제목 : [일반원칙] 칼슘 및 비타민D 포함 복합경구제
관련근거 : 고시 제2025-189호(약제)
개최일/시행일 : 2025-12-01
■ 고시 신설 전체내용
1. 각 약제별 허가사항 범위내에서 골다공증 치료제 일반원칙에 따라 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
2. 육체피로·체력저하 등으로 투여하****** 하는 경우에는 국민건강보험 요양급여의 기준에 관한 규칙 별표2 비급여대상에 해당되므로, 비급여함.
■ 고시 신설 고시번호(시행일자)
고시 제2025-189호(2025.12.01.)
■ 고시 신설 사유
○국내 허가사항, 교과서, 가이드라인, 임상논문, 학회 (전문가) 의견 등을 참조하여 칼슘 및 비타민D 포함 복합경구제 관련 급여기준 일반원칙을 신설
■ 관련문헌 등
· Harrison’s Principles of Internal Medicine, 22e
· Goldman-Cecil Medicine, 27e
· 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
· 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.
· 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
