OBJECTIVES: (1) To give a brief overview and review of the key components of the HTA Core Model^® developed by EUnetHTA. (2) To explore its current status, benefits, and limitations. (3) To determine the likely impact of EU HTA in 2025 and provide our recommendations regarding future development.

METHODS: Given the prominence of the HTA Core Model^® in supporting collaborative HTA policies in Europe, we assessed current and archived model guidelines, and conducted a targeted review of relevant publications. This allowed for the critical review of the model’s current status, key components, benefits and limitations.

RESULTS: The model consists of a standardised set of HTA questions (ontology) that define the specific research questions, methodological guidance, and a common reporting structure. The model comprises 9 domains, 4 clinical and 5 non-clinical, assessed at the EU and national level, respectively.¹

Upon evaluation, the model has been considered useful by global market access teams and praised on its flexibility and coverage to allow country specific adaptation and alignment to the health technology under assessment.^2-4 However, comparative assessments of the model, with national reports in the Netherlands² and Luxembourg,³ reported ≤50% of the assessment elements as relevant; domains with the lowest proportion of relevant elements included ethical, social, legal and clinical effectiveness.² Elements of limited value were considered time consuming.³ Concerns were also raised regarding limited resources, model acceptance by decisionmakers, and missing elements, including re-intervention and secondary prevention.^{2, 3}

CONCLUSIONS: To further improve and adapt the model’s robustness and usability, we advise recurrent analysis and evaluation of the model’s national uptake and continued opportunities for stakeholder input as the collaborative HTA landscape evolves. We also implore HTA bodies that wish to diverge from the core model to provide justification, to highlight areas where improvement may be required.