Post-market Review Products Used in the Management of Diabetes Report to Government Stage 2: Insulin Pumps February 2015

Post-market Review

Products Used in the Management of Diabetes

Report to Government

Stage 2: Insulin Pumps

February 2015

Contents

Report Structure 3

Abbreviations and Glossary 4

Executive Summary 7

Part 1 - Review background and context 11

1.1 Diabetes Post-market Review 11

1.2 Insulin Pumps Review 11

1.3 Context for the Diabetes Post-market Review 15

Part 2 - Diabetes mellitus: treatment and access to insulin pumps 17

2.1 Diabetes mellitus 17

2.2 Prevalence of diabetes in Australia 17

2.3 Complications 18

2.4 Diagnosis 19

2.5 Monitoring blood glucose and glycaemic control 20

2.6 Treatment options and technologies for type 1 diabetes 21

2.7 Access to insulin pumps via the Type 1 Diabetes Insulin Pump Programme 24

2.8 Access to insulin pumps via private health insurance 26

2.9 Regulation of insulin pumps in Australia 27

Part 3 – Stakeholder consultation outcomes 29

3.1 Public consultation processes 29

3.2 Key issues raised in written submissions by stakeholders 29

3.3 Key issues raised by stakeholders at the Stakeholder Forum 30

3.4Key stakeholder views in response to the draft Insulin Pumps Report 30

3.5 Inter-Departmental Working Group 31

3.6 Reference Group 32

3.7 Advice from the Australasian Paediatric Endocrine Group (APEG) 32

Part 4 – ToR 8

Benefits and safety of insulin pump therapy 34

4.1 Key findings for ToR 8 34

4.2 Introduction 36

4.3 First literature review: randomised controlled trials (RCTs) 38

4.4 Second literature review: observational studies 42

4.5 Third literature review: observational studies in pregnant women 46

4.6 AIHW Insulin Pump User Survey 48

4.7 Potential safety risks associated with insulin pump therapy 48

4.8 Potential safety risks associated with multiple daily injections 49

Part 5 – ToR 9

Costs and comparative effectiveness of insulin pumps 50

5.1 Key findings for ToR 9 50

5.2 Introduction 53

5.3 Effectiveness of insulin pumps available under the Insulin Pump Programme 53

5.4 Cost of insulin pump therapy 54

5.5 Literature review: cost-effectiveness studies of insulin pumps 57

5.6 Insulin pump use under the Programme 59

5.7 Issues identified 61

Part 6 – ToR 10
Programme eligibility criteria 63

6.1 Key findings for ToR 10 63

6.2 Introduction 65

6.3 Literature review: RCTs and observational studies 65

6.4 Literature review: Australian and international clinical guidelines 66

6.5 Government subsidised access to insulin pump therapy in other countries 70

6.6 Issues identified 71

References 74

Appendices 81

Appendix A – Information on insulin pumps available under the Prostheses List as at February 2014 81

Appendix B – Insulin pumps no longer available under the Prostheses List as at February 2014 89

Appendix C – Breakdown of insulin pump brands supplied under the Insulin Pump Programme from commencement to 31 March 2013 90

Appendix D – National and international guidelines for the management of type 1 diabetes using insulin pump therapy 91

Appendix E – Current Guidelines hosted by the NHMRC Clinical Guidelines Portal that reference insulin pumps as at January 2015 98

Report Structure

This report is separated into seven parts, as briefly outlined below. The Report structure is designed to clearly address the Terms of Reference on insulin pumps and the Insulin Pump Programme for Stage 2 of the Diabetes Postmarket Review.

Executive Summary – This summary is a stand-alone document that summarises the process and results of the Insulin Pumps Review.

Part 1 – Review background and context.

Part 2 – Diabetes background including prevalence, impact in Australia, complications, diagnosis, monitoring, and treatment options. This section also contains information on access to insulin pumps including detail on the Insulin Pump Programme and the regulation of insulin pumps in Australia.

Part 3 – Stakeholder consultation and input.

