title: The Cost of Relapsing-Remitting Multiple Sclerosis Patients Who Develop Neutralizing Antibodies during Interferon Beta Therapy.
abstract: BACKGROUND
  Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with interferon beta (IFN beta) can develop neutralizing antibodies (NAbs) that reduce treatment efficacy. Several clinical studies explored the association of NAb+ status with increased disease activity.
  
  
  OBJECTIVE
  The aim of this study was to estimate the cost of RRMS patients who develop NAbs while treated with IFN beta by the Italian National Healthcare Service (NHS) and the Italian Society perspectives.
  
  
  METHODS
  The clinical data derived from a published observational study on 567 RRMS Italian patients treated with IFN beta. The management cost data derived from the published literature. Cost data were inflated to Euro 2014.
  
  
  RESULTS
  The annual direct cost to treat a patient was estimated in €15,428 in the NAb+ cohort and €14,317 in the NAb- cohort. The annual societal cost was estimated in €33,890 and €30,790 in NAb+ and NAb- patients, respectively. The cost increase related to the NAb+ status was €3,100 in the Italian societal perspective and €1,111 in the Italian NHS perspective.
  
  
  CONCLUSIONS
  The results of this economic evaluation suggest the presence of an association between NAb+ status and increased costs for the management of RRMS in Italy. Further pharmacoeconomic research will be needed to confirm this first result.
authors.affiliation: Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Damiano
authors.identifier: http://orcid.org/0000-0002-8645-1763
authors.initials: D
authors.lastname: Paolicelli
authors.affiliation: SIHS Health Economics Consulting, Torino, Italia.
authors.forename: Sergio
authors.initials: S
authors.lastname: Iannazzo
authors.affiliation: Biogen Italia, Milano, Italia.
authors.forename: Laura
authors.initials: L
authors.lastname: Santoni
authors.affiliation: Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Iaffaldano
authors.affiliation: Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Di Lecce
authors.affiliation: Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Manni
authors.affiliation: Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Vito
authors.initials: V
authors.lastname: Lavolpe
authors.affiliation: Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Tortorella
authors.affiliation: Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: D'Onghia
authors.affiliation: Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Vita
authors.initials: V
authors.lastname: Direnzo
authors.affiliation: Biogen Italia, Milano, Italia.
authors.forename: Elisa
authors.initials: E
authors.lastname: Puma
authors.affiliation: Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
mesh_terms: D000328:Adult; D057134:Antibodies, Neutralizing / Q000378:metabolism*; D017281:Cost of Illness; D005260:Female; D006801:Humans; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000191:economics* / Q000276:immunology / Q000378:metabolism*; D016896:Treatment Outcome
chemical_list: D057134:Antibodies, Neutralizing; D016899:Interferon-beta