OBJECTIVES: Project Orbis is an international regulatory collaboration led by the US Food and Drug Administration (FDA) Oncology Center of Excellence. It represents a framework for concurrent submission and review of oncology products, with the aim to give patients faster access to promising cancer treatments. However, products with limited clinical evidence can pose challenges for health technology assessment (HTA) and public-payer decisions. We examined HTA and reimbursement outcomes for Project Orbis drugs reviewed in Canada and other jurisdictions globally from program inception in 2019 to end of 2022.

METHODS: We identified all Project Orbis drugs approved by Project Orbis partner jurisdictions: Canada, Australia, and UK. We collected all related HTA recommendations and reimbursement outcomes for all three countries plus two other EU jurisdictions: France and Germany until Mar/2023. Using publicly available information, we collected clinical details that might affect decision-making, including level of evidence assessed and disease context to identify trends. We determined concordance in regulatory approvals, HTA recommendations and funding across jurisdictions and compared timelines where possible.

RESULTS: Most drug-indications approved through Project Orbis by the US were approved by Canada (49, 72%), or Australia (42, 62%). International consistency was more limited, with 37 (55%) approved by both Canada and Australia, and 11 (16%) by Canada, Australia and UK. Only 30% of approved drug-indications had completed HTA in Canada within 6 months of regulatory approval despite availability of parallel regulatory-HTA review. Of drug-indications with Canadian and Australian approvals and 6+ months follow-up, 68% had initial HTA outcomes across both jurisdictions.

CONCLUSIONS: We present evidence assessing whether Project Orbis is delivering on its intent to facilitate access to oncology therapies in jurisdictions around the world. We provide insights into health-system context, HTA recommendations and reimbursement decision-making internationally for therapies that have been granted expedited regulatory approval with potentially high uncertainty.