Post-market Review of Products Used in the Management of Diabetes
Page last updated: 29 May 2015
Recent Updates:
- Final Report and PBAC Outcomes for Stage 1 on Blood Glucose Test Strips
- Final Report for Stage 2 on Insulin Pumps
- Final Report and PBAC Outcomes for Stage 3 on Type 2 Diabetes Medicines
Purpose of Review
The objective of the Review was to systematically evaluate the body of clinical evidence regarding diabetes interventions to ensure the most appropriate management of diabetes in clinical practice. The Review aimed to ensure that patients are using the most appropriate medicines and products, effectively, and safely, to achieve optimal health outcomes and support quality use of medicines.
Background
The Australian Government's post-market monitoring programme aims to ensure the continued safe, cost effective and quality use of medicines listed on the Pharmaceutical Benefits Scheme (PBS). The post-market monitoring programme aims to provide a more targeted and focused approach to National Medicines Policy (NMP) objectives and Quality Use of Medicines (QUM) principles.
In 2012, the Drug Utilisation Sub-committee (DUSC) requested a complete review of diabetes medicines. The Pharmaceutical Benefits Advisory Committee (PBAC) agreed to the Review due to the considerable recent changes in diabetes management, including the PBS listing of a number of new anti-diabetic medicines. From this, a broader review was developed that encompassed other aspects of diabetes management, including medicines used in the management of type 2 diabetes, blood glucose test strips, and insulin pumps.
Terms of Reference
In August 2012, the PBAC endorsed the following Terms of Reference for the review of diabetes management.
Purpose: To examine and characterise the complexity and heterogeneity of PBS listings for drugs used in type 2 diabetes mellitus (T2DM); and to review self-monitored blood glucose testing for people with T2DM; and insulin pumps for people with type 1 diabetes mellitus (T1DM), to inform an assessment of their effectiveness in terms of clinical outcomes and cost.
- Describe the utilisation and patterns of treatment of PBS listed drugs for T2DM, and compare these with PBS restrictions;
- Consider if the utilisation of PBS listed drugs in current clinical practice represents expected cost effective use;
- Consolidate the clinical trial evidence used to support PBS listings of diabetes medicines listed since 2002;
- Collate and evaluate any additional clinical studies or meta-analyses for drugs currently PBS listed for T2DM that the Pharmaceutical Benefits Advisory Committee (PBAC) has not seen and that would inform their consideration;
- Describe the utilisation and patterns of use of self-monitoring of blood glucose (SMBG) for people with type 2 diabetes;
- Determine the clinical outcomes and benefits (e.g. HbA1C) of self-monitoring of blood glucose (SMBG) relative to HbA1C monitoring alone for people with type 2 diabetes not treated with insulin;
- Consider the clinical criteria for eligibility for subsidised access to blood glucose test strips under the PBS and NDSS, accounting for clinical benefits offered through SMBG compared to regular HbA1C monitoring;
- Determine the clinical outcomes (e.g. HbA1C, health-related quality of life, and other potential benefits and harms) for people with type 1 diabetes) of insulin pump therapy. In this, consideration should be given to different age groups, with a particular reference to those under 18 who may be eligible for the Insulin Pump Programme which is funded by the Australian Government;
- Investigate the cost-effective use of different insulin pumps available under the Insulin Pump Programme; and
- Consider the clinical criteria and eligibility under the Insulin Pump Programme, to ensure those who would most benefit from insulin pump therapy receive support to assist in their care.
Outline of Process
The Review was undertaken in three stages:
- Stage 1 – Blood Glucose Test Strips.
- Stage 2 – Insulin Pumps.
- Stage 3 – Type 2 Diabetes Medicines.
Each stage was progressed in line with work being undertaken across other NMP partners including the Therapeutic Goods Administration (TGA), the National Health and Medical Research Council (NHMRC), and NPS MedicineWise.
Open public consultation processes were undertaken on the Terms of Reference for each stage of the Review to ensure that all stakeholders were provided with the opportunity to contribute. Each stage of the Review provided further opportunities for consultation through a Stakeholder Forum and public submissions on the draft reports.
