5. Diabetes technologies

Overview

5.1Owing to advancements in medical and digital health technologies, the treatment of diabetes has changed substantially over the past two decades.[1] The development of new medical devices in particular has had a transformative effect on diabetes management. The introduction of continuous glucose monitors (CGM) has allowed for real-time reading of the blood glucose levels on a continual basis – a significant improvement compared to periodical readings obtained by drawing blood from a finger.

5.2Equally significant has been the shift away from the use of needles and syringes for the administration of insulin, which has been enabled by products such as the insulin pump. The integration of CGMs and insulin pumps through applications that allow for these two devices to share user’s data has allowed for the almost fully-automated management of diabetes – a major advancement that has been hailed as the gold standard for diabetes management.

5.3The inquiry received substantial evidence regarding the many promising technologies that have been and are being developed for the prevention and diagnosis of diabetes. The ensuing discussion focuses specifically on the new methods for monitoring glucose levels, including the use of CGMs and their integration with insulin pumps. Evidence regarding the advantages and challenges presented by new diabetes treatment technologies is also considered, along with the issue of patient access to and the current framework for the assessment and reimbursement of new diabetes technologies.

Glucose monitoring methods

5.4Controlling blood glucose levels is the principal goal of diabetes treatment. Maintaining levels in a target range helps to reduce the risk of adverse health events, and prevent complications of the disease.

5.5Traditionally, glucose levels were monitored using urine samples, with the first commercial urine glucose tests becoming available at the beginning of the 20th century.[2] The first blood glucose tests were developed in the mid-1960s, and during the 1980s the self-monitoring of blood glucose (SMBG) method, which involves taking regular finger-prick blood samples, became the standard of care.[3]

5.6SMGB continued to improve throughout the 1980s, 1990s and early 2000s. Patients with diabetes used test strips and portable meters to obtain a reading of their glucose levels; daily injections of insulin would be then manually administered based on the patient’s reading of glucose from the blood sample.

5.7In its submission to the inquiry, the Medical Technology Association of Australia (MTAA) suggested that the SMBG method ‘whilst safe and effective and still widely employed today, came with significant disadvantages, including routine pain and discomfort for patients.’[4] As a consequence, patients might avoid the test, which limits the usefulness of this treatment.

5.8Multiple submissions to the inquiry have highlighted the fact that these manual monitors provide only a snapshot of blood glucose levels at a particular moment in time, and thus tend to miss any fluctuations that might occur throughout the day.

5.9In addition to SMBG being ineffective at providing comprehensive information about the glucose levels, the method of administering insulin with a needle and syringe or insulin pen had its own drawbacks. MTAA highlighted that while effective, ‘insulin pens and injections, as tools of treatment, present significant challenges for diabetes care.’[5]Administering multiple injections during the day presents difficulty for many patients. Furthermore, ‘the use of syringes is associated with poor dose accuracy, a long training period, unpleasant psychological impact, and difficulties in conveyance.’[6] The challenges with these traditional methods of both monitoring glucose levels and administering insulin often results in non-adherence, and as a consequence, poor glycaemic control.

New diabetes technologies

5.10The most significant advancement in diabetes technology in recent years has been the development of the hybrid closed loop (HCL) system, also referred to as the automated insulin delivery (AID) or an artificial pancreas. The HCL consists of three main components: a CGM, an insulin pump, and an algorithm that uses data from the monitor and the pump to automatically adjust the amount of insulin delivered.

Continuous glucose monitoring

5.11A CGM is a device that provides real time, continuous data about an individual's glucose levels throughout the day and night. CGM systems consist of a small, flexible sensor, a transmitter, and a monitoring device. The sensor, which is inserted just beneath the skin, continuously measures glucose levels in the interstitial fluid, which is found in the space surrounding the body cells.[7]

5.12This system provides detailed data about a person’s glucose levels, with a more accurate and a more dynamic understanding of blood glucose fluctuations than the finger-prick method. In appearing before the Committee, Dr Sarah Price, Director of Obstetric Medicine at the Royal Women’s Hospital, Melbourne, commented that ‘[t]he technology in terms of diabetes has absolutely revolutionised care,’[8] and highlighted its advantages for her patients:

…at the moment they do four finger stick tests a day, and really that's four points in time. If you have continuous glucose monitoring you get 288 points per day, so you know where you are in time.[9]

5.13In its submission to the inquiry, CGM manufacturer Dexcom explained that the access to this real-time glucose data enables users to make timely adjustments to insulin dosing, dietary choices, and physical activity, which helps them to better control their glucose levels and keep them within the target range.[10]

5.14The Committee received numerous submissions from patients with diabetes describing the impact of CGMs as being life changing. In presenting evidence before the Committee, Ms Jessica Hart, who lives with Type 1 diabetes, described her experience with CGM:

With the CGMs, you have visibility. Prior to that manual testing, you get a number and five minutes later it could have changed, but you don't know. When you eat a particular food or have something to drink, you can see what is happening and the effect it is having. So you go from that and then try and navigate that the next time you have that same intake.[11]

5.15Mr Omar Alim, who was diagnosed with Type 2 diabetes 15 years ago and has been reliant on insulin to manage his condition, described the introduction of CGM into his diabetes management routine as ‘a game-changer,’ and explained that:

With its real-time glucose monitoring and almost real-time feedback capabilities, I am now able to effectively monitor and adjust my diet and insulin dosages which enabled me to achieve normal blood sugar levels, something I struggled to accomplish before the use of my CGM.[12]

5.16In addition to providing real-time awareness of blood glucose levels, CGM is also less invasive than traditional forms of monitoring. In generating critical trend data, the system can also produce alerts and alarms in case of emergency. Furthermore, the ability to share CGM data allows health care providers to remotely monitor patients and provide targeted guidance on changes in treatment methods.[13]

5.17The ability to share this data is also invaluable for family members of diabetes patients. Professor Daryl Higgins, who lives with Type 1 diabetes, explained the advantages of data-sharing:

Previously, I’ve had instances of having a hypo where I was unaware, and not responding to my phone (which was on silent as I had been in meetings). My partner was left worried as he didn’t know whether my BGLs [blood glucose levels] were OK or not, and whether or not he needed to do something.

