title: Health technology assessment of belimumab: a new monoclonal antibody for the treatment of systemic lupus erythematosus.
abstract: OBJECTIVE
  Systemic lupus erythematosus (SLE) is treated with anti-inflammatory and immunosuppressive drugs and off-label biologics. Belimumab is the first biologic approved after 50 years as an add-on therapy for active disease. This paper summarizes a health technology assessment performed in Italy.
  
  
  METHODS
  SLE epidemiology and burden were assessed using the best published international and national evidences and efficacy and safety of belimumab were synthesized using clinical data. A cost-effectiveness analysis was performed by a lifetime microsimulation model comparing belimumab to standard of care (SoC). Organizational and ethical implications were discussed.
  
  
  RESULTS
  Literature review showed that SLE affects 47 per 100,000 people for a total of 28,500 patients in Italy, 50% of whom are affected by active form of the disease despite SoC. These patients, if autoantibodies and anti-dsDNA positive with low complement, are eligible for belimumab. SLE determines work disability and a 2-5-fold increase in mortality. Belimumab with SoC may prevent 4,742 flares in three years being cost-effective with an incremental cost-effectiveness ratio of €32,859 per quality adjusted life year gained. From the organizational perspective, the development of clear and comprehensive clinical pathways is crucial.
  
  
  CONCLUSIONS
  The assessment supports the use of belimumab into the SLE treatment paradigm in Italy.
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Maria Lucia
authors.identifier: 0000-0002-3859-4591
authors.initials: ML
authors.lastname: Specchia
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Chiara
authors.identifier: 0000-0002-4346-1494
authors.initials: C
authors.lastname: de Waure
authors.affiliation: Department of Public Health, University of Turin, 10126 Turin, Italy.
authors.forename: Maria Rosaria
authors.identifier: 0000-0001-7357-2892
authors.initials: MR
authors.lastname: Gualano
authors.affiliation: Rheumatology Department, Padua Hospital, 35128 Padua, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Doria
authors.affiliation: Institute of Management, Scuola Superiore Sant'Anna, 56127 Pisa, Italy.
authors.forename: Giuseppe
authors.identifier: 0000-0002-1877-5459
authors.initials: G
authors.lastname: Turchetti
authors.affiliation: GSK, 37135 Verona, Italy.
authors.forename: Lara
authors.identifier: 0000-0001-6414-3500
authors.initials: L
authors.lastname: Pippo
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Francesco
authors.identifier: 0000-0003-3655-0904
authors.initials: F
authors.lastname: Di Nardo
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Capizzi
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Chiara
authors.identifier: 0000-0003-0149-1078
authors.initials: C
authors.lastname: Cadeddu
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Flavia
authors.identifier: 0000-0002-5756-0776
authors.initials: F
authors.lastname: Kheiraoui
authors.affiliation: Rheumatology Department, Padua Hospital, 35128 Padua, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Iaccarino
authors.affiliation: Institute of Management, Scuola Superiore Sant'Anna, 56127 Pisa, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Pierotti
authors.affiliation: Institute of Management, Scuola Superiore Sant'Anna, 56127 Pisa, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Palla
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Maria Assunta
authors.initials: MA
authors.lastname: Veneziano
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Gliubizzi
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Sferrazza
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Nicolotti
authors.affiliation: GSK, 37135 Verona, Italy.
authors.forename: Rolando
authors.identifier: 0000-0002-5430-8727
authors.initials: R
authors.lastname: Porcasi
authors.affiliation: Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: La Torre
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Di Pietro
authors.affiliation: Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
authors.forename: Walter
authors.identifier: 0000-0002-5655-688X
authors.initials: W
authors.lastname: Ricciardi
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D007558:Italy / Q000453:epidemiology; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy / Q000191:economics / Q000453:epidemiology; D008297:Male; D011788:Quality of Life
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; C511911:belimumab