Global value dossier (GVD)

What is a global value dossier (GVD)?

A global value dossier is the central, modular evidence document a manufacturer maintains for a product. It pulls the clinical, economic and humanistic evidence into one place, argued rather than simply listed, so that every affiliate is working from the same value story. The GVD is not itself a submission. It is the source that country teams draw on when they build an HTA submission, a payer dossier, a formulary pack or a value message set for a local market.

What goes into a GVD?

Most dossiers follow a recognisable structure, even if the running order differs by company:

• Disease background and unmet need: epidemiology, burden of illness, current treatment pathway and where it fails patients.
• Product profile: mechanism of action, licensed indication, dosing, administration and place in therapy.
• Clinical evidence: pivotal trial design and results, subgroup and long-term data, safety, and indirect or network meta-analyses against relevant comparators.
• Real-world evidence: registry, claims and observational data on effectiveness, adherence and treatment patterns.
• Humanistic evidence: patient-reported outcomes, quality of life and caregiver burden.
• Economic evidence: cost-effectiveness and budget impact models, cost-offset arguments, and the assumptions behind them.
• Value messages and evidence gaps: the claims the company will make, the evidence supporting each one, and an honest register of what is still missing.

Why is a GVD important in market access?

Without one, each market rebuilds the argument from scratch, and the claims start to diverge. A good GVD keeps global and local teams aligned, cuts duplicated analytical work, shortens the time it takes an affiliate to produce a submission, and makes the evidence base auditable when a payer challenges a claim. It also surfaces evidence gaps early, while there is still time to run a study or an analysis to close them.

When should a GVD be developed?

Earlier than most teams expect. Ideally a first version exists around two to three years before launch, in parallel with phase III, so that evidence gaps can still influence trial design, comparator choice and outcome selection. A dossier written after the data lock can only describe the evidence that exists.

How is a GVD different from an AMCP dossier or a local value dossier?

The GVD is global and internal. It is written for affiliate teams and is deliberately broad, holding more evidence than any single market will use. A local value dossier is the adaptation: the same story cut down to the comparators, cost inputs, treatment pathway and decision criteria of one country. An AMCP dossier is a specific, format-driven submission for US payers following the AMCP Format for Formulary Submissions. A GVD feeds both.

How often should a GVD be updated?

Treat it as a living asset, not a launch deliverable. A typical rhythm is a scheduled review every six to twelve months, plus an out-of-cycle update whenever pivotal data reads out, a label changes, a new comparator enters the market, or a major HTA decision reshapes the evidence expectations in a key country.

What makes a GVD actually get used?

Affiliates use dossiers that are easy to lift from. That usually means modular sections that can be pulled independently, a slide or message library alongside the narrative, clear statements of which claims are approved for which markets, referenced sources for every number, and a searchable format rather than a 300-page PDF nobody opens twice.

Common pitfalls

• Cataloguing evidence instead of arguing a case, so the reader has to construct the value story themselves.
• Writing for the global team rather than the affiliate who has to use it under time pressure.
• Ignoring comparators that matter locally but not in the pivotal trial.
• Leaving evidence gaps unstated, so they surface for the first time in a payer meeting.
• Letting the dossier go stale after launch, at exactly the point where reimbursement negotiations depend on it.