Global Market Access & Reimbursement

A global value dossier is the internal reference document that consolidates the full evidence story for a product: disease burden, unmet need, clinical evidence, comparator context, and economic value. Global teams build it once, then affiliates adapt the relevant sections into local HTA and payer submissions. It is not itself submitted to an agency, which is why it can carry more depth than any single submission format allows.

JCA under HTA Regulation (EU) 2021/2282 requires a single clinical dossier that answers the PICO questions raised across participating member states, delivered to a fixed timeline. MadeAi supports that workflow end to end: PICO scoping, systematic search and screening, data extraction, and the production of Annex I aligned outputs. Because every extracted data point stays linked to its source, assessor questions can be answered without reopening the underlying searches.

Audience and format. A global value dossier is an internal reference written for your own teams, with no prescribed structure. An AMCP dossier follows the AMCP Format for Formulary Submissions and is written for US payers and P&T committees, with a set structure and specific handling of unapproved use information. In practice the AMCP dossier draws on the same evidence base, reorganized to the format payers expect.

Coding, coverage, and payment. Coding gives the procedure or product an identifier payers can process, usually a CPT or HCPCS code. Coverage is the policy decision that the indication qualifies for reimbursement, made by CMS at national or regional level and separately by each commercial payer. Payment is the amount attached to that code. All three have to line up before a device is reimbursed in practice, and each rests on different evidence, which is why device access programs often stall on whichever one was left until last.

Assessors do not take claims on trust. They check them, and a claim that cannot be traced to a study, table, or figure is treated as unsupported regardless of whether it is correct. Traceability also protects you internally: when new data arrives or a reviewer challenges a number, you can see exactly which source it came from and what changes if that source is updated.

That is the point of building it once. The searches, screening decisions, and extracted data behind a global value dossier are the same inputs a JCA submission, an AMCP dossier, and a local HTA file need. What changes is the framing, the comparators of interest, and the format. Reusing the evidence base is what removes the duplicated work that usually sits between global and affiliate teams.

Yes, though the pathways differ. Pharma access work centers on HTA and formulary submissions built around clinical and economic evidence. Medtech access work centers on coding, coverage, and payment, often with a thinner published evidence base and more weight on procedural and health system economics. Both draw on the same synthesis and traceability foundations.