Evidaxia
HTA in England

NICE technology appraisal submissions.

Company evidence submissions for NICE single technology appraisals, highly specialised technologies and managed access, led by a former NICE HTA Technical Lead and Analyst. Built for the committee, the external assessment group and the 2026 rules.

Reviewed by Hasan Bari, Founder and Managing Director · Updated October 2026

NICE technology appraisal in 2026

NICE technology appraisals run under the technology appraisal and highly specialised technologies manual (PMG36). Three changes make 2026 a natural moment to revisit how a NICE evidence package is planned. From 2 April 2026, committees apply a standard cost-effectiveness range of £25,000 to £35,000 per QALY gained, replacing £20,000 to £30,000, to both new and ongoing evaluations. From 1 April 2026, the MHRA-NICE aligned pathway has been fully open, aiming to bring medicines to NHS patients 3 to 6 months sooner through same-time decisions on licensing and value. And appraisals invited after 27 August 2026 use the new UK EQ-5D-5L value set (see what the EQ-5D-5L value set means for NICE submissions).

For the full practitioner view, read our guide to NICE technology appraisal in 2026.

The single technology appraisal, step by step

  1. Scoping and the decision problem: Population, comparators, care pathway and outcomes are agreed, with a decision problem meeting before the evaluation starts.
  2. Evidence submission: Due 56 calendar days after the invitation to participate for an STA (28 days for cost comparison).
  3. Clarification: Questions within 21 days of submission, with 14 days for the company to respond.
  4. External assessment and progression: NICE normally decides the route within 14 days of the external assessment report, including optional technical engagement with a 28-day comment period.
  5. Committee and guidance: Draft guidance, a 28-day consultation, then final draft guidance and a 15-working-day appeal period.
  6. Funding: The funding requirement normally applies within 3 months of publication, with NHS England commercial discussions where net budget impact is expected to exceed £40 million in any of the first 3 years.

How the new threshold range works

Below £25,000 per QALY, decisions rest on the cost-effectiveness estimate and the acceptability of the technology as an effective use of NHS resources. Between £25,000 and £35,000, committees weigh the certainty of the ICER, benefits not captured in the QALY, and health inequalities, referring to these explicitly as the ICER rises. Above £35,000, the case for the technology needs to be increasingly strong.

The severity modifier applies on top: a QALY weight of 1.2 or 1.7 depending on proportional or absolute QALY shortfall. Try the interactive explorer in our 2026 guide, or read the worked example in the NICE severity modifier explained.

Highly specialised technologies and managed access

Highly specialised technologies for very rare conditions are evaluated with their own approach, including QALY weighting linked to the size of the lifetime QALY gain, and the standard threshold change does not apply to them. Where evidence is still maturing, a recommendation with managed access through the Cancer Drugs Fund or the Innovative Medicines Fund can give patients access while further data are collected. See managed access agreements and our guide to the CDF and IMF.

Calculate QALY shortfall and the NICE severity weight for your own population in our free calculator.

Open the nICE severity modifier calculator

What we deliver

  • Evidence planning and decision problem preparation, including comparators, subgroups and the modelling approach
  • The company evidence submission, written to the NICE template
  • De novo or adapted cost-effectiveness models, with severity modifier and EQ-5D-5L analyses
  • Clinical systematic literature reviews and indirect treatment comparisons
  • Budget impact analysis for NICE and NHS England commercial discussions
  • Clarification responses, technical engagement and draft guidance consultation responses
  • Committee meeting preparation
  • Managed access proposals and resubmission planning

Planning NICE alongside Scotland, Wales, Ireland and the EU

One well-built evidence package can serve several decisions. Scotland has its own assessment through the Scottish Medicines Consortium, Wales fills gaps through AWMSG, and Ireland assesses every medicine through the NCPE. For EU launches, the joint clinical assessment shapes the clinical evidence too: see one evidence plan for NICE and the JCA.

Why Evidaxia

Our founder, Hasan Bari, worked inside NICE as an HTA Technical Lead and Analyst on technology appraisals and HealthTech guidance, and brings more than a decade of healthcare experience. We know how committees and external assessment groups read a submission, which uncertainties shape a decision, and how to present a case clearly. The person who scopes your project builds the model and joins the meetings.

FAQ

Common questions

Anything else? Email info@evidaxia.com.

What is the NICE cost-effectiveness threshold in 2026?

Since 2 April 2026, NICE technology appraisal committees use a standard range of £25,000 to £35,000 per QALY gained, replacing £20,000 to £30,000. It applies to new and ongoing appraisals, but not to highly specialised technologies.

How long does a NICE single technology appraisal take?

The evidence submission is due 56 days after the invitation to participate, followed by clarification, external assessment, committee meetings, draft guidance consultation and final guidance. The funding requirement normally applies within 3 months of publication.

What is the MHRA-NICE aligned pathway?

A route, fully open since 1 April 2026, that brings licensing and NICE value decisions together, with the aim of bringing medicines to NHS patients 3 to 6 months sooner.

Does the new threshold change the severity modifier?

No. The severity modifier still applies QALY weights of 1.2 or 1.7 based on proportional or absolute QALY shortfall; the weighted ICER is then considered against the new range.

Do you support resubmissions and managed access proposals?

Yes. We support clarification responses, technical engagement, draft guidance consultations, resubmissions and managed access proposals through the Cancer Drugs Fund or the Innovative Medicines Fund.

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