[Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy]

BACKGROUND: Each drug therapy with an anticoagulant effect may require, in emergency conditions, a rapid and specific strategy for a prompt restoration of coagulation. Dabigatran is the first-in-class of the so-called new oral anticoagulants (NAO), that have been made available in recent years in ad...

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Main Authors: Andrea Belisari, Sergio Iannazzo, Giuseppe Di Pasquale, Claudio Fresco, Lorenzo Giovanni Mantovani, Maria Pia Ruggeri, Danilo Toni, Raffaele Landolfi
Format: Article
Language:English
Published: SEEd Medical Publishers 2016-06-01
Series:Farmeconomia: Health Economics and Therapeutic Pathways
Subjects:
Online Access:https://journals.seedmedicalpublishers.com/index.php/FE/article/view/1243
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author Andrea Belisari
Sergio Iannazzo
Giuseppe Di Pasquale
Claudio Fresco
Lorenzo Giovanni Mantovani
Maria Pia Ruggeri
Danilo Toni
Raffaele Landolfi
author_facet Andrea Belisari
Sergio Iannazzo
Giuseppe Di Pasquale
Claudio Fresco
Lorenzo Giovanni Mantovani
Maria Pia Ruggeri
Danilo Toni
Raffaele Landolfi
author_sort Andrea Belisari
collection DOAJ
description BACKGROUND: Each drug therapy with an anticoagulant effect may require, in emergency conditions, a rapid and specific strategy for a prompt restoration of coagulation. Dabigatran is the first-in-class of the so-called new oral anticoagulants (NAO), that have been made available in recent years in addition to traditionally-used vitamin K antagonists (VKA). Idarucizumab is a monoclonal antibody that binds to dabigatran, neutralizing its anticoagulant effect. OBJECTIVE: To assess the economic effect of idarucizumab in patients treated with dabigatran when the rapid reversal of its anticoagulant effect is required. METHODS: The analysis was carried over through the development of a budget impact model specifically adapted to the context of Italian care. The analysis was conducted along a time horizon of five years. The target population was defined by those patients on dabigatran treatment presenting uncontrolled and life-threatening bleedings (gastro-intestinal, intracranial or other) or requiring emergency surgery or urgent procedures. The estimation of healthcare resources (i.e. diagnostic procedures, medications, and other in-hospital services) needed for the management of uncontrolled bleeding and emergency surgery in patients treated with dabigatran was obtained from a panel of five Italian Clinical Experts. Unit costs were derived from current prices and tariffs. RESULTS: The total cost of management with the current therapeutic modalities ranged from € 16.5 million in year 1 to € 20.1 million in year 5. In the scenario with idarucizumab the total cost ranged from € 15.4 million in year 1 to € 18.7 million in year 5. The adoption of idarucizumab resulted in a cumulative 5-year savings of 6.5 million euro corresponding to 7.1% of the total expense. CONCLUSION: Idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations has the potential for substantial savings, compared to treatments currently available. This preliminary assessment will require further confirmatory evidence when the product will become available in Italian healthcare setting. [Article in Italian]
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spelling doaj.art-e141542ce4dc459bb7607f1b3b0a19662022-12-21T19:02:12ZengSEEd Medical PublishersFarmeconomia: Health Economics and Therapeutic Pathways2240-256X2016-06-01172475810.7175/fe.v17i2.12431169[Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy]Andrea Belisari0Sergio Iannazzo1Giuseppe Di Pasquale2Claudio Fresco3Lorenzo Giovanni Mantovani4Maria Pia Ruggeri5Danilo Toni6Raffaele Landolfi7Fondazione CHARTA, Center for Health Associated Research & Technology Assessment, MilanoCentro di Ricerca in Sanità Pubblica, Scuola di Medicina, Università Milano Bicocca, MonzaUO Cardiologia, Ospedale Maggiore, BolognaSOC Cardiologia, Azienda Ospedaliero Universitaria "Santa Maria della Misericordia", UdineCentro di Ricerca in Sanità Pubblica, Scuola di Medicina, Università Milano Bicocca, MonzaUOC Pronto Soccorso Breve Osservazione, Azienda Ospedaliera San Giovanni Addolorata, RomaDipartimento di Neurologia e Psichiatria, Ospedale Policlinico Umberto I, Università “La Sapienza”, RomaIstituto di Medicina Interna e Geriatria, Università Cattolica del Sacro Cuore, Fondazione Policlinico Gemelli, RomaBACKGROUND: Each drug therapy with an anticoagulant effect may require, in emergency conditions, a rapid and specific strategy for a prompt restoration of coagulation. Dabigatran is the first-in-class of the so-called new oral anticoagulants (NAO), that have been made available in recent years in addition to traditionally-used vitamin K antagonists (VKA). Idarucizumab is a monoclonal antibody that binds to dabigatran, neutralizing its anticoagulant effect. OBJECTIVE: To assess the economic effect of idarucizumab in patients treated with dabigatran when the rapid reversal of its anticoagulant effect is required. METHODS: The analysis was carried over through the development of a budget impact model specifically adapted to the context of Italian care. The analysis was conducted along a time horizon of five years. The target population was defined by those patients on dabigatran treatment presenting uncontrolled and life-threatening bleedings (gastro-intestinal, intracranial or other) or requiring emergency surgery or urgent procedures. The estimation of healthcare resources (i.e. diagnostic procedures, medications, and other in-hospital services) needed for the management of uncontrolled bleeding and emergency surgery in patients treated with dabigatran was obtained from a panel of five Italian Clinical Experts. Unit costs were derived from current prices and tariffs. RESULTS: The total cost of management with the current therapeutic modalities ranged from € 16.5 million in year 1 to € 20.1 million in year 5. In the scenario with idarucizumab the total cost ranged from € 15.4 million in year 1 to € 18.7 million in year 5. The adoption of idarucizumab resulted in a cumulative 5-year savings of 6.5 million euro corresponding to 7.1% of the total expense. CONCLUSION: Idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations has the potential for substantial savings, compared to treatments currently available. This preliminary assessment will require further confirmatory evidence when the product will become available in Italian healthcare setting. [Article in Italian]https://journals.seedmedicalpublishers.com/index.php/FE/article/view/1243dabigatran, idarucizumab, emergency surgeryurgent procedures
spellingShingle Andrea Belisari
Sergio Iannazzo
Giuseppe Di Pasquale
Claudio Fresco
Lorenzo Giovanni Mantovani
Maria Pia Ruggeri
Danilo Toni
Raffaele Landolfi
[Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy]
Farmeconomia: Health Economics and Therapeutic Pathways
dabigatran, idarucizumab, emergency surgery
urgent procedures
title [Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy]
title_full [Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy]
title_fullStr [Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy]
title_full_unstemmed [Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy]
title_short [Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy]
title_sort budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency urgent situations in italy
topic dabigatran, idarucizumab, emergency surgery
urgent procedures
url https://journals.seedmedicalpublishers.com/index.php/FE/article/view/1243
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