Human coagulation factor X 주사제(품목: 코아가덱스주250IU 등)

기준 내용

1. 입원 환자의 경우 식품의약품안전처장이 인정한 범위 내에서 투여 시 요양급여를 인정함.

2. 외래 환자의 경우 식품의약품안전처장이 인정한 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.

가. 투여대상 유전성 X인자 결핍이 확인된 환자로서

1) 응고인자 활성도 110 혈액응고질환

· Williams Hematology, 10e > Chapter 123: Inherited Deficiencies of Coagulation Factors II, V, V+VIII, VII, X, XI, and XIII

· Hematology Basic Principles and Practice, 7e (2018) > Chapter 137 Rare Coagulation Factor Deficiencies

· British Committee for Standards in Haematology (BCSH), Guideline for the diagnosis and management of the rare coagulation disorders. British J of Haematology, 2014, 167, 304-326

· 혈우병 진료 매뉴얼 3판, 대한혈액학회 혈우병연구회 2017

· HUANG et al. Plasma-derived factor X concentrate compassionate use for hereditary factor X deficiency: Long-term safety and efficacy in a retrospective data-collection study. Res Pract Thromb Haemost. 2021;5:e12550.

· Austin, et al, Efficacy, safety and pharmacokinetics of a new high-purity factor X concentrate in subjects with hereditary factor X deficiency. Haemophilia (2016), 22, 419-425

· Escobar, et al, Experience of a new high-purity factor X concentrate in subjects with hereditary factor X deficiency undergoing surgery. Haemophilia (2016), 1-8

· Liesner, et al, Prophylactic treatment of bleeding episodes in children <12 years with moderate to severe hereditary factor X deficiency (FXD): Efficacy and safety of a high-purity plasma-derived factor X (pdFX) concentrate. Haemophilia. 2018;941-949.

· Aetna (COAGADEX® (coagulation Factor X [human]) 1942-A SGM P2021, rev May 11, 2021)

· NHS England, Clinical Commissioning Policy: Human coagulation factor X for hereditary factor X deficiency (all ages) NHS England Reference: 200208P