Budget impact of upadacitinib in patients with moderate to severe rheumatoid arthritis in Argentina
DOI:
https://doi.org/10.17843/rpmesp.2024.412.12934Keywords:
Budget impact, Rheumatoid arthritis, Argentina, biological drugs, upadacitinibAbstract
Objectives. To analyze the budget impact of upadacitinib (UPA) 15 mg + methotrexate (MTX) for the treatment of moderate-to-severe rheumatoid arthritis (RA) in patients with an inadequate response to conventional disease-modifying antirheumatic drugs (cDMARD-IR) from the perspective of social security and the private health sector in Argentina. Materials and methods. A budget impact analysis model was developed for a hypothetical cohort of 100,000 adults with health insurance coverage who were diagnosed with RA over a 5-year time horizon. The model parameters were obtained through literature review and validated by local experts. The costs are expressed in 2024 US dollars (USD). Results. The introduction of UPA 15 mg + MTX for the treatment of moderate-to-severe RA and cDMARD-IR resulted in minimal increase, with a five-year total cumulative incremental cost of USD 1,855 for social security and USD 1,812 for the private health sector, representing 2% of the total budget. The acquisition cost of UPA was the most influential variable in the sensitivity analysis. Conclusions. The introduction of UPA 15 mg + MTX for the treatment of moderate-to-severe RA and cDMARD-IR can provide an effective treatment option with a minimal increase in costs for the healthcare system in Argentina, which is especially important in developing countries where health system budgets are more limited. Providing evidence-based estimates is a valuable tool for informing healthcare policies and can help policymakers make informed decisions about the allocation of healthcare resources to improve patient outcomes while also managing costs.
Downloads
References
Aletaha D, Smolen JS. Diagnosis and Management of Rheumatoid Arthritis: A Review. JAMA [Internet]. 2018; 320 (13):1360-72. doi:
1001/jama.2018,1103.
Scublinsky D, Venarotti H, Citera G, Messina OD, Scheines E, Rillo O, et al. The prevalence of rheumatoid arthritis in argentina: A capture-recapture study in a city of Buenos Aires Province. J. Clin Rheumatol. 2010; 16(7) :317-21. doi: 10.1097/RHU.0b013e3181f3bfdd .
Di WT, Vergara F, Bertiller E, De Los Ángeles Gallardo M, Gandino I, Scolnik M, et al. Incidence and prevalence of rheumatoid arthritis
in a health management organization in Argentina: A 15-year Study. J Reumatol. 2016;43(7):1306-11. doi: 10.3899/jrheum.151262.
Secco A, Alfie V, Bardach A. Epidemiología, uso de recursos y costos de la artritis reumatoidea en Argentina. Rev Per Med Exp Salud
Publica. 2020;37(3):532-40. doi: 10.17843/rpmesp.2020,373,4766.
Sociedad Argentina de Reumatología, Grupo de Estudio Artritis Reumatoidea. Actualización de las Guías de Práctica Clínica en el
tratamiento de la artritis reumatoidea. 2013. Disponible en: https://www.reumatologia.org.ar/recursos/guia_artritis_reumatoidea_2013.pdf. Consultado en febrero de 2021.
Smolen JS, Landewé RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum
Dis. 2020;79(6):S685-99. doi: 10.1136/annrheumdis-2019-216655.
Singh JA, Saag KG, Bridges SL, Akl EA, Bannuru RR, Sullivan MC, et al. 2015 American College of Rheumatology Guidelines for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2016;68(1):1-25. doi: 10.1002/acr.22783.
National Institute for Health and Clinical Excellence Guideline. Rheumatoid arthritis in adults: management. NICE clinical guideline.
;(July):1–31. Disponible en: https://www.nice.org.uk/guidance/ng100. [Acceso: 12 de febrero de 2021].
Citera G SEE. Actualización de las guías de práctica clínica en el tratamiento de la Artritis Reumatoidea. Grupo de Estudio de Artritis Reumatoidea. Sociedad Argentina de Reumatología 2014. Disponible en: https://www.reumatologia.org.ar/recursos/guia_tofacitinib_2014.pdf. Consultado en febrero de 2021.
Food and Drug Administration (FDA). RINVOQTM (upadacitinib) extended-release tablets, for oral use Initial U.S [Internet]. 2019 .
