Risankizumab for treating moderate to severe plaque psoriasis

3.1 The company proposed that risankizumab should be considered in adults as an alternative to other biological therapies for psoriasis that has not responded adequately to non-biological systemic treatment or phototherapy, or if these are contraindicated or not tolerated. The company's proposed decision problem was narrower than risankizumab's marketing authorisation because it excluded people who had not had systemic non-biological therapy or phototherapy. However, the committee agreed that the proposed population was consistent with previous NICE recommendations for biological treatments for psoriasis, and with their use in clinical practice. The company presented a comparison with a NICE-recommended biological treatment (NICE technology appraisal guidance on guselkumab for treating moderate to severe plaque psoriasis). The committee agreed that this was consistent with the criteria for a cost-comparison appraisal (see section 3.6). The committee recalled that NICE's technology appraisal guidance on guselkumab recommends that treatment should stop if there is an inadequate response at 16 weeks. An adequate response is defined as:

3.2 Risankizumab has been studied in 4 randomised controlled trials including a total of about 2,200 adults with plaque psoriasis. It was directly compared with ustekinumab in 2 trials (UltIMMa‑1 and UltIMMa‑2), and to adalimumab in the 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 noted that an improvement in PASI 90 response, a primary endpoint of the trials, is particularly important to patients. Risankizumab was associated with a higher PASI 90 response at week 16 than ustekinumab (UltIMMa‑1: PASI 90 response rates 75.3% and 42.0% respectively, p<0.001) or adalimumab (IMMvent: PASI 90 response rates 72.4% and 47.4% respectively, p<0.001). The committee accepted that the results of these trials showed that risankizumab was more effective than adalimumab and ustekinumab.

3.3 The company did a series of network meta-analyses on PASI response rates, health-related quality of life (using DLQI) and safety outcomes. These compared risankizumab with guselkumab and with all other NICE-recommended biological agents (using data from 57 randomised controlled trials). The ERG was satisfied with the search strategy, the methodological quality of the included trials and the methodology used for the network meta-analyses. The committee accepted the ERG's view, concluding that the network meta-analyses provided by the company was suitable for decision making.

3.4 The committee acknowledged that PASI 75 is a key outcome when deciding whether to continue treatment. It noted that the results of the network meta-analysis suggested that risankizumab was similarly effective to guselkumab in terms of PASI 75 response. The committee appreciated that the company analyses also covered a range of outcomes, and that the results for PASI 100 were broadly consistent with those for PASI 75. It noted the safety and tolerability outcomes in the company's network meta-analysis and considered that risankizumab had a similar safety profile to other biologicals for psoriasis. The committee concluded that risankizumab provides similar benefits to guselkumab, and clinical benefits either similar to or greater than other biological agents.

3.5 The company presented a cost-comparison analysis that modelled the total costs of risankizumab and the comparator guselkumab over 10 years. It took into account stopping treatment based on PASI 75 response rates, which was consistent with the stopping rules specified in NICE's technology appraisal guidance for guselkumab. The base-case analysis used the same PASI 75 response rates and applied the same rate of long-term stopping of treatment during maintenance therapy for both risankizumab and guselkumab. 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 (the exact results cannot be reported here because the discounts are confidential).

3.6 The committee concluded that the criteria for a positive cost comparison were met because:

3.7 The committee noted, as in previous NICE technology appraisals on psoriasis, potential equality issues: