We are excited to attend this year’s conference with CorEvitas, Thermo Fisher Scientific’s latest acquisition that complements and strengthens our real-world data and evidence solutions. Together, Evidera and CorEvitas are uniquely positioned to provide clients the evidence needed to improve decision making and further accelerate innovation and productivity.
Stop by our booth (#C2-001) or set up a time to meet with one of our experts to talk about our enhanced offerings and see how we can help you identify, generate and communicate the right evidence to move your products forward toward success.
Real-world data and evidence that promote drug development, regulatory approval and market growth
Patient-centered research to ensure the patients’ perspectives, outcomes and preferences are included throughout product development
Evidence synthesis and modeling to build your foundation of evidence, simulate expected outcomes, and quantify and demonstrate value
Value and access solutions to navigate complex global payer and HTA requirements and changing regulations, and communicate your value story effectively
Non-interventional studies to generate real-world evidence to inform clinical trial design and meet regulatory and payer peri- and post-approval safety and long-term follow-up requirements
HEOR Theater Presentation
Tuesday, 14 November
11:45 – 12:15
Are You Scoping Ready for the New EU HTA Regulation Implementation?
Paulina Rolska-Wojcik, director of consulting, value and access consulting, Evidera, part of PPD, Warsaw, Poland
Jessica Griffiths, senior consultant, value and access consulting, Evidera, part of PPD, London, U.K.
The European Union’s new regulation for health technology evaluation (Regulation (EU) 2021/2282), focusing on reducing duplication of efforts by national HTA bodies and ensuring efficient use of resources, will be applied starting in January 2025 with oncology treatments and advanced therapy medicinal products (ATMPs), with full implementation in all therapeutic areas by 2030. This regulation affects all companies wanting to market products in the EU, so it is critical to be adequately prepared for new submissions.
One significant consideration, and potential challenge, to anticipate is Population, Intervention, Comparator and Outcomes (PICO) scoping. Given the short timeframe between scoping and submission, companies developing healthcare products will need to identify the most likely PICOs and do the associated analytics well in advance. This session will discuss some of the challenges, issues and considerations when preparing for this major step of the new EU HTA process, including:
- The number of potential PICOs
- Variable levels of management within companies
- Key tradeoff decisions in trial design and operations
Additionally, the speakers will compare the new EU HTA approach with NICE’s approach for perspective and will discuss ways to optimize success with the new submission process moving forward. Please join us to better understand how to prepare for your HTA submissions moving forward!
Workshop Panel Discussion
Tuesday, 14 November
13:45 – 14:45
W9: Every Patient Matters: Introduction to Multi-Dimensional Thresholding in Health Preference Research Tommi Tervonen, Sebastian Heidenreich, Douwe Postmus, Kerrie-Anne Ho
Wednesday, 15 November
8:00 – 9:00
301: Longitudinal Qualitative Research: Methodological Approaches and Potential Applications to Patient Centered Outcomes Research
Discussion Leader: Carla Dias Barbosa, MSc, Evidera, Bethesda, MD, USA;
Discussants: Vanessa Leigh Merker, PhD, Massachusetts General Hospital/Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA; Kimmie McLaurin, MS, Real World Evidence Strategy, AstraZeneca, Gaithersburg, MD, USA; Eduard Sidelnikov, MD, PhD, Global Health Economics, Amgen (Europe) GmbH, Rotkreuz, Switzerland
Member Group Meeting
Monday, 13 November
13:15 – 14:15
ISPOR Good Practice Task Force Recommendations on Valuing HRQoL of Children & Adolescents in Economic Evaluation Open Meeting (Pediatric Utilities) Donna Rowen, Nancy Devlin, Louis S. Matza, Elly Stolk
Podium Presentation
Monday, 13 November
13:45 – 14:45
P16: What trade-offs are women willing to make when choosing between potential treatments for moderate to severe vasomotor symptoms due to menopause? Sebastian Heidenreich, Katelyn Cutts, Anastasia Doldols, Lora Todorova, Tim Hillard, Tommaso Simoncini, Tomi Mikkola
Poster Presentations
Monday, 13 November
12:30 – 13:30
EE148: Are General Population Utilities Appropriate to Use as Baselines for Age-Adjustment of Utility Values? Chang-Douglass S, Bungey G
EE29: Clinical and Economic Impact of Pre-Exposure Prophylaxis with Tixagevimab+Cilgavimab in 2022 in Switzerland to Protect Immunocompromised Individuals Rivolo S, Bungey G, Morris W, Nagy E, Williams S, Maillat L, Jańska A, Arnetorp S
