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

Part 1 - Review background and context

1.1 Diabetes Post-market Review

Appropriate medication and treatment management is a significant National Medicines Policy (NMP) issue and the Department of Health (the Department) is working with key partners to improve the management of diabetes in Australia, including a focus on medicines, devices and the delivery of support services to consumers. The Post-market Review of Products used in the Management of Diabetes (Diabetes Review) aims 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.

The Diabetes Review has three stages:

1. 
   Blood glucose test strips use in people with type 2 diabetes not using insulin;
   
2. 
   Insulin pumps for people with type 1 diabetes, and the Insulin Pump Programme; and
   
3. 
   Medicines used in the management of type 2 diabetes.
   

Each stage is being progressed separately with the findings presented in an associated written report. Each report is designed to be read as a stand-alone document and may contain some shared information with previous reports. This report will be provided to the Government for consideration in the context of the broader Diabetes Review. The findings will be published on the Diabetes Review website.

Each stage will be 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 the National Prescribing Service Medicinewise (NPS Medicinewise).

The Review aligns with the objectives of the current National Diabetes Strategy as it aims to improve patient outcomes by ensuring that the use of medicines and products in clinical practice reflects best evidence and guidelines. The Department will work via the Review’s Inter-Departmental Working Group to ensure that outcomes align with the new National Diabetes Strategy, currently in development.

1.2 Insulin Pumps Review

1.2.1 Review purpose and Terms of Reference (ToR)

In August 2012, the PBAC endorsed the following Terms of Reference (ToR) for the Insulin Pumps Review (Stage 2). The Insulin Pumps Review comprises ToR 8–10 of the Diabetes Review:

8. 
   Determine the clinical outcomes (e.g. HbA_1c, 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.
   
9. 
   Investigate the cost-effective use of different insulin pumps available under the Insulin Pump Programme.
   
10. 
    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.
    

The purpose of the Insulin Pumps Review is to examine the use of insulin pumps for people with type 1 diabetes, to inform an assessment of their effectiveness in terms of clinical outcomes and cost. Ongoing representations from the Juvenile Diabetes Research Foundation (JDRF), Diabetes Australia, and consumers regarding the current Insulin Pump Programme parameters, eligibility criteria and funding, lead to a review of the Programme. The Insulin Pumps Review was incorporated into the overarching Diabetes Review to provide an established framework that includes opportunities for public consultation and expert input, and to ensure that the Programme was not considered in isolation.

Although a number of the insulin pumps listed on the Prostheses List are compatible with sensor-augmented pump therapy, the sensors and transmitters required for continuous glucose monitoring are not currently subsidised under private health insurance or any Australian Government programme. Therefore, sensor-augmented pump therapy was considered outside of the scope of the Review.

1.2.2 Overview of the Insulin Pumps Review process

Post-market reviews follow a standard process detailed on the Post-Market Review website (as at February 2014).

1. Process for written stakeholder submissions

Direct stakeholder input was sought by announcing a call for submissions to address ToR 8–10, along with information about the Insulin Pumps Review, on the PBS website. The call for submissions was open between 20 December 2012 and 13 February 2013. Thirty-three submissions were received from a range of stakeholders including: consumers/carers (19), health professionals (1), professional peak bodies (4), non-government organisations (6), government organisations (1), and industry (2).

In particular, the Department requested information regarding the current clinical outcomes for patients with type 1 diabetes on insulin pump therapy; the range of insulin pumps available including their differences, advantages and disadvantages; and how investment in the Insulin Pump Programme should be directed to achieve the most benefit.

The full submissions were published on the Diabetes Review webpage, except where requested to be withheld by the author. A summary of key issues raised by stakeholders is in Part 3.2.

1.2.2.2 Process for the Stakeholder Forum

A Stakeholder Forum was held in Canberra on 12 September 2013. The Forum was a further opportunity for stakeholders to contribute to Stage 2 of the Diabetes Review. Prior to the Forum, attendees were provided with a discussion paper that included background information, the ToR, a summary of the literature review undertaken by the University of South Australia, and issues and themes raised by stakeholders through the public submission process. Discussion focussed on four questions posed by the Department, with opportunities for additional comments.

The main themes of the Forum were:

• 
  consumer and clinician views on the advantages and disadvantages of insulin pump therapy (manufacturer views were well expressed via the written submissions to the ToRs);
  
• 
  differences between brands or types of insulin pumps, including aspects that might be important for clinical outcomes or desirable to patients; and
  
• 
  the eligibility criteria for the Insulin Pump Programme and types of patients that should be prioritised to receive a subsidised pump.
  

The Forum Summary was published on the Diabetes Review webpage. A summary of key issues raised by stakeholders is in Part 3.3.

1.2.2.3 Process for the Departmental Working Group

An Inter-Departmental Working Group was formed consisting of key Australian Government agencies and relevant divisions of the Department to provide a forum to discuss potential interactions with other Government programmes and priorities.

