国立保健医療科学院 保健医療経済評価研究センター
Center for Outcomes Research and Economic
Evaluation for Health (C2H), National Institute ofPublic Health (NIPH) | URL:http://c2h.niph.go.jp

June 21, 2024

[C2H2209] Summary of cost-effectiveness evaluationof deucravacitinib (Sotyktu®)
1. Indications
Patients with plaque psoriasis (an inflammatory disease causing red, scaly
patches on the skin) not responding sufficiently to existing treatments.
2. Price of the drug
Deucravacitinib (Sotyktu®) has been reimbursed from November 2022 at JPY
2,770.90 (as of April 2024). This price is calculated using a similar efficacy
comparison method, with a usefulness premium (I) of 5%. This product isdesignated as an H1 cost-effectiveness evaluation item.
3. Scope of cost-effectiveness evaluation
This product is indicated for the treatment of plaque psoriasis patients who are
not sufficiently responding to existing treatments. The scope of evaluationagreed upon at the first session of the Expert Committee of Cost-EffectivenessEvaluation (ECCEE) is described below.
Plaque psoriasis patients who are not sufficiently respondingto existing treatments
Population(a) Patients who are not sufficiently responding to nonbiologic systemic treatments with no prior biologic
treatments(b) Patients with no prior systemic treatments(a) Biologics (ixekizumab, risankizumab, and bimekizumab)

Comparator

with the lowest price(b) Apremilast

4. Evaluation of additional benefits[Plaque psoriasis patients who are not sufficiently responding to non-biologic
systemic treatments with no prior biologic treatments] The manufacturer notedthat

norandomized

controlledtrials(RCTs)

that

directlycompareddeucravacitinib and risankizumab were identified. The manufacturer identified 96
RCTs by conducting a systematic review and performing a network meta-analysis(NMA). The manufacturer asserted that deucravacitinib had additional benefits
over risankizumab because the NMA using only Asian patient data showed animprovement in the odds ratio of achieving psoriasis area and severity index(PASI) for deucravacitinib over risankizumab at 10–16 weeks compared to theglobal NMA using all literature. However, in both cases, the odds ratio was lessthan 1. Thus, the ATAG rated deucravacitinib as having "no additional benefit"(inferior efficacy) over risankizumab.
[Patients with plaque psoriasis with no prior systemic treatments] Randomized
POETYK-PSO-1 and POETYK-PSO-2 trials were included in the ATAG’s systematicreview. Deucravacitinib showed significantly higher response rates thanapremilast at week 16 in POETYK-PSO-1 (PASI 75 was achieved in 58.4% vs.
35.1%) and POETYK-PSO-2 (53.0% vs. 39.8%) patients. The ATAG concluded that
deucravacitinib has additional benefits over apremilast owing to its significantly
higher percentage of achieving PASI at 16 weeks in the randomized POETYKPSO-1 and POETYK-PSO-2 trials.
5. Results of the cost-effectiveness analysis
The manufacturer conducted a Markov cohort simulation analysis based on thestructure 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 states (PASI100, PASI 90–99, and PASI 75–89). Patients who did not achieve PASI 75 ordiscontinued the primary treatment were assumed to transition to a secondary
treatment. In the event of discontinuation of the tertiary treatment, all patientswere assumed to transition seamlessly to 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 theprevious technology appraisals conducted by the National Institute for Health andCare Excellence. The ATAG judged that using EQ-5D-3L, which was not converted

by Japanese tariff, was inappropriate. Therefore, the ATAG conducted a reanalysis using the pooled EQ-5D-3L data converted by Japanese tariff fromPOETYK trials. Additionally, the manufacturer assumed that patients who
received BSC would be hospitalized once a year. The ATAG revised thehospitalization charges for BSC based on the annual hospitalization risk compiledin the National Database. The ECCEE accepted the following results:

Population

Comparator(a) Plaque psoriasis patients
Risankizumab

systemic treatments with(b) Plaque psoriasis patientstreatments

ICER (JPY/QALY)

benefit(inferiorefficacy)

no prior biologic treatmentswith no prior systemic

benefits
No additional

who are not sufficiently
responding to non-biologic

Additional

Apremilast

Additional
benefit

6,045,505

The ATAG rated deucravacitinib as having "no additional benefit" (inferiorefficacy) over risankizumab and did not examine its cost-effectiveness.