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Assessment Report Matrix-induced autologous chondrocyte implantation and autologous chondrocyte implantation December 2010 MSAC application 1140 Assessment report © Commonwealth of Australia 2011 ISBN (Print) 978-1-74241-400-0 ISBN (Online) 978-1-74241-401-0 ISSN (Print) 1443-7120 ISSN (Online) 1443-7139 First printed Paper-based publications © Commonwealth of Australia 2011 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice,all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Communications Branch, Department of Health and Ageing, GPO Box 9848, Canberra ACT 2601, or via e-mail to [email protected]. Internet sites © Commonwealth of Australia 2011 This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice,all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Communications Branch, Department of Health and Ageing, GPO Box 9848, Canberra ACT 2601, or via e-mail to [email protected]. Electronic copies of the report can be obtained from the Medical Service Advisory Committee’s Internet site at http://www.msac.gov.au/ Printed copies of the report can be obtained from: The Secretary Medical Services Advisory Committee Department of Health and Ageing Mail Drop 853 GPO Box 9848 Canberra ACT 2601 Enquiries about the content of the report should be directed to the above address. The Medical Services Advisory Committee (MSAC) is an independent committee which has been established to provide advice to the Minister for Health and Ageing on the strength of evidence available on new and existing medical technologies and procedures in terms of their safety, effectiveness and cost effectiveness. This advice will help to inform government decisions about which medical services should attract funding under Medicare. MSAC’s advice does not necessarily reflect the views of all individuals who participated in the MSAC evaluation. This report was prepared by MSAC with the assistance of Mr Luis Zamora, Dr Prema Thavaneswaran, Ms Karen Humphreys, and Dr Alun Cameron from the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S) and Dr Stephen Goodall from the Centre for Health Economics Research and Evaluation (CHERE). Publication approval number: D0210 Contents Executive summary ............................................................................................................. x Introduction ..................................................................................................................1 Background ................................................................................................................. 2 Articular cartilage damage .............................................................................................. 2 Matrix-induced autologous chondrocyte implantation and autologous chondrocyte implantation............................................................................................... 3 Intended purpose............................................................................................................. 4 Clinical need/burden of disease .................................................................................... 4 Existing procedures......................................................................................................... 4 Comparator....................................................................................................................... 6 Marketing status of the technology............................................................................... 8 Current reimbursement arrangement ........................................................................... 8 Approach to assessment .....................................................................................................10 Objective......................................................................................................................... 10 Review of literature ....................................................................................................... 10 Literature sources and search strategies............................................................... 10 Inclusion/exclusion criteria................................................................................... 10 Data extraction and analysis.................................................................................. 13 Validity assessment of individual studies............................................................. 13 Assessment of the body of evidence .......................................................................... 16 Expert advice.................................................................................................................. 17 Results of assessment.........................................................................................................18 Descriptive characteristics of included studies.......................................................... 18 Studies for assessment of safety ........................................................................... 18 Studies for assessment of effectiveness............................................................... 18 Duplication of results............................................................................................. 19 Systematic reviews and health technology assessments........................................... 20 MACI/ACI for cartilage defects of the knee ..................................................... 20 MACI/ACI for cartilage defects of the ankle .................................................... 23 Critical appraisal of randomised controlled studies.................................................. 24 Study design details................................................................................................. 25 Results reporting and analyses .............................................................................. 25 Critical appraisal of non-randomised comparative studies...................................... 27 Study design details................................................................................................. 27 Results reporting and analysis ............................................................................... 27 Is it safe?.......................................................................................................................... 28 Summary of safety data from level II and III studies............................................... 28 Included studies ...................................................................................................... 28 Adverse events ........................................................................................................ 31 MACI and ACI for articular cartilage defects iii Summary of safety data from level IV studies........................................................... 33 Included studies ...................................................................................................... 33 Adverse events ........................................................................................................ 33 Is it effective? ................................................................................................................. 34 Clinical outcomes.................................................................................................... 34 Imaging outcomes................................................................................................... 39 What are the economic considerations?..................................................................... 41 Objective ..................................................................................................................41 Search strategies ...................................................................................................... 41 Background – evidence of cost-effectiveness..................................................... 41 Cost-effectiveness..........................................................................................................48 What are the other considerations?............................................................................
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