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

6.5 Government subsidised access to insulin pump therapy in other countries

6.5.1 Canada

The Canadian Government subsidises insulin pumps in several provinces. Ontario provides a full subsidy; Saskatchewan and Newfoundland subsidise insulin pumps for people with type 1 diabetes up to 25 years of age; and British Columbia, New Brunswick, and Newfoundland subsidise up to 18 years of age.

The established eligibility criteria is that the person must have demonstrated to a diabetes assessment team an ongoing commitment to blood glucose monitoring, the safe and appropriate use of the insulin pump, participation in an insulin pump education programme and regular diabetes clinic attendance, as well as meeting certain clinical requirements.

6.5.2 New Zealand

Since September 2012, the New Zealand Pharmaceutical Management Agency (PHARMAC) has been subsidising insulin pumps and consumables for people with type 1 diabetes. The expected cost of this funding is $13.2 million over five years (201213 to 2016-17) to assist around 1,000 patients (PHARMAC 2012). The subsidy amount is equivalent to the listed price (ex-manufacturer, GST exclusive) of the insulin pump on Section B of the Pharmaceutical Schedule. The listed pumps (as at 1 October 2014) include the Animas Vibe^™ listed at NZ$4,500, and the Medtronic MiniMed Paradigm^™ 522 and 722, both listed at NZ$4,400 (PHARMAC 2014).

An Insulin Pump Panel of six clinicians assesses patient applications for subsidy. To qualify for a PHARMAC subsidised pump, a patient must either:

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  Have permanent neonatal diabetes, and a trial of multiple daily injections is inappropriate.
  
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  Have type 1 diabetes, undergone a pancreatectomy or have cystic fibrosis-related insulin, and despite adhering to an intensive multiple daily injection regimen using analogue insulins for at least six months still has either:
  
  • 
    Hypoglycaemia: four severe unexplained hypoglycaemic episodes (requiring assistance of another person) over a six month period due to nocturnal hypoglycaemia or hypoglycaemia unawareness.
    
  • 
    HbA_1c: unpredictable and significant variability in blood glucose including significant hypoglycaemia affecting the ability to reduce HbA_1c, and in the opinion of the clinician HbA_1c could be reduced by 10 mmol/mol (1%) by initiating insulin pump therapy (PHARMAC 2012).
    

There are also criteria for continuing on therapy (i.e. receiving a second insulin pump) and continuing access to consumables, including:

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  Hypoglycaemia: Patient has achieved a 50% reduction in hypoglycaemic events and HbA_1c has not increased.
  
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  HbA1c: Patient is maintaining a reduction in HbA_1c of 10 mmol/mol (1%), and the number of severe unexplained hypoglycaemic episodes has not increased (PHARMAC 2012).
  

The cost-effectiveness of insulin pumps for these sub-groups was estimated at NZD$40,000-$90,000 per QALY.

6.5.3 United Kingdom

The National Health Service provides subsidies for insulin pumps. In England and Wales it is mandatory to fund technologies approved by NICE. If a specialist team recommends insulin pump therapy for people in line with the NICE technology appraisal guidance on insulin pump therapy (2009) (see 6.4.3.1) the Primary Care Trusts will fund this and there are no waiting lists.

6.5.4 United States

The U.S. Centers for Medicare and Medicaid Services provides assistance for low-income families to get healthcare. Medicare may pay part of the cost of an insulin pump and insulin for some patients. With Original Medicare, Medicare pays 80% of the cost of the insulin pump and patients pay 20% of the Medicare-approved cost after the yearly Part B (medical insurance) is deducted. Patients may be required to pay coinsurance or a co-payment for diabetes supplies (U.S. Department of Health and Human Services 2012). Insulin pump patient eligibility criteria are those determined by the American Association of Clinical Endocrinologists’ consensus panel (Grunberger 2010) (see 6.4.3.4).

