Changeflow GovPing Pharma & Drug Safety Spesolimab GPP flare prevention appraisal termi...
Routine Notice Added Final

Spesolimab GPP flare prevention appraisal terminated, no evidence

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Summary

NICE has terminated its appraisal of subcutaneous spesolimab (Spevigo) 1-ml formulation for preventing generalized pustular psoriasis flares in patients 12 years and older. The termination occurred because the manufacturer did not provide an evidence submission, leaving NICE unable to assess clinical effectiveness or cost-effectiveness. No NHS funding guidance will be issued for this indication.

What changed

NICE has terminated appraisal TA1144 for subcutaneous spesolimab 1-ml formulation in generalized pustular psoriasis flare prevention. The company withdrew from the process by failing to provide an evidence submission, preventing NICE from conducting its standard health technology assessment.\n\nHealthcare providers treating GPP patients will not receive NHS commissioning guidance on this spesolimab formulation. Pharmaceutical companies considering NICE submissions should ensure timely evidence packages to avoid appraisal termination, which delays patient access to potentially beneficial treatments.

What to do next

  1. Monitor for updates if the manufacturer decides to submit evidence for future appraisal

Archived snapshot

Apr 8, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Subcutaneous spesolimab 1-ml formulation for preventing generalised pustular psoriasis flares in people 12 years and over (terminated appraisal)

  • Technology appraisal
  • TA1144
  • Published:

08 April 2026

Download guidance (PDF)

Overview

NICE is unable to make a recommendation on subcutaneous spesolimab (Spevigo) 1-ml formulation for preventing generalised pustular psoriasis flares in people 12 years and over. This is because the company did not provide an evidence submission.

Last reviewed: 08 April 2026

Next review: We will review this decision if the company decides to make a submission.

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Last updated

Classification

Agency
NICE
Published
April 8th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
TA1144

Who this affects

Applies to
Pharmaceutical companies Healthcare providers NHS bodies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Technology appraisal Prescribing guidance Market access
Geographic scope
United Kingdom GB

Taxonomy

Primary area
Healthcare
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Pharmaceuticals Public Health

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