Authors' objectives: The Academic Technology Assessment Group (ATAG) reviewed a report submitted by the manufacturer of valbenazine (Mitsubishi Tanabe Pharma Corporation) on the additional benefits and cost-effectiveness of valbenazine compared to watchful waiting in patients with tardive dyskinesia. This report summarizes the results of the review and reanalysis by the ATAG. In evaluating the additional benefits of valbenazine, the manufacturer conducted a meta-analysis of three endpoints for the 40 mg/day and 80 mg/day doses: changes in the Abnormal Involuntary Movement Scale (AIMS) total score from baseline at Week 6; the percentage of patients with ? 50% improvement from baseline in the AIMS total score; and changes in the clinical global impression of improvement of the tardive dyskinesia score from baseline obtained from J-KINECT, KINECT3, and KINECT2 trials. According to the results of the meta-analysis, valbenazine showed statistically significant efficacy for these endpoints; therefore, the manufacturer concluded that valbenazine had additional benefits over the comparator. In the reanalysis, the ATAG conducted a meta-analysis for the 80 mg/day dose without KINECT2 trial, because the dose was not 80 mg/day in the trial. The ATAG concluded that valbenazine had additional benefits. Thus, because performing a cost-effectiveness analysis was appropriate, the ATAG examined the manufacturer' s analysis. The manufacturer developed a microsimulation model that accounted for antipsychotic discontinuation, resumption, and relapse of the primary diseases over time to reflect the time course of each simulation sample. In this model, the manufacturer defined the health status based on treatment response, antipsychotic medication use, and relapse of the primary diseases. The ATAG revised the treatment response rate for valbenazine because the manufacturer's assumption was not appropriate in that the treatment response rate was higher than that obtained from the available evidence in clinical trials. The base-case analysis, based on a 50-time repetition of 10,000 samples, showed that valbenazine incurred an additional cost of JPY 3,666,420 and an additional 0.55 quality-adjusted life years (QALYs) compared to the comparator. This resulted in an incremental cost-effectiveness ratio (ICER) of JPY 6,719,339/QALY. In conclusion, for patients with tardive dyskinesia, the results by the ATAG suggested that the ICER for valbenazine compared to watchful waiting was likely to fall between JPY 5 and 7.5 million/QALY from the perspective of public healthcare payers in Japan.

Project Status: Completed

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

Year Published: 2023

URL for published report: https://c2h.niph.go.jp/en/results/C2H2205.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