Cryotherapy for Recurrent Prostate Cancer and Renal Cancer Part A – Salvage cryotherapy for recurrent or persistent prostate cancer after radiotherapy Part B – Cryotherapy for renal cancer September 2009 MSAC application 1124 Assessment report © Commonwealth of Australia 2009 ISBN (Print) 1-74186-958-7 ISBN (Online) 1-74186-959-5 ISSN (Print) 1443-7120 ISSN (Online) 1443-7139 First printed December 2009 Paper-based publications © Commonwealth of Australia 2009 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and enquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney General’s Department, Robert Garran Offices, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca Internet sites © Commonwealth of Australia 2009 This work is copyright. You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, non-commercial use or use within your organisation. Apart from any use as permitted under the Copyright Act 1968, all other rights are reserved. Requests and enquiries concerning reproduction and rights should be addressed to Commonwealth Copyright Administration, Attorney General’s Department, Robert Garran Offices, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca 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 106 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 Ms Zhaohui Liufu, Ms Skye Newton and Professor Janet Hiller from Adelaide Health Technology Assessment (AHTA), Discipline of Public Health, the University of Adelaide, with the assistance of an Advisory Panel of experts. The report was commissioned by the Department of Health and Ageing on behalf of the Medical Services Advisory Committee (MSAC). It was edited by Ms Jo Mason, Mason Edit, South Australia. Publication approval number: P3 -5567 Template Version updated Nov 08 Contents Part A – Salvage cryotherapy for recurrent or persistent prostate cancer after radiotherapy Executive summary ................................................................................................... 1 Introduction.................. ........................................................................................... 7 Rationale for assessment................................................................................................. 7 Background................ .............................................................................................. 8 Prostate cancer ................................................................................................................. 8 Primary treatment and treatment failure ...................................................................... 9 The procedure .................................................................................................................. 9 Intended purpose ........................................................................................................... 11 Existing procedures ....................................................................................................... 13 Comparators ................................................................................................................... 14 Clinical need for the procedure ................................................................................... 16 Marketing status of the technology ............................................................................. 17 Current reimbursement arrangement ......................................................................... 17 Approach to assessment .......................................................................................... 19 Objectives ....................................................................................................................... 19 Research questions ........................................................................................................ 19 Expert advice .................................................................................................................. 19 Review of literature ....................................................................................................... 20 Assessment of the body of evidence .......................................................................... 25 Results of assessment ............................................................................................. 27 Is it safe? .......................................................................................................................... 27 Is it effective? ................................................................................................................. 36 What are the economic considerations? ..................................................................... 51 Discussion................ .............................................................................................. 63 Is it safe? .......................................................................................................................... 63 Is it effective? ................................................................................................................. 64 What are the economic considerations? ..................................................................... 65 Other relevant considerations ...................................................................................... 66 Patient journey ............................................................................................................... 70 Conclusions............ ................................................................................................ 72 Cryotherapy for recurrent prostate cancer and renal cancer – MSAC 1124 i of 247 Safety ............................................................................................................................... 72 Effectiveness .................................................................................................................. 72 Economic considerations ............................................................................................. 73 Appendix A Advisory Panel and Evaluators ..................................................... 75 Appendix B Search strategies ............................................................................ 76 Appendix C Studies included in the review ...................................................... 80 Appendix D Excluded studies ........................................................................... 88 Appendix E Critical appraisal checklist ............................................................ 99 Appendix F Questionnaires ............................................................................. 100 Appendix G Further scenarios for financial analysis ....................................... 105 Glossary and abbreviations ................................................................................... 109 References........ ..................................................................................................... 110 ii of 247 Cryotherapy for recurrent prostate cancer and renal cancer – MSAC 1124 Part B – Cryotherapy for renal cancer Executive summary ............................................................................................... 121 Introduction...... .................................................................................................... 125 Rationale for assessment............................................................................................. 125 Background..... ...................................................................................................... 126 The procedure .............................................................................................................. 126 Intended purpose ......................................................................................................... 126 Existing treatments ...................................................................................................... 127 Comparators ................................................................................................................. 128 Clinical need / burden of disease .............................................................................. 130 Marketing status of the technology ........................................................................... 131 Current reimbursement arrangement ......................................................................