- Medications and other interventions for diabetes and obesity
- Pharmacotherapy – treatment through the use of pharmaceutical products as medication – is a critical component of diabetes treatment for a significant portion of patients.
- Since its discovery more than a century ago, insulin has been the principal medication for treatment of insulin-dependent forms of diabetes. Today there are also a range of medications used in the treatment of both insulin-dependent and non-dependent patients. In recent years, however, there have been major advancements in diabetes medicines with the introduction of Glucagon-like Peptide-1 receptor agonists (GLP-1 RAs). In examining the current state of diabetes pharmacotherapy, the ensuing discussion places particular focus on GLP-1 receptor agonists, examining their function, suitability for treatment of both diabetes and obesity in different cohorts, and their availability.
- In considering additional procedures for the treatment of diabetes and obesity, the final sections also discuss the use of bariatric surgery. Acknowledged by medical professionals, health experts and patient groups as one of the most effective methods for managing obesity and obesity-related conditions such as diabetes, the following discussion considers current barriers to access to this treatment, as well as its compatibility with the new generation of diabetes and obesity medications.
Insulin
6.4The discovery of insulin in 1921 enabled the first meaningful treatment of diabetes. A meeting between Canadian physician Frederick Banting and Scottish biochemist John Macleod at the University of Toronto in late 1920 set this process of discovery in motion. With the help of undergraduate student Charles Best, Banting and Macleod made considerable progress with their experiments in isolating and administering insulin to dogs.
6.5Biochemist James Collip subsequently improved the methods for extracting and purifying insulin, and the first human patient with diabetes, 14-year-old Leonard Thomson, was treated in January 1922. By March the Canadian Medical Association Journal reported on the effect of insulin in several patients. Soon after, pharmaceutical companies Eli Lilly (Indianapolis, Indiana, United States (US)) and Nordisk (Bagsværd, Denmark) commercialised the production of insulin.
6.6The discovery of insulin saw Bantin and Macleod receive a Nobel Prize in 1923, which they shared with Best and Collip. Over the ensuing century, insulin has evolved continuously from being extracted from the pancreas of animals, to genetically engineered, synthetic human insulin that first became available in the early 1980s.
6.7Today, Type 1 diabetes is still managed primarily through insulin therapy. In recent years there have been significant advances in blood glucose monitoring and insulin delivery technologies, which has allowed patients to better manage their condition. Combined with healthy eating and regular exercise, for some patients these methods have shown to slow down the progression of long-term complications associated with Type 1 diabetes.
6.8Indeed, in his submission Mr Richard Rains, who has had Type 1 diabetes for 38 years, noted that he has enjoyed ‘a relatively normal life’ by watching his diet closely, exercising regularly, and being able to use new technologies such as a continuous glucose monitor (CGM) and an insulin pump. Mr Rains has even appeared before a university class run by his endocrinologist as a proof that ‘it is possible to have Type 1 Diabetes for such a length of time and have zero complications.’
Oral diabetes medication
6.9While some patients with Type 2 diabetes who are insulin dependent rely on regular insulin administration similar to patients with Type 1 diabetes, the majority of people with this form of diabetes use oral diabetes medications to manage the disease.
6.10There are several different classes of oral diabetes medications that are used to help manage blood sugar levels:
- Alpha-glucose inhibitors (Acarbose)
- Biguanides (Metformin)
- Bile acid sequestrants (BASs)
- Dopamine-2 agonists
- Dipeptidyl peptidase-4 (DPP-4) inhibitors (Gliptins)
- Meglitinides (Glinides)
- Sodium-Glucose co-transporter-2 (SGLT2) inhibitors
- Sulfonylureas
- Thiazolidinediones (Glitazones).
- Metformin is a class of medication that is often first prescribed for Type 2 diabetes. This medication helps the insulin that the body makes work more effectively, and reduces insulin resistance and the amount of stored glucose released from the liver.
- In addition to metformin, the most common class of medications are DPP-4 inhibitors and SGLT2 inhibitors. DPP-4 and SGLT2 are often used as a second or third form of medication. DPP-4 inhibitors work by increasing the amount of insulin the pancreas releases after eating and reducing the amount of stored glucose released from the liver. SGLT2 inhibitors achieve the increase of glucose by removing it from the body via urine. This class of medications can reduce cardiovascular risks and delay the progression of kidney decline.
