Building a Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in HematologY Added Value Framework for Hematologic Malignancies: A Comparative Analysis of Existing Tools.

Fecha de publicación: 17/05/2022 Fecha Ahead of Print: 17/05/2022

Autores de IIS La Fe

Guillermo Sanz Santillana

Autor

Participantes ajenos a IIS La Fe

Cerisoli, Francesco
Ali, Farzad
Bereczky, Tamas
Bolanos, Natacha
Bullinger, Lars
Dhanasiri, Sujith
Gallagher, James
Pérez SG
Geissler, Jan
Guillevic, Yann
Harrison, Kathryn
Naoum, Anastasia
Portulano, Carla
Rodriguez Vicente, Ana E.
Schulze-Rath, Renate
Gómez GY
Hernandez Rivas, Jesus Maria

Grupos

Hematología y Hemoterapia

Investigador Principal

Javier De La Rubia Comos

Abstract

OBJECTIVES: The Innovative Medicines Initiative-funded, multistakeholders project Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in hematologY (HARMONY) created a task force involving patient organizations, medical associations, pharmaceutical companies, and health technology assessment/regulator agencies' representatives to evaluate the suitability of previously established value frameworks (VFs) for assessing the clinical and societal impact of new interventions for hematologic malignancies (HMs). METHODS: Since the HARMONY stakeholders identified the inclusion of patients' points of view on evaluating VFs as a priority, surveys were conducted with the patient organizations active in HMs and part of the HARMONY network, together with key opinion leaders, pharmaceutical companies, and regulators, to establish which outcomes were important for each HM. Next, to evaluate VFs against the sources of information taken into account (randomized clinical trials, registries, real-world data), structured questionnaires were created and filled by HARMONY health professionals to specify preferred data sources per malignancy. Finally, a framework evaluation module was built to analyze existing clinical VFs (American Society of Clinical Oncology, European Society of Medical Oncology, Magnitude of Clinical Benefit Scale, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, Institute for Clinical and Economic Review, National Comprehensive Cancer Network Evidence Blocks, and patient-perspective VF). RESULTS: The comparative analysis describes challenges and opportunities for the use of each framework in the context of HMs and drafts possible lines of action for creating or integrating a more specific, patient-focused clinical VF for HMs. CONCLUSIONS: None of the frameworks meets the HARMONY goals for a tool that applies to HMs and assesses in a transparent, reproducible, and systematic way the therapeutic value of innovative health technologies versus available alternatives, taking a patient-centered approach and using real-world evidence.

Datos de la publicación

ISSN/ISSNe:: 1098-3015, 1524-4733
Tipo:: Article
Páginas:: 1760-1767
DOI:: 10.1016/j.jval.2022.04.1729
Factor de Impacto:: 1,472 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Keywords

Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in hematologY; clinical value framework; hematology; patient-reported outcomes