NICE technology appraisal in 2026: a practitioner guide to the STA process, the new £25,000 to £35,000 threshold and what else has changed

Why 2026 is a reset year for NICE technology appraisal

For most of NICE's history, the cost-effectiveness range used in technology appraisal was a fixed point of reference. That changed on 2 April 2026, when NICE confirmed that its committees would apply a standard range of £25,000 to £35,000 per QALY gained, immediately, to both new and ongoing medicines evaluations.^[1] NICE notes that no government since NICE was created had changed the core threshold before.^[2] The change was announced on 1 December 2025, replacing the previous range of £20,000 to £30,000.^[3] It formed part of a wider package agreed alongside the UK-US Economic Prosperity Deal on pharmaceuticals.^[4]

The threshold is the headline, but it is not the only change. From 1 April 2026, the MHRA-NICE aligned pathway has been fully open, with the aim of bringing medicines to NHS patients 3 to 6 months sooner through same-time decisions on licensing and value.^[5] And from 27 August 2026, any technology appraisal with an invitation to participate issued after that date must use the new UK EQ-5D-5L value set.^[6]

Each change touches a different part of the evidence package: the decision rule, the timetable and the utilities. This guide sets out the single technology appraisal (STA) end to end, then how the 2026 changes fit into it.

91%of the medicines NICE evaluates are recommended, around 70 a year

3 to 5additional medicines or indications a year expected under the new range

3 to 6 monthsearlier patient access targeted by the MHRA-NICE aligned pathway

£5,000uplift applied to paused topics during the threshold transition

Sources: NICE, April 2026; NICE and MHRA, April 2026; NICE ECD19, February 2026.

The single technology appraisal, end to end

The STA is set out in NICE's technology appraisal and highly specialised technologies manual (PMG36). The manual was last updated on 13 October 2026.^[7] The sequence below follows its process chapters.

Scoping and the decision problem

Scoping defines the question the evaluation will answer: population, comparators, care pathway and outcomes.^[7] NICE consults on the draft scope for either 28 days (long) or 14 days (medium), depending on how much is still open, and may hold a scoping workshop.^[7] Before the evaluation starts, the company can discuss the decision problem with the NICE team and the external assessment group (EAG). It submits an outline covering evidence sources, evidence expected during the evaluation, the modelling approach and the proposed handling of uncertainty.^[8] In our experience, this is one of the most valuable meetings in the whole process. Comparators, subgroups and the modelling approach agreed here shape everything that follows. For a single plan that also serves the EU joint clinical assessment, see our article on one evidence plan for NICE and the JCA.

Submission and clarification

For an STA, the evidence submission is due 56 calendar days after the invitation to participate. It is 28 days for a cost-comparison evaluation and 84 days for a multiple technology evaluation.^[8] Where clarification is needed, NICE and the EAG send a letter within 21 days of receiving the submission. The company then has 14 days to respond and provide any additional analyses.^[8] The company should not submit further evidence during the evidence review phase unless NICE requests it or agrees in advance.^[8]

The external assessment report and the progression decision

Once the external assessment report arrives, NICE decides how the appraisal will progress. It can go straight to committee preparation, add a technical engagement step, follow a streamlined decision outside a formal meeting in selected circumstances, or pause while NICE considers the most efficient course.^[8] That decision is normally communicated within 14 days of receiving the report.^[8] Technical engagement is optional. Its purpose is to note evidence gaps and possible resolutions before committee, and to consider any commercial or managed access proposals. Stakeholders have 28 days to comment on the report.^[8]

Committee, draft guidance and final draft guidance

Committee papers usually go to attendees 1 to 2 weeks before the first meeting, and a brief statement of the outcome is shared within 7 days.^[8] If the committee issues draft guidance, NICE usually circulates it within 21 days, and stakeholders have 28 days to comment.^[8] After draft guidance, new evidence is accepted only if the committee requests it or NICE confirms in writing that it will accept it. NICE says it prefers additional evidence to come in at technical engagement.^[8] The committee then usually meets again before agreeing final draft guidance.^[8]