- Patients who use insulin or certain types of glucose lowering medications can be at risk of hypoglycaemia – a situation when patients with diabetes have too little glucose in their blood (i.e. a glucose level lower than 4 mmol/L). If it occurs, hypoglycaemia must be addressed quickly to avoid adverse outcomes such as a loss of consciousness.
Glucagon-like Peptide-1 receptor agonists
6.14As part of the inquiry, the Committee investigated the latest diabetes pharmacotherapies, placing particular focus on a new generation of medications that have the potential to revolutionise treatment of diabetes and obesity. These medications include Glucagon-like Peptide-1 (GLP-1) receptor agonists such as semaglutide and dulaglutide. The most well-known medications in this group are Ozempic and Wegovy (both semaglutide) produced by Novo Nordisk, and Trulicity (dulaglutide) launched by Eli Lilly.
6.15Glucagon-like peptide-1 (GLP-1) is a naturally occurring hormone produced in the stomach and released in response to food intake. GLP-1 targets hormones that are responsible for the metabolism of glucose in the body – insulin and glucagon.
6.16Insulin is produced in beta cells in the pancreas, and its role is to allow glucose to leave the bloodstream and move into cells where it is used for energy. As glucose moves into the cells, the level of blood glucose decreases. Glucagon in turn is a hormone produced in alpha cells in the pancreas that stimulates glucose production by signalling the release of excess glucose stored in the liver and muscle cells. The activities of glucagon thus counteract the action of insulin.
6.17GLP-1 receptor agonists work by simultaneously triggering an enhanced rate of insulin production and an inhibition of glucagon secretion. They reduce appetite and delay glucose absorption because the hormone slows the emptying of the stomach, which makes patients feel fuller for longer. According to the Pharmacy Guild of Australia, GLP-1 receptor agonists are capable of lowering plasma glucose levels in a manner comparable to insulin regimes. In addition, these medications present a lower risk of hypoglycaemia, and have the added benefit of weight loss and the ability to prevent cardiovascular complications in high-risk patients.
6.18There is also currently an effort to boost efficacy of these drugs by combining GLP-1 with other agonists. Eli Lilly has already launched Mounjaro (tirzepatide), which impacts both GLP-1 and another hormone that is involved in blood sugar control called glucose-dependent insulinotropic polypeptide (GIP).
6.19Professor Rachel Batterham, Senior Vice-president for International Medical Affairs at Eli Lilly, explained to the Committee how tirzepatide worked:
It’s based on GIP and GLP-1 that act together to regulate blood sugar, so it acts on the pancreas to increase insulin in response to food intake, but it also acts on the brain, to tell your brain that you've eaten and really switch off appetite and that's the way that it reduces body weight. It also impacts on the distribution of body fat, so it moves body fat from around your abdomen, where it's particularly bad in terms of cardiometabolic risk, more subcutaneously, so that it has an impact on body composition as well.
6.20This new generation of medications is delivered by injection under the skin, similar to insulin (these medications are thus categorised as non-insulin injectables). They are administrated once a week, which according to the Department of Health and Aged Care, has the potential to improve treatment compliance.
6.21Giving evidence before the Committee, Mr Cem Ozenc, Corporate Vice-President and General Manager for Oceania at Novo Nordisk, similarly highlighted the advantage of this dosage regime especially for patients in remote communities.
6.22In her response to the Committee’s question about her experience with GLP-1 medications, Mrs Elizabeth Watkins, Clinical Nurse Manager and Diabetes Educator at the Royal Darwin Hospital also emphasised this point:
In the remote context […] rather than having to come everyday [sic] for insulin injections, it's like a thing, where every week the bus goes around, picks everybody up and brings them back to the clinic. They can do everything else while they're there that they might need to, as well as get that weekly injection. It seems to have worked really well.
6.23According to recent media reports, the development of a pill version is also currently underway.
6.24The early introduction of this class of medication in the treatment course has the potential to break what has been termed the ‘treat to fail’ approach in managing Type 2 diabetes. Professor Batterham told the Committee that this approach entailed starting the patient on the cheapest drug, then adding another and another as the previous treatment proves inefficient in achieving glucose control. Better results – including achieving normoglycaemia (normal levels of blood sugar) – can be obtained by putting patients onto these new medications early.
6.25Primary Care Diabetes Society of Australia submitted that the Pharmaceutical Benefits Scheme (PBS) is positioning these drugs as a third line of intervention. In noting that these drugs are most beneficial when used earlier, especially for young people, the organisation echoes the need to reconsider the current treatment approach.
