Aclidinium bromide 흡입제(품명: 에클리라제뉴에어 400마이크로그램)

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: 2015.4.1

* 신설사유:신규 등재 예정인 약제로 국내·외 허가사항, 교과서, 임상진료지침, 임상논문 등을 참조하여 허가 범위 내 급여인정하되, 동일한 적응증에 사용되는 기존의 LAMA 단일제제와 동일한 급여기준을 적용함.

* 관련근거:· Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12e;Chapter 36. Pulmonary Pharmacology, Mechanisms of Chronic Obstructive Pulmonary Disease

· Pharmacotherapy: A Pathophysiologic Approach, 9e Chapter 16. Chronic Obstructive Pulmonary Disease

· Global initiative for chronic obstructive lung disease (GOLD) guideline, updated 2013

· Karabis A et al. Comparative efficacy of aclidinium versus glycopyrronium and tiotropium, as maintenance treatment of moderate to severe COPD patients: a systematic review and network meta-analysis. Int J Chron Obstruct Pulmon Dis. 2013;8:405-23

· Beier J et al. Efficacy and safety of aclidinium bromide compared with placebo and tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease: results from a 6-week, randomized, controlled Phase IIIb study. COPD. 2013 Aug;10(4):511-22.

· Rennard SI et al. ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients. Clin Drug Investig. 2013 Dec;33(12):893-904

· Gelb AF et al. Long-term safety and efficacy of twice-daily aclidinium bromide in patients with COPD. Respir Med. 2013 Dec;107(12):1957-65.

· D'Urzo A et al. One-year extension study of ACCORD COPD I: safety and efficacy of two doses of twice-daily aclidinium bromide in patients with COPD. COPD. 2013 Aug;10(4):500-10.

· Jones PW et al. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6.

· Kerwin EM et al. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012 Apr;9(2):90-101.

· Fuhr R et al. Efficacy of aclidinium bromide 400 μg twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest. 2012 Mar;141(3):745-52.

· Jones PW et al. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12:55.