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BioMed Research International
Volume 2014, Article ID 704207, 9 pages
Research Article

Health Technology Assessment of Belimumab: A New Monoclonal Antibody for the Treatment of Systemic Lupus Erythematosus

1Institute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy
2Department of Public Health, University of Turin, 10126 Turin, Italy
3Rheumatology Department, Padua Hospital, 35128 Padua, Italy
4Institute of Management, Scuola Superiore Sant’Anna, 56127 Pisa, Italy
5GSK, 37135 Verona, Italy
6Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy

Received 2 May 2014; Accepted 29 June 2014; Published 17 August 2014

Academic Editor: Norberto Ortego-Centeno

Copyright © 2014 Maria Lucia Specchia et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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.