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EU HTA Publication Digest: Shaping a suitable EU HTA dossier template: why the German template is not fit for purpose
MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest.
In a recent publication, Schweitzer et al. explored the suitability of the current German HTA dossier templates for the impending EU joint clinical assessment (JCA).
The study examined how extensively safety endpoint and subgroup analyses in German dossiers were actually considered by IQWiG and the G-BA.
The authors found that the current German HTA templates significantly increased the workload of HTA developers while leaving many reported outcomes unconsidered by IQWiG and G-BA. To mitigate duplicative efforts and ensure prompt availability of medicinal products in line with the EU HTA Regulation framework, the authors recommend well-defined dossier requirements, early consultations, and proactive engagement with HTA developers.
Access the full-text article here