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

5.2 Introduction

In this section, the aim is to assess the costs of insulin pump therapy for pumps available through the Insulin Pump Programme, and investigate the difference, if any, in their effectiveness. This section also looks at the utilisation of insulin pumps supplied under the Programme and the demographics of the recipients. The QUMPRC was contracted to undertake a review of cost-effectiveness studies comparing insulin pump therapy to multiple daily injections.

Further background about the Insulin Pump Programme is detailed in Part 2.7.

5.3 Effectiveness of insulin pumps available under the Insulin Pump Programme

5.3.1 First literature review: RCTs of insulin pump comparisons

What is the evidence for the impact of different types of continuous subcutaneous insulin infusion systems on outcomes?

None of the RCTs directly compared different insulin pumps. The type of insulin pump has not been considered as a factor for sub-group or sensitivity analysis in systematic reviews. A range of insulin pumps have been used in RCTs. In the 21 RCTs performed between 2000 and 2011, the most frequently used insulin pumps were the MiniMed 508 and Disetronic H-TRON, neither of which are currently available under the Programme. The effectiveness of the newest insulin pumps that involve real-time continuous glucose monitoring in sensor-augmented insulin pumps has not been reviewed in this report as it is beyond the scope of the Review and is not currently funded under private hospital cover or the Insulin Pump Programme.

The difference in effectiveness between insulin pumps has not been assessed, as there is no literature analysing the differences between the insulin pumps available. There is no evidence available to suggest that one brand of insulin pump is superior to another listed on the Prostheses List or the ARTG, and subsequently those pumps available through the Programme. No trial or observational evidence was brought forward through the public consultation process by stakeholders to demonstrate any difference in effectiveness between insulin pump brands.

It is traditionally the role of the patient or guardian and a diabetes health professional to make the decision on which brand or type of insulin pump to choose based on information provided by the manufacturer (Diabetes Queensland 2009). Appendix A compares the different features of insulin pumps available on the Prostheses List. The Insulet OmniPod is excluded as it is not on the Prostheses List and is not funded under the Programme. The appendix does not include information on efficacy of the pumps for improving glycaemic control or quality of life.

5.4 Cost of insulin pump therapy

In Australia, there are different pathways for obtaining funding for an insulin pump. Low-income families with children under 18 years of age are eligible for subsidy under the Insulin Pump Programme, while those with an appropriate level of health insurance can claim a benefit for the cost of an insulin pump. Further information about the costs of the Programme, including co-payment arrangements are detailed in Part 2.7.

The benefit prices of the insulin pumps available under the Prostheses List range from $4,000 to $9,500. These benefit amounts are approximately market value, and have been negotiated between the manufacturer and the insurer, mediated by the Department.

Of the $7.1 million in funding allocated between 2012-13 and 2015-16 for the Insulin Pump Programme, $522,000 per year is allocated to insulin pump subsidies. On 18 October 2013, the Australian Government provided an additional $870,400 in Programme funding for 201314, to clear the waiting list of up to 136 families waiting to have their application processed. This increased the funding for insulin pumps in 201314 to $1,392,400. The remainder of the Programme funding, around $4.1 million, is allocated to account for the expected cost of consumables through the NDSS.

5.4.1 Costs of consumables supplied under the NDSS

The Australian Government subsidises diabetes products, including insulin pump consumables, for people with diabetes through the NDSS. Consumables include reservoirs, cartridges, cannulas, and tubing lines. The NDSS is funded through an uncapped special appropriation and provides insulin pump consumables for all registrants, not just people who obtained an insulin pump through the Programme.

Diabetes Australia administers the NDSS on behalf of the Australian Government. The Department manages the product listings process, including the NDSS current product schedules, which are provided to Diabetes Australia on a monthly basis.

It should be noted that insulin pump therapy is more costly than multiple daily injections, including the ongoing costs of consumables (Cohen 2007). This is the case for both Government and patients. According to the AIHW Insulin pump use in Australia (2012b) report, on average, patient expenditure on consumables was $29 per month in 2010–11 for those using insulin pump therapy, compared with $6 per month for injection therapy.

With regard to the Insulin Pump Programme, the funding required for consumables increases each year as the Programme continues to provide funding for consumables for people who have received a pump under the Programme for the life of the insulin pump. In the first year of the Programme (2008-09), $989,000 (GST exclusive) was allocated for consumables, while in year four (2011-12), $1,569,000 (GST exclusive) was allocated for consumables.

Suppliers and manufacturers supply products to the NDSS at benchmarked prices. The prices are based on standard supply quantities. NDSS registrants pay a co-payment amount and the Government pays the remainder. Table 2 details the NDSS benchmarked prices and co-payment amounts for insulin pump consumables. The Government also pays a Product Supply and Delivery fee for each dispensing of a consumable of $5.10 (value for 2014). The co-payment and Product Supply and Delivery fee are indexed each year on 1 January.

