The ILAP first launched in January 2021 to offer an integrated pre-market pathway awarding an Innovation Passport for promising medicines across England, Scotland and Wales. The pathway has seen an unprecedented number of applications and 160+ Innovation Passports have been awarded since it was launched.
What are some of the reasons for a relaunch of the ILAP?
- The MHRA wants to build on the successes, learnings and feedback from the first iteration of the ILAP to develop a more sustainable and impactful pathway that delivers benefits for medicine developers and patients in the NHS.
- The feedback from stakeholders on the first version of the ILAP has been that the offer was not clear enough, the entry criteria were overly permissive leading to the pathway becoming unsustainable, and there was a lack of direct NHS involvement to support timely adoption of ILAP products.
- The ILAP partner organisations have worked together to address the previous challenges and to clearly position the ILAP as the pathway in England, Scotland and Wales for transformative medicines that meet NHS unmet needs and require coordinated system support to take time out of the path to patient access.
When is the expected relaunch of the ILAP pathway?
January 2025
The MHRA intends to provide further information on the relaunch in January 2025, with full details of the new pathway, including:
- the new eligibility and selection criteria
- the new benefits package on offer within the ILAP
- the guidance documents for applications, being available by then.
March 2025
The new ILAP will launch and be open to applications in March 2025.
Until when will the current ILAP accept applications?
The current ILAP will only be accepting applications received up until 20 November 2024 in order to allow system partners and medicine developers to transition to the new pathway.
What will the new ILAP offer?
When relaunched, the ILAP will be the only end-to-end access pathway where the developer can work collaboratively with the following from the early stages of clinical development:
- UK’s national health system
- the Regulator (MHRA), and
- Health Technology Assessment (HTA) bodies .
The new ILAP offer will streamline important product development activities to reduce the time to patient access for transformative new medicines. This will be done by providing a single integrated platform for sustained collaborative working between:
- the developer
- the Regulator (MHRA)
- UK Health Technology Assessment (HTA) bodies and
- the NHS.
The MHRA will maintain exclusive access to ILAP Joint Scientific Advice and Access Forums which uniquely span regulatory, HTA and healthcare system expertise from across England, Scotland and Wales.
Which medicines will the new ILAP focus on?
The new ILAP will focus on medicines that have not yet entered their confirmatory trial, which will give more opportunity to benefit from the support offered within the pathway.
What are some of the key improvements that the new ILAP will bring compared to the existing pathway?
Some of the key improvements that the new ILAP will bring compared to the existing pathway are:
- Better quality bespoke service through more selective entry and dialogue between the ILAP partner organisations and the developers.
- Simpler roadmap and more predictable timelines, enabling developers to plan more effectively.
- The NHS will be involved as a core partner and will bring a focus on operational planning and system preparedness for the introduction of innovative new medicines into the NHS for the benefit of patients.
- Prioritised scheduling of the ILAP Joint Scientific Advice (JSA), the ILAP Access Forums, the MHRA scientific advice and pre-submission meetings and access to Clinical Practice Research Datalink (CPRD).
- The ILAP will be future-proofed to accelerate access for transformational products by broadening to drug-device combinations.
What about improvements to the initial step for Innovation Passport holders known as the Target Development Profile (TDP)?
The initial step for Innovation Passport holders, known as the Target Development Profile (TDP), will include a simpler ‘roadmap’ to help developers entering ILAP to more effectively navigate the support on offer and meet evidential requirements.
Will there be any changes to the entry criteria to the new ILAP?
The refreshed ILAP pathway will introduce more selective entry criteria to ensure that the focus remains on an identifiable cohort of potentially transformative medicines, which provide a step-change in care while also addressing unmet needs in the NHS.
Who can you contact if you have any queries about this announcement?
If you have general queries about this announcement, contact the MHRA on: innovationpassport@mhra.gov.uk
Source: MHRA