■ 고시 신설 전체내용 1. 각 약제의 허가사항 범위 내에서 투여 시 요양급여 함을 원칙으로 함. 2. 만 24세 이하인 자의 우울병에 투여하는 경우에는 허가사항 중 사용상의 주의사항(경고, 이상반응, 일반적주의 항목 등)에 따른 임상적 유용성이 위험성보다 높은지 신중하게 고려하여 투여하여야 함. ■ 고시 신설 고시번호(시행일자) 고시 제2024-155호(2024.8.1.) ■ 고시 신설 사유 ○ Lurasidone hydrochloride 경구제(품명 : 라투다정)가 신규 등재 예정임에 따라, 교과서, 가이드라인, 임상논문, 학회의견, 제외국 평가결과 등을 참조하여 급여기준을 신설함. ■ 관련문헌 등 1) Goodman & Gilman’s: The Pharmacological Basis of Therapeutics, 14e, 2022. 2) Katzung’s Basic & Clinical Pharmacology, 16th Edition (2023) 3) Current Medical Diagnosis & Treatment 2023 (2023) 4) 2019-2020 Florida Best Practice Psychotherapeutic Medication Guidlines for Adults 5) 2022-2023 Florida Best Practice Psychotherapeutic Medication Guidelines for Children and Adolescents 6) Antony Loebel et al. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: A randomized, double-blind, placebo- and active-controlled trial. Schizophrenia Research 145 (2013) 101？109 7) Melissa P. DelBello. et al. Efficacy and Safety of Lurasidone in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study. Journal of child and adolescent psychopharmacology;volume 27; 2017; 516-525 8) Antony Loebel et al. Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: A 12-month, double-blind, noninferiority study. Schizophrenia Research 147 (2013) 95？102. 9) Prof Stefan Leucht MD et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. The lancet Volume; 382, Issue 9896, 14-20 september 2013, Pages 951-962 10) Antony Loebel, M.D. et al. Lurasidone Monotherapy in the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study. American Journal of Psychiatry. 2014; 171:160？168 11) Antony Loebel, M.D. et al. Lurasidone as Adjunctive Therapy With Lithium or Valproate for the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study. American Journal of Psychiatry. 2014; 171:169？177 12) Jun Ishigooka et al. Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study. Journal of Affective Disorders Volume 281, 2021, Pages 160-167 13) Michael Ostacher. et al. Lurasidone compared to other atypical antipsychotic monotherapies for bipolar depression: A systematic review and network meta-analysis. The World Journal of Biological Psychiatry;volume 19; 2018; 586-601 14) Melissa P. DelBello. et al. Efficacy and Safety of Lurasidone in Children and Adolescents with Bipolar I Depression: A Double-Blind, Placebo-Controlled Study. Journal of child and adolescent psychopharmacology;volume 56; 2017; 1015-1025 15) Melissa P. DelBello. et al. Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression. Journal of child and adolescent psychopharmacology;volume 31; 2021; 494-503 16) 대한우울조울병학회 (대우조 제2023-02호, 2023.12.7.) 17) 대한조현병학회 (대조