Value & Dossier advises Pharmaceutical and Biotechnology Companies in the AMNOG Process and in all matters of Market Access and Reimbursement.
Strategic dossier development with medical writing and statistical expertise for AMNOG and EU HTA
Tailored strategies for your product with our HTA expertise, gap and market analyses, our reference price calculator and more
Our AMNOG tool gives you a compact overview of the possible price range for your product.
Our experienced team supports pharmaceutical companies in bringing new products to market – whether through the German or the European procedure. From strategic planning and dossier preparation to successful price negotiations, we guide you safely through the entire health technology assessment process. We offer customized, business-specific solutions that highlight the value of your product and translate it effectively into benefit dossiers. Our expertise covers all aspects of the market access process, including reimbursement support and topics such as reference pricing, rebate contracts, and market analyses.
After more than 25 years of experience in market access, we are still fascinated by the unique strategic and substantive challenges that each individual project brings. Our clients’ success is what drives us and fuels our ambition. We approach every project with passion and provide high-quality analyses and customized solutions that best serve our clients’ interests.
Pediatric drug shortages: has the situation really improved? In recent years, Germany has faced shortages of essential medicines for children, including antipyretics and antibiotics. To encourage manufacturers to increase production and supply, the GKV-SV (GKV-Spitzenverband, German SHI association)…
Since the beginning of 2025, member states of the European Economic Area (EEA) have been working together on joint clinical assessments (JCA) of new medicines. Recently, the first 9 JCAs were announced, assessing 2 ATMPs with Orphan drug status and 7 oncologics. Germany, France, and Ireland are curr…
Products with initial market entry after January 1st, 2025 are now benefiting from less strict pricing guidelines if the studies used for AMNOG benefit assessment included ≥ 5 % German patients. The benefit will last for 3 years and can be maintained even afterwards for companies with active R&D…
Changes to the German pricing system for innovative drugs are now in effect due to the Medical Research Act (Medizinforschungsgesetz, MFG). As of January 1st, 2025, European reference prices will no longer be included in the price negotiations according to § 130b SGB V following AMNOG benefit assess…
