Diabetes technology access: Is Australia falling behind?

MedTech & Diagnostics News: The Australian Diabetes Alliance, comprising leading organisations such as Diabetes Australia, Australian Diabetes Educators Association, Australian Diabetes Society, and JDRF Australia among others, has made a comprehensive submission to the Health Technology Assessment (HTA) Review consultation. The Alliance seeks to address key areas of improvement in Australia’s healthcare system, particularly regarding access to diabetes technology and medicines.

The submission is particularly timely as the alarming rise of diabetes cases and its severe consequences on the healthcare system and economy, has led to launch of the new diabetes inquiry by the Standing Committee on Health, Aged Care and Sport.

The Australian Diabetes Alliance acknowledged recent advancements, such as the expanded access to CGM and Flash Monitoring subsidies for all people with type 1 diabetes. Innovative technologies like the Medtronic 780G insulin pump, the Dexcom G6 CGM system, and the Omnipod DASH patch pump have been included on the NDSS. These technological breakthroughs have improved diabetes self-management, reduced hospitalisations stemming from complications, and significantly enhanced mental and emotional wellbeing.

However, the Alliance emphasised several areas requiring improvement in the HTA process. Firstly, there is a pressing need for more flexibility in assessing evolving health technologies that do not conform to existing criteria. The emergence of interoperable insulin pump and CGM systems, smart insulin pens, and bionic pancreases, which offer substantial physical and mental health benefits, demands an agile and adaptable assessment process. Current policy frameworks struggle to accommodate these ground-breaking technologies that transcend traditional categories.

One such novel technology is the FDA-approved iLet ACE insulin pump, utilising adaptive closed-loop algorithms to calculate insulin needs – a potential game-changer for type 1 diabetes management. Despite its transformative potential, the absence of an approval pathway in Australia hinders its availability to those in need. Similarly, the Omnipod Dash system, designed to simplify insulin delivery, faced significant delays locally due to its deviation from conventional pump models despite gaining FDA approval back in 2005.

To expedite access to life-changing technologies, the Alliance proposed greater weighting of international approvals from reputable agencies such as the FDA, EMA, and MHRA. Aligning with established assessments conducted by these agencies would streamline the introduction of updated or advanced models into the Australian market, benefiting patients and reducing unnecessary delays.

Equitable access remains a top priority for the Alliance, particularly in the context of insulin pumps. Currently, two pathways exist for accessing subsidised pumps: the Federal Government’s Insulin Pump Program, administered by JDRF Australia, for eligible individuals under 21 years of age. This means only around 1.4% of children and young people can access insulin pumps via this pathway.

The other access pathway is through private health insurance coverage. Pumps must be included on the Prostheses List (PL) which sets out the minimum requirements for private health insurance coverage of certain medical devices including insulin pumps. The eligibility requirements of the PL are not flexible enough to respond to novel and emerging technologies. Moreover, the requirement for insulin pumps to be offered exclusively under premium health insurance plans exacerbates the health inequality, excluding those on basic plans.

Around 80% of all pumps in Australia are provided to people with private health insurance. Australians without private insurance do not have affordable access to insulin pumps. Due to cost and poor access, only 14,990 Australians with type 1 diabetes, or 12% of people living with type 1, have access to insulin pump therapy. This compares poorly to the US which has twice the level of access, estimated at 25%.

Diabetes Australia is also advocating for the expansion of access to CGM and Flash Monitoring technology to people living with type 2 diabetes who use multiple daily injections of insulin to manage the condition.

Up to 50% of people living with diabetes experience mental health challenges annually. This is why the Australian Diabetes Alliance believes assessment of diabetes technology and medicines should consider the quality of life and mental and emotional health benefits of new therapies. This could include Patient Reported Outcomes, international experiential reviews, quality of life measures, and other data to ensure the HTA process remains person-centred.

Additionally, Time in Range (TIR) is fast emerging as a more accurate indicator of improved long-term outcomes in comparison to HbA1c check. The more time spent in range, the lower the risk of diabetes-related complications.

“As improvements in clinical criteria evolve, our assessment and approval systems need to be flexible enough to incorporate them,” stressed the Australian Diabetes Alliance in its submission.

By improving flexibility in the HTA processes and ensuring affordability for individuals, the Alliance aims to enhance the quality and equity of diabetes care, and reduce the burden of this chronic condition.

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