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EU Needs Market Access Improvements Beyond New HTA Regulation

 
• By Eliza Slawther

While the EU Health Technology Assessment Regulation could reduce divergence in reimbursement decisions made across member states, many national-level HTA hurdles and challenges will remain, market access experts from EFPIA say.

Euro pills
• Source: Alamy

The Health Technology Assessment Regulation ((EU) 2021/2282), which is set to apply in the EU from January 2025, will see some elements of HTAs undertaken at an EU level. For example, medicines will undergo joint clinical assessments (JCAs), which are similar to relative efficacy assessments and will be carried out in parallel with the centralized regulatory assessment of a drug.

The HTA Regulation presents an opportunity for member states to “speak with a more unified voice, in terms of their expectations,” Mihai Rotaru, director for market access at the R&D-based pharmaceutical industry body EFPIA, told the Pink Sheet in an interview

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