Investigational treatments for hepatocellular carcinoma and dementia with Lewy bodies have been granted Innovation Passports through the UK’s Innovative Licensing and Access Pathway (ILAP).
The designations will give the developers access to earlier and more coordinated guidance from medicines regulators, health technology assessment bodies and the NHS as they generate evidence and prepare for potential regulatory and reimbursement decisions.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced the awards as it opened the next ILAP application round, which will run from 4 August until 4 November 2026.
Supporting treatments for areas of unmet need
Innovation Passports are awarded to products that could address an unmet clinical need and have the potential to deliver significant benefits for patients.
Following consideration by the ILAP Selection Panel, passports have been awarded to:
- A biological medicine for hepatocellular carcinoma, the most common form of liver cancer; and
- A small-molecule medicine for dementia with Lewy bodies.
Around 7,000 people are diagnosed with liver cancer in the UK each year, while dementia with Lewy bodies is estimated to affect approximately three in every 20 people living with dementia. Treatment options for both conditions remain limited.
The products are still under development. Their future availability will depend on clinical evidence demonstrating that they are safe, effective and provide value to patients and the health service.
A coordinated route through regulation and market access
ILAP is intended to give developers a more joined-up route through the processes that shape the development, licensing, assessment and potential adoption of innovative medicines.
The programme brings together the MHRA, NHS England and the UK’s health technology assessment organisations: the National Institute for Health and Care Excellence, the Scottish Medicines Consortium, the All Wales Therapeutics and Toxicology Centre and the Department of Health in Northern Ireland.
Through the pathway, developers can engage earlier with the organisations responsible for regulation, evidence assessment, reimbursement and NHS access. The aim is to identify evidence requirements and potential barriers earlier in a product’s development, rather than waiting until regulatory and market-access submissions are already under way.
James Pound, MHRA Executive Director for Innovation and Compliance, said:
“These latest Innovation Passport awards demonstrate the breadth and ambition of the Innovative Licensing and Access Pathway.
“By supporting innovative medicines across a diverse range of therapeutic areas, the ILAP helps developers engage with the regulatory system earlier and more effectively, with the ultimate goal of enabling earlier patient access to innovative new treatments.
“We are delighted to recognise these two innovative products and look forward to supporting their development through the pathway.”
Evidence generation must begin early
Receiving an Innovation Passport does not constitute regulatory approval or a recommendation that the NHS should adopt a treatment.
Instead, it provides a structured route through which developers can discuss the evidence that regulators, assessment bodies and health services will ultimately require.
This early engagement may be particularly valuable for medicines targeting complex conditions, where clinical trial design, suitable outcomes, patient populations and longer-term evidence requirements can be difficult to establish.
John Spoors, Programme Director for Commercial, Managed Access and Medicines Policy at NICE, said:
“We welcome the announcement that these two medicines have been granted Innovation Passports through the Innovative Licensing and Access Pathway. As an organisation committed to getting the best care to people fast, NICE welcomes the opportunity, through ILAP, to work with developers and partners across the health system to support evidence generation and early engagement on the issues that will shape future evaluation and patient access.”
Potential benefits for patients with limited options
NHS England said the awards recognised the potential of the two treatments to benefit patients facing diseases for which therapeutic choices remain restricted.
Sarah Knight, Senior Commercial Lead at NHS England, said:
“These Innovation Passport awards recognise promising new medicines in development that have the potential to benefit people living with liver cancer and dementia, who have limited treatment options.
“Through this innovative programme, NHS England is helping to provide pharmaceutical companies with earlier, joined-up advice and support, helping to fast-track drug development so treatments that prove safe, effective and good value can get to the people who need them sooner.”
The UK-wide structure of ILAP also means the developers will engage with assessment and access organisations representing England, Scotland, Wales and Northern Ireland.
Dr Rob Peel, Chair of the Scottish Medicines Consortium, said:
“The Scottish Medicines Consortium, as part of Healthcare Improvement Scotland, is pleased to see two more products enter the ILAP. Liver cancer is a devastating diagnosis for patients. The impact of dementia with Lewy bodies on patients and their families is far-reaching. We look forward to working with developers for these two products.”