HTA32: When Should the Conduct of RWE Studies Be Prioritized for Reimbursement: Insights from Canadian and Global Stakeholders Boss J, Sullivan S, Shulak L, Rao T, Tam C
HTA59: NICE to Have – How Patient Preference Considerations in Recent NICE Decisions Compare to the New ISPOR Good Practices Roadmap Molenkamp V, Omohwo S, Gruber P, Heidenrich S, Whitty J
MSR25: Uncertain About Uncertainty in Matching-Adjusted Indirect Comparisons (MAIC)? A Simulation Study to Compare Methods for Variance Estimation Chandler C, Proskorovsky I
PCR18: Humanistic Burden in Relapsed or Refractory (R/R) Follicular Lymphoma (FL): A Systematic Literature Review (SLR) Forbes C, Pustulka I, Nunez-Gonzalez S, Kumar J
RWD32: Hearing the Patient Voice in Japan- Utilisation of Patient-Reported Outcomes and Wearable Device Data for Patient- Centric Real World Research Hamaguchi A, Kondo D, Mitani A, Yates M, Pulfer A, Lambrelli D
SA5: Innovative Direct-To-Physician Retrospective Chart Review Approach: Synthesized Learnings From Completed And Ongoing Studies Neil R. Brett, Celena Kent, Annamaria Kiure, Philippe Capart, Alice Rouleau
SA7: Emerging Biomarkers in Metastatic Castration Resistant Prostate Cancer As Evaluated in Early Phase Clinical Trials: A Targeted Literature Review Lee LJ, Jones M, Timmel EE, Masten L, Liu L, Andreu-Vieyra C, Serfass L
Monday, 13 November
16:00 – 17:00
EE269: Cost-Effectiveness Analysis of Hypothetical Interventions for the Treatment of Focal Segmental Glomerulosclerosis Milev S, Stargardter M, Lemyre G
EPH101: Assessing the Relative Benefits Associated With Developing Vaccines for Nipah Virus Infection and Rift Valley Fever From Local, National, and Global Perspectives Gani R, Pinsent A, Chapman R
HPR68: Comprehensive Genomic Profiling Approaches in Europe and the US: A Review of Guidelines and Recommendations for Solid Tumors von Wilamowitz-Moellendorff C, Kadambi A, Deshpande S
HTA114: How are Companion Diagnostics Evaluated and Reimbursed in Europe? Comparative Analysis of the EU-4 and UK Mitchell C, Kumichel A, D’Ausilio A, Gibbs K
HTA83: Economic Evaluations in Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Challenges for Health Technology Assessment (HTA) Submissions Forbes C, Pustulka I, Zuchinali P, Kumar J
HTA147: Similarities and Differences Between the HTA Methods for Indirect Comparisons in the EU Joint Clinical Assessment and National Assessments by Member States Laughlin WE, Bretton D, Olid-Gonzalez A, Bending M
PCR78: Establishing Meaningful Change Thresholds for EORTC QLQ-CLL17 Domain Scores: An Analysis Based on the TRANSCEND CLL 004 Study in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Eliason L, Medaglia A, Fofana F, Wang L, Riedell PA, Guo S
RWD48: Identification and assessment of real-world oncology data in China: a data landscaping study Ban L, Li J, Pulfer A
Tuesday, 14 November
12:30 – 13:30
HTA186: Accelerating Access to Medical Technologies: An Overview of the NICE Early Value Assessment Pilot Project in the UK So D, Hearne E, Stapleton N, Chang-Douglass S
HTA209: A Review of the Differences Between the New EMA-EUnetHTA Joint Scientific Consultation Versus the Previous Ema-HTA Parallel Scientific Consultation D’Ausilio A, Arora R, Delaitre-Bonnin C
MSR77: Can Bayesian Informative Priors Improve Extrapolation of Immature Overall Survival? A Case Study in Advanced Melanoma Prawitz T, Rivolo S, Anato A, Ishak J
MSR78: Use of External Control Data to Adjust for Treatment Switching in Cost-Effectiveness Analyses: Lisocabtagene Maraleucel (Liso-Cel) Versus Standard of Care (SOC) in Second-Line Relapsed or Refractory Large B-CellLymphoma Chandler C, Liu F, Klijn S, Elsada A, Proskorovsky I
SA48: Comparative Effectiveness Based on Win Ratios: Do Conventional ITC Approaches Work? Ishak J, Shukla P, Caro J
PCR135: Selecting preference-based measures (PBMs) for pediatric studies: A proposed decision making framework Sutherland S, Davies E, Sully K, Patel A, Martí Y, Lloyd A, Rowen D, Stewart K, Matza L, Powell P, Daig M
PCR157: Assessment of Health State Utilities For Invasive Pneumococcal Disease, Pneumonia, and Acute Otitis Media in Young Children Matza L, Howell T, Chun B, Hetherington L, White M, Weiss T, Huand M, Rowen D, Tan T, Feemster K, Nozad B, Kelly M, Mohanty S
Tuesday, 14 November
16:00 – 17:00
HSD88: The Propensity to Receive Haematopoietic Stem Cell Transplantation in Diffuse Large B-Cell Lymphoma Patients Based on Sex, Ethnicity, and Deprivation: Results From National Cancer Registry Linked Real-World Datasets in England João Carvalho S, Baird J, Brewer H, Hamlyn M, Davidson J, Rice C (CorEvitas)
HTA244: Evaluation of the Acceptance of Real-World Evidence (RWE) in EUnetHTA Joint Clinical Assessments (JCA) to Support Evidence for Reimbursement Decisions Natividad A, Sestak I, Luna G, Luijken J, Gibson B, Delaitre-Bonnin C, Rouleau A.
