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EU HTA Regulation: Expect The Unexpected When It Comes To PICOs

 
• By Eliza Slawther

Manufacturers should undertake scenario planning exercises and simulations to prepare for questions that will be asked under the upcoming EU HTA Regulation, but unpredictable questions are likely to arise, experts from Cencora caution in this first of two articles on the new EU joint clinical assessments.

Unexpected questions
• Source: Shutterstock

The forthcoming EU-level joint clinical assessments (JCAs), which will apply for advanced therapies and oncology products from 12 January 2025, will involve companies answering questions in their dossiers known as PICOs (population, intervention, comparator, outcomes).

The PICO framework forms the basis of JCAs under the new HTA Regulation ((EU) 2021/2282). JCAs are similar to relative...

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