ISPOR EU 2025

Analysis of Historical European Medicines Agency (EMA) Marketing Authorization (MA) Timelines: Will EU Joint Clinical Assessment (JCA) Timelines Be Longer Than Expected?

Paula Skowron, Ajinkya Bendre, Julieta Zlateva, Vivek Chandola, Vinay Kanthi, Peter Wagner, Anke van Engen, Sian Tanner, Edel Falla, Ikhlaas Kasli

Are we there yet? Mapping member state readiness for local implementation of the EU Health Technology Assessment (HTA) Regulation

Savvas Dimiou, Edel Falla, Sian Tanner, Ansa Ibok, Valentine Berthet, Doreen Bonduelle, Daniel Callejo, Tijl De Celle, Brittany du Preez, Maaike Janssen, Maria Kalogeropoulou, Agnieszka Koppolu, Robert Krüger, Gloria Lombardi, Pauline Pasman, Anke van Engen, Max van Wijk, Jacek Wieczorek

Challenges at the interface between EU-HTA (JCA) and national HTA in Germany (AMNOG): Expected limitations to synergy effects and implications for AMNOG dossier preparation

Marie Becker, Janika Drews, Sandra Gellert, Magdalena Oberhauser, Angelika Poppele, Caroline Scheulen, Penelope Gallinger, Doreen Bonduelle

External controls: What does it take to get real?

Aimée Hamblin, Hopin Lee, Kellyn Arnold, Lourens Bloem, Emmanuelle Boutmy, Natasha Bury, Stephen Duffield, Wim Goettsch, Ashley Jaksa, Carmen Tsang, Anke van Engen

Get JCA-ready: Mastering PROs for market access success

Xenia Sitavu-Radu, Edel Falla, Livia Lai, Montserrat Casamayor, McVin Cheen, Mohamed Gad, Sofia Oliveira Ferreira, Tom Halmos

Guidance for real-world evidence generation for the Joint Clinical Assessment process and its implications for country-specific HTA body acceptability

Georgios Papadakis, Ansa Ibok, Spyros Kolovos, Jennifer Gaultney, Edel Falla

Lifecycle stage-specific prioritization of Joint Clinical Assessment PICOs: Balancing access potential, feasibility, and likelihood

Savvas Dimiou, Ana Lisica, Sian Tanner, Edel Falla

Optimizing PICO scoping in EU HTA: Lessons from an HTA Coordination Group PICO exercise in advanced NSCLC to inform future best practice

Nebibe Varol, Reginald Villacorta, Max Prokopovich, Adam Lee, Ana Lisica, Adam Parnaby

Overall Survival adjusted for subsequent treatments: A review of health technology assessments

Mariëtte Strydom, Maximilian Schlueter, Pauline Herscu, Evelina Bertranou

Paving the path to success for Joint Clinical Assessments – one asset at a time

Dorothee Mugele, Paula Skowron, Nicole Papenhagen, Saskia van Dijk, Anke van Engen

Readying for the second wave: What, when and how must orphan medicine manufacturers prepare for EU HTAR?

Dan Newsome, Edel Falla, Sian Tanner, Anke van Engen

Simulating PICOs to predict evidence requirement implications of the EU Joint Clinical Assessment: Learnings from 24 case studies

Savvas Dimiou, Edel Falla, Sian Tanner, Lise Amoura, Pascaline Faivre, Nabila Faour; Natalie Green, Ansa Ibok, Fani Kotseva, Robert Krüger, João Leite, Ana Lisica, Benjamin Mynors-Wallis, Dan Newsome, Corinna Oswald, Alexandre Quequet-Leyssieux, Xenia Sitavu-Radu, Benedetta Spadaro, Anastasia Stamoulou, Paula Skowron, Anke van Engen, Jessica Walters

The Evolving Horizon of Oncology: Predicting the Impact of the EU HTA Regulation for 2026-2029

Laura Candelora, Margherita Marchetto, Gloria Lombardi, Duccio Urbinati

Transparency tested: Conflict of interest in EU HTA

Jessica Walters, Ioannis Reklos, Anke van Engen, Sian Tanner, Edel Falla

ISPOR EU 2024

Comparison of the guidelines for quantitative evidence synthesis in the European Union (EU) joint clinical assessment (JCA) of medicinal products to current methods for health technology assessment (HTA) in Germany

Martina Maier, Christina Meier, Marie Becker, Caroline Scheulen, Julia Specks, Marie Hinnenthal, Katrin Blondrath, Alexander Rich, Magdalena Oberhauser, Penelope Gallinger, Doreen Bonduelle, Anke van Engen

Comparison of the joint clinical assessment (JCA) dossier with the German Medicines Market Reorganization Act (AMNOG) dossier – what content remains to be presented in the AMNOG dossier after implementation of JCA?