HTA293: Challenges and Opportunities in Implementing the EUNETHTA21 Methodological Guidelines in the Context of EU HTA Regulation: Perspectives from Different Stakeholders on Different Markets (FRANCE, ITALY, AND POLAND) De Rosa V, Rolska-Wójcik P, Delaitre-Bonnin C
EE509: Cost-Effectiveness of Multicancer Early Detection (MCED) with Preferential Detection of Clinically Agressive Cancers Kansal A, Tafazzoli A, Shaul A, Ye W, Chavan A, Zou D, Fendrick AM
EE516: Cost-Utility Analysis (CUA) in Chronic Lymphocytic Leukemia (CLL): Is COVID-19’s Impact on National Life Tables Important to Consider? Leyla Mohseninejad, Simone Rivolo, Anna Rudas, Balazs Peter, Alberto Prieto, Nasim Bahar, Keri Yang
EE517: Cost-Effectiveness Analysis of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Greece Karaiskou M, Avgitidou A, Vostitsanou Z, Batsi M, Bungey G, Prawitz T, Balazs P, Panos S
EPH39: Epidemiology and Patient Characteristics of Pemphigus Vulgaris in UK: A Retrospective Cohort Study Using Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) Blein C, De Ruyck F, Davidson J, Rice C, Wittlin B, Iannazzo S, Agalarov Y (CorEvitas)
RWD135: A Demographic Description of Women With Uncomplicated Urinary Tract Infection in England: A Primary Care Electronic Health Records and Notes Review Brewer H, Hamlyn M, Davidson J, Rice C, L’esperance V (CorEvitas)
SA57: Unmet Needs and Evidence Gaps in Relapsed/Refractory Marginal Zone Lymphoma: Findings From a Systematic Literature Review Mohseninejad L, Deshpande S, Borkowska K, Wittkopf P, Yang K, Weber D
PCR193: Health State Utilities Associated with X-Liked Retinitis Pigmentosa in the United Kingdom Matza L, Li N, Stewart K, Hashim M, Denee T, Pan F, Zhang Q, Lee J, Michaelides M, Scholl H
Wednesday, 15 November
9:00 – 10:00
EPH268: Effectiveness of pneumococcal vaccination in older adults in a Real-World setting: a systematic review and meta-analysis of observational studies using test-negative designs Wolf A, Huang Q, Song C
HTA314: A Review of Pediatric Medicines Assessed by NICE Between 2018 and 2023 Karinou E, Beugre-Guyot M, Bungey G, Vilu H
MSR149: Cost-Effectiveness Model Conceptualisation in Chronic Graft Versus Host Disease Elisheva L, Abdul-Jabbar OA, Kongnakorn T, Houisse I, Hudson R, Skinner L, Szabo G, Prawitz T, Dobi B, Nicholls C
MSR163: Artificial Intelligence (AI)-Based Screening: Exploration of Differences in Two Health Technology Assessment (HTA)-Compliant Systematic Literature Reviews (SLRS) Deshpande S, Cichewicz A, Slim M
PCR240: Incorporating a holistic patient perspective when assessing the value of non-small cell lung cancer (NSCLC) therapies Damera V, Sullivan S, Tallarigo D, Dunlop W, Bracke B, Martin M
SA72: Current Practices for the Selection of Effect Modifiers and Confounders in Population-Adjusted Indirect Comparisons (PAIC): A Review of Technology Appraisals (TA) Chandler C, Liu F, Klijn S, Ishak J
EE667: Cost-Minimization Analysis (CMA) of Bruton Tyrosine Kinase Inhibitors (BTKis) in Adults with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) Chanan-Khan A, Mohseninejad L, Walder L, Ubi S, Gani R, Shah A, Yang K
EPH273: Using Real-World Data Sources in England to Quantify the Burden of Non-Alcoholic Steatohepatitis Davidson J, Brewer H, Rice C, Baird J, Fishman J (CorEvitas)
HPR195: Market Access Implications of Early Access to Medicines Scheme in the UK Jaiswal H, Blake L, D’Ausilio A, Parkinson M
HPR179: A Review of Innovative Payment Models and New Policies for Innovative Anti-Infective Treatments in Europe and in the USA Lingois N., Connelly B., Dabbous M. Parkinson M