The final reports were provided to the Pharmaceutical Benefits Advisory Committee (PBAC), where appropriate, and Government. For more information refer to the description of activities undertaken under each stage of the Review.
A Reference Group was formed to provide a platform for expert advice on issues for the Diabetes Review. The final membership of the Reference Group included:
- Felicity McNeill (Chair), Department of Health
- Professor Shane Hamblin, Endocrinologist
- Professor Jenny Gunton, Endocrinologist and PBAC member
- Dr John Bennett, General Practitioner and PBAC member
- Dr Clement Loy, Neurologist and PBAC Economic Sub-Committee member
- Professor Patricia Dunning, Nurse Practitioner/Diabetes Educator
- Ms Guiliana Murfet, Nurse Practitioner/Diabetes Educator
- Dr Shane Jackson, Pharmacist
- Associate Professor Margarite Vale, Dietician
- Dr Alison Hayes, Health Economist
- Dr Kylie Mosely, Psychologist
- Ms Helen Edwards, Consumer advocate
- Professor Warwick Anderson, National Health and Medical Research Council
- Dr Yeqin Zuo, NPS MedicineWise
- Professor John Horvath, Department of Health.
The Department appreciates the contribution of all organisations and individuals who made submissions to the Diabetes Review.
Further Information
For further information on the Review, please email the Review Secretariat.
Requests for access to analyses commissioned by the Department can be made to the Review Secretariat. The release is at the discretion of all parties involved in the production, and will be assessed on a case-by-case basis.
Stage 1: Blood Glucose Test Strips
This stage of the Review focussed on the utilisation and patterns of use of self-monitoring of blood glucose, and the clinical outcomes and benefits of self-monitoring of blood glucose for people with type 2 diabetes not treated with insulin.
Public Submissions
The call for submissions closed on 15 November 2012. Unless otherwise requested, submissions addressing Terms of Reference 5 to 7 were published on the Blood Glucose Test Strips Public Consultation page.
Stakeholder Forum
The Stakeholder Forum for Stage 1 (Blood Glucose Test Strips) was held in Canberra on 19 November 2012. The Forum summary is available on the Blood Glucose Test Strips Public Consultation page.
Draft Report
Public comments on the draft Report on Blood Glucose Test Strips closed on 30 January 2013.
Final Report and PBAC Outcomes
The Review found that there is limited evidence that self-monitoring of blood glucose improves blood glucose control, quality of life or long-term complications in people with type 2 diabetes who are not using insulin. Some stakeholders raised concerns about restricting access to test strips, but most were generally supportive of clinically appropriate use supported by consistent guidance and education. The final Report is available below:
The final Report for Stage 1 of the Diabetes Review, and stakeholder comments, were considered by the PBAC on 16 August 2013. The PBAC recommended that the number of blood glucose test strips subsidised under the PBS and National Diabetes Services Scheme (NDSS) be restricted for patients with type 2 diabetes who are not using insulin and who have their blood glucose level under control. The PBAC recommended that these patients be limited to a six month supply following changes to their diabetes management, with a further six months’ supply available at the prescriber’s discretion.
The PBAC recommended that the following patients be exempt from access changes:
- people using insulin
- people with gestational diabetes
- people who are using medicines that may adversely affect blood glucose, such as corticosteroids and sulfonylureas
- people with inter-current illness that may cause fluctuations in blood glucose.
Further, the PBAC considered that the changes to access for blood glucose test strips through the PBS and NDSS should be made concurrently, and that consumer education on access changes should be provided through NPS MedicineWise.
The ratified PBAC Minutes for this item are below:
- Ratified PBAC Minutes for the Review of Blood Glucose Test Strips – August 2013 (PDF 402KB) – (Word 29KB)
Stage 2: Insulin Pumps
This component of the Review aimed to evaluate the clinical evidence of the benefits of ongoing use of insulin pumps in patients across all age groups, and to support appropriate access arrangements.
Public Submissions
Public submissions to Stage 2 of the Diabetes Review on Insulin Pumps closed on 13 February 2013. Unless otherwise requested, submissions addressing Terms of Reference 8 to 10 were published on the Insulin Pumps Public Consultation page.