Now, he can easily check my BGLs in real time, know whether they are rising or falling, and knows whether he needs to do anything to support me or not.[14]

5.18Dexcom submitted that this feature has been transformative in paediatric diabetes management, as it helps parents and caregivers monitor children's glucose levels more effectively.[15]

5.19The use of CGMs has also shown to have a positive effect on patient behaviour, by helping patients to adopt habits that improve their health outcomes.[16] The ability to see the immediate impact of their diet or physical activities helps them to understand and calibrate their behaviour to better manage their glucose levels.

Insulin pump therapy

5.20Patients with insulin-dependent diabetes can currently use several different methods to administer insulin: multiple daily injections (MDI); continuous subcutaneous insulin infusion (CSII) or insulin pump therapy; or a sensor-augmented pump (SAP) that includes a pump and a CGM sensor that wirelessly transmits glucose readings to a receiver or to the pump (or HCL).[17]

5.21The common approach to administering insulin includes MDI, usually using needle and syringe. Insulin pens – which are an injection device that patients use to deliver preloaded insulin into their subcutaneous tissue (the innermost layer of skin) – are a type of MDI. These devices look like writing pens, with a single-use needle at their point and an insulin reservoir. Also available are ‘smart’ insulin pens, which can track and share insulin dosing data to enable more accurate dosages.[18]

5.22The CSII method – or insulin pump – is a small, portable, programmable, battery-powered pump used to infuse insulin subcutaneously via a specifically designed fine tube (cannula) inserted into the body. Insulin is stored in a reservoir contained within the pump. The infusion rates are accurately controlled by the pump, and can be adjusted with a slow baseline rate administered around the clock, and supplementary boosts (bolus shots) given at, or shortly before, mealtimes. The pump thus mimics the natural multi-rate insulin delivery of a healthy pancreas.[19]

5.23The information used by insulin pumps is obtained either through traditional finger-prick readings or, more commonly, through being integrated with CGM as part of the HCL system. When used with CGM, insulin pumps can both deliver insulin when blood glucose levels are above the target range, and withhold insulin when levels are trending down towards low blood glucose levels.[20] This method allows the patient to maintain good metabolic control automatically, or with little manual intervention.

5.24Glucose self-management is a complex process whereby, according to Diabetes Australia, patients make more than 180 diabetes-related decisions per day.[21] The new technology significantly reduces this burden of care and decision making.[22] As such, HCL systems are considered to be the optimal form of care for patients with insulin-dependent diabetes.[23]

Telehealth

5.25The introduction of new technologies in diabetes management has allowed for remote monitoring of patient data, and by extension, greater opportunities for the use of remote health-related services, which is often referred to as telehealth. Evidence received throughout the inquiry highlighted the increasingly important role of telehealth in diabetes management.[24] This form of care provision helps with onboarding new patients, monitoring existing patients, and improving accessibility to services. As the MTAA submitted, ‘modern remote monitoring tools can help track blood glucose levels, dietary intake, and physical activity, providing healthcare professionals with comprehensive data to personalise treatment plans.’[25]

The use of continuous glucose monitors

5.26A substantial amount of evidence gathered during the inquiry related to different contexts in which CGMs and HCL systems are used.

5.27As is the case internationally, in Australia HCL systems are considered to be the optimal method of care for patients with Type 1 diabetes. In aiming to provide this level of care, the Australian Government subsidises CGMs for all patients with Type 1 diabetes. In addition, a portion of patients within this group are also eligible for an insulin pump.[26]

5.28The Committee heard that HCL systems represented the optimal form of care not only for patients with Type 1 diabetes, but for all insulin-dependent diabetes patients. Mr Samy Saad, Senior Director of Commercial Operations at Dexcom, submitted that ‘a person with type 2 diabetes needing injections of insulin has similar medical needs and requirements for access to CGM devices as a person with type 1 diabetes.’[27] Regardless of the type, Mr Saad highlighted:

…the consequences of not properly managing diabetes are significant for individuals, the health system, and the economy in terms of morbidity, mortality, quality of life and hospital admissions due to complications as well as productivity losses.[28]

5.29Other groups of patients that require insulin include those suffering from cystic fibrosis. There are approximately 3600 Australians living with this disease, which is a genetic condition that causes severe damage to the lungs, digestive system and other organs in the body, and does not have a cure.[29] Cystic Fibrosis Australia submitted that up to a third of people with cystic fibrosis also suffer from diabetes and require insulin.[30]

5.30Equally dependent on insulin treatment are those patients who have undergone a pancreatectomy – the surgical removal of all or part of the pancreas (most frequently due to tumours or pancreatitis). The burden of care and treatment requirements for these groups of patients are frequently the same as for those living with Type 1 diabetes.[31] Mr Michael Pipe, who lives with Type 3c diabetes, submitted that this condition was particularly difficult to manage: unlike Type 1 diabetes, which is characterised by a total absence of insulin, with Type 3c ‘the pancreases may randomly produce insulin in variable and unpredictable quantities,’ making it harder to maintain a controlled glucose level.[32]

5.31Although the use of CGM and HCL is more readily available for people living with Type 1 diabetes, there is broad consensus among health care professionals and patient groups that this technology would be equally beneficial for all insulin dependent patients.

