작성일 | 2017-05-08 | 조회수 | 2,637 |
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시행일자: 2017-05-01 |
[629] 기타의 화학요법제 | |||||||||||||||||||||
구 분 | 현 행 | 개 정 (안) | 사유 | ||||||||||||||||||
Elbasvir + Grazoprevir 경구제 (품명: 제파티어정) | (개별고시 없음) | 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
※ 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. | 신규 등재 예정인 약제로 교과서, 임상진료지침, 임상논문 등을 참조하여 급여기준을 설정함. |
※ 관련근거 - HEPATOLOGY. 7th Edition. 2016. - Ferri's Clinical Advisor. 2017. - Mandell, Douglas, and Bennett's Principles and Practice of Infectious Disease, Updated Edition. 2015. - 2015 대한간학회 C형 간염 진료가이드라인. 2015. - AASLD(American Association for the Study of the Liver Disease). 2016 July. - EASL(European Association for the Study of the Liver) Recommendations on Treatment of Hepatitis C 2016. - WHO Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection. Updated version. 2016 April. - APASL(The Asian-Pacific Association for the Study of the Liver). APASL consensus statements and recommendation on treatment of hepatitis C. 2016 April. - Roth D, et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet 2015;386:1537-45. - Zeuzem S, et al. Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Annals of internal medicine 2015;163:1-13. - Lawitz E et al. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. Lancet 2015;385:1075-86. - Sulkowski M, et al. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial. Lancet 2015;385:1087-97. - Buti M, et al. Grazoprevir, Elbasvir, and Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection After Failure of Pegylated Interferon and Ribavirin With an Earlier-Generation Protease Inhibitor: Final 24-Week Results From C-SALVAGE. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America 2016;62:32-6. - Rockstroh JK, et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. The lancet HIV 2015;2:e319-27. - NICE (2016.10.) - CADTH (2016.5.) - PBAC (2016.7.) · Yokoyama O et al. (1)-adrenoceptor blocker naftopidil improves sleep disturbance with reduction in nocturnal urine volume.World J Urol. 2011 Apr;29(2):233-8. · MOON KH. et al, A 12-Week, Open Label, Multi-Center Study to Evaluate the Clinical Efficacy and Safety of Silodosin on Voiding Dysfunction in Patients with Neurogenic Bladder. Low Urin Tract Symptoms. 2015 Jan;7(1):27-31 · Osman NI et al. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol. 2015 May;33(5):697-706. · Oelke M et al. Cardiovascular and ocular safety of1-adrenoceptor antagonists in the treatment of male lower urinary tract symptoms. Expert Opin Drug Saf. 2014 Sep;13(9):1187-97. |
[일반원칙] | |||
구 분 | 현 행 | 개 정 (안) | 사유 |
간장용제 | 1. ~ 2. 생략 3. 항바이러스제(Lamivudine, Clevudine, Telbivudine, Entecavir, Adefovir, Tenofovir, Asunaprevir, Daclatasvir, Sofosbuvir, Ledipasvir+ Sofosbuvir 경구제, 인터페론제제, 페그인터페론제제)와 병용투여시 1종은 약값 전액을 환자가 부담토록 함 | 1. ~ 2. 현행과 같음 3. 항바이러스제(Lamivudine, Clevudine, Telbivudine, Entecavir, Adefovir, Tenofovir, Asunaprevir, Daclatasvir, Sofosbuvir, Ledipasvir+Sofosbuvir, Elbasvir+Grazoprevir 경구제, 인터페론제제, 페그인터페론제제)와 병용투여시 1종은 약값 전액을 환자가 부담토록 함 | 항바이러스제(만성 B형, C형 간염치료제)와 간장용제 병용투여시 1종은 약값 전액을 환자가 부담토록 하고 있는 급여기준에 신규 등재 예정인Elbasvir+Grazoprevir 경구제의 성분명을 추가함. |