ILAP 2025: A new formula for faster market access in the UK?

Last week the new Innovative Licensing Access Pathway (ILAP) was announced, aiming to address the criticisms and challenges of the 2021 pathway. What does this mean for manufacturers and does the new ILAP do what it set out to?

The 2021 iteration aimed to improve speed of access to the public for innovative medicines

• Launched in January 2021 to accelerate time to market by providing manufacturers of innovative medicines access to support when designing their submissions. This would include advice from MHRA and NICE and SMC covering both regulatory and HTA advice. 
• Despite promising aims there has been criticism that the program has not yielded the results expected. There have been reports of decreasing numbers of manufacturers using the pathway, time to access increasing and products being later withdrawn following approval due to low uptake.

The 2025 ILAP tries to address some of these issues through new partnerships

• The refreshed pathway aims to offer a ‘streamlined’ service partnering with the MHRA, NICE, SMC and the NHS to provide support from development to patient access, linking up key players across the healthcare system.

What is new in 2025 ILAP?

• Eligibility criteria has been refined and drug-devices are now in scope
  • The ILAP will now focus on products that have yet to reach pivotal clinical trial stage to best support the development of the therapy at an earlier stage, where outputs of advice and recommendations can be implemented with the end in mind.
  • Novel medicines and drug-device combinations designed to achieve specific therapeutic aims will be in scope of the ILAP. Previously, only medicines were in scope opening up a new route to improved access for drug-device manufacturers.
  • The entry criteria is more selective, which will impact the types of products suitable for ILAP. The updated criteria includes specific definitions to provide clearer guidance regarding a product’s eligibility:

• Timelines and processes have been updated to improve time to market
  • Timelines are more predictable to support planning.
  • Each product will have a single point of contact to help streamline communication and ensure clarity of next steps at each milestone.
• Increased NHS involvement to support patient access once approved
  • The NHS will be a core partner to the ILAP process to support with operational planning and ensuring system readiness at the time of launch.
  • Early engagement with patients and the NHS is expected to facilitate faster routes to access, which in turn aims to support the adoption of such medicines and improve uptake.
• Updated Target Development Profile (TPD) structure
  • The new TPD has a simpler ‘roadmap’ to help developers navigate the process.  The full details are still to be published but they are expected to include guidance on evidence development requirements.
• Prioritised scheduling of advice
  • The ILAP will offer access to ILAP joint scientific advice and the ILAP access forum as well as a priority scheduling pass for services including MHRA scientific advice, NICE advice, and prioritised access to services from the Clinical Practice Research Datalink (CPRD).
  • The services offered include clear guidance at which stage each meeting would support the development.
  • Partnering with the NHS will also include development of a UK-wide adoption strategy and monitoring the uptake of the ILAP product within the NHS.

Who stands to benefit from ILAP 2025?

• The changes to the pathway appear to go some way in addressing previous criticisms. In particular, the monitoring of uptake should allow course correction and understanding of roadblocks to encourage manufacturers that the process is designed to succeed.  However, until further details are published the true impact is still to be seen, and the more selective entry criteria may cause manufacturers to not consider the ILAP at all. However, there are some manufacturers in particular who should be considering ILAP at this point:
  • Drug-device developers: The inclusion of drug-devices is an exciting update which will offer medical device manufacturers a more streamlined and structured process to access. 
  • Those in early-stage development: The updated ILAP places a greater emphasis on early-stage clinical development, with a view to getting healthcare products addressing areas of high unmet need to patients faster. Products for which a pivotal study has already been developed, will not generally be eligible for ILAP. Manufacturers with products in early- stage development should review the guidance to consider if they may be eligible for ILAP.
  • Those with rare disease treatments: Despite some changes to the selection criteria, the 2025 ILAP provides continued encouragement to rare disease product manufacturers and suggests that such manufacturers should consider ILAP.

The updated 2025 ILAP represents a significant and positive advancement over the prior 2021 iteration. In particular, it recognises and sets out a framework for stronger collaboration between manufacturers and key actors in the UK healthcare system setting out clearer, more selective criteria for products considered eligible for the scheme, with the ultimate goal of getting faster access to products that hold promise of delivering transformative benefits to patients and the healthcare system at large. Assuming that the reality matches the aspiration, the earlier interaction between developers and key system-wide decision makers, should help make the UK a more desirable place to launch innovative products. Despite this positive optimism, it remains to be seen whether the updated scheme will actually deliver a “formula” for success.