AstraZeneca’s Anna Litsiou, Carolyn Hynes and Allison Guy, contributing to the September 2024 edition of DIA’s Global Forum magazine, discuss the importance of improving interactions between health technology assessment (HTA) bodies and regulatory authorities.

 

The need to optimize drug development and facilitate faster access for patients has focused discussions on the importance of improving interactions between health technology assessment (HTA) bodies and regulatory authorities. In most cases, once the medicine is authorized, market access is determined by the healthcare system’s financing mechanisms, and payers usually rely on the assistance of HTA bodies who decide whether to reimburse a product based on its relative value under current clinical practice scenarios. This is usually a lengthy process that occurs after regulatory review. Though regulators have been working to reduce review timelines through regulatory reliance and work-sharing procedures, HTA timelines have remained unchanged, and thus the overall benefit of these regulatory reforms to patients is far less significant than it might be. In recent years, however, international collaborative cross-border regulatory and HTA body frameworks have been established to optimize decision making.

International Regulatory Collaborative Frameworks

Several national regulatory authorities (NRAs) are collaborating to make the regulatory review process more efficient through reliance and work-sharing pathways across international borders. The most commonly known international work-sharing partnerships are Project Orbis and the ACCESS Consortium.

 

Project Orbis

Established by FDA’s Oncology Center of Excellence (OCE), Project Orbis is a framework for concurrent submission and review of oncology products led by US FDA in collaboration with NRAs from Australia, Brazil, Canada, Israel, Singapore, Switzerland, and the UK. Japan’s PMDA and the EMA (European Medicines Agency) recently joined as observers.

Though the official Project Orbis review timelines are aligned with the established review timelines of the NRAs participating in the procedure, FDA has reported a reduction in time to approval for both the FDA and other participating Project Orbis NRAs.

 

To read the full article, visit the DIA Global Forum website