Aside from the reported benefits of insulin pump therapy, there are some potential safety risks associated with its use. Potential adverse events include DKA from pump malfunction, and catheter-site infection or irritation (Guinn 1988). The risk of DKA from insulin pump failure can be caused by the cannula bending, air bubbles affecting insulin delivery, unintentional misuse, or mechanical problems (Shalitin & Phillip 2008). Multiple daily injection therapy provides a reservoir of long-acting insulin, whereas insulin pump therapy provides frequent doses of short-acting insulin, and therefore, may increase the risk of rapidly developing DKA if there is an interruption to insulin supply (Pickup 2008).
Barnard (2007) found that the continual reliance on an external device, with the need to programme the pump and change over consumables, makes insulin pumps challenging for a significant number of users.
Product safety regulation of insulin pumps in Australia is managed by the Therapeutic Goods Administration. For further information, see Part 2.9.
4.8 Potential safety risks associated with multiple daily injections
Long-acting insulin analogues cannot be modulated after injection and may produce a peak of insulin dosing in the middle of the night with a consequent risk of hypoglycaemia, and a waning of insulin dosing before breakfast, resulting in fasting hyperglycaemia (also known as the “dawn phenomenon”) (Pickup 2008).
There is also variability in the subcutaneous absorption of delayed-action insulin suspensions, contributing to fluctuations and unpredictability in within-day and between-day glycaemic control. However, the differences in fluctuations between therapies may be more apparent in relative terms than in absolute terms (Pickup 2008).
Part 5 – ToR 9
Costs and comparative effectiveness of insulin pumps
Investigate the cost-effective use of different insulin pumps available under the Insulin Pump Programme.
5.1 Key findings for ToR 9
Literature review
-
The systematic literature search commissioned by the Department showed that there is currently no literature available on the comparative effectiveness of different brands of insulin pumps. The Department has compiled an information table to compare the insulin pumps available under the Prostheses List at Appendix A.
-
The technology used in insulin pump therapy and multiple daily injections, including the types of insulin, have all improved over time. It is therefore difficult to determine the specific impact of different types of insulin pumps on outcomes over time.
Costs of insulin pumps and consumables
-
The Insulin Pump Programme provides funding for the costs of both insulin pumps, administered by JDRF, and consumables, administered by Diabetes Australia through the NDSS. Programme funding totals $6.97 million over four years from 2012-13 to 2015-16.
-
Insulin pumps available under the Programme are generally those on the Prostheses List, with the benefit prices ranging from $4,000 to $9,500. There are currently six2 insulin pumps available.
-
On average, consumables available through the NDSS cost $316 per annum to the consumer, and $2,098 per annum to the Australian Government. The prices are benchmarked and do not vary between brands. All people with type 1 diabetes are able to access subsidised insulin pump consumables through the NDSS, not just those who have received a subsidised pump through the Programme.
-
The cost to Government for each insulin pump supplied through the Programme is $14,779 over four years (the warranty period of most insulin pumps), or $3,695 per annum. This estimate is based on the median pump subsidy amount and the associated cost of consumables.
-
Of the 466 pumps supplied under the Programme since it began in 2008-09, the most common pump supplied is the Medtronic Paradigm Veo 754, supplied to 47% of recipients and currently valued at $9,500.
Cost-effectiveness of insulin pump therapy
-
Based on four cost-effectiveness studies available (Australia, UK, Canada and US), assuming reductions in HbA1c levels of 0.51% to 0.675% with insulin pump therapy compared to multiple daily injections, the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) converted to AUD $ 2013 prices ranged from AUD$63,274 in a US study to AUD$292,952 in a UK study.
-
The ICERs were highly sensitive to the level of HbA1c reduction. The modelled reductions in HbA1c with insulin pump therapy compared to multiple daily injections in the base case models (1.2% in three studies and 0.9% in one study) are greater than the reductions in HbA1c from RCT evidence for adults (0.19% to 0.3%), and adolescents and children (0.1% to 0.22%).
-
All studies used the CORE model (Palmer 2004). The CORE model may overestimate the incidence of macrovascular complications in people with type 1 diabetes (Cummins 2010).
-
ICERs were sensitive to changes in reductions in severe hypoglycaemia rates only when the cost of severe hypoglycaemia was valued in the high range (2007 USD$1,234).
-
With the exception of the UK study, all studies appear to underestimate the ICER by assuming a pump life span longer than the warranty period of 4 years for most insulin pumps currently marketed in Australia. In the US study, reducing the pump life span from 7 years in the base case to 4 years in the sensitivity analysis increased the ICER by 54%.
-
The studies did not examine improvements in quality of life with the exception of changes to quality of life associated with fear of severe hypoglycaemia. In submissions, stakeholders emphasised the quality of life benefits of insulin pumps including greater flexibility and enhanced participation in sports, work and social activities.
Use of insulin pumps in Australia
-
Uptake for the Insulin Pump Programme increased following the announcement that some key manufacturers would cover the co-payment gap for low-income families. This has led to a waiting list. The Government announced additional Programme funding on 18 October 2013, to help clear the waiting list.
-
Since the Programme commenced in 2008-09 to February 2014, a total of 466 pumps have been subsidised.
-
NDSS data indicates that there are around 10,300 people aged between 0–18 years with type 1 diabetes in Australia, of which around 3,400 (33%) have been recorded as using insulin pump therapy for their form of treatment (AIHW 2012a, 2012b).
Stakeholder input
-
Noting that the most important features of an insulin pump may be different for each patient, stakeholders indicated that features such as bolus calculators, dose increments suitable for children, and the ability to download data might have additional advantages for the paediatric population. Stakeholders stated that it is important to have a range of insulin pumps available to suit a range of patients.
-
New features such as continuous glucose monitoring, including algorithms to detect hypoglycaemia and suspend insulin delivery, may provide additional safety and efficacy advantages. These technologies are not currently funded through any Australian Government programme and stakeholders advocated for a pathway for the evaluation and funding of new technologies.
-
Other factors such as ease of use, waterproof casing, and calculators for carbohydrate content of common foods, also featured as important to improve the lifestyle benefits of insulin pumps.
Reference Group input
-
Members noted a number of factors that may influence the choice between insulin pump brands, including: colour, size, waterproof casing, ease of use, low dose increments for basal and bolus insulin, continuous glucose monitoring technology, and software algorithms.
-
Customer support services offered by the manufacturer were considered to be essential when choosing between insulin pump brands. When insulin pumps fail, some manufacturers will immediately send a replacement pump free of charge or arrange access to another insulin pump whilst waiting for the replacement to arrive.
-
Marketing to people with diabetes, diabetes educators and health care professionals, has considerable influence on brand preference and in guiding patient choice.
-
Patient factors were noted, such as adolescents being technologically savvy, but not as compliant as adults with following advice. Conversely, adult patients were considered more compliant than adolescents with following advice, but found the insulin pump to be more technologically challenging.
Issues identified
-
The current co-payment may be too expensive for many families receiving Family Tax Benefit Part A to afford and it may be less expensive to access an insulin pump through private health insurance.
-
The Programme generally supplies insulin pumps that are available on the Prostheses List. This List is primarily used for private health insurance purposes and does not consider the requirements of the Programme. Benefit amounts are not determined by cost-effectiveness and may not be appropriate for a Government-subsidised scheme.
Dostları ilə paylaş: |
