OBJECTIVES: To evaluate the Innovative Licensing and Access Pathway (ILAP) in the United Kingdom, designed to accelerate development and access to innovative medicines.
METHODS: Public information on products granted an "innovation passport" under ILAP since its inception in January 2021 through 27 June 2024 was evaluated for:
1. Trends in therapeutic areas seeing the most innovation
2. Clinical development stage at the time of receiving an innovation passport
3. Influence of the pathway on licensing and health technolgoy assessment (HTA) outcomes (National Institute for Health and Care Excellence [NICE], Scottish Medicines Consortium [SMC] and All Wales Therapeutics and Toxicology Centre [AWTTC])
4. Comparison of expedited status with other regulatory agencies (Food and Drug Administration [FDA] and European Medicines Agency [EMA])
RESULTS: A lack of transparency on the ILAP means there are no official publicly available resources to identify innovation passport awardees. Products can be entered into the ILAP at various stages of clinical development, from the preclinical stage through to mid-development, although products in the late stage of clinical development are less suitable for the ILAP. Most products are entered at early stage (phase 1 or 2). Therapeutic categories include oncology (39%), rare genetic disorders (22%) and metabolic disorders (6%). Information on the Medicines and Healthcare products Regulatory Agency (MHRA) website indicates an acceptance rate of 50% for ILAP applications. Among the 90 ILAP participants, 13 were recommended by NICE, 2 were discontinued and 1 was withdrawn. Among the ILAP awardees 32% received FDA Fast Tract designation.
CONCLUSIONS: Information related to the identification, clinical development stage at the time of application, evaluation, and outcomes is limited and inconsistent. Further clarity on information about the products awarded would be more useful for future applicants to evaluate their chance of success.
