BlueCross BlueShield of Tennessee Medical Policy Manual

Autologous Chondrocyte Implantation

DESCRIPTION

Autologous chondrocyte implantation (ACI) attempts to treat damaged articular cartilage that fails to heal on its own. Articular cartilage damage can be associated with pain and loss of function. This can lead to debilitating osteoarthritis over time, severely impairing an individual's activities of daily living and adversely affecting their quality of life.

In 2016, MACI® (matrix-induced autologous chondrocyte implantation [ACI]; Vericel) received FDA approval for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients.  The first-generation product, Carticel, is being phased out. Matrix-induced ACI consists of four steps:  (1) initial arthroscopy and biopsy of normal cartilage, (2) culturing of chondrocytes on an absorbable collagen matrix, (3) a separate arthrotomy to place the implant and (4) postsurgical rehabilitation.

The only matrix-induced autologous chondrocyte implantation product currently approved by the FDA is MACI®.

POLICY

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MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of ACI for other conditions / diseases.

SOURCES

American Academy of Orthopaedic Surgeons. (2010, December). The diagnosis and treatment of osteochondritis dissecans: guideline and evidence report. Retrieved October 26, 2015 from www.aaos.org/research/guidelines/OCD_guideline.

Basad, E., Wissing, F., Fehrenbach, P., Rickert, M., Steinmeyer, J., & Ishaque, B. (2015). Matrix-induced autologous chondrocyte implantation (MACI) in the knee: clinical outcomes and challenges. Knee Surgery, Sports Traumatology, Arthroscopy, 23 (12), 3729-3735. Abstract retrieved April 21, 2017 from PubMed database.

Biant, L.C., Bentley, G., Vijayan, S., Skinner, J.A., & Carrington, R.W. (2014). Long-term results of autologous chondrocyte implantation in the knee for chronic chondral and osteochondral defects. American Journal of Sports Medicine, 42 (9), 2178-2183. Abstract retrieved October 27, 2015 from PubMed database.

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2017). Autologous chondrocyte implantation for focal articular cartilage lesions (7.01.48). Retrieved April 21, 2017 from BlueWeb. (24 articles and/or guidelines reviewed)

Ebert, J., Smith, A., Fallon, M., Buitler, R., Nairn, R., Breidahl, W., & Wood, D. (2015). Incidence, degree and development of graft hypertrophy 24 months after matrix-induced autologous chondrocyte implantation: association with clinical outcomes. American Journal of Sports Medicine, 43 (9), 2208-2215. Abstract retrieved April 21, 2017 from PubMed database.

Li, Z., Zhu, T., & Fan, W. (2016). Osteochondral autograft transplantation or autologous chondrocyte implantation for large cartilage defects of the knee: a meta-analysis. Cell Tissue Bank, 17 (1), 59-67. Abstract retrieved October 3, 2016 from PubMed database.

Micheli, L., Moseley, B., Anderson, A., Browne, J., Erggelet, C., Arciero,R., et al. (2006). Articular cartilage defects of the distal femur in children and adolescents: treatment with autologous chondrocyte implantation. Journal of Pediatric Orthopedics, 26 (4), 455-460.

National Institute for Health and Clinical Excellence (NICE). (2014, March). The use of autologous chondrocyte implantation (ACI) for the treatment of cartilage defects in knee joints. Retrieved October 23, 2015 from http://www.nice.org.uk/guidance/ta89/chapter/1-Guidance.

Niemeyer, P., Albrecht, D., Andereya, S., Angele, P., Ateschrang, A., Aurich, M., et al. (2016). 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). The Knee, (2016), 426-435. (Level 2 evidence)

Oussedik, S., Tsitskaris, K., & Parker, D. (2015). Treatment of articular cartilage lesions of the knee by microfracture or autologous chondrocyte implantation: a systematic review. Arthroscopy, 31 (4), 732-744. Abstract retrieved September 30, 2016 from PubMed database.

Pestka, J.M., Bode, G., Salzmann, G., Sűdkamp, N.P., & Niemeyer, P. (2012). Clinical outcome of autologous chondrocyte implantation for failed microfracture treatment of full-thickness cartilage defects of the knee joint. American Journal of Sports Medicine, 40 (2), 325-331. Abstract retrieved October 27, 2015 from PubMed data base.

Riboh, J., Cvetanovich, G., Cole, B., & Yanke, A. (2016). Comparative efficacy of cartilage repair procedures in the knee: a network meta-analysis. Knee Surgery, Sports Traumatology, Arthroscopy. 2016 Sep 7. [Epub ahead of print]. Abstract retrieved September 30, 2016 from PubMed database.

Rosenberger, R., Gomoll, A., Bryant, T., & Minas, T. (2008). Repair of large chondral defects of the knee with autologous chondrocyte implantation in patients 45 years or older. The American Journal of Sports Medicine, 36 (12), 2336-2344. (Level 4 evidence)

U. S. Food and Drug Administration. Vaccines, Blood & Biologics. 2016 Biological License Application Approvals. MACI. Retrieved April 21, 2017 from https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm482397.htm.

Winifred S. Hayes, Inc. Medical Technology Directory. (2013, July, last update search July 2016). Autologous chondrocyte implantation of the knee. Retrieved September 30, 2016 from www.Hayesinc.com/subscribers. (105 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  10/1998

MOST RECENT REVIEW DATE:  8/23/2017   

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