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



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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

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