5.32The benefits of using CGM have been also recognised among patients with non-insulin therapies. In discussing the use of CGMs for women with diabetes during pregnancy, Dr Nisha Khot, Vice President of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, told the Committee that these devices should be available in respect of both Type 1 and Type 2 diabetes, noting that:

From a pregnancy point of view, certainly we know that having better sugar control means better outcomes. So from a pregnancy point of view, absolutely it's important; otherwise, from a lifelong health point of view, it is just as important.[33]

5.33To date the use of CGM to improve glycaemic control in gestational diabetes has only been tested in smaller studies, but there are indications of their beneficial impact on health outcomes in this context as well. As Dr Greg Norman, Director of Health Economics and Outcomes Research at Dexcom, explained:

The evidence does suggest improvements in glycaemic control. I know that physicians, OB-GYNs in the US [United States] do use them more proactively for any patient who is at high risk. […] The American Association of Clinical Endocrinologists guidelines recommend CGM for women with GDM [gestational diabetes] on insulin and may recommend for women who are not on insulin. Their guidelines are pretty progressive in that sense.[34]

5.34CGMs have also been used as biofeedback tools in the context of pre-diabetes. In this situation, a person diagnosed with pre-diabetes uses the device for a specific period of time in order to better understand the impact of (and regulate) dietary and lifestyle choices, and in doing so delay or prevent the onset of diabetes. According to Dr Norman, available testimonials suggest that CGMs can be an effective tool in diabetes prevention:

From a behaviour change perspective, it's almost like you can have these micro interventions; so you're getting that feedback—what happens when I eat this? What happens if I take a walk after I eat this food? Should I avoid this because my glucose is already running a bit high? It's not randomised evidence, but there are indications that people are using this for behaviour change.[35]

5.35Professor Robyn Langham, Chief Medical Adviser within Health Products Regulation at the Department of Health and Aged Care, noted, however, that CGMs in Australia are indicated for patients with Type 1 diabetes and patients with Type 2 diabetes who require insulin, explaining further that:

Their utility is really just in those patients who use insulin. For patients with type 2 diabetes who are not necessarily on insulin but take medications in oral form, there's not a lot of evidence that sort of technology helps with their diabetes control.[36]

5.36As part of the inquiry, the Committee also investigated whether there were significant differences between different brands of CGMs currently available in Australia. Reflecting on this question, Dr Shanal Kumar, endocrinologist at the Prince Charles and Princess Alexandra Hospitals in Brisbane, explained:

There are differences in accuracy. There are differences in warm-up times, so how long they take to start working. There are differences in compatibility, so what other diabetes technology they link up to. Then there is patient preference. I think cost has been the biggest driver that we've seen for preference of one of the types of continuous glucose monitors that we have available in Australia, despite there being three different ones available at this stage.[37]

Issues with the new technology

5.37Although CGMs and HCL systems have significant advantages over other available methods of diabetes management, the Committee received evidence relating to the potential drawbacks of these technologies.

5.38In its submission, the Department of Health and Aged Care drew attention to the fact that CGM systems worked by measuring glucose levels in the interstitial fluid, which could lag behind levels present in blood.[38] According to Diabetes Australia, CGM readings lag behind blood glucose readings by 5–10 minutes, and as a result devices may require calibration during the day.[39]

5.39User intervention is also required in the context of current HCL systems, which are not fully automated. In their appearance before the Committee, insulin pump manufacturer Ypsomed explained that CGM and the pump are linked via an algorithm, which is on the user’s mobile phone.[40] The algorithm adjusts the insulin dosing, but the patient has to announce meals and prompt the pump via the phone application to deliver the insulin boost. Ypsomed Head of Australian Operations, Mr James Mayjor, explained to the Committee that in their experience the level of technological literacy necessary to manage this process has not been a barrier for users across different age and language groups; the aim for the next generation of products, however, is to be a ‘fully closed loop’ without the need for meal announcements.[41]

5.40The Australian Diabetes Educators Association (ADEA) submitted that it is important to provide formal support for patients so that they can learn how to best use the technology.[42] ADEA suggested that offering five hours of support by a diabetes health professional with training and experience in diabetes technology would optimise the use of these devices. This suite of training would include one visit to an endocrinologist or a Credentialled Diabetes Educator (CDE) to support the initiation of diabetes technology, and up to four additional hours of either in-clinic or out-of-clinic advice on how to interpret and respond to changing blood glucose data. Such training may reduce emergency department presentations, and help people living with diabetes better manage their glucose levels.[43]

5.41Patients living in remote parts Australia face additional challenges in the use and maintenance of these devices. In appearing before the Committee, Dr Kristen Neal, endocrinologist from Alice Springs Hospital, highlighted some practical difficulties that remote patients face:

…it can be quite diabolical to manage pumps in terms of hygiene, having to change the sets every three days, using the technology remotely and often needing to have a mobile phone for the continuous glucose monitor to talk to the pump. Remote patients are gone because they don't have any reception. There are a lot of barriers for type 1 patients in these communities. For type 2 patients, I think the practicalities would be the same in terms of safety and all the paraphernalia that goes with the access to technology.[44]

5.42The Committee also heard about the challenges presented by inconsistent advice regarding the sensitivity of diabetes devices to X-ray machines and body scanners. According to one submitter some manufactures state that these devices should not be scanned to ensure their accuracy is not impacted; meanwhile security screening machines are often categorised as being safe for scanning of medical devices by their manufacturers.[45] The lack of clear guidelines on whether diabetes devices can be scanned has been a source of confusion and frustration for users, often resulting in delays and distressing experiences at security check points.

