MHRA-NICE Aligned Pathway: HTA Evidence Strategies

Sanja StanisicDirector, Certara Evidence & Access

2026 年 5 月 1 日

MHRA-NICE Accelerated Pathway Launched on April 01

The pathway delivers on commitments made in the UK’s government 10-Year Health Plan for England and Life Sciences Sector to bring medicines to patients faster.

It enables MHRA and NICE to get medicines to patients 3 to 6 months sooner by delivering same time decisions on licensing and value, including:

New Integrated Scientific Advice service with streamlined process – one point of contact, one advice meeting, one report and one fee (~25% lower than previous and ~40% for small and medium-sized enterprise
Earlier NHS entry and a longer period of rebate-free sales before the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) applies
Eligibility of all therapeutic areas without a cap on the number of companies who can use it

The pilot of the new aligned scheme includes 27 companies signed up last year, with the first guidance expected in June 2026.

Image of MHRA/NICE webinar titled Aligned decisions, faster patient access. Subtitle, Official launch of MHRA-NICE aligned pathway and integrated advice service. Date: Wednesday 25 March 2026 2-3pm GMT.

Optimize readiness for accelerated pathways with Certara

When HTA strategy becomes “locked” earlier than the regulatory assessment, manufacturers need to optimize integrated evidence generation planning to become the “single evidence strategy” for regulatory and payer value assessment

Collaboration and early alignment across key functions is essential to building an HTA-ready study (e.g. ensure payer and patient relevant endpoints, power study for NICE relevant subgroup analysis)
Build early evidence generation strategies to inform Phase III program, and understand probability of success
Develop early indirect treatment comparison modules and accelerate design / planning of real-world evidence studies
Engage with formal Scientific Advice early in Phase II
Project and forecast with early cost-effectiveness modeling even with immature data
De-risk with earlier NICE-outcomes scenario planning and scenarios for access schemes

The MHRA–NICE Aligned Pathway represents a meaningful shift toward faster patient access, but success will depend on how well evidence strategies evolve to meet earlier, more integrated demands. Organizations that invest in alignment, foresight, and evidence readiness today will be best positioned to realize the full value of acceleration tomorrow.

At Certara, we help organizations turn accelerated timelines into a strategic advantage by aligning evidence, reducing uncertainty, and enabling confident decisions earlier in development. 联系我们.

HTA decision-grade integrated evidence generation

Integrated evidence-generation planning

HTA scenario-based asset planning

Indirect treatment comparisons

Certara's integrated evidence business solutions team can support you to assess how published #EQ-5D-5L new value set for UK impact your cost-effectiveness assumptions.

网络研讨会点播

The Pursuit of Certainty: Integrated Evidence and the evolving drug development and reimbursement landscape

Hear from leaders in medical affairs, real-world data, HEOR, market access and clinical development to move beyond isolated findings toward a more holistic understanding of therapeutic impact.

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Sources

NICE, MHRA-NICE pathway opens for business – everything you need to know to get started, Apr 2026;

Barrie R, Pharmaceutical Technology, Mar 2026

Author

Sanja Stanisic

Director, Certara Evidence & Access

Sanja Stanisic is a Director at Certara Evidence & Access with over 12 years of experience in market access and research consultancy. She advises global pharmaceutical companies on access planning across complex healthcare systems. She specializes in building compelling value narratives and integrated evidence strategies that inform pricing, reimbursement and payer decision making. She brings experience across a range of therapeutic areas including rare diseases, oncology, neurology, cardiovascular, and metabolic disorders. She is a trained pharmacist, holds a Master’s degree in International Health Care Management, Economics and Policy from the Bocconi University (Milan, Italy), and has authored multiple peer-reviewed publications.

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