29.07.2025

Access Briefing Q2 - German Insights

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The latest Access Briefing is out - and from a German perspective, Q2 brought several noteworthy HTA decisions and developments. Curious about key outcomes and ongoing trends? Here’s a quick summary of what shaped the German HTA landscape this quarter by Ecker + Ecker. 👇

 Our highlights in a nutshell:

🏛️ 26 resolutions published by G-BA

First orphan drug for which a non-quantifiable additional benefit was granted (as a legal consequence) although no dossier was submitted

⚠️ One assessment for last-resort antibiotic (Ceftazidim/Avibactam)

🔁 38th and probably last assessment of Pembrolizumab due to loss of market exclusivity in 2026

🚫 One full assessment after repeal of regulatory orphan status (Epcoritamab)

📊One assessment led to reimbursement with data generation (Epcoritamab)

🚼️ Four assessments due to new pediatric indication; one (Eliglustat) 10 years after the first assessment

🔗 6 parallel assessments of Tislelizumab due to bundling of procedures

The stats:

👍 Considerable additional benefit: 5 (19%)

👌 Minor additional benefit: 2 (8%)

⭕️ Non quantifiable benefit: 3 (11%)

No additional benefit proven: 16 (62%)

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