5.43Finally, the issue of trust in technology can also be a significant barrier to the take-up of new diabetes devices. Ypsomed submitted that their market research suggested that some patients are reluctant to go onto insulin pump therapy as they ‘don’t trust a device to deliver their insulin.’[46] In addition, some patients simply do not like the notion of ‘being attached to a device.’[47] In reflecting on her experience with using an insulin pump, Ms Jessica Hart told the Committee about her initial reservations:

It took me quite a long time to decide to move to pump therapy because of the prosthetic attachment. To be honest, I am glad that I did. It is now a way of life. I certainly believe that, for me in particular, there is a lot of body shaming around having a device attached to your body and the changes that your body goes through when you are diagnosed.[48]

5.44The Committee heard from many submitters and witnesses who indicated that their experience using new technologies has been positive, and that health professionals, patient groups, and manufacturers support greater access to these devices.

5.45These innovations in diabetes management are foreshadowing the future of personalised approach to health care.[49] By integrating scientific and clinical data and applying this information to individual patient profiles, these new technologies are able to optimise the diagnosis, prediction, prevention and treatment of diabetes. The control of diabetes that uses personalised devises, artificial intelligence, and allows for remote monitoring by clinician, as MTAA further highlighted, provides ‘a window into the future of personalised management and prevention for all chronic disease.’[50]

Access to new technology

5.46In Australia there are five key pathways that enable patient access to medication and other technologies for the treatment of diabetes:

• Pharmaceutical Benefits Scheme (PBS)
• National Diabetes Service Scheme (NDSS)
• Insulin Pump Program (IPP)
• Prescribed List for Medical Devices and Human Tissue Products (formerly known as the Prosthesis List)
• Self-funded Care.[51]
  47. The Australian Government provides support to people with diabetes through the PBS, the NDSS, the IPP and Medicare.[52]
  48. Essential medicines such as insulin are subsidised under the PBS; furthermore, a range of medicines currently listed on the PBS may be used in the management of diabetes. Some of these are subsidised only where a patient meets certain eligibility criteria, while others are unrestricted.[53]
  49. The NDSS provides subsidised products and support services to people with diabetes. The scheme has been administered by Diabetes Australia since 1987. Subsidies for CGMs and insulin pump consumables are made available to patients who meet the eligibility criteria through the NDSS.[54]
  50. In April 2017, the NDSS began providing subsidised CGM products to children and adolescents under the age of 21 with Type 1 diabetes. In 2019, the scheme was expanded to include women with Type 1 diabetes who are actively planning pregnancy, pregnant, or immediately post-pregnancy; children and young people under 21 years with conditions similar to Type 1 diabetes who require insulin also gained access to this technology.[55] In July 2022, the eligibility criteria for this scheme were further expanded to provide a partial or full subsidy of these products to all registrants with Type 1 diabetes – meaning that this scheme is now available to more than 130,000 Australians.[56]
  51. The Department of Health and Aged Care’s submission noted that the Juvenile Diabetes Research Foundation (JDRF) Australia conducts research on behalf of the Department into the effectiveness of CGM use in the self-management of Type 1 diabetes. This data, the submission stated, ‘indicates funding of CGM for people with Type 1 diabetes in Australia has led to sustained improvements in HbA1c (the amount of blood sugar (glucose) attached to a person’s haemoglobin) and a reduction in diabetic ketoacidosis episodes with continued use.’[57]
  52. The IPP, which is administered by the JDRF and funded by the Australian Government, provides means-tested subsidies for patients under the age of 21 with Type 1 diabetes whose family cannot afford or does not have private health insurance.[58] The Department of Health and Aged Care submitted that the program aimed to provide 315 insulin pumps per year to eligible people.[59] Pumps are given with approximately one month initial supply of pump consumables with ongoing consumables accessed via the NDSS for approved persons.[60]
  53. In appearing before the Committee, Ms Adriana Platona, the Department’s First Assistant Secretary for Technology Assessment and Access, explained that multiple suppliers currently provide CGM products for the Department. Last year, the Department announced a new request for tenders for a CGM supplier, and is currently in the process of assessing the tenders received.[61]
  54. In the case of insulin pumps, the Department issued a request for tenders last year, with Ypsomed becoming the sole provider for the IPP.[62] Previously, the Department used exclusively Medtronic products for four years. The Committee queried about the rationale for selecting a single supplier and the issue of the lack of choice for the users. Ms Platona noted that Ypsomed offered a price that allowed the Department to obtain more pumps with its caped budget, and thus support more patients with diabetes. The price, however, was not the sole factor with Ms Platona explaining that the Department also considered access to uninterrupted supply and user acceptability and quality of life, as best as those criteria could be appraised.[63]
  55. Insulin pumps are also available for individuals with private health insurance via the Prescribed List for Medical Devices and Human Tissue Products (formerly known as the Prosthesis List). Ypsomed data suggests that around 83 percent of patients with Type 1 diabetes have private health insurance. Most insurers, according to Ypsomed, allow a member to claim an insulin pump replacement after a set period of time, which is not fixed or regulated; currently the interval is commonly between four and five years.[64]
  56. In addition to the devices themselves, software applications are a critical part of CGMs and HCL systems. There is currently no routine reimbursement for digital health applications in Australia.[65]
  57. It is therefore the case that CGMs are currently available for all Type 1 diabetes patients in Australia and pumps to a small subset of these patients who are either eligible for the IPP, or who have gold tier private health insurance.[66] For most people living with diabetes, however, there are significant barriers to accessing new technologies designed to assist in the management of this disease.
  58. In noting that current pathways to accessing new technologies are fragmented and inequitable, MTAA highlighted the ‘unique limitations which combine to restrict access to innovations in treatment options for Australians living with diabetes.’[67] MTAA further expressed concern that none of the pathways provide comprehensive diagnostic, treatment, or management options to Australians living with diabetes.
  59. In examining the current prices of new diabetes technologies, the Committee learned that the cost of CGM is currently approximately $330 per month, and that the out-of-pocket cost of an insulin pump is between $6,000 and $10,000 every four years.[68]
  60. In support of the inquiry, the Parliamentary Budget Office (PBO) undertook cost modelling of insulin pump subsidies for all Australians living with Type 1 diabetes. The following six options were considered:
• Option 1: Fully subsidise Medtronic, AMSL Tandem, YpsoPump and Omnipod DASH insulin pumps for all Australians living with type 1 diabetes.
• Option 2: Partially subsidise (50 per cent) Medtronic, AMSL Tandem, YpsoPump and Omnipod DASH insulin pumps for all Australians living with type 1 diabetes.
• Option 3: Fully subsidise the Medtronic insulin pump only for all Australians living with type 1 diabetes.
• Option 4: Fully subsidise the AMSL Tandem insulin pump only for all Australians living with type 1 diabetes.
• Option 5: Fully subsidise the Ypsomed insulin pump only for all Australians living with type 1 diabetes.
• Option 6: Fully subsidise the Omnipod DASH insulin pump only for all Australians living with type 1 diabetes.[69]
  61. In submitting its analysis, PBO noted that the demand for insulin pumps and the departmental impacts were the same under all options. The only variance between the options was the price of the pumps. For Options 1 and 2, the price is the average of the four pumps while the remaining four options use the price of the specified pump.[70]
  62. The PBO advised that the introduction of:

