I first wrote about the Innovative Licensing and Access Pathway (ILAP) back in 2021 (and again in 2023) so many of you will be familiar with terms such as Innovation Passport (IP), Target Development Profile (TDP) and TDP Toolkit.
Over the last few years significant experience of the pathway has shown that the process can be improved and we will explore the relaunch here.
A quick recap on the ILAP and its aims
ILAP is an initiative which aims to speed up the time to patient care for transformative new medicines and drug-device combinations, aiding patient access by providing a single integrated platform for sustained collaborative working between the following partners:
- the developer
- the Medicines and Healthcare Regulatory Agency (MHRA)
- the UK Health Technology Assessment (HTA) bodies
- the National Health Service (NHS)
- the patients
Lessons learnt from the first ILAP launch in 2021
The ILAP pathway was becoming unsustainable due to the volume of applications and not specific enough criteria, and there was a lack of direct NHS involvement to support timely adoption of ILAP products. The following items were identified:
- more clarity needed
- entry criteria too broad
- more direct involvement of NHS needed
ILAP 2025 Relaunch
ILAP will focus on medicines that have not yet entered their confirmatory trial, thus giving more opportunity to benefit from the support offered within the pathway. Some of the key improvements that the new ILAP will bring compared to the existing pathway include:
- a better quality bespoke service through more selective entry and communication between the ILAP partners and developers
- a simpler roadmap and more predictable timelines
- the involvement of the NHS as a core partner focusing on operational planning and system preparedness for the introduction of innovative new medicines
- Prioritised scheduling of the ILAP Joint Scientific Advice (JSA), ILAP Access Forums, MHRA scientific advice and pre-submission meetings and access to Clinical Practice Research Datalink (CPRD).
ILAP can help with:
- Prioritised Access to Key Services
- Clinical Development
- Clinical Trial Delivery
- Market Access
- Health System Adoption
If you would like to discuss how Fusion Pharma can support you with ILAP Relaunched, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
