The problem with the GVD…

Almost all companies with a product in development will develop a global value dossier (GVD) to support launch. Every product needs a well-defined value strategy that answers the question “what is the benefit of the product in the context of the current unmet need?” There is a clear need for a vehicle to capture and disseminate both the value strategy and the supporting evidence. However, the traditional approach to the GVD is no longer fit for purpose.

Firstly, we have observed that the objective of the GVD has expanded over the years to an unachievable state. The GVD should be the tool by which the value strategy is communicated – concise, strategically focused, regularly updated. However, many companies try to also use the GVD as a repository of all evidence and a source of content for reimbursement submissions. As an internally focused strategic tool, the GVD was never intended as a source of text for an HTA submission. Trying to achieve both goals in a single vehicle necessarily results in neither being met effectively. The result is a lengthy data repository that is difficult to navigate, and which requires careful study to understand the value messaging for the product.

Secondly, we have observed that many companies have developed a template structure for the GVD that must be used consistently across products. While the intent behind this is admirable, the reality for many teams is that this structure has not been revisited for many years and feedback from the end users has either not been sought or not been integrated into a revised approach. While it ensures consistency, a template can stifle innovation, force inclusion of irrelevant content, and divert attention away from the true goal – communication of the value strategy for the specific product in the specific patient population.

Finally, a key gap that is consistent across all GVD templates that we have seen is the patient voice. With the patient at the heart of what we do, their wants, needs, and activities are not captured anywhere in the traditional GVD. This cannot continue, and will require more than the insertion of an additional chapter or section within an existing GVD template. At Parexel we understand value strategy, and have a clear perspective on how to achieve market access using the value strategy as the framework for all activities – including the development of the GVD. For more information stop by our booth # C3-083 at ISPOR Europe, Copenhagen or reach out to me via email ebony.samuals@parexel.com.

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Ebony Samuels

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