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

5.7 Issues identified

5.7.1 Patient affordability

Following the Health Technology Assessment Review finalised in February 2010 by the Medical Benefits Division, Department of Health, the minimum benefit amounts for insulin pumps on the Prostheses List increased from 1 August 2012. The Programme’s capped subsidy is now less than 80% of the most expensive and most used pump available under the Programme, which has a minimum benefit cost of $9,500. For this pump, the patient co-payment ranges from $3,100 to $8,550, dependent on family income. Families on the lowest eligible incomes of under $71,230 (2013-14) per annum are unlikely to be able to afford the co-payment gap, which has increased from $1,600 to $3,100 for the most used pump, without further subsidy or the assistance of manufacturers.

In October 2011, some manufacturers agreed to cover the co-payment gap for the lowest income families, which increased use of the Programme. Most manufacturers have not confirmed their position to continue co-payment support following the increases to the minimum benefit prices on the Prostheses List. The current availability of assistance with the cost of the co-payment makes it difficult to determine whether the subsidy available is the most effective amount.

For eligible families on incomes between $71,230 and $101,653 (2013-14) per annum, it is likely to be less expensive to have private hospital insurance than to access an insulin pump under the Programme, particularly for the first pump. The cost of private health insurance varies between insurers, and states and territories in Australia. In general, a single parent with children up to 18 years of age can get top hospital cover for around $1300–$2100 per annum inclusive of the 30% Government rebate (Private Health Insurance Ombudsman, 2014).³ Some insurers will allow a single child to be insured, which may further reduce costs. There is usually a 12-month waiting period for the first insulin pump. For subsequent pumps, where the pump is not fitted in a hospital or as part of hospital substitute treatment, insurers may require patients to maintain their insurance at a certain level in the intervening years.

The median family income data shown in Figure 5 indicates that families on incomes ranging from $71,230-$101,653(2013-14) per annum rarely access the Programme and make up less than 7% of Programme recipients (JDRF data). In addition, the AIHW’s insulin pump user survey identified that for 12-17 year olds the highest proportion of insulin pump users were those in the highest socioeconomic group (46%) followed by those in the lowest socioeconomic group (39%), while for those over 17 years, the proportion of insulin pump use increased with socioeconomic status. This difference was attributed to the possible effects of subsidy and pump loan schemes (AIHW 2012b).

The co-payment gap was designed to equal the cost of private health insurance for a period of 12 months, the waiting period before a person is eligible for a rebate for an insulin pump under private health insurance. The patient co-payment for the most used pump under the Programme is now significantly more than the cost of private health insurance, even for families on the lowest eligible incomes. However, for subsequent insulin pumps, the Programme may be a less expensive option than private health insurance, depending on family income and insurance requirements regarding the level of cover and maintenance of cover in the intervening years.

5.7.2 Dependency on the Prostheses List

The Programme generally supplies insulin pumps that are available on the Prostheses List. The benefit amounts on this List are negotiated between private health insurers and pump manufacturers, mediated by the Department. Although PLAC has an increased focus is on assessing new listings for devices based on comparative and cost-effectiveness, for existing products there has previously been limited information provided by manufacturers to support cost-effectiveness for insulin pump products on the Prostheses List. Maintaining the link between the Programme and the Prostheses List may not be sustainable or appropriate, although there will remain a need for evidence to be provided to inform funding decisions in relation to pumps available under the Programme.

Insulin pumps not on the Prostheses list can be recommended and in such cases the applicable cost is determined by JDRF and the Department of Health. Several factors are considered including the insulin pump manufacturer’s recommended retail price, the prescribed minimum benefit payable for comparable insulin pumps listed on the Prostheses List and other information determined to be relevant at the time. Insulin pump consumables are subsidised for all patients with type 1 diabetes through the NDSS, irrespective of whether the insulin pump is on the Prostheses List or how the patient acquired their pump.

