보험인정기준 상세내용

■ 고시 개정 전체내용

1. 각 약제별 허가사항 범위내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.

- 아 래 -

가.골다공증치료제·비타민제·폐경기증후군·필수경구약제(만성신부전증환자) 일반원칙에 해당하는 경우

나. 갑상선전절제술 등으로 인한 부갑상선기능장애



2. 육체피로·체력저하 등으로 투여하고자 하는 경우에는 국민건강보험 요양급여의 기준에 관한 규칙 별표2 비급여대상에 해당되므로, 비급여함.



■ 고시 개정 고시번호(시행일자)

고시 제2026-24호(2026.2.1.)



■ 고시 개정 사유

○국내 허가사항, 교과서, 가이드라인, 임상논문, 전문가 의견 등을 참조하여 칼슘 및 비타민D 포함 복합경구제 관련 갑상선전절제술 등으로 인한 부갑상선기능장애에 대한 세부인정기준을 확대함.



■ 관련근거

· Harrison’s Principles of Internal Medicine, 22e

· Goldman-Cecil Medicine, 27e

· Current Medical Diagnosis & Treatment, 65e

· 대한골대사학회, 골다공증 진료지침, 2024

· NOGG(National Osteoporosis Guideline Group, UK), Clinical Guideline for the prevention and treatment of osteoporosis, 2024

· Endocrine Society, Pharmacological Management of Osteoporosis in Postmenopausal Women, 2019

· AACE/ACE(American Association of Clinical Endocrinologists/Amaerican College of Endocrinology), Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis, 2020

· Endocrine Society, Evaluation, Treatement and Prevention of Vitamin D Deficiency, 2011

· European Society of Endocrinology Clinical Guideline: Treatment of chronic hypoparathyroidism in adults, 2015

· Zhi-Chao Hu, et al. Comparison of fracture risk using different supplemental doses of vitamin D, calcium or their combination: a network meta-analysis of randomised controlled trials, BMJ Open 2019;9:e024595

· Benjamin M P Tang, et al. Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta-analysis, Lancet. 2007 Aug 25;370(9588):657-66

· Heike A Bischoff-Ferrari, et al. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials, JAMA. 2005 May 11;293(18):2257-64

· Cortney Bosworth, et al. The effect of combined calcium and cholecalciferol supplementation on bone mineral density in elderly women with moderate chronic kidney disease, Clin Nephrol. 2011 Dec 21;77(5):358-365

· Choe JH, et al. Comparison of calcitriol versus cholecalciferol therapy in addition to oral calcium after total thyroidectomy with central neck lymph node dissection: a prospective randomized study, Head & Neck, 2011, 33(9), 1265-1271

· SMC(2011)

· CADTH, Vitamin D Supplementation for the Prevention of Falls and Fractures in Residents of Long-Term Care Facilities, 2021

· NHS, Hull and East Riding, Clinical guideline for testing and replacement of Vitamin D, 2021



■ 변경 전 고시번호(시행일자)

고시 제2025-189호(2025.12.1.)