The Innovative Licensing and Access Pathway (ILAP): Early Pathway Experience, Examining, Process Adaptations, and Industry Impact
Author(s)
Elzbieta Soltysiak, MSc, PhD1, Jelena Sostar, MSc2, Sanja Stanisic, MSc2.
1Certara Evidence and Access, Krakow, Poland, 2Certara Evidence & Access, Milan, Italy.
1Certara Evidence and Access, Krakow, Poland, 2Certara Evidence & Access, Milan, Italy.
OBJECTIVES: The Innovative Licensing and Access Pathway (ILAP), launched in 2021, aims to accelerate drug approval and patient access through multi-agency collaboration including MHRA, NICE, SMC, and others. In March 2025, ILAP was relaunched with significant revisions. This research reviews these changes and summarizes experience to date.
METHODS: ILAP policy updates, eligibility, and selection criteria were reviewed using MHRA public sources. Publicly available information on products granted an Innovation Passport (IP) from ILAP’s inception in January 2021 to 30th April 2025 were extracted and analysed.
RESULTS: Between January 2021 and November 2024, 235 IP application were submitted, of which 160 were granted. Data on indication, and issuance date were available for 72 IPs, corresponding to 62 unique medicines-47% of which held Orphan Designation Drug (ODD). At the time of IP award, 15% of products were in Phase 3 or Phase 2/3, 24% in Phase 2, 36% in Phase 1 or Phase 1/2, and 17% were in preclinical development. More therapies entering ILAP pathway were in earlier development stage (Phase 1/2 or preclinical), a trend expected to increase with ILAP relaunch, which prioritizes products prior to their confirmatory trials initiation. Among the 53% of IPs granted to non-orphan drugs, the most common therapeutic areas were oncology (37%), central nervous system disorders (29%), and cardiovascular/ metabolic disease (18%). Most of these were disease-modifying therapies (79%), with 52% targeting conditions for which no treatments are available or where existing options are only symptomatic (52%).
CONCLUSIONS: The new ILAP policy introduces somewhat more stringent eligibility criteria, but aims to offer more targeted and timely support for qualifying products. While diagnostics, immunizations, and medicines already in confirmatory clinical trials are now excluded, the scope has expanded to include novel drug-device combinations. The real-world impact of these changes on patient access remains to be fully evaluated.
METHODS: ILAP policy updates, eligibility, and selection criteria were reviewed using MHRA public sources. Publicly available information on products granted an Innovation Passport (IP) from ILAP’s inception in January 2021 to 30th April 2025 were extracted and analysed.
RESULTS: Between January 2021 and November 2024, 235 IP application were submitted, of which 160 were granted. Data on indication, and issuance date were available for 72 IPs, corresponding to 62 unique medicines-47% of which held Orphan Designation Drug (ODD). At the time of IP award, 15% of products were in Phase 3 or Phase 2/3, 24% in Phase 2, 36% in Phase 1 or Phase 1/2, and 17% were in preclinical development. More therapies entering ILAP pathway were in earlier development stage (Phase 1/2 or preclinical), a trend expected to increase with ILAP relaunch, which prioritizes products prior to their confirmatory trials initiation. Among the 53% of IPs granted to non-orphan drugs, the most common therapeutic areas were oncology (37%), central nervous system disorders (29%), and cardiovascular/ metabolic disease (18%). Most of these were disease-modifying therapies (79%), with 52% targeting conditions for which no treatments are available or where existing options are only symptomatic (52%).
CONCLUSIONS: The new ILAP policy introduces somewhat more stringent eligibility criteria, but aims to offer more targeted and timely support for qualifying products. While diagnostics, immunizations, and medicines already in confirmatory clinical trials are now excluded, the scope has expanded to include novel drug-device combinations. The real-world impact of these changes on patient access remains to be fully evaluated.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR206
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Approval & Labeling
Disease
No Additional Disease & Conditions/Specialized Treatment Areas