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New HTA Decisions in England
January 2020
Drug name
SKYRIZI™ (risankizumab)
Decision date
Therapeutic area
Skin conditions
Therapeutic sub area
Recommended with restrictions
As an option for treating plaque psoriasis in adults.
Decision Detail
Risankizumab is recommended as an option for treating plaque psoriasis in adults, only if: 1) 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, 2) the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and 3) the company provides the drug according to the commercial arrangement.
The clinical evidence for risankizumab was studied in four randomised controlled trials, two of which directly compared risankizumab with ustekinumab (UltIMMa‑1 and UltIMMa‑2) and one to adalimumab (IMMvent trial). In these trials, risankizumab was associated with statistically significant improvements compared with ustekinumab and adalimumab in primary and secondary outcomes, including PASI response rates. The committee accepted that the results of these trials showed that risankizumab was 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. The company presented a cost-comparison analysis that modelled the total costs of risankizumab and the comparator guselkumab over 10 years. The committee accepted the company's base-case model. Taking into account the confidential patient access schemes for risankizumab and guselkumab, the committee concluded that the total costs associated with risankizumab were 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.