Hostname: page-component-cd9895bd7-jn8rn Total loading time: 0 Render date: 2024-12-22T22:44:02.489Z Has data issue: false hasContentIssue false
  • English
  • Français

BUDGET IMPACT ANALYSIS OF BELIMUMAB IN TREATING SYSTEMIC LUPUS ERYTHEMATOSUS

Published online by Cambridge University Press:  05 December 2016

Francesca Pierotti ,
Iaria Palla ,
Lara Pippo ,
Valentina Lorenzoni  and
Giuseppe Turchetti
Francesca Pierotti
Affiliation:
Institute of Management, Scuola Superiore Sant'Anna
Iaria Palla
Affiliation:
Institute of Management, Scuola Superiore Sant'Anna
Lara Pippo
Affiliation:
GlaxoSmithKline
Valentina Lorenzoni
Affiliation:
Institute of Management, Scuola Superiore Sant'Anna
Giuseppe Turchetti
Affiliation:
Institute of Management, Scuola Superiore Sant'[email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: The study evaluates the costs of systemic lupus erythematosus (SLE) and the budget impact due to the introduction of belimumab in the Italian setting.

Methods: Adaptation to the Italian setting of a budget impact model with a time horizon of 4 years (year 0 without belimumab, years 1–3 with belimumab) to compare treatment, administration, and clinical monitoring costs of standard therapy and of the alternative scenario in which belimumab is administered in addition to the standard therapy to the subgroup of patients selected according to the label approved by the European Medicines Agency. The model takes also into account the costs of flares.

Results: Over 3 years, belimumab is able to prevent cumulatively 1,111 severe flares and 3,631 nonsevere flares with a total saving for the Italian National Health System (NHS) of approximately €6.2 million. Budget impact ranges from €4.4 million in the first year to €20.3 million in the third year.

Conclusions: The decrease in the number of flare partially counterbalances the costs of the new technology (impact attenuation of approximately 16 percent). These data elucidate the importance to control and monitor the disease progression and to prevent exacerbations, which are the major causes of the increase in costs paid by the NHS and by the society. The financial impact could be replicate on a regional basis, to inform local decision makers. Further developments are possible as the model does not consider the additional clinical and economic benefits of reduced damage accrual and slowed disease progression.

