Australian patients with established cardiovascular disease and obesity may soon have access to subsidised semaglutide after the Pharmaceutical Benefits Advisory Committee endorsed a new PBS listing.

The PBAC also gave the nod to listings of several other treatments in the endocrinology space, including additional treatment options for menopausal and post-menopausal patients.

The new listing for semaglutide would be for patients who have already experienced a cardiovascular event like heart attack or stroke or who have symptomatic peripheral arterial disease.

Given the high costs of treatments, the PBAC decided PBS access would be limited to those with a BMI of 35 kg/m² or higher, or 32.5 kg/m² or higher for people of Asian, Aboriginal, or Torres Strait Islander ethnicity. 

“The PBAC acknowledged that, while there are effective treatments on the PBS for people with [established] CVD, they still face residual risk of future cardiovascular events and adding semaglutide to current therapies may help reduce this risk,” the November meeting minutes said. 

The committee considered there was a “significant risk” individuals would access subsidised semaglutide outside of the proposed criteria – for example, patients with existing cardiovascular disease who had a BMI of less than 35 kg/m². 

Federal health minister Mark Butler asked the PBAC for advice on equitable access to GLP-1s in 2025.

“It therefore advised that a risk sharing arrangement with the sponsor was required to adequately manage the expenditure risk to the Commonwealth,” the PBAC said. 

The November 2025 meeting minutes also revealed the committee’s advice to federal health minister Mark Butler on equitable access priorities for GLP-1RA treatments and priority populations.

“PBAC considered this should 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,” it said. 

A “slow and managed roll-out” of subsidised GLP-1RA treatments was recommended to manage uncertainties about the long-term use and outcomes of the medications, the committee said. 

New hot flush treatments given the nod

Meanwhile, post-menopausal women with vasometer symptoms could soon have another subsidised treatment option. The PBAC recommended a new listing for estradiol and progesterone, sold under the brand name Bijuva, as an alternative for patients unable to use patches or gels. 

“The PBAC noted that there is currently no oral fixed dose combination product containing estradiol and progesterone (or a similar progestogen hormone) for continuous menopausal hormone therapy listed on the PBS,” November meeting minutes said. 

Fezolinetant also received a listing recommendation as an additional treatment option for menopausal women with moderate to severe vasometer symptoms.

Its sponsor’s initial application for listing in March 2025 was not successful, with the committee noting increasing concerns of liver damage among some patients.

“In this resubmission, the sponsor proposed revised clinical criteria that more clearly defined who could access fezolinetant on the PBS. The PBAC considered these proposed criteria were clinically appropriate,” the committee said.

The acute hepatic porphyria treatment givosiran and hereditary tyrosinaemia type 1 drug were also endorsed for new listings.

The full meeting outcome minutes for November 2025 can be read on the PBS website [link here].