Publications Digest

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, Caro noted the increasing use of models to forecast disease outcomes and intervention effects, particularly highlighted during the COVID-19 pandemic. To address the need for validation and systematic critical review of increasing numbers of models, the journal Pharmacoeconomics is launching a series of papers focusing on critical reviews of modeling approaches in specific disease areas, including pharmaceutical and non-pharmaceutical interventions, as well as diagnostic procedures. The short introduction outlines the scope and coverage of the review papers in the series.

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, Thokala et al. introduced the concept of “Living Health Technology Assessment (HTA)”, which is considered to be an approach to address the issue of outdated reports by establishing a process for regular updates. The authors described the practical implementation of the “living HTA” approach including the challenges and considerations involved and highlighted scenarios where “living HTA” could be especially advantageous.

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, Michaels et al. described the challenges surrounding the implementation of evidence-based clinical guidelines developed by national authorities and organizations. The authors examined the conflicts (objectives, values, and preferences) between stakeholders that develop and those that should implement clinical guidelines by analysing the situation at the National Institute of Health and Care Excellence (NICE) in England. Furthermore, the authors discussed the implications of these conflicts and provided recommendations for implementing guidelines effectively.

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, Tarricone et al. reviewed the new EU regulations for medical devices and health technology assessment, highlighting their potential benefits in increasing clinical evidence quality and reducing fragmentation in the EU market access process. The authors also provided recommendations for the structure of a potential new Accelerated Access Pathway for innovative, high-risk (in particular implantable and class III) medical devices which would fit the pan-European context and safely accelerate patient access.

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, Otten et al. conducted a comprehensive review of methods for uncertainty assessment in model-based health economic evaluations. The authors identified a total of 80 uncertainty methods and categorized them into identification, analysis, and communication methods. The findings of this review can support analysts and decision-makers in selecting appropriate uncertainty assessment methods for their purposes and stage of assessment.

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, Gensorowsky et al. reviewed the legal framework and challenges for market access and pricing of digital health applications (DiGA) in German statutory health insurance (SHI) settings. In addition, the authors provided an evidence-based approach to value-based DiGA pricing that considers the positive healthcare effects and approximates the willingness to pay by the sickness funds. The proposed approach can provide objective guidance for price negotiations, although numerous methodological and procedural issues related to DiGA pricing are still unsolved.

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, Boriani et al. evaluated the expectations and opinions of healthcare professionals in Europe on reimbursement policies for the use of digital devices (including wearables) in atrial fibrillation and other arrhythmias. The study summarized information about the use of digital devices, trust in digital technologies, and availability of reimbursement of digital technologies in individual EU countries.

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, Drummond et al. analyzed the actual alignment between the current practice of coverage with evidence development (CED) schemes for medical devices in Europe and the theoretical principles proposed by health economists. In addition, the authors provided a series of recommendations that should support decision-makers in developing and conducting CED schemes in the future, as these schemes can provide real-world evidence on the performance of 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, Drummond et al. analyzed the actual alignment between the current practice of coverage with evidence development (CED) schemes for medical devices in Europe and the theoretical principles proposed by health economists. In addition, the authors provided a series of recommendations that should support decision-makers in developing and conducting CED schemes in the future, as these schemes can provide real-world evidence on the performance of 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, Ciani et al. analyzed international HTA practice of the actual considerations around using surrogate endpoint evidence for both pharmaceuticals and medical devices. Based on the analysis, the authors developed a web-based tool which helps health technology assessment agencies and payers assess the clinical and cost-effectiveness of healthcare technologies by considering surrogate endpoints and, thus, support the decision-making 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, Messori et al. analyzed five HTA reports of high-risk medical devices (classes IIb and III, and active implantable devices) that included cost-effectiveness data, developed in the Tuscany region. The analysis demonstrated a high level of concordance between value-based prices and actual prices, which suggests a wider application of the value-based pricing framework for high-risk medical devices, which, however, requires an adequate level of cost-effectiveness data.

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, Weir et al. reviewed the use of surrogate endpoints in health technology assessment (HTA) processes used to evaluate drugs and biologic therapies and developed an overview of statistical methods for surrogate evaluation. In addition, the authors described how regulatory authorities, payers, and HTA agencies use clinical trial evidence based on surrogate outcomes. Despite the focus on pharmaceuticals, the article can be of interest to the audience from the med tech space as well.