Marie Becker, Martina Maier, Isabel Ernst, Denise Böckmann, Maximilian Rauch, Magdalena Oberhauser, Penelope Gallinger, Doreen Bonduelle, Anke van Engen

EU joint clinical assessment (JCA): Uncertain impact on German AMNOG timelines and potential delays

Janika Drews, Martina Maier, Edel Falla, Anke van Engen, Penelope Gallinger

Could the European joint clinical assessment (EU JCA) delay access to new medicines in France?

Dima Samaha, Valentine Berthet, Lise Amoura, Marine Olive

From clinical assessment to drug reimbursement in Spain: Current timelines and potential impact from the joint clinical assessment

Mafalda Carmo, Pablo Encina, Marco Pinel, Daniel Callejo-Velasco

Potential impact of joint clinical assessment (JCA) on health technology assessment timelines in Ireland

Michael McCarthy, Edel Falla

When timelines collide: How EMA regulatory milestones can impact the JCA process, and implications for manufacturers and member states

Dan Newsome, William Fox, Edel Falla, Anke van Engen

The butterfly effect: Impact of EU HTA on price evolution via international reference pricing

Sian Tanner, Rebecca Coady, Benedetta Spadaro, Giorgio Karapetsas, Anke van Engen

A blueprint for success: The importance of multi-stakeholder alignment for EU health technology assessment (HTA)

Aikaterini Fameli, Sally Chung, Sian Tanner, Thomas Paulsson, Indranil Bagchi

Indirect treatment comparisons with full individual patient data for joint clinical assessment: Lessons learned and best practices from a review of HTA appraisals

Max Schlueter, George Nikolaidis, Robert Krüger

Predicting PICOs to prepare for joint clinical assessment – learnings from 19 case studies

Anke van Engen, Edel Falla, Corinna Oswald, Paula Szawara, Ana Lisica, Robert Krüger, Dan Newsome, Sian Tanner, Benedetta Spadaro, Jess Walters, Anastasia Stamoulou, João Leite, Ansa Ibok, Fani Kotseva, Alexandre Quequet-Leyssieux, Oliver Curtis, Anna Kullnigg, Xenia Sitavu-Radu, Lise Amoura

Vaccines and EU HTA: Exploring misalignments between joint clinical assessment requirements and a hypothetical vaccine evidence package

Sian Tanner, Dorothee Mugele, Rebecca Coady, Pascaline Faivre, Anke van Engen

A comparison of the acceptability of evidence in the new joint clinical assessment and nine European Union countries

Veronique Lambert, Bhakti Arondekar, Justin Doan, Savvas Dimiou, Ana Lisica, Corinna Oswald, Edel Falla, Sarah Karchere

Predicting the evidence requirement implications of the European Union (EU) joint clinical assessment (JCA) by conducting a Population, Comparator, Intervention, Outcome (PICO) simulation for two anticancer investigational medicinal products (IMPs)

Eirini Anastasaki, Nicolas Despiegel, Franziska Dirnberger, Anke van Engen, Istvan Majer, Corinna Oswald, Paula Szawara, Rumbi Takundwa, Sunny Ubi

The horizon of oncology: Estimating the impact of new EU Regulation on health technology assessment for 2025-2028

Laura Candelora, Margherita Marchetto, Gloria Lombardi, Michele Caimmi, Paola La Malfa, Duccio Urbinati

Including patient experience data in the HTA decision-making framework: A proposal based on HTA-stakeholder interviews

Isa Hemmer, Marieke Krol

Use of artificial intelligence and machine learning (AI/ML) in systematic literature reviews (SLR): Review of state-of-the-art health technology assessment and future directions

Ketevan Rtveladze, Theodora Oikonomidi, Nermina Ferizovic, Kalyan Pulleddula, Bala Ganesh Geddamuri, P Agrawal, Tanushree Chaudhary

Do we need to adapt our health technology assessment (HTA) systematic literature review (SLR) methods to comply with the new Joint Clinical Assessment (JCA) SLR?

Theodora Oikonomidi, Tanushree Chaudhary, Sheily Kamra, Kalyan Pulleddula, Bala Ganesh Geddamuri, P Agrawal, Jennifer Gaultney, Ketevan Rtveladze