EU HTA Publication Digest: What is needed to successfully implement the EU HTA Regulation enabling broad patient access in Europe

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Cucherat et al. proposed formalized methodological criteria for observational studies to serve as credible evidence for health product effectiveness, comparable to randomized controlled trials. Developed through a French expert roundtable, the framework emphasizes predefined protocols and statistical analysis plans, robust causal inference, and minimization of bias. The results offer a structured approach to support regulatory decisions and guideline development.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Vanderwee et al. introduced a pragmatic decision-making approach for healthcare facilities with tools to select environmentally sustainable alternatives to replace single-use options. A cross-sectional multi-center survey in Belgian hospitals was performed, followed by an exploratory analysis of the sustainability of commonly used healthcare materials. The authors developed a structured assessment method, combining real-world procurement data and literature-based evaluations to inform sustainable, safe, and cost-effective material choices.

On March 4, 2025, the Member State Coordination Group on Health Technology Assessment (HTACG) published submission (‘briefing’) templates for Joint Scientific Consultations (JSC) of medical devices and in-vitro diagnostics under the EU HTAR framework. Health Technology Developers submit completed briefing templates as part of the briefing package to be considered for JSC. The JSC Outcome Document template was published as well.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, Elsner et al. conducted a literature review to evaluate the economic value of cardiovascular implantable electronic devices for heart failure treatment, with a focus on the European context over the past 10 years. The review assessed the economic implications of various device therapies, including cardiac resynchronization therapy with a pacemaker (CRT-P), CRT with a defibrillator (CRT-D), implantable cardioverter-defibrillators (ICDs), pacemakers, and (semi)automated telemonitoring, using QALYs and ICERs as standardized measures of cost-effectiveness. All cardiovascular implantable electronic devices were found to fall within commonly accepted cost-effectiveness thresholds.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Arcà et al. conducted a comparative analysis of national HTA frameworks for digital therapeutics (DTx) assessed in Germany, the UK, and France. By analyzing cross-country HTAs for two digital therapeutic products, the study revealed substantial differences in assessment criteria and evidence requirements. Despite the divergence, there was a shared emphasis on product positioning within the clinical pathway, the appropriateness of chosen comparators, and considerations of usability. Safety received limited attention, but a request is often made for the addition and evaluation of risk-flagging systems.