The options in the proposal would be expected to decrease the fiscal and underlying cash balances by between around $348 million (Option 2) and $749 million (Option 6), over the 2023-24 Budget forward estimates period.[71]

5.63Private Healthcare Australia (PHA), private health industry’s peak representative body, provided the Committee with additional information regarding the current cost of insulin pumps. The price for insulin pumps is set by the government through its prescribed list for medical devices. When the pumps were originally added to the list, they were new to the market. Since then, their price has decreased, but this is not reflected on the government prescribed list as pricing changes require a lengthy review process. As Mr Ben Harris, PHA Director of Policy and Research, noted:

…our system has a set and forget. So the market price was $8,000 when [the insulin pumps] were put on. The market price is now 4½ and they're still $8,000.[72]

5.64Although private health insurers are one of the largest collective buyers of these devices, they are unable to obtain globally competitive rates due to the protected pricing system maintained by the prescribed list.[73] According to PHA, one of the most common pumps in Australia costs Australians $8,574 while the same devise costs NZ$4,500 for people in New Zealand.[74]

5.65There is a general consensus among medical professionals and patient groups that all insulin dependent patients, regardless of diabetes type, should have access to subsidised new technologies. Dr Ashim Kumar Sinha, Director of Diabetes and Endocrinology at Cairns Hospital and Health Service District emphasised that access to technology should be based on patient’s clinical need, rather than the type of diabetes they have:

I think the availability of continuous glucose monitoring should be patient centred and focused and not diabetes focused. Whether they have type 1 or type 2 diabetes, we have complex patients with type 2 diabetes who have multiple complications and are on complex medical treatment, including multidose insulin therapy as well as many other medications, which requires continuous monitoring at least over a period of time.[75]

5.66Dr Sinha further noted that to mitigate the cost of this technology for patients who do not have access to subsidies, CGMs were used sporadically at critical points in care management:

We're not using it continuously for type 2. We say to use it for a short period, then once you are stabilised, come off it and use finger prick. If we make any major change to your treatment, use it for that period. They simply can't afford to use it for a longer period, but they can probably afford that $100 or $200.[76]

5.67The Committee received a substantial number of submissions from Australians living with insulin dependent diabetes who rely on CGMs, but often struggle to meet the costs of the technology as they are not eligible for subsidies.

5.68Mr Thomas Francis, electrical engineer and pancreatic cancer survivor, explained in his submission that since his pancreatomy he has relied on his CGM to help him manage his condition, enabling him to ‘focus on challenges at work without being anxious about hypoglycaemia.’[77] Although suffering complex clinical needs since the complete removal of his pancreas, he is not eligible for NDSS subsidies as the scheme does not recognise Type 3c diabetes. As such, Mr Francis faces a significant financial burden in securing access to this critical piece of technology.

5.69In Australia, approximately 25 per cent of people with Type 2 diabetes are insulin dependent.[78] This cohort is similarly not eligible for the CGM subsidy, and as a consequence a number of these patients only use the devices sporadically. In sharing his experience as an insulin-dependent Type 2 diabetes patient, Dr David Rose explained:

I can achieve satisfactory monitoring with frequent finger pricks but even better and more continuous monitoring is available from skin patches measuring interstitial fluid glucose levels. Such patches are expensive and are not subsidised for type 2 diabetes, so that I use them only on special occasions such as on extended bushwalks.[79]

5.70The Committee received an overwhelming body of evidence pointing to the significant benefits and increase in quality of life among non insulin-dependent diabetes patients who use CGM. Ms Susan Lloyd, for example, submitted that since being diagnosed with Type 2 diabetes in 2021 she has been unsuccessful in managing the disease through diet and lifestyle changes. She has found that CGM has enabled her to better manage her condition than the use of regular finger prick, but noted that the technology was not affordable on an ongoing basis without a subsidy.[80]

5.71The need for greater access to both CGMs and insulin pump technology has also been raised in the context of managing diabetes in pregnancy. As Dr Price from the Royal Women’s Hospital, Melbourne, explained:

Our key recommendations for providing diabetes management in pregnancy would include consideration of subsidised access to insulin pumps for women with type 1 diabetes who are pregnant or planning pregnancy. This will allow women to use closed loop in pregnancy, which has been shown to improve glycaemic control and reduce diabetes distress. Secondly, consideration of subsidised access to CGM for women with type 2 diabetes. These women have similar pregnancy outcomes to women with type 1 diabetes, but they're more likely to come from minority groups, women who don't speak English or women with mental illness or who are affected by drug and alcohol dependence. This tool will allow them to improve glycaemic control.[81]

