Orphan drugs: market access challenges in Europe from a German perspective

Mon, 2018 / 11 / 19
Nowadays, market access of pharmaceuticals requires a health technology assessment (HTA) in most European countries. Particularly orphan drugs are assigned a special role in most countries. The German AMNOG process belongs to the most straightforward and transparent HTAs in Europe.

A publication from Tim Kirchmann, Astrid Ewald and Prof. Matthias P. Schönermark M.D., Ph.D. evaluates the AMNOG procedures with subsequent price negotiations involving drugs with orphan drug designation and compares the results at European level to figure out success and failure strategies in Europe, especially in Germany. Challenges for the European market access of orphan drugs were analyzed, mainly based on learnings from AMNOG procedures supported by results from the rest of Europe, especially HAS and NICE, also reflecting the inclusion of International Reference Pricing (IRP) in the price-determination mechanisms in the different countries.

The publication will be published in one of the next issues in “Value in Health”, a monthly international, indexed journal. A poster had been presented at the ISPOR Europe 2018 in Barcelona showing the corresponding analysis and results. Please download the full ISPOR poster here. As experts for market access of orphan drugs, we at SKC look forward to exchanging our thoughts with you.
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