OBJECTIVES: ILAP is a new pathway supporting innovative approaches to the safe, timely, and efficient development of medicines to improve patient access in the UK. The objective is to analyse the time to HTA recommendation for medicines following ILAP and evaluate how well the pathway is delivering against its stated objectives, from a manufacturer, regulatory, HTA, and payer perspective.

METHODS: Review of public information by targeted searches mentioning ‘Innovative Licensing and Access Pathway’. Analyses performed include quantitative analysis through descriptive statistics of the mean time from ILAP designation to regulatory approval and HTA recommendation, and qualitative analysis based on published statements including company stakeholders, regulatory, HTA, and payer opinion.

RESULTS: Thirty-six products awarded an Innovation Passport (IP) have been publicly identified from 1st January 2021 to 17th June 2022. The majority are in oncology (42%), followed by neurological diseases (11%), mental health (11%), and other areas (36%), including 16 products with an orphan designation. Approximately 47% of applications were submitted in early phase and 33% of identified products are recommended, under review, or prioritised for review by NICE. Specifically, six products have been prioritised for NICE appraisal, two have received a positive recommendation from NICE, and four have received a positive recommendation from SMC. Mean time from IP achievement to regulatory approval, MHRA 7 months and EMA 9 months, and from IP achievement to HTA recommendation, NICE 13 months, SMC 11 months. Interest in ILAP has exceeded expectations and manufacturers acknowledge its potential to expedite time to marketing authorisation.

CONCLUSIONS: As ILAP is a relatively new pathway, available data is immature, and further monitoring is needed to determine if ILAP delivers against its goals. For future investigation, we propose conducting analyses on the features that lead to successful applications and the impact on regulatory and HTA processes.