Clinical Drug Investigation

, Volume 36, Issue 7, pp 567–578 | Cite as

Cost-Effectiveness Analysis of Omalizumab for the Treatment of Severe Persistent Asthma in Real Clinical Practice in Spain

  • María del Carmen Vennera
  • Antonio Valero
  • Estefany Uría
  • Carles Forné
  • César Picado
Original Research Article


Background and Objective

Omalizumab is a humanized monoclonal antibody that targets circulating immunoglobulin E molecules to treat severe uncontrolled asthma. The aim of this study was to determine the cost effectiveness of omalizumab compared with standard treatment for the control of severe persistent asthma according to data from patients treated in a specialized asthma unit.


This was an observational, retrospective, single-center study in the setting of the Pulmonology and Respiratory Allergy Service, Thorax Institute, Hospital Clínic de Barcelona, Barcelona, Spain. Data were collected by review of medical records of 86 uncontrolled severe persistent asthma patients treated with omalizumab from January 2005 to April 2014. Effectiveness was assessed by the reduction in asthma exacerbations and 3-point increases in the Asthma Control Test (ACT) score. The economic evaluation was performed from the societal perspective, including direct health costs (resource use and drug treatments) and indirect costs (disease impact on labor productivity) in 2016 Euros. The time horizon was 12 months before and after the initiation of treatment with omalizumab. Results were expressed using the incremental cost-effectiveness ratio (ICER).


Taking into account only direct costs, the ICERs were €1487.46 (95 % confidence interval [CI] 1241.21–1778.34) per exacerbation avoided and €5425.13 (95 % CI 4539.30–6551.03) per 3-point increase in the ACT. When indirect costs were included, the ICERs were €1130.93 (95 % CI 909.08–1392.86) per exacerbation avoided, and €4124.79 (95 % CI 3281.69–5186.73) per 3-point increase in the ACT.


The results of this study confirm the effectiveness of the addition of omalizumab to standard therapy in patients with uncontrolled severe persistent asthma.


Asthma Indirect Cost Salmeterol Asthma Control Asthma Exacerbation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Author contributions

María del Carmen Vennera, Antonio Valero, Estefany Uria, Carles Forné, and César Picado conceived and designed the study. Estefany Uria and Carles Forné performed the data analysis, obtained the results, and drafted the manuscript. All authors contributed to the writing and review of the manuscript, and read and accepted the final manuscript. María del Carmen Vennera acts as overall guarantor of the manuscript.

Compliances with Ethical Standards


This study was funded by Novartis International AG.

Conflict of interest

This study was carried out with the financial collaboration of Novartis. Estefany Uria and Carles Forné are employed by Oblikue Consulting, which received financing from Novartis to carry out the study. María del Carmen Vennera, Antonio Valero, and César Picado have received funding for attending meetings, courses and congresses (Novartis). The authors alone are responsible for the content and writing of the paper.


  1. 1.
    Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. GINA 2015. Available at: Accessed 15 Mar 2016.
  2. 2.
    Martinez-Moratalla J, Almar E, Sunyer J, Ramos J, Pereira A, Payo F, et al. European Asthma Study. Identifying and treating young adults with epidemiological criteria for asthma in five areas of Spain [in Spanish]. Arch Bronconeumol. 1999;35(5):223–8.CrossRefPubMedGoogle Scholar
  3. 3.
    Garcia-Marcos L, Quiros AB, Hernandez GG, Guillen-Grima F, Diaz CG, Ureña IC, et al. Stabilization of asthma prevalence among adolescents and increase among schoolchildren (ISAAC phases I and III) in Spain. Allergy. 2004;59(12):1301–7.CrossRefPubMedGoogle Scholar
  4. 4.
    The ENFUMOSA Study Group. The ENFUMOSA cross-sectional European multicentre study of the clinical phenotype of chronic severe asthma. Eur Respir J. 2003;22(3):470–7.CrossRefGoogle Scholar
  5. 5.
    Hermosa JL, Sanchez CB, Rubio MC, Minguez MM, Walther JL. Factors associated with the control of severe asthma. J Asthma. 2010;47(2):124–30.CrossRefPubMedGoogle Scholar
  6. 6.
    Rabe KF, Adachi M, Lai CK, Soriano JB, Vermeire PA, Weiss KB, et al. Worldwide severity and control of asthma in children and adults: the global asthma insights and reality surveys. J Allergy Clin Immunol. 2004;114:40–7.CrossRefPubMedGoogle Scholar
  7. 7.
    Borderias Clau L, Zabaleta Murguionda M, Riesco Miranda JA, Pellicer Ciscar C, Hernandez Hernandez JR, Carrillo Diaz T, et al. Cost and management of asthma exacerbations in Spanish hospitals (COAX study in hospital services) [in Spanish]. Arch Bronconeumol. 2005;41(6):313–21 (Spanish).Google Scholar
  8. 8.
    Summary of product characteristics: Xolair. Novartis International AG. April 2014. Available at: Accessed 15 Mar 2016.
  9. 9.
    McKeage K. Omalizumab: a review of its use in patients with severe persistent allergic asthma. Drugs. 2013;73(11):1197–212.CrossRefPubMedGoogle Scholar
  10. 10.
    Plosker GL, Keam SJ. Omalizumab: a review of its use in the treatment of allergic asthma. BioDrugs. 2008;22(3):189–204.CrossRefPubMedGoogle Scholar
  11. 11.
    Soresi S, Togias A. Mechanisms of action of anti-immunoglobulin E therapy. Allergy Asthma Proc. 2006;27(2 Suppl 1):S15–23.PubMedGoogle Scholar
  12. 12.
    Holgate S, Smith N, Massanari M, Jimenez P. Effects of omalizumab on markers of inflammation in patients with allergic asthma. Allergy. 2009;64(12):1728–36.CrossRefPubMedGoogle Scholar
  13. 13.
    Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, Zhu J, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154(9):573–82.CrossRefPubMedGoogle Scholar
  14. