Global Value Dossier
Pubrica develops global value dossiers and AMCP Format dossiers for life-science companies preparing products for launch and payer submissions. Without a central dossier, affiliates often develop their own versions of the value proposition, some of which cite superseded trial results. A global value dossier is a single maintained evidence source that every market draws from, and in the United States the AMCP Format submission is built to version 5.0. Pubrica’s value dossier writers develop and maintain the dossier, prepare the AMCP Format submission where the United States needs one and provide adaptation guidance for affiliates.
- One source, many submissions: the dossier serves as the evidence base rather than another document to keep aligned
- AMCP Format 5.0 for the US, published April 2024, including its guidance on health disparities and Pre-Approval Information Exchange
- Structured for Format 6.0, for which public comment closed on 22 April 2026, with the final version expected in October 2026
- Every claim traced to its source, so that affiliates can see which claims may be made in their market
- Ongoing maintenance, because the evidence changes and an outdated dossier creates risk
Evidence base assembled and sourcedIncluded
Value messages with evidence behind eachIncluded
AMCP Format 5.0 versionIncluded
Affiliate adaptation guidanceIncluded
Promotional claims beyond the labelNot offered
Evidence → sourced → messaged → dossier → adapted
- One maintained evidence source
- Every claim traced to a reference
- AMCP Format 5.0 where the market is US
- Adaptation guidance for affiliates
- Updated as evidence changes
Deliverables
Four Components of Every Global Value Dossier
A global value dossier is a reference document rather than a sales document, and it allows every downstream claim to be checked against its source.
From the dossierWithout this, affiliates receive a message deck with no sources, which they either ignore or use in ways that create compliance problems.
From the US submissionPublic comment on Format 6.0 closed on 22 April 2026, and the final version is expected in October 2026. A dossier structured now can incorporate the changes without being rewritten.
From the structureA dossier that opens with product attributes rather than unmet need presents a value argument before establishing the need for it.
From the maintenanceA dossier citing a superseded analysis is harmful, because affiliates will use it and payers are likely to notice.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Global Value Dossier Standards and Guidelines
Claims in a value dossier are limited by the product label and the evidence that supports them.
AMCP Format 5.0 (formulary submissions)
The US format for unsolicited and pre-approval evidence submission to health care decision makers, published April 2024. Version 6.0 is in development, with public comment closed on 22 April 2026 and the final expected October 2026.
CHEERS 2022 (reporting economic evaluations)
The consolidated health economic evaluation reporting standard. Twenty-eight items covering model structure, inputs, assumptions, uncertainty and conflicts — and the checklist reviewers and HTA bodies increasingly ask to see completed.
PRISMA 2020 (systematic review reporting)
The reporting standard an HTA body expects a submission’s systematic review to meet, including the flow of records, the search reproducibility and the handling of studies excluded at full text.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our certified quality system governs how work is run, recorded and released.
Responsible Use of AI
Our Approach to AI Use in Value Dossier Development
HTA reviewers examine every part of a submission, so each structural assumption, input and source must be attributable. NICE has published a position on AI use in submissions, and traceability, rather than speed, governs how we use AI tools.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote its own accuracy figures, as they would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Our Process
How Our Value Dossier Development Process Works
We assemble the evidence before developing value messages, so that every message is supported from the start.
Evidence Assembly
We gather evidence on the burden of disease, the current standard of care, clinical outcomes and economics systematically rather than relying on readily available sources.
Evidence Gap Identification
We identify and state what the evidence does not support, so that gaps can be addressed through further studies rather than through wording.
Value Message Development
We write value messages from the evidence, each with its source and an assessment of the strength of that source.
Local Adaptation and Maintenance
We provide market-specific guidance for affiliates, an AMCP Format version where the US is in scope, and scheduled updates as new evidence becomes available.
Our Experts
Your Global Value Dossier Team
A named team of subject specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Determines what the work can claim on the basis of the evidence. The subject expert is matched to your topic and tells you clearly when the evidence does not support the intended conclusion.
Responsible for every decision that depends on the numbers. Confirms before analysis begins whether the data can answer the question, and hands over the code so the analysis can be re-run independently.
Identifies the evidence on which the work is based and documents the search so that it can be reproduced. Writes the search strategy line by line for each platform and delivers it dated and reproducible.
Reviews the work independently of the first pass and reconciles the two, because most errors in this work are transcription errors rather than errors of reasoning. All disagreements are logged and adjudicated.
Packages
Value Dossier Packages
Pricing depends on the indication, the volume of evidence and the number of markets that adapt the dossier.
Global value dossier
For products approaching launch
Quoted per projectOn indication and evidence volume
Delivery By scope
- ✓Burden of disease and unmet need
- ✓Clinical and economic evidence assembled
- ✓Value messages with sources
- ✓Evidence gaps identified
- ✓Adaptation guidance for affiliates
Best completed before affiliates begin writing their own materials, when it provides the most value.
Deliverables Request a quoteAMCP Format submission
For US formulary submissions and PIE
Quoted per projectOn evidence and product type
Delivery By scope
- ✓Built to AMCP Format 5.0
- ✓Structured for the Format 6.0 transition
- ✓Pre-Approval Information Exchange deck
- ✓Economic evidence to the format
- ✓Health disparities section where relevant
Format 5.0 calls for brevity, and a dossier that does not follow this guidance is read less carefully.
Deliverables Request a quoteMaintenance
For dossiers already in use
Quoted per projectOn update frequency
Delivery Scheduled
- ✓New evidence folded in
- ✓Superseded analyses removed
- ✓HTA decisions and guideline changes tracked
- ✓Version history available to affiliates
- ✓Messages revised where evidence moved
An outdated dossier that remains in circulation carries more risk than having no dossier.
Deliverables Request a quoteSend us your current dossier and we will audit its claims against their sources at no cost, identifying any that the evidence no longer supports.
FAQs
Global Value Dossier FAQs
If your question is not answered here, please ask an expert. No quote is required.
No. A global value dossier is the internal evidence source every market draws from. An AMCP Format submission is a specific US document, built to a published format, addressed to health care decision makers.
The AMCP submission is usually derived from the value dossier, which is the most economical approach and keeps the two documents consistent.
Version 5.0, published in April 2024, is the current format and the one health care decision makers are working to.
Version 6.0 is in development. Public comment closed on 22 April 2026 and the final version is expected in October 2026, so a dossier built now should be structured to incorporate it without being rewritten.
At a minimum, the dossier should be updated when a pivotal readout arrives, a comparator changes, a guideline is revised or a major HTA decision is published. For an active product, this is usually more often than once a year.
The version history is as important as the update, because affiliates need to know whether the copy they are using is current.
No, and it should not be written as a promotional document. A value dossier is an evidence reference, and in the US the AMCP Format exists specifically to govern unsolicited and pre-approval information exchange.
Promotional material is a separate discipline governed by different rules, and combining the two creates compliance risk.
Related Services
Related Market Access Services
The global value dossier is the central evidence source for the documents below.
1DOCUMENTS DERIVED FROM ITdownstream
HTA submission dossierOne per agency, from the same evidence core. EU Joint Clinical AssessmentThe clinical assessment.2ECONOMIC ANALYSISdeveloped alongside
Cost-effectiveness modelThe economic argument. Budget impact modelThe affordability argument.3EVIDENCE SYNTHESISbuilt first
Payer evidence reviewSystematic review and comparison. Health economicsThe discipline behind all market access work.Request a Free Claim Audit of Your Current Value Dossier
You will receive a list of the claims the evidence still supports, those it never supported, and those that have since been superseded.