November PBAC agenda unveiled amid tensions over tariff risks

The Department of Health has unveiled the agenda for the November 2025 meeting of the Pharmaceutical Benefits Advisory Committee (PBAC), as concerns mount over tariff implications that could prompt local pharmaceutical companies to delay or withdraw submissions to safeguard US pricing thresholds.

Despite the policy headwinds, the upcoming PBAC meeting includes a diverse range of evaluations for new Pharmaceutical Benefits Scheme (PBS) listings across oncology, ophthalmology, dermatology, vaccines and biosimilars.

Apellis Australia is seeking PBS listing for Syfovre (pegcetacoplan) for the initial and continuing treatment of bilateral geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Notably, Syfovre is the first TGA-approved ocular injection for “dry” AMD – a progressive and irreversible disease of the macula affecting over 75,000 Australians.

In the oncology line-up, Pfizer’s Tukysa (tucatinib) is being considered for PBS listing in combination with trastuzumab and capecitabine, for treating metastatic HER2-positive breast cancer in patients who have progressed on trastuzumab deruxtecan after two lines of prior HER2-directed therapy.

Specifically in lung cancer, AstraZeneca is seeking an expanded listing of Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of Stage IIIB or IV EGFR mutation-positive non-small cell lung cancer (NSCLC).

Pierre Fabre’s Braftovi (encorafenib) with binimetinib is being considered for funding in the treatment of advanced or metastatic NSCLC harbouring a BRAF V600E mutation, with no prior systemic treatment in the metastatic setting.

Also in lung cancer, Specialised Therapeutics Pharma’s Zepzelca (lurbinectedin) is being considered in combination with atezolizumab as first-line maintenance therapy for extensive-stage small cell lung cancer (SCLC) in patients who have not progressed after induction therapy.

Two vaccines are under review for inclusion on the National Immunisation Program (NIP), including Moderna’s is mResvia for the prevention of RSV-related lower respiratory tract disease in people over 75 and Aboriginal and Torres Strait Islander people aged over 60, and MSD’s pneumococcal vaccine Capvaxive for adults under 70 with specific risk factors, Aboriginal and Torres Strait Islander adults over 50, and all adults aged 70 or over, including Aboriginal and Torres Strait Islander people aged 25 to 49.

Addressing chronic and rare inflammatory skin diseases, Boehringer Ingelheim is seeking PBS listing for Spevigo (spesolimab), for preventing flares of generalised pustular psoriasis in patients aged 12 and above. Leo Pharma’s Anzupgo (delgocitinib) is also being evaluated for funding for the treatment of moderate to severe chronic hand eczema where topical corticosteroids are ineffective or inappropriate.

Lastly, Celltrion is pushing for reimbursement of denosumab biosimilars, aimed at mirroring the originator’s listings for osteoporosis, bone metastases, and giant cell tumour of bone.

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