EU HTA Publication Digest: Implementation of the EU's Health Technology Assessment regulation: where does existing methods guidance require concretization and what are the relevant methodological options?

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, Polmear et al. examined the growing application of Bayesian statistical methods in orthopedic research, highlighting their advantages over traditional P value-based approaches. The authors emphasized how Bayesian analysis can offer more nuanced interpretations in clinical contexts. Through practical examples ‒ such as diagnostic decision-making in prosthetic joint infection and comparative analysis from the orthopedic trial ‒ the review illustrated key Bayesian concepts and offered guidance for critically evaluating such studies.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Ali et al. explored practical strategies to reduce the ecological impact of dermatological surgery in the UK, aligning with the National Health Service's commitment to sustainability. The review outlined key system-wide approaches, including reducing overall surgical activity through prevention, promoting research and innovation, and enhancing service management. The authors also highlighted the critical role of managerial policy, procurement practices, and supply chain dynamics in supporting broader national and international sustainability goals.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, Donovan et al. introduced Cost-IS, a novel tool designed to support the economic evaluation of implementation strategies for digital health solutions. Its development followed a structured, multi-phase approach involving a literature review, expert interviews, and a modified e-Delphi process. A panel of 12 multidisciplinary experts reached a consensus on the instrument’s core design, though additional piloting is required to evaluate its real-world feasibility and generalizability.

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, Bourke et al. proposed a novel conceptual framework to support Health Technology Assessment (HTA) processes in reflecting the real-world burden on caregivers. Addressing the current gap in HTA practices caused by limited methodological guidance, the authors offer a structured approach to capture caregiving intensity and duration. Their recommendations aim to assist policymakers, researchers, and manufacturers in aligning HTA submissions with a broader societal perspective.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Tanner et al. examined key cross-functional challenges stemming from Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA) and how manufacturers should address them in their EU HTAR readiness plans. Conducted through literature review, guidance analysis, and manufacturer insights, the study identified five key cross-functional areas: global asset strategy, non-EU regional readiness, launch sequence evolution, brand perception, and pricing impacts. Given the central role of market access in bringing innovation to patients, the EU HTAR will have far-reaching implications, with early Joint Clinical Assessment reports expected to significantly influence brand strategy, pricing dynamics, and global launch sequencing.