Blog Anke van Engen
Gaining reimbursement for new medicines is complex. First you need to generate the right evidence and second you must successfully communicate it to a wide range of organisations. 

Clinical development is a global function but value communication is the responsibility of local teams requiring collaboration between market access, marketing and medical affairs. The Global or Core Value Dossier (GVD) are essential tools in the collaboration between local affiliates and Global HQ. The GVD is intended to support affiliates with national Health Technology Assessments (HTAs) and pricing and reimbursement submissions. GVDs are usually produced centrally with the intention of ensuring alignment of the value story across countries. They are typically single documents that contain all the evidence of the clinical, economic, and humanistic value of a new intervention as well as data on the global burden of illness for that particular therapeutic area. 

However, local affiliates are rarely satisfied with the materials. Common complaints are that they are delivered too late and don’t address the reality of the local situation. Further, our research found that the understanding of what a GVD) is and what it should do is inconsistent between HQ and local affiliates. This can mean the global value dossier is simply not used by local markets, particularly those outside of the EU-5. 

Quintiles conducted qualitative interviews with 53 health economics and outcomes research (HEOR) and market access professionals to: identify their views on the purpose, use and utility of the GVD; identify key differences and alignments in HQ and local affiliate views and the ideal contents and format of a GVD. Key findings were that better communication of the purpose of the GVD is needed between HQ and affiliates and that there should be more active participation by local affiliates in developing the dossier, to ensure it is relevant and appropriate for their market. 

Can changes be applied to the current GVD to improve its fit for purpose? 

Improving the process could lead to earlier and more comprehensive launch readiness for companies. A few key changes would ensure that the needs of affiliates are met which would lead to a better process for local HTA submissions, better evidence for discussions with national and regional payers, more effective budget impact assessment and earlier. Value communications between HQ and affiliates should be iterative as evidence is developed and analyzed. This will help ensure that the GVD is used by local affiliates and that the core market access strategy is aligned across markets. 

These changes would involve:

  • The development of a platform to facilitate interaction between affiliate and HQ and allow for sequential and timely publication of key documents
  • Advanced training for affiliates to become familiar with the new product or therapeutic area and provide useful insights on what their local needs will be for market access. 
  • A core economic model and budget impact model supported by guidance for local adaptations, such as objection handling. 
  • A core set of materials that focuses on burden of disease, treatment pathway and clinical value of the intervention. This should be written and disseminated prior to final FDA/EMA approval and early enough for affiliates to start preparing local submissions. 
  • Process for sharing best practices, including encouraging affiliates to publish lessons learned and share developed documents such as adapted models, local HTA dossiers, and case studies 
In terms of structure, a living set of documents that is aligned with the different HQ departments will help integrate the varying needs and strategies. Moving from a single GVD file that serves multiple purposes to an easy accessible, modular information set with specific purposes will help affiliates to easily find the information they need as they develop materials in preparation for launch. It would be easily accessed and contain both a section with core documents relevant to all affiliates as well as a country-specific section addressing all the requirements specific to each country.
Topics in this blog post: Biopharma, Evidence, EU, Emerging Markets, Market Access, Payers, Value