Benefit assessment and market access for medicinal products

From consultation meetings with the Federal Joint Committee (G-BA) to dossier strategy, dossier preparation, statement, hearing and price negotiations – we offer a comprehensive service

At the centre of the benefit assessment lies the benefit dossier, which is divided into 5 different modules. The modular or complete compilation of this dossier is one of the core competencies of co.value. A multi-professional team of medical writers, health economists and medical statisticians experienced in benefit assessment reliably ensures that you enter the benefit assessment with an optimal dossier. The better the dossier, the better your prospects of a positive benefit assessment and successful price negotiations with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds). This is why we do not compromise on dossier quality.

Before the dossier is prepared, we will define the dossier strategy with you in a joint strategy workshop and prepare you for the consultation meeting at the G-BA. We then prepare the dossier in close consultation with you. Once the dossier has been evaluated, we will make a draft statement, prepare you for the hearing and, if you wish, represent you in price negotiations with the GKV-Spitzenverband. co.value has already been involved in over 50 AMNOG proceedings.

How you can benefit from our services:

  • Comprehensive monitoring of the benefit assessment procedure - from strategic planning and dossier preparation to statement, hearing and price negotiation
  • Preparation of high-quality benefit dossiers - single modules and complete dossiers
  • Comprehensive strategic advice on dossier strategy, and analysis of evidence gaps
  • AMNOG-compliant statistical analyses and data preparation, meta-analyses, indirect comparisons and network meta-analyses according to the methods paper of the independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG)
  • Development of epidemiological models for Module 3 of the benefit dossier
  • Comprehensive preparation/simulation of the early consultation meeting with the Federal Joint Committee (G-BA) and hearing
  • On request, representation in the hearing and price negotiations

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