OBJECTIVES: The EU Regulation on HTA applies as of January 2025 which covers joint clinical assessments (JCA) and joint scientific consultations (JSC) across Member States (MS). Although the operating procedures are still being developed by the HTA coordination group (HTACG), this study aims to analyze the regulation and its presumable impact on manufacturers’ preparation, and present an adapted Market Access framework including core activities to ensure commercial success considering price and reimbursement decisions remain under the remit of MS.

METHODS: We analyzed the current provisions and gaps of the regulation, press releases and grey literature, to assess the implications on Market Access activities from a manufacturer’s perspective. The conclusions drawn are based on the authors experience in advising manufacturers on pricing, reimbursement in Europe.

RESULTS: Gaps still exist in the procedure: the JSC process, timeframe of the JCA PICO scoping process and publication of the final report, the integration of JCA to MS HTA processes. Mapping the process with informed assumptions, manufacturers should potentially request a JSC at Phase 2, parallel to an Early Scientific Advice if needed, to validate PICO scope at both EU and national levels. Insights are then integrated to the Phase III trial. The year following EMA regulatory submission is dense with activities. Assuming the PICO scoping process lasts 2 months from EMA submission, the manufacturer will only have 4 months to finalize their EU-HTA dossier hence preparation must start prior to EMA submission. National HTA dossiers preparation must also run in the same period after regulatory submission.

CONCLUSIONS: The EU-HTA regulation condenses core activities in a shorter timeframe. Our analysis presents an initial Market Access framework pending more guidance being released in the coming months. Timelines may become shorter as the new EU Pharma Strategy also proposes the reduction of authorization time of new medicines.