An assessment of nucleic acid amplification testing for active mycobacterial infection
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- © Commonwealth of Australia 2014
- MSAC’s advice does not necessarily reflect the views of all individuals who participated in the MSAC evaluation.
© Commonwealth of Australia 2014 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. Electronic copies of the report can be obtained from the Medical Service Advisory Committee’s internet site. Enquiries about the content of the report should be emailed to hta@health.gov.au. The technical information in this document is used by the Medical Services Advisory Committee (MSAC) to inform its deliberations. MSAC is an independent committee that has been established to provide advice to the Minister for Health 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.
This report was prepared for by Dr Judy Morona, Ms Arlene Vogan, Ms Sharon Kessels, Dr Debra Gum, Ms Jo Milverton, Ms Jacqueline Parsons, Ms Skye Newton, Ms Camille Schubert and Assoc. Prof. Tracy Merlin from Adelaide Health Technology Assessment (AHTA), University of Adelaide. Clinical advice was provided by Assoc. Prof. Jim Black, a member of the Health Expert Standing Panel. The report was commissioned by the Australian Government Department of Health. It was edited by Jo Mason of MasonEdit, Adelaide. The suggested citation for this document is: Morona JK, Vogan A, Kessels S, Gum D, Milverton J, Parsons J, Newton S, Schubert C & Merlin T (2014). Nucleic acid amplification testing for active mycobacterial infection. MSAC application no. 1234, Assessment Report. Commonwealth of Australia, Canberra, ACT. Contents Executive summary 5 An assessment of nucleic acid amplification testing for active mycobacterial infection 5 Main issues for MSAC consideration 5 Rationale for assessment 5 Proposed medical service 6 Current funding arrangements 6 Proposal for public funding 6 Comparator details 7 Clinical use of the intervention 7 Key differences in the delivery of the proposed medical service and the main comparator 8 Clinical claim 8 Approach taken to the evidence assessment 8 Characteristics of the evidence base 9 Results of assessment 9 Other relevant considerations 13 Economic evaluation 14 Glossary and abbreviations 18 Introduction 20 Background 21 Approach to assessment 36 Objective 36 Clinical pathway 36 Comparator 42 The reference standard 42 Research questions 42 Diagnostic assessment framework 43 Review of literature 44 Expert advice: Health Expert Standing Panel (HESP) 56 Results of assessment and discussion 57 Is it safe? 57 Is it effective? 58 Direct evidence of the effectiveness of NAAT in the diagnosis of MTB 58 Linked evidence of effectiveness of NAAT in the diagnosis of MTB 62 Is it accurate? 62 Does it change patient management? 83 Does change in management improve patient outcomes? 89 Linked evidence of diagnostic effectiveness of NAAT in the diagnosis of NTM 104 Is it accurate? 104 Other relevant considerations 112 TB in the Australian Indigenous population 112 What are the economic considerations? 116 Economic evaluation 116 Population and setting for the economic evaluation 116 Structure and rationale of the economic evaluation 117 Inputs to the economic evaluation 125 Outputs from the economic evaluation 140 Financial implications 149 Data sources used in the financial analysis 149 Net financial implications to the MBS 149 Other Australian healthcare system costs 154 Conclusions 155 Is NAAT safe? 155 Is NAAT effective? 155 Is NAAT cost-effective? 163 Costing 164 Appendix Search strategies 166 Appendix Diagnostic accuracy 2x2 data from included studies 169 Appendix Analysis of diagnostic accuracy data 197 Appendix Meta-analysis of studies assessing the diagnostic accuracy of AFB compared with culture 216 Appendix Study profiles of studies included in the assessment 221 Appendix Excluded studies 270 Appendix Economic literature search 287 Appendix Additional information relating to the economic evaluation 288 Appendix Alternative NAAT fees 295 References 296
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