Abstract

The start of the EU-HTA in 2025 requires a framework guiding HTA bodies and manufacturers reliably and efficiently through the process. The necessary guidelines are currently developed by the EUnetHTA 21. Herein, the scoping process is of particular importance as it defines the scientific questions to be addressed in the assessment. Stakeholders (e.g., manufacturers, associations, service providers) are supposed to be involved in the guideline development by means of a public consultation. It is unclear if and how the hereby identified criticism is addressed by the EUnetHTA 21.

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