Author: Ben Barron-Millar, Senior Consultant, Value Communication
Kintiga colleagues attended the free webinar hosted by the National Institute for Health and Care Excellence (NICE) and Medicine and Healthcare product Regulatory Agency (MHRA) on 1st October 2025. This signified the launch of this reinvigorated collaboration between NICE and MHRA, which aims to build on an existing close relationship to aid decision-making and optimisation of the regulatory and reimbursement timelines.
Priority scheduling for topics following the aligned NICE-MHRA pathway
- Early UK PharmaScan registration at least 3 years prior to MHRA marketing authorisation (MA).
- NICE were keen to highlight that existing topics in the pipeline are not automatically pulled across to the aligned pathway.
- Represents parallel guidance on clinical efficacy, safety and cost-effectiveness, removing duplication but remain as two separate submissions.
- New aligned pathway à Health Technology Assessment (HTA) submission to NICE prior to MA.
Alternative scheduling for complex, divergent topics
- Challenges and barriers to optimised pathway include inability to submit early to NICE prior to MA, launch sequencing of global developmental programme, and alignment between company HTA and regulatory colleagues.
- However, NICE expects a small number of complex topics will require alternative scheduling.
- Companies may request a later submission date after the expected MA.
- In these cases, NICE will publish a deferral once MA is granted.
NICE and MHRA Integrated Advice Service
- Currently in development till December 2025, with pilot, proof of concept in early 2026.
- Once fully launched in April 2026, this integrated advice will replace NICE-MHRA joint advice (current initiative).
- Synergised workflow with single entry point (via government website), single integrated report, and single payment for service.
- Aims to improve clarity and confidence.
Webinar Q&A insights from NICE and MHRA
- Currently in development till December 2025, with pilot, proof of concept in early 2026.
- Once fully launched in April 2026, this integrated advice will replace NICE-MHRA joint advice (current initiative).
- Synergised workflow with single entry point (via government website), single integrated report, and single payment for service.
- Aims to improve clarity and confidence.
Things not anticipated to change
- 90 day implementation period for patient access post-approval.
- Key stakeholder clinical expert and patient advocacy group (PAG) engagement.
- Orphan drugs process.
- NICE processes (apart from committee meeting prior to MA) and NICE committee role.
- NHS integral involvement for implementation and service readiness.
- No plans for inclusion of medical devices currently.
HTA and MHRA logistics and requirements
- Aligned pathway is an opt-in service, companies are encouraged to contact NICE and/or MHRA if they think they could be eligible.
- Communication with NICE and MHRA is encouraged early in clinical developmental programme.
- NICE/MHRA ‘pipeline’ meetings (single and joint) have been piloted with a commitment for these to carry on.
- These meetings are industry driven facilitating open and transparent conversation about innovative medicines and potential challenges to the market.
- Not for every topic is applicable for aligned pathway à NICE wants to understand these challenges.
- NICE technical appraisal is dependent on company submitted scientific evidence, otherwise clinical and cost-effectiveness cannot be evaluated.
- Resourcing planned proactively 2-3 years in advance (where possible).
- MHRA have onboarded new staff, while NICE predicts on significant impact on capacity (based on retrospective analysis and current number of appraisals).
- Shared information between NICE and MHRA include: drug name, indication, and MHRA decision dates (no clinical detail).
MHRA regulatory issues
- Preference for national access routes but not a strict requirement.
- International Recognition Procedure (IRP) using reference regulators (EMA/FDA) is ideal for early access to patients.
- Innovative Licensing and Access Pathway (ILAP) is complimentary to NICE-MHRA aligned pathway.
- Early Access to Medicines Scheme (EAMS) is not part of the new aligned pathway BUT new EAMS guidance is in development by the MHRA.
NICE committee meetings pre-MA
- Potential for active topics to be held in public to aid transparency.
- In cases of complex issues necessitating multiple NICE committee meetings, the MHRA regulatory process will not be delayed.
- Optimal aligned pathway is expected to consist of 1 NICE committee meeting prior to MA, with patient access shortened by ~3 months.
- Even with 2 committee meetings, accelerated access is still possible but this depends on submission timing.
The new NICE-MHRA aligned pathway is expected to provide faster access (3-6 months) to medicines. Additional value of the new optimised approach include earlier system readiness (via PharmaScan early engagement) as well as fewer barriers to access and integrated advice. Pharmaceutical companies must engage and collaborate with NICE and the MHRA to take advantage of this alignment between HTA and regulatory agencies.
Glossary of Abbreviations
- EAMS – Early Access to Medicines Scheme: MHRA programme allowing patients access to medicines before Marketing Authorisation is granted.
- EMA – European Medicines Agency: EU agency responsible for the evaluation of medicinal products.
- FDA – Food and Drug Administration: US agency responsible for regulating food, drugs, and medical devices.
- HTA – Health Technology Assessment: Evaluation of the clinical and cost-effectiveness of health technologies.
- ILAP – Innovative Licensing and Access Pathway: MHRA initiative to accelerate access to innovative medicines.
- IRP – International Recognition Procedure: MHRA process recognising approvals from reference regulators (e.g., EMA, FDA).
