HTA Quarterly | Summer 2023
By AmerisourceBergen
In this issue, our editors examine how the new Innovative Medicines Fund offers a faster route to market for promising non-cancer drugs in the UK, learnings from the first 5 years with the Danish Medicines Council, and implications of the US’s new drug pricing law.
HTA Quarterly | Summer 2023
10 years of HTA Quarterly: Looking back to see how far we’ve come
HTA Quarterly | Summer 2023
Project Orbis: A three-year review
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.
HTA Quarterly | Summer 2023