Jörg Ruof

Two Survival Cuts, One Silent Substitution: The Lurbinectedin Joint Clinical Assessment

Mondher Toumi, Samuel Aballéa, Laurent Boyer, Maarten Postma et autres

This methodological commentary examines the Joint Clinical Assessment (JCA) report of lurbinectedin combined with atezolizumab as maintenance therapy for extensive-stage small-cell lung cancer, based on the phase 3 IMforte trial. The JCA's evaluation rests on two overall survival data cuts: a confirmatory, …

Begleitgedanken zur DIN SPEC 91494

Jörg Ruof

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Critical Analysis and Feasibility of PICO Exercise Developed by the Joint Clinical Assessment Subgroup for etranacogene dezaparvovec

Mondher Toumi, Aleksandra Matjaszek, Izabela Moszkowicz, Aleksandra Caban et autres

Avoiding Error and Finding the Right Balance in European Health Technology Assessments: Insights Generated by the European Access Academy

Elaine Julian, Tom Belleman, Maria João Garcia, Maureen Rutten‐van Mölken et autres

BACKGROUND: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment (EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures …

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HPR133 The Global Impact of EU HTA: Insights From 13 Non-EU Countries

M. A. C. G. Garcia, Isabel M. Monteiro, SA Kommandantvold, T Buckfelder et autres

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HPR68 How to Overcome the Remaining Challenges for Successful Implementation of the EU HTA Regulation: Key Insights From the 2023 European Access Academy Spring Convention and Survey

Francine Brinkhuis, Elaine Julian, Hendrika van den Ham, Jörg Ruof et autres

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PD226 Integration Of Patient And Clinician Insights Into The European Union Joint Scientific Consultations And Joint Clinical Assessments

Elaine Julian, Robin Doeswijk, Rosa Giuliani, Wim Goettsch et autres

Introduction To summarize insights generated during the preceding four conventions of the European Access Academy (EAA) regarding the interface of patient organizations and medical societies with the evolving European Union (EU) health technology assessment (HTA) process. Methods In 2022 and 2023 four …

OP54 Different Perceptions Of Additional Benefit By Payers And Providers: Discrepant Voting Within G-BA’s Benefit Appraisals

Andrej Rasch, Elaine Julian, Jörg Ruof

Introduction Appraisal decisions on additional benefit of new medicines within the German health technology assessment (HTA) body Gemeinsamer Bundesausschuss (G-BA) are made by voting among the member of the G-BA plenary. We identified and analyzed key characteristics of decisions that were not …

Technology Assessment vs. Technology Appraisal—How to Strengthen the Science/Value Dichotomy with EU HTA?

Sandro Gsteiger, Heiner C. Bucher, James M Ryan, Jörg Ruof

Many countries around the world use health technology assessment (HTA) to inform reimbursement and pricing decisions. HTA is often split into two steps, called assessment and appraisal. While the term HTA itself has been defined by international consortia, there is heterogeneity in …

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Evaluating progress towards implementation of the European HTA Regulation: Insights generated from the European Access Academy's multi-stakeholder survey

Francine Brinkhuis, Jörg Ruof, Hendrika van den Ham, Fabrizio Gianfrate et autres

Objectives We conducted a multi-stakeholder survey to assess stakeholders' perceptions of the progress made towards the implementation of the European Regulation on Health Technology Assessment (EU HTA R) and to identify and prioritize the remaining challenges for implementation. Methods Using two iterative …

Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy

Francine Brinkhuis, Elaine Julian, Hendrika van den Ham, Fabrizio Gianfrate et autres

BACKGROUND: The European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At "midterms" of the preparation phase …

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The Role of Medical Societies and the Relevance of Clinical Perspective in the Evolving EU HTA Process: Insights Generated at the 2023 Fall Convention and Survey of the European Access Academy

Elaine Julian, Oriol Solà-Morales, Maria João Garcia, Francine Brinkhuis et autres

BACKGROUND: This work aimed to determine the role and action points for the involvement of medical societies in the European Health Technology Assessment (EU HTA) Methods: An online pre-convention survey was developed addressing four areas related to the EU HTA: (i) medical …

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