OBJECTIVES: EU HTA is a new process, commencing 2025. Intention is to facilitate national market access activities. For this, both workstreams (EU, national) have to be aligned. With EU HTA applicable to 27 countries with the same number of reimbursement systems, a common conceptual understanding is required to support alignment. What would be the characteristics of such an EU Market Access core model?

METHODS: The analysis identifies common denominators for the various national Market Access activities from the perspective of the health technology developer and sets them into the context of EU HTA. Based on this a draft core model is developed. Applicability is verified with a Delphi panel of Market Access experts covering key European countries.

RESULTS: Each national Market Access process can be separated into four phases, each with distinct work packages. National strategy development consists of clarifying the specific Market Access route, PICO simulation, gap analysis, pricing simulation, definition of strategy, national advice meeting with HTA agency, and early access activities. National dossier development covers dossier outline, HTA SAP, statistical (re)analysis, dossier writing, dossier alignment, quality check, dossier submission, product launch. National assessment includes assessment strategy, submission defense, and reviewing the HTA report. National price negotiation is made up of negotiation strategy, negotiation preparation, actual negotiation, conflict resolution, price submission, lessons learned. Monitoring and stakeholder management are additional work packages, relevant for all phases. EU HTA can also be separated in three phases, i.e., EU strategy development, EU dossier development, and EU dossier assessment. For each phase of EU HTA similar work packages can be defined.

CONCLUSIONS: This EU Market Access core model covers the complete national as well as EU Market Access workstreams. Thereby it provides a common conceptual framework to align various work packages around Market Access from the perspective of the health technology developer.