[Consultado: 12 de febrero de 2021. Disponible en: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
European Medicine Agency (EMA). RINVOQ 15 mg prolonged-release tablets [Internet]. [Acceso: 12 de febrero de 2021]. Disponible
en: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
Administracion Nacional de Medicamentos A y T (ANMAT). Disposición ANMAT DI-2019-10475-APN-ANMAT#MSYDS
[Internet]. 2019 [Acceso: 12 de ferebro de 2021]. Disponible en: http://www.anmat.gov.ar/boletin_anmat/diciembre_2019/Dispo_MSYDS_10475-19.pdf
Burmester GR, Kremer JM, Van den Bosch F, Kivitz A, Bessette L, Li Y, et al. Safety and efficacy of upadacitinib in patients with
rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018; 391(10139):2503-12. doi: 10.1016/S0140-6736 (18) 31115-2.
Fleischmann R, Pangan AL, Song IH, Mysler E. Upadacitinib versus placebo or adalimumab in patients with rheumatoid arthritis
and an inadequate response to methotrexate: results of a phase III, double‐blind, randomized controlled trial. Artritis Reumatol. 2019;71(11):1788-1800. doi: 10.1002/art.41032.
Smolen JS, Pangan AL, Emery P, Rigby W, Tanaka Y, Vargas JI, et al. Upadacitinib as monotherapy in patients with active rheumatoid
arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019;393(10188):2303-11. doi: 10.1016/S0140-6736(19): 30419-2.
van Vollenhoven R, Takeuchi T, Pangan AL, Friedman A, Mohamed M-EF, Chen S, et al. Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial. Arthritis Rheumatol. 2020; 72(10):1607-20. doi: 10.1002/art.41384.
Rubbert-Roth A, Enejosa J, Pangan AL, Haraoui B, Rischmueller M, Khan N, et al. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. N Engl J Med. 2020;383(16):1511-21. doi: 10.1056/nejmoa2008250.
Catay E, Del Cid CC, Narváez L, Narváez L, Velozo EJ, Rosa JE, Catoggio LJ, et al. Cost of rheumatoid arthritis in a selected population from Argentina in the prebiologic therapy era. Clinicoecon Outcomes Res. 2012; 4:219-25. doi: 10.2147/CEOR.S28845.
Pichon-Riviere A, Garcia-Marti S, Oortwijn W, Augustovski F, Sampietro-Colom L. Definiendo el valor de las tecnologías sanitarias en Latino-América: desarrollo de marcos de valor para informar la priorización de recursos sanitarios. Int J Technol Assess Health Care.
;35(1) :69-74. doi: 10.1017/S0266462319000126.
Tundia N, Kotze PG, Rojas Serrano J, Mendes de Abreu M, Skup M, Macaulay D. Economic impact of expanded use of biologic therapy for the treatment of rheumatoid arthritis and Crohn’s disease in Argentina, Brazil, Colombia, and Mexico. J Med Econ. 2016; 19 (12):1187-99. doi: 10.1080/13696998.2016.1209508.
Mauskopf J, Earnshaw SR, Brogan A, Wolowacz S, Brodtkorb T-H. Budget-Impact Analysis of Health Care Interventions [Internet]. Springer International Publishing; [citado 2019]. 18 p. doi: 10.1007/978-3-319-50482-7.
Augustovsky F, Garay OU, Pichon-Riviere A, Rubinstein A, Cabo JE. Directrices de evaluación económica en América Latina: un panorama actual. Perito Rev. Pharmacoecon Outcomes Res [Internet]. 2010; 10 (5) :525—37. doi: 10.1586/erp.10.56.
Sullivan SD, cabeza de ratón JA, Augustovski F, Jaime Caro J, Lee KM, Minchin M, 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(1):5-14. doi: 10.1016/j.jval.2013,08,2291.
Arturi P, Orazio A, Citera G, Maldonado Cocco JA. Indicación de terapia biológica en pacientes con enfermedades reumáticas
de la consulta ambulatoria Biologic treatment in patients with Rheumatic Diseases from the clinic. Reumatol Rev Silver. 2008;19(1):34-8.
Ministerio de Salud de la Nacion, (MSN) [Internet]. ¿Cuánto gasta Argentina en salud? 2020 [Consultado: 12 de febrero de
. Disponible en: https://economiaygestiondelasalud.finance.blog/2020/01/31/cuanto-gasta-argentina-en-salud/.
IECS. Base de datos de Costos Unitarios (BCU) de Argentina. Información parcial. Documento Técnico N° 3 Base de datos de costos
sanitarios Argentinos.