Part 4 – Benefits and safety of insulin pump therapy (Terms of Reference 8).

Part 5 – Costs and comparative effectiveness of insulin pump therapy (Terms of Reference 9).

Part 6 – Examination of the Insulin Pump Programme eligibility criteria (Terms of Reference 10).

Abbreviations and Glossary

AADE	American Association of Diabetes Educators
ADEA	Australian Diabetes Educators Association
AIHW	Australian Institute of Health and Welfare
APEG	Australasian Paediatric Endocrine Group
APGAR score	A simple method to assess the health of a newborn baby that considers appearance/complexion, pulse rate, reflex irritability, activity and respiratory effort, to determine if immediate medical attention is required.
ARTG	Australian Register of Therapeutic Goods
CADTH	Canadian Agency for Drugs and Technologies in Health
CGM	Continuous Glucose Monitoring
CHD	Coronary Heart Disease
CI	Confidence Interval
Commonwealth	Commonwealth of Australia as represented by the Department of Health
CSII	Continuous subcutaneous insulin infusion (insulin pump therapy)
DAEN	Database of Adverse Event Notifications
Dawn phenomenon	Long-acting insulin analogues may cause a trough of insulin dosing before breakfast resulting in fasting hyperglycaemia, known as the dawn phenomenon.
Department	Department of Health
DCCT	Diabetes Control and Complications Trial
DHS	Department of Human Services
Diabetes	Diabetes Mellitus
DKA	Diabetic Ketoacidosis
DUSC	Drug Utilisation Sub-Committee (of the PBAC)
DVA	Department of Veterans’ Affairs
ESC	Economics Sub-Committee (of the PBAC)
HbA1c	Glycated Haemoglobin, measured as a per cent or in mmol/mol, 1% HbA1c is equivalent to 11mmol/mol.
Insulin Pump	A small computerised device that delivers small amounts of continuous rapid acting insulin throughout the day
IPC	Insulin pump consumable
IU	International Units
JDRF	Juvenile Diabetes Research Foundation (Australia)
Macrovascular complications	Damage to large blood vessels of the heart, brain, and legs leading to heart attack and stroke
MDI	Multiple daily injections (multiple insulin injections (MII))
Microvascular complications	Damage to small blood vessels causing problems in the eyes, kidney, feet and nerves
NDSS	National Diabetes Services Scheme
NICE	National Institute for Health and Clinical Excellence, United Kingdom
NHMRC	National Health and Medical Research Council
NMP	National Medicines Policy
NPS Medicinewise	National Prescribing Service Medicinewise
NZSSD	New Zealand Society for the Study of Diabetes
PBAC	Pharmaceutical Benefits Advisory Committee
PBS	Pharmaceutical Benefits Scheme
PLAC	Prostheses List Advisory Committee
Programme	Type 1 Diabetes Insulin Pump Programme
Prostheses List	A determination under Section 72-10 (5) of the Private Health Insurance Act 2007 which lists devices that are provided as part of an episode of hospital treatment (or hospital substitute treatment) where a Medicare benefit is payable for the associated professional services (surgery) which private health insurers are required to pay mandatory benefits for.
PVD	Peripheral Vascular Disease
QoL	Quality of Life
QUM	Quality Use of Medicines
QUMAX	Quality Use of Medicine Maximised for Aboriginal and Torres Strait Islander People
QUMPRC	Quality Use of Medicines and Pharmacy Research Centre (University of South Australia)
RCT	Randomised Controlled Trial
RPBS	Repatriation Pharmaceutical Benefits Scheme
SARA	System for Australian Recall Actions
SF-12	Medical Outcomes Study 12-Item Short-Form Survey
SF-36	Medical Outcomes Study 36-Item Short-Form Survey
SIGN	Scottish Intercollegiate Guidelines Network
TGA	The Therapeutic Goods Administration
ToR	Terms of Reference
UKPDS	United Kingdom Prospective Diabetes Study
WHO	World Health Organization