6.26The main counterindication for these drugs include nausea and diarrhoea. Between six and 13.5 per cent of patients stop the medication because of the side effects not being tolerable. As Professor Batterham explained to the Committee:
If I gave you a dose, you would feel either completely full or slightly nauseous. It's a bit like eating the most food you've ever eaten, and you go from feeling 'that's good' to 'I feel like I'm going to be sick'. That's because it's telling the brain that you've had a huge amount of food, because that's the signal that goes to the brain.
6.27Furthermore, the positive effects of the medication only last with continued use. Once use stops, patients feel hungry again, their blood sugar increases and, over the long term, people experience weight regain, and a return to previous blood pressure and cholesterol levels.
6.28The recent shortage of these medications has meant that access to the drug has often been sporadic. Mrs Watkins explained the challenges that patients face in going off GLP-1 receptor agonists:
It's so dangerous. You have to then stabilise them as well. It takes time. You've got to start the insulin, whether that's once a day or multiple times a day, and then it's regular titration and stabilisation. Then we get a supply, so they're off it, and they're back on their weekly injection. Then it's gone, and we can't get it again. So it's dangerous, and they're up and down. It's not a good reflection on us as well.
GLP-1 receptor agonists and obesity
6.29The reduction of weight that is caused by this class of medications has major implications for the treatment of Type 2 diabetes. The Australian and New Zealand Metabolic and Obesity Surgery Association (ANZMOSS) explained that obesity interferes with insulin sensitivity and insulin production. Diabetes, ANZMOSS submitted, is seven times as prevalent in obese populations compared to those with normal weight, and the risk of Type 2 diabetes indeed increases exponentially with increasing severity of obesity.
6.30Evidence received throughout the inquiry indicated that obesity is the principle modifiable risk factor for diabetes, and that both international as well as Australian guidelines recommend weight reduction alongside blood glucose control as the optimal diabetes management approach. According to Novo Nordisk, 53 per cent of the diabetes burden in Australia is due to overweight or obesity. As such, weight loss has been identified as vital in preventing or delaying the onset of the disease, and in some cases even leading to remission.
6.31According to the Department of Health and Aged Care, Australia has one of the highest rates of overweight and obesity in the world:
- Two in three Australians live with overweight or obesity
- One in four children aged between 5 and 17 live with overweight or obesity
- One in two young people between 18 and 24 live with overweight or obesity.
- As outlined in Chapter 2, the number of adults living with obesity has doubled in the last ten years, and it is estimated that at this rate 40 per cent of the Australian population will be living with obesity in the next ten years. People living in regional and remote areas are more at risk, as are older Australians (aged between 65 and 74), with men in this group 1.25 times more likely to be affected than women. People with disability are similarly at higher risk of being overweight or obese, and First Nations peoples are 1.2 times more likely to be either overweight or obesity than non-Indigenous Australians.
- Weight regulation is a complex process that is influenced by multiple physiological, social and environmental factors. As the Novo Nordisk submission outlined:
Many of these factors we cannot control ourselves, including an underlying biology that prevents people from achieving and sustaining weight loss. Studies have shown that up to 70% of the cause of obesity can be linked to genetics, family history and ethnicity.
6.34Weight management has conventionally been understood as an individual responsibility, and a matter of one’s will power to alter lifestyle choices. Current research, however, goes beyond this simplistic view to demonstrate the complex interplay between the social, environmental, economic, cultural, biomedical, and commercial factors that impact achieving and maintaining weight loss.
6.35The notion that obesity can be addressed through the principle ‘eat less and move more’ has thus proven ineffective for a majority of patients. According to the data provided by Johnson and Johnson, most non-surgical treatment programs often result in weight loss, but long-term maintenance of weight loss is much less likely to be achieved. Between 30 and 60 per cent of patients, according to Johnson and Johnson, regain weight within 12 months and almost all by five years: ‘Diet and life-style behavioural interventions have health benefits and can generate between 1–4% weight-loss, however little is sustained beyond two years.’
6.36The introduction of GLP-1 receptor agonists, which have demonstrated an ability to tackle obesity and by extension obesity-related complications (which amounts to over 200 health issues, including strokes, kidney problems, and fatty liver), has thus understandably been described as a revolutionary change in diabetes pharmacotherapy.
6.37The Committee, however, heard that these medications have their limitations, and that long term management remains challenging. Sydney Low Carb Specialists submitted that:
Today we have a plethora of glucose lowering drugs, including the latest and most expensive GLP1 agonists, as the most common initial therapy for T2DM. Even in the best-case scenarios with good medication compliance […] in this standard of care patients often become progressively more reliant on multiple medication agents, none of which completely mitigate the complications of diabetes.
