1.1 Risankizumab is recommended as an option for treating plaque psoriasis in adults, only if:
the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and
the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and
the company provides the drug according to the commercial arrangement.
1.2 Stop risankizumab treatment at 16 weeks if the psoriasis has not responded adequately. An adequate response is defined as:
a 75% reduction in the PASI score (PASI 75) from when treatment started or
a 50% reduction in the PASI score (PASI 50) and a 5‑point reduction in DLQI from when treatment started.
1.3 If patients and their clinicians consider risankizumab to be one of a range of suitable treatments, including guselkumab, secukinumab and ixekizumab, the least expensive should be chosen (taking into account administration costs, dosage, price per dose and commercial arrangements).
1.4 When using the PASI, healthcare professionals should take into account skin colour and how this could affect the PASI score, and make the clinical adjustments they consider appropriate.
1.5 When using the DLQI, healthcare professionals should take into account any physical, psychological, sensory or learning disabilities, or communication difficulties that could affect the responses to the DLQI and make any adjustments they consider appropriate.
1.6 These recommendations are not intended to affect treatment with risankizumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Risankizumab is proposed as an alternative to other biological therapies already recommended by NICE for treating severe plaque psoriasis in adults. Evidence from clinical trials shows that risankizumab is more effective than adalimumab and ustekinumab. Indirect comparisons suggest that risankizumab is likely to provide similar health benefits compared with guselkumab, and better PASI response rates compared with many other biologicals.
For the cost comparison, it is appropriate to compare risankizumab with guselkumab. The total costs associated with risankizumab are similar to or lower than those associated with guselkumab. Therefore, risankizumab is recommended as an option for use in the NHS for severe plaque psoriasis that has not responded to systemic non-biological treatments, or if these are contraindicated or not tolerated.