Novartis has applied to widen government funding for its prostate cancer drug Pluvicto, in a bid to reach more Australian men before they need chemotherapy.

The company applied to the TGA to expand the approved use of Pluvicto (lutetium-177 vipivotide tetraxetan, or 177Lu-PSMA-617). The new indication would cover patients who have had androgen receptor pathway inhibitor (ARPI) therapy and could delay starting taxane-based chemotherapy.

On Thursday, it confirmed the treatment’s ARTG listing had been updated to include this indication.

At the same time, Novartis applied to the Medical Services Advisory Committee (MSAC) for full reimbursement for this same group of patients, known as the PSMAfore population. According to the application, released publicly last month, this would cover patients who:

• are PSMA-positive
• have progressive disease after ARPI therapy
• have not yet had taxane-based chemotherapy

MBS items for Lu-PSMA therapies took effect in July 2025, following an application by a group of specialists working independently of Novartis but access remains limited. Patients can currently only use the subsidy if they have already had at least one round of taxane chemotherapy, and even then receive only partial reimbursement, often facing significant up-front costs.

Novartis said its new application would address this gap. “Only a subset of eligible patients currently has access, and these patients receive partial reimbursement, not full reimbursement,” the company said.

The Medical Oncology Group of Australia (MOGA) has backed the MSAC application but has warned against any conditions that tied access to whether patients had taxane chemotherapy before or after Lu-PSMA treatment.

In a message to members, it said evidence showed Lu-PSMA extended survival and maintained quality of life, with limited toxicity, regardless of whether it was given before or after docetaxel. The group argued clinicians needed flexibility to decide when to start treatment, and said it “fully endorses MSAC’s review of Pluvicto” and encouraged removal of any restriction based on prior docetaxel use.

Novartis also flagged an alternative route to funding. Given possible delays through MSAC and what it called current inequities in reimbursement, the company said it believed the Pharmaceutical Benefits Advisory Committee (PBAC) process could offer a faster path to equitable access for TGA-registered radioligand therapies such as Pluvicto.

Consultation on the MSAC application is open until 10 July.