Infusion sets and reservoirs/cartridges are replaced approximately every three days and come in packs of 10, i.e. around a 30 day supply. On average, consumers use 12.17 packs per annum of infusion sets and reservoirs/cartridges (NDSS data).

Table 3 examines the estimated costs of insulin pump consumables to consumers and Government, annually, over a four-year period from 2012-13 to 2015-16. On average, consumers currently pay around $316 per annum for insulin pump consumables and the Government pays $2094 per annum. Insulin was not considered in this cost model.

Table 2. NDSS benchmarked consumable costs and patient co-payments

Product	Benchmarked price	Patient co-payment (2014)
Infusion Sets (10 cannula + 10 tubing lines)	$145.83	$15.60
Reservoirs/cartridges (10)	$42.00	$10.40

Table 3. Costs to consumers and Government for insulin pump consumables through the NDSS for 2012-16

a. Annual costs to consumers (forecast to June 2016).

Product	2012-13	2013-14	2014-15*	2015-16*	Total
Infusion Set	$186.20	$189.85	$189.85	$189.85	$755.75
Reservoir/ cartridges	$124.13	$126.57	$126.57	$126.57	$503.84
Total	$310.33	$316.42	$316.42	$316.42	$1,259.59

b. Annual costs to Government per patient (forecast to June 2016).

Product	2012-13	2013-14	2014-15*	2015-16*	Total
Infusion Set	$1,649.64	$1,647.09	$1,647.09	$1,647.609	$6,590.91
Reservoir/ cartridges	$448.10	$446.76	$446.76	$446.76	$1,788.38
Total	$2,097.74	$2,093.85	$2,093.85	$2,093.85	$8,379.29

* NDSS registrant co-payments and Product Supply and Delivery fees are indexed annually on 1 January. Indexation beyond 2014 has not been considered as the expected rates of indexation are not known.

5.4.2 Expected associated costs with the Insulin Pump Programme

Cost of consumables over four years per patient	$8,379.29
Median insulin pump subsidy per patient	$6,400.00
Cost of consumables and median subsidy over 4 years per patient	$14,779.29
Cost of consumables and median subsidy per patient per year	$3,694.82

The estimated cost to Government associated with insulin pump use for each patient on the Insulin Pump Programme is $14,779 over four years, or $3,695 per annum. This estimate is based on the following assumptions:

• 
  The average warranty period of four years was used as the lifespan of the pump.
  
• 
  The price listed as a minimum benefit on the Prostheses List, is approximately the commercial cost of the insulin pump as the actual commercial price could not be determined.
  
• 
  The price for consumables between insulin pump brands is the same, as it could not be determined from the NDSS data.
  
• 
  The cost of insulin pump consumables is $2,093.85 annually and $8,379.29 across four years, according to NDSS data (Table 3).
  
• 
  The median subsidy income of $42,000 per annum was used rather than the average, due to the skewed distribution. This is based on subsidy cohort incomes ranging from $0 to $120,000 using the subsidy data to date (supplied by JDRF). The median subsidy amount is $6,400 as most families receiving a benefit were under the low-income threshold of $69,496 (2011-12) and eligible for the full, capped subsidy amount.
  

After the initial four years, for each additional year of pump life after expiration of the warranty, the cost to Government would be $2,093.85 (the cost of consumables).

5.4.3 Additional health system costs

The potential costs of the Programme are not limited to the insulin pump and the consumables. There may also be additional health system costs associated with the following:

• 
  pump commencement education;
  
• 
  diabetes educator;
  
• 
  dietician;
  
• 
  hospitalisation to install the pump (2-3 nights) or out-patient services;
  
• 
  post-discharge follow-up;
  
• 
  additional yearly follow-up;
  
• 
  hospitalisation for complications arising from the pump;
  
• 
  hypoglycaemic events (although many studies show a reduction in the number of severe hypoglycaemic episodes);
  
• 
  DKA (although Johnson 2013 showed a reduction in DKA);
  
• 
  cannula site infection;
  
• 
  group meetings/support; and
  
• 
  additional assistance with weight management (Diabetes Control and Complications Trial Group 1995).
  

However, there may also be a reduction in costs associated with fewer severe hypoglycaemic episodes, and reduction in the incidence of the following complications:

• 
  diabetic retinopathy;
  
• 
  end-stage renal disease;
  
• 
  nephropathy death;
  
• 
  cardiovascular complications;
  
• 
  peripheral vascular death;
  
• 
  peripheral neuropathy; and
  
• 
  amputation (St Charles 2009).