GLP-1 receptor agonists shortage
6.38Since its release onto the market, this new generation of diabetes medications has been in high demand. The two pharmaceutical companies with significant history in providing diabetes pharmacotherapy – Eli Lilly and Nordisk (operating as Novo Nordisk since the 1980s) – are expected to together capture more than 90 per cent of the market for these medications in the coming years.
6.39In recent times there has been a global shortage GLP-1 agonists, which has also impacted Australia. These shortages appear to be caused by insufficient supply of both the active ingredient semaglutide and the ‘skinny pens’ used to inject the medicine.
6.40In Australia, the shortages might also be exacerbated by the size of the market, and pricing that may not be highly attractive to manufacturers. In reflecting on this point, Associate Professor Neale Cohen, Head of Clinical Diabetes at the Baker Heart and Diabetes Institute noted:
I think it's got a lot to do with funding of these agents and the fact that we don't pay as much as other countries. We wouldn't be top of their list, in terms of supply […] you won't see these sort of shortages in the US, let's put it that way. They pay a lot more for these agents, and we're a long way away and a small market. We just need to think about how we manage this. It's going to be a cost related issue. We're not going to be top of these companies' lists at all. But these are important drugs. It's really important that we don't fall behind.
6.41While being registered as a Type 2 diabetes treatment, since early 2022 medications such as Ozempic have been prescribed off-label in high volumes for weight-loss treatment.When therapeutic goods are entered onto the Australian Register of Therapeutic Goods (ARTG), the entry will specify therapeutic uses (or indications) for that drug. ‘Off-label’ use refers to a situation where a health professional is prescribing the use of the drug for indications other than those recorded on the ARTG.
6.42According to the Department of Health and Aged Care ‘off-label prescribing is not illegal and a decision to prescribe a medicine for a condition other than the registered indication is made by the prescriber in consultation with their patient.’ This practice is particularly common in the treatment of rare and paediatric diseases. In the case of medications such as Ozempic, however, frequent off-label prescription has contributed to shortages and an inability to secure supply for patients who rely on it to manage diabetes.
6.43When appearing before the Committee, Mr Ozenc emphasised that the level of demand far exceeded the Novo Nordisk’s original expectations. Mrs Victoria Brown, President and General Manager for Eli Lilly Australia and New Zealand, expressed a similar sentiment: ‘We didn't expect to stock out; we brought enough in to think we'd have an ample supply.’ Seeking to meet demand for this medicine, Novo Nordisk has made significant investments into new manufacturing sites, which will allow the company to increase supply in the future. Eli Lilly is taking similar steps.
6.44In the short term, Novo Nordisk is managing the current imbalance between demand and supply by working together with the TGA to advise health professionals not to start new patients on these drugs due to limited supply. Novo Nordisk submitted that before approaching the TGA to discuss current shortages almost 40 per cent of these medications were being used off-label; since TGA advice was issued, it has decreased to 20 per cent. The shortages are, however, likely to continue throughout 2024.
6.45In addition to off-label prescription, there are a number of other ways in which medical practitioners are able to access and prescribe medicines through unapproved pathways. As Professor Anthony Lawler, Deputy Secretary, Health Products Regulation within the Department of Health and Aged Care, explained: ‘The pathways themselves are approved, but it's for medicines that are not on the register under that specific medication.’ Access to therapeutic goods that are not on the ARTG is possible through the Special Access Scheme (SAS) and the Authorised Prescriber Scheme (APS), where medicines that are not registered can be ordered, and provided and dispensed.
6.46Another pathway for accessing this new generation of medications is through compounding. Compounding is a practice of combining and altering the ingredients of a drug to create a medication tailored to an individual patient. Pharmacists are allowed to compound medication where commercially manufactured products are not suitable for a patient, although these products are not necessarily at the same level of safety, quality or efficacy.
6.47Pharmacies in Australia have used compounding rules to access semaglutide and produce off-brand Ozempic for sale to consumers around the country. As Professor Lawler explained to the Committee: ‘It's really important to note that this is not Ozempic; this is semaglutide. This is a substance that has been imported through the SAS or AP [sic] mechanisms and then is being compounded.’
