■ 고시 신설 전체내용 허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정함. - 아 래 - ○ 복잡성 복강 내 감염(Complicated intra-abdominal infections), 복잡성 요로감염(Complicated urinary tract infections)과 원내 감염 폐렴(Hospital-acquired and ventilator-acquired pneumonia)에 Carbapenem계 항생제에 실패한 경우 또는 다제내성 녹농균이나 카바페넴 내성 장내세균이 증명된 경우 요양급여를 인정하며, 투여소견서를 첨부하여야 함. ■ 고시 신설 고시번호(시행일자) 고시 제2024-20호(2024.2.1.) ■ 고시 신설 사유 ○ Ceftazidime + Avibactam 주사제 (품명: 자비쎄프타주)가 신규 등재 예정임에 따라, 교과서, 가이드라인, 임상논문, 학회의견, 제외국 평가결과 등을 참조하여 급여기준을 신설함. ■ 관련 근거 · Harrison’s Principles of Internal Medicine, 21e, 2022. · Current Medical Diagnosis and Treatment, 62e, 2023. · Goldman-Cecil Medicine, 26e, 2020. · Principles and Practice of Pediatric Infectious Diseases, 6e, 2023. · 성인 복강 내 감염 감염 항생제 사용지침, 2022. · 요로감염 항생제 사용지침, 2018. · European Association of Urology (EAU) Guidelines on Urological Infections, 2022. · NICE guideline: Pneumonia (hospital-acquired): antimicrobial prescribing, 2019. · Infectious Diseases Society of America (IDSA) Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections, Version 1.0, 2022.3. · Infectious Diseases Society of America (IDSA) Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections, Version 2.0, 2022.3. · John E. Mazuski, at el. Efficacy and Safety of Ceftazidime-Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-abdominal Infection: Results From a Randomized, Controlled, Double-Blind, Phase 3 Program Clin Infect Dis . 2016 Jun 1;62(11):1380-1389. · Florian M. Wagenlehner, at el. Ceftazidime-avibactam Versus Doripenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: RECAPTURE, a Phase 3 Randomized Trial Program Clinical Infectious Diseases® 2016;63(6):754？62. · Antoni Torres, at el. Ceftazidime-avibactam versus meropenem in nosocomial pneumonia, including ventilator- associated pneumonia (REPROVE): a randomised, double-blind, phase 3 non-inferiority trial Lancet Infect Dis 2018;18: 285？95. · John S. Bradley, at el. Safety and Efficacy of Ceftazidime-Avibactam Plus Metronidazole in the Treatment of Children ≥3 Months to <18 Years With Complicated Intra-Abdominal Infection: Results From a Phase 2, Randomized, Controlled Trial Pediatr Infect Dis J 2019;38:816？824. · John S. Bradley, at el. Safety and Efficacy of Ceftazidime？Avibactam in the Treatment of Children ≥3 Months to <18 Years With Complicated Urinary Tract Infection: Results from a Phase 2 Randomized, Controlled Trial Pediatr Infect Dis J 2019;38:920？928. · NICE (2022.8.) · G-BA (2022.11.)