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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.

HTAQ 10 year anniversay

HTA Quarterly | Summer 2023

10 years of HTA Quarterly: Looking back to see how far we’ve come

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.
htaq project orbis

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. 

HTAQ AI File 1

HTA Quarterly | Summer 2023

Reflections on an interview with a ghost 

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).

HTA by the numbers

511 days
Average delay for medicines launched in Europe, aggravated by “rigid health technology assessment interpretations of value.”

Heard on the street

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“… [B]uilding our understanding of the relationship between surrogate outcomes and how they influence longer-term health outcomes … has led to an increase in drugs that are approved based on improving a surrogate outcome in clinical trials.”
– Dr. Jacoline Bouvy, Technical Director, UK NICE Scientific Advice