6.48On 29 February 2024, TGA commenced consultation on removing GLP-1 receptor agonists from Australia’s compounding exemptions, which would effectively ban pharmacies from making off-brand Ozempic. The Committee heard from Professor Robyn Langham, Chief Medical Adviser at the Department of Health and Aged Care that:
we've just taken a step to undertake a focused consultation on the proposal, which is to carve out all GLP-1 receptor agonists from the compounding exemptions. Following consultation, should that be the final decision, the plan would be that GLP-1 agonists would no longer be able to be compounded by pharmacists. That's really being done on a safety basis because of the scale of what we can see is happening with some providers.
6.49On 18 June 2024, the TGA announced that GLP-1 receptor agonists would no longer be able to be compounded by pharmacists and supplied to patients. This amendment, according to the TGA, ‘will apply to all medicines containing GLP-1 RA analogues, regardless of dosage form, compounded on or after 1 October 2024.’
Ring-fencing the GLP-1 receptor agonists for at-risk patients
6.50Both Novo Nordisk and Eli Lilly told the Committee that they have started ‘ring-fencing,’ or reserving, some of their supply of these medications for remote communities that have high numbers of at-risk patients.
6.51According to Mr Ozenc, the ability to access medications such as Ozempic has been a major game-changer in these communities. Ozempic appears to be particularly suitable for the phenotypes of Indigenous Australians. Furthermore, the Committee heard that medication delivers immediate improvements – the patients ‘can see results very quickly and they feel good.’ Equally important is the fact that it is administered once a week, unlike insulin which is more complicated and where benefits are not so immediately obvious. With these advantages, Ozempic has been positively received in the community.
6.52There are, however, significant logistical challenges in supplying these medications to remote communities. According to Mr Ozenc, ‘it’s almost impossible to send medicines to targeted places in Australia.’ Novo Nordisk was able to partner with Central Pharmacy to ring-fence both Ozempic and insulin for distribution in Northern Queensland. The company also has arrangements with the Kimberley and Broome in Western Australia, but the process is ‘very manual and not really easy to do […] in a systematic way.’ Eli Lilly similarly explained that they were able to ring-fence supply of Trulicity for Indigenous communities in partnership with healthcare providers in the Kimberley and the Northern Territory and with distributors, but there was much ‘logistical clunkiness.’
6.53GLP-1 receptor agonists come in injectable form that requires refrigeration. The Committee heard that lack of cold-chain logistics further complicates the supply process, with Novo Nordisk stating that in the middle of a shortage some of the products sent to the Northern Territory ‘were scrapped because of the heat, because they were not taken inside.’
6.54Mrs Brown of Eli Lilly recognised that at the moment there are patients who are getting the medications but perhaps they do not need it the most:
As we think about Australia specifically, we have some opportunities to think about how we can look at the right population who has the most need for this product, making sure that the innovative medicines are valued in a way that's representative of a global norm or a Westernised country and then making sure that we can secure that supply accordingly.
But the key is making sure that we have those controls in place and that they are the patients who are getting it and it's not leaking to somebody else.
6.55A government-led initiative to ensure remote communities receive priority access to these medications would be much welcome intervention in this domain.
Assessment processes for new medications
6.56Assessment processes for the registration and reimbursement of the new generation of medications for diabetes was a common feature of much of the evidence gathered by the Committee through the course of the inquiry.
6.57Responsibility for the assessment and registration of new medications in Australia rests with the TGA. Novo Nordisk’s Ozempic and Wegovy (semaglutide) and Eli Lilly’s Trulicity (dulaglutide) and Mounjaro (trizepatide) are registered by the TGA for use in Australia.
6.58Access to subsidised medications in Australia occurs primarily through the PBS. The assessment of which medications should be funded via the PBS is performed by the Pharmaceutical Benefits Advisory Committee (PBAC) – an independent body comprising doctors, health professionals, health economics and consumer representatives. An application for assessment by the PBAC is generally initiated by the pharmaceutical company responsible for the supply of the medicine in Australia.
6.59The Department of Health and Aged care explained that ‘the Government cannot list a new medicine on the PBS unless the PBAC makes a recommendation in favour of its listing.’ The PBAC is also consulted when the Government considers changes to the circumstances under which existing PBS medicines are listed. As part of the assessment process, the PBAC takes into account the cost effectiveness of the medicine, and how well it works compared to other available therapies.
6.60In Australia, Ozempic and Trulicity are subsidised under the PBS for Type 2 diabetes treatment. Wegovy and Mounjaro are not subsidised. Wegovy is not presently available in Australia. Mounjaro has been launched on the private market; it has a recommended retail price of $315 per month for a 5-milligram dose, $515 a month for a 10-milligram dose, and $645 a month for a 15-milligram dose.
