허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
- 아 래 -
가. 대상환자 및 투여방법·기간
대상 환자: 성인 만성 C형 간염 환자 중
유전자형 1a형
이전 치료 경험이 없는 환자 또는 페그인터페론 알파/리바비린 치료에 실패한 환자: 이 약 12주
이전 페그인터페론 알파/리바비린+HCV NS3/4A 단백분해효소억제제 치료에 실패한 환자: 이 약+리바비린 12주
유전자형 1b형
이전 치료 경험이 없는 환자 또는 페그인터페론 알파/리바비린 치료에 실패한 환자: 이 약 12주
이전 페그인터페론알파/리바비린+HCV NS3/4A 단백분해효소억제제 치료에 실패한 환자: 이 약+리바비린 12주
유전자형 4형
이전 치료 경험이 없는 환자: 이 약 12주
페그인터페론 알파/리바비린 치료에 실패한 환자: 이 약+리바비린 16주
※ 페그인터페론 알파 치료 실패: 부작용이나 낮은 순응도로 인한 사용중지, 치료 무반응 또는 부분반응, 재발, 바이러스 돌파현상
나. 혈중 ALT(Alanine Transaminase) 수치 증가 등 환자상태에 따라 Hepatotonics(Carduus marianus ext., Ursodeoxycholic acid, DDB 함유 제제 등)와의 병용투여는 인정 가능하나, 동 약제와 Hepatotonics 중 1종의 약값 전액을 환자가 부담토록 함.
■ 고시 신설 고시번호(시행일자)
고시 제2017-77호(2017.5.1.)
■ 고시 신설 사유
신규 등재 예정인 약제로 교과서, 임상진료지침, 임상논문 등을 참조하여 급여기준을 설정함.
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