Accelerated Access and Early-Phase Evidence: Lessons from 15 Years of PBAC Submissions

9 Pages

This analysis reviews 57 PBAC submissions supported by early-phase clinical data between 2010 and 2025. Although only 3.8% of total submissions relied on early-phase evidence, many—particularly those based on Phase II data—achieved high recommendation rates when supported by strong clinical rationale and economic justification. Oncology dominated submissions, reflecting unmet need and trial complexity. The report shows increasing regulatory flexibility in recent years and provides strategic insights for sponsors seeking reimbursement using earlier-stage evidence.

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Accelerated Access and Early-Phase Evidence: Lessons from 15 Years of PBAC Submissions

Accelerated Access and Early-Phase Evidence: Lessons from 15 Years of PBAC Submissions

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