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 Publications Digest. In a recent publication, Edgar et al. introduced Performance Outcome assessments as a valuable tool that indirectly assesses the meaningful aspects of health for evaluating the clinical benefit of therapeutic interventions. These assessments involve standardized tasks actively undertaken by patients, reflecting their various important functional skills, especially when self-report is limited, or heterogeneity is a concern. However, the authors underscored the importance of adhering to established good practice recommendations for other clinical outcome assessment types, which remain directly applicable.

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, Manetti et al. developed a novel framework for assessing readiness in successful Medical Device (MD) development and deployment. Through a four-stage process, the authors developed and validated checklists for both small (21 items) and large (15 items) enterprises. The study identified three key drivers of MD success: R&D assessment strategy, device-outcome measures, and company profiling. Additional retrospective validation with 40 case studies on MDs highlighted the crucial role of early Health Technology Assessment in industry success, varying by enterprise size.

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, Solà-Morales et al. proposed recommendations for international standards in evaluating the acceptability of data governance practices for real-world data (RWD) and real-world evidence (RWE) in healthcare. Through a literature review and the following Delphi panel with 21 European experts, the authors identified key topics in RWD/RWE data governance, such as data privacy and security, data management and linkage, data access management, and the generation and use of RWE. The resulting refined checklist can assist RWD/RWE users in ensuring the quality and integrity of data governance while complementing data protection regulations.

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, Angelis et al. appraised the methodological changes proposed by the National Institute for Health and Care Excellence (NICE) in their recent review of HTA methods. The authors categorized proposed changes as critical, moderate, or limited updates and analyzed key decisions. The study found that most changes were appropriate and had a modest impact, although some decisions lacked justification. The authors emphasize the need for further research on certain topics and the importance of safeguarding NICE's role in resource allocation for valuable interventions while maintaining rigorous evidence standards.

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, Martin et al. calculated the marginal cost per quality-adjusted life year (QALY) for different categories of care (primary care, locally commissioned secondary care, specialised services) using the data from 2016 and analysed the mortality response to healthcare expenditure on the three categories of care. The results revealed that additional investments in primary care and locally commissioned services are likely the most productive, suggesting the potential benefits of directing resources towards these categories of care.