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

Part 3 – Stakeholder consultation outcomes

3.1 Public consultation processes

The public consultation processes involved three main milestones:

1. 
   a written public submission process addressing the Terms of Reference;
   
2. 
   a Stakeholder Forum; and
   
3. 
   public consultation on the draft Insulin Pumps Report.
   

An Inter-Departmental Working Group and an expert Reference Group were established by the Department to provide advice and information to the Diabetes Review.

Disclaimer: Parts 3.2–3.4 are intended to provide a broad summary of the views expressed by stakeholders and only information provided in the submissions or at the Stakeholder Forum has been included. No attempt was made to reach consensus and the views and opinions should not be considered as medical advice or the views of the Department. This Summary and all other comments contributed were provided to the Diabetes Review Reference Group for consideration.

3.2 Key issues raised in written submissions by stakeholders

• 
  Stakeholders were unanimous in considering that insulin pump therapy has advantages for people with type 1 diabetes. Any restrictions to current access arrangements are strongly opposed.
  
• 
  Consumers and consumer groups strongly expressed that transitioning from multiple daily injections to insulin pump therapy provides a significant improvement in the quality of life of paediatric type 1 diabetes patients, including a reduction in physical and mental stress, and greater independence and flexibility for the child and family. In terms of clinical outcomes, this includes lower HbA_1c levels, stable blood glucose levels, and reduced frequency of severe hypoglycaemic attacks.
  
• 
  Consumers and consumer groups expressed strong support for the continuation of the Insulin Pump Programme, including funding to alleviate the waiting list (which has now been provided, see Part 2.7.4 for further information). Consumers and consumer groups also supported extension of the Programme to include lowincome adults, or at least to continue subsidies for current paediatric patients after transitioning into adulthood to support them in continuing access to an insulin pump.
  
• 
  Consumers, consumer groups, industry organisations and sponsors expressed that improvements in glycaemic control, including lower HbA_1c levels, from accessing insulin via insulin pump therapy may reduce long-term diabetes-related complication rates. Lifetime use may improve the costeffectiveness ratio of an insulin pump when the longterm health and quality of life improvements are considered.
  

3.3 Key issues raised by stakeholders at the Stakeholder Forum

• 
  Insulin pump use can lead to benefits in clinical outcomes, including glycaemic control, reducing the frequency and severity of hypoglycaemic events, and reducing the frequency of sick days.
  
• 
  Insulin pumps can greatly improve quality of life, specifically, reducing patients’ and their families’ anxieties, and allowing greater flexibility, independence, and insight into managing their type 1 diabetes.
  
• 
  Success with insulin pump therapy depends on the type of patient (e.g. those with high risk of diabetes complications), the motivation of patients and their families, and the quality of education and support for patients, families and health professionals.
  
• 
  The clinical data to date seem to compare datasets that are not comparable. By pooling data (i.e. in a systematic literature review), the context and nuance is generally lost. In the literature, there is limited evidence for the benefits of insulin pumps due to this cancellation effect, which is also apparent in the NHMRC National Evidence-Based Clinical Care Guidelines for Type 1 Diabetes in Children, Adolescents and Adults. There is some dissent between the literature review and on-the-ground experience. Randomised controlled trials (RCTs) are not appropriate to measure insulin pump therapy outcomes. Observational and cohort studies may provide stronger and more beneficial evidence on the use, benefits and effectiveness of insulin pump therapy.
  
• 
  There are high costs associated with insulin pump therapy, such as specialised training and ongoing support. Insulin pumps may have some cost-benefits associated with reduced hypoglycaemic events and hospital admissions.
  
• 
  It is necessary to support the rapidly changing technologies in this area, including avenues for government subsidy. Education and support needs to adapt to these rapid changes as well.
  
• 
  All patients with type 1 diabetes should be considered for eligibility for the Insulin Pump Programme.
  
• 
  Some patients with private health insurance experience problems when trying to access an insulin pump through their insurer, including denial of access to an insulin pump. Note: This issue is outside the scope of the Insulin Pumps Review and was referred to the appropriate area of the Department.
  
• 
  Many patients are adequately managed on multiple daily injections.
  
• 
  Specific insulin pump features are important, such as small dose increments for children or those requiring low amounts of insulin, waterproof casing, tubing or tubeless design, and the potential for a closed loop system.
  
• 
  It is important to ensure a baseline quality control and to have a wide variety of insulin pumps available to allow adequate patient choice, and guaranteed supply and replacement of insulin pumps. Education for patients, families and health professionals with the variety of insulin pumps is critical.
  

4. Key stakeholder views in response to the draft Insulin Pumps Report

• 
  Access to the Insulin Pump Programme should be based on clinical need and financial disadvantage, and should be widened to all ages. The current age restriction is inequitable as it denies access to an insulin pump to those over 18 years who are unable to afford private health insurance and who would benefit from insulin pump therapy. With the exception of age, the Programme eligibility criteria are appropriate.
  
• 
  Insulin pumps under the Programme should be affordable, and the Programme should fully subsidise the cost of the pump for those in the lowest income bracket.
  
• 
  The Programme should be expanded to include: women who are pregnant or trying to conceive, and people with high HbA_1c (i.e. ≥8.5%) or disabling (severe or unpredictable) hypoglycaemia. There is evidence for the benefits of insulin pump therapy and good glycaemic control in women who are pregnant.
  
• 
  Insulin pumps reduce hospitalisations and the development of complications, reducing healthcare costs.
  
• 
  Treatment should be part of a multidisciplinary team care arrangement.
  
• 
  Pump consumable costs should be funded through the NDSS, to provide additional Programme funding. Insulin pump consumables should be available through local pharmacies to prevent access delays. Note: Comments relating to the administration and delivery of insulin pump consumables were directed to the relevant area of the Department to consider as part of a broader review of the NDSS.
  
• 
  Quality of life benefits associated with insulin pump use include: greater flexibility with meals and sleeping times; enhanced participation in social and school activities; and enhanced participation in employment for carers of children with type 1 diabetes.
  
• 
  Important features of insulin pumps include: continuous glucose monitoring, user-friendly software, adjustable bolus (e.g. square wave, multiwave, etc.), ability to set different basal rates and daily profiles, low glucose insulin suspension, education/training and user support, waterproofing, child lock, and the ability to download data for review.