6.61While pharmaceutical companies that appeared before the Committee noted that their experience with the TGA registration process has generally been positive, the PBS assessment process was raised as an impediment to accessing new therapies in Australia. In their appearance before the Committee, Mr Ozenc of Novo Nordisk confirmed ‘the registration is fast, but when we get [medicines] onto the PBS is where we are probably lagging behind other countries similar to this economy.’
6.62Indeed, in its submission to the inquiry, Novo Nordisk cited data from Medicines Australia, the peak body for Australia’s research-based pharmaceutical industry, outlining that it takes on average 391 days for an innovative medicine to go from registration to funding in Australia, compared to 101 days in Japan, 121 in Germany and 167 in the UK. Australian patients, that is, are currently waiting seven to ten months longer on average for new medicines to become available through the PBS than is the case in these other nations.
6.63In addition to the length of the process, witnesses noted that the PBAC takes ‘a fairly conservative view’ in its assessment of new medications. Dr Gabrielle Reppen, Associate Vice-President at Eli Lilly explained:
Of course, when we bring a new medicine to market we don't have very long-term data, we don't have all the evidence, and I think that the PBAC takes a conservative view and assumes that those benefits over the longer term don't occur. So what we've found across all classes of diabetes is that the PBAC has never recommended a new medicine on the basis of superior efficacy. Every time we have a head-to-head trial, which has a superior HbA1c reduction, it's deemed either to be not big enough to be clinically significant or does not translate into long-term outcomes.
6.64In investigating how new therapies for managing Type 2 diabetes are currently accessed, the Committee also learned that the Department of Health and Aged Care has recently considered the request to broaden the subsidised access to GLP-1 receptor agonists and SGLT2 inhibitors in dual therapy with metformin. In June 2024 the Government announced an expansion of the subsidy for GLP-1 receptor agonists. These medications were originally only available if treatment with other diabetes medicines had failed to reduce blood glucose, or had produced an adverse reaction. The rules have now been changed to increase access by requiring that only one other medicine has been tried (for example, metformin).
6.65In support of the inquiry, the Parliamentary Budget Office (PBO) undertook cost modelling for subsidising GLP-1 receptor agonists on the PBS for people who are obese and people with Type 2 diabetes requiring intensive insulin therapy. The following eight options were considered:
- Option 1: Fully subsidise the patient PBS co-contribution for all GLP1 receptor agonists available in Australia for people with Type 2 diabetes requiring intensive insulin therapy.
- Option 2: Fully subsidise the patient PBS co-contribution for all GLP1 receptor agonists available in Australia for people with Type 2 diabetes and who are obese requiring intensive insulin therapy.
- Option 3: Fully subsidise the patient PBS co-contribution for all GLP1 receptor agonists available in Australia for people with Type 2 diabetes, with or without requiring intensive insulin therapy.
- Option 4: Fully subsidise the patient PBS co-contribution for all GLP1 receptor agonists available in Australia for people with Type 2 diabetes and who are obese, with or without requiring intensive insulin therapy.
- Option 5: Partially subsidise (50%) the patient PBS co-contribution for all GLP1 receptor agonists available in Australia for people with Type 2 diabetes requiring intensive insulin therapy.
- Option 6: Partially subsidise (50%) the patient PBS co-contribution for all GLP1 receptor agonists available in Australia for people with Type 2 diabetes and who are obese requiring intensive insulin therapy.
- Option 7: Partially subsidise (50%) the patient PBS co-contribution for all GLP1 receptor agonists available in Australia for people with Type 2 diabetes, with or without requiring intensive insulin therapy.
- Option 8: Partially subsidise (50%) the patient PBS co-contribution for all GLP1 receptor agonists available in Australia for people with Type 2 diabetes and who are obese, with or without requiring intensive insulin therapy.
- The PBO advised that the introduction of such a measure would be ‘expected to decrease the fiscal balance by between around $1.1 million and $55.6 million, and the underlying cash balance by between $1.1 million and $54.4 million over the 2023-24 Budget forward estimates period […].’
- In appearing before the Committee, Mrs Victoria Brown, President and General manager for Eli Lilly Australia and New Zealand, emphasised that increased interest in accessing the new generation of diabetes medications stands as evidence of the lack of obesity treatment options. According to Mrs Brown, ‘the lack of available treatment for people with obesity shows the need to ensure that the medicines are available and reimbursed […] no contemporary medicines are available in Australia to treat obesity and only a very small number of patients can get bariatric surgery.’
