Article

HTA Quarterly Winter 2024

In this edition, we look ahead to the introduction of the European Union (EU) Joint Clinical Assessment (JCA), with a focus on predicting likely PICOs (population, intervention, comparator, outcomes) mandated in the submission template. Two related articles review completed German AMNOG assessments in detail to evaluate how the stringent G-BA requirements translate into practice, considering how evidence requirements vary between orphan and non-orphan drugs, and acceptance – or not – of indirect comparisons when head-to-head evidence is not available.
HTAQ

Article

Not long until the Joint Clinical Assessment begins: Will PICO anxiety become a reality?
HTAQ

Article

Unveiling the evidence gap: Orphan drugs vs. non-orphan drugs in German health technology assessments
HTAQ

Article

Navigating indirect comparisons in health technology assessments: Insights from German AMNOG evaluations

Heard on the street

“Confirmation that a breakdown of country-level PICOs will not be released as part of the new JCA process coming into force in January 2025. This means manufacturers will need to engage directly with HTA bodies to understand what additional evidence or information will be required to achieve national access – bearing in mind that duplication with the JCA content is not permitted.”

- Dr. Ruairi O’Donnell, Senior Director, Global Consulting Business Development at Cencora, comments from the European Federation of Pharmaceutical Industries and Associations (EFPIA) meeting at the European Parliament, Strasbourg, France

Source: Health Technology Assessment in Europe, Transformation, Performance?

By the numbers

25%

The UK Medicines and Healthcare products Regulatory Agency (MHRA) expects approval applications for new active substances to rise by 25% by 2026. The target is for at least 50% of its future evaluations of new innovative therapies for marketing authorisation to be conducted under its national assessment route, with other applications going through the new International Recognition Procedure (IRP). 

Source: UK MHRA: ‘At Least Half’ of Novel Drug Filings to Take National Assessment Route

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