Keywords

Systemic lupus erythematosusBudget Impact Model (BIM)flares
Type
Assessments
Information
International Journal of Technology Assessment in Health Care , Volume 32 , Issue 5 , 2016 , pp. 348 - 354
Copyright
Copyright © Cambridge University Press 2016 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Agmon-Levin, N, Mosca, M, Petri, M, Shoenfeld, Y. Systemic lupus erythematosus one disease or many? Autoimmun Rev. 2012;11:593–595.Google Scholar
2. Mosca, M, Tani, C, Carli, L, Bombardieri, S. Glucocorticoids in systemic lupus erythematosus. Clin Exp Rheumatol. 2011;29 (Suppl 68):S126–S129.Google Scholar
3. Mosca, M, Tani, C, Aringer, M, et al. Development of quality indicators to evaluate the monitoring of SLE patients in routine clinical practice. Autoimmun Rev. 2011;10:383–388.CrossRefGoogle ScholarPubMed
4. Nossent, J, Kiss, E, Rozman, B, et al. Disease activity and damage accrual during the early disease course in a multinational inception cohort of patients with systemic lupus erythematosus. Lupus. 2010;19:949–956.Google Scholar
5. Mosca, M, Bombardieri, S, Carmona, L. Assessment of multiple organ systems in systemic lupus erythematosus. What will the new guidelines mean? Int J Clin Rheumatol. 2010;5:291–297.Google Scholar
6. Mosca, M, Tani, C, Aringer, M, et al. European League Against Rheumatism recommendations for monitoring patients with systemic lupus erythematosus in clinical practice and in observational studies. Ann Rheum Dis. 2010;69:1269–1274.Google Scholar
7. Nossent, J, Cikes, N, Kiss, E, et al. Current causes of death in systemic lupus erythematosus in Europe, 2000-2004: Relation to disease activity and damage accrual. Lupus. 2007;16:309–317.Google Scholar
8. Panopalis, P, Clarke, AE, Yelin, E. The economic burden of systemic lupus erythematosus. Best Pract Res Clin Rheumatol. 2012;26:695–704.CrossRefGoogle ScholarPubMed
9. Mosca, M, Boumpas, DT, Bruce, IN, et al. Treat-to-target in systemic lupus erythematosus: Where are we today? Clin Exp Rheumatol. 2012;30 (Suppl 73):S112–S115.Google Scholar
10. Turchetti, G, Yazdany, J, Palla, I, Yelin, E, Mosca, M. SLE and the economic perspective: A systematic literature review and points to consider. Clin Exp Rheumatol. 2012;30 (Suppl 73):S116–S122.Google Scholar
11. Slawsky, KA, Fernandes, AW, Fusfeld, L, Manzi, S, Goss, TF. A structured literature review of the direct costs of adult systemic lupus erythematosus in the United States. Arthritis Care Res. 2011;63:1224–1232.CrossRefGoogle Scholar
12. Li, T, Carls, GS, Panopalis, P, et al. Long term medical costs and resource utilization in systemic lupus erythematosus and lupus nephritis: A five-year analysis of a large Medicaid population. Arthritis Rheum. 2009;61:755–763.Google Scholar
13. Meacock, R, Dale, N, Harrison, MJ. The humanistic and economic burden of systemic lupus erythematosus. Pharmacoeconomics. 2013;31:49–61.CrossRefGoogle ScholarPubMed
14. Bexelius, C, Wachtmeister, K, Skare, P, Jönsson, L, van Vollenhoven, R. Drivers of cost and health-related quality of life in patients with systemic lupus erythematosus (SLE): A Swedish nationwide study based on patient reports. Lupus. 2013;22:793–801.Google Scholar
15. Doria, A, Amoura, Z, Cervera, R, et al. Annual direct medical cost of active systemic lupus erythematosus in five European countries. Ann Rheum Dis. 2014;73:154–160.Google Scholar
16. Zhu, TY, Tam, LS, Lee, KK, Li, EK. The impact of flare on disease costs of patients with Systemic Lupus Erytemathosus. Arthritis Rheum. 2009;61:1159–1167.Google Scholar
17. Mathieu, A, Doria, A, Perna, A, et al. The annual direct medical cost of Systemic Lupus Erythematosus (SLE) patients and costs drivers (LUCIE study): Italian results. Poster presentation 9th HTA International Annual Meeting, Bilbao, 2012.Google Scholar
18. Pierotti, F, Palla, I, Treur, M, Pippo, L, Turchetti, G. Assessment of the economic impact of belimumab for the treatment of systemic lupus erythematosus in the Italian setting: A cost-effectiveness analysis. PLoS One. 2015;10:e0140843.Google Scholar
19. Sullivan, SD, Mauskopf, JA, Augustovski, F, et al. Budget impact analysis-principles of good practice: Report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014;17:5-14.CrossRefGoogle ScholarPubMed
20. Italian Institute of Statistics (ISTAT) [Internet]. Popolazione residente al primo gennaio 2011. http://demo.istat.it/pop2011/index.html (accessed December 6, 2013).Google Scholar
21. van Vollenhoven, RF, Petri, MA, Cervera, R, et al. Belimumab in the treatment of systemic lupus erythematosus: High disease activity predictors of response. Ann Rheum Dis. 2013;71:1343–1349.Google Scholar