- In addition to current concerns regarding the reimbursement assessment processes and limited access to new medication, the issue of access to medications approved for Type 2 diabetes by Type 1 diabetes patients was also raised during the inquiry. JDRF Australia submitted that medications such as metformin can be prescribed off-label for Type 1 patients to help with their blood glucose management. The lack of formal approval for such use, however, tends to discourage doctors from prescribing these medications, and thus undermines the optimal management of the disease. Similarly, while medications such as Ozempic have only been approved for Type 2 diabetes, according to JDRF they have shown to be beneficial for Type 1 diabetes patients as well. There is, however, currently no effective pathway for repurposing medications for other conditions that have shown to be beneficial for Type 1 diabetes patients.
- The Committee acknowledges concerns regarding the reimbursement assessment processes that have been raised during the inquiry, many of which echo those associated with the assessment of new medical technologies. The Committee reiterates that many of these concerns have been outlined in the November 2021 report by the House of Representatives Committee on Health, Aged Care and Sport entitled The New Frontier – Delivering better health for all Australians, and that as such the current inquiry has not canvassed issues relating to the regulatory and reimbursement system for medicines and new medical technologies in detail. The Committee again expresses its support for the complete and efficient implementation of the changes set out in the New Fronter report.
- The Committee recognises that there is a need for greater access to the new generation of medications for the treatment of both diabetes and obesity, particularly for high-risk patients.
Bariatric surgery
6.71Bariatric (or metabolic) surgery is a surgical procedure that involves making changes to the digestive system to achieve weight loss. The procedure can apply several mechanisms: alternation of gut hormones; physical reduction of the gut size; reduction or blockage of nutrient absorption; or a combination of these three mechanisms.
6.72Giving evidence before the Committee, Professor Batterham explained:
Over the last 30 years, we’ve now come to understand that the gut plays a critical role in regulating body weight. When you eat, there are cells throughout your GI tract that release hormones that regulate appetite and tell your body that you've eaten. That's how bariatric surgery works; it alters all of those hormones, when you replumb the gut.
6.73According to the American Society for Metabolic and Bariatric Surgery (ASMBS) and the guidelines of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), bariatric surgery is recommended for:
- Individuals with a BMI higher than 35, regardless of presence, absence, or severity of comorbidities
- Individuals with a BMI higher than 30 and Type 2 diabetes
- Individuals with a BMI between 30 and 34.9 who do not achieve substantial or durable weight loss or comorbidity improvement using nonsurgical methods.
- ASMBS and IFSO further noted that BMI thresholds should be adjusted in the Asian population, with a BMI over 25 in that population suggesting clinical obesity, and individuals with a BMI higher than 27.5 offered bariatric surgery. Appropriately selected children and adolescences should also be considered for the procedure.
- In its submission to the inquiry, the Department of Health and Aged Care noted that bariatric surgery is currently the most efficacious long-term treatment for adults with obesity. According the Centre for Diabetes, Obesity and Endocrinology Research at Westmead Institute of Medical Research in Sydney, the use of bariatric surgery early in Type 2 diabetes reverses the condition in more than 75 per cent of people. The benefits of bariatric surgery have been emphasised in a number of submissions to this inquiry, including by the ANZMOSS and the Australian Academy of Health and Medical Sciences.
- The Committee heard that despite its efficacy, however, bariatric surgery is significantly underutilised as method for treating obesity. According to the Bariatric Surgery Registry, in 2022 there were 16,308 primary (or first) bariatric surgeries in Australia. The Registry also recorded 3,914 revision procedures (a subsequent procedure performed upon a person who has previously undergone the bariatric procedure) in the same year.
- In 2023 the IFSO published its 8th Global Registry Report, which captures data from 24 countries and two regional registries, representing 81.4 per cent of known registries. The number of procedures offered for each combines primary and revisional procedures. According to the report, 20,222 procedures were completed in total in Australia; in the same period there were 2108 in New Zealand; 6734 in the United Kingdom and 38,890 in France. Over 230,000 procedures were undertaken in the US.
- Bariatric surgery is not a widely accessible treatment option in Australia. The Department of Health and Aged Care’s submission noted that ‘bariatric surgery for obesity is delivered through the public hospital system and funded through the National Health Reform Agreement. Relatively few such procedures take place as public hospital services, however, and the majority are being delivered through private hospitals.’
- According to the Bariatric Surgery Registry, in 2022 96.8 per cent of primary bariatric surgeries in Australia were privately funded. This procedure is accessible to private patients paying the highest premiums for private hospital insurance; alternatively patients are paying high out of pocket costs for surgery, often accessing superannuation to afford the procedure.
