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Why NICE’s new cost-effectiveness threshold matters for pharmaceutical access in the UK
NICE’s decision to revise its cost-effectiveness threshold marks a meaningful evolution in the UK market access landscape. The updated range is expected to support broader access to innovative medicines while offering greater clarity for pricing, reimbursement, and launch planning through 2028.
How NICE’s cost-effectiveness threshold is being updated
NICE has confirmed a revision to the cost-effectiveness threshold used in Technology Appraisals, increasing the range from £20,000 to £30,000 to £25,000 to £35,000 per quality-adjusted life year (QALY). The change, linked to the UK–US Economic Prosperity Deal, was presented to the NICE Board during its recent public meeting (1).
This adjustment reflects a shift in how value is assessed within the UK health technology assessment (HTA) framework.
What this update could mean for highly specialised technologies
It remains uncertain whether similar revisions will be applied to the Highly Specialized Technologies (HST) threshold for ultra-rare conditions. NICE has stated it will consult with the Department of Health & Social Care (DHSC) before determining whether changes to the HST framework should be pursued.
Why the threshold change matters for patient access and industry planning
The increase in the NICE CE threshold represents a significant policy development with the potential to expand patient access to innovative therapies. NICE has indicated that the updated threshold may enable 3 to 5 additional treatments or indications to become available each year (2).
The impact of this change is further reinforced by broader UK pricing reforms, including the proposed three-year 15% cap on the VPAG rebate. This cap is notably lower than the 22.5% rebate in 2025and closely aligned with the 14.5% rebate confirmed for 2026 (3).
Together, these developments represent one of the most consequential access-focused shifts in recent years and provide improved predictability for manufacturers planning UK submissions and launches through at least 2028.
What to expect next in the implementation process
On December 9th, the government launched a consultation to introduce regulatory powers allowing the DHSC to formally set the revised CE threshold. Following this process, NICE is expected to open a separate consultation detailing how the updated threshold will be applied in practice (4).
How ongoing NICE appraisals will be managed
NICE has confirmed that current appraisals will continue under existing timelines. However, specific provisions will apply in some instances.
For appraisals with committee meetings scheduled before the revised threshold is implemented, where a product does not meet the current threshold but would be considered cost-effective under the new range, publication of the final draft guidance will be temporarily paused. Once the updated threshold is in effect, anticipated no earlier than April 2026, NICE would proceed to publication (5).
NICE has also confirmed there are no plans to retrospectively reassess previously published guidance (5).
Timeline for NICE threshold implementation
Information Source (4)
How Acumetis delivers impact
As NICE’s cost-effectiveness framework evolves, manufacturers face new considerations across pricing strategy, HTA evidence development, and UK launch planning. Acumetis helps life sciences leaders reframe what’s possible by translating policy change into actionable access strategy, supported by connected expertise across Global Value and Access, evidence generation, commercial strategy, and launch planning.
Our teams can help with:
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UK HTA and NICE readiness, including value strategy aligned to revised CE thresholds
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Pricing and reimbursement scenario planning under VPAG and emerging policy reforms
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Evidence and economic modeling to support cost-effectiveness and value demonstration
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Launch sequencing and submission strategy for specialty and rare disease portfolios
If you would like to explore how these changes may affect your pipeline or upcoming submissions, connect with our Global Value and Access team for a focused discussion.
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Gaia Geraci
FAQs on competitor analysis for gene therapy
1. Why has NICE revised its cost-effectiveness threshold?
2. What is the new NICE cost-effectiveness threshold?
3. Will the change apply to ultra-rare disease assessments?
4. How will the update affect ongoing appraisals?