Raising the standard for GVDs

Developing a better Global Value Dossier

BY Ebony Samuels, Vice President & Beenish Majeed, Senior Associate, Parexel - 10.17.19

The global value dossier (GVD) has become a standard tool throughout the life sciences industry for supporting product launch and local health technology assessment (HTA) submissions.  There is a clear need for internal dissemination of both the value strategy for the product and the supporting evidence required for reimbursement.

However, 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.  As a result, GVDs often become lengthy documents that lack a clear value strategy.  The risk here is that what was a strategic tool becomes an evidence repository – and when that happens, where does local affiliate understanding of the value strategy come from?

The optimal GVD is concise and value-focused, with clear identification of the unmet need for a given patient population (value drivers) and specific messaging focused on how the product fulfills this unmet need (value messages).  The key value messages should form the backbone for the GVD that, supported by the relevant, KEY evidence, creates a clear value story. 

This easy-to-understand narrative allows affiliates to build their local HTA submissions, applying local country-specific evidence, to ensure global alignment on the product strategy.  This also avoids the generation of a “data dump” that becomes difficult to navigate.  The GVD should never be used as a repository – additional supportive information can and should be housed in a separate document that can be used for reimbursement support (“reimbursement support dossier”).

Linked to this issue, many companies choose to have a standard template for their GVDs.  The aim is admirable: alignment across products that provides familiarity and aids affiliates in navigation/data identification within the dossier.

While this may be the intention, a restrictive template can divert attention away from the value strategy for the product and lead to the inclusion of content that is not applicable simply because it is a section within the template.  Every product is different, has a unique value strategy, and individual value messages focused on the value drivers in the patient population. 

As such, no two GVDs can be, or should be, exactly alike in included content and structure. Further, as the global reimbursement landscape continues to evolve and payer needs change, any GVD template that is in place cannot remain static.  It is therefore important to constantly innovate your GVD both in terms of intended use, achieved via feedback from end users, and functionality in achieving the overall goal: internal communication of the value strategy.

Finally, the GVD should incorporate the patient voice. Patient perspectives serve to anchor in our minds the tangible significance of the relevant disorder, and thereby effectively illustrate the burden of disease and the impact of treatment in ways that statistics cannot.  Traditionally, the patient voice is not an aspect that is incorporated in the GVD, as is reflected by a historic disconnect between the payer and the patient and the growing use of the GVD to feed reimbursement submissions.  However, patients are at the heart of what we do, and are becoming increasingly important stakeholders in the market access of medicines.

Further, while the patient voice needs to be carefully considered when included in formal reimbursement submissions, inclusion within the GVD as an internal tool can be very effective.  The patient perspective underlies why your teams should invest their time and energy on this product, for example, through the addition of individual patient quotes and/or patient group survey results throughout the dossier.

Indeed, the majority of us working within the pharmaceutical industry do so out of a desire to make a difference in patient lives, and omitting this voice from an internal strategy document fails to acknowledge that motivator.  When your team needs to work long days and nights to achieve reimbursement, understanding the benefit the patient will receive as a result of their efforts can be a significant behavioral driver.

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