- In its submission, Johnson and Johnson highlighted the fact that Australians with the highest clinical need for bariatric surgery belong to the lowest socioeconomic groups:
Adults living in the lowest socioeconomic areas were 1.2 times more likely to be overweight or obese than those in the highest socioeconomic areas, and Indigenous Australians aged 15 and over were less likely than non-Indigenous Australians to be overweight but 1.5 times as likely to be obese.
6.81These patients face prolonged waiting times to access the procedure in the public health system, as private health services remain beyond their financial means. Furthermore, the submission also notes the adverse effect that the COVID-19 outbreak has likely had on the access to this treatment due to the need for a pause in elective surgery services during the pandemic.
6.82The National Obesity Strategy 2022–2032, developed by the Commonwealth and all the states and territories, recognised the need for Australian governments to provide equitable access to this treatment. Reiterating the findings from investigations such as those conducted by the Senate Select Committee into Obesity Epidemic in Australia in 2018 and of the Parliament of Western Australia inquiry into the role of diet in Type 2 prevention and management in 2019, the Strategy states that ‘bariatric surgery is currently the most efficacious long-term treatment for adults with obesity,’ and calls for ‘a shift in the health system […] to provide equitable access to medical and surgical obesity treatment.’
6.83As part of the inquiry, the Committee investigated whether access to the new generation of GLP-1 receptor agonists would render this procedure less relevant. According to Professor Batterham, medications and bariatric surgery relate to different patient groups. In case of patients with severe obesity (BMI 50), bariatric surgery is the first line of treatment. For this cohort ‘pharmacotherapy is not going to bring them down and they're still going to have a BMI in the 40s,’ emphasising that ultimately ‘you need to get the right treatment to the right person at the right time.’
6.84Dr Anna Wood, Head of Endocrinology at the Royal Darwin Hospital, also noted that while the GLP-1 medications are effective, bariatric surgery remains an important treatment option:
I think the GLP-1, particularly the dual agonists, like tirzepatide, are certainly becoming as effective as bariatric surgery. However, you need to be on them lifelong and we don't have the long-term evidence for their effectiveness and the long-term safety profile, whereas we do have that for bariatric surgery. We do have long-term mortality data showing that bariatric surgery works and saves lives. […] I would not say that there is no role for bariatric surgery. I still think, if you have an individual in front of you who has access to bariatric surgery, I would still be recommending it for those reasons.
Committee comment
6.85The Committee acknowledges that the introduction of a new class of medications for the treatment of diabetes and obesity has been game-changing. These medications have the ability to break the cycle of obesity and related complications in patients suffering from morbid obesity who are resistant to other treatments. Ensuring those with the greatest need have access to these drugs should be a priority, and the Committee welcomes the changes to the restrictions of GLP-1 receptor agonists that were introduced on 1 June 2024. Similarly, the 18 June 2024 announcement by the TGA that GLP-1 receptor agonists would no longer be able to be compounded by pharmacists is a timely, positive step in the right direction for the treatment of diabetes and obesity in Australia.
6.86The cost of these medications, however, along with the side effects and the fact that we are unsure of the long-term impact of their use are all major concerns. In the coming years, there will be an avalanche of these types of medications available for use, and Australia needs to be prepared to manage this change in pharmacotherapy. Here the TGA has a critical role to play, as do GPs and pharmacists who need to be well informed about these medications.
6.87The Committee further recognises that the successful treatment of diabetes and obesity involves numerous strategies and treatments. As such, the introduction of new medications does not render other methods (such as bariatric surgery) obsolete, and ensuing greater access to different treatment options should be regarded as a priority.
6.88The Committee recommends that the Australian Government, subject to a positive recommendation from the Pharmaceutical Benefits Advisory Committee, expands the eligibility criteria for Glucagon-like Peptide-1 (GLP-1) receptor agonists, particularly for high-risk patients.
6.89The Committee recognises that GLP-1 receptor agonists have shown to be highly effective in particular cohorts of diabetes patients. Providing more widespread access to these medications would be a positive step in managing diabetes in Australia.
6.90The Committee recommends that the Australian Government establishes mechanisms for securing supplies of Glucagon-like Peptide-1 (GLP-1) receptor agonists for disadvantaged and remote communities, including Aboriginal and Torres Strait Island communities.
6.91The Committee recommends that the Australian Government considers expanding access to bariatric surgery within the public system for eligible patients.