<P>1. 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 허가사항 범위이지만 동 인정기준 이외에 투여하는 경우에는 약값 전액을 환자가 부담토록 함.(고시 제2013-68호)<BR>- 아 래 -<BR> ○ 발작성 또는 지속성 심방세동 병력을 가진 현재 정상 동율동(sinus rhythm)인 심방세동 환자에서 심방세동으로 인한 입원 위험성 감소에 투여 시<BR> - 기저 심질환(좌심실 비대, 허혈성 심질환 등)이 있는 경우</P>
<P>2. 다만, 허가사항 중 사용상의 주의사항 경고 등(영구적 심방세동 환자, 심부전의 기왕력이 있거나 현재 심부전이 있는 환자 또는 좌심실 수축기능부전 환자, 분당 50회 미만의 서맥 환자 등)을 반드시 참고하여 투여하여야 함.</P>
<P>* 시행일: 2013.5.1.<BR>* 신설사유: 신규등재 예정인 약제로 국내·외 허가사항, 교과서, 관련 학회의견, 임상진료지침, 임상논문, 외국보험 평가자료 및 경제성 평가 등을 참조하여 허가사항 범위내에서 기저 심질환이 있는 환자에 대하여 요양급여를 인정함.<BR>* 관련근거: · Bonow-Braunwald's Heart Disease. A Textbook of Cardiovascular Medicine. 9th ed. Chapter 37 - Therapy for Cardiac Arrhythmias<BR> · Bope and Kellerman Conn's Current Therapy 2012 1st ed. Chapter 7 - Cardiovascular System<BR> · 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline). Heart Rhythm, Vol 8, No 1, January 2011.<BR> · 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: An update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. European Heart Journal Advance Access published August 24, 2012.<BR> · Society Guidelines: Focused 2012 Update of the Canadian Cardiovascular Society Atrial Fibrillation Guidelines: Recommendations for Stroke Prevention and Rate/Rhythm Control. Canadian Journal of Cardiology 28 (2012) 125-136.<BR> · Lafuente-Lafuente C, et al. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Syst Rev. 2012 May 16;5:CD005049.<BR> · Dagres N et al. Dronedarone and the Incidence of Stroke in Patients with Paroxysmal or Persistent Atrial Fibrillation: A Systematic Review and Meta-Analysis of Randomized Trials. Am J Cardiovasc Drugs. 2011 Dec 1;11(6):395-400. <BR> · Connolly SJ, et al. Dronedarone in High-Risk Permanent Atrial Fibrillation. N Engl J Med 2011;365:2268-76.<BR> · Torp-Pedersen C, et al. Impact of dronedarone on hospitalization burden in patients with atrial fibrillation: results from the ATHENA study. Europace. 2011 Aug;13(8):1118-26.<BR> · Page RL, et al. Rhythm- and rate-controlling effects of dronedarone in patients with atrial fibrillation (from the ATHENA trial). Am J Cardiol. 2011 Apr 1;107(7):1019-22. <BR> · Freemantle N, et al. Mixed treatment comparison of dronedarone, amiodarone, sotalol, flecainide, and propafenone, for the management of atrial fibrillation. Europace. 2011 Mar;13(3):329-45.<BR> · Levine TB, et al. Effect of dronedarone on exercise capacity and cardiac function in patients with severe left ventricular dysfunction and compensated stable heart failure. Cardiovasc Drugs Ther. 2010 Dec;24(5-6):449-58.<BR> · Hohnlosers SH, et al. Dronedarone in patients with congestive heart failure: insights from ATHENA. Eur Heart J. 2010 Jul;31(14):1717-21. <BR> · Singh D, et al. Dronedarone for atrial fibrillation have we expanded the antiarrhythmic armamentarium?. J Am Coll Cardiol. 2010 Apr 13;55(15):1569-76.<BR> · Kober L, et al. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med. 2008 Jun 19;358(25):2678-87.<BR> · Le Heuzey JY, et al. A Short-Term, Randomized, Double-Blind, Parallel-Group Study to Eval‎uate the Efficacy and Safety of Dronedarone versus Amiodarone in Patients with Persistent Atrial Fibrillation: The DIONYSOS Study. J Cardiovasc Electrophysiol. 2010 Jun 1;21(6):597-605. <BR> · Hohnloser SH, et al. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med. 2009 Feb 12;360(7):668-78.<BR> · Connolly SJ, et al. Analysis of stroke in ATHENA: a placebo-controlled, double-blind, parallel-arm trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter. Circulation. 2009 Sep 29;120(13):1174-80. Epub 2009 Sep 14.<BR> · Davy JM, et al. Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study. Am Heart J. 2008 Sep;156(3):527.e1-9.<BR> · Singh BN, et al. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med. 2007 Sep 6;357(10):987-99.<BR> · CEDAC Final Recommendation(Dated recommendation issued 2010.5.27.). DRONEDARONE HYDROCHLORIDE<BR> · PBAC(November 2010). Dronedarone hydrochloride, tablet, 400 mg, Multaq?<BR> · Scottish Medicines Consortium(6 August 2010). Dronedarone, 400mg, film-coated tablets (Multaq)<BR> · NICE technology appraisal guidance 197: Issue date August 2010. Dronedarone for the treatment of non-permanent atrial fibrillation</P>
<P> </P>
<!-- -->