22. Navarra, SV, Guzman, RM, Gallacherm, AE, et al. BLISS-52 Study Group: Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377:721–731.Google Scholar
23. Furie, R, Petri, M, Zamani, O, et al. BLISS-76 Study Group: A phase 3, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits BLyS, in patients with systemic lupus erytematosus. Arthritis Rheum. 2011;63:3918–3930.CrossRefGoogle Scholar
24. Petri, MA, Levy, RA, Merrill, JT, et al. Belimumab, a BLyS-specific inhibitor, reduced disease activity, flares, and prednisone use in patients with seropositive SLE: Combined efficacy results from the phase 3 BLISS-52 and-76 studies. Arthritis Rheum. 2010;62 (Suppl 10):452.Google Scholar
25. Ministery of Health. Tariffario prestazioni di assistenza specialistica ambulatoriale. Ricognizione e primo aggiornamento delle tariffe massime per la remunerazione delle prestazioni sanitarie. Accessed 6 December 2013. http://www.salute.gov.it/ (2006).Google Scholar
26. Agenzia Italiana del Farmaci (AIFA). Liste di rimborsabilità dei farmaci di Classe A e H. http://www.agenziafarmaco.gov.it/it/content/farmaci-di-fascia-e-h-liste-aggiornate (accessed December 6, 2013).Google Scholar
27. Conferenza delle Regioni e delle Province Autonome. Tariffa unica convenzionale per le prestazioni di assistenza ospedaliera regole e tariffe valide per l'anno 2009. http://www.regioni.it/upload/270110TUC_ASSISTENZA_OSPEDALIERA.pdf (accessed December 6, 2013).Google Scholar
28. Turchetti, G. et al. Valutazione dell'impatto economico dell'introduzione di belimumab per la cura del LES: una analisi di impatto sul budget. In: De Waure, C. et al., eds. L'impiego di belimumab nel Lupus Eritematoso Sistemico: risultati di una valutazione di HTA. Quaderni Italian Journal of Public Health. 2013;111–125.Google Scholar
29. Davidson, JE, Galway, N, Egger, PJ. The prevalence of systemic lupus erythematosus in Europe: A systematic review and meta-analysis. Poster presentation Annual European Congress of Rheumatology, European League Against Rheumatism (EULAR), 2002, Berlin.Google Scholar
30. Ippolito, A, Wallace, DJ, Gladman, D, et al. Autoantibodies in systemic lupus erythematosus: Comparison of historical and current assessment of seropositivity. Lupus. 2011;20:250–255.Google Scholar
31. Nikpour, M, Urowitz, MB, Ibanez, D, Gladman, DD. Frequency and determinants of flare and persistently active disease in systemic lupus erythematosus. Arthritis Rheum. 2009;61:1152–1158.Google Scholar
32. Zen, M, Bassi, N, Nalotto, L, et al. Disease activity patterns in a monocentric cohort of SLE patients: A seven-year follow-up study. Clin Exp Rheumatol. 2012;30:856–863.Google Scholar
33. Turchetti, G, Pierotti, F. Innovazione e sostenibilità. Una farmacoeconomia a servizio del sistema sanitario. In: Carnevali, G, Manzi, P, eds. Linee guida per una nuova governance del sistema sanitario, Roma: Aracne Editore; 2013:559–573.Google Scholar
34. Turchetti, G, Scalone, L, Della Casa Alberighi, O, et al. The rationale of pharmacoeconomic analysis in rheumatologic indications. Clin Exp Rheumatol. 2012;30 (Suppl 73):S64–SS71.Google Scholar
35. Furneri, G, Mantovani, LG, Belisari, A, et al. Systematic literature review on economic implications and pharmacoeconomic issues of rheumatoid arthritis. Clin Exp Rheumatol. 2012;30 (Suppl 73):S72–S84.Google Scholar
36. Palla, I, Trieste, L, Tani, C, et al. A systematic literature review of the economic impact of ankylosing spondylitis. Clin Exp Rheumatol. 2012;30 (Suppl 73):S136–S141.Google ScholarPubMed
37. Trieste, L, Palla, I, Fusco, F, et al. The economic impact of gout: A systematic literature review. Clin Exp Rheumatol. 2012;30 (Suppl 73):S145–S148.Google Scholar
38. Trieste, L, Palla, I, Baldini, C, et al. Systemic vasculitis: How little we know about their societal and economic burden. Clin Exp Rheumatol. 2012;30 (Suppl 73):S154–S156.Google Scholar
39. Assessment, Turchetti G. L'Health Technology. Riflessioni sulla dimensione e sulle implicazioni organizzative. In: Mantovani, LG, ed. L'Health Technology Assessment. Principi, concetti, strumenti operativi, Milano: Il Sole 24ore Libri; 2011:179–191.Google Scholar
40. Turchetti, G, Spadoni, E, Geisler, E. Health technology assessment. Evaluation of biomedical innovative technologies. IEEE Eng Med Biol. 2010;29:70–76.Google Scholar
Supplementary material: File

Pierotti supplementary material

Tables S1-S6

Download Pierotti supplementary material(File)
File 107.5 KB
Supplementary material: Image

Pierotti supplementary material

Figure S1

Download Pierotti supplementary material(Image)
Image 58.5 KB
Supplementary material: Image

Pierotti supplementary material

Figure S2

Download Pierotti supplementary material(Image)
Image 43.4 KB