허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
- 아 래 -
가. 대상 질병： 대퇴과(Femur condyle)의 연골손상
나. 연골손상의 크기
1) 4㎠를 초과하는 단독 병변
2) 2㎠ 이상 4㎠ 이하의 단독 또는 다발성 병변: 관절경하 시술(Chondroplasty, Debridement 등) 또는 수술적 복원술(Subchondral bone stimulation - abrasion, Multiple drilling, Microfracture 등)에 적절히 반응하지 않았을 경우(통증, 기능저하 등)
다만, 수술적 복원술을 한 경우 6개월 이상의 관찰 기간 후 투여하여야 함
다. 연골손상의 상태： 국소적이며 전층의 연골 손상(Outerbridge Ⅲ～Ⅳ)으로 손상부위 인접 연골상태가 비교적 건강한 상태(OuterbridgeⅠ～Ⅱ)로서 체중부하 방사선 촬영(weight-bearing radiography) 상 슬관절 간격이 50%이상 유지되어 있는 경우
라. 연령： 만 15세 ∼ 만 55세
마. 투여 용량 : 시술당 1개
■ 고시 개정 고시번호(시행일자)
고시 제2022-184호(2022.8.1.)
■ 고시 개정 사유
국내ㆍ외 허가사항, 교과서, 임상진료지침, 임상연구문헌, 관련 학회의견 등을 고려하여 문구를 수정 및 보완함.
■ 관련문헌 등
1. Campbell's Operative Orthopaedics, 13e. 2017
2. Insall & Scott Surgery of the knee, 6th edition, 2018
5. Surgical Techniques of the Shoulder, Elbow, and Knee in Sports Medicine, 2nd ed, 2013
6, 슬관절학, 2011,
7.Autologous chondrocyte implantation (ACI) for cartilage defects of the knee: A guideline by the working group “Clinical Tissue Regeneration” of the German Society of Orthopaedics and Trauma (DGOU), 2016
8. Surgical Guideline for Work-related Knee Injuries, 2016, Washington State Department of Labor & Industries
9.Gou GH et al. Autologous Chondrocyte Implantation Versus Microfracture in the Knee: A Meta-analysis and Systematic Review Arthroscopy. 2020 Jan;36(1):289-303.
10. Kim MK et al. Clinical, radiological, and histological outcomes after the fibrin-matrix autologous chondrocyte implantation for chondral lesions of the knee in patients more than 50 years old: A prospective case series with minimum 2-year follow-up. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(1):2309499019893509.
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15. Saris DB et al. Characterized chondrocyte implantation results in better structural repair when treating symptomatic cartilage defects of the knee in a randomized controlled trial versus microfracture. Am J Sports Med. 2008 Feb;36(2):235-46.
16.Yoon TH et al. Arthroscopic gel-type autologous chondrocyte implantation presents histologic evidence of regenerating hyaline-like cartilage in the knee with articular cartilage defect. Knee Surg Sports Traumatol Arthrosc. 2020 Mar;28(3):941-951.
17. Choi NY et al. Gel-type autologous chondrocyte (Chondron) implantation for treatment of articular cartilage defects of the knee. BMC Musculoskelet Disord. 2010 May 28;11:103.
18. NICE guidance. Autologous chondrocyte implantation for treating symptomatic articular cartilage defects of the knee.
19.Australia, Medical Services Advisory Committee Public Summary Document Application, No. 1140 - Matrix Induced Autologous Chondrocyte Implantation and Autologous Chondrocyte Implantation
20. AETNA, Autologous Chondrocyte Implantation, Last Review: 2020.5.14.
21. Cigna, Medical Coverage Policies ？ Musculoskeletal Knee Surgery: Arthroscopic and Open Procedures, Effective August 15, 2019
22. BlueCross Blueshield of North Carolina, Autologous chondrocyte Implantation, Corporate Medical Policy, Last Review: 6/2020
23. Emblemhealth, Autologous Chondrocyte implantation, Last Review Date: August 14, 2020