허가사항 범위 내에서 아래와 같이 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
- 아 래 -
가. Allopurinol 제제 또는 Rasburicase 투여에도 불구하고 종양용해증후군에 의한 고뇨산혈증이 확진된 경우
나. 항암제 치료에 의한 오심 구토가 심하여 경구용 Allopurinol 제제를 사용할 수 없는 사유가 확인된 경우
다. 신기능 장애 또는 종양에 의한 신장 침범이 있는 환자에서 종양용해증후군에 의한 고뇨산혈증이 확진된 경우
라. 악성 종양 환자 중 종양용해증후군 발생 고위험군
○ 투여대상 : 다음 중 하나에 해당하는 경우
- 다 음 -
1) 버킷림프종, 림프모구림프종
2) 10cm 이상의 소아 고형암
3) 백혈구 50,000/uL 이상인 급성 백혈병
4) 골수 침범이 있는 림프종
5) 자연발생 종양용해증후군 또는 요산 수치 상승(단, 성인 고형암 제외)
6) 신기능 장애 또는 종양에 의한 신장 침범이 있는 경우(단, 성인 고형암 제외)
○ 투여용량 : 최대 6mg
■ 고시 개정 고시번호(시행일자)
고시 제2018-253호(2018.12.1.)
■ 고시 개정 사유
국내 외 허가사항, 관련 학회의견, 교과서, 임상진료지침, 임상연구 논문 등을 참조하여, ‘악성 종양 환자 중 종양용해증후군 발생 고위험군’에 대해 급여를 확대함.
■ 관련문헌 등
· Harrison’s Principles of Internal Medicine 19th Edition > Chap. 331. Oncology Emergencies
· 혈액학 Hematology : 대한혈액학회 2011 범문에듀케이션
· Nelson Textbook of Pediatrics, Twentieth Edition > Chapter 494 Principles of Treatment
· Williams Hematology, 9e > Chapter 91: Acute Lymphoblastic Leukemia
· Wintrobe’s Clinical Hematology 13th Edition > 69. Supportive Care in Hematologic Malignancies
· NCCN Clinical Practice Guidelines in Oncology ？ T ？cell Lymphomas ver 2. 2017
· Management of infusion reactions to systemic anticancer therapy: ESMO Clinical Practice Guidelines Rosello S et al. Annals of Oncology 2017;28(Suppl.4):iv100-iv118
·Guidelines for the Management of Pediatric and Adult Tumor Lysis Syndrome: An Evidence-Based Review Coiffier B et al. J Clin Oncol 2008;26:2767-78
· Guidelines for the management of tumour lysis syndrome in adults and children with haematological malignancies on behalf of the British Committee for Standards in Haematology. Jones GL et al. British journal of Haematology 2015;169:661-671
· A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Blood 2001;97:2998-3003
· Control of plasma uric acid in adults at risk for tumor Lysis syndrome: efficacy and safety of rasburicase alone and rasburicase followed by allopurinol compared with allopurinol alone-results of a multicenter phase III study. J Clin Oncol 2010;28:4207-4213
· Efficacy and cost of single-dose rasburicase in prevention and treatment of adult tumour lysis syndrome: a meta-analysis. J Clin Pharm Ther. 2013 Aug;38(4):301-8
· Urate oxidase for the prevention and treatment of tumour lysis syndrome in children with cancer. Cochrane date syst. rev. 2017. Mar. 8.
· Rasburicase (recombinant urate oxidase) for the management of hyperuricemia in patients with cancer : report of an international compassionate use study. Cancer 2003;98:1048-54
· Recombinant urate oxidase (Rasburicase) for the treatment of hyperuricemia in pediatric patients with hematologic malignancies: Results of a compassionate prospective multicenter study in Korea. Pediatr Blood Cancer 2006;46:439-445
· Single dose Rasburicase is a clinically effective pharmacoeconomic approach for preventing tumour lysis syndrome in children with high tumour burden. Br J Haematol 2017 May 8.
· Efficacy and Safety of Rasburicase (recombinant urate oxidase) for the Prevention and Treatment of Hyperuricemia During Induction Chemotherapy of Aggressive Non-Hodgkin’s Lymphoma: Results of the GRAAL1 (Groupe d’Etude des Lymphomes de l’Adulte Trial on Rasburicase Activity in Adult Lymphoma) Study. J Clin Oncol 2003;21:4402-4406
· Effectiveness of Single-dose Rasburicase in Patients With Lymphoid Malignancies at a High Risk for Tumor Lysis Syndrome. Clinical Lymphoma, Myeloma & Leukemia. 2017;17(9):595-603
· A study of rasburicase for the management of hyperuricemia in pediatric patients with newly diagnosed hematologic malignancies at high risk for tumor lysis syndrome. Int J Hematol. 2009 Nov;90(4):492-500.
· Rasburicase: a review of its use in the management of anticancer therapy-induced hyperuricaemia. Drugs. 2006;66(4):529-45.