OBJECTIVES: To evaluate products that have been accepted under the Innovative Licensing and Access Pathway (ILAP) and investigate any trends and benefits.

METHODS:

Since the programme was launched, 113 applications have been made with 59 passports awarded by April 2022. Out of the 59 awarded, the information for 28 innovation passports has been made publicly available by the manufacturer, and therefore these were the technologies and companies we were able to investigate further by literature review and revision of primary and secondary data.

RESULTS: Of the 28 innovation passports, 25% qualify as advanced therapy medicinal products and 32% are oncology products. The majority (71%) of companies applied for the passport prior to stage III clinical trials, with 25% of medicines in pre-clinical development at the time of the passport being awarded. Due to most technologies being in such early stages, only 11% have submitted to the Scottish Medicines Consortium (SMC) and 18% have submitted to the National Institute of Health and Care Excellence (NICE). For the three that have applied, there has been a 100% success rate of technologies being recommended with the SMC and one positive recommendation with NICE while others await development (N=2) or are in progress (N=1). In the case of Lumykras (sotorasib), it received positive NICE and SMC recommendations approximately 60 days after EMA marketing authorisation, achieving reimbursement ~6 months sooner than what is commonly observed for oncology products.

CONCLUSIONS:

Most innovation passports are awarded during early stages of product development, although those at later stages have had a 100% success rate and reduced time for reimbursement. Although ILAP is a fairly new programme, it has shown popularity with 113 applications since January 2021; this may continue as awareness of the programme grows, and more details on the eligibility criteria and benefits of ILAP come to light.