of asynchronous
specialist
dermatology services
delivered by
telecommunications
October 2014
MSAC application 1360
Assessment report
Commonwealth of Australia 2008
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The Medical Services Advisory Committee (MSAC) is an independent committee which 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.
MSAC’s advice does not necessarily reflect the views of all individuals who participated in the MSAC evaluation.
Contents
Contents iii
Executive summary xi
The procedure xi
Medical Services Advisory Committee – role and approach xi
Purpose of Application xi
Proposal for public funding xii
Current arrangements for public reimbursement xv
Consumer Impact Statement xxii
Clinical need xxii
Scientific basis of comparison xxiii
Economic evaluation xxv
Financial/budgetary impacts xxxi
Main issues around the evidence and conclusions for clinical effectiveness xxxv
Overall conclusion with respect to comparative clinical effectiveness xxxvi
Other relevant factors xxxvii
Introduction 38
Background 39
Intervention name 39
The procedure /test 39
Intended purpose 41
Clinical need 42
Existing procedures 48
Marketing status of technology 48
Current reimbursement arrangements 48
Approach to assessment 65
Objective 65
Population 65
Clinical decision pathway 66
Comparators 67
The reference standard 68
Research questions 69
Review of literature 70
Appraisal of the evidence 81
Assessment of the body of evidence 96
Expert advice 97
Results of assessment 98
Is it safe? 98
Is it effective? 100
Other relevant considerations 119
Current Model used to provide store and forward dermatological services. 119
What are the economic considerations? 120
Review of published economic evaluations 120
Overview of the economic evaluations 121
Population and circumstances of use reflected in the economic evaluation 123
Structure of the economic evaluation 123
Variables in the economic evaluation 127
Basecase analysis 132
Costing 140
Conclusions 152
Safety 152
Effectiveness 152
Economic considerations 152
Costing 153
Appendix A MSAC membership 154
Evaluators 154
Appendix B Search strategies 155
Search results of Medline (including all EBM reviews) 155
Search results of EMBASE 156
Appendix C Studies included in the review 157
Appendix D Excluded studies 217
Appendix E Review of economic literature 222
Economic evaluations 222
Appendix F Assessment of the body of evidence 242
Glossary and abbreviations 246
References 247
Tables
Table 1: Feature comparison of Asynchronous and Synchronous teledermatology xii
Table 2: Applicant’s MBS item descriptor. xiii
Table 3: Proposed MBS descriptor and fee xiv
Table 4: Current MBS consultation items providing specialist dermatology services and Telehealth specialist services xvi
Table 5: Telehealth Patient-end Support Services by Health professionals xviii
Table 6: Body of evidence assessment matrix—SAF compared to VC xxiv
Table 7: Probabilities assigned in the model xxviii
Table 8: Results of the cost minimisation xxix
Table 9: Results of modelled economic evaluation current and proposed scenario where SAF becomes available xxix
Table 10: Cost-minimisation sensitivity analysis varying cost of SAF xxx
Table 11: Sensitivity analysis of modelled economic evaluation varying cost of SAF xxx
Table 12: Cost-effectiveness and sensitivity analyses of the SAF becoming available to people with disabilities residing outside eligible areas xxxi
Table 13: Number of patients referred to dermatologist from outside metropolitan areas xxxii
Table 14: Medicare Benefits paid for dermatology services to patients outside metropolitan areas, treated by specialist dermatologist & GPs xxxii
Table 15: Medicare Benefits paid if patients reside outside metropolitan areas and SAF is available xxxiii
Table 16: Medicare Benefits paid if patients reside outside metropolitan areas and SAF is available and MBS item available for referrer xxxiii
Table 17: Estimated cost to Medicare if asynchronous specialist dermatology services by telecommunications is extended to people with disabilities xxxiv
Table 18: Feature comparison of Asynchronous and Synchronous teledermatology 39
Table 19: Patient reasons for encounter with GP and individual problems managed by GP for skin conditions 45
Table 20: skin problems managed with a procedural treatment by GP 46
Table 21: The top problems most frequently referred by type of medical specialist 47
Table 22: referrals to a medical specialist by GP for skin conditions 47
Table 23: Current MBS consultation items providing specialist dermatology services and Telehealth specialist services 49
Table 24: Telehealth Patient-end Support Services by Health professionals 52
Table 25: Derived fees for Telehealth item 99 58
Table 26: Fees for MBS Telehealth items that provide for multiple patients to receive clinical support during video consultations. 59
Table 27: Utilisation data for specialist dermatology services* by State (01/7/11-30/06/14) 60