5.72Many submissions provided to the Committee argued that access to the new diabetes technologies should be based on patient’s clinical needs, echoing Dr Sinha’s maxim: ‘treat the patient, not the type of diabetes.’[82]

Assessment process for new technologies

5.73As part of the inquiry, the Committee heard evidence regarding the impact that assessment and reimbursement processes have on patient access to new diabetes technologies. The Australian Government regulates the use and supply of medical devices, along with medicines, biologicals (goods that contain or are derived from human cells or tissues), and other therapeutic goods. Under the Therapeutic Goods Act 1989 (Cth), this regulatory responsibility rests with the Secretary of the Department of Health. This responsibility has been delegated to the Department’s Therapeutic Goods Administration (TGA), which ensures that therapeutic goods are safe and fit for purpose.[83]

5.74Reimbursement for the cost of therapeutic goods in Australia occurs through the health technology assessment (HTA) process.[84] The reimbursement programs for medicines include the Pharmaceutical Benefits Scheme, the Repatriation Pharmaceutical Benefits Scheme, and the Life Saving Drugs Program. The Pharmaceutical Benefits Advisory Committee (PBAC) is designated as a relevant body that recommends drugs to the Minister for Health for listing. Reimbursement for the cost of medical devices is provided through the Medicare Benefits Schedule and the NDSS, with the Medical Services Advisory Committee (MSAC) charged with recommending medical devices to the Minister for public reimbursement.[85]

5.75In its submission to the inquiry, the Department of Health and Aged Care highlighted the importance of balancing timely access to technological advances in diabetes management with regulation ‘to ensure the intended use matches available evidence.’[86] The Department further noted:

The TGA aims to achieve this balance by applying an appropriate extent of assessment that is proportionate to the level of risk. This aligns with the TGA’s role to safeguard and enhance the health of the Australian community through the effective and timely regulation of therapeutic goods.[87]

5.76In 2020, the Australian Government designated MSAC as the relevant HTA body to assess diabetes-related products for subsidisation under the NDSS.[88] According to MTAA, this process has proven to be both lengthy – taking up to four years in some cases – and not designed to account for technologies with digitally-enabled components such as CGM systems or digitally-based technologies such as glucose data monitoring, transmitting and disease self-management applications.[89] As Mr Paul Dale, MTAA Director of Policy observed:

It's not like a pharmaceutical life cycle, where you can collect enormous amounts of data and then the product is pretty stable over time. It's a very different way of assessing.[90]

5.77In appearing before the Committee, Ms Platona explained that MSCA first examined CGMs in July 2021 but that the assessment processed was placed on hold once the decision was made to expand the eligibility criteria for the device:

It's hard to do health technology assessments while the eligibility criteria are all expanding at the same time, so MSAC stopped and allowed government to make its decisions and for the program to be expanded. We are hoping that MSAC will recommence its evaluation of both type 1 and type 2 towards the end of this year. We'll have to redo all the evaluation documents and all the evidence gathering.[91]

5.78MSAC is expected to provide advice in 2025.[92]

5.79The MTAA highlighted the fact that the pace of innovation in diabetes ‘has been nothing short of remarkable,’ with this trend likely to continue and even accelerate into the future.[93] Medtronic, a medical technology producer, further noted that the future for innovation in diabetes management will be in the evolution of software and algorithms. Australia’s regulatory and reimbursement frameworks need to be prepared for this evolution, and it would be appropriate to establish suitable evaluation frameworks to ensure these innovations are recognised and included in models of care.[94]

5.80In November 2021, the House of Representatives Standing Committee on Health, Aged Care and Sport published a report entitled The New Frontier – Better Health for All Australians following its inquiry into approval processes for new drugs and novel medical technologies in Australia.[95] This report examined the opportunities to deliver better health care through regulatory and assessment processes for medicines and medical technologies, and highlighted the importance of developing ‘a more flexible system to provide for timely access to the latest medicines, devices and treatment.’[96]

5.81Evidence provided in support of the inquiry into diabetes in Australia echoes many of the issues that were raised during the inquiry into approval processes for new drugs and technologies. In particular, the Committee has heard concerns regarding the assessment complexity and review times. In addition, manufacturers of medical equipment have reiterated the fact that there is presently no parallel assessment process for medical devices: unlike the assessment of medicines, which allows for simultaneous TGA and PBAC review, it is presently not possible for a device to undergo parallel review with both TGA and MSAC. The unsuitability of Australia’s regulatory and reimbursement system, particularly in respect to advanced medicines and technologies, has also been frequently raised.

5.82On 30 November 2023, the Government issued its response to the New Frontier report, agreeing in principle or in part to all of the report recommendations relating to the assessment of medical devices.[97] More details will be available with the completion of current HTA Review, which is due to report in May 2024.

5.83This current inquiry has accordingly not canvassed in detail the issues related to the regulatory and reimbursement system for medicines and new medical technologies.

Committee comment

5.84Diabetes technology has come a long way since the introduction of the first glucose tests and insulin injections. The Committee was encouraged by the overwhelmingly positive patient experience with continuous glucose monitors and insulin pumps, and the prospects of further innovation and technological advancement in this field.

5.85It is evident that the expansion of the CGM subsidy to cover all patients with Type 1 diabetes has produced positive health outcomes for this cohort. Ensuing better access to this technology for all Australians must be a priority. The Committee recognises that all patients with insulin dependent diabetes have similar clinical needs, and should thus be supported regardless of diabetes type.

5.86The Committee recognises that insulin pumps have had a positive impact on the ability of patients to manage their diabetes. The price of these devices in Australia, however, is prohibitive, with only a small cohort of patients currently being able to use insulin pumps.

