허가사항 범위(과민성 방광의 배뇨 절박감, 빈뇨 및 절박성 요실금 증상의 치료) 내에서 투여 시 요양급여를 인정함.
■ 고시 신설 고시번호(시행일자)
고시 제2025-176호(2025.9.1.)
■ 고시 신설 사유
○Vibegron 경구제(품명 : 베오바정50밀리그램)가 신규 등재 예정임에 따라, 교과서, 가이드라인, 임상논문, 학회의견, 제외국 평가결과 등을 참조하여 급여기준을 신설함.
■ 관련문헌 등
1) Quick Medical Diagnosis & Treatment 2025
2) Current Medical Diagnosis & Treatment 2026
3) The AUA/SUFU Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder (2024)
4) Masaki Yoshida et al. Vibegron, a Novel Potent and Selective b3-Adrenoreceptor Agonist, for the Treatment of Patients with Overactive Bladder: A Randomized, Double-blind, Placebo-controlled Phase 3 Study EUROPEAN UROLOGY 2018;73;pages 783-790.
5) Masaki Yoshida et al. Long-term safety and efficacy of the novel b3-adrenoreceptor agonist vibegron in Japanese patients with overactive bladder: A phase III prospective study INTERNATIONAL JOURNAL OF UROLOGY 2018;25;pages 668-675.
6) Manami Kinjo et al. Comparison of Mirabegron and Vibegron in Women With Treatment- Naive Overactive Bladder: A Randomized Controlled Study UROLOGY 2023;175;pages 67-73.
7) Zhonyu Jian et al. Vibegron 50 mg is the optimal algorithm in the pharmacologic management of overactive bladder: outcomes from a systematic review and meta？analysis International Urology and Nephrology 2020;12;pages 2215-2221.