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, 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.

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, Vogler et al. provided an overview of the current situation regarding HTA, pricing, and funding policies for point-of-care (POC) diagnostic tests for community-acquired acute respiratory tract infections (CA-ARTI) in 17 European countries by conducting a qualitative survey of healthcare authorities. In addition, the authors provided recommendations for improvement in decision-making processes.

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, Hoogendoorn et al. presented a study, the goal of which was to develop a new framework for assessing the quality and reliability of health and wellness apps. While developing the framework, the authors obtained feedback from 83 experts, predominantly from Europe, using a two-round Delphi method. The final framework includes 81 questions that impact four overarching quality aspects, and it will help manufacturers enhance and demonstrate the quality of health 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, Klein et al. evaluated the use of real-world evidence (RWE) by HTA agencies in Europe for assessing the cost-effectiveness of high-risk medical devices. In total, 25 HTA reports using RWE data were reviewed. Authors offered a critical review of the use of RWE in these reports and provided recommendations for improvement.

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, Mantovani et al. reviewed the current regulatory and reimbursement approaches adopted for digital therapeutics (DTx) and in-vitro diagnostics (IVDs) in the US, Europe, and Australia. In Europe, authors offer an overview of reimbursement pathways in France, Germany and the United Kingdom for digital and in-vitro diagnostic technologies.

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, Ibargoyen-Roteta et al. summarized the main initiatives in relation to Early Dialogue/Scientific Advice/Early Advice given by international HTA bodies to manufacturers of medical technologies. In relation to medical technologies, the authors reviewed early dialogue frameworks of NICE (UK), Health Technology Wales and HAS (France).

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 status of the implementation of remote monitoring of cardiac implantable electrical devices. Among other topics, the study provides a useful overview of the reimbursement situation with remote monitoring of cardiac implants in Europe.

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, Ferrante et al. reviewed methodological approaches from seven HTA organizations, which perform assessments of diagnostic tests and compared approaches with non-diagnostic test HTAs. With the exception of dealing with test accuracy data, approaches were largely based on general approaches to HTA with few test-specific modifications. Elucidation of test claims and attitude to direct and indirect evidence were the areas where authors identified the biggest dissimilarities in approach.

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, Trippoli et al. examined the sufficiency of DRG tariffs for medical procedures and devices in Italy. The analysis included 24 class III or implantable devices. Authors discovered a large variability in the ratios between device price and DRG associated with its use. This ratio ranged from a minimum of about 3% in the case of the Hyalobarrier gel for post-surgical adhesion to a maximum of 132% in the case of the Neovasc Reducer, a device indicated in the narrowed coronary sinus.