Why the value story comes first
A value dossier is most useful when it is written early enough to shape the evidence, not only to summarise it. Drafting the value story before pivotal data read out exposes the gaps that payers will notice, while there is still time to plan analyses that close them.
What we deliver
- Early value stories and evidence gap analysis
- Global value dossiers (GVDs), including interactive formats
- Payer value propositions and payer question-and-answer guides
- Value message testing with payers and HTA advisers
- Affiliate adaptation guides and training
- Publication planning for economic and burden-of-illness evidence
- AMCP-format dossiers for US payers
Consistent from dossier to submission
We keep the clinical, economic and patient value narrative consistent from the GVD to HTA submissions and market access strategy, so affiliates and payers hear the same, defensible story.
What a strong global value dossier looks like
A global value dossier is a reference document first and a persuasive one second. Affiliates, HTA teams and medical colleagues return to it many times, so its qualities are practical ones:
- A clear value story: A short set of value messages, each linked to the evidence that supports it, so readers see the argument before the detail.
- Every claim referenced: Statements traceable to trials, systematic reviews, indirect comparisons or published economic evidence, with the strength of each source made clear.
- Balanced presentation: Uncertainties and evidence gaps acknowledged alongside the benefits, which builds credibility with payers and HTA advisers.
- Modular structure: Disease burden, unmet need, clinical value, economic value and patient perspectives in sections that affiliates can lift into local documents.
- Consistency with the HTA evidence: The same populations, comparators and assumptions as the submission models and dossiers.
- A planned update cycle: Clear version control, with updates timed to data readouts, label changes and new comparators.
A dossier with these qualities also works as a planning tool. Writing each value message next to the evidence behind it shows, early and precisely, where a claim rests on a single trial, an indirect comparison or an assumption that a payer may ask about. Those observations feed directly into the evidence plan: a further analysis, a utility study, a real-world data source or a refined claim. In our experience, this is where an early GVD repays the effort most clearly.
Value dossier, value story and HTA submission
These documents share the same evidence but serve different readers:
| Global value dossier | Value story and payer question-and-answer guides | HTA submission | |
|---|---|---|---|
| Main reader | Affiliates, market access and medical teams | Field teams and payer-facing colleagues | HTA body and its assessors |
| Purpose | Comprehensive, referenced reference source | Concise messages and prepared answers to likely questions | Formal evidence for a reimbursement recommendation |
| Format | Long-form document or interactive tool | Short summaries, slides or cards | Agency template, model and appendices |
| Evolves | Updated through development and launch | Refined as messages are tested | Fixed at submission, then responses and resubmissions |
| Economic content | Summary of global economic evidence and the core model | Headline value and affordability messages | Full model to the agency reference case, with budget impact where required |
Keeping the three aligned is as important as the quality of each. When the value story, the dossier and the submission draw on the same populations, comparators and estimates, affiliates can move quickly from the global materials to local documents, and payers hear a consistent account of the product wherever they meet it.
How it connects to the evidence and HTA work
The value dossier sits at the centre of the evidence plan. Its clinical sections draw on systematic literature reviews and indirect treatment comparisons; its economic sections draw on cost-effectiveness and budget impact models. In the EU, the joint clinical assessment covers relative clinical effects only, so the economic value story is told nationally, and a GVD designed around the expected PICOs can support both the JCA dossier and national submissions. Our analysis of one evidence plan for NICE and the JCA and our HTA requirements comparison show how the pieces fit together.
For launches in England, Scotland, Wales and Ireland, the GVD becomes the starting point for NICE, SMC and AWMSG submissions and NCPE submissions, with the global model adapted to each reference case through model adaptation.
For the United States, the same evidence base can be organised to the AMCP Format for Formulary Submissions, a widely used framework for presenting clinical and economic evidence to US health plans and other payers. In our experience the content overlaps substantially with a GVD, so planning both together saves work and keeps the messages aligned across regions.