보험인정기준 상세내용

Lanthanum carbonate 경구제(품명: 포스레놀정 등)
  • 분류고시
  • 관련근거고시 제2018-174호(약제)
  • 게시일2018-09-01
  • 조회수1463
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■ 고시 개정 전체내용

허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.

- 아 래 -

○ 투석을 받고 있는 말기 신부전증 환자(ESRD)중 인 제한 식이요법에도 불구하고 동 약제 투여 전 혈중 인(P) 수치가 5.6mg/dL 이상인 경우



- 다만, 동 약제 유지요법의 경우 혈중 인(P) 수치가 4.0mg/dL 이상에서 인정함.



■ 고시 개정 고시번호(시행일자)

고시 제2018-174호(2018.9.1.)



■ 고시 개정 사유

교과서, 임상진료지침, 임상연구 논문, 학회의견 등을 반영하여 투석중인 만성신부전 환자에게 약제 투여 전 혈중 인 수치가 5.6mg/dL(허가사항 범위) 이상인 환자에게 급여 인정하며, 유지요법의 경우 혈중 인수치 4.0mg/dL 이상에서 투여 가능하도록 급여 확대함.



■ 관련문헌 등

?Harrison's Principles of Internal Medicine, 19e> Chap. 335 Chronic Kidney Disease

?CURRENT Diagnosis & Treatment: Nephrology & Hypertension >William G. Goodman, MD

?Brenner & Rector's the kidney, Tenth Edition> 2019-2033. e5 Copyright ⓒ 2016 by Elsevier

?KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease?ineral and Bone Disorder (CKD-MBD)

?KDIGO 2009 CKD-MBD GL KI Suppl 113

?KDOQI US Commentary on the 2017 KDIGO Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Am J of Kidney Dis., 2017

?KDOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease Am J Kidney Dis 2003 Oct;42(4 Suppl 3):S1-201

?Clinical Practice Guideline for the Management of Chronic Kidney Disease-Mineral and Bone Disorder, Japanese Society for Dialysis Therapy and Japanese Society of Nephrology, Tokyo, Japan; Therapeutic Apheresis and Dialysis 2013; 17(3):247?-288

?The UK eCKD guide: CLINICAL PRACTICE GUIDELINE CKD-MINERAL AND BONE DISORDERS (CKD-MBD)

?Sekercioglu N, Thabane L et, al. Comparative Effectiveness of Phosphate Binders in Patients with Chronic Kidney Disease: A Systematic Review and Network Meta-Analysis. PLoS One. 2016 Jun 8;11(6):e0156891.

?Patel L, Bernard LM et, al. Sevelamer Versus Calcium-Based Binders for Treatment of Hyperphosphatemia in CKD: A Meta-Analysis of Randomized Controlled Trials. Clin J Am Soc Nephrol. 2016 Feb 5;11(2):232-44.

?Zhai CJ, Yang XW et, al. Efficacy and safety of lanthanum carbonate versus calcium-based phosphate binders in patients with chronic kidney disease: a systematic review and meta-analysis. Int Urol Nephrol. 2015 Mar;47(3):527-35.

?Lorio BD et, al. Sevelamer Versus Calcium Carbonate in Incident Hemodialysis Patients: Results of an Open-Label 24-Month Randomized Clinical Trial. Clin J Am Soc Nephrol 7;487-493, 2012

?O'Neill WC, The fallacy of the calcium-phosphorus product. Kidney Int. 2007 Oct;72(7):792-6. Epub 2007 Jul 4.

?Hwang E, Choi BS et, al. Management of chronic kidney disease-mineral and bone disorder: Korean working group recommendations. Kidney Res Clin Pract. 2015 Mar;34(1):4-12

?Kwon YJ. Management of chronic kidney disease-mineral and bone disorder. 대한내과학회지: 제 86권 제 3호 2014

?Palmer SC, Hayen A et, al. Serum levels of phosphorus, parathyroid hormone, and calcium and risks of death and cardiovascular disease in individuals with chronic kidney disease: a systematic review and meta-analysis. JAMA. 2011 Mar 16;305(11):1119-27.

?Naves-Diaz M, Passlick-Deetjen J et, al. Calcium, phosphorus, PTH and death rates in a large sample of dialysis patients from Latin America. The CORES Study. Nephrol Dial Transplant. 2011 Jun;26(6):1938-47.

?Cho JH, Jang HM et, al. A Real-world Cost-effectiveness Analysis of Sevelamer Versus Calcium Acetate in Korean Dialysis Patients. Clin Ther. 2018 Jan;40(1):123-134.

?Yang L, Chuen Tan S et, al. Economic Evaluation of Sevelamer versus Calcium-based Binders in Treating Hyperphosphatemia among Patients with End-stage Renal Disease in China. Clin Ther. 2016 Nov;38(11):2459-2467.e1.

?Bernard L et, al. A modeled economic evaluation of sevelamer for treatment of hyperphosphatemia associated with chronic kidney disease among patients on dialysis in the United Kingdom. J Med Econ. 2013;16(1):1-9.

?Hutchison AJ, Wilson RJ et, al. Lanthanum carbonate: safety data after 10?years. Nephrology (Carlton). 2016 Dec;21(12):987-994.

?Burke SK et, al. RenaGel, a novel calcium- and aluminium-free phosphate binder, inhibits phosphate absorption in normal volunteers. Nephrol Dial Transplant. 1997 Aug;12(8):1640-4.



■ 변경 전 고시번호(시행일자)

고시 제2015-154호(2015.9.1)
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