5.87In providing access to new diabetes technologies, patient preferences should be taken into consideration, and individuals should be able to access the type of technology that best suits their clinical requirements and lifestyle.

5.88The Committee understands that technological literacy is also vital in ensuring that these new devices are used in an optimal manner. Greater support should be given to health professionals and patients to familiarise themselves with the technologies that are available, and their inherent features.

5.89The Committee recommends that subsidised access to Continuous Glucose Monitors (CGMs) be further expanded. In the first instance, all access limitations in relation to patients with Type 1 diabetes should be removed. Furthermore, individuals with insulin-dependent Type 3c diabetes and patients with gestational diabetes should be made eligible for subsidised CGMs and for those with Type 2 diabetes requiring regular insulin. The Committee recommends prioritising the removal of age limitations on access to subsidised access for Type 1 diabetes patients.

5.90The Committee acknowledges that patients living with Type 3c diabetes should be prioritised in the eligibility expansion due to equal and at times even more complex needs than Type 1 diabetes patients.

5.91The priority should also be given to patients with gestational diabetes due to risks that the condition presents to both the mother and the child.

5.92The eligibility expansion should subsequently continue to gradually encompass all Australians with insulin-dependent diabetes.

5.93The first priority should be to ensure that people with Type 1 diabetes with current subsidised access to CGMs are not disadvantaged when they turn 21 due to reduction of subsidies.

5.94The Australian Government should explore expanding subsidised access to insulin pumps for all Australians with Type 1 diabetes. A gradual increase, such as expanding access to those aged 40 and under, would be useful as an initial step.

5.95Insulin pumps are vital for the optimal management of diabetes. Australians should have equitable access to these devices.

5.96The Committee recommends that the Australian Government undertakes a review of the price and choice of insulin pumps in Australia.

5.97The Committee acknowledges concerns related to the price of insulin pumps in Australia, including in comparison to peer countries. The review of current prices is necessary to ensuring greater access to this vital technology.

Footnotes

[1]See, for example: Department of Health and Aged Care, Submission 152; Medical Technology Association of Australia (MTAA), Submission 426.

[2]IB Hirsch, ‘Introduction: History of Glucose Monitoring,’ in Role of Continuous Glucose Monitoring in Diabetes Treatment, American Diabetes Association, Arlington, 2018, p. 1.

[3]Hirsch, ‘Introduction: History of Glucose Monitoring,’ p. 1.

[4]MTAA, Submission 426, p. 4.

[5]MTAA, Submission 426, p. 6.

[6]MTAA, Submission 426, p. 6.

[7]Dexcom, Submission 375, n.p.

[8]Dr Sarah Price, Director of Obstetric Medicine, Royal Women’s Hospital, Committee Hansard, Melbourne, 23 November 2023, p. 8.

[9]Dr Price, Royal Women’s Hospital, Committee Hansard, Melbourne, 23November 2023, p. 9.

[10]Dexcom, Submission 375, n.p.

[11]Ms Jessica Hart, Private capacity, Committee Hansard, Canberra, 1 March 2024, p. 8.

[12]Omar Alim, Submission 134.

[13]MTAA, Submission 426, p. 4.

[14]Professor Daryl Higgins, Submission 120.

[15]Dexcom, Submission 375, n.p.

[16]Dr Greg Norman, Director, Health Economics and Outcomes Research, Dexcom/Australasian Medical and Scientific Limited, Committee Hansard, Canberra, 22 March 2024, p. 22.

[17]Medtronic, Submission 397, p. 6.

[18]MTAA, Submission 426, p. 6.

[19]Medtronic, Submission 397, p. 6.

[20]Medtronic, Submission 397, pp. 6–7.

[21]Diabetes Australia, Submission 248, p. 20.

[22]See Hon Emily Suvaal MLC, Submission 472.

[23]MTAA, Submission 426, p. 14.

[24]Department of Health and Aged Care, Submission 152, p. 24; MTAA, Submission 426, p. 8.

[25]MTAA, Submission 426, p. 8.

[26]Department of Health and Aged Care, Submission 152, pp. 18–19.

[27]Mr Samy Saad, Senior Director, Commercial Operations, Australia and New Zealand, Dexcom/Australasian Medical & Scientific Limited, Committee Hansard, Canberra, 22 March 2024, p. 17.

[28]Mr Saad, Dexcom/Australasian Medical & Scientific Limited, Committee Hansard, Canberra, 22 March 2024, p. 17.

[29]Cystic Fibrosis Australia, Submission 71.

[30]Cystic Fibrosis Australia, Submission 71. See also: Dr Shanal Kumar, Submission 74.

[31]Adult Cystic Fibrosis Centre, TPCH Brisbane, Submission 145.

[32]Mr Michael Pipe, Submission 142, p. 1.

[33]Dr Nisha Khot, Vice President, Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Committee Hansard, Melbourne, 23 November 2023, p. 31.

[34]Dr Norman, Dexcom/Australasian Medical and Scientific Limited, Committee Hansard, Canberra, 22 March 2024, p. 22.

[35]Dr Norman, Dexcom/Australasian Medical and Scientific Limited, Committee Hansard, Canberra, 22 March 2024, p. 22.

[36]Professor Robyn Langham, Chief Medical Adviser, Health Products Regulation, Department of Health and Aged Care, Committee Hansard, Canberra, 1 March 2024, p. 16.

[37]Dr Shanal Kumar, Private capacity, Committee Hansard, Brisbane, 20 November 2023, p. 39.

[38]Department of Health and Aged Care, Submission 152, p. 9.

[39]Diabetes Australia, Blood glucose monitoring, accessed 4 June 2024, www.diabetesaustralia.com.au/managing-diabetes/blood-glucose-monitoring/

[40]Mr James Mayjor, Head of Australian Operations, Ypsomed, Committee Hansard, Canberra, 17 November 2023, p. 35.

