Publication Digest: Methodological expectations for demonstration of health product effectiveness by observational studies

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, Mascarenhas et al. analyzed the landscape of economic evaluations for medical devices in pediatrics, critically appraising their methodological rigor. The systematic literature review identified 39 economic evaluations, with a focus on high-risk therapeutic devices mostly studied in high-income countries. The analysis showed a predominant use of cost-utility analysis and considerable variation in adherence to CHEERS 2022 reporting standards. The findings highlight the need to improve reporting quality and develop methods that reflect the unique health needs of children, including outcome measures meaningful to pediatric patients and their families.

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, Lipska et al. explored the policy challenges surrounding the implementation of the EU HTA Regulation, drawing from the discussions of a high-level expert group convened in Rome. The authors proposed actionable recommendations to facilitate the effective launch of the Joint Clinical Assessment framework. Their key insights stress the need for transparent communication, stakeholder engagement, and equitable commitment from all member states to reduce access delays across Europe.

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.

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.