Presentation (CTI)

OBJECTIVES: The MHRA has recently refreshed and relaunched the Innovative Licensing and Access Pathway (ILAP) aimed at accelerating patient access to transformative new medicines. It is important that the life sciences sector understands how this will be achieved. This research aims to identify the key changes from the previous ILAP and explore the value that ILAP 2.0 could have for patient access.
METHODS: All published information from the MHRA and NICE on ILAP was leveraged to compile updates on the key changes. Functional experts within Takeda with prior experience of ILAP and responsibility for Clinical Science, Regulatory Affairs, Medical Affairs, and Market Access were consulted to evaluate the impact of the changes on pharmaceutical development and patient access. Three research questions were explored: What are the changes to ILAP, How does ILAP offer value for pharmaceutical development and patient access, What considerations are needed by pharmaceutical companies before using ILAP.
RESULTS: Key changes focus on: entry criteria, NHS involvement, application process, and support for developers to create a sustainable and impactful pathway. From the perspective of a global pharmaceutical company the services of the highest value are those associated with the prioritised scheduling pass and support achieving health system adoption. When assessing the value of ILAP we considered the likelihood of globally determined clinical development plans along with what services are also available outside of ILAP.
CONCLUSIONS: The refreshed ILAP could add value to pharmaceutical development and patient access for products which have not yet reached confirmatory trials, especially those with a rare disease focus. The ILAP service offerings provide a useful route for earlier engagement with regulators, HTA bodies and the NHS, although it is unclear how the abolition of NHS England could impact this pathway.