BACKGROUND: To support product Market Access, organizations will develop a GVD and an AMCP dossier. Both documents require substantial time and effort to develop. Disease Burden: AMCP dossiers require high-level disease descriptions and US-specific burden of disease information. GVDs require the same information, but from a detailed global perspective. Clinical Evidence: While both dossiers require clinical study summaries, AMCP study summaries include specific elements and are more detail than GVD study summaries. Additionally, AMCP dossiers require extensive evidence tables; GVDs may not include evidence tables. Economic Value: AMCP modeling sections are based on US-specific models; GVDs generally contains the core model(s). Other areas of overlap include presentation of relevant treatment guidelines and HTA decisions. Additionally, it is important to consider the overall focus and “theme” of the dossiers. AMCP dossiers are focused on the product’s clinical evidence, organized in a specific format, with limited interpretation of data and no explicit value story. GVDs are built around a specific value story, with flexibility in organization and evidence presentation. While content may overlap, directly transferring text between documents is rarely possible, and content revisions are required to align with the specific type, audience, and messaging/theme of each dossier.
OBJECTIVES: To determine areas of overlap and possible efficiencies when developing GVDs and AMCP dossiers.
METHODS: AMCP Format guidelines (version 4.0) and GVD content and best practices were reviewed and compared. Internal process maps for constructing each type of dossier were developed and compared to identify areas of overlap and possible efficiencies.
RESULTS: Areas of overlap exist regarding dossier content:
CONCLUSION: While there are several areas of overlap between the dossiers, specific content must be tailored to different audiences and purposes. Developing a clear plan before beginning work can help identify potential efficiencies, allowing for a more streamlined and perhaps less costly development process.