Página oficial del Banco Central de la República Argentina (BCRA) [Internet]. 2019. Disponible en: http://www.bcra.gob.ar/PublicacionesEstadisticas/Tipos_de_cambios.asp [Accessed: February 27, 2024]
Kairos Web Argentina - Buscador de precios de Medicamentos y Drogas [Internet]. 2024. Disponible en: https://ar.kairosweb.com/
[Consultado: 27 de febrero de 2012]
SACIFyS A. Grupo Alfa Beta [Internet]. 2024. [Consultado: 27 de febrero de 2012 4]. Disponible en: http://www.alfabeta.net/home/.
Garfinkel F, Méndez Y. Informes de Cadenas de Valor. Salud, farmacia y equipamiento médico. 2016. Disponible en: https://www.argentina.gob.ar/sites/default/files/sspe_cadena_de_valor_salud.pdf. [Consultado: 12 de febrero de 2021]
Rolón Campuzano R, Dal Pra F, Schneeberger EE, Coronel Ale AL, Cerda OL, Correa MA, et al. Patrones de tratamiento con agentes
biológicos: Eficacia y sobrevida a largo plazo en pacientes con artritis reumatoidea. Reumatol Rev Silver. 2018;29(4):14-9.
Pichon-Riviere A, Drummond M, García Martí S, Augustovski F. Aplicación de la evidencia económica en la evaluación de las tecnologías de la salud y la toma de decisiones para la asignación de recursos de salud en América Latina: siete temas clave y una
propuesta preliminar para su implementación [Internet]. Banco Interamericano de Desarrollo; julio de 2021. [Consultado: 4 de ferebrero de 2024] Disponible en: https://publications.iadb.org/publications/spanish/document/Aplicacion-de-la-evidencia-economica-
en-la-evaluacion-de-tecnologias-sanitarias-y-la-toma-de-decisiones-sobre-asignacion-de-recursos-sanitarios-en-America-Latina-siete-temas-clave-y-una-propuesta-preliminar-de-implementacion.pdf.
Instituto Nacional de Estadísticas y Censos (INDEC). Censo 2022 [Internet]. Estadísticas de población. 2022 [Consultado: 4 de febrero
de 2012 4]. Disponible en: https://www.indec.gob.ar/indec/web/Nivel4-Tema-2-41-165.
Sitio web [Internet]. Disponible en: World Bank. Datos abiertos del Banco Mundial [Internet]. Datos abiertos del Banco Mundial.
[citado el 18 de diciembre de 2023]. Disponible en: https://data.worldbank.org.
Bergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with
Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021;38(12):5649-61. doi: 10.1007/s12325-021-01930-4.
Acayaba de Toledo R, Arruda MS, Morais CGV, Dos Santos R. PBI13 Cost-Minimization Analysis and Budget Impact of Upadacitinib in
the Treatment of Rheumatoid Arthritis in the Brazilian Public Health System. Value in Health. 2021; 24 (Supp 1):S16-S17. doi: 10.1016/j.
val.2021.04.084.
Navarro F, Martínez-Sesmero JM, Balsa A, Peral C, Montoro M, Valderrama M, et al. Análisis de coste-efectividad de las secuencias de tratamiento que contienen tofacitinib para el tratamiento de la artritis reumatoide en España. Clin Rheumatol. 2020; 39(10):2919-30. doi: 10.1007/s10067-020-05087-3.
Claxton L, Taylor M, Gerber RA, Gruben D, Moynagh D, Singh A, et al. Modelling the cost-effectiveness of tofacitinib for the treatment of rheumatoid arthritis in the United States. Curr Med Res Opin [Internet]. 2018;34(11):1991–2000. doi: 10.1080/03007995.2018.1497957.
Claxton L, Taylor M, Soonasra A, Bourret JA, Gerber RA. An Economic Evaluation of Tofacitinib Treatment in Rheumatoid Arthritis After Methotrexate or After 1 or 2 TNF Inhibitors from a U.S. Payer Perspective. J Manag Care Spec Pharm [Internet]. 2016;22(9):1–8. doi: 10.18553/jmcp.2018.17220.
Wehler E, Boytsov N, Nicolay C, Herrera-Restrepo O, Kowal S. A Budget Impact and Cost Per Additional Responder Analysis for Baricitinib for the Treatment of Moderate-to-Severe Rheumatoid Arthritis in Patients with an Inadequate Response to Tumor Necrosis
Factor Inhibitors in the USA. Pharmacoeconomics [Internet]. 2020;38(1):39–56. doi: 10.1007/s40273-019-00829-x.
Downloads
Published
Issue
Section
License
Copyright (c) 2024 Natalia Espínola, Anastasia Secco, Dario Balan, Diego Kanevsky, Guido Calvi, Pierre Morisset, Ariel Bardach, Federico Augustovski
This work is licensed under a Creative Commons Attribution 4.0 International License.