Push for weight-loss drugs’ PBS listing ramps up

Mounjaro, Wegovy, Ozempic – these viral drugs have all become household names.
 
In recent years, the medications’ popularity has skyrocketed across the globe leading to shortages, off-label prescribing, and a black market.
 
Now, the Therapeutic Goods Administration (TGA) has indicated some of the medications as a treatment for overweight and obesity, allowing GPs to prescribe tirzepatide (sold as Mounjaro) and semaglutide (sold as Wegovy) to eligible patients.
 
A shortage of Ozempic is also expected to continue until the end of 2025, and, although it is only indicated for the management of type 2 diabetes in Australia, the TGA says it is continuing to be prescribed off-label.
 
But so far, none have been listed on the Pharmaceutical Benefits Scheme (PBS), despite the efforts of manufacturers.
 
However, is a successful listing getting closer?
 
This year, everyone from customers to advocacy groups, the RACGP, and even Federal Health and Ageing Minister Mark Butler has questioned whether the medications belong on the PBS.
 
In response to a petition calling for Wegovy to be added to the PBS, Minister Butler confirmed he wrote to the Pharmaceutical Benefits Advisory Committee (PBAC) in March, asking it to provide advice on equitable access to medicines for the treatment of obesity.
 
‘This may include, but not be limited to, the Australian population cohorts most likely to benefit from the potential future availability of Wegovy, or other anti-obesity medications such as tirzepatide, through the PBS,’ he said.
 
‘I also requested advice from the PBAC on the optimal duration of subsidisation, noting the limited long term safety data on the use of these medicines.
 
‘And on whether these medicines are effective standalone therapies or best used in combination with other interventions, such as bariatric surgery or supporting models of care to achieve optimal patient outcomes.’
 
Dr Mark Mellor, a West Australian GP with an interest in obesity, has written a report to the Federal Government calling for patients to have better access to weight-loss treatments.
 
Dr Mellor is hopeful change is on the way.
 
‘We are advocating for funded access to treatment, as a first step, for people with a body mass index over 40 with three weight-related health impairments or at least one severe weight-related health impairment,’ he told newsGP.
 
‘People in the lower socioeconomic groups are disproportionately affected but the least able to afford these treatments, but also you see higher rates of obesity and therefore weight-related health impairment in those groups.
 
‘I believe there is an appetite there from the Department of Health to tackle this, they’re just not sure exactly how to approach it.’
 
Currently, TGA-approved weight-loss medications remain out of reach for many.
 
Mounjaro is only available on private prescription with its recommended price beginning at $395 per month for the initiation dose, while the 2.4 mg dosage of Wegovy, which is the ‘recommended dose for the most effective results for weight management’, costs $460 per dose.
 
The PBAC has previously considered applications to list weight-loss medications on the PBS, but has knocked these back for various reasons, including submissions having ‘poorly justified the population access it had requested’ and that the listing ‘would not be cost-effective at the requested price’.
 
However, Dr Terri-Lynne South, Chair of RACGP Specific Interests Obesity, told newsGP a weight-loss medication’s addition to the PBS would begin to tackle Australia’s health inequities.
 
‘It would significantly help because the patients who often need these medications the most are the ones who can least afford it,’ she said.
 
‘It’s changing people’s perspective that obesity can be considered a chronic, clinical condition of its own and understanding that management of obesity is more than the individual’s responsibility.
 
‘It’s more than just being told to eat less and move more, and that it can significantly improve people’s health.
 
‘But it can also improve the health budget if we can have access to evidence-based, equitable, multi-modal management options so we’re not just saying “medications only”, we’re saying we need it in addition to interventions from a lifestyle point of view.’
 
In March this year, the RACGP updated its Obesity prevention and management position statement to recommend obesity management medication be subsided on the PBS.
 
The college said its position was updated due to a growing body of evidence that semaglutide medicines can be an effective way for patients to reduce their risk of developing the complex and chronic conditions that are linked to overweight and obesity.
 
It comes as doctors report being inundated with patient questions on the medications, with almost half of GPs saying they are asked about weight-loss drugs at least once every day.
 
Dr Mellor said that given this interest, a staggered approach is one which could be successfully adopted in Australia.
 
‘This is exactly what the Department of Health is looking for – a realistic, tangible approach to funding these treatments for people that need it the most,’ he said.
 
‘It’s a no-brainer that if we treat obesity, we will see huge cost savings down the line and not just in terms of health, but in terms of economics, sick days, psychological wellbeing.
 
‘There are many clinicians, in particular GPs, that are upskilling in obesity and really have the specialist knowledge to be able to prescribe these medicines and manage patients comprehensively.’
 
Dr South agrees, saying the first step to creating change is for the Federal Government to provide funding for therapies for those patients who need them most.
 
‘We are asking not for a blanket for everybody, but for the more severe stages of obesity, but also this should be in context with appropriate, wraparound care as well,’ she said.
 
‘It’s not just about anybody who’s got a script pad writing a single script – it has to be part of a broad plan.
 
‘It has to be used well and not in a way that is expensive and potentially detrimental if it’s accessed by people who don’t actually have the health complications or don’t have access to that wraparound care.’
 
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Mounjaro obesity Ozempic Pharmaceutical Benefits Scheme semaglutide tirzepatide Wegovy