Appeal, publication and funding

The appeal period opens when final draft guidance is issued and runs for 15 working days.^[9] Final guidance follows. NICE will not publish final guidance until UK regulatory approval has been granted and the price is known or can be determined.^[8] By regulation, the funding requirement normally applies within 3 months of publication.^[8] If net budget impact is expected to exceed £40 million in any of the first 3 years, NHS England offers commercial discussions and may ask for a longer implementation period.^[8] The October 2026 update to the manual introduced a new approach to these funding variation requests, including an external advisory group.^[10] Our budget impact modelling work is built around this test.

1. Before day 0Scope28-day or 14-day consultation on the draft scope
2. Day 0Invitation to participateKey dates issued to stakeholders
3. Day 56Company submissionClarification letter within 21 days, 14 days to respond
4. EAG reportProgression decisionNormally within 14 days; optional technical engagement
5. CommitteeOutcome sharedWithin 7 days; draft guidance usually within 21 days, then 28-day consultation
6. Final draft guidanceAppeal period15 working days
7. PublicationFundingNormally within 3 months

Source: NICE PMG36 chapters 2 and 5; NICE PMG41. Intervals between stages vary by topic.

Routes through the process and the recommendations available

Committees do not choose between yes and no. PMG36 lists a set of recommendation types matched to how well the case for adoption is supported.^[11] For medicines these include routine recommendation, recommendation in specific circumstances (an "optimised" recommendation), recommendation with managed access, and recommendation only in a research context.^[11] NICE has also updated its recommendation wording, so that a recommended technology is now described as one that "can be used".^{[10, 11]}

Two other routes matter for planning. Cost-comparison evaluations use a shorter submission window. A technology is usually recommended where it offers at least equivalent benefit at lower overall cost, or significantly greater benefit at similar cost.^{[8, 11]} And where a base-case ICER is significantly above the standard threshold and has not yet been addressed through a patient access scheme or commercial discussions, NICE may pause the topic to agree the most efficient way forward with the company.^[8] In our experience, starting commercial planning early keeps the evaluation on its published timetable. NICE's commercial liaison team reviews commercial intentions a few weeks before the invitation to participate.^[8]

1. ScopeDecision problem agreed with NICE and the EAG
2. SubmissionClinical and economic evidence, plus any commercial or managed access proposal
3. External assessmentEAG report and progression decision
4. EngagementTechnical engagement where it helps resolve key issues
5. CommitteeDraft and final draft guidance

• Can be usedRoutine recommendation within the marketing authorisation
• OptimisedRecommendation for specific circumstances or populations
• Managed accessTime-limited use while further evidence is collected (medicines only)
• Research contextUse within research while evidence develops

The new threshold: how the £25,000 to £35,000 range works

The new range is written into PMG36, which was updated in March 2026.^[10] The decision rule itself is the same; only the values have moved.^[11]

• Below £25,000 per QALY: The decision is normally based on the cost-effectiveness estimate and the acceptability of the technology as an effective use of NHS resources. If a committee does not recommend a technology in this range, it must explain its view on the plausibility of the model inputs or the certainty of the ICER.^[11]
• Between £25,000 and £35,000: Committees consider the certainty around the ICER, uncaptured benefits and non-health factors, and health inequalities. As the ICER rises through the range, they must refer to these factors explicitly.^[11]
• Above £35,000: The committee needs to identify an increasingly stronger case for the technology as an effective use of NHS resources.^[11]

£20k to £30k (previous)£25k to £35k (from April 2026)

£0£20k£25k£30k£35k£50k

Cost per QALY gained. Source: NICE, December 2025 and April 2026.

