Implementation of the EU's Health Technology Assessment regulation: where does existing methods guidance require concretization and what are the relevant methodological options?

ABSTRACT:

Objectives

The EUnetHTA Core Model^® is well-established in the HTA community. Some recommendations of corresponding guidance documents leave room for alternative methodological choices. Considering the new HTA regulation (HTAR), we aimed to identify needs for concretization (NCs) in EUnetHTA guidance and provide indicative methodological options.

Methods

We carried out a qualitative document analysis and structured group discussion. Twenty-two EUnetHTA documents were screened using transparent criteria. Identified NCs were classified into topics according to the PRISMA statement and presented to Austrian HTA practitioners (n = 11) during a structured group discussion. Participants rated NC's importance. To identify potential solutions, selected key handbook

SUBMITTER: Goetz G 

PROVIDER: S-EPMC11811951 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature