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International Journal of Clinical Pharmacy

, Volume 40, Issue 6, pp 1528–1538 | Cite as

Cost evolution of biological agents for the treatment of spondyloarthritis in a tertiary hospital: influential factors in price

  • Mariángeles González-FernándezEmail author
  • Elena Villamañán
  • Inmaculada Jiménez-Nácher
  • Francisco Moreno
  • Chamaida Plasencia
  • Francisco Gaya
  • Alicia Herrero
  • Alejandro Balsa
Research Article

Abstract

Background Spending on biological agents has risen dramatically due to the high cost of the drugs and the increased prevalence of spondyloarthritis. Objective To evaluate the annual cost per patient and cost for each biological drug for treating patients with spondyloarthritis from 2009 to 2016, and to calculate factors that affect treatment cost, such as optimizing therapies by monitoring drug serum levels, the use of biosimilar-TNF inhibitors, and official discounts or negotiated rebates in biologicals acquired by the pharmacy department. Method Retrospective, observational study in a Spanish tertiary hospital. Main outcome Annual cost per patient and per drug. Factors that influenced the costs and socio-demographic parameters and disease activity. Results A total of 129, 215, and 224 patients were treated in 2009, 2013, and 2016, respectively. The annual cost per patient decreased: EUR11,604 in 2009, EUR8513 in 2013, and EUR7464 in 2016. The introduction of new drugs drives economic competition, leading to total savings per drug, with discounts reaching 5.8, 12.4, 16.7, 17.7, 13.7, and 24.8% for original infliximab, etanercept, adalimumab, ertolizumab, golimumab, and secukinumab, respectively, while rebates for biosimilar infliximab reached 31.90% in 2016. The number of patients with optimized therapies reached 47.5% in 2016, which led to cost savings of EUR798,614, in addition to savings from official discounts and rebates of EUR252,706 and savings from optimized therapies of EUR545,908 in 2016. Conclusion The cost of biological treatments declined after official discounts, negotiated rebates, and optimized therapies, leading to a significant decrease in the annual cost per patient. The greatest contribution to economic savings in biological therapy according to our study was biological therapy optimization.

Keywords

Ankylosing spondylitis Biological agents Disease-modifying antirheumatic drugs Biosimilars Cost Optimization Spondyloarthritis 

Notes

Funding

None.

Conflicts of interest

No conflicts of interest have been declared.

References

  1. 1.
    Zochling J, Smith EUR. Seronegative spondyloarthritis. Best Pract Res Clin Rheumatol. 2010;24:747–56.CrossRefPubMedGoogle Scholar
  2. 2.
    Hukuda S, Minami M, Saito T, Mitsui H, Matsui N, Komatsubara Y, et al. Spondyloarthropathies in Japan: nationwide questionnaire survey performed by the Japan Ankylosing Spondylitis Society. J Rheumatol. 2001;28:554–9.PubMedGoogle Scholar
  3. 3.
    Muñoz-Fernández S, de Miguel E, Cobo-Ibáñez T, Carmona L, Steiner M, Descalzo MA, et al. Early spondyloarthritis: results from the pilot registry ESPIDEP. Clin Exp Rheumatol. 2010;28:498–503.PubMedGoogle Scholar
  4. 4.
    Quintana G, Coral-Alvarado P. Economic impact of rheumatic diseases. Chall Rheumatol [Internet]. 2011. http://www.intechopen.com/books/challenges-in-rheumatology/economic-impact-of-rheumatic-diseases. Citado 5 marzo 2018.
  5. 5.
    Ward MM, Deodhar A, Akl EA, Lui A, Ermann J, Gensler LS, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol Hoboken NJ. 2016;68:282–98.CrossRefGoogle Scholar
  6. 6.
    van der Heijde D, Ramiro S, Landewé R, Baraliakos X, Van den Bosch F, Sepriano A, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76:978–91.CrossRefPubMedGoogle Scholar
  7. 7.
    Tanaka Y. Next stage of RA treatment: is TNF inhibitor-free remission a possible treatment goal? Ann Rheum Dis. 2013;72(suppl 2):ii124–7.CrossRefPubMedGoogle Scholar
  8. 8.
    Informe técnico ANTI-TNF-reumatología. infliximab_y_adalimumab.pdf [Internet]. http://sescam.castillalamancha.es/sites/sescam.castillalamancha.es/files/documentos/farmacia/infliximab_y_adalimumab.pdf. Cited 8 March 2018.
  9. 9.
    Plasencia C, Pascual-Salcedo D, García-Carazo S, Lojo L, Nuño L, Villalba A, et al. The immunogenicity to the first anti-TNF therapy determines the outcome of switching to a second anti-TNF therapy in spondyloarthritis patients. Arthritis Res Ther. 2013;15:R79.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Machado P, Landewé R, Lie E, Kvien TK, Braun J, Baker D, et al. Ankylosing Spondylitis Disease Activity Score (ASDAS): defining cut-off values for disease activity states and improvement scores. Ann Rheum Dis. 2011;70:47–53.CrossRefPubMedGoogle Scholar
  11. 11.
    Ariza-Ariza R, Hernández-Cruz B, Navarro-Sarabia F. La versión española del BASDAI es fiable y se correlaciona con la actividad de la enfermedad. Rev Esp Reumatol. 2004;31:372–8.Google Scholar
  12. 12.
    Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994;21:2286–91.PubMedGoogle Scholar
  13. 13.
    Real Decreto Legislativo 3/2011, de 14 de noviembre, por el que se aprueba el texto refundido de la Ley de Contratos del Sector Público [Internet]. Noticias Jurídicas. http://noticias.juridicas.com/base_datos/Admin/rdleg3-2011.html. Cited 11 March 2018.
  14. 14.
    González Fernández MAG, Ramos FM, Hugo AV, Plasencia C, Salcedo DP, Pinto PH, et al. Anti-TNF dose and anti-drug antibody levels in rheumatic and psoriasis patients: economic repercussion. Eur J Clin Pharm. 2015;17:4.Google Scholar
  15. 15.
    Real Decreto-ley 4/2010, de 26 de marzo, de racionalización del gasto farmacéutico con cargo al Sistema Nacional de Salud. BOE.es—Documento BOE-A-2010-5030 [Internet]. https://www.boe.es/buscar/doc.php?id=BOE-A-2010-5030. Cited 11 March 2018.
  16. 16.
    Anuncio de formalización de contratos de: Dirección del Instituto Nacional de Gestión Sanitaria (INGESA). Objeto: Acuerdo Marco para la selección de suministradores de medicamentos inmunosupresores para varias Comunidades Autónomas y Organismos de la Administración del Estado. Expediente: AM 13/160.BOE-B-2014-9305.pdf [Internet]. https://www.boe.es/boe/dias/2014/03/15/pdfs/BOE-B-2014-9305.pdf. Cited 17 Oct 2017.
  17. 17.
    Garrison Jr. LP, Towse A, Briggs A, de Pouvourville G, Grueger J, Mohr PE, Severens JL, et al. Performance-based risk-sharing arrangements—good practice for design, implementation and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force. Show Value Health. 2013;16:703–719. https://www.ispor.org/ValueInHealth/ShowValueInHealth.aspx?issue=5E4EB78D-D58F-48A3-9FD7-E96C7B626C11. Cited 17 Oct 2017.