6.6 Issues identified

6.6.1 Age restriction and continuity of access into adulthood

Currently, the Programme provides means-tested access to people with type 1 diabetes up to 18 years of age. There may be a difficult transition for adolescents with type 1 diabetes when they turn 18 years old and their dependency status for welfare entitlements may change, with a resulting potential increase in health care costs as they transfer into the adult healthcare system. This is a common problem internationally, and an issue with the Australian Programme (International Diabetes Federation Europe 2011).

6.6.2 Waiting list and prioritising applications

At present, JDRF supplies insulin pumps chronologically according to application date. Recently, there has been a waiting list for an insulin pump subsidy due to the high Programme uptake. On 18 October 2013, the Australian Government provided an additional $870,400 in funding for 201314 to clear the waiting list.

The Programme is now in its fifth year of operation with most insulin pumps supplied under the Programme having a four-year warranty period. Some people who have received an insulin pump under the Programme will now be looking at re-applying for another insulin pump subsidy, if they are still eligible.

Under the Programme, applicants may reapply for a replacement insulin pump provided that the recipient is under 18 years of age at the date of application, the manufacturer's warranty on the recipient's current insulin pump has expired, and either:

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  the current insulin pump has ceased to operate as designed; or
  
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  a replacement insulin pump has been clinically recommended by the recipient's health professional.
  

This raises questions about the process of assessing applications and whether access should be granted in order of application date or prioritised based on whether the patient has previously received an insulin pump under the Programme.

6.6.3 Access for Aboriginal and Torres Strait Islander people

While the Indigenous Chronic Disease Package funds some medical aids such as blood glucose monitoring equipment, it does not cover expenditure for insulin pumps. However, Indigenous and Torres Strait Islander status does not preclude access to the Programme. It is not possible under the current data collection for the Programme to assess whether this population is accessing the insulin pump subsidies.

The Diabetes Review Inter-Departmental Working Group raised the issue of ensuring that Aboriginal and Torres Strait Islander children and adolescents have equal access in practice to insulin pumps under the Programme. This Group suggested collecting Programme data on Aboriginal and Torres Strait Islander status and rural and remote identifiers for all people accessing the Programme in the future.

6.6.4 Access for women who are pregnant or trying to conceive

For women with type 1 diabetes, high HbA_1c levels early in pregnancy are associated with an increased risk of congenital malformations, such as cardiac and neural tube defects, miscarriage and perinatal mortality. Pregnant women may also be predisposed to severe hypoglycaemia and DKA (Craig 2011). Reductions in the rate of adverse outcomes can be achieved by optimal care and tight glycaemic control before conception and throughout pregnancy (Pearson 2007; Bismuth 2012).

The NZSSD position statement (2008) and Australian guidelines (Victorian CSII Working Party 2009; Craig 2011) recommend insulin pump therapy for women with type 1 diabetes who are pregnant or trying to conceive, ideally initiated preconception. The NZSSD position statement indicates women trying to conceive with suboptimal glycaemic control. Stakeholders also highlighted pregnant women as a group that could be prioritised to receive access to insulin pumps under the Programme.

Two meta-analyses of RCT evidence comparing insulin pumps with multiple daily injections for pregnant women with diabetes, found no difference in HbA_1c, hypoglycaemia, hyperglycaemia, macrosomia, preterm delivery, caesarean, perinatal mortality, foetal anomaly, or worsening of diabetes complications (Farrar 2007; Mukhopadhyay 2007). The literature review of observational studies, showed that the majority of studies did not show significant differences between insulin pump therapy and multiple daily injections in diabetes management, or maternal or newborn outcomes. However, both RCTs and observational studies were small and may lack statistical power to detect differences in outcomes between insulin pump and injection therapy.

To ensure Programme value for money, patients should use their pump for at least four years (warranty period). Some manufacturers have a loan system for people seeing out the waiting period for their private health insurance, or for use when a pump under warranty has broken down. There may be scope to adapt this arrangement to suit the period of preconception and pregnancy, for those planning a single pregnancy.