Assessment of preimplantation genetic diagnosis

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Assessment of preimplantation genetic diagnosis

April 2015



MSAC application 1165

Assessment Report



Assessment 1165 – Preimplantation Genetic Diagnosis – April 2015
ISBN (Online) <number>

ISSN (Online) <number>
Internet site http://www.msac.gov.au
© Commonwealth of Australia 2015
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 Online, Services and External Relations Branch, Department of Health, GPO Box 9848, Canberra ACT 2601, or via e-mail to copyright@health.gov.au.
Electronic copies of the report can be obtained from the Medical Service Advisory Committee’s Internet site at http://www.msac.gov.au/
Enquiries about the content of the report should be directed to the above address.
This report is a contracted technical report for use by the Medical Services Advisory Committee (MSAC) to inform its deliberations. 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.
This report was prepared for MSAC by Dr Diah Elhassen, Dr Kristina Coleman, Dr Suzanne Campbell, Dr Lisa Fodero and Mr Joe Scuteri from HealthConsult Pty Ltd with the assistance of the MSAC Health Expert Standing Panel (Appendix 1). The economic evaluation was undertaken by Mr Paul Mernagh (subcontractor for HealthConsult Pty Ltd). The report was commissioned by the Department of Health on behalf of MSAC.
This report should be referenced as follows:

Elhassen D, Coleman K, Mernagh P, Campbell S, Fodero L, Scuteri J. (2015). Preimplantation genetic diagnosis. MSAC Application 1165, Assessment Report. Commonwealth of Australia, Canberra, ACT.


Publication approval number <number>

Contents


Assessment of preimplantation genetic diagnosis 11

2.Details of the proposed medical service and its intended use 28

2.1.Address all items in the Protocol 28

2.2.Proposed medical service 29

2.3.Proposed listing sought for funding 40

2.4.Comparator details 47

3.Clinical evaluation for the main indication 57

3.1.Description of search strategies 57

3.2.Listing of all included studies 60

3.3.Assessment of the measures taken by investigators to minimise bias 66

3.4.Characteristics of the studies 73

3.5.Outcome measures and analysis 83

3.6.Systematic overview of the results 89

3.7.Interpretation of the clinical evidence 123



4.Translating the clinical evaluation to the economic evaluation 124

4.1.Identification of issues to be addressed 124

4.2.Issue 1: Population and circumstances of use 124

4.3.Issue 2: Downstream impacts related to affected live births 126

4.4.Issue 3: Modelling the natural history of pregnancy and the IVF cycle 128

4.5.Issue 4: Utility weights applied to the economic model 131

4.6.Issue 5: Healthcare resource use and associated costs 141

5.Economic evaluation for the main indication 150

5.1.Overview of the economic evaluation 150

5.2.Population and circumstances of use reflected in the economic evaluation 150

5.3.Structure and rationale of the economic evaluation 151

5.4.Variables in the economic evaluation 158

5.5.Results of the economic evaluation 164

5.6.Sensitivity analyses 169

6.Estimated utilisation and financial implications 174

6.1.Justification of the selection of sources of data 174

6.2.Estimation of use and costs of the proposed medical service 176

6.3.Estimation of changes in use and cost of other medical services 178

6.4.Estimated financial implications on the MBS 187

6.5.Estimated financial implications for Government health budgets 189

6.6.Identification, estimation and reduction of uncertainty 189

7.Options to present additional relevant information 191

7.1.Issues relating to equity principles 191

Health Expert Standing Panel 203

Assessment Group 203

Studies excluded following full text review based on the number of cycles (<200 cycles) 206

7.2.Identifying risk probabilities for the economic model 211



8.Risk of miscarriage following PGD – in early pregnancy or prior to prenatal testing. 220

9.Risk of miscarriage following PGD – late pregnancy or after prenatal testing 222

10.Risk of miscarriage following natural conception – early pregnancy or late pregnancy 222

11.Risk of miscarriage following natural conception – prior to prenatal testing 223

12.Risk of miscarriage following natural conception – after prenatal testing 223

12.1.National Health and Medical Research Council regulatory framework for ART 242






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