Presentation (CTI)

OBJECTIVES: Project Orbis aims to accelerate global access to innovative oncology treatments through coordinated regulatory review. This research examined the reimbursement status of drugs approved by the FDA under Project Orbis to explore how different HTA frameworks impact access to treatments in England, Australia, and Canada.
METHODS: NICE, PBAC, and CDA (previously CADTH) databases were searched for HTAs of FDA-approved drugs through Project Orbis in 2022-2023. Indications with final recommendations from all 3 HTA bodies were included for data extraction of pre-defined topics including recommendations and decision drivers.
RESULTS: Of the 38 FDA-approved indications under Project Orbis (2022-2023), 9 received final guidance from all 3 HTA bodies. Overall, 8/9, 7/9, and 9/9 indications received positive recommendations from NICE, PBAC, and CDA, respectively. Decisions were largely aligned, with 6/9 indications receiving a positive recommendation from all HTA bodies. All positive recommendations by NICE depended on discount agreements and half required Managed Access Agreements. All positive recommendations from CDA relied on a price reduction, while 86% (6/7) of PBAC's positive recommendations required Risk-Sharing Arrangements or price reductions to accommodate clinical or economic uncertainty. Differing recommendations (3/9) from HTA bodies included NICE (n=1) in a newly classified subgroup of breast cancer, critiquing lack of cost-effectiveness despite a severity modifier, and PBAC (n=2) due to inadequate data specific to the treatment positioning, an inappropriate comparator, or inadequate comparative evidence causing clinical and economic uncertainty.
CONCLUSIONS: Project Orbis accelerates regulatory approval, but does not guarantee access outside the US, with challenges in data uncertainty and cost-effectiveness. Discounts and agreements allow payers to accommodate a degree of uncertainty, thereby avoiding delayed patient access. Access is further delayed by negative recommendations driven by clinical and economic uncertainty. Optimizing the evidence base, particularly for model inputs, is essential to mitigate payer risk and improve patient access to innovative new treatments.