Same time decisions on licensing and value - what pharmaceutical companies need to know

We recently brought together representatives from the pharmaceutical industry, health and care system, health technology assessment bodies and patients to discuss our plans to get medicines to patients sooner. Last week's webinar, 'Aligned decisions: faster patient access', attracted over 3,000 registrations and generated more than 200 questions during our interactive Q&A session, demonstrating keen interest from across the healthcare ecosystem in understanding NICE and the Medicines and Healthcare products Regulatory Agency (MHRA) role in improving how quickly new medicines reach NHS patients in England. We're keen to build on this momentum and invite stakeholders to participate in our ongoing user research to help shape this work.

In this blog, we outline key points from the webinar and discuss next steps.

Delivering on government ambitions

Together, we’re working to deliver on the government’s ambitions, outlined in the 10 Year Health Plan for England and Life Sciences Sector Plan, to streamline regulation and market access. Our initiative centres on closer collaboration and information sharing between NICE and MHRA to enable parallel publication of decisions on licensing and value. The impact of this will be significant with time to patient access reduced by 3 to 6 months.

We’ll achieve this ambition through 2 key services: an aligned pathway and a fully integrated joint scientific advice service. Together, these will get medicines to patients sooner, provide the NHS with earlier signalling and benefit industry with a smoother and more predictable pathway to market.

How the aligned pathway will work

Currently, there's a 90-day gap between MHRA marketing authorisation and NICE guidance publication. Under the aligned pathway, we're bringing forward NICE’s scheduling processes to eliminate this delay.

NICE appraisal committee meetings will now be able to take place in public before marketing authorisation. NICE can also publish both draft guidance and final draft guidance before the MHRA decision – with the caveat that recommendations are subject to marketing approval. This represents a significant shift in how we coordinate our activities.

What’s required from pharmaceutical companies?

To facilitate these changes, the aligned pathway requires companies to engage with us early by registering their product on UK PharmaScan at least 3 years prior to expected MHRA marketing authorisation. Companies will also need to commit (at global level) to adhering to the timelines. To support this approach, NICE will offer priority scheduling, ensuring these medicines can progress through our evaluation process in time to achieve simultaneous publication with regulatory decisions. We’re also offering an improved and fully integrated scientific advice service, designed to help companies adhere to the timings by gaining clarity on evidence requirements and avoiding unnecessary delays.

When earlier submission to NICE is not possible

We recognise that not all medicines will be suitable for the aligned pathway. Some complex topics may require alternate scheduling, where NICE will not progress to committee until marketing authorisation is granted. This ensures we maintain our rigorous evaluation standards while providing flexibility for more challenging assessments.

Importantly, the aligned pathway is entirely optional, giving companies full control over their submission strategy. Companies can choose to request a later submission date, following the traditional sequential approach. This flexibility is particularly valuable for companies whose global development programmes or regulatory timelines do not currently align with the earlier submission requirements.

For companies that cannot meet NICE submission timelines which puts the start of their NICE evaluation before marketing authorisation, NICE will publish a deferral. This will provide complete transparency on when NICE will evaluate a medicine following marketing authorisation.

Fully integrated scientific advice

To help companies successfully adhere to aligned pathway timelines, we’re launching a refreshed and improved joint scientific advice service. This optional, yet recommended, paid-for service helps pharmaceutical companies design evidence plans that meet both regulatory and health technology assessment needs.

The service is designed to provide enhanced clarity and confidence in investment decisions by optimising evidence requirements early, ensuring they meet the requirements of both organisations and avoid unforeseen delays. Through greater operational alignment and secure data sharing, the integrated advice service will offer a much smoother user experience.

Users can expect more predictable timelines and will access the service through a single enquiry form, receive one advice meeting, an integrated report and make a single payment.

Maintaining independence and transparency

A crucial factor underpinning our entire approach is that NICE and MHRA will continue to operate independently, maintaining our distinct evaluation standards. While we're aligning our timelines and improving operational information sharing, each organisation retains its own rigorous assessment criteria and decision-making processes. MHRA will continue to focus on safety, quality and efficacy for regulatory approval, while NICE maintains its established framework for evaluating clinical and cost effectiveness. NICE also remains committed to maintaining our public committee meetings and transparency standards.

What’s next?

Where possible, NICE is now actively scheduling topics to the aligned pathway. To enable further real-world testing, we’re also interested in identifying topics already scheduled for technology appraisal which may be suitable for this approach. Please contact scheduling@nice.org.uk if you are awaiting a NICE technology appraisal and believe your medicine could be suitable.

Over the next 6 months, we’ll also be conducting user research to help shape these services further. We received some incredibly useful feedback during the webinar, which we intend to explore further through this research. For example, 42% of respondents to a webinar poll indicated that an inability to submit early to NICE was a significant concern, followed by challenges with global development programmes (23%) and difficulty aligning with health technology assessment and regulatory colleagues (19%). These insights are invaluable as we continue developing the service. If you’d like to contribute to this research, please register your interest.

The aligned pathway and fully integrated scientific advice service are due to fully launch by April 2026.