For years, the Global Value Dossier (GVD) has served as the foundation for communicating a product's value story across global and regional teams. While highly effective as a strategic reference, traditional GVDs are inherently static documents. As evidence evolves and affiliate teams begin adapting materials for local Health Technology Assessment (HTA), pricing, and reimbursement submissions, maintaining consistency across markets becomes increasingly complex.
This challenge became particularly apparent when a US-headquartered, clinical-stage biotech prepared to launch its first product in Europe. With regulatory timelines approaching and investor commitments looming, the company needed to tailor its pricing and reimbursement strategy across five priority European markets while maintaining a consistent global value narrative.
Rather than relying on a traditional Global Value Dossier alone, our consulting partner, AESARA, used Arysana’s software platform ATLAS to create a connected digital environment for managing country-specific value messages, supporting evidence, and evidence-generation activities throughout the launch program.
Launching across Europe requires balancing a consistent global strategy with the unique requirements of individual HTA agencies and variations in clinical practice. The evidence, comparators, and value messages that resonate in one market may differ from those required in another.
Managing these relationships through spreadsheets, slide decks, and static documents makes it difficult to maintain alignment between value messages, supporting evidence, identified evidence gaps, and ongoing evidence-generation activities. As projects evolve, ensuring that every market is working from the most current strategy becomes increasingly resource intensive.
Using ATLAS as the central platform, the AESARA team digitally organized the product's value strategy into a connected framework that could be accessed by both global and country-level teams.
This enabled several key capabilities:
Dynamic Value Mapping: Core clinical, economic, and humanistic value messages were digitally linked directly to the specific clinical studies, post-hoc analyses, and real-world evidence (RWE) activities supporting them.
Market-Specific Views: Local country teams could instantly filter the global strategy to focus on the value messages, evidence, and activities most relevant to their local HTA requirements while remaining aligned with the broader global strategy.
Continuous Alignment: As strategies, evidence, and timelines evolved, updates were reflected centrally, keeping cross-functional teams aligned in real time. Reducing the delay between evidence generation and its incorporation into the global value strategy helped ensure that market access planning and HTA submission preparation were informed by the latest available evidence.
This article highlights the software platform that supported the engagement. To learn more about the consulting strategy and execution behind this European launch, read the AESARA European HTA Submission Programme Case Study.
Learn about the Digital Global Value Dossier
Learn how ATLAS functions as a connected digital Global Value Dossier for value messages, evidence, and activities.
