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The Evidence Base Post

ISPOR Europe 2024: Navigating the conference program – focus on health technology assessment and health policy

  • The Evidence Base

As the healthcare landscape continues to evolve, the ISPOR—The Professional Society for Health Economics and Outcomes Research (ISPOR) Europe 2024 conference (November 17–20, 2024, Barcelona, Spain) will once again serve as a pivotal gathering for experts across health economics, health technology assessment (HTA), and health policy. Here we preview some of the most anticipated sessions exploring next steps in health policy and access, highlighting key debates, expert insights, and future directions that will shape the healthcare landscape in Europe and beyond.

Selected sessions

HTA and health policy have never been more critical, as recent changes in European HTA regulation (HTAR) have ushered in a period of profound transformation, affecting all stakeholders from industry, academia, patient organisations, HTA bodies and more. Globally, health systems are facing similar shifts, with increasing emphasis on evidence-based decision-making, value assessment, and aligning policy frameworks to meet the evolving needs of patients and healthcare providers.

Keynote Address: Translating from EU to Africa to Empower Patient Involvement and Access to Healthcare (Monday November 18, 8:45am – 9:45am)

Opening ISPOR Europe 2024, Mimi Choon-Quinones (NGO partner of the Pan African Parliament of the African Union, South Africa) will discuss building healthcare capacity to tackle cancer in Africa, drawing lessons from the EU’s Beating Cancer Plan. She will highlight initiatives involving African and European leaders and explore the role of global HEOR stakeholders in advancing health policy. Choon-Quinones will reflect on what can and cannot be translated to Africa, aiming to foster patient involvement in healthcare decision-making across the continent.

The Evidence-Price Conundrum: What Is the Way Forward for Patient Access? (Monday November 18, 8:45am – 9:45am)

Following the keynote, in the first Plenary session, Yannis Natsis (European Social Insurance Platform [ESIP], Brussels, Belgium) will lead the discussion exploring strategies and policy interventions aimed at addressing two critical challenges: the high cost of certain medications and the insufficient evidence supporting many products at the time of their market entry. These issues are particularly relevant with the new EU HTA Regulation (EU HTAR) set to commence in 2025. The speakers (Richard Bergstrom [IQVIA, Switzerland]; Valérie Paris [OECD, France]; Pedro Facon [National Institute for Health and Disability Insurance, Belgium] and Birgitte Klindt Poulsen [Danish Medicines Council, Denmark]) will examine the progress made through collaborative intergovernmental efforts, such as the Beneluxa initiative, and assess where EU-level interventions can be both practical and impactful. They will also review trends in pharmaceutical spending and provide insights on how European countries can collaborate to ensure timely access to cost-effective, evidence-based treatments for patients.

Empowering Patients to Be Effective Stakeholders and Partners in the EU HTA Process (Monday November 18, 10:15am – 11:15am)

As the EU HTAR nears implementation in January 2025, patients and patient organizations need to be fully informed to provide meaningful contributions to the new EU HTA process. A panel moderated by Maria Dutarte (EUPATI, The Netherlands) will discuss educational content for patients, with EUPATI panelists Finn McCartney (The Netherlands), Lotte Klim (Denmark), and Mitchell Silva (Belgium) addressing challenges and previewing EUPATI's HTA4Patients Project.

Learn more about the pivotal role patients can play in shaping the new EU HTA process in our interview with Maria Dutarte.

Will Europe’s Pharmaceutical Policy and HTA Stakeholders Respond to Medicare Price Negotiation? (Monday November 18, 10:15am – 11:15am)

Sean Sullivan (University of Washington, USA) will moderate a panel discussing the impact of the US Drug Price Negotiation Program on EU healthcare systems and pharmaceutical policy. Inma Hernandez (University of California San Diego, USA) will present data that led to the final negotiated drug prices for the first 10 drugs selected for negotiation. Ansgar Hebborn (F. Hoffmann-La-Roche AG, Switzerland) will assess EU consequences of the program, including policy trends. Jens Grueger (Boston Consulting Group, Switzerland) will compare US and EU prices and discuss industry strategic responses to both US and EU pharmaceutical policy changes.

Using HRQoL Data From Children and Youth to Strengthen HTA: What Are the Barriers? How Can We Improve Current Practice? (Monday November 18, 11:45am – 12:45am)

Supported by the EuroQol Research Foundation, this Educational Symposium will see Nancy Devlin (University of Melbourne, Australia) moderate a discussion on the challenges in using age-appropriate health-related quality of life (HRQoL) tools for pediatric HTA. Koonal Shah (NICE, UK) will discuss the limitations of current evidence used by decision-makers such as NICE. Saskia Knies (Zorginstituut Nederland, The Netherlands) will present Dutch efforts to include pediatric care in appraisals. Through the industry lens, Fleur Chandler (Sanofi and Duchenne UK) will share challenges in generating robust evidence to support pediatric health-care products, and Wendy Ungar (The Hospital for Sick Children, Canada) will discuss advancing methodologies for pediatric evaluations.

How Do We Facilitate the Implementation of Needed Novel HTA Methodologies in National and EU HTA Practice? (Monday November 18, 11:45am – 12:45am)

Wim Goettsch (National Health Care Institute, Netherlands) will introduce the EU Horizon Europe-funded SUSTAIN-HTA project, which aims to align academic HTA methods with HTA body needs. Dalia Dawoud (NICE, UK) will argue that current HTA methods suffice but require better data and randomized controlled trials (RCTs) from health technology developers. Zoltan Kalo (Semmelweis University, Hungary) and Oresta Piniazhko (Ministry of Health of Ukraine, Ukraine) will highlight the need for new methodologies, particularly for targeted populations, in light of EU HTAR changes.

Access to Medicines in Low- and Middle-Income Countries: What Is Being Done? What More Can Be Done? What Can ISPOR Do? (Monday November 18, 11:45am – 12:45pm)

This workshop will explore access delays to innovative medicines in low- and middle-income countries (LMICs), aiming to foster discussion on policy changes that could improve access. Moderated by Mikkel Oestergaard (MSD Innovation & Development GmbH, Switzerland), the panel, featuring Kärt Veliste (Estonian Health Insurance Fund, Estonia), Marlene Gyldmark (Idorsia Pharmaceuticals, Switzerland), and Silvana Lay Ma (FIFARMA, USA), will present findings from the Global Differential Pricing Initiative Working Group (part of the ISPOR Special Interest Group on Global Access to Medical Innovation) on the delays and programs developed by companies, payers, and regions to address these challenges.

Can Generative AI Aid Readiness for Joint Clinical Assessment (JCA)? (Monday November 18, 1:45pm – 2:45pm)

Ramiro Eugenio Gilardino (MSD, Switzerland) will moderate a panel on generative AI's role in preparing for Joint Clinical Assessment (JCA) in Europe. Ipek Özer Stillman (Takeda Pharmaceuticals, USA) will discuss industry preparations, Jag Chhatwal (Mass General Hospital, Harvard Medical School, Value Analytics Labs, USA) will share technological applications, such as AI-driven PICO scenario simulations, and Diana Delnoij (Erasmus School of Health Policy & Management, Dutch National Health Care Institute, The Netherlands) will offer the HTA perspective, emphasizing AI's role and capacity building within HTA agencies.

Ready for 2025? How Lessons Learned From National System Reforms Can Guide Our Response to the New EU HTA Regulations (Monday November 18, 3:15pm – 4:15pm)

In this Educational Symposium, moderator Herbert Altmann (Cencora, UK) will be joined by Iga Lipska (Medical University of Gdańsk, Poland), François Meyer (FIPRA Public Affairs, France), Oriol Solà-Morales (Health Innovation Technology Transfer, Spain), and Mihai Rotaru (European Federation of Pharmaceutical Industries and Associations, Belgium) as they provide exclusive insights into JCA launching in January 2025 and its impact on European healthcare innovation evaluation. The panel will discuss HTA reforms in Germany, Spain, France, and Poland, their impact on healthcare access, and strategies for aligning national systems with EU regulations to accelerate patient access to innovative medicines.

Are you ready EU HTAR launch in January 2025? Register for our webinar on Tuesday December 3 to hear experts from this session discuss the critical success factors to implementing this new regulation.

Broader Value Elements: Methods to Quantify Each and Their Relevance for European Markets (Monday November 18, 5:00pm – 6:00pm)

Richard Willke (Scintegral Health Economics, USA) will lead a workshop discussing best practices for quantifying broader value elements of the ISPOR Value Flower and their relevance for European HTA bodies. Jason Shafrin (University of Southern California, USA) and Melanie Whittington (Tufts Medical Center, USA) will present methods for quantifying elements, including severity of disease, value of hope, productivity, family spillovers and equity. Lotte Steuten (Office of Health Economics, UK) will then discuss the likelihood of adoption of these value elements by HTA bodies in the UK, France, Germany, and Spain.

Ready, Set, Go: The Last Sprint for the EU HTAR  (Monday November 18, 8:45am – 9:45am)

The second Plenary session will see Roisin Adams (National Centre for Pharmacoeconomics, Ireland), Vanessa Schaub (F. Hoffmann-La Roche, Switzerland), Michal Stanak (National Institute for Value and Technologies in Healthcare, Slovakia), and Valentina Strammiello (European Patients’ Forum, Belgium) discuss the readiness of stakeholders for the new EU HTAR. The session will explore challenges faced by industry, HTA bodies, and patient organizations in adapting to the new system, including PICO assessments, AI use, and preparation for JCAs. The panelists will also discuss the interaction of HTAR with initiatives like Beneluxa and the International Horizon Scanning Initiative (IHSI).

EU Joint Clinical Assessment: Indirect Treatment Comparisons for Evaluating Relative Clinical Effectiveness Across Multiple PICO Questions (Tuesday November 19, 10:15am – 11:15am)

Given variations in national standards of care, indirect treatment comparisons (ITCs) are crucial for the JCA process when head-to-head trials are infeasible. However, challenges such as data limitations and resource demands remain. The panel will summarize the expected opportunities and challenges, from their diverse viewpoints, in using ITCs to assess clinical effectiveness for stakeholders. Wim Goettsch (Utrecht University), Iñaki Gutiérrez-Ibarluzea (BIOEF), and Mahmoud Hashim (Johnson & Johnson) will present, moderated by Sophia van Beekhuizen (Cytel).

Using Generative AI Methods for Evidence Generation and Health Technology Assessment: Perspectives From NICE and Industry (Tuesday November 19, 12:45pm – 1:45pm)

Stephen Duffield (NICE, UK) and Benjamin Bray (LCP Health Analytics, UK) will discuss the evolving capabilities of generative AI, including large language models like ChatGPT, in RWE generation and healthcare decision-making. The Exhibit Hall Theater session will provide an overview of current AI applications and explore implications for HTA from both NICE and industry perspectives.

Role of Global Indirect Treatment Comparison (ITC) Programs in Supporting Europe’s Joint Clinical Assessments (JCA): Insights from Global and EU Experts (Tuesday November 19, 1:45pm – 2:45pm)

Continuing the exploration around ITCs for evidence generation, the panel will explore opportunities and challenges with leveraging global ITCs for EU JCAs, including complexities with multiple PICOs across Europe and the benefits of well-designed global ITC programs. Chris Cameron (EVERSANA, Canada) will moderate and be joined by Shannon Cope (Precision AQ, Canada), Justin Doan (Pfizer, USA), and Uwe Siebert (UMIT TIROL, Austria), providing perspectives from ITC producers, industry, and HTA.

The Future of Single-Arm Trials and External Controls in Health Technology Assessment  (Tuesday November 19, 3:15pm – 4:15pm)

Martin Scott (Numerus, Germany) will moderate a session on the challenges and guidelines for using single-arm trials (SATs) and external controls arms (ECAs) in JCAs. Min-Hua Jen (Eli Lilly, UK), David McConnell (National Centre for Pharmacoeconomics, Ireland), and Sarah Ren (University of Sheffield, UK) will discuss the guidelines and conditions for accepting SATs and ECAs, with the session aiming to clarify expectations and foster dialogue between HTA bodies and the industry regarding SAT use in HTA submissions.

Contextualizing Uncertainty in EU HTA by Coming to Terms With Imperfect Data: Can We Use Novel Analytic Methods to Quantify the Data Imperfections and Biases? (Tuesday November 19, 5:00pm – 6:00pm)

Grammati Sarri (Cytel, UK) will lead an interactive workshop on the challenges of using non-randomized evidence in JCAs, especially for rare diseases or complex evidence needs. Attendees will engage in role play, guiding a hypothetical JCA submission and discussing the impact of bias-adjusted methods. Luis G Hernandez (Takeda Pharmaceuticals, USA) will take the industry role, examining the challenges in generating robust evidence. Seamus Kent (Erasmus University Rotterdam, The Netherlands) will address non-randomized studies and bias analysis methods, presenting example results of the Q-BASEL study, an assessment of quantitative bias analysis methods for ECAs in lung cancer. Hugo Pedder (University of Bristol, UK) will explore bias adjustment to strengthen limited randomized evidence.

