The UK Innovative Licensing and Access Pathway—A new paradigm in market access

Introduction

Following the departure of the United Kingdom (UK) from the European Union (EU) on January 31, 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) became the main body for the regulation of medicines in the UK. In parallel, and as a result of Brexit, a new and unprecedented era was born for the approval of medicines in the UK. This article explores the Innovative Licensing and Access Pathway (ILAP) and the opportunities it has introduced in potentially transforming the future of UK* market access.

The ILAP was launched on January 1, 2021 as a pioneering pathway for commercial and non-commercial product developers. The pathway created a single integrated platform for collaborative consultation with both regulatory and reimbursement bodies and was the first time the MHRA, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the All Wales Therapeutics and Toxicology Centre (AWTTC) had come together with supporting partners to facilitate a unified process for streamlining the “bench to bedside” pathway. 

New MHRA marketing authorisation routes 

Marketing authorisation for new medicines in the UK has been historically granted by the European Medicines Agency (EMA) under a unified licence for all countries in the EU. Companies wishing to license medicines in the UK outside of the EMA’s centralised authorisation procedure have sought marketing authorisation with the MHRA. Post-Brexit, the MHRA will continue to adopt EMA decisions until December 31, 2022 via the European Commission Decision Reliance Procedure (ECDRP) and the decentralised and mutual recognition reliance procedure (MRDCRP). Furthermore, following Brexit, the MHRA has maintained international links by joining a couple of collaborative regulatory associations: Project Orbis (a United States Food and Drug Administration-led international collaboration of selected global regulatory bodies for the review and approval of new oncology treatments); and the Access Consortium (an alliance of regulators from Australia, Canada, Singapore, and Switzerland who share a joint strategy for increased and expedited patient access to new technologies). This article, however, focuses on national MHRA marketing authorisation channels, a number of which have been launched as new and enterprising routes for manufacturers to consider after Brexit (Figure 1).

Post-Brexit new national marketing authorisation routes

(i) Accelerated 150-Day Review, enabling potential regulatory approval of a product within 150 days of submission in the UK.

(ii) Rolling Review, enabling the modular evaluation of a treatment as data become available to simplify and accelerate approval in the UK. The first Covid-19 vaccines underwent a rolling review thus enabling expedited patient access, in advance of other countries in Europe.

(iii) Unfettered Access Procedure (UAP) for Marketing Authorisation in Northern Ireland.
Northern Ireland continues to fall under the EMA's centralised authorisation procedure after Brexit. Manufacturers holding product marketing authorisation in Northern Ireland, the EU, or the European Economic Area (EEA) states can potentially secure MHRA approval in the other devolved nations that constitute the UK (England, Scotland, Wales) within 67 days unless major objections are raised, which would result in transfer to the national marketing authorisation process.

New national route encompassing MHRA marketing authorisation and reimbursement in the UK

(iv) The ILAP, a novel pathway formed by the MHRA, NICE, SMC, and the AWTTC to constitute a unified and seamless path for patient access to innovative new technologies in the UK.*  

Figure 1. National marketing authorisation channels in the UK

The ILAP

The ILAP aims to provide significant benefits to patients, the National Health Service (NHS) and the life sciences industry by delivering a safe and efficient route for accelerated access to new medicines, as well as encouraging growth of pharmaceutical research and investment in the UK. In addition to the 4 main bodies (MHRA, NICE, SMC, AWTTC), supporting organisations such as NHS England and NHS Improvement (NHSEI) and the National Institute for Health Research (NIHR) are associated partners within the pathway. The ILAP has notably for the first time facilitated collaboration between NICE, the AWTTC, and the SMC under a unified umbrella to support activities, provide scientific advice, and engage a variety of stakeholders in the health technology assessment (HTA) evaluation of new technologies. Product developers within the ILAP are able to jointly consult all partners as required at each stage and discuss potential hurdles in advance for obtaining concurrent advice on navigating the path for successful market access. In spite of this, it is important to note HTA processes for each body remain distinct within the pathway.
 
