MHRA–NICE Aligned Pathway – Is the NHS Ready?

Our latest article explores whether faster regulatory and HTA decisions will translate into faster patient access, and what more is needed to support NHS adoption of innovative medicines.

Is the NHS ready for the MHRA–NICE aligned pathway? 

Here, Charlotte Harding (Consultant – Market Access, Petauri Evidence) explores how well‑equipped the National Health Service (NHS) in England is to facilitate faster access to medicines and deliver patient benefit, following the launch of the Medicines and Healthcare products Regulatory Agency (MHRA)–National Institute for Health and Care Excellence (NICE) aligned pathway. While the pathway aims to enable new medicines to reach NHS patients 3–6 months sooner (a welcome development for industry and patients alike), it raises an important question: is the NHS ready to realise the full value of accelerated access? 

 

Why does the MHRA–NICE aligned pathway matter?

The launch of the MHRA–NICE aligned pathway marks a significant milestone for patients, the NHS, and the pharmaceutical industry. The pathway integrates the MHRA’s licensing process with NICE’s health technology assessment (HTA) procedures, enabling the simultaneous publication of decisions on marketing authorisation and cost effectiveness, while maintaining independent assessment and decision‑making by both. By aligning regulatory approval with HTA timelines, the pathway aims to enable new medicines to reach NHS patients 3–6 months sooner than under previous sequential processes.^1,2 

The UK Government has recognised that the country’s life sciences sector is not reaching its full potential. In its Life Sciences Sector Plan, ministers identified streamlining regulation and improving market access as key priorities, with MHRA–NICE alignment representing an early but critical step toward a more integrated and efficient pathway.² 

This is a welcomed step forward. Earlier access to clinically valuable treatments, particularly in areas of high unmet need such as oncology and cardiovascular disease, has the potential to improve outcomes and reinforce the UK’s position as an attractive market for innovation. 

However, while the opportunity is clear, faster approval does not automatically result in faster access for patients. 

 

Will faster approval deliver faster access for NHS patients?

Earlier approval does not necessarily translate into faster NHS adoption or improved patient access to innovative treatments. Historically, MHRA licensing and NICE appraisal occurred in sequence, followed by a further implementation phase within the NHS. Even today, there remains a 90-day target between marketing authorisation and NICE guidance, with additional delays often occurring before medicines are embedded into routine care. 

In practice, adoption is influenced by factors beyond regulatory and HTA timelines, including system readiness, financial constraints, prescribing restrictions, and local prioritisation, resulting in significant variation in uptake across the NHS. 

The aligned pathway aims to reduce some of this delay by enabling parallel decision-making, providing earlier visibility of positive guidance to NHS systems. In theory, this should support better forward planning and faster implementation once a medicine is recommended.^1,3 

Experience from Canada indicates that greater regulatory–HTA alignment can accelerate access, with parallel submissions linked to faster rollout and more favourable HTA outcomes, although the reasons for this remain unclear.5 However, differences in healthcare system structure, mean these insights may not fully translate to the UK context. 

This raises a more fundamental question: is the NHS ready to act on earlier decision-making? 

 

Is the NHS ready to deliver on faster access?

In principle, the aligned pathway is a much needed and welcome initiative. However, in practice implementation of new medicines remains dependent on factors that sit outside the regulatory and HTA timelines. 

NICE guidance is not adopted uniformly or rapidly across the NHS in England. NICE itself acknowledges variation in uptake of guidance is driven by system pressures, workforce capacity, financial constraints, and local prioritisation. They set themselves a target of improving uptake and adoption of NICE guidance in priority areas, including cardiovascular disease, diabetes, cancer, mental health, and obesity, by 10% by 2028.⁴ 

Integrated care systems (ICSs) and integrated care boards (ICBs) are operating in a challenging environment: 

• Constrained by short-term annual budget cycles, with multi-year financial planning still not fully realised in practice 

• Multiple competing national and local priorities 

• Challenges in workforce and service backlogs 

• Significant variation in local pathway development and commissioning decisions 

Bringing regulatory and HTA decisions forward by several months alone is unlikely to improve patient access. Medicines may technically become available earlier, but remain unembedded within local pathways, formularies, and service models. In addition, those medicines that require pathway redesign or service transformation may experience more pronounced implementation challenges. Unless initiatives, such as the proposed single national formulary, and system readiness progress in parallel with regulatory reform, the aligned pathway could risk providing little to no benefit in narrowing the gap between approval and real‑world patient benefit. 

Addressing these challenges will require coordinated action across the system. Success should be judged not by how quickly guidance is published, but by whether patients actually see the benefits sooner and more consistently. This is not a failure of the policy initiative itself, but a reflection that adoption requires planning, resourcing, appropriate funding, and alignment. 

This creates an important role for industry in supporting NHS readiness. 

 

What role can industry play in enabling NHS adoption?

The aligned regulatory pathway presents an opportunity for industry to rethink how and when it supports NHS systems. 

If regulatory decisions are coming sooner, then engagement on pathway design, service impact, and system readiness must also start sooner, and move beyond traditional post-licence or NICE approval market access activities. 

Practical ways that industry can help bridge the gap could include: 

• Earlier ICS‑level planning conversations, aligned to anticipated approval timelines 

• Pathway mapping tools to support local adaptation and service integration 

• Budget impact and population modelling tailored to local system needs 

• Practical resources to support implementation such as commissioning guidance, pathway development, and workforce planning considerations 

The focus should be on ensuring that engagements focus on enabling efficient and equitable adoption of new and innovative medicines/technologies, as well as prioritising the provision of services that meet the needs of the populations they serve, rather than appearing promotional in nature. 

 

Need support navigating the aligned pathway?

If you are exploring the aligned pathway for your medicine and would value support in navigating these changes, including how best to support the NHS with the implementation of innovative therapies, we would be delighted to collaborate. 

At Petauri Evidence, we are leaders in supporting industry with market access strategy, enabling clients to navigate the complex and evolving NHS landscape, alongside value proposition development, budget impact modelling, and real‑world data solutions. Through robust evidence generation and communication, we support the successful adoption of life‑changing medicines within the NHS. 

To start a conversation, reach out to the team at Petauri Evidence, email evidence@petauri.com. 

 

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References 

1. NICE. MHRA–NICE pathway opens for business – everything you need to know to get started. Available from: https://www.nice.org.uk. Accessed: 28 April 2026. 
2. GOV.UK. Get medicines to NHS patients earlier via the MHRA–NICE aligned pathway. Available from: https://www.gov.uk. Accessed: 28 April 2026. 
3. Pharmaceutical Technology. MHRA and NICE launch aligned pathway for faster medicine regulation. Available from: https://www.pharmaceutical-technology.com. Accessed: 28 April 2026. 
4. NICE. Strategy for improving the uptake and adoption of medicines (presentation). March 2025. 
5. Sola‑Barrado B, Wang T, McAuslane N. HTA submission strategies and their associations with rollout times and type of HTA recommendation in Australia and Canada. 2026. Available from: https://www.cambridge.org/core/services/aop-cambridgecore/content/view/BC90B5BB8A61734AB430C6D02D68C323/S0266462326103511a.pdf. Accessed: 28 April 2026.