Indacaterol maleate + Glycopyrronium bromide 흡입제(품명: 조터나흡입용캡슐)

기준 내용

※ 동 고시는 고시 제2018-253호(2018.12.1.)로 삭제되었습니다

허가사항 범위 내에서 중등도 이상의 만성폐쇄성폐질환[FEV1(1초 강제호기량) 값이 예상 정상치의 80% 미만] 환자의 유지요법제로 투여 시 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.

* 시행일: 2015.5.1

* 신설사유: 신규 등재 예정인 약제로 국내·외 허가사항, 교과서, 임상논문 참조하여 유사 약제(LABA+LAMA 복합제)와 동일 급여기준을 적용함.

* 관련근거

· Harrison's Principles of Internal Medicine, 18th ed. (2011) Ch.260 Chronic Obstructive Pulmonary Disease

· Pharmacotherapy: A Pathophysiologic Approach, 9th ed. (2014) Chapter 16. Chronic Obstructive Pulmonary Disease

· COPD 진료지침 2012 개정판, 대한결핵 및 호흡기학회 COPD 진료지침 개정위원회

· Global initiative for chronic obstructive lung disease (GOLD) guideline, updated 2013. CHAPTER 4: MANAGEMENT OF STABLE COPD

· Rodrigo GJ, EFFICACY AND SAFETY OF A FIXED-DOSE COMBINATION OF INDACATEROL AND GLYCOPYRRONIUM (QVA149) FOR THE TREATMENT OF COPD: A SYSTEMATIC REVIEW. Chest. 2014 Feb 20

· Wedzicha JA et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013 May;1(3):199-209

· Dahl R et al. Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study.; Int J Chron Obstruct Pulmon Dis. 2013;8:501-8.

· Eric D. Bateman et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study; Eur Respir J 2013; 42: 1484-1494

· Donald A. Mahler et al. Dual bronchodilation with QVA149 reduces patient-reported dyspnoea in COPD: BLAZE study; ERJ Express. Published on October 31, 2013