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.
Integrated evidence-generation planning
HTA scenario-based asset planning
Indirect treatment comparisons
Advanced Health Economic Modeling
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.
確実性の追求：統合的エビデンスと変化する医薬品開発・償還の状況
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.
NICE, MHRA-NICE pathway opens for business – everything you need to know to get started, Apr 2026;
Barrie R, Pharmaceutical Technology, Mar 2026
Sanja Stanisic
Director, Certara Evidence & AccessSanja 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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At Certara, we help organizations turn accelerated timelines into a strategic advantage by aligning evidence, reducing uncertainty, and enabling confident decisions earlier in development.
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Certara’s team of experts is ready to help you navigate the design and execution of real-world data studies aimed to support peri- and post-approval discussions with stakeholders.
