MOGA supports the Novartis application to MSAC for the use of Pluvicto

MOGA supports the Novartis application to MSAC for the use of Pluvicto (Lu‑177 PSMA‑617) in men with metastatic castration‑resistant prostate cancer (mCRPC) after failure of androgen receptor pathway inhibitor (ARPI) therapy.

Lu‑PSMA therapy has been extensively used and trialed within Australia over the past decade, with strong clinical experience and published evidence demonstrating its effectiveness and tolerability in appropriately selected patients. Indeed, Australia, through the Australian and New Zealand Urogenital and Prostate (ANZUP) collaborative trials group has generated internationally recognised evidence supporting the use of Lu-PSMA in men with prostate cancer. MOGA feels that access to Lu-PSMA for patients with mCRPC is “clinically necessary”.

Furthermore, MOGA believes the current treatment paradigm for Lu‑PSMA therapy should be expanded, and that the present positioning—with listing requiring use either before or after docetaxel chemotherapy—should be reconsidered. Evidence now demonstrates that Lu-PSMA extends survival and maintains quality of life, with limited toxicity in patients both pre‑ and post‑docetaxel.

Clinically, the optimal use of Lu‑PSMA is nuanced. There are patients for whom the benefit of docetaxel is questionable or limited due to performance status, comorbidity burden, or patient preference. For these patients, Lu‑PSMA is an appropriate and often preferred option, avoiding the systemic toxicity associated with cytotoxic chemotherapy. Conversely, some patients—particularly those with high‑burden bone disease—may be best served by docetaxel upfront to minimise the risk of long‑term bone‑marrow suppression from Lu‑PSMA. These scenarios illustrate the need for flexibility, allowing clinicians to individualise sequencing rather than adhering to rigid, mandatory ordering of chemotherapy relative to radioligand therapy.

MOGA therefore fully endorses MSAC’s review of Pluvicto and encourages consideration of removing any listing restriction that makes access contingent on prior docetaxel use, should the therapy be approved. Such flexibility ensures that treatment decisions remain patient‑centred, evidence‑based, and responsive to the heterogeneous biological and clinical profiles seen in Australian men with advanced prostate cancer. It likewise addresses the significant inequity faced by patients when considering Lu-PSMA in the post docetaxel setting in Australia.

MOGA would be happy to be involved further if the Committee had any questions.