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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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    Are the recommendations sound and a suitable basis for guidance to the NHS?

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1 Recommendations

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1 Recommendations

1.1

Spesolimab is not recommended, within its marketing authorisation, for treating generalised pustular psoriasis (GPP) flares in adults.

1.2

This recommendation is 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, so the clinical evidence is from a comparison of spesolimab with placebo for the treatment of moderate-to-severe GPP flares. It shows that spesolimab resolves flares faster than placebo, but it is uncertain how it affects the rate of hospital and intensive care admissions, or the length of hospital stays.

There are uncertainties in the economic evidence for spesolimab because:

  • the clinical evidence used to model treatment response is uncertain, and

  • the treatment of subsequent flares was not included.

Because of these uncertainties, it is not possible to determine the most likely cost-effectiveness estimates for spesolimab. So, it is not recommended.