Publication Digest: Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges

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, Dijk et al. piloted the CHEQUE tool in the context of systematic reviews of health economic studies in medical education, aiming to assess its usability and inform future improvements. The authors applied CHEQUE to 21 economic evaluations, uncovering a wide range in quality scores (18%‒94%) and a positive correlation between methodological rigor and reporting standards. The study highlighted CHEQUE’s value as a structured assessment tool but also pointed to the need for refinements to reduce complexity and enhance clarity.

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, Freitag et al. explored negotiation strategies for pricing and reimbursement of prescription-based mHealth apps (DiGA) in Germany. Based on 16 expert interviews, the authors introduced a four-step framework detailing price determination, payment conditions, payment modalities, and negotiation governance. Statutory insurers expressed a preference for usage-based pricing, while a value-based care model was identified as delivering the greatest patient benefit.

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, Pannelay et al. explored the evolving challenges of implementing the EU Health Technology Assessment Regulation, highlighting the burden of aligning national PICO requirements across Member States. The study showed that up to 720 evidence analyses per product may be required ‒ covering various permutations of population, comparator, and outcome ‒ raising serious concerns about feasibility and submission quality. The article also presented a user guide for applying generalized cost-effectiveness analysis to better capture societal value and examined the ongoing debate over NICE’s implementation of the severity modifier tool in the UK.

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, De Simone et al. evaluated the environmental impact of liver transplantation procedures performed in Italy by a retrospective bottom-up approach. The authors assessed energy use, waste, anesthetic consumption, and units of blood products transfused for each transplant. The study revealed that each transplant procedure generated about 310 kg of CO₂ emissions, with operating room energy consumption contributing the largest share. The findings highlight the importance of engaging transplant clinicians, hospital administrators, policymakers, and patients in efforts to promote more sustainable practices.

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, Kachapila et al. conducted a systematic review to investigate the integration of economic evaluations into multiarm, multistage, adaptive Randomized Controlled Trials. The review included 17 articles, with four reporting results of economic evaluations and 13 presenting economic evaluation protocols. Although costs and benefits could be estimated at interim stages in 14 studies, only five interim cost-effectiveness analyses were performed, and just three influenced decisions to drop or maintain trial arms. Overall, the use of economic evidence remains limited, despite its potential value in guiding adaptive decisions.