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, Brönneke et al. examined the implications of Germany's 2019 Digital Healthcare Act on the reimbursement pathway for patient-centered digital health applications (DiGA).  The authors outlined the challenges facing DiGA manufacturers in generating evidence required for ongoing price negotiations and reimbursement, proposing adaptations to current health technology assessment methods to accommodate the dynamic nature of DiGA assessment, and emphasizing the role of continuous evaluation using real-world evidence (RWE) in this process.

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, Steigenberger et al. investigated barriers and facilitators in health technology assessment (HTA), pricing, and funding policies pertaining to the utilization of rapid point-of-care diagnostics for patients with community-acquired acute respiratory tract infections. The authors conducted expert interviews with representatives from five European countries and identified key challenges, such as the lack of evidence and limited transferability of methods from drug-based HTA to diagnostics, alongside pricing barriers due to the absence of price regulation and weak purchasing power. They underscored the importance of optimized peri-launch policies to enhance the adoption of point-of-care tests.

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, Pearson et al. proposed a novel value assessment framework for digital health technologies (DHTs). Given the diversity of DHT modalities and the lack of standard regulatory and payer pathways, the authors aimed to establish evidence standards tailored specifically for DHTs, guiding technology developers in generating robust evidence. This framework can help organizations in adopting high-impact DHTs with the strongest evidence for delivering improved clinical outcomes and cost savings.

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, Dittrich et al. conducted a systematic review to assess the evidence quality and manufacturers' approaches regarding digital health applications (DiGA) in Germany following the Digital Healthcare Act. The results revealed evidence-related gaps, such as the relatively low quality of most of the available studies for inclusion in the DiGA directory with high potential for bias and limited external generalizability. The authors highlighted the need for addressing found evidence gaps and further studies of higher quality to improve the evidence base concerning the benefits of prescribable apps.

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, Eckhardt et al. investigated the evolution of clinical evidence and the utilization of 25 innovative technologies in German inpatient care. Through systematic searches and empirical analysis, the authors revealed that the body of clinical evidence per technology often consisted mainly of non-comparative studies, and its robustness increased over time for many but not all technologies. The results highlighted the need for strengthened market approval standards, HTA pathways, and approaches like coverage with evidence development to ensure informed reimbursement decisions.