Ideally, organisations should apply to enter the pathway as early as possible in the initial stages of product development when the ILAP bodies can provide timely advice on clinical trial design and data generation to meet the needs of both regulatory and reimbursement assessment. Organisations can, however, enter the ILAP at any stage of development (Figure 2) and receive support to achieve successful approval in the UK. Medicines currently supported by the ILAP include new chemical entities, biological medicines, new indications and repurposed medicines. Similar pathways are planned to support medical devices, diagnostics, genomics, and digital health technologies in the future.

Figure 2. Comparison of the UK market access route with and without the ILAP

The Innovation Passport and Target Development Profile

Entry to the ILAP is granted upon successful application for the Innovation Passport (IP), which is mandatory for entry to the pathway. The product should meet specific criteria to achieve the IP, including the fulfillment of significant patient or public health need. On successful IP designation, the development of a Target Development Profile (TDP)-tailored roadmap is initiated for the product together with a selection of innovative tools for market access, for example, novel clinical trial design support and Clinical Practice Research Datalink (CPRD)-assisted recruitment for clinical trials. Fees are payable on application to the ILAP as well as at specific stages within the pathway. Fees are also likely to be attached to the tools in the TDP if organisations choose to employ them. Notably, the ILAP includes patient representatives as consultees at each stage, including the initial decision-making stage for IP designation and entry to the pathway. The ILAP and IP do not replace the Promising Innovative Medicines (PIM) designation and the NHS Early Access to Medicines Scheme (EAMS) which remain incumbent with separate objectives and distinct pathways in the NHS, but products within the ILAP could also take the PIM/EAMS route. 

Opportunities provided by the ILAP and the future of UK medicines approval 

In addition to Brexit, the pandemic has precipitated an urgent need for active collaboration and a unified approach across regulatory, scientific, and reimbursement bodies for the approval of new treatments. The ILAP has created the first consolidated UK platform for optimised patient access. 

If an applicant embarks on the ILAP and follows the advice provided by the ILAP partners throughout the process, potential market access obstacles that may have otherwise arisen could be obviated. Moreover, multi-stakeholder consultation with the ILAP partners as required at each stage should result in consistent dialogue and a fluid and homogenous market access route.

A number of channels now exist for organisations to seek regulatory approval in the UK. The ILAP has certainly positioned itself as a model to consider for accelerated market access and one whereby both marketing authorisation and reimbursement in the UK could be achieved efficiently and in tandem.  Small- to medium-sized organisations, in particular, could gain advantage in securing regulatory, reimbursement, and scientific advice from the outset for a smoother patient access path. As a result of this, considerable time and resources could be saved that may otherwise have been expended in achieving market access outside of this novel channel.

^{*Northern Ireland remains in the European single market following Brexit. The ILAP is technically a pathway for England, Scotland, and Wales, the countries constituting Great Britain. However, in most cases MHRA licensing continues to apply to Northern Ireland, as does NICE guidance (post-licence). As a result of this, market access in Northern Ireland is also covered by the ILAP.}

The article should be referenced as follows:

Baig F. The UK Innovative Licensing and Access Pathway—A new paradigm in market access. HTA Quarterly. Spring 2022. https://www.xcenda.com/insights/htaq-spring-2022-uk-innovative-licensing-and-access-pathway/

Sources

•  https://www.gov.uk/guidance/innovative-licensing-and-access-pathway
•  https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
•  https://www.gov.uk/guidance/decentralised-and-mutual-recognition-reliance-procedure-for-marketing-authorisations
•  https://www.gov.uk/guidance/guidance-on-project-orbis
•  https://www.gov.uk/guidance/access-consortium
•  https://www.gov.uk/guidance/rolling-review-for-marketing-authorisation-applications
•  https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine
•  https://www.gov.uk/guidance/unfettered-access-procedure-for-marketing-authorisations-approved-in-northern-ireland