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Global & Regional Health Technology Assessment
Scopus
ISSN 2283-5733 · AboutScience Srl · 277 articles in the index
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Journal Article Full text
Erratum in: Economic evaluation of distribution modalities for ostomy and incontinence medical devices within the Italian healthcare context
Also available at: DOAJ
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Journal Article
The societal costs associated with patients with chronic spontaneous urticaria (CSU) in Italy
Introduction: Chronic spontaneous urticaria (CSU) is a debilitating dermatological disease. The study aimed to estimate the indirect costs and out-of-pocket expenses incurred by CSU patients in Italy. Methods: The economic model was based on data collected through a survey conducted among patients…
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Multicriteria and economic evaluations: toward a proposal for a new framework for drug pricing in Italy
Introduction: The drug pricing and reimbursement process in Italy lacks a structured and shared framework to translate therapeutic value into consistent economic criteria, especially in a regulatory context characterized by spending caps and increasing pressure on access to innovations. The present…
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Clinical and economic burden of migraine in Italy: a real-world evidence analysis
Introduction: This retrospective observational analysis evaluated the clinical, demographic, and economic burden of migraine patients in real-world Italian clinical practice. Methods: A retrospective observational analysis was conducted using Italian administrative databases, involving…
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Use of artificial intelligence to draft a mini-HTA report on a new medical device belonging to class IIb–III
The rapid evolution of artificial intelligence (AI) in the pharmaceutical and medical device (MD) sectors has prompted interest in its potential role in supporting health technology assessment (HTA). This editorial presents an innovative project aimed at facilitating and expanding HTA activities…
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Economic and organizational impact of implementing Peristeen Plus in the management of neurogenic bowel dysfunction: evidence from Italy
Introduction Neurogenic bowel dysfunction (NBD) is a chronic and disabling condition affecting individuals with spinal cord injury (SCI), commonly presenting as constipation and fecal incontinence. Transanal irrigation (TAI) represents a minimally invasive alternative to conventional management…
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The evolution of dialogue and relations between AIFA, clinicians, scientific societies, patient associations, and civic activism organizations
Introduction: This document aims to provide an overview of the interactions between the Italian Medicines Agency (AIFA) and various stakeholders, placing them in the context of the European and national regulatory framework, with particular reference to Regulation 536/2014 and HTA Regulation…
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Cooperation among stakeholders for the sustainability of the new pharmaceutical paradigm in Italy
The XXIII National Conference on Pharmaceuticals, held in Catania on February 27-28, 2025, represented a key event for multidisciplinary and cross-sectoral dialogue on the pharmaceutical governance in Italy, with a particular focus on stakeholders’ cooperation. Structured around a plenary session…
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Exploring the current and future role of artificial intelligence in pharmaceutical market access: insights from a European survey
Introduction: Artificial Intelligence (AI) is rapidly expanding across the pharmaceutical value chain; however, empirical evidence on its application in Market Access (MA) remains limited. Given the strategic relevance and regulatory complexity of MA, understanding current AI adoption and…
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Impact of Ministerial Decree 77/2022 from different stakeholders’ perspectives: clinicians, pharmacists, patients, and industry
Introduction: Assess the implications of Ministerial Decree (MD) 77/2022 in Italy, which decentralizes healthcare through proximity-based models, from the perspective of key actors involved, and discuss its relevance to sustainability and value assessment. Methods: A cross-sectional survey was…
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Optimizing CAR-T therapy delivery in the Italian healthcare system: economic and organizational insights in follicular lymphoma
Introduction: Follicular Lymphoma (FL) is the second most common lymphoid malignancy, with 20% of patients progressing within 24 months of first-line therapy. Chimeric antigen receptor T-cell (CAR-T) therapies have improved outcomes in relapsed or refractory FL, yet their use requires significant…
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Procedural activity and dynamics of the new Italian Scientific and Economic Committee (CSE): a one-year observational analysis
Introduction: In January 2024, the Commissione Scientifica ed Economica (CSE) became the national body responsible for the integrated scientific and economic evaluation of medicines in Italy. This study provides the first systematic description of the CSE’s activity during its initial operational…
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Economic and organizational impact of implementing Peristeen Plus in the management of neurogenic bowel dysfunction: evidence from Italy
Introduction: NBD is a chronic condition in people with spinal cord injury, commonly manifesting as constipation and fecal incontinence. TAI is a minimally invasive alternative to conventional management. Peristeen Plus, a TAI device recommended, enables predictable bowel evacuation, reducing…
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Burden of primary biliary cholangitis on the Italian National Health Service: retrospective analysis from an administrative database
Introduction: Primary biliary cholangitis (PBC) is a rare, chronic, cholestatic, autoimmune, and disabling liver disease whose treatments are aimed at reducing its progression. The aim was to describe patients with PBC, their healthcare resource utilization (HCRU) and costs on the Italian National…
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Pharmacoeconomic analysis of switch to faricimab for neovascular age-related macular degeneration in real clinical practice
Introduction: Neovascular age-related macular degeneration (nAMD) is one of the leading causes of severe vision loss among older adults. This condition impairs patients’ quality of life and imposes a significant economic burden on the healthcare system. This study aims to determine the difference…
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Journal Article
A decision algorithm for interpreting immature overall survival in onco‑hematology: development and application
Introduction: In indolent haematological malignancies, interim overall survival (OS) analyses are frequently limited by few events and immature follow-up. Relying exclusively on hazard ratio (HR) and log-rank test may provide insufficient information for clinical and HTA decision-making. We propose…