Authors' objectives: The academic technology assessment group (ATAG) reviewed a report on deucravacitinib's additional benefits and cost-effectiveness in patients with plaque psoriasis who are not sufficiently responding to existing treatments submitted by the manufacturer of deucravacitinib (Bristol Myers Squibb). This report summarizes the results of the review and the re-analysis by the ATAG. The target population was divided into two groups: (a) Patients who are not sufficiently responding to non-biologic systemic treatments with no prior biologic treatments and (b) Patients with no prior systemic treatments. In evaluating the additional benefits of deucravacitinib for the target population (a), the manufacturer noted that no randomized controlled trials (RCT) that directly compared deucravacitinib and risankizumab were identified. Given this, the manufacturer identified 96 RCTs by conducting a systematic review and performed a network meta-analysis (NMA). The manufacturer asserted that deucravacitinib has additional benefits over risankizumab because the NMA using only Asian patient data showed an improvement in the odds ratio of achieving psoriasis area and severity index (PASI) for deucravacitinib over risankizumab at 10-16 weeks compared to the Global NMA using all literature. However, in both cases, the odds ratio was clearly less than 1. Thus, the ATAG rated deucravacitinib as having gno additional benefith(inferior efficacy) over risankizumab and did not examine its cost effectiveness. In evaluating the additional benefits of deucravacitinib for the target population (b), the manufacturer asserted that deucravacitinib has additional benefits over apremilast due to its significantly higher percentage in achieving PASI at 16 weeks in the randomized POETYK-PSO-1 and POETYK- PSO-2 trials that directly compared deucravacitinib and apremilast. These trials were also detected in the ATAG's systematic review. The ATAG judged that the manufacturer's method for evaluating the additional benefits based on the POETYK trials was appropriate. Thus, as the costeffectiveness analysis was appropriate, the ATAG examined the manufacturer's analysis. The manufacturer conducted a Markov cohort simulation analysis based on the structure of the York model. The model assumed that all patients would initiate treatment with either deucravacitinib or apremilast and patients who achieved PASI 75 would transition to a maintenance phase consisting of three-state (PASI 100, PASI 90-99, and PASI 75-89). Patients who didn't achieve PASI 75 or discontinued the primary treatment were assumed to transition to a secondary treatment. In the event of discontinuation of the tertiary treatment, all patients were assumed to transition seamlessly to a Best Supportive Care (BSC), which would be continued for the rest of their lives. The ATAG conducted a re-analysis due to the identification of several challenges in the manufacturer's analysis. First, the manufacturer used pooled EQ-5D-3L data from POETYK trials and the previous technology appraisals conducted by National Institute for Health and Care Excellence (NICE). The ATAG judged that using EQ-5D-3L that was not converted by Japanese tariff was inappropriate. Therefore, the ATAG conducted re-analysis using the pooled EQ-5D-3L data converted by Japanese tariff from POETYK trials. Additionally, the manufacturer assumed that patients who received BSC would be hospitalized once in a year. The ATAG revised the hospitalization charges for BSC based on the annual hospitalization risk compiled in the National Database (NDB). The base-case analysis showed that deucravacitinib incurred an additional cost of JPY 880,270 and conferred an additional 0.15 quality-adjusted life years (QALYs) compared to apremilast. This resulted in an incremental cost-effectiveness ratio (ICER) of JPY 6,045,505 per QALY gained. In conclusion, for plaque psoriasis patients who are not sufficiently responding to existing treatments, the results by the ATAG suggested that the ICER for deucravacitinib compared to apremilast was likely to belong to the interval between JPY 5 and 7.5 million per QALY from the perspective of public healthcare payer in Japan.

Project Status: Completed

URL for project: https://c2h.niph.go.jp/en/

Year Published: 2024

URL for published report: https://c2h.niph.go.jp/en/results/C2H2209.html

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Japan

Organisation Name: Center for Outcomes Research and Economic Evaluation for Health

Contact Address: 2-3-6 Minami, Wako-shi, Saitama 351-0197 Japan

Contact Name: Takeru Shiroiwa

Contact Email: t.shiroiwa@gmail.com