German HTA insights from April to June 2026

Last week, we’ve announced the release of our analysis of HTA decisions across 10 countries in Europe and Canada. This week, we're taking a closer look at Germany. 🔍

 

Key Insights:

🔹 12 orphan drug assessments: 7 with an "additional benefit by law" designation and 5 full benefit assessments following the exceeding of the €30 million annual sales threshold

🔹 Three dossiers with incomplete content

🔹 One accepted adjusted indirect comparison, resulting in non-quantifiable positive effects

🔹 One time-limited benefit assessment decision due to an ongoing clinical study

🔹 Tumor volume reduction was exceptionally recognized as patient-relevant

🔹 Patient-reported outcomes (PROs) were accepted in sensitivity analyses under specific result constellations, even though response rates were well below 70%

 

🔎 Dive deeper into the German insights in our latest Access Briefing.

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🙏 Many thanks to our local partners and experts.

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