The UK offers a unique advantage to manufacturers of new medicinal products, an accelerated pathway known as the Innovative Licensing and Access Pathway (ILAP) procedure. The ILAP procedure was introduced in January 2021 and is available at the pre-clinical trial stage through to the mid-development point. It smooths the regulatory process by bringing key stakeholders to the same table to discuss and advise on the roadmap to support the development and launch of the new product. These stakeholders include UK regulator MHRA and the health technology assessment (HTA) bodies of England, Wales, and Scotland (which are responsible for assessing the cost-effectiveness of treatments), the UK’s National Institute for Clinical Excellence (NICE), the All Wales Therapeutics and Toxicology Centre, and Scottish Medicines Consortium.
Through the ILAP, procedure developers can find out, at different stages, what evidence the regulators will require to assess their product to get it authorized and also assessed as cost-effective so that it can be recommended by the national healthcare provider. Such a process does not exist in any other country at the moment, although the EU is contemplating a similar approach through the European Commission’s horizontal measures, part of its ongoing review of pharmaceutical legislation.
To enter the new ILAP pathway, medicine developers need to apply for an Innovation Passport designation. Their applications will be assessed by the ILAP Steering Group based on criteria that include whether the condition to be treated is life-threatening, whether the product is an innovative medicine, and whether it offers better efficacy than existing products.
Although it is still early days, ILAP has already shown the potential to accelerate the effective market access of innovative products. This is largely because the process means companies generate and submit relevant data and well-evidenced value propositions that not only support the granting of a marketing authorization from the MHRA but are likely to lead to the product’s being recommended by NICE.
The UK is also a world leader, in many respects, in its acceptance of Real World Evidence (RWE) for both marketing authorization and pricing. In May 2022, NICE restructured its entire method and processes for product review. As part of this restructuring, it said it would accept interim recommendations based on RWE while the final data set is being generated. The allowance of RWE addresses what was a key hurdle to launching a new product in the UK: that there is often not enough evidence on the clinical and cost effectiveness of the proposed treatment compared with existing alternatives. This new approach from NICE will particularly benefit products that are authorized under an accelerated procedure due to unmet medical needs and life-threatening conditions where the full set of scientific clinical data is not available.