ensure timely access to innovative oncology products, the UK joined Project Orbis, an FDA-led review programme. This research compares UK reimbursement outcomes for medicines approved through Project Orbis with EU4.

METHODS: MHRA-approved products through Project Orbis were identified from https://www.gov.uk/guidance/guidance-on-project-orbis. MHRA, EMA authorisations, and EU4 reimbursement assessments were extracted from their respective websites (19-Dec-2022).

RESULTS: 14 products have been authorised in Great Britain via Project Orbis, with 9/14(64%) also authorised in Europe. MHRA approval was, on average, 55.6 days earlier than EMA. Time from regulatory approval to HTA publication was 249 days (NICE), 199 (SMC), 263 (HAS), 241 (G-BA), 295 (AIFA), 328 (AEMPS). However, 5/14(36%) agreed on NHSE funding before NICE guidance publication, which expedited access by a mean of 69 days. In England, 7/14(50%) were NICE-assessed, 6 were recommended (3/6[50%] via the CDF). In Scotland, 7/14(50%) were SMC-assessed and 5/7(71%) recommended. In France, 6/14(43%) were HAS-assessed, but only 1/6(17%) achieved an ASMR I-III. In Germany, 7/14(50%) were G-BA assessed but only 2/7(29%) achieved additional benefit. In Italy, 3/14(21%) were AIFA-assessed, and all were reimbursed. In Spain, 2/14(14%) were assessed by AEMPS, and both were reimbursed.

CONCLUSIONS: Most therapies approved under Project Orbis in the UK have also been EMA-approved. Although the UK Orbis approvals are earlier versus EMA, this is by <2 months. Nevertheless, several have achieved favourable NICE and SMC outcomes, whereas both the number of therapies assessed, their time to reimbursement and outcomes are much less favourable in many EU4 countries. Project Orbis offers a route for expedited UK oncology access, but manufacturers need to ensure that they have a tailored pricing and market access strategy ready to take advantage of this fully.