Draft Report to the PBAC – Post Market Review of Pharmaceutical Benefits Scheme Products Used in the Management of Diabetes on Stage One: Blood Glucose Test Strips
Page last updated: 8 March 2013
PDF printable version of this Report
Report to the Pharmaceutical Benefits Advisory Committee
Date: December 2012
Report Prepared by:
Department of Health and Ageing
Pharmaceutical Policy Branch
University of South Australia
Veterans' Medicines Advice and Therapeutics Education Services
The objective of this review is to systematically evaluate the body of clinical evidence regarding diabetes interventions. This will help 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.
Diabetes is a major health issue, as recognised by its status as a National Health Priority Area (NHPA). As such, the current review will take time to properly assess all relevant components.
Given the scope of the Review and the significant health issue that diabetes represents, the review is being progressed in a staged approach to ensure all aspects of diabetes management are considered comprehensively. The first component under consideration focuses on blood glucose test strips given that they are a precursor to other medicines and aspects of diabetes management. That is, testing is intended to be used to achieve stability and better inform the best therapeutic approach.
This Report contains the findings of the first component of the Review focussing on the clinical benefit and how the use of blood glucose testing facilitates improved outcomes for people with type 2 diabetes not using insulin. This includes terms of reference 5 - 7 to the Review:
5. Describe the utilisation and patterns of use of self-monitoring of blood glucose (SMBG) for people with Type 2 diabetes;
6. 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; and
7. 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;
This review has been informed by relevant research and evidence, including:
- Relevant guidelines;
- International experience;
- Public consultation;
- Literature review;
- Utilisation analysis; and
- Input by an Expert Advisory Group.
The Report is comprised of four parts, including:
- Part 1 - Provides the background and context for the Review.
- Part 2 - Provides the background regarding the condition, diabetes, and its prevalence and impact in Australia. This part also provides a synopsis of the current national guidelines for self-monitoring of blood glucose in type 2 diabetes.
- Part 3 - Provides the analysis of current research on blood glucose test strips used in the treatment of diabetes including their history of PBS listing, costs and restrictions. A systematic literature review, analysis of the utilisation of blood glucose test strips in Australia, summaries of the stakeholder submissions, stakeholder forum, Working Group and Expert Advisory Group advice to the Review are also provided.
- Part 4 - Provides a summary of the findings of the Review.
Comments on the draft Report of Stage One of the Review focusing on Blood Glucose Test Strips closed on Wednesday 30 January 2013. The Department appreciates the contribution of all organisations and individuals who made a submission.
Stakeholder comments on the draft report, along with PBAC advice received at its December 2012 meeting, will be taken into account in the final consideration of the first component of the broader review of diabetes management. The final Report, including stakeholder comments and PBAC advice, will be provided to the PBAC for consideration in 2013. Any recommendations from the PBAC will subsequently be provided to the Minister for Health and Ageing for consideration.