How Data Packages Lacking Phase III Pivotal Trial Data Can Support Regulatory Approval and Reimbursement for Oncologics in Australia

The TGA will approve oncologics that offer potentially substantial clinical benefits on the basis of an indirect comparison of single-arm trials but at a delay versus the EMA and the FDA. The PBAC reimbursement approval also requires more rigorous supportive clinical data and acceptable cost-effectiveness as demonstrated on a cost-benefit or cost-quality-adjusted life-year metric.