  18. 18.
    Rueda FG-D, Robles-Rodríguez L, Tena-Sempere ME, López AML, Zafra-López F, Horno IE, et al. Análisis y evaluación del coste del tratamiento anti-TNFalfa en artritis reumatoide y espondilitis anquilosante. Dosis individualizadas frente a comercializadas. J Negat No Posit Results. 2017;2:233–9.Google Scholar
  19. 19.
    Escudero-Vilaplana V, Ramírez-Herráiz E, Alañón-Plaza E, Trovato-López N, García-Vicuña R, Carreño-Pérez L, et al. Efficiency of adalimumab, etanercept and infliximab in ankylosing spondylitis in clinical practice. Int J Clin Pharm. 2015;37:808–14.CrossRefPubMedGoogle Scholar
  20. 20.
    Martiarena Ayestarán A, Martínez Martínez C, Mínguez Cabeza AC. Estudio del coste de las terapias biológicas en patologías reumáticas según práctica clínica de un hospital. Rev OFIL. 2017;27:181–6.Google Scholar
  21. 21.
    Pascual-Salcedo D, Plasencia C, Ramiro S, Nuño L, Bonilla G, Nagore D, et al. Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatol Oxf Engl. 2011;50:1445–52.CrossRefGoogle Scholar
  22. 22.
    Pascual-Salcedo D, Plasencia C, Jurado T, Valle LG del, Sabina P, Diego C, et al. Dose-tapering of TNF inhibitors in daily rheumatology practice enables the maintenance of clinical efficacy while improving cost-effectiveness. J Pharmacovigil. 2015;3. https://www.omicsonline.org/open-access/dosetapering-of-tnf-inhibitors-in-daily-rheumatology-practice-enables-the-maintenance-of-clinical-efficacy-while-improving-costeffectiveness-2329-6887-1000172.php?aid=58635. Cited 21 Oct 2017.
  23. 23.
    Westhovens R, Annemans L. Costs of drugs for treatment of rheumatic diseases. RMD Open. 2016;2:e000259.CrossRefPubMedPubMedCentralGoogle Scholar
  24. 24.
  25. 25.
    Inflectra. Product information; Inflectra; INN: infliximab-WC500151490.pdf [Internet]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf. Cited 8 July 2017.
  26. 26.
    Remsima. Product information, INN: infliximab-WC500151486.pdf [Internet]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf. Cited 8 July 2017.
  27. 27.
    Benepali. Product information, INN-etanercept-WC500200380.pdf [Internet]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_. Cited 8 July 2017.
  28. 28.
    Real Decreto 177/2014, de 21 de marzo, por el que se regula el Sistema de precios de referencia y de agrupaciones homogéneas de medicamentos en el Sistema Nacional de Salud, y determinados sistemas de información en materia de financiación y precios de los medicamentos y productos sanitarios BOE-A-2014-3189.pdf [Internet]. https://www.boe.es/boe/dias/2014/03/25/pdfs/BOE-A-2014-3189.pdf. Cited Oct 2017.
  29. 29.
    Rencz F, Péntek M, Bortlik M, Zagorowicz E, Hlavaty T, Śliwczyński A, et al. Biological therapy in inflammatory bowel diseases: access in central and eastern Europe. World J Gastroenterol WJG. 2015;21:1728–37.CrossRefPubMedGoogle Scholar
  30. 30.
    McCarthy G, Bitoun CE, Guy H. introduction of an infliximab biosimilar (ct-p13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland. Value Health. 2013;16:A558.CrossRefGoogle Scholar
  31. 31.
    Farfan-Portet M-I, Gerkens S, Lepage-Nefkens I, Vinck I, Hulstaert F. Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures? Eur J Health Econ HEPAC Health Econ Prev Care. 2014;15:223–8.CrossRefGoogle Scholar
  32. 32.
    Paintaud G, Passot C, Ternant D, Bertolotto A, Bejan-Angoulvant T, Pascual-Salcedo D, et al. Rationale for therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases. Ther Drug Monit. 2017;39:339–43.CrossRefPubMedGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  • Mariángeles González-Fernández
    • 1
    Email author
  • Elena Villamañán
    • 1
  • Inmaculada Jiménez-Nácher
    • 1
  • Francisco Moreno
    • 1
  • Chamaida Plasencia
    • 1
  • Francisco Gaya
    • 2
  • Alicia Herrero
    • 1
  • Alejandro Balsa
    • 1
  1. 1.Rheumatology DepartmentLa Paz University HospitalMadridSpain
  2. 2.Biostatistic DepartmentLa Paz University HospitalMadridSpain

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