Part 6 – ToR 10
Programme eligibility criteria

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.

6.1 Key findings for ToR 10

Literature review: RCTs and observational studies

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  The trial and observational study evidence does not enable a particular sub-group in the type 1 diabetes population that receives greater benefit from insulin pump therapy to be clearly defined for the purposes of a third party operating a subsidy programme.
  
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  Systematic reviews of RCTs comparing insulin pump therapy and multiple daily injections have not undertaken sub-group analyses of children on characteristics other than age.
  
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  Two small observational studies suggest that insulin pump therapy may be more beneficial in children under 6 years old, or when initiated in children under 6 years old. There is also some evidence from observational studies that patients with higher initial HbA_1c may achieve greater reductions in HbA_1c with insulin pump therapy.
  

Literature review: Australian and international clinical guidelines

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  Five guidelines or position statements by professional organisations that made recommendations on the use of insulin pump therapy were identified (published between 2009 and July 2012). A New Zealand position statement published in 2008 was also included in this Report. Information on eligibility criteria for Government subsidy programmes was included for Canada, New Zealand, the UK and USA.
  
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  With regard to children and adolescents, the Programme’s eligibility criteria are similar to the practice points for initiation of insulin pump therapy in the Australian clinical guidelines for type 1 diabetes (Craig 2011). Both include technological and cognitive capacity to manage use of the pump, and high levels of patient/carer motivation to intensively manage diabetes.
  
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  Most guidelines identified in the review state that the decision to initiate insulin pump therapy is ultimately at the discretion of a healthcare professional in consultation with the patient or carer.
  
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  Guidelines identified often recommend insulin pump therapy for: children under 12 years where multiple daily injections are impractical; women who are pregnant or trying to conceive; and anyone with poor glycaemic control as indicated by frequent severe hypoglycaemia, hypoglycaemia unawareness, dawn phenomenon, or development of microvascular complications.
  
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  It is also generally recommended that patients/carers are supported by a team of health professionals, and have the technical and physical skills, and motivation, to use insulin pump therapy effectively.
  

Stakeholder input

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  Advice from APEG indicates that the current Programme eligibility criteria are appropriate for children. APEG considered that there is a risk of inequitable distribution of insulin pump use in the current Programme from the creation of eligibility criteria without strong clinical evidence. There is insufficient evidence on which to base any additional criteria. However, APEG advised that, ideally, there would not be age limits for patients initiating the Programme.
  
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  Stakeholders were unanimously supportive of the benefits of insulin pump therapy and recommended expanding the Programme so that patients of any age were eligible to commence pump therapy.
  

Reference Group input

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  Members considered that prioritisation of patients is a difficult issue. Patients with heightened risk of hypoglycaemia, those with a significant impairment to quality of life with multiple daily injections, young children who are not yet able perform multiple daily injections, and patients who have tried other methods but are still shown to have poor glycaemic control, may be groups to target for insulin pump therapy.
  

Issues identified

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  Reference Group members considered that continuity of care for patients who are turning 18 years old and are no longer eligible under the Programme was an important issue. These people are unlikely to be able to afford a new insulin pump outright or to be covered by private health insurance.
  
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  With the Programme in its fifth year of operation, many recipients may now be reapplying for another subsidy. This presents the issue of whom to give priority to in the event of a waiting list developing: those who have received a pump previously, or those who have never received a subsidy through the Programme or have never used an insulin pump before.
  
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  The Diabetes Review Inter-Departmental Working Group suggested that Programme data be collected on Aboriginal and Torres Strait Islander status and rural and remote identifiers, to ensure that these people are accessing the Programme.
  
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  A number of Australian and international guidelines recommend access to insulin pumps for women with type 1 diabetes who are pregnant or trying to conceive. Stakeholders also highlighted the importance of access for this group. However, there is insufficient evidence available from randomised trials to determine the superior method of insulin delivery for pregnant women.