Table 28: Utilisation data for specialist dermatology services by remoteness area (01/7/11-30/06/14) 62
Table 29: Definitions of primary and secondary outcomes 69
Table 30: Electronic databases searched 70
Table 31: Selection criteria 72
Table 32: Studies included in assessment of diagnostic accuracy of SAF teledermatology 75
Table 33 Studies included in the assessment of diagnostic concordance of SAF teledermatology 77
Table 34: Studies included in assessment of diagnostic concordance of VC teledermatology 78
Table 35: Studies on management accuracy of SAF teledermatology 78
Table 36: Studies on management concordance of SAF teledermatology 79
Table 37: Studies on management concordance of VC teledermatology 80
Table 38 Selected characteristics of the studies assessing diagnostic accuracy of SAF teledermatology 85
Table 39 Selected characteristics of studies assessing diagnostic concordance of SAF teledermatology 87
Table 40: Landis and Koch scale for the qualitative interpretation of Cohen’s K coefficient 91
Table 41 Evidence dimensions 93
Table 42 Summary of the assessment of the bias 93
Table 43 Body of evidence assessment matrix- SAF compared to VC 96
Table 44: Results of the higher quality systematic reviews 101
Table 45: Inter-observer diagnostic concordance observed in the head-to-head trial 102
Table 46: SAF vs FTF correct diagnosis of primary diagnosis of skin lesion (histology is reference) 104
Table 47: Diagnostic accuracy of SAF teledermatology and teledermatoscopy in primary diagnosis of skin lesions, all identified studies (histology is reference standard) 108
Table 48: SAF vs FTF comparison of aggregate diagnosis* of skin lesions 109
Table 49: Studies included in assessment of diagnostic concordance of SAF teledermatology 111
Table 50: Studies included in assessment of diagnostic concordance of VC teledermatology 112
Table 51 Management accuracy of SAF teledermatology 114
Table 52 Management concordance of SAF teledermatology 114
Table 53: Studies on management concordance of VC teledermatology 115
Table 54: Study included in assessment of diagnostic performance of GP diagnosis of skin conditions 116
Table 55: List of health care resource items and unit costs included in the economic evaluation 128
Table 56: probabilities assigned in the model 129
Table 57: results of the cost minimisation analysis 132
Table 58: Results of modelled economic evaluation current and proposed scenario where of SAF becomes available 133
Table 59: Cost-effectiveness of SAF vs VC where differential diagnostic performance is assumed 133
Table 60: Cost-minimisation sensitivity analysis varying cost of SAF 134
Table 61: Sensitivity analysis of modelled economic evaluation varying cost of SAF 134
Table 62: Results of the sensitivity analysis 136
Table 63: Cost-effectiveness and sensitivity analyses of the SAF becoming available to people with disabilities residing outside eligible telehealth areas 139
Table 64: Number of services claimed from 1 July 2011 to 30 June 2014 provided by dermatologist specialist for telehealth items by remoteness index 141
Table 65: Benefit paid for services claimed from 1 July 2011 to 30 June provided by dermatologist specialist for telehealth items by remoteness index 142
Table 66: Services claimed from 1 July 2011 to 30 June 2014 provided by dermatologist specialist by remoteness index 142
Table 67: Benefit paid for services claimed from 1 July 2011 to 30 June 2014 provided by dermatologist specialist by remoteness index 142
Table 68: Number of patients referred to dermatologist from outside metropolitan areas 143
Table 69: assumptions used to calculate benefits 144
Table 70: Medicare Benefits paid for dermatology services to patients outside metropolitan areas, treated by specialist dermatologist & GPs 145
Table 71: Medicare Benefits paid if patients reside outside metropolitan areas & SAF available 146
Table 72: Medicare Benefits paid if patients reside outside metropolitan areas and S& F is available and MBS item available for referrer 148
Table 73: Estimated cost to Medicare if asynchronous specialist dermatology services by telecommunications is extended to people with disabilities 150
Table 74: Assessment of the quality and results reported in systematic reviews 157
Included RCTTable 75: Flow of participants in the included RCT 174
Table 76: baseline characteristics of the participants of the included RCT 175
Table 77: Included RCT 176
Table 78: Inclusion/exclusion criteria in observational cohort studies 178
Table 79: Flow of participants 183
Table 80: Baseline characteristics of the participants in SAF trials 187
Table 81 Baseline characteristics of the participants in SAF trials (cont.) 188
Table 82: Baseline characteristics of the participants in VC trials 190
Table 83: Characteristics of the included SAF studies 192
Table 84:Characteristics of the included VC studies 212
