August 9, 2023

HTA Quarterly | Fall 2023

By Xcenda

With just 17 months until Joint Clinical Assessment (JCA) is implemented for oncology drugs and advanced therapy medicinal products (ATMPs) in the European Union, in this edition we consider what we know so far and what is still uncertain. The authors also reflect on the industry’s perception of the current UK Voluntary Pricing and Access Scheme and hopes for the new scheme scheduled to start in January 2024. Against the backdrop of increased payer interest in and use of US value assessment tools, we question whether ICER’s assessment framework is sufficiently rigorous to accurately capture the value of potentially transformational therapies.

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Insight

Only 17 months until the implementation of the new EU JCA—Latest developments and remaining uncertainties

The clock is ticking down to the implementation of the EU JCA, yet many questions remain. What do we know and how can we prepare for what comes next?

Insight

The cures conundrum: The importance of getting value assessment right for transformational therapies

To ensure meaningful patient access to innovative therapies, US healthcare decision-makers must embrace evidence-based value assessment methods. In this article, we consider whether ICER’s assessment framework is sufficiently rigorous to accurately capture the value of potentially transformational therapies

Insight

VPAS—Where next?

What is VPAS? No, it’s not a swear word, although anyone sitting in on recent management meetings in pharma companies across the United Kingdom (UK) could be forgiven for thinking so. VPAS is the UK’s Voluntary Pricing and Access Scheme for branded medicines. It is a voluntary agreement between the Department of Health (DOH) and the Association of the British Pharmaceutical Industry (ABPI). As the terms of the new scheme that is scheduled to start in January 2024 are being negotiated, what does this mean for biopharma companies?

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# of Joint Clinical Assessments (JCAs) for medical devices performed during the pilot phase organised by the EUnetHTA 21 consortium; no JCAs were performed for pharma products

EUnetHTA European Network for Health Technology Assessment

Heard on the street

“We are opening a dialogue with developers, academics, and other regulators, to discuss ways forward, ensuring that the full potential of these [AI] innovations can be realised for the benefit of patients’ and animal health.”

- Peter Arlett, European Medicines Agency (EMA) Head of Data Analytics and Methods, co-chair of the Big Data Steering Group

Reflection paper on the use of artificial intelligence in the lifecycle of medicines | European Medicines Agency (europa.eu)

Topics:

Consulting Market access Policy