■ 고시 개정 전체내용

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

- 아 래 -

가. 투여대상

1) 중심골[Central bone; 요추, 대퇴(Ward's triangle 제외)]: 이중 에너지 방사선 흡수계측(Dual-Energy X-ray Absorptiometry: DEXA)을 이용하여 골밀도 측정시 T-score가 -2.5 이하인 경우(T-score ≤ -2.5).



2) 방사선 촬영 등에서 골다공증성 골절이 확인된 경우



나. 투여기간: 투여대상 1)에 해당하는 경우에는 1년(2회), 2)에 해당하는 경우에는 3년(6회)로 하며, 추적검사에서 T-score가 -2.5 이하로 약제투여가 계속 필요한 경우는 급여토록 함.



다. 단순 X-ray는 골다공증성 골절 확인 진단법으로만 사용할 수 있음.



■ 고시 개정 고시번호(시행일자)

고시 제2019-57호(2019.4.1.)



■ 고시 개정 사유

교과서, 가이드라인, 임상문헌, 제·외국 보험기준, 학회의견 등을 참고하여, 투여대상과 투여기간을 확대 함.



■ 관련문헌 등

· Harrison's Principles of Internal Medicine, 19e> Chap 425. Osteoporosis.

· Goldman-Cecil Medicine 25e> Chap 243.Osteoporosis.

· Amir Qaseem, Mary Ann Forciea, Robert M. McLean, et al. Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update from the American College of Physicians. Ann Intern Med. doi:10.7326/M15-1361.

· NOGG 2017: Clinical guideline for the prevention and treatment of osteoporosis. Updated March 2017.

· AACE/ACE Guidelines: AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY CLINICAL PRACTICE GUIDELINES FOR THE DIAGNOSIS AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS

· National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2014.

· 골절을 동반한 골다공증의 진료지침, 2017. 대한골다공증학회.

· 골다공증의 진단 및 치료 지침, 2015. 대한골대사학회 지침서편찬위원회.

· PBS(Australia) - Prolia(Denosumab 60mg/mL injection, 1 mL syringe)

· NICE guidance. Denosumab for the prevention of osteoporotic fractures in postmenopausal women. Published: 27 October 2010.

· CEDAC FINAL RECOMMENDATION-DENOSUMAB

· Steven R. Cummings, et al. Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis(The FREEDOM trial). Engl J Med. 2009 Aug 20;361(8):756-65.

· Bone et al. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017 Jul;5(7):513-523.

· Jacques P Brown, et al. Comparison of the Effect of Denosumab and Alendronate on BMD and Biochemical Markers of Bone Turnover in Postmenopausal Women With Low Bone Mass: A Randomized, Blinded, Phase 3 Trial. J Bone Miner Res 2009;24:153？61.

· Recknor et al. Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy: a randomized open-label trial. Obstet Gynecol. 2013 Jun;121(6):1291-9.

· C. Roux, et al. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: Efficacy and safety results from a randomized open-label study. Bone 58 (2014) 48？54.

· PD Miller, et al. Denosumab or Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates. J Clin Endocrinol Metab. 2016 Aug;101(8):3163-70.

· Langdahl et al. A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: results from the ADAMO trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1335-42.



■ 변경 전 고시번호(시행일자)

고시 제2017-180호(2017.10.1.)