NICE’s new Innovative Licensing and Access Pathway (ILAP) is a novel, streamlined process for new medicines in the United Kingdom. Himani Jaiswal from Clarivate reviews how to participate and what benefits this can bring for manufacturers aiming to get their treatments to market more quickly.
Applying for the ILAP in the early product development stage can maximize benefits
The Innovative Licensing and Access Pathway (ILAP) process supports companies –– both commercial and non-commercial developers –– that are launching their medicines in the United Kingdom.
Companies are encouraged to apply in the early product development stage. The Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) will provide companies with advice and input on clinical trial design, to ensure optimal data generation for both regulatory approval and health technology appraisal (HTA). The pathway enables very early entry based on non-clinical data, leading to quicker market access for companies and faster access to innovative medicines for patients.
The ILAP process is a collaboration between drug regulators, permanent partners (MHRA, NICE and Scottish Medicines Consortium [SMC]), supporting partners (National Health Insurance [NHS] England and NHS Improvement) and other organizations, such as the Health Research Authority (HRA) and National Institute for Health Research (NIHR).
“The pathway enables very early entry based on non-clinical data, leading to quicker market access for companies and faster access to innovative medicines for patients.”
A product’s entry point depends on: the data available; the stage of product development; the applicant’s choice for new, innovative ways of working; and engagement with United Kingdom stakeholders. Products near the end of their development program are generally not suitable for the ILAP, as it is broader in scope and open to all innovative products. It does not replace the Early Access to Medicines Scheme (EAMS); applicants can apply for both.
The ILAP will lead to a new “innovative medicine” designation (Innovation Passport, a mandated entry point). The Innovation Passport utilizes the Target Development Profile (TDP) and tools from a toolkit.
Who can participate in ILAP?
Figure 1: Eligibility criteria for Innovation Passport
What steps do pharma companies need to take to kick off?
Figure 2: ILAP process
- The applicant applies for an Innovation Passport by completing the MHRA Innovation Passport submission form. The company is then invited to meet with the MHRA to discuss how their product fulfils the three criteria. Following the meeting, the partners (MHRA, NICE and SMC) jointly consider if the criteria have been fulfilled. The company is informed of the outcome within four weeks.
- After step one is completed, a TDP submission form is submitted by the company. The TDP defines key regulatory and development features, identifies potential pitfalls and creates a road map for delivering early patient access. As new knowledge is generated, the TDP (a living document) is updated along the development program timelines and milestones. After TDP form submission, the Innovation Passport holder is expected to present a summary of the content of each section of the TDP, highlighting specific challenges and opportunities for discussion and indicating which tools of the toolkit they are interested in utilizing, at the meeting with MHRA and partner colleagues. After the meeting, the partners develop the TDP road map, which is given to the Innovation Passport holder within four weeks, unless otherwise agreed.
- The toolkit includes innovative tools designed to support the ILAP and to bring promising medicinal products quickly, safely and more efficiently to patients. The toolkit provides a variety of application tools (such as adaptive tools and certifications), which can be individually selected based on the product, to support evidence generation and ensure regulatory compliance. Various novel tools, which are currently being developed, are expected to be added to the TDP toolkit during 2021.
What does this mean for pharma companies planning to launch medicines in the United Kingdom?
Figure 3: With and without the ILAP
The ILAP process includes input from drug regulators, HTA agencies and other partners to generate robust evidence leading to more efficient and quicker regulatory and HTA approvals. In 2019, the average time to HTA approval (NICE and SMC) in the United Kingdom after regulatory approval was 405.5 days (source: Context Matters Market Access Platform). The ILAP has the potential to significantly reduce the time to marketing authorization, market access and patient access.
Additional information about the ILAP can be found here.
To stay up to date on regulatory requirements and save time during submissions, visit clarivate.com/cortelliscmc.