Five Commonly Made Mistakes and Case Studies for Global Value Dossier/Core Value Dossier and AMCP Dossiers

NOVEL Health Strategies
3 min readSep 17, 2019

In the dynamic global market of today, the key to the success of any medical product’s pricing and market access lies in how well the product value story resonates with the consumers, how distinctly its value attributes align with the needs of the customers, and how it differentiates versus comparators. For medical products the Global Value Dossier (GVD) is a critical document to demonstrate these attributes of a product value proposition. Here, NOVEL Health Strategies team is sharing insights from more than a 100 GVDs that the team has developed, updated or reviewed.

What is a Global Value Dossier or Core Value Dossier?

The Global Value Dossier is a fundamental market access tool that enables the organization to communicate the value of its products and conveys the product value story. It is a single strategy document that presents a summary of all clinical, quality of life, health outcomes, and economic evidence on a product. A GVD organizes all the supporting data for the medical product into a complete offering, facilitating the user to make the best use of its unique selling points concerning its market. In short, the Global Value Dossier communicates the value proposition story to all relevant stakeholders.

Unfortunately, a few common mistakes make it challenging for Global Value Dossier to communicate the value proposition. Preventing the following errors while developing the GVD can genuinely enable it to be used in the right capacity;

It is not a Data Dump: The primary purpose of a Global Value Dossier is to be a value presenting the document. Many times this function of the GVD is violated when large amounts of data and tables are incorporated in the document. Instead of being able to present the meaningful value of the product to the users, the Global Value Dossier becomes a data dump. Incorporating unnecessary data and tables causes an information overdose for the user, and the real value of the GVD is lost. Like a CV or resume, information in the GVD should help sell the product.

Missing the Message: Effective communication should be at the core of every Global Value Dossier, enabling the consumer to find the relevant information easily and quickly. The foremost goal of a GVD should be to present the critical message, supported by all the needed evidence, in an effective and efficient manner. By excessively focusing on providing a compendium of evidence, the key message to be communicated may get lost in the noise.

Missing the Payer Perspective: In order for the Global Value Dossier to establish an effective communication structure with the consumer, it needs to be customized to the needs and requirements of the end-user. The GVD has to be tailored to include the product relevant payer perspective. The definition of payer stakeholders vary by product type (drug versus device), settings of use (out-patient versus in-patient) and reimbursement mechanism (bundled payments, high co-pay/coinsurance). By targeting the message to the relevant payer stakeholder, the GVD will be able to communicate the message more efficiently.

Lack of Systematic Literature Review: Another commonly made mistake when developing the Global Value Dossier is not conducting a systematic review of the literature. A well-defined research methodology is at the heart of any document that strives to convey its message to the targeted audience effectively. Conducting a systematic review of the literature towards the development of the GVD helps in preventing errors and also aids in presenting the GVD in a Health Technology Assessment (HTA) approved methodology.

Lack of Total Value Proposition: One of the major goals of a Global Value Dossier is a total value proposition to the stakeholder. The overall value proposition should incorporate all the clinical, safety, humanistic, economic, and market access value story for the consumer. If any such aspect of the value proposition is missing, it fails the entire purpose of the GVD.

Case Study on Leveraging Real-World Evidence to Demonstrating Value of Product Class and Product Versus Comparators

Case Study on Building a Clear and Concise Value Story Versus a Large Data Dump

Recent case study of a global value dossier for a medical device:

Contact NOVEL Health Strategies GVD team at