Cost-effectiveness analysis of belimumab in patients with systemic lupus erythematosus in Spain;Análisis coste-efectividad de belimumab en pacientes con lupus eritematoso sistémico en España

Farmacia Hospitalaria

Volumn 39, Issue 3, 2015, Pages 161-170

  Díaz Cerezo, Silvia ^a   García Aparicio, Ángel María ^b   Parrondo, Javier ^a   Vallejo Aparicio, Laura Amanda ^a  

^a GSK   (Spain)

^b HOSPITAL VIRGEN DE LA SALUD   (Spain)

Author keywords

Belimumab; Cost effectiveness; Economic model; Systemic lupus erythematosus

Indexed keywords

BELIMUMAB; IMMUNOSUPPRESSIVE AGENT; MONOCLONAL ANTIBODY;

ARTICLE; COHORT ANALYSIS; COST EFFECTIVENESS ANALYSIS; COST UTILITY ANALYSIS; HUMAN; QUALITY OF LIFE; SPAIN; SYSTEMIC LUPUS ERYTHEMATOSUS; TREATMENT DURATION; UNITED STATES; AGED; COST BENEFIT ANALYSIS; DRUG COST; ECONOMICS; FEMALE; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; MIDDLE AGED; QUALITY ADJUSTED LIFE YEAR;

AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; COST-BENEFIT ANALYSIS; DRUG COSTS; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; MIDDLE AGED; QUALITY-ADJUSTED LIFE YEARS; SPAIN;

EID: 84932120643     PISSN: 11306343     EISSN: 21718695     Source Type: Journal    
DOI: 10.7399/fh.2015.39.3.8814     Document Type: Article

References (36)