[41]Mr Mayjor, Ypsomed, Committee Hansard, Canberra, 17 November 2023, pp. 35–36.

[42]Australian Diabetes Educators Association (ADEA), Submission 221, p. 5

[43]ADEA, Submission 221, p. 5.

[44]Dr Kristen Neal, Endocrinologist, Alice Springs Hospital, Committee Hansard, Alice Springs, 6 March 2024, p. 34.

[45]Jessica Hart, Submission 466, n.p.

[46]Mr Mayjor, Ypsomed, Committee Hansard, Canberra, 17 November 2023, p. 35.

[47]Mr Mayjor, Ypsomed, Committee Hansard, Canberra, 17 November 2023, p. 35.

[48]Ms Hart, Committee Hansard, Canberra, 1 March 2024, p. 5.

[49]Department of Health and Aged Care, Submission 152, p. 9.

[50]Mr Paul Dale, Director, Policy, Medical Technology Association of Australia (MTAA), Committee Hansard, Canberra, 22 March 2024, p. 44.

[51]MTAA, Submission 426, p. 13.

[52]Department of Health and Aged Care, Submission 152, p. 3.

[53]Department of Health and Aged Care, Submission 152, p. 17.

[54]Department of Health and Aged Care, Submission 152, p. 17.

[55]Dexcom, Submission 375, n.p.

[56]Department of Health and Aged Care, Submission 152, p. 18.

[57]Department of Health and Aged Care, Submission 152, p. 19.

[58]Department of Health and Aged Care, Submission 152, p. 19. See also: Ypsomed, Submission 416, p. 5.

[59]Department of Health and Aged Care, Submission 152, p. 19.

[60]Ypsomed, Submission 416, p. 5.

[61]Ms Adriana Platona, First Assistant Secretary, Technology Assessment and Access, Department of Health and Aged Care, Committee Hansard, Canberra, 1 March 2024, p. 18.

[62]Ms Platona, Department of Health and Aged Care, Committee Hansard, Canberra, 1 March 2024, p. 18.

[63]Ms Platona, Department of Health and Aged Care, Committee Hansard, Canberra, 1 March 2024, pp. 18–19.

[64]Ypsomed, Submission 416, pp. 5–6.

[65]MTAA, Submission 426, p. 15.

[66]Department of Health and Aged Care, Submission 152, pp. 18–19; MTAA, Submission 426, p. 14.

[67]MTAA, Submission 426, p. 13.

[68]Mr Saad, Dexcom/Australasian Medical & Scientific Limited, Committee Hansard, Canberra, 22 March 2024, p. 19; Ypsomed, Submission416, p. 6.

[69]Parliamentary Budget Office (PBO) costings, Appendix F, p. 1.

[70]Parliamentary Budget Office (PBO) costings, Appendix F, p. 2.

[71]Parliamentary Budget Office (PBO) costings, Appendix F, p. 2.

[72]Mr Ben Harris, Director, Policy and Research, Private Health Australia (PHA), Committee Hansard, Canberra, 16February 2024, p. 5.

[73]Mr Harris, PHA, Committee Hansard, Canberra, 16February 2024, p. 2.

[74]Mr Harris, PHA, Committee Hansard, Canberra, 16February 2024, p. 2.

[75]Dr Ashim Kumar Sinha, Director of Diabetes and Endocrinology, Cairns Hospital and Health Service District, Committee Hansard, Cairns, 22 November 2023, p. 1.

[76]Dr Sinha, Cairns Hospital and Health Service District, Committee Hansard, Cairns, 22 November 2023, p. 7.

[77]Mr Thomas Francis, Submission 4.

[78]National Diabetes Support Service (NDSS), Diabetes Data Snapshots, accessed 4 June 2024, www.ndss.com.au/about-diabetes/diabetes-facts-and-figures/diabetes-data-snapshots/

[79]Dr David Rose, Submission 20.

[80]Ms Susan Lloyd, Submission 12.

[81]Dr Price, Royal Women’s Hospital, Committee Hansard, Melbourne, 23November 2023, p. 7.

[82]Dr Sinha, Cairns Hospital and Health Service District, Committee Hansard, Cairns, 22 November 2023, p. 7.

[83]House of Representatives Standing Committee on Health, Aged Care and Sport, The New Frontier – Delivering better health for all Australians, Inquiry into approval processes for new drugs and novel medical technologies in Australia, November 2021, pp. 12–13.

[84]House of Representatives Standing Committee on Health, Aged Care and Sport, The New Frontier, p. 23.

[85]House of Representatives Standing Committee on Health, Aged Care and Sport, The New Frontier, pp. 22–29.

[86]Department of Health and Aged Care, Submission 152, p. 9.

[87]Department of Health and Aged Care, Submission 152, p. 9.

[88]MTAA, Submission 426, p. 14.

[89]MTAA, Submission 426, p. 14.

[90]Mr Dale, MTAA, Committee Hansard, Canberra, 22 March 2024, p. 47.

[91]Ms Platona, Department of Health and Aged Care, Committee Hansard, Canberra, 1 March 2024, p. 17.

[92]Ms Platona, Department of Health and Aged Care, Committee Hansard, Canberra, 1 March 2024, p. 17.

[93]MTAA, Submission 426, p. 1.

[94]Medtronic, Submission 397, p. 3.

[95]House of Representatives Standing Committee on Health, Aged Care and Sport, The New Frontier.

[96]House of Representatives Standing Committee on Health, Aged Care and Sport, The New Frontier, p. iv.

[97]Australian Government response to the Standing Committee on Health, Aged Care and Sport report The New Frontier – Delivering better health for all Australians, Inquiry into approval processes for new drugs and novel medical technologies in Australia, November 2023.