Dr Andrew Champion, Programme Director at the All Wales Therapeutics and Toxicology Centre, said:
“The latest Innovation Passports awarded through the Innovative Licensing and Access Pathway highlight the value and purpose of the process in supporting assessment of innovative medicines for patients with significant unmet clinical needs. AWTTC is proud to work alongside our UK partners to help improve access to promising new medicines that will ultimately benefit patients in Wales and across the UK.”
Investigational liver cancer treatment enters the pathway
BeOne Medicines has secured an Innovation Passport for BGB-B2033, an investigational biological medicine being developed for hepatocellular carcinoma.
Hepatocellular carcinoma accounts for the majority of primary liver cancer cases and can be difficult to treat, particularly where the disease is diagnosed at a later stage or cannot be addressed through surgery.
James Harris, Interim General Manager of BeOne Medicines UK and Ireland, said:
“Patients with hepatocellular carcinoma continue to face a poor prognosis, underscoring the urgent need for new treatment options.”
“We believe BGB-B2033 has the potential to make a meaningful difference for this patient population, and we welcome the opportunity to participate in the UK’s Innovative Licensing and Access Pathway, which promotes early collaboration to accelerate patient access to potentially transformative medicines. We look forward to working closely with the MHRA and ILAP partners as we advance the development of this investigational medicine.”
Support for dementia with Lewy bodies research
CervoMed’s investigational treatment neflamapimod has also received an Innovation Passport.
Dementia with Lewy bodies is a progressive neurological condition that can affect cognition, movement, behaviour, sleep and the body’s automatic functions. Its complexity can make diagnosis and treatment challenging, while its effects are often felt extensively by patients, families and carers.
Dr John Alam, Chief Executive of CervoMed, said:
“We’re grateful that CervoMed’s investigational treatment, neflamapimod, will benefit from the integrated support provided by ILAP. The UK has been a global leader in research that has advanced the understanding and management of Dementia with Lewy bodies.
“With this designation, the UK Government further demonstrates its conviction to accelerate access to treatments such as neflamapimod that have the potential to be a ‘step change’ in the management of the estimated approximately 100,000 people in the UK living with this devastating disease. We look forward to the collaboration with UK regulators, HTA bodies, and NHS partners and work with those groups towards early alignment in the regulatory and reimbursement review process.”
Next application round opens
Commercial and non-commercial developers from around the world can apply to enter ILAP.
Applicants must put forward a medicine or drug-device combination that has not yet entered its confirmatory trial. This is intended to ensure that the pathway’s advice can influence evidence generation and development plans early enough to make a practical difference.
The next application period opened on 4 August and will close on 4 November 2026. Developers working across any therapeutic area can apply, provided their products meet the pathway’s eligibility criteria and seek to address significant unmet patient needs.
Final thought: Acceleration must not come at the expense of evidence
Joanne Bekis
Chief Executive, UK Healthcare and Life Sciences Innovation (UKHLSI)ILAP’s success will depend on whether earlier collaboration produces stronger evidence and helps safe, effective treatments reach patients sooner.
The two Innovation Passports illustrate the potential value of bringing regulation, health technology assessment and NHS access discussions together earlier.
For developers, earlier engagement can reduce the risk of reaching the end of an expensive development programme only to discover that the evidence collected does not answer the questions regulators, NICE or the NHS need resolved. For patients, a more coordinated system may shorten avoidable delays between scientific progress and access to an effective treatment.
However, an Innovation Passport is the beginning of a process, not proof that a medicine works.
Neither BGB-B2033 nor neflamapimod has yet been approved for routine patient use. Both must still demonstrate safety, clinical effectiveness and value through appropriate evidence. The credibility of ILAP will therefore depend on its ability to combine speed with rigorous assessment, rather than allowing the desire for faster access to weaken the standards protecting patients and public money.
The wider test will be whether early collaboration translates into treatments moving efficiently from investigation to approval and adoption. Success should ultimately be measured not by the number of passports issued, but by whether promising medicines generate stronger evidence, navigate the system more effectively and reach patients sooner when that evidence justifies their use.
Find out more
UKHLSI is helping to prepare the health system for these treatments by convening NHS leaders, clinicians, policymakers and innovators to shape the adoption pathways, evidence requirements and delivery models needed to move new therapies safely from approval into routine patient care.
To find out more about UKHLSI’s work in this area, please contact enquiries@ukhlsi.co.uk