Scope of the change

The new range applies to technology appraisals, both new and in progress. It is not applied retrospectively, although a company can ask for a new appraisal where significant new evidence is likely to have a material effect on the recommendation.^[2] It covers medicines and health technologies evaluated through the technology appraisal programme. NICE is awaiting a government decision on HealthTech and guidelines.^{[2, 12]} The Department of Health and Social Care has indicated that the highly specialised technologies threshold will stay as it is.^[12]

The transition

NICE's February 2026 statement of intent (ECD19) set out how topics heard before the change would be handled. Where a committee had met but final draft guidance was not yet issued, and the company indicated that the new range could lead to a positive recommendation, release was paused. Once the new range applied, NICE automatically raised the committee's maximum acceptable ICER by £5,000, with no further committee discussion.^[12]

The evidence behind the number

The threshold has long been the subject of academic debate, and both sides are worth knowing. A 2015 analysis for the NIHR estimated the most relevant central threshold at £12,936 per QALY, based on the health effects of changes in NHS spending.^[13] An Office of Health Economics critique of an earlier version argued that the estimate rests on assumptions to which it is highly sensitive, and that the true value could be higher.^[14] Commenting on the 2026 change, OHE researchers welcomed a formal mechanism for setting the threshold. They also asked how and when future values will be calculated, and how the change will interact with the VPAG.^[15]

NICE's own framing is clear: committees still consider the opportunity cost of every recommendation, now at a higher value.^[12] We would expect committees to keep asking just as closely about uncertainty, and companies should plan on that basis.

How severity weights combine with the new range

The severity modifier itself is unchanged. QALY weights of 1.2 and 1.7 apply where proportional QALY shortfall reaches 0.85 or 0.95, or absolute shortfall reaches 12 or 18. The measure implying greater severity is used, and a value on a cut-off takes the higher weight.^[11] Our article on the NICE severity modifier covers the calculation in full. Here the question is how the weight and the new range work together.

Because the weight multiplies the QALY gain, it divides the ICER. A weighted ICER of £35,000 therefore corresponds to an unweighted ICER of £35,000 times the weight. The table shows the unweighted ICER at each end of the range, before and after April 2026.

Illustrative: our arithmetic from the PMG36 range and severity weights.^[11] These are reference points, not decision rules. Committees weigh uncertainty and other factors across the whole range.

Use the explorer below to see how a given incremental cost, QALY gain and severity level place an ICER against the previous and current ranges.

Transparency requirements move with the range. Where decision modifiers apply, companies must present net health benefit at £25,000 and £35,000 per QALY, with and without the QALY weight. A technology whose unweighted net health benefit is below zero may still be recommended once a modifier applies.^[11] Two further points matter for 2026. The EQ-5D-5L value set now also feeds the general population norms used to calculate shortfall, with the table 6.1 cut-offs unchanged.^[16] And NICE continues to monitor the average severity weight across appraisals, with research on societal preferences ongoing.^[16]

The range moved by £5,000. For a condition that earns the 1.7 weight, the room it creates at the top of the range is £8,500. That makes the comparator arm of the model, where severity is measured, one of the most valuable places to invest evidence effort in 2026.

In practice, comparator QALYs depend on survival extrapolation, utilities and the point in the pathway being modelled. Our article on survival extrapolation for HTA shows how the choice of curve can move the comparator arm.

The MHRA-NICE aligned pathway

The aligned pathway changes when the appraisal happens, not how it is done. NICE has stated that its processes are not changing. It is bringing its appraisal forward so that the MHRA's marketing authorisation and NICE's guidance can be published at the same time, with both bodies remaining independent.^[5] Since 1 October 2025, every topic submitted to NICE for scheduling can follow the pathway, provided NICE is notified in time. Topics join automatically, with no separate application or extra fee.^[5]

The pathway comes with an Integrated Scientific Advice service: one entry point on GOV.UK, one meeting, one report and one payment. Fees are around 25% lower than the previous joint service, and 40% lower for small and medium-sized enterprises. The final written advice is delivered within 18 weeks of the briefing book.^[5] For companies, NICE and the MHRA point to earlier NHS entry and a longer period of rebate-free sales before VPAG applies.^[5] Draft guidance issued before authorisation will say that final guidance depends on the licence being granted, consistent with PMG36.^{[5, 8]}

1. 3+ yearsUK PharmaScanRegister and keep details updated
2. 2 to 5 yearsIntegrated Scientific AdviceIdeally before pivotal study plans are final
3. 16 to 20 monthsTiming confirmedNICE confirms the optimal submission timing
4. 8 monthsHTA beginsNICE assessment starts ahead of the licensing decision
5. AuthorisationSame-time publicationLicence and NICE guidance published together

Source: NICE and MHRA, 1 April 2026.

