HPR161 International Comparisons of Health Technology Assessment and Reimbursement Outcomes for Oncology Drugs with Regulatory Review through Project Orbis

Abstract

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.