White Paper
Accelerated Access and Early-Phase Evidence: Lessons from 15 Years of PBAC Submissions
Explores how early‑phase clinical trial evidence is increasingly shaping PBAC decision‑making in Australia
Feb 03, 2026
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As the push for faster access to innovative therapies intensifies, this white paper explores how early‑phase clinical trial evidence is increasingly shaping PBAC decision‑making in Australia. It uncovers where earlier data can meaningfully influence reimbursement outcomes, the therapy areas where accelerated access is most viable, and the strategic considerations that help sponsors navigate uncertainty and build stronger value cases. Drawing on insights from IQVIA’s Australian market access experts, the paper offers practical guidance for teams developing PBAC strategies, pricing approaches and payer engagement plans in an environment where evidentiary expectations — and opportunities — are rapidly evolving.

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