The practical effect is that the evidence package has to be ready around 8 months before authorisation. In our experience, the parts that take longest are the economic model, the indirect comparisons and the UK-specific inputs, so these benefit most from an earlier start. Our guide to adapting global models for NICE and NCPE covers the UK-specific inputs.

EQ-5D-5L: what has changed and what is still to come

NICE's interim methods statement (PMG51), published on 27 August 2026, makes the EQ-5D-5L descriptive system and the new UK value set NICE's preferred approach for adults. It replaces NICE's earlier position statement on the EQ-5D-5L value set for England, under which 5L data were mapped to the 3L value set.^[17] The key rules are:

• Which topics: The 5L value set must be used for any technology appraisal or HST with an invitation to participate issued after 27 August 2026. Ongoing topics continue to map 5L data to 3L, and published guidance will not be reviewed just to apply the new value set.^[6]
• Mapping: Where only 3L data are available, they should be mapped to 5L utilities using the DSU and EEPRU mapping model. Non-EQ-5D measures need a fully justified mapping model, with sensitivity analysis across models.^[17]
• No 3L scenarios: Utilities from the 3L value set should not appear in sensitivity or scenario analyses.^[17]
• Severity: General population utilities for shortfall calculations also use the 5L value set.^{[16, 17]}

The formal manual update is still in progress. NICE consulted on the modular update from 15 April to 27 May 2026. As of 1 November 2026, the project page lists the expected publication date as to be confirmed.^[18] PMG51 says the updated manuals and NICE's response to consultation will be published later in 2026.^[6]

For the full technical picture, including how the new value set compares with 3L and its effect on ICERs and severity weights, read NICE and the new UK EQ-5D-5L value set.

Our view

The 5L value set changes utilities in both arms of a model, so its net effect on an ICER, or on a severity weight, cannot be assumed in advance. We would recommend running both the cost-effectiveness and the shortfall calculations on the new basis early, before pricing assumptions are finalised.

Managed access: the Cancer Drugs Fund and the Innovative Medicines Fund

Managed access is available only for medicines evaluated through technology appraisal or HST.^[8] It is designed for situations where immature evidence would otherwise leave significant uncertainty. A committee first considers whether a routine recommendation is supported, and only then whether managed access is appropriate.^[8] To make that possible, the company submits a managed access proposal with its evidence submission. The proposal has two parts, a data collection proposal and a commercial access proposal.^[8] NICE then assesses whether the proposed data collection can resolve the key uncertainties, and shares that assessment 28 days before the committee meeting.^[8]

Medicines recommended with managed access are available for a time-limited period under an agreement between NHS England and the company. They are funded from dedicated managed access funds, not routine budgets, and are not treated as established practice.^[11] The Cancer Drugs Fund has run in its current form since 29 July 2016 and provides interim funding for all newly recommended cancer drugs.^[19] The Innovative Medicines Fund, launched in June 2022, covers non-cancer medicines recommended with managed access. Together the two funds provide £680 million of ring-fenced funding, with the CDF's £340 million budget unchanged, and IMF funding starts when NICE publishes draft final guidance.^[20] We explore proposal design on our managed access agreements page.

Highly specialised technologies: a separate framework

HST evaluations for very rare conditions sit within the same manual but use different decision parameters, and the 2026 threshold change does not apply to them.^{[2, 12]}

Technology appraisal (STA)

• Standard range of £25,000 to £35,000 per QALY from April 2026
• Severity weights of 1.2 or 1.7 based on QALY shortfall
• Net health benefit at £25,000 and £35,000 where modifiers apply
• Managed access through the CDF or IMF for medicines

Highly specialised technologies

• £100,000 per QALY, unchanged in 2026
• No severity weight: severity is captured in topic selection
• QALY weight of 1 to 3 for lifetime gains of 10 to 30 QALYs per patient
• Described by NICE as a £100,000 to £300,000 per QALY range

Sources: NICE PMG36 sections 6.2 and 6.3; NICE threshold Q&A.

