title: Budget impact analysis of the simplification to atazanavir + ritonavir + lamivudine dual therapy of HIV-positive patients receiving atazanavir-based triple therapies in Italy starting from data of the Atlas-M trial.
abstract: BACKGROUND
  This analysis aimed at evaluating the impact of a therapeutic strategy of treatment simplification of atazanavir (ATV)+ ritonavir (r) + lamivudine (3TC) in virologically suppressed patients receiving ATV+r+2 nucleoside reverse transcriptase inhibitors (NRTIs) on the budget of the Italian National Health Service (NHS).
  
  
  METHODS
  A budget impact model with a 5-year time horizon was developed based on the clinical data of Atlas-M trial at 48 weeks (in terms of percentage of patients experiencing virologic failure and adverse events), from the Italian NHS perspective. A scenario in which the simplification strategy was not considered was compared with three scenarios in which, among a target population of 1,892 patients, different simplification strategies were taken into consideration in terms of percentage of patients simplified on a yearly basis among those eligible for simplification. The costs considered were direct medical costs related to antiretroviral drugs, adverse events management, and monitoring activities.
  
  
  RESULTS
  The percentage of patients of the target population receiving ATV+r+3TC varies among the scenarios and is between 18.7% and 46.9% in year 1, increasing up to 56.3% and 84.4% in year 5. The antiretroviral treatment simplification strategy considered would lead to lower costs for the Italian NHS in a 5-year time horizon between -28.7 million € and -16.0 million €, with a reduction of costs between -22.1% (-3.6 million €) and -8.8% (-1.4 million €) in year 1 and up to -39.9% (-6.9 million €) and -26.6% (-4.6 million €) in year 5.
  
  
  CONCLUSIONS
  The therapy simplification for patients receiving ATV+r+2 NRTIs to ATV+r+3TC at a national level would lead to a reduction of direct medical costs over a 5-year period for the Italian NHS.
authors.affiliation: Centre for Research on Health Economics, Social and Health Care Management (CREMS), LIUC - Università Cattaneo, Castellanza, Italy; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Umberto
authors.initials: U
authors.lastname: Restelli
authors.affiliation: Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fabbiani
authors.affiliation: Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart.
authors.forename: Simona
authors.initials: S
authors.lastname: Di Giambenedetto
authors.affiliation: Health Economics, Bristol-Myers Squibb S.r.l., Rome, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Nappi
authors.affiliation: Centre for Research on Health Economics, Social and Health Care Management (CREMS), LIUC - Università Cattaneo, Castellanza, Italy; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Davide
authors.initials: D
authors.lastname: Croce
keywords: Italian National Health Service; antiretroviral therapy; cost; de-intensification; economic evaluation; protease inhibitor