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 of
Public Health (NIPH) | URL:https://c2h.niph.go.jp

November 15, 2023

[C2H2205] Valbenazine (Dysval)
1. Purpose of use
Tardive dyskinesia
2. Price of the drug
Valbenazine has been reimbursed since May 2023, and its drug price is JPY
2331.2 for Dysval® capsule 40mg as of September 2023. The price is determinedbased on the Similar Efficacy Comparison Method with a 5% premium. The
product is designated as an item for the Cost-effectiveness Evaluation with H2classification.
3. Scope of Cost-effectiveness Evaluation
Valbenazine is used to improve the symptoms of tardive dyskinesia, primarilycaused as side effects of antipsychotic drugs. The scope of Cost-effectivenessEvaluation determined at the first session of the Expert Committee of Cost–
Effectiveness Evaluation (ECCEE) is described below.
In treating patients with tardive dyskinesia, reducing dose of and discontinuing
drugs for underlying disease such as antipsychotic drugs is considered firstwhenever possible. Therefore, the target population is “Tardive dyskinesia
patients whose symptoms are not sufficiently improved by reducing dose ofand/or discontinuing drugs for underlying diseases”. The comparator is ”watchfulwaiting” since treatment options are limited for the target population.

Targetpopulation
Comparator

Tardive

dyskinesia

patients

whosesymptoms

arenotsufficiently improved by reducing dose of and/or discontinuing
drugs for underlying diseases
Watchful waiting4. Evaluation of additional benefits
The manufacturer conducted a systematic review of randomized controlled
trials to evaluate additional benefits of Valbenazine. Using identified articles, themanufacturer performed a mixed-model meta-analysis comparing Valbenazine
and placebo as a substitute for the comparator, with the outcomes changes frombaseline in Abnormal Involuntary Movement Scale (AIMS) score, AIMS responder
rates (defined as rate of improvement of 50% from baseline in AIMS score), andchanges from baseline in Clinical Global Impression of Change - Tardive
Dyskinesia (CGI-TD) score.
As a result, for the case of Valbenazine 40mg/day, the changes in AIMS score
were larger (mean difference -2.10[95%CI: -2.83, -1.38]), AIMS responder rates
were higher (risk ratio 2.50[95%CI: 1.39, 4.49]), and the changes in CGI-TD
scores were larger (mean difference -0.53 [95% CI: -0.77, -0.29]) for
Valbenazine group. Valbenazine also significantly improved those outcomes forthe case of Valbenazine 80mg/day. Based on the results, the manufacturer
concluded that Valbenazine 40mg/day had additional benefits.
The academic group considered the analysis by manufacturer was acceptablefor Valbenazine 40mg/day. Since the meta-analysis for Valbenazine 80mg/day
included a trial with different dosage of Valbenazine, the academic groupperformed a meta-analysis excluding that trial.
Based on these results, the academic group concluded that Valbenazine hadadditional benefits.
5. Results of the cost-effectiveness analysis
The manufacturer conducted cost-utility analysis using a microsimulation
model, which had health states set based on responses from interventions,prescription of antipsychotic drugs, and recurrence of underlying diseases.
In the academic analysis, the response rate of Valbenazine was revised
according to the results of clinical trials for Valbenazine.
The ECCEE accepted the following:
Population
Tardive

dyskinesia

patients

ICER (JPY/QALY)

Watchful waiting

6,719,339

whosesymptoms are not sufficiently improved by
reducing the amount of and discontinuing
drugs for underlying diseases

Comparator