The committee advises staged subsidy and priority groups as evidence and costs evolve.
Australia’s medicines advisory committee has outlined a cautious, targeted pathway for subsidised access to GLP-1 RA obesity medicines, recommending a staged rollout focused on high-risk groups while broader use remains under review.
The Pharmaceutical Benefits Advisory Committee (PBAC) has advised the federal government that any Pharmaceutical Benefits Scheme (PBS) subsidy for glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for obesity should initially prioritise specific patient populations most likely to benefit.
These include people with established cardiovascular disease; Aboriginal and Torres Strait Islander patients with obesity-related comorbidities; people with syndromic obesity; people with medication-induced obesity; and patients requiring weight loss to be eligible for surgery.
“The PBAC invited sponsor submissions for these populations, noting that any PBS listing would be subject to the legislative requirements to demonstrate clinical and cost-effectiveness through a sponsor-initiated submission,” it said in a statement.
“The PBAC advised a slow and managed roll-out of access to PBS-subsidised GLP-1 treatments in the Australian health care system would help to manage leakage and uncertainties around long-term use and outcomes.
“The PBAC considered that there may be merit in broader subsidy of GLP-1 RAs for early intervention and prevention of obesity-related comorbidities, but such subsidy would need to be established as a program outside of the PBS as it would be difficult to achieve a cost-effective price of providing obesity medicines for these broader purposes at this time.”
The advice followed a request from federal health minister Mark Butler in March 2025.
At the time, he sought guidance on how obesity medicines could be incorporated into the PBS, including appropriate patient cohorts, treatment duration and the role of the drugs alongside other interventions.
The committee also recommended a “slow and managed rollout” of GLP-1 RA obesity treatments through the PBS. The PBAC said this approach would help manage uncertainties about long-term outcomes, costs and patterns of use, and reduce the risk of “leakage”, where subsidised medicines were prescribed outside approved criteria.
While the committee acknowledged that GLP-1 RA therapies could potentially play a broader role in preventing obesity-related complications, it advised that large-scale early-intervention programs would be difficult to fund within the PBS framework at current prices.
Instead, such prevention strategies might require separate programs outside the PBS if governments wanted to pursue wider access.
“The PBAC noted the rapid emergence of research in obesity treatments and real-world evidence in this area, which is expected to drive significant changes in cost, supply, dosing, and utilisation over coming years,” it said.
“The PBAC noted the importance of real-world data to inform effective, equitable, safe and cost-effective use of GLP-1s.”
During the same November 2025 meeting at which the GLP-1 RAs were discussed in detail, the PBAC recommended listing semaglutide (Wegovy) on the PBS for adults with obesity and established cardiovascular disease, contingent on a price reduction and risk-sharing arrangement with the sponsor.
This recommendation for semaglutide has not yet resulted in a PBS listing. Before a subsidy can be introduced, the government and the manufacturer must negotiate pricing and other listing conditions, with the final decision resting with the federal government. If an agreement is reached, implementing a listing typically takes several months.
The recommendation applies to patients who have already experienced a cardiovascular event, such as myocardial infarction, stroke or symptomatic peripheral arterial disease.
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To target those at highest risk and manage costs, the PBAC recommended restricting PBS eligibility to patients with a body mass index of at least 35kg/m², or 32.5kg/m² for people of Asian, Aboriginal or Torres Strait Islander ethnicity.
The committee considered evidence from a large trial of more than 17,000 participants, which showed fewer major cardiovascular events among patients receiving semaglutide in addition to standard cardiac therapy.
Based on trial estimates, PBAC calculated that treating 1000 eligible patients for around 3.5 years could prevent 39 major cardiovascular events and four deaths compared with usual care alone.
However, the committee cautioned that real-world outcomes may be more modest due to slower dose escalation, continued use of lower doses and higher treatment discontinuation rates observed internationally.
The PBAC also questioned some of the economic assumptions used to justify the sponsor’s requested price, suggesting that benefits may have been overstated, particularly regarding how long cardiovascular protection persists after treatment discontinuation.
As a result, the committee said a lower price would be needed to ensure cost-effectiveness for taxpayers.
Another concern was the potential for off-criteria prescribing, particularly among patients with cardiovascular disease whose BMI falls below proposed thresholds or among people at high cardiovascular risk without a prior event.
The PBAC recommended a risk-sharing arrangement with the sponsor to manage potential budget impacts if usage exceeds expectations.
The committee’s latest advice to the health minister also emphasised that pharmacotherapy should sit alongside broader obesity management strategies. However, it warned against mandating these for PBS access.
“The PBAC considered that there was a need to improve access to non-pharmacological interventions, such as diet and physical activity support, and that digital models may provide an equitable avenue for broad access to these supports,” the committee said in its statement.
“The PBAC considered that there should not be any mandatory requirements for use of wraparound allied health services for PBS-subsidised access to GLP-1s, as this would create a barrier to accessing therapy, particularly for people who were already at higher risk of obesity and its associated comorbidities.”
Public consultation on equitable access to GLP-1 RA therapies generated 540 submissions, the majority from individuals who had used these medicines.
Respondents frequently highlighted financial barriers to accessing treatment privately and supported differential eligibility thresholds for populations at higher metabolic risk at lower BMI levels.
Three injectable GLP-1 RA-based medicines are currently registered in Australia for weight management, including semaglutide, liraglutide and tirzepatide, but none are currently subsidised for obesity through the PBS.
“The PBAC has twice considered submissions for semaglutide (Wegovy) for the treatment of obesity but not recommended this medicine for PBS listing,” the committee said.
“While the PBAC recognised that this treatment has the potential to offer substantial benefits to patients experiencing severe obesity, the PBAC raised concerns about the clinical rationale for the patient cohorts that were proposed to receive subsidised access and the cost-effectiveness of the medicine at the requested price.”
Semaglutide and dulaglutide remain listed for type 2 diabetes, and regulators report there are currently no national shortages of GLP-1 RA medicines.
