ISPOR Europe 2024

Moderator: Malwina Holownia, MSc, PhD, Certara

Panelist: Gergo Meresz, PhD, MediConcept

Panelist: Oresta Piniazhko, PhD, Ukraine Ministry of Health

Panelist: Eva Turk, PhD, MBA, Slovenia Ministry of Health

Artificial Intelligence (AI) 

Can Artificial Intelligence (AI) Accurately Screen Abstracts in Systematic Literature Reviews? ​
Dmitry Gltyaev, Noemi Hummel, Linnea Koller, Lee Stern, Ananth Kadambi, Carl de Moor 

Digital Health Technologies 

A Comparative Analysis of Requirements for Gaining Market Access of Digital Health Technologies in Germany, Spain, Poland, and Hungary​
Kurt Neeser, Michael Heupel, Malwina Holownia 

Gene Therapies 

Drivers of Access to Gene Therapies in Poland and Selected Central and Eastern Europe Countries
Elzbieta Soltysiak, Katarzyna Lasota, Gabrielle DeOcampo, Sanja Stanisic, Malwina Holownia 

Finding a Way for Patients to Access Gene Therapies​
Katarzyna Lasota, Elzbieta Soltysiak, Gabrielle DeOcampo, Matias Junghahn, Sanja Stanisic, Maximillian Vargas, Roman Casciano 

Joint Clinical Assessment (JCA) 

National Perspectives on the European Joint Clinical Assessment: Insights from HTA Stakeholders in Four Countries 
Elvira Muller, Kurt Neeser, Linnea Koller 

Benefit vs. Uncertainties: The Potential Impact of Joint Clinical Assessment (JCA) on Market Access and Reimbursement of Novel Drugs 
Kurt Neeser, Elvira Muller 

Bridging the Gap: Should Health Policy Practices from Western Europe Influence CEE Countries
Malwina Holownia, Grzegorz Obrzut, Jacek Walczak, Roman Casciano 

Real-World Evidence 

Leveraging Real-World Evidence to Extend Drug-Drug Interaction Assessment From Drug Development to Clinical Care: A Targeted Review of the Literature ​
Nadia Quignot, Nina Shigesi, Kazue Kikuchi, Sophie Argon, Isabelle Ragueneau-Majilessi 

Weight Loss Therapies 

Is There an Opportunity for Reimbursement of Anti-Obesity Drugs in Central and Eastern Europe
Katarzyna Lasota, Malwina Holownia, Roman Casciano, Jacek Walczak 

Other Topics 

Cost-Consequence Analysis of Cabozantinib in Combination With Nivolumab in Treatment of First-Line Advanced Renal Cell Carcinoma in Germany: A Payer Perspective
Dmitry Gltyaev, Emmanuelle Kaltenbach, Mickael Lothgren, Julia Stiefel, Jens Kisro 

Impact of Anaemia and Transfusion on Healthcare Resource Utilisation in Patients With Myelofibrosis in France
Alex Slowley (1), Celine Pribil (2), Naima Kerbouche (2), Gaëlle Nachbaur (2), Nadia Quignot (3), Giancarlo Pesce (4), Heng Jiang (5), Cacylde Amouzou (2), JJ Kiladjian (6) 

Carbetocin for the prevention of postpartum haemorrhage due to uterine atony following vaginal delivery – a retrospective cost-benefit analysis based on clinical experience from Polish medical centres ​
Adam Bierut, M. Kozlowski, S. Kwiatkowski, Patryk Miernik, P. Oszukowski, Kinga Pacocha, Izabela Pieniazek, A. Pięta-Dolińska, A. Spiczonek, K. Zielińska, J. Zwoliński 

Prepare timely and high quality Joint Clinical Assessment (JCA) deliverables to achieve European market access goals 

The European Commission is implementing the Regulation on Health Technology Assessment (HTA) to be applied from 2025 onward. The rules are meant to “facilitate better access to evidence-based healthcare and innovative technologies to patients across Europe.” 

To achieve the benefits promised by the new regulation, health technology developers (HTDs) need a flexible and knowledgeable strategic partner that is well versed in the expectations of EU HTA authority and national/regional HTA bodies. 

As an industry leader, Certara’s global HTA and market access experts provided guidance and support to clients in the context of programs such as EMA-HTA Parallel Scientific Advice and EUnetHTA Joint Assessments, both of which functioned as pilot programs for the new EU Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC) starting in 2025. 

Certara can provide strategic support for: 

• Workshops and training on EU HTA regulation (JCA and JSC) 
• PICO scenario planning 
• Data review and evidence synthesis to identify and fill data gaps  
• Comparative effectiveness research (NMA, MAIC, STC, and other complex methods as needed)   
• Complete JCA support including:  
• Guidance and development of submission strategy  
• Project management to ensure critical deadlines are met  
• Writing and compilation of the JCA EU HTA submission dossier 
• Development of complementary national dossiers  
• Participation in HTA/regulatory discussion meetings   
• Discussion of strategic implications on advice received 

Imagine if payers fully understood the clinical and economic impact of your product. Many life science companies miss market access opportunities because traditional presentations (PPTs, Excel) don’t tell the full story. 

BaseCase helps you clearly demonstrate improved patient outcomes, quantify economic benefits, and create interactive, data-driven narratives that engage payers—no coding required. 

Visit us at ISPOR EU (Booth #1121) for a free consultation and see how BaseCase can transform your value communication strategy. 

Get to know BaseCase now!

• Sample apps from BaseCase: Merging Story and Data for Maximum Impact 
• Expert Insight: Digital Payer Portals for Enhanced Value Communication
• Mastering Value Storytelling in Healthcare: Leveraging Digital Tools to Meet Stakeholders’ Expectations
• Navigating the “Patient Cliff”: Omni-channel Strategies for Loss of Exclusivity and Established Products

• FACT SHEET – Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) Solutions
• ANALYSIS – JCA and Potential Consequences for Gene Therapies
• BROCHURE – Health Economics & Pricing Models
• BROCHURE – BaseCase Value Communication Software