OBJECTIVES: In January 2021, the UK joined Project Orbis, a multi-nation programme coordinated by the FDA that provides a framework for concurrent submission and review of innovative oncology products to deliver faster patient access. This research evaluates all medicines approved by the MHRA under Project Orbis compared to EU, and how these were reimbursed in England by NICE and NHSE.

METHODS: All medicines approved by the MHRA under Project Orbis were identified from https://www.gov.uk/guidance/guidance-on-project-orbis, their corresponding reimbursement status in England from https://www.nice.org.uk/ and https://www.england.nhs.uk/, and their EMA regulatory status from https://www.ema.europa.eu/en (28-JUN-2022).

RESULTS: 11 oncology medicines have been authorised in the UK under Project Orbis, beginning in May 2021 (6: 2021, 5: 2022). 4/11 were new indications for already licensed therapies and 7/11 were new marketing authorisation applications. The EMA has authorised 10/11 (91%) of these medicines, 7/10 after the MHRA (mean delay: 31 days (range: -103 to +51 days). Only 4/11 (36%) have had a NICE appraisal, an average of 218 days after MHRA approval (range: 174 to 258 days). 3/4 were recommended (2/3 via the CDF) and 1/4 not recommended. However, 5/11 (45%) have been subject to a NHSE press release prior to NICE appraisal, 4/5 confirming funding (an average of 16 days after MHRA approval [range: 1-27]). 3/4 NHSE agreements confirming funding were on a budget neutral basis whilst NICE undertakes its appraisal.

CONCLUSIONS: Project Orbis has provided an opportunity for oncology medicines to be licensed in the UK several months before the EU. However, these earlier MHRA approvals have not translated into expedient NICE appraisals. Nevertheless, patient access is being achieved for some of these medicines in the interim through NHSE. Manufacturers should accordingly tailor their early engagement and pricing strategies to leverage the potential for expedient UK access through Project Orbis.