Zoledronic acid 5mg/100ml 주사제(품명: 대웅졸레드론산주사액 5밀리그램/100밀리리터 등)
■ 고시 개정 전체내용
허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
– 아 래 –
가. X선 소견에서 확인된 골파제트병(Paget’s disease)
나. 골다공증에 투여 시 골다공증치료제 일반원칙을 따르며, 다음과 같은 대상에게 투여 시 인정함
– 다 음 –
1) 투여대상
가) 중심골(Central bone; 요추, 대퇴(Ward’s triangle 제외)] : 이중 에너지 방사선 흡수계측(Dual-Energy X-ray Absorptiometry: DXA)을 이용하여 골밀도 측정시 T-score가 -2.5 이하인 경우
나) 정량적 전산화 단층 골밀도검사(QCT) : 80mg/㎤ 이하인 경우
다) 방사선 촬영 등에서 골다공증성 골절*이 확인된 경우
* 골다공증성 골절 인정가능 부위: 대퇴골, 척추, 요골, 상완골, 골반골, 천골, 발목골절
2) 투여횟수 및 기간: 1회/년
가) 투여대상 가), 나)에 해당하는 경우 1회, 다)에 해당하는 경우 3회 인정하며, 추적검사상에서 T-score가 -2.5 이하(QCT 80㎎/㎤ 이하)로 약제투여가 계속 필요한 경우 총 6회까지 인정함
나) 다만, 1) 투여대상 가)에 해당하여 투여 후, 추적검사에서 1) 투여대상 가)에 따른 골밀도 측정시 T-score가 ？2.5 초과 ？2.0 이하(-2.5
※ -2.5
3) 단순 X-ray는 골다공증성 골절 확인 진단법으로만 사용할 수 있음.
다. 글루코코르티코이드(Glucocorticoid) 투여환자의 경우 아래와 같은 기준으로 요양급여를 인정함.
– 아 래 –
1) 투여대상
6개월 이내에 최소 90일을 초과하여 prednisolone을 총 450mg 이상(또는 그에 상응하는 글루코코르티코이드 약제 용량)을 투여받은 환자로서
가) 폐경 후 여성 및 만 50세 이상 남성 : T-score※ < -1.5
나) 폐경 전 여성 및 만 50세 미만 남성 : Z-score※ < -3.0
※ 중심골[Central bone; 요추, 대퇴(Ward’s triangle 제외)]을 이중 에너지 방사선 흡수계측(Dual-Energy X-ray Absorptiometry: DXA)을 이용하여 측정해야 한다.
2) 투여 횟수
– 1회 인정하며, 추적검사에서 1) 의 기준이 유지되고 약제 투여가 계속 필요한 경우에 총 6회까지 인정함.
■ 고시 개정 고시번호(시행일자)
고시 제2024-72호(2024.5.1.)
■ 고시 개정 사유
○교과서, 가이드라인, 임상논문, 학회(전문가) 의견 등을 참조하여 DEXA를 이용하여 T-score ？2.5 이하인 경우로 진단된 환자가 ？2.5 초과 ？2.0 이하로 호전될 경우 지속투여를 급여 확대함.
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