The most significant of these new routes to market authorisation is the
Innovative Licensing and Access Pathway (ILAP) launched in January 2021 by
National Institute for Health and Care Excellence (NICE),
the Scottish Medicines Consortium (SMC), and later joined by the
All Wales Therapeutics and Toxicology Centre (AWTTC) as a new pathway to support the safe, timely and efficient licensing and access to innovative medicines. The ILAP partners work with other organisations to provide a single collaborative route for drug development, drug licencing and patient access. Although Brexit was the main stimulus for the ILAP, elements of its design were inspired by other activities including the collaborative and multi-disciplinary RAPID C-19 initiative
(Research to Access Pathway for Investigational Drugs for COVID-19) that was assembled to tackle the concurrent COVID pandemic. Rather than being reliant on ad hoc support, the ILAP enables sponsors to obtain end-to-end integrated support from MHRA, relevant HTA bodies and other invited stakeholders. To be eligible to enter ILAP, sponsors must first ensure their IMP programme fulfils the Innovation Passport designation criteria outlined in Table 1. Eligible medicines include, but are not restricted to, novel chemical entities, advanced therapies, medicines for rare diseases, special populations or new indications for repurposed medicines. ILAP is open to both commercial and non-commercial sponsors based within UK or internationally and can support projects in very early stages of development or at mid-development stages.
Table 1: Criteria for obtaining an Innovation Passport
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Criteria 1: Details of the condition, patient, or public health area
a) The condition is life-threatening or seriously debilitating or
b) There is a significant patient or public health need
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Criteria 2: The medicinal product fulfils one or more of the following areas:
a) Innovative medicine such as an ATMP or new chemical or biological entity or novel drug device combination
b) Medicine is being developed in a clinically significant new indication for an approved medicine
c) Medicine for rare disease and/or other special populations such as neonates and children, elderly and pregnant women
d) Development aligns with objectives for UK public health priorities (Chief Medical Officer, DHSC or Life Sciences Sector Deal)
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Criteria 3: Medicinal product has the potential to offer benefits to patients
Summary of how patients are likely to benefit, including improved efficacy or safety, contribution to patient care or quality of life, as compared to alternative therapeutic options.
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The process of engaging in ILAP is stepwise.
ILAP Innovation Passport: To join ILAP, sponsors are first required to complete an
Innovation Passport application online which requires brief information about the IMP and its target patient population. The passport is allocated to the IMP and a lead indication, previous clinical evidence is not a requirement, and applicants can draw from non-clinical models or other relevant models. Applicants will then be invited to discuss how their IMP fulfils the criteria, usually within 4-6 weeks. The decision to award a passport is made within 4 weeks of this meeting by the ILAP partners.
Target Development Profile: After successfully obtaining an Innovation Passport, sponsors are required to complete a
“Target Development Profile” (TDP) submission form providing more detailed information about the development of the IMP, foreseeable goals and challenges as well as the amount of patient engagement required. They are then invited for a meeting with ILAP partners to develop a TDP roadmap. The roadmap is jointly produced with the sponsor; utilising the appropriate tools from the ILAP toolkit to address any issues that may potentially hinder regulatory and access approval. The TDP is designed to be a living document and will include a timeline and milestones as new information is added. This enables upfront descriptions of what is required from sponsors at specific stages along the development programme with the aim of expediting approvals and increasing the likelihood of positive reviews from ILAP partners during the later approval steps.
The ILAP toolkit: Tools within the toolkit are listed on the MHRA website; there are currently eight tools available that can be selected by sponsors to support a “regulation and access ready” development programme. Available tools include continuous benefit-risk assessment integrating real world evidence, access to recruitment populations via the
Clinical Practice Research Datalink, increased support for novel trial methodologies, and provision of enhanced patient engagement. Depending on the medicine and the sponsors’ position in the development programme, one or more of the tools in the toolkit can be used.