Table 85: Excluded RCT with reasons 217
Table 86: Excluded observational cohort studies with reasons 218
Table 87: Review of economic evaluations 222
Table 88 Designations of levels of evidence according to type of research question (including table notes) (NHMRC 2008). 242
Table 89 Grading system used to rank included studies 244
Figures
Figure 1. Structure of the economic analysis xxvii
Figure 2: Trends in incidence of melanoma of the skin, Australia, 1991 to 2009, with estimates to 2012 43
Figure 3: Age-specific rate for non-melanoma skin cancer treatments, 1997-2015 44
Figure 4: Telehealth Eligible Areas 60
Figure 5: Remoteness Areas of Australia 62
Figure 6: Clinical management algorithm with and without asynchronous dermatology services 67
Figure 7: Summary of the process used to identify and select studies for the review 74
Figure 8: Forest Plot of comparison of SAF and FTF in correct diagnosis of primary lesion no dermoscopy 106
Figure 9: Forest Plot of comparison of SAF and FTF in correct diagnosis of primary lesion with dermoscopy 107
Figure 10: Structure of the economic analysis 131
Page xxxvii of 255 Asynchronous specialist dermatology services delivered by telecommunications—Assessment 1360
Executive summary
The procedure
Medical Services Advisory Committee – role and approach
The Medical Services Advisory Committee (MSAC) was established by the Australian Government to strengthen the role of evidence in health financing decisions in Australia. MSAC advises the Minister for Health on the evidence relating to the safety, effectiveness and cost-effectiveness of new and existing medical technologies and procedures, and under what circumstances public funding should be supported.
A rigorous assessment of evidence is thus the basis of decision making when funding is sought under Medicare. A team from Deakin Health Economics, Deakin University, was engaged to conduct a systematic review of the literature and an economic evaluation of asynchronous specialist dermatology services delivered by telecommunications to patients with inflammatory skin conditions or skin lesions.
Purpose of Application
An application requesting MBS listing of specialist dermatology services delivered by asynchronous store and forward technology for inflammatory skin conditions and skin lesions was received from Australasian College of Dermatologists by the Department of Health and Ageing in May 2013.
Description of the proposed intervention
The application relates to a new approach of providing specialist dermatology services. The application of store and forward technology enables patients who currently do not have access, or timely access, to specialist dermatology services to receive these services by an asynchronous specialist dermatology consultation delivered by telecommunications. As it is the current telecommunications system that allows for the provision of asynchronous consultations and not the store and forward technology per se, the application has been renamed to the ‘Assessment of asynchronous specialist dermatology services delivered by telecommunications’.
There are two types of teledermatology which are defined by the patient’s temporal relationship with the dermatologist; store-and-forward (SAF) and real time (RT). Store-and-forward technology is used to record a patient’s clinical data and digital images of their dermatological condition (store), and to transfer this information, via the telecommunications network (forward), to a dermatologist who then responds with a diagnosis and therapeutic recommendation (asynchronous consultation) but not at the same time. RT or live interactive teledermatology uses synchronous data transfer technologies (videoconferencing) to communicate with all parties (e.g. GP, dermatologist and patient), and all parties to the consultation need to be available at the same time. This type of consultation is already provided for on the MBS. This assessment will use the terms ‘asynchronous specialist dermatology services delivered by telecommunications’ and store and forward teledermatology (SAF) interchangeably.
Table 1 compares the features of the two types of teledermatology.
Table 1: Feature comparison of Asynchronous and Synchronous teledermatology
Relative comparison / Store and Forward / Real TimeVirtual “hands-on” examination possible / No / Yes
Patient interactivity / None, written comments sent to referring provider / Live, by way of video link
Response time / Delayed
Image quality / Still photos, usually higher quality / Live streaming video, usually lower quality
Bandwidth requirement / Lower / Higher
Scheduling requirement / Teledermatologist may review history and images at his/her convenience / Imager, patient, teledermatologist and patient-support must all be available at the same time
Time Requirement / Low / High
Convenience / Higher / Lower
Training / Low / Higher
Source: Levin and Warshaw, 2009 and Table 1 (IMCSF )