Stakeholder Forum
A Stakeholder Forum for Stage 2 (Insulin Pumps) was held in Canberra on 12 September 2013. The forum summary is available on the Insulin Pumps Public Consultation page.
Draft Report
Public comments on the draft Report on Insulin Pumps closed on 21 July 2014.
Final Report
The Review found that randomised controlled trial evidence did not support the superior safety or efficacy of insulin pumps over the traditional method of multiple daily insulin injections. Only observational study evidence indicated that children and adults may achieve better glycaemic control, have improved quality of life and have a lower risk of severe hypoglycaemia with insulin pump therapy. Due to the greater risk of bias with observational studies, these studies provide less confidence on which to base a conclusion that the insulin pump alone was responsible for the benefits measured.
Neither the trial nor observational studies showed any benefit to pregnant women from the use of insulin pump therapy compared to multiple daily injections on maternal or foetal outcomes. A review of published cost-effectiveness analyses showed a high cost and uncertain cost-effectiveness for insulin pump therapy, indicating that these devices are unlikely to be cost-effective in the majority of patients with type 1 diabetes.
Stakeholders supported continuation of the Insulin Pump Programme and expansion of this Programme to include pregnant women and adults in high risk groups.
The final Report is available below:
Stage 3: Type 2 Diabetes Medicines
Public Submissions
Public submissions for Stage 3 of the Diabetes Review on Type 2 Diabetes Medicines closed on 2 July 2013. Unless otherwise requested, submissions addressing Terms of Reference 1 to 4 were published on the Stage 3 (Medicines) Public Consultation page.
Stakeholder Forum
A Stakeholder Forum for Stage 3 (Medicines) was held in Canberra on 12 September 2013. The forum summary is available on the Diabetes Medicines Public Consultation page.
Draft Report
The draft Report on the Review of Type 2 Diabetes Medicines was made available for public comment from 9–23 October 2014.
Final Report and PBAC Outcomes
The PBAC considered the final Report, supporting studies and stakeholder submissions to the Post-market Review of Type 2 Diabetes Medicines (Terms of Reference 1–4) on 5 November 2014. The final Report is available below:
Please note that information provided in-confidence to the Department has been redacted from the Report.
The PBAC noted that there are currently limited options for subsidised triple therapy for type 2 diabetes, and that consumers and clinicians had indicated a clinical need for greater access to triple oral therapy. The PBAC considered that there was limited evidence of benefit in reduction of blood glucose (HbA1c), reduced rates of hypoglycaemia and weight loss associated with most combinations that are not currently subsidised. The exception was the combination of metformin with a sulfonylurea and a sodium-glucose linked transporter-2 (SGLT2) inhibitor. The PBAC indicated that it would welcome submissions for this combination.
The PBAC also recommended that the following combinations should not be PBS subsidised on the basis that no trial data demonstrating efficacy was available at the time:
- Metformin + dipeptidyl peptidase 4 (DPP-4 inhibitor) + SGLT2 inhibitor.
- Metformin + DPP-4 inhibitor + glucagon-like peptide-1 (GLP-1) receptor agonist.
- Metformin + DPP-4 inhibitor + insulin.
- Sulfonylurea + DPP-4 inhibitor + SGLT2 inhibitor.
- Sulfonylurea + DPP-4 inhibitor + GLP-1 receptor agonist.
- Sulfonylurea + DPP-4 inhibitor + insulin.
- Metformin + SGLT2 inhibitor + GLP-1 receptor agonist.
- Sulfonylurea + SGLT2 inhibitor + GLP-1 receptor agonist.
- Any triple therapy combination of the following medicines: DPP-4 inhibitor, thiazolidinedione (TZD), SGLT2 inhibitor, insulin, and GLP-1 receptor agonist.
- Any combination of insulin with three oral therapies.
For further information, the ratified PBAC Minutes for this item are below:
- Ratified PBAC Minutes for the Review of Type 2 Diabetes Medicines – November 2014 (PDF 656KB) – (Word 704KB)
The documents on this page may not be accessible. If you need help please email the Review Secretariat.
