Australia's Wegovy Developments: Liver Disease Approval and Obesity Subsidy Progress
Australia has seen two significant developments regarding the medication semaglutide, marketed as Wegovy. The Therapeutic Goods Administration (TGA) has provisionally approved the drug for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), marking the first medication approved for this liver condition in the country. Concurrently, the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended a phased rollout for a Pharmaceutical Benefits Scheme (PBS) listing of Wegovy to subsidize its use for eligible patients with obesity, particularly those with established cardiovascular disease.
TGA Provisionally Approves Wegovy for MASH Treatment
The TGA has provisionally approved semaglutide (Wegovy) for adults with non-cirrhotic MASH who have moderate to advanced liver fibrosis (stages F2 to F3).
This landmark approval is based on evidence indicating the drug's ability to resolve steatohepatitis and improve liver fibrosis. The provisional status requires the manufacturer to conduct further trials to confirm clinical benefits for ongoing approval.
MASH, a progressive form of metabolic dysfunction-associated fatty liver disease (MAFLD), is projected to increase by 40% in Australia by 2030, a trend directly linked to rising rates of obesity and type 2 diabetes. Medical experts have stated that this treatment option could support earlier diagnosis and intervention, potentially slowing disease progression.
While offering a new avenue for treatment, concerns have been noted regarding the drug's cost, which could significantly limit patient access if not listed on the PBS. Potential side effects include nausea, diarrhea, mental health deterioration, and the challenge of rebound weight gain upon cessation.
PBS Subsidy Recommended for Obesity Treatment with Phased Rollout
Following a March 2025 request from Federal Health and Ageing Minister Mark Butler for advice on equitable access to GLP-1 medicines, the PBAC at its November 2025 meeting recommended a PBS listing for semaglutide (Wegovy) as an obesity treatment.
This PBS listing is specifically for eligible patients with established cardiovascular disease, such as a history of heart attack or stroke, and a Body Mass Index (BMI) of 35 or higher.
The PBAC advised a "slow and managed" rollout to address several concerns, including potential prescriptions outside approved criteria, uncertainties about long-term outcomes, and the significant cost implications. The initial phase would prioritize high-risk patient groups, including:
- Patients with established cardiovascular disease (CVD)
- Aboriginal and Torres Strait Islander patients with obesity-related comorbidities
- Individuals with syndromic obesity
- People with medication-induced obesity
- Patients requiring weight loss to be eligible for surgery
Under the proposed PBS listing, the cost of Wegovy for eligible patients is projected to decrease significantly from an annual market price of $4,000-$5,000 to $25 per prescription, or $7.70 for concession card holders.
Minister Butler has confirmed the government's commitment to a PBS listing for Wegovy to enhance affordability for eligible Australians. He acknowledged that subsidizing the medication would incur a substantial cost to taxpayers. The exact financial impact and timeline for the listing are subject to ongoing negotiations between the government and the manufacturer.
The committee also acknowledged broader subsidies for GLP-1s for early intervention and prevention of obesity-related comorbidities, though it suggested such programs might need to be established outside the PBS due to cost-effectiveness challenges. The PBAC further emphasized that pharmacotherapy should complement broader obesity management strategies, including diet and physical activity, and highlighted the need to improve access to non-pharmacological interventions.