The Working Group assisted in steering the Review and worked in parallel to the Reference Group. The Group convened three times on: 23 October 2012, 10 April 2013, and 10 October 2013.

A summary of key issues raised by Working Group members is in Part 3.5.

1.2.2.4 Process for the Reference Group

A Reference Group was formed to provide a platform for expert advice to inform the Diabetes Review. Reference Group advice was used to guide the development of the Insulin Pumps Review and this Report. The Reference Group included experts from a range of fields including endocrinology, diabetes education, general practice, consumer advocacy, clinical epidemiology, pharmacy, health economics, nutrition, and psychology. The Reference Group membership will be published on the Diabetes Review website following completion of all stages of the Diabetes Review.

The Reference Group discussed the Insulin Pumps Review at meetings on 17 April 2013, 17 July 2013, and 16 January 2014, and provided out-of-session comments on the draft Report. In addition to the results from the commissioned literature reviews, the Reference Group also considered the:

• 
  written stakeholder submissions, comments received at the Stakeholder Forum, and public comments on the draft Report;
  
• 
  literature on potential safety risks associated with insulin pump therapy and multiple daily injections;
  
• 
  the Australian Institute of Health and Welfare (AIHW) Insulin Pump User Survey (2012b); and
  
• 
  the regulatory requirements for insulin pumps to be included on the Australian Register of Therapeutic Goods (ARTG).
  

Following public consultation on the draft Insulin Pumps Report and further consideration by the Reference Group, the final Report will be provided to the Minister for Health for consideration.

1.2.2.5 Process for literature searches

The Department engaged the Quality Use of Medicines and Pharmacy Research Centre (QUMPRC) of the University of South Australia to conduct a literature review on the efficacy and safety of insulin pump therapy versus multiple daily injections. Further detail on the literature review findings is included in Part 4, Part 5, and Part 6.

The Reference Group considered the literature review. The evidence from randomised controlled trials (RCTs) did not conclusively support superior effectiveness or safety of insulin pump therapy over multiple daily injections. The Reference Group suggested expanding the scope of the literature review to assess whether other sources of evidence such as observational studies, would be able to provide any further information about the benefits of insulin pump therapy in people with type 1 diabetes or subsets of this population. The Department subsequently engaged the QUMPRC to conduct a second literature search to include observational studies.

The literature reviews considered studies that assessed the effects of each therapy on: HbA_1c levels, quality of life measures in all age groups, and hypoglycaemia. The literature searches did not identify any RCTs or studies comparing the different types of insulin pumps or long-term health outcomes of insulin pump therapy.

In response to stakeholder comments on the draft Insulin Pumps Report, the QUMPRC was further contracted to update the draft Report and literature reviews. This work included:

• 
  Extending the review of observational studies to include literature published between May 2013 and October 2014.
  
• 
  Extending the review of observational studies to include women who are pregnant or planning to conceive. Diabetes-related, and perinatal and maternal outcomes were considered.
  
• 
  Undertaking a literature review of full cost-effectiveness studies of insulin pumps compared to multiple daily injections published between 2007 and October 2014.
  

The literature review reports are available by email to the Review Secretariat.

1.2.2.6 Process for consultation on the draft Review Report

The draft Insulin Pumps Report contained the considerations of the Reference Group, stakeholder comments collected at the Stakeholder Forum and through the public submission process addressing ToR 8–10 of the Diabetes Review, and key findings from the literature reviews. The draft Report was published on the Diabetes Review website between 7 and 21 July 2014, for a two-week period of public consultation. Sixteen submissions were received from a range of stakeholders including: government organisations (4); health professionals and professional peak bodies (4); consumers and consumer organisations (4); industry (3); and a joint submission (1).

In addition to providing general comments on the draft Report, stakeholders were asked to address six focus questions:

1. 
   Should the Insulin Pump Programme prioritise any age groups in providing subsidised access to insulin pumps, and why?
   
2. 
   Should the Programme be expanded to provide access to women with type 1 diabetes who are pregnant or planning a pregnancy and meet the financial eligibility requirements?
   
3. 
   Do you consider it a greater priority to provide expanded access to the Programme in terms of age ranges covered and pregnant women, or more affordable access for the currently eligible population, i.e. children and adolescents aged 18 years and under?
   
4. 
   In your experience in dealing with service providers, is the delivery of type 1 diabetes products particularly insulin pumps and consumables, satisfactory? Do you have any suggested improvements?
   
5. 
   Are the clinical eligibility criteria for the Insulin Pump Programme appropriate? If not, what should the criteria be?
   
6. 
   What are the most important features of an insulin pump that assist in achieving optimal health outcomes or impact greatly on quality of life?
   

The submissions were reviewed and themes checked in order to update stakeholder views on the ToR. Part 3.4 contains a summary of the key stakeholder viewpoints on the draft Report. The draft Report was updated in response to stakeholder comments and the final Report includes the key findings from the updated literature reviews.