가. 검토배경 ○ 이 건(3사례)은 TNF-α inhibitor 제제(이하 ‘항 TNF제제’)의 급여 인정 기간이 확대됨에 따라 장기간 휴약 후 재 투여하는 사례가 발생하여 급여기준 및 임상진료지침 등을 참조하여 요양급여 인정여부를 논의하고자 부의함. 나. 관련근거 ○「국민건강보험 요양급여의 기준에 관한 규칙」[별표 1] 요양급여의 적용기준 및 방법(제5조 제1항 관련) ○ 식품의약품안전처 허가사항 ○「Adalimumab 주사제(품명: 휴미라주 등)」(보건복지부고시 제2024-273호(약제), 2025.1.1. 시행) ○「Golimumab 주사제(품명: 심퍼니프리필드 시린지주 50밀리그램 등)」(보건복지부고시 제2023-296호(약제), 2024.1.1. 시행) ○「류마티스질환에서 TNF-α inhibitor 제제(품명: 엔브렐주사 등)를 휴약 후 재 투여 시 적용기준」(공고 제2019- 429호(약제), 2011.3.1. 진료분부터) ○「생물학적제제 및 소분자억제제 투여 전 잠복결핵감염 진단검사 시행 시기」(공고 제2024-282호(약제), 2025.1.1. 진료분부터) ○ 대한류마티스학회. 류마티스학 2판. 범문에듀케이션. 2018. ○ 대한결핵 및 호흡기학회. 결핵진료지침(5판). 2024. ○ Liana Fraenkel, Joan M Bat hon et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021 Jun 8;73(7):924？939. ○ Josef S Smolen et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):3-18. ○ Glen S Hazlewood et al. Canadian Rheumatology Association Living Guidelines for the Pharmacological Management of Rheumatoid Arthritis With Disease-Modifying Antirheumatic Drugs. J Rheumatol. 2022 Oct;49(10):1092-1099. ○ Rheumatoid Arthtirits Drug Treatment Pathway. Last reviewed and approved: December 2024. ○ Josef S Smolen et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010 Mar 9;69(4):631？637. ○ Sofia Ramiro et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):19-34. ○ Sherry Rohekar et al. Canadian Rheumatology Association/Spondyloarthritis Research Consortium of Canada Living Treatment Recommendations for the Management of Axial Spondyloarthritis. Practice Guideline J Rheumatol. 2025 Jan 1;52(1):10-22 ○ Mi Ryoung Seo et al. Korean treatment recommendations for patients with axial spondyloarthritis. Korean J Intern Med. 2023 Jul 24;38(5):620？640. ○ 류마티스관절염 치료제 임상평가지침. 식품의약품안전청 생물의약품본부. 2007. ○ Jennifer Jooha Lee. Treatment Guidelines for Rheumatoid Arthritis. Korean J Med. 2022. Vol.97, No.2 ○ J Fransen et al. Remission in rheumatoid arthritis: agreement of the disease activity score (DAS28) with the ARA preliminary remission criteria. Rheumatology (Oxford). 2004 Oct; 43(10):1252-5. ○ H. Makinen et al. Definitions of remission for rheumatoid arthritis and review of selected clinical cohorts and randomised clinical trials for the rate of remission. Clin Exp Rheumatol 2006; 24 (Suppl.43): S22-S28. ○ Jordi Gratacos et al. Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis. Randomized Controlled Trial Arthritis Res Ther. 2019 Jan 8;21(1):11. ○ Mireia Moreno et al. Withdrawal of infliximab therapy in ankylosing spondylitis in persistent clinical remission, results from