Spesolimab for treating generalised pustular psoriasis flares

  • Technology appraisal guidance
  • TA1070
  • Published: 
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1 Recommendations

1.1

Spesolimab is recommended as an option for treating generalised pustular psoriasis (GPP) flares in adults, only if it is used to treat:

  • initial moderate to severe flares when:

    • the Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score is 3 or more (at least moderate), and

    • there are fresh pustules (new appearance or worsening of existing pustules), and

    • the GPPGA pustulation subscore is at least 2 (at least mild), and

    • at least 5% of the body's surface area is covered with erythema (abnormal redness of the skin or mucous membranes) and has pustules

  • subsequent flares with a GPPGA pustulation subscore of 2 or more (at least mild), if the last flare was treated with spesolimab and resolved to a GPPGA pustulation subscore of 0 or 1 (clear or almost clear skin).

    Spesolimab can only be used if the company provides it according to the commercial arrangement.

1.2

A second dose of spesolimab can be used after 8 days if a flare has not resolved to a GPPGA pustulation subscore of 0 or 1.

1.3

Take into account how skin colour could affect the GPPGA score and make any adjustments needed.

1.4

These recommendations are not intended to affect treatment with spesolimab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

Why the committee made these recommendations

There is no licensed standard care for GPP flares. Usual treatment includes ciclosporin, acitretin and biological treatments used to treat other forms of psoriasis.

The licence for spesolimab does not include definitions for initial or subsequent GPP flare severity. For this evaluation, the severity definition used for initial flares is based on the criteria used in the clinical trial. The severity definition used for treating subsequent flares and retreating initial and subsequent flares are based on the criteria used in the economic model. Clinical advice is that these definitions align with how spesolimab would be used in clinical practice.

Clinical trial evidence shows that spesolimab resolves moderate to severe GPP flares faster than placebo. But it is uncertain how it affects the proportion of people who need hospital and intensive care admissions, or the length of hospital stays. There is no evidence comparing spesolimab with usual treatments used for GPP flares in the NHS.

The cost-effectiveness estimates for spesolimab are uncertain. This is because of uncertainties with the clinical evidence and assumptions used in the economic model around inpatient and intensive care admissions and spesolimab's long-term effects. But there are also potential benefits not captured in the model. These include the potential for people to have fewer biological treatments for future GPP flares and the potential to live longer if they have spesolimab compared with usual treatment.

When taking this into consideration, the most likely cost-effectiveness estimates for spesolimab are within the range that NICE considers an acceptable use of NHS resources. So, it is recommended.