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