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Biomed Res Int. 2014;2014:704207. doi: 10.1155/2014/704207. Epub 2014 Aug 17.

Health technology assessment of belimumab: a new monoclonal antibody for the treatment of systemic lupus erythematosus.

Author information

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

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.

PMID:
25243173
PMCID:
PMC4150460
DOI:
10.1155/2014/704207
[Indexed for MEDLINE]
Free PMC Article

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