The HST weight rises in equal increments between 10 and 30 incremental QALYs gained per patient over a lifetime horizon, and needs compelling evidence of significant QALY gains.^[11] NICE describes the result as a £100,000 to £300,000 per QALY range.^[2]

What this means for evidence planning

Taken together, the 2026 changes reward early, joined-up planning. The new range creates room for medicines close to the old upper bound. The 5L value set changes the inputs. And the aligned pathway brings the timetable forward. The practical steps below follow from the guidance cited above.

• Register early on UK PharmaScanAt least 3 years before authorisation, so the aligned pathway timetable is available
• Use Integrated Scientific Advice before pivotal plans are finalOne process aligns regulatory and HTA evidence needs
• Prepare the decision problem against the draft scopeAgreed comparators and subgroups shape the whole appraisal
• Collect EQ-5D-5L in trialsDirect 5L data avoid mapping for topics invited after 27 August 2026
• Estimate severity on the 5L basis earlyShortfall now uses 5L population norms; the cut-offs are unchanged
• Present net health benefit at £25,000 and £35,000With and without any QALY weight, as PMG36 requires
• Test budget impact against £40 millionAllows commercial discussions with NHS England to start in good time
• Decide on managed access at the submission stageA data collection and commercial proposal go in with the evidence

In our experience, the most efficient NICE submissions treat the scope, the model, the indirect comparisons and the commercial position as one piece of work, not four.

Evidaxia supports companies across the full NICE process, from scoping and the decision problem through to the economic model, the EAG and committee stages, and managed access. Find out more on our NICE technology appraisal service page, or contact us to discuss a specific topic.

