Abstract
Rare diseases can have a catastrophic impact on patients’ lives. The European Medical Agency (EMA) has developed new Health Technology (HTA) regulations and has recently launched a Joint Clinical Assessment (JCA) for medicines (including orphan drugs [ODs]), which is now in the pilot phase. The JCA process aims to ensure a uniform clinical assessment at European (EU) level. This review explores how the new JCA route has been implemented for ODs following publication of the new EMA regulations (December 2021).
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Schedule a callMore From: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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