Original Title: [C2H2303] リトレシチニブ(リットフーロカプセル)

Authors' objectives: The academic technology assessment group (ATAG) reviewed a report on ritlecitinib's additional benefits and cost-effectiveness in adults and adolescents (12 years or older) with alopecia areata and 50% or greater scalp hair loss submitted by the manufacturer of ritlecitinib (Pfizer). This report summarizes the results of the review and re-analysis by the ATAG. When evaluating the additional benefits of ritlecitinib, the manufacturer noted that no randomized controlled trials (RCTs) directly comparing ritlecitinib with baricitinib were identified. Similarly, these RCTs were not identified in ATAG's systematic review. The ATAG also identified the ALLEGRO-2b/3 study and the BRAVE-AA1/AA2 studies, which were consistent with the manufacturer's review. For the adult population, the manufacturer insisted that additional benefits could not be adequately evaluated through a naive comparison of the treatment effects from the ALLEGRO-2b/3 and BRAVE-AA1/AA2 studies due to high uncertainty. The ATAG performed a network meta-analysis using these studies. However, the ATAG considered that the estimated treatment effects had high uncertainty given the wide 95% confidence intervals. The ATAG concluded that ritlecitinib had no additional benefits compared with baricitinib in the adult population. Thus, the ATAG examined the manufacturer's cost-minimization analysis, as this analysis was appropriate. For the adolescent population, the manufacturer stated that ritlecitinib would show efficacy similar to the statistically significant results observed in the overall population of the ALLEGRO-2b/3 study. Therefore, the manufacturer insisted that ritlecitinib demonstrated additional benefits over best supportive care (BSC). While the estimated treatment effects could show uncertainty due to limited number of samples in the trial, the ATAG considered that the manufacturerfs evaluation was reasonable. The ATAG concluded that ritlecitinib had additional benefits compared with BSC in adolescents. Thus, the ATAG examined the manufacturer's cost-effectiveness analysis, as this analysis was appropriate. The manufacturer's analysis was conducted using a Markov model of nine health states stratified by the presence or absence of active treatments (ritlecitinib and baricitinib) and severity of alopecia tool score, and death. The ATAG conducted a re-analysis in several points, such as stage age, efficacy parameter, and subsequent treatment for the adolescent population. In particular, in the manufacturer's analysis, patients were assumed to continue BSC throughout lifetime despite baricitinib is available in clinical practice for patients aged 15 years or olde. The ATAG's re-analysis applied baricitinib after patients aged 15 years and older in the adolescent population. As a result, ATAG's base-case analysis showed that ritlecitinib led to a cost increase of JPY 1,710,932 compared to baricitinib in the adult population. For the adolescent population, ATAG's base-case analysis showed that ritlecitinib incurred the additional cost of JPY 1,210,540 and conferred the additional 0.06 quality-adjusted life years (QALYs) compared to the comparator, resulting in the incremental cost-effectiveness ratio (ICER) of JPY 19,436,419 per QALY. In conclusion, for patients with alopecia areata and 50% or greater scalp hair loss, the results of the ATAG's analysis suggested that the ICERs for ritlecitinib compared to comparators are likely to be "cost increase" in the adult population and "more than JPY 15 million per QALY" in the adolescent population from the perspective of public healthcare payers in Japan.

Project Status: Completed

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

Year Published: 2025

URL for published report: https://c2h.niph.go.jp/en/results/C2H2303.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