What is a global value dossier?

A global value dossier (GVD) is an internal document designed to be used as a global source material for local market access teams in pharmaceutical and biotechnology companies.

A GVD helps to establish the product value proposition with decision-makers who will be responsible for adoption, access, reimbursement, and funding.

How should a GVD be structured?

A GVD should be structured with worldwide submission templates, requirements, and guidelines in mind, allowing efficient population of local submissions, while maintaining the integrity of the global value story.

The aim of a great GVD should be to cover as many ‘global payer requirements’ as possible, with coherent and robust value story

Source: How to build an optimized GVD to populate local HTA/payer templates

What should be included in a high-quality GVD?

A GVD aims to meet the requirements of health technology assessment (HTA) templates; but up to 30% of global HTA template requirements may not be met by a traditional GVD.

A high-quality GVD should include the following elements.

1. Adequate justification

HTA agencies require robust justification for all submission parameters. Clear rationale in global documents will provide local teams with the strategic guidance or depth of information required for their submissions.

Key parameters requiring justification may include (but are not limited to):

• appropriate comparator
• patient-relevance and validity of endpoints
• generalizability of the data
• economic model inputs

2. Sufficient trial and analysis information

HTAs require comprehensive trial and analysis information; this is often included in the GVD summaries but the detail is often insufficient.

For global teams to provide local markets with the correct data cuts and the detailed information required, additional information should be provided in appendices, or through clear links to signpost affiliates to the data they need.

3. Consideration of humanistic burden

Several HTA agencies assesses patient-reported outcomes (PROs) as part of health-related quality of life (HRQL) and patient-relevant morbidity outcomes.

A clear narrative between demonstrating the humanistic burden of the disease and current treatments, and the benefits of the proposed product, should therefore be demonstrated in a GVD.

4. Economic impact

Although many HTA agencies do not formally assess cost-effectiveness, information on the investment and tools required to use the proposed product versus the current standard of care should be included in GVDs, to meet HTA requirements. For example, changes to treatment setting and service organization.

5. Evidence summaries

One size does not fit all when it comes to GVDs and HTA templates; therefore, evidence summaries should be reported alongside the detail, to address different levels of information requirements in local submissions.

Free resources for developing a high-quality GVD: helping you save time and resources and accelerate patient access

Within the HTA process, effective communication of global strategy and product value to affiliate teams is crucial. These free guides provide recommendations for improving the structure and content of your GVD to support the efficient development of high-quality local HTA submissions:

Designing a GVD that meets local payer requirements

How to build an optimized GVD to populate local HTA/payer templates

How to accelerate the generation of simultaneous, high-quality HTA submissions

Source: How to build an optimized GVD to populate local HTA/payer templates

Supporting your market access teams with their GVDs

PRMA Consulting is part of Fishawack Heath, and our international experts are on hand to help you overcome the common challenges experienced when creating GVDs and HTA submissions.

Focused on the key value messages for your product, our digitally enabled GVD services map evidence to HTA and payer requirements in major markets and provide strategic insights to guide affiliates.

Case studies

Find out how we partner with clients to enable faster patient access to therapies that improve health outcomes.

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