HTA Quarterly | Summer 2023

On the 10th anniversary of HTA Quarterly, the editors take a look back at some of the articles published to date, identify key themes that resonate with our readers, and consider how shifts in the constantly changing world of market access have shaped article content.

Project Orbis was launched by the FDA Oncology Center of Excellence to facilitate faster patient access to innovative cancer therapies in multiple countries. Leveraging a consortium of participating countries, Project Orbis aims for concurrent submission, review, and regulatory action for high-impact, clinically significant marketing applications among participating countries. This article provides an overview of the process and recent experiences of participating regulatory agencies, highlighting the benefits and challenges for stakeholders in the 3½ years since the first regulatory decision under Project Orbis took place in September 2019. 

Is artificial intelligence (AI) set to take over the world? In this article, we reflect on an interview we conducted with one of the current AI tools, in which we explored its “knowledge” of and potential role in health technology assessment (HTA).