References

1. National Institute for Health and Care Excellence. Changes to NICE's cost-effectiveness thresholds take effect [Internet]. London: National Institute for Health and Care Excellence; 2026 Apr 2 [cited 2026 Nov 1]. Available from: https://www.nice.org.uk/news/articles/changes-to-nice-s-cost-effectiveness-thresholds-take-effect
2. National Institute for Health and Care Excellence. Changes to NICE's cost-effectiveness thresholds: Q&A [Internet]. London: National Institute for Health and Care Excellence; 2026 [cited 2026 Nov 1]. Available from: https://www.nice.org.uk/what-nice-does/faqs/changes-to-nice-s-cost-effectiveness-thresholds
3. National Institute for Health and Care Excellence. Changes to NICE's cost-effectiveness thresholds confirmed [Internet]. London: National Institute for Health and Care Excellence; 2025 Dec 1 [cited 2026 Nov 1]. Available from: https://www.nice.org.uk/news/articles/changes-to-nice-s-cost-effectiveness-thresholds-confirmed
4. Robertson J. NICE cost-effectiveness thresholds increased as UK strikes trade deal with United States [Internet]. London: The Pharmaceutical Journal; 2025 Dec 2 [cited 2026 Nov 1]. Available from: https://pharmaceutical-journal.com/article/news/nice-cost-effectiveness-thresholds-increased-as-uk-strikes-trade-deal-with-united-states
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6. National Institute for Health and Care Excellence. Interim methods statement: implementing the EQ-5D-5L value set (PMG51). Introduction, process considerations and next steps [Internet]. London: National Institute for Health and Care Excellence; 2026 Aug 27 [cited 2026 Nov 1]. Available from: https://www.nice.org.uk/process/pmg51
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8. National Institute for Health and Care Excellence. NICE technology appraisal and highly specialised technologies guidance: the manual (PMG36), chapter 5: developing the guidance [Internet]. London: National Institute for Health and Care Excellence; [date unknown] [updated 2026 Oct 13; cited 2026 Nov 1]. Available from: https://www.nice.org.uk/process/pmg36/chapter/developing-the-guidance
9. National Institute for Health and Care Excellence. Guide to the technology appraisal and highly specialised technologies appeal process (PMG41), section 4: making an appeal [Internet]. London: National Institute for Health and Care Excellence; [date unknown] [updated 2025 Sep 2; cited 2026 Nov 1]. Available from: https://www.nice.org.uk/process/pmg41/chapter/making-an-appeal
10. National Institute for Health and Care Excellence. NICE technology appraisal and highly specialised technologies guidance: the manual (PMG36). Update information [Internet]. London: National Institute for Health and Care Excellence; [date unknown] [updated 2026 Oct 13; cited 2026 Nov 1]. Available from: https://www.nice.org.uk/process/pmg36/chapter/update-information
11. National Institute for Health and Care Excellence. NICE technology appraisal and highly specialised technologies guidance: the manual (PMG36), chapter 6: committee recommendations [Internet]. London: National Institute for Health and Care Excellence; [date unknown] [updated 2026 Oct 13; cited 2026 Nov 1]. Available from: https://www.nice.org.uk/process/pmg36/chapter/committee-recommendations
12. National Institute for Health and Care Excellence. Statement of intent on NICE's approach to ongoing evaluations ahead of proposed changes to NICE's standard cost-effectiveness thresholds (ECD19) [Internet]. London: National Institute for Health and Care Excellence; 2026 Feb 20 [cited 2026 Nov 1]. Available from: https://www.nice.org.uk/corporate/ecd19
13. Claxton K, Martin S, Soares M, Rice N, Spackman E, Hinde S, et al. Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol Assess. 2015;19(14):1-503. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC4781395/
14. Barnsley P, Towse A, Karlsberg Schaffer S, Sussex J. Critique of CHE Research Paper 81: methods for the estimation of the NICE cost effectiveness threshold [Internet]. London: Office of Health Economics; 2013 [cited 2026 Nov 1]. Available from: https://www.ohe.org/publications/critique-che-research-paper-81-methods-estimation-nice-cost-effectiveness-threshold/
15. Cookson G, Garau M, Sampson C. NICE's new cost-effectiveness threshold: significance, consequences, and unanswered questions [Internet]. London: Office of Health Economics; 2026 Feb 25 [cited 2026 Nov 1]. Available from: https://www.ohe.org/insights/nices-new-cost-effectiveness-threshold-significance-consequences-and-unanswered-questions/
16. National Institute for Health and Care Excellence. Interim methods statement: implementing the EQ-5D-5L value set (PMG51). Appendix C: technical frequently asked questions [Internet]. London: National Institute for Health and Care Excellence; 2026 Aug 27 [cited 2026 Nov 1]. Available from: https://www.nice.org.uk/process/pmg51/chapter/appendix-c-technical-frequently-asked-questions-faqs
17. National Institute for Health and Care Excellence. Interim methods statement: implementing the EQ-5D-5L value set (PMG51). Statement on using the EQ-5D-5L value set [Internet]. London: National Institute for Health and Care Excellence; 2026 Aug 27 [cited 2026 Nov 1]. Available from: https://www.nice.org.uk/process/pmg51/chapter/statement-on-using-the-eq-5d-5l-value-set
18. National Institute for Health and Care Excellence. Modular update to NICE manuals: EQ-5D-5L value set (GID-NGC10027) [Internet]. London: NICE; in development [cited 2026 Nov 1]. Available from: https://www.nice.org.uk/guidance/indevelopment/GID-NGC10027
19. NHS England. Cancer Drugs Fund [Internet]. London: NHS England; [date unknown] [cited 2026 Nov 1]. Available from: https://www.england.nhs.uk/cancer/cdf/
20. NHS England. Innovative Medicines Fund [Internet]. London: NHS England; [date unknown] [cited 2026 Nov 1]. Available from: https://www.england.nhs.uk/medicines-2/innovative-medicines-fund/

Sources accessed October 2026. This article is analysis for information and is not legal, regulatory or tax advice.