〔별지〕

[333] 혈액응고저지제

구 분	세부 인정기준 및 방법
Fondaparinux sodium 주사제 (품명 : 아릭스트라주)	아래와 같은 기준으로 투여시 요양급여를 인정하며, 허가사항 범위이지만 동 인정기준 이외에 투여한 경우에는 약값 전액을 환자가 부담토록 함. - 아 래 - ○ 고관절 골절수술, 슬관절 및 고관절 대체수술을 받은 환자(단, 체중 50kg 이상의 환자)에서의 정맥혈전 색전증의 예방 ○ 응급 침습적 치료가 적용되지 않는 보존적 치료를 받는 환자의 불안정형 협심증 또는 비-ST분절상승 심근경색의 치료

※ 관련근거

ㆍGoldman : Cecil Medicine, 23rd edition.

ㆍHarrison's Principles of Internal Medicine, 17th edition.

ㆍBraunwald's Heart Disease : A Textbook of Cardiovascular Medicine, 8th edition.

ㆍAmerican College of Chest Physicians Evidence-Based Clinical Practice Guidelines(8th Edition), CHEST 2008; 133:71 S.105 S3.0

ㆍACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007 Aug 14;50(7):e1-e157

ㆍGuidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. The Task Force for the Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of the European Society of Cardiology, European Heart Journal (2007) 28, 1598-1660.

ㆍBudaj A, et al. Improving clinical outcomes by reducing bleeding in patients with non-ST- elevation acute coronary syndromes. Eur Heart J. 2008 Aug 18.

ㆍMehta SR, et al. Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the OASIS-5 trial. J Am Coll Cardiol. 2007 Oct 30;50(18):1742-51.

ㆍThe Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators. Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes, N Engl J Med 2006;354:1464-76.

〔629〕기타의 화학요법제

구 분	세부 인정기준 및 방법
Palivizumab 주사제 (품명: 시나지스주)	아래와 같은 기준으로 투여시 요양급여를 인정하며, 허가사항 범위이지만 동 인정기준 이외에 투여한 경우에는 약값 전액을 환자가 부담토록 함. - 아 래 - 1. RSV(Respiratory Syncytial Virus) 계절(10월-3월) 시작 시점으로부터 이전 6개월 이내에 기관지폐이형성증(bronchopulmonary dysplasia)치료가 필요했던 만 2세 미만(24개월+0일)의 소아 2. 혈류역학적으로(haemodynamically) 유의한 선천성 심장질환이 있는 소아로서 RSV 계절(10월-3월) 시작 시점에 만 1세 미만(12개월+0일)이면서 다음 중 하나에 해당하는 경우 가. Infants who are receiving medication to control congestive heart failure(CHF) 나. Infants with moderate to severe pulmonary arterial hypertension 다. Infants with cyanotic heart disease

※ 관련근거

ㆍRichard E. Behrman, et al. NELSON. Respiratory syncytial virus infections (18th)

ㆍAmerican Academy of Pediatrics. Updated recommendations for RSV prophylaxis (2008)

ㆍSIGN. Bronchiolitis in children (2006)

ㆍFeltes TF, et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr. 2003 Oct; 143 (4):532-40.