OBJECTIVES: Since 2018, the treatment pathway for non-squamous (NS) non-small cell lung cancer (NSCLC) has undergone significant transformation in the UK with 24 treatment options recommended for use by the National Institute for Health and Care Excellence (NICE). Of these treatments, 10 made use of the MHRA’s early access pathways (EAP), including Early Access to Medicines Scheme (EAMS), Innovative Licensing and Access Pathway, and Project Orbis. The aim of this research was to determine whether an EAMS positive scientific opinion, awarding of an innovation passport, or approval through Project Orbis provided an advantage for NICE review timelines.

METHODS: Treatments reimbursed in England for patients with NS NSCLC between 1^st January 2018 and 31^st May 2023 were identified from published NICE technology appraisals. The identified treatments were cross-checked against current and expired positive scientific opinions for EAMS and the list of treatments assessed through Project Orbis. A web search was also conducted to determine whether an innovation passport had been awarded. The time between marketing authorisation (MA) and NICE appraisal was compared between newly available treatments.

RESULTS: In NS NSCLC, the time from MA to NICE reimbursement varied between 69 and 958 days. The average length of time from MA to reimbursement was 296 days for drugs that entered into EAP, compared to 355 days for those not using EAP. Note that two treatments, atezolizumab monotherapy and entrectinib, were both approved in less than 100 days despite not entering any of the EAP. Nivolumab and pembrolizumab, which received EAMS positive scientific opinions, both took over 500 days from MA to NICE.

CONCLUSIONS: Entry into the MHRA early access programmes does not seem to have reduced the length of time taken for NICE reimbursement for NS NSCLC treatments.