보험인정기준 상세내용

Cinacalcet HCl 경구제(품명: 레그파라정 등)
  • 분류고시
  • 관련근거고시 제2018-81호(약제)
  • 게시일2018-05-01
  • 조회수4019
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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 -

이차성 부갑상선 기능항진증을 보이는 투석중인 만성신부전 환자로서 동 약제를 투여하기 전 혈청칼슘이 9.0mg/dL 이상이고 부갑상선호르몬(iPTH)이 300pg/mL 이상인 경우

- 다만, 동 약제 투여 중 부갑상선호르몬(iPTH)이 150pg/mL 이상인 경우 지속투여를 인정함.



■ 고시 개정 고시번호(시행일자)

고시 제2018-81호(2018.5.1.)



■ 고시 개정 사유

교과서, 가이드라인, 임상연구 논문 등을 반영하여, 투석중인 만성신부전환자의 이차성 부갑상선 기능항진증 치료에 일정 혈청칼슘 기준 수치(9.0㎎/㎗) 이상일 때 사용가능하도록 기준을 확대함



■ 관련문헌 등

?Harrison's Principles of Internal Medicine, 19e

?Goldman cecil medicine Twenty-Fifth Edition (2015)

?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-Mineral and Bone Disorder (CKD-MBD) Kidney International Supplements (2017) 7, 1?59

?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

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

?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

?Elder G, Faull R, Branley P, et al.: Caring for Australasians with Renal Impairment (CARI): Use of calcimimetic drugs. Nephrology 11 Suppl 1:S 240-4, 2006

?Jindal K, Chan CT, Deziel C, et al.: Canadian Society of Nephrology Committee for Clinical Practice Guidelines: Hemodialysis clinical practice guidelines for the Canadian Society of Nephrology. J Am Soc Nephrol 17 Suppl 1:S1-27, 2006

?만성콩팥병 진료지침, 2008, 대한신장학회

?Sekercioglu N, Busse JW et, al. Cinacalcet versus standard treatment for chronic kidney disease: a systematic review and meta-analysis. Ren Fail. 2016 Jul;38(6):857-74.

?Li D, Shao L, Zhou H et, al. The efficacy of cinacalcet combined with conventional therapy on bone and mineral metabolism in dialysis patients with secondary hyperparathyroidism: a meta-analysis. Endocrine. 2013 Feb;43(1):68-77.

?Zhang Q, Li M, You L, Li H et, al. Effects and safety of calcimimetics in end stage renal disease patients with secondary hyperparathyroidism: a meta-analysis. PLoS One. 2012;7(10):e48070.

?EVOLVE Trial Investigators, Chertow GM, Block GA et, al. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. N Engl J Med. 2012 Dec 27;367(26):2482-94.

?Taniguchi M, Fukagawa M et, al. Serum Phosphate and Calcium Should Be Primarily and Consistently Controlled in Prevalent Hemodialysis Patients. Therapeutic Apheresis and Dialysis 2013; 17(2):221?-228

?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



■ 변경 전 고시번호(시행일자)

제2017-77호(2017.5.1.)
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