Market access in Germany
Demonstrating the added clinical benefit of an innovative medicine is key for a successful launch.
Successful launches demonstrate the clinical benefits of innovative medicinal products
Benefit assessments as part of market access in Germany
Conducting a structured analysis of clinical evidence is an integral part of HTAs in Germany
AMNOG benefit dossiers, an overview of § 35a SGB V
AMNOG benefit dossiers, according to the German Social Code, Book Five (SGB V), section 35a.
In Germany, AMNOG and the resulting requirements for benefit assessment according to § 35a SGB V have fundamentally changed the conditions for market access and pricing of pharmaceuticals. Almost without exception, all new medicinal products including hospital products, orphan drugs, and advanced therapy medicinal products, fall under regulations for benefit assessment, which trigger mandatory submissions to the G-BA for an HTA.
All of Xcenda’s offerings in this area are based on your individual needs. We develop and prepare complete value dossiers, or only individual modules or sections. We offer strategic advice and support in developing a value dossier for Germany, as well as professional reviews or stress tests of existing dossiers.
On every project, we take a scientific approach, coupled with a broad understanding of the needs and objectives of your company’s diverse functions and perspectives. Our approach ensures communication with your global process-related issues.
Based on experience gained from 200+ AMNOG-related projects, more than 100 medicinal products, and the preparation of 80 complete dossiers, we have a deep understanding of the opportunities and pitfalls in the German HTA process. Xcenda’s AMNOG expertise and our highly qualified market access team—staffed with pharmacists, epidemiologists, and experts in biomedicine—form the basis of our consulting work. Previous assignments focused on hematology-oncological indications, orphan drugs, diabetes, and various immunological diseases are all represented in our portfolio.
Full support on AMNOG-related market access—from strategy through price negotiation
Dossier preparation is just one of many integrated tasks to ensure successful market access in Germany
Our portfolio for AMNOG-related market access support includes the following:
Supporting medical devices that are subject to extensive assessment by the G-BA
Market access for medical devices
Systematic reviews: meta-analyses and indirect comparisons
Addressing data gaps through systematic assessment of existing evidence compared to an innovation
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