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German Ordinance To Implement HTA Reg Leaves Room For Doubt

 
• By Francesca Bruce

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.

Germany publishes ordinance on implementing the HTA Regulation. (Shutterstock)
Key Takeaways
  • Germany has published an ordinance to implement the EU Health Technology Assessment Regulation into the German benefit assessment process.
  • The pharmaceutical industry is calling for rules on how joint clinical assessment reports are considered in the national benefit assessment process to guarantee consistency.
  • Companies need to be mindful of differences in timelines of EU-level joint clinical assessments and Germany’s national benefit assessment procedure.

The German legislator’s approach to implementing the EU Health Technology Assessment (HTA) Regulation and incorporating EU joint clinical assessment (JCA) reports into the national pricing and reimbursement system is “hesitant and

Meanwhile, the German pharmaceutical association, the VFA, welcomed the ordinance but said it “falls short” in terms of achieving the objectives of the HTA Regulation, including reducing the duplication of work

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