Real-World Evidence Policy: Is Harmonization Between Regulatory and HTA a Help or Hindrance? (Tuesday November 19, 5:00pm – 6:00pm)

This workshop, led by Rita Peeters (J&J MedTech, Belgium), will delve into the potential benefits and challenges of harmonizing RWE policies between regulatory and HTA bodies. Speakers Katharine Cresswell (NICE, UK), Patrice Verpillat, and Niklas Hedberg (Dental and Pharmaceuticals Benefits Agency (TLV), Sweden) will provide insights on policy evolution, gaps, and differing perspectives. The session will include interactive discussions and real-time polling to identify consensus on whether harmonization supports or hinders effective RWE policy development in healthcare decision-making.

Finally It's Out! What the NICE Position on the AI Use in Evidence Generation and Synthesis Means for HTA Submissions – The Do’s and Don’ts (Wednesday November 20, 9:15am – 9:45am)

The recent NICE position statement on using AI in evidence generation for health technology submissions sets a precedent for other HTA agencies to follow. In this Exhibit Hall Session, Grammati Sarri (Cytel, UK) will introduce the NICE AI statement and relevant HEOR research, while panelists Sophia van Beekhuizen (Cytel, The Netherlands), and Grace Hsu (Cytel, USA) will discuss opportunities and challenges in applying AI to systematic reviews, effectiveness analysis, and RWE. The session will conclude with a proposed roadmap for AI integration in NICE submissions.

The Dawn of a New Era: Cross-Border Collaborations—Regional, Pan-European, and Transcontinental—How Will They Shape the Future of Access? (Wednesday November 20, 10:00am – 11:00am)

This Spotlight Session will see Roisin Adams (National Centre for Pharmacoeconomics, Ireland), Meindert Boysen (Boysen Consulting International, UK), Johan Pontén (Medicine Evaluation Committee, Sweden), and Neil Grubert (Independent, UK) discuss cross-border collaboration on horizon scanning, HTA, pricing, and procurement in Europe. Grubert will provide an overview of regional and international initiatives, with Adams reflecting on partnerships like Beneluxa and their evolution. Pontén will discuss Nordic collaboration on HTA and procurement and Meindert Boysen will examine the Novel Medicines Platform's role in improving access and highlight cross-continental HTA alliances.

Reality Check: Are We Bridging the Evidence Gaps for Patients? (Wednesday November 20, 10:10am – 11:00am)

Following the payer perspective in plenary one, and HTA viewpoint in plenary two, the final plenary will round off ISPOR Europe 2024 with a focus on the regulatory landscape. Regulators, HTA agencies, payers, and the pharmaceutical industry are collaborating closely with patients to ensure innovative drugs reach patients as early as possible. This effort focuses on generating reliable, meaningful evidence from RCTs and real-world data (RWD) to support various assessments, such as benefit-risk and relative effectiveness. Despite differences in scope, commonalities exist in evidence generation, though uncertainties remain at different decision-making stages. This session will explore how to minimize these uncertainties and ensure all stakeholders have the necessary evidence for informed decisions, enabling timely patient access to innovative treatments. Patrice Verpillat (European Medicines Agency, The Netherlands) will moderate the conversation with Nikos Dedes (Greek Patients' Association, Greece), Peter Mol (College ter Beoordeling van Geneesmiddelen, The Netherlands), Yannis Natsis (European Social Insurance Platform, Belgium), Almath Spooner (AbbVie, Ireland) and Anne Willemsen (Dutch National Healthcare Institute, The Netherlands).

Latest research in health technology assessment and health policy

On Tuesday November 19 (11:30am – 12:15pm), Kejsi Begaj (Rutgers University, USA) and Alin Kalayjian (GSK, Somerset, USA) will lead a Poster Tour of selected research on “Joint Clinical Assessment”. Featured research includes:

The Podium Session “Improving Transportability of Evidence in HTA: Methodological Investigations” later on Tuesday November 19 (1:45pm – 2:45pm) will include research on the methods used to assess and improve transportability of evidence in HTA across patient populations and jurisdictions:

During the final Podium Session on Wednesday November20 (10:00am – 11:00am) presenters will discuss their research on “Health Technology Assessment in Action”. Selected posters includes:

Coverage by The Evidence Base

The Evidence Base will be providing exclusive coverage of ISPOR Europe 2024 (November 17–20, 2024, Barcelona, Spain), providing daily rounds-ups of many of the sessions as well as deep dives into the three plenaries. Register on The Evidence Base and follow us on LinkedIn to make sure you don't miss any of our coverage and to ensure you stay up-to-date with the latest insights and developments from the conference.

 

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