On Wednesday 3rd December, NICE held a webinar to explain how the threshold increase to £25,000-£35,000 per QALY will work in practice. For pharmaceutical companies with products currently under evaluation or planning to submit in the UK, the operational details are just as important as the policy itself.
Here’s what we learned and what it means for your market access strategy.
The implementation timeline
The new threshold takes effect in April 2026. This timing is not random. The Department of Health needs to change regulations that govern NICE’s work, which requires a specific consultation process. NICE will conduct a short consultation on how the threshold will be applied in their manuals, but the value itself is not open for discussion.
Companies should keep in mind that this is not a standard update to NICE methods. It is a government policy decision carried out through regulatory change. This distinction affects how quickly it can be put into action and what flexibility there is around implementation.
What happens to ongoing evaluations
NICE has created three categories for managing products currently under appraisal:
- Products found cost-effective under current thresholds: These will proceed to positive recommendations as planned. NICE wants to ensure quick patient access where decisions are clear.
- Products not cost-effective now but possibly cost-effective under new thresholds: These will be paused. When the new threshold is in effect, NICE will automatically use the increased threshold the committee identified as appropriate. For example, if a committee used a £25,000 threshold and the product’s ICER is £28,000, it would currently be rejected. Under the new threshold (where the committee would use £30,000), it would be recommended. This category will provide three to five additional approvals per year.
- Products not cost-effective even under new thresholds: These will continue to receive negative guidance. There is no point in delaying a decision that won’t change.
NICE has around 40 topics scheduled for second committee discussions before April, plus about 20 topics post-committee but pre-final guidance. They are determining which category each falls into and will contact companies individually.
Revisiting previous negative decisions
NICE will not automatically review past negative recommendations. Their standard approach is that they will reconsider guidance only when substantial new evidence suggests a different decision could be made.
The threshold change alone does not count as “new evidence.” However, if you have new clinical data, real-world evidence, or updated economic models that significantly change the assessment, that could prompt a review. Companies with products rejected near the old upper threshold should assess if they have truly new evidence to present, rather than relying on the threshold change alone to overturn the decision.
The EQ-5D-5L value set change
This topic received less attention in the webinar but is important. NICE will introduce a new value set for the EQ-5D-5L instrument following standard methods update procedures, including public consultation. The timeline relies on peer review and publication of the underlying research, expected in early 2026.
The value set impacts how health states translate into utility values, which directly influences QALY calculations. NICE has not yet clarified whether this will impact ongoing evaluations or only new submissions starting after a certain date. More details will be provided during the methods consultation.
The severity modifier remains unchanged
The severity modifier will continue to function as before. Committees will apply the quality-adjusted life year weighting for severity first, then check if the resulting ICER falls within the acceptable threshold. This threshold will now be £25,000-£35,000 instead of £20,000-£30,000. The cutoffs and modifiers themselves will not change.
Commercial arrangements and managed access
The new thresholds will apply to commercial negotiations with NHS England. They now expect commercial flexibility to achieve value below £20,000 per QALY, shifting that baseline to £25,000. Products finishing managed access periods in the Cancer Drugs Fund or Innovative Medicines Fund will be evaluated against the new thresholds when they are reviewed.
What NICE won’t be doing
NICE confirmed they are not planning any significant new impact tracking beyond their standard performance reports. They will continue to track approval rates, optimised recommendations, and terminations as usual, but will not publish additional threshold-specific analysis. Some of this data remains confidential due to pricing agreements.
The budget impact test (recently increased to £40 million) was not definitively addressed. NICE mentioned this is owned by NHS England and needs separate discussion.
What this means strategically
The webinar clarified the mechanics, but the strategic implications remain as we identified in our initial analysis:
Products with ICERs in the £30,000-£35,000 range need immediate attention regarding submission timing and evidence packages. If you are approaching a committee meeting before April, know which category your product falls into and what that means for your timeline.
The pause mechanism creates both opportunities and uncertainty. If your product qualifies for a pause, you gain time, but you also face delayed patient access and commercial uncertainty. Plan accordingly.
The combination of the threshold increase and value set change can create compounded effects in some therapeutic areas. Do not assess them in isolation.
This policy shift shows that the UK government is treating pharmaceutical pricing as industrial policy, not just healthcare resource allocation. This suggests a willingness to consider further market access reforms, especially regarding life sciences investment and trade relationships.
Questions you should ask your team
Where do our current submissions stand in relation to the £30,000-£35,000 range?
Do we have products in NICE’s pause category, and what does that mean for our commercial planning?
Should we speed up or delay any planned submissions based on the April timeline?
For products rejected previously, do we have genuinely new evidence that would justify a review request?
How does the EQ-5D-5L value set change affect our disease areas specifically?
Have we tested our UK portfolio strategy against various threshold scenarios?
The key takeaway
NICE has carefully considered how to minimise disruption while implementing a major policy change. The three-bucket approach for ongoing evaluations is practical. Their refusal to automatically review past negative decisions aligns with their resource constraints and reinforces the principle that new evidence, not just new policy, drives reconsideration.
The threshold increase is significant but not transformative. We are looking at 3-5 additional approvals per year in a system with a 91% approval rate. The real benefit comes from strategic flexibility in managing the portfolio and what this signals about the UK’s openness to reform market access policy.
Companies that understand the implementation details and act decisively will capture more value than those viewing this only as a straightforward threshold adjustment.
Need support with your UK market access strategy?
GPI specialises in pharmaceutical pricing intelligence and market access strategy. Our team can help you evaluate where your portfolio stands relative to the new thresholds and identify the opportunities these changes create.
Get in touch to discuss the implications for your pipeline.
