Publications Digest: Decision-analytic modeling for early health technology assessment of medical devices - a scoping review

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, Hulstaert et al. investigated the level of evidence supporting innovative high-risk medical devices (class IIb-III) during their market entry phase. The authors reviewed assessment reports from the Belgian healthcare payer (RIZIV-INAMI) concerning novel implants and invasive medical devices (n=18) available between 2018 and mid-2019 and conducted a literature review on evidence gaps within the European legal and ethical frameworks. The findings highlighted issues with the evidence provided for CE marking, indicating that clinical effectiveness is not ensured by regulatory compliance alone. The study underscored the necessity for improved clinical evidence transparency and alignment with international ethical standards to ensure patient safety and efficacy in the realm of novel medical devices.

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, Schaefer et al. assessed the effect of official evaluation criteria, including the role of budget impact (BI), on health technology assessment (HTA) outcomes employed by the Federal Joint Committee (G-BA), Institute for Quality and Efficiency in Health Care (IQWiG) in Germany, and National Institute for Health and Care Excellence (NICE) in England. Analyzing data from 2011 to 2018, the authors underscored the consistent adherence of G-BA/IQWiG and NICE to official evaluation criteria while also revealing an independent influence of BI on HTA outcomes, potentially carrying implications for health policy decisions.

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.

In late June 2023, the Belgian Health Care Knowledge Center (KCE) published a report on relevance of transversal budget impact analysis. This type of analysis should be submitted as part of the application to the National Institute for Health and Disability Insurance (INAMI-RIZIV) to obtain reimbursement for implants and invasive medical devices.