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Impatto clinico ed economico dell’emicrania in Italia: un’analisi di real-world evidence
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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Multicriterio e valutazioni economiche: verso una proposta per un nuovo framework per il prezzo dei farmaci in Italia
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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L’evoluzione del dialogo e dei rapporti tra AIFA, clinici, Società scientifiche e associazioni dei pazienti/organizzazioni di attivismo civico
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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La cooperazione tra gli stakeholder per la sostenibilità del nuovo paradigma farmaceutico in Italia
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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Valutazione economica delle modalità distributive dei dispositivi medici per stomia e incontinenza nel contesto sanitario italiano
INTRODUCTION: The clinical management of ostomy and urinary incontinence poses a substantial challenge for healthcare systems and patients, as it necessitates the provision of specialized medical devices. In Italy, these devices are distributed through multiple distribution modalities. METHODS…
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Come le Regioni possono utilizzare il Rapporto OsMed per condividere le azioni di miglioramento dell’appropriatezza
INTRODUCTION: Italy retains a unique wealth of information on drug usage, embodied in the OsMed Report, published since 2001 and based on data collected by the National Observatory on the Use of Medicines. The Report analyzes data on drug dispensing, pharmaceutical expenditure, and prescribing…
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Verso un Green Health Technology Assessment: il ruolo del Life Cycle Assessment per scelte sanitarie più sostenibili
The healthcare sector significantly contributes to global greenhouse gas emissions. Among the various strategies available, exploring the integration of environmental sustainability into Health Technology Assessment (HTA) presents a potential avenue for addressing these impacts. The HTA Core Model…
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La durata delle procedure di negoziazione di prezzo e rimborso in Italia nel periodo 2021-2023 è stata indipendente dal prezzo dei medicinali
BACKGROUND: The duration of price&reimbursement (P&R) procedures is taken as a key performance indicator of Regulatory Agencies in Europe. In this study we have tested the hypothesis that the price of medicines may have negatively affected the duration of P&R negotiations in Italy in the period…
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Gestione e utilizzo del Fondo Farmaci Innovativi: un’indagine qualitativa multistakeholder sulle pratiche regionali e locali
INTRODUCTION: The Fund for Innovative Medicines, Fondo Farmaci Innovativi (FFI), enables financing, non-competition, and fast access to innovative medicines. However, limited evidence exists regarding its management processes and the stakeholders involved. In order to identify characteristics…
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Valutazione dei tempi di accesso per le nuove entità chimiche in Italia: un’analisi critica del periodo 2018-2024
OBJECTIVE: This study aims to provide an up-to-date analysis, for new chemical entities on the market, on the timing of pricing and reimbursement (P&R) in Italy, covering the entire period of activity (from September 2018 to January 2024) of the last evaluation Commission (Technical Scientific…
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Analisi di costo-efficacia di Brentuximab Vedotin + CHP in pazienti con linfoma anaplastico a grandi cellule sistemico
OBJECTIVE: Systemic anaplastic large cell lymphoma (sALCL) is a rare and severe non-Hodgkin lymphoma. Despite its clinical relevance, the aetiology of this disease is unknown, not allowing the patient to prevent and counteract it. This study investigates the cost-effectiveness of Brentuximab…
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Gli strumenti regionali di governo del comportamento prescrittivo e della spesa farmaceutica: dalla letteratura alle esperienze concrete e raccomandazioni di un panel di esperti
INTRODUCTION: The increasing pharmaceutical spending in Italy represents a significant challenge for the national health system and requires the adoption of instruments of expenditure management and prescriptive appropriateness both at national and regional levels. METHODS: The paper aims to…
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Health Technology Assessment del vaccino antinfluenzale quadrivalente adiuvato Fluad Tetra(®): update
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Atti 57° Congresso Nazionale Società Italiana Igiene, Medicina Preventiva e Sanità Pubblica (SItI)
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L’assessment e il valore del farmaco: una sintesi dei focus group della XXII Conferenza Nazionale sulla Farmaceutica
The XXII National Conference on Pharmaceuticals, held in Catania from 29 February to 1 March 2024, involved the participation of representatives from more than forty pharmaceutical industries, national authorities, academia, clinicians and clinical pharmacists. The 22(nd) edition represented a key…
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Ottimizzazione nel trattamento del soggetto con HIV: analisi di impatto economico e organizzativo di Bictegravir/Emtricitabina/Tenofovir Alafenamide
INTRODUCTION: Given the availability of a growing number of HIV treatment options, it becomes essential to have a clear understanding of the related economic-organizational evidence, to operate informed and conscious choices. The study aims to define the economic and organizational impact related…
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Analisi di costo-efficacia di nirmatrelvir/ritonavir in pazienti adulti ad alto rischio di progressione a COVID-19 severo
OBJECTIVE: This study aimed to estimate the cost-effectiveness of nirmatrelvir/ritonavir (NMV/r) versus the standard of care (SoC) for patients with mild-to-moderate coronavirus disease 2019 (COVID-19) at high risk for progression to severe illness from the perspective of the Italian National…
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Costo per responder di upadacitinib 30 mg e di dupilumab 300 mg nel trattamento di pazienti con dermatite atopica moderata-grave in Italia
PURPOSE: The objective of this economic evaluation was to compare the cost per responder between upadacitinib (Upa) 30 mg and dupilumab (Dup) 300 mg in patients with moderate-to-severe atopic dermatitis in Italy. METHODS: A cost per responder analysis was developed based on results of Heads Up, a…
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RWE in oncologia: uso dei database per identificare i sottotipi molecolari del cancro mammario metastatico in Italia
INTRODUCTION: The use of Real-World Evidence (RWE) is gaining increasing relevance in oncology, offering a complementary perspective to randomised clinical trials (RCTs). In Italy, administrative databases represent a promising source to explore treatment patterns and distribution of molecular…