Bridging gaps in clinical trial accessibility and reimbursement for large B-cell lymphoma therapies across Europe

. 2025 Sep ; 9 (9) : e70204. [epub] 20250923

Status PubMed-not-MEDLINE Jazyk angličtina Země Spojené státy americké Médium electronic-ecollection

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid40995467

Assistance Publique Hôpitaux de Paris Hôpital Cochin Paris Université Paris Paris France

Biostatistics and Medical Informatics Department Assistance Publique Hôpitaux de Paris Hôpital Necker Enfants Malades Paris France

Candiolo Cancer Institute FPO IRCCS Candiolo Turin Italy

Department of Hematology and INSERM U1245 Centre Henri Becquerel Rouen France

Department of Hematology Hospital Clinic y Provincial de Barcelona Barcelona Spain

Department of Hematology Universitair Medische Centra Amsterdam Amsterdam The Netherlands

Department of Medicine 3 LMU Munich Germany

Department of Oncology University of Helsinki and Helsinki University Hospital Helsinki Finland

Department of Radiation Oncology University Hospital Münster Münster Germany

Department of Radiology and Nuclear Medicine Amsterdam UMC University Amsterdam The Netherlands

Division of Cancer Sciences University of Manchester Manchester United Kingdom

European Hematology Association The Hague The Netherlands

Hemato Oncologie Assistance Publique Hôpitaux de Paris Hôpital Saint Louis Paris France

Hematology and Oncology University Hospital Münster Münster Germany

Hematology Department Instituto Portugues de oncologia Lisbon Portugal

Institut Carnot Calym Paris France

Institute of Pathology University of Wuerzburg Würzburg Germany

Lymphoma Coalition Mississauga Ontario Canada

Maria Skłodowska Curie National Research Institute of Oncology Warsaw Poland

Medical Oncology Charles University Prague Czech Republic

Medical Oncology Department Southampton General Hospital University Hospital Southampton NHS Trust Southampton United Kingdom

School of Medicine University of Nottingham Nottingham United Kingdom

University Hospital Centre Zagreb and School of Medicine University of Zagreb Zagreb Croatia

Zobrazit více v PubMed

Tilly H, Gomes da Silva M, Vitolo U, et al. Diffuse large B‐cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow‐up. Ann Oncol. 2015;26(suppl 5):v116‐v125. PubMed

Prüfert A, Bruinsma IJ, Kadir A, et al. Early access programmes in Europe versus key markets in other regions: an in‐depth comparison. Poster146303, ISPOR 2024.

Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on Health Technology Assessment and Amending Directive 2011/24/EU. Accessed December 16, 2023. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:3202%201R2282.

Guidance on outcomes for joint clinical assessments. European Commission. Adopted on 10 June 2024 by the HTA CG pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282 on Health Technology Assessment.

Outcome document for Joint Scientific Consultations (JSC) on Medicinal Products (MP). European Commission. Adopted on 28 November 2024 by the HTACG pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282 on Health Technology Assessment.

Meeting report: how can patient reported outcomes (PROs) and health related quality of life (HRQoL) data inform regulatory decisions for cancer treatments? EMA EORTC workshop, European Medicines Agency (EMA), February 29, 2024.

Gsteiger S, Bucher HC, Ryan J, Ruof J. Technology assessment vs. technology appraisal‐how to strengthen the science/value dichotomy with EU HTA? J Mark Access Health Policy. 2024;12(4):369‐377. 10.3390/jmahp12040028. PubMed DOI PMC

Schuster V. EU HTA regulation and joint clinical assessment—threat or opportunity? J Mark Access Health Policy. 2024;12(2):100‐104. 10.3390/jmahp12020008. PubMed DOI PMC

Thieblemont C, Gomes Da Silva M, Leppä S, et al. Large B‐cell lymphoma (LBCL): EHA Clinical Practice Guidelines for diagnosis, treatment and follow‐up. HemaSphere. 2025;9(8): e70207.

Eberhardt N, McNamee L . The EU in vitro diagnostic regulation: implications and challenges for manufacturers, laboratories and patients. Clin Chem Lab Med. 2022;60(7): 1033‐1042. 10.1515/cclm-2022-0189. DOI

IQVIA . Assessing the clinical trial ecosystem in Europe. IQVIA Institute for Human Data Science; 2024.

Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab vedotin in previously untreated diffuse large B‐cell lymphoma. N Engl J Med. 2022;386(4):351‐363. PubMed PMC

Pe M, Voltz‐Girolt C, Bell J, et al. Using patient‐reported outcomes and health‐related quality of life data in regulatory decisions on cancer treatment: highlights from an EMA‐EORTC workshop [published correction appears in PubMed DOI

ASCERtain Project . Advancing Sustainable and Comprehensive European Models for Equitable Reimbursement of High‐Cost Innovative Therapies. Horizon Europe; 2025. https://www.access2meds.eu.

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