1. Carmona L, Ballina J, Gabriel R, Laffon A on behalf of the EPISER Study Group. The burden of musculoskeletal diseases in the general population of Spain: results from a national survey. Rev Esp Reumatol 2001;60:1040-45.
2. López P, Mozo L, Gutiérrez C, Suárez A. Epidemiology of systemic lupus erythematosus in a northern Spanish population: gender and age infuence on immunological features. Lupus 2003;12:860-5.
3. Mak A, Cheung MW, Chiew HJ, Liu Y, Ho RC. Global trend of survival and damage of systemic lupus erythematosus: meta-analysis and meta-regression of observational studies from the 1950s to 2000s. Semin Arthritis Rheum. 2012;41:830-9
4. Jolly M. How does quality of life of patients with systemic lupus erythematosus compare with that of other common chronic illnesses? J Rheumatol.2005;32:1706-8.
5. Schmeding A, Schneider M. Fatigue, health-related quality of life and other patient-reported outcomes in systemic lupus erythematosus. Best Practice & Research Clinical Rheumatology 2013;27:363-75.
6. Wolfe F, Michaud K, Li T, Katz RS. EQ-5D and SF-36 quality of life measures in systemic lupus erythematosus: comparisons with rheumatoid arthritis, noninflammatory rheumatic disorders, and fibromyalgia. J Rheumatol. 2010;37:296-304.
7. Campbell R Jr, Cooper GS, Gilkeson GS. Two Aspects of the Clinical and Humanistic Burden of Systemic Lupus Erythematosus: Mortality Risk and Quality of Life Early in the Course of Disease. Arthritis Rheum. 2008;59:458-64.
8. Alarcon GS, McGwin G, Jr., Uribe A, Friedman AW, Roseman JM, Fessler BJ, et al. Systemic lupus erythematosus in a multiethnic lupus cohort (LUMINA). XVII. Predictors of self-reported health-related quality of life early in the disease course. Arthritis Rheum 2004;51:465-74.
9. Almehed K, Carlsten H, Forsblad-d'Elia H. Health-related quality of life in systemic lupus erythematosus and its association with disease and work disability. Scand J Rheumatol 2010;39:58-62.
10. Rinaldi S, Doria A, Salaffi F, Ermani M, Iaccarino L, Ghirardello A, et al. Health-related quality of life in Italian patients with systemic lupus erythematosus. I. Relationship between physical and mental dimension and impact of age. Rheumatology (Oxford) 2004;43:1574-9.
11. Grupo de estudio de Enfermedades Autoinmunes Sistémicas, Sociedad Española de Medicina Interna. Lupus Eritematoso Sistémico. Guías Clínicas de Enfermedades Autoinmunes Sistémicas, 2011.
12. Calvo-Alén J, Silva-Fernández L, Úcar-Angulo E, Pego-Reigosa JM, Olivé A, Martínez-Fernández C, et al. Consenso de la Sociedad Española de Reumatología sobre el uso de terapias biológicas en el lupus eritematoso sistémico. Reumatol. Clin 2013;9:281-96.
13. Ficha Técnica Benlysta® (belimumab). Disponible en: http://www.aemps.gob.es/cima/fichasTecnicas.do?metodo=detalleForm. Consultado: Enero 2015.
14. Ramos-Casals M, Ruiz-Irastorza G, Jiménez-Alonso J, Khamashta MA, en nombre del Comité de Consenso sobre el uso de belimumab, Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Sociedad Española de Medicina Interna (SEMI). Recomendaciones sobre el uso de belimumab en el lupus eritematoso sistémico. Guía de Práctica Clínica GEAS-SEMI. Rev Clin Esp.2013;213:42-58.
15. Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet 2011;26:721-31.
16. Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzová D, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011;63:3918-30.
17. Van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012;71:1343-9.
18. Gouveia M, Borges M, Augusto M, Costa J, Treur M, Lopes S. Cost-effectiveness and cost-utility analysis of belimumab for the treatment of patients with Systemic Lupus Erithematosus in Portugal. Value in Health 2013;16:A384.
19. Specchia ML, de Waure C, Gualano MR, Doria A, Turchetti G, Pippo L, et al. Health technology assessment of belimumab: a new monoclonal antibody for the treatment of systemic lupus erythematosus. Biomed Res Int. 2014;17;704207.
20. Walczak J, Kopel J, Sołtys E, Dziurda D. Cost-utlity analysis of belimumab in the treatment of adult patientes with active, autoantibody-positive Systemic Lupus Erithematousus (SLE). Value in Health 2013;16:A385.
21. Manzi S, Sanchez-Guerrero J, Merrill JT, et al. Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials. Ann Rheum Dis 2012;71:1833-1838.
22. Ibanez D, Urowitz MB, Gladman DD. Summarizing disease features over time: I. Adjusted mean SLEDAI derivation and application to an index of disease activity in lupus. J Rheumatol. 2003;30:1977-82.
23. Petri M. Lupus in Baltimore: evidence-based 'clinical pearls' from the Hopkins Lupus Cohort. Lupus. 2005;14(12):970-73.
24. Dolan P. Modeling valuations for EuroQoL health states. Med Care 1997;35:1095-1108.
25. Badia X, Roset M, Monserrat S, Herdman M. The Spanish VAS tariff based on valuation of EQ-5D health states from the general population. In: Rabin RE et al, editors. EuroQol Plenary meeting Rotterdam 1997, 2-3 October. Discussion papers. Centre for Health Policy & Law, Erasmus University, Rotterdam, 1998:93-114.
26. Cervera R, Rúa-Figueroa I, Gil-Aguado A, Sabio JM, Pallarés L, Hernández-Pastor LJ, et al. Coste económico directo del control y el tratamiento del lupus eritematoso sistémico activo y sus brotes en España: estudio LUCIE. Rev Clin Esp. 2013;213:127-37.
27. Sutcliffe N, Clarke AE, Taylor R, Frost C, Isenberg DA. Total costs and predictors of costs in patients with systemic lupus erythematosus. Rheumatology (Oxford) 2001;40:37-47.
28. López Bastida J, Oliva J, Antoñanzas F, García-Altés A, Gisbert R, Mar J, et al. Propuesta de guía para la evaluación económica aplicada a las tecnologías sanitarias. Gac Sanit. 2010;24:154-70.
29. Sacristán JA, Oliva J, Del Llano J, Prieto L, Pinto JL. ¿Qué es una tecnología sanitaria eficiente en España? Gac Sanit. 2002;4:334-43.
30. De Cock E, Miravitlles M, González JR, Azanza-Perea JR. Valor umbral del coste por año de vida ganado para recomendar la adopción de tecnologías sanitarias en España: evidencias procedentes de una revisión de la literatura. Pharmacoeconomics. Spanish Research Articles 2007;4:97-107.
31. Lau CS, Mak A. The socioeconomic burden of SLE. Nat Rev Rheumatol 2009;5:400-4.
32. Huscher D, Merkesdal S, Thiele K, et al. Cost of illness in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and systemic lupus erythematosus in Germany. Ann Rheum Dis 2006;65:1175-83.
33. Ginzler EM, Wallace DJ, Merrill JT, Furie RA, Stohl W, Chatham WW, et al. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014;41:300-9.
34. Collins C.E., Kan H., Dall'era M., Macahilig C., Pappu R., Molta C.T., et al. 24-month outcomes associated with belimumab in patients with systemic lupus erythematosus in clinical practice settings. Arthritis and Rheumatology 2014;66:S291.
35. Cortes J., Marras C., Luis Andreu J., Calvo-Alen J., Garcia-Aparicio A.M., Alvarez E.D., et al. Evolution of patients with systemic lupus erythematous treated with belimumab in clinical practice settings. Arthritis and Rheumatology 2014; 66: S291-S292.
36. Rúa-Figueroa I, López-Longo FJ, Calvo-Alén J, Galindo-Izquierdo M, Loza E, García de Yebenes MJ, et al. Registro nacional de pacientes con lupus eritematoso sistémico de la Sociedad Española de Reumatología: objetivos y metodología. Reumatol Clin. 2014;10:17-24.