급여기준 · "NET" 찾기 결과

Paricalcitol주사제(품명: 젬플라주)

약제 고시 제2019-93호(약제) · 2019-06-07 게시

기준 내용

※ 동 고시는 고시 제2020-161호(2020.8.1.)로 변경되었습니다

기준 내용

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

○ 만성신부전으로 인한 이차성 부갑상선 기능항진증이 있는 환자 중 투석을 받는 환자로서 Calcitriol 주사제의 적절한 치료에도 불구하고 동 약제를 투여하기 전 부갑상선호르몬(iPTH)이 300pg/mL 이상인 경우

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

고시 개정 고시번호(시행일자)

고시 제2019-93호(2019.6.7.)

고시 개정 사유

교과서, 임상진료지침, 임상연구 논문, 학회의견 등을 참조하여, 교과서 등에서 목표 iPTH 수치를 150∼300 pg/mL로 설정하고 있는 점을 반영하여 동 약제 투여 중 부갑상선호르몬이 150 pg/mL 이상인 경우 지속투여를 인정하는 유지요법 기준을 신설함.

관련문헌 등 20줄

· 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

· Current medical Diagnosis & Treatment 2017

· 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

· Management of chronic kidney disease-mineral and bone disorder: Korean working group recommendations. Kidney Res Clin Pract. 2015 Mar;34(1):4-12

· 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

· 만성콩팥병 진료지침, 2008, 대한신장학회

· Ye H, Ye P et al. A Bayesian network analysis on comparative efficacy of treatment strategies for dialysis patients with secondary hyperparathyroidism. Exp Ther Med. 2019 Jan;17(1):531-540.

· Zhang T, Ju H et al. Comparison of Paricalcitol and Calcitriol in Dialysis Patients With Secondary Hyperparathyroidism: A Meta-Analysis of Randomized Controlled Studies. Ther Apher Dial. 2018 Oct 16.

· Ve·eri·-Haler ·, Romozi K et al. Comparison of the Pharmacological Effects of Paricalcitol Versus Calcitriol on Secondary Hyperparathyroidism in the Dialysis Population. Ther Apher Dial. 2016 Jun;20(3):261-6.

· Abdul Gafor AH, Saidin R et al. Intravenous calcitriol versus paricalcitol in haemodialysis patients with severe secondary hyperparathyroidism. Nephrology (Carlton). 2009 Aug;14(5):488-92.

· Ketteler M, Martin KJ et al. Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study. Nephrol Dial Transplant. 2012 Aug;27(8):3270-8.

· 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

· Floege J, Kim J et al. Serum iPTH, calcium and phosphate, and the risk of mortality in a European haemodialysis population. Nephrol Dial Transplant. 2011 Jun;26(6):1948-55.

· 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.

· Teng M et al. Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy. N Engl J Med. 2003 Jul 31;349(5):446-56.

· Brancaccio D et al. Secondary hyperparathyroidism in chronic dialysis patients: results of the Italian FARO survey on treatment and mortality. Blood Purif. 2011;32(2):124-32.

· Hosaka K, Kazama JJ et al. Alterations in serum phosphate levels predict the long-term response to intravenous calcitriol therapy in dialysis patients with secondary hyperparathyroidism. J Bone Miner Metab. 2008;26(2):185-90.

변경 전 고시번호(시행일자)

고시 제2013-127호(2013.9.1.)

첨부파일

  • 고시 제2019-93호 Paricalcitol 주사제.hwp

첨부파일은 심평원 원문 화면에서 내려받습니다.

출처: 건강보험심사평가원 보험인정기준 고시 고시 제2019-93호(약제) · 심평원 원문 보기. 참고용 정보이며 청구·심사의 최종 판단은 고시 원문과 심평원 기준을 따릅니다.

이 기준을 AI에게 묻기