허가사항 범위(성인의 급성 허혈성 뇌졸중에 증상 발현 후 4.5시간 이내에 투여한 경우) 내에 투여 시 요양급여를 인정함.
■ 고시 신설 고시번호(시행일자)
고시 제2026-159호(2026.8.1.)
■ 고시 신설 사유
○Tenecteplase 주사제(품명: 메탈라제주 25mg)가 신규 등재 예정임에 따라 교과서, 가이드라인, 임상논문, 학회 및 전문가의견, 제외국 평가결과 등을 참조하여 급여기준을 신설함
■ 관련문헌 등
1) FDA (2025.2.)
2) EMA (2023.12.)
3) Tintinalli's Emergency Medicine: A Comprehensive Study Guide, 9e
4) Harrison's Principles of Internal Medicine, 21st, 22nd Edition
5) Dipiro’s Pharmacotherapy: A pathophysiologic Approach, 13th Edition
6) 한국뇌졸중학회 Tenecteplase in Acute Ischemic Stroke (2025)
7) European Stroke Organisation (ESO) expedited recommendation on tenecteplase for acute ischaemic stroke (2023)
8) Ischemic stroke Guidelines (2019)
9) Key Changes to the 2022 Acute Stroke Management Canadian Stroke Best Practice Recommendations (2022)
10) Bijoy K Menon Intravenous tenecteplase compared with alteplase for acute ischemic stroke in Canada Lancet 2022;400:161-69
11) Yongjun Wang Tenecteplase versus alteplase in acute ischaemic cerebrovascular events (TRACE-2): a phase 3, multicentre, open-label, randomised controlled, non-inferiority trial Lancet 2023; 401: 645？54
12) Keith W Muir Tenecteplase versus alteplase for acute stroke within 4·5h of onset (ATTEST-2): a randomised, parallel group, open-label trial Lancet Neurol 2024; 23: 1087？96
13) Xia Meng Tenecteplase vs Alteplase for Patients With Acute Ischemic Stroke The ORIGINAL Randomized Clinical Trial JAMA. 2024;332(17):1437-1445
14) Mark W Parsons Tenecteplase versus alteplase for thrombolysis in patients selected by use of perfusion imaging within 4·5 h of onset of ischaemic stroke (TASTE): a multicentre, randomised, controlled, phase 3 non-inferiority trial Lancet Neurol 2024; 23: 775？86
15) B.C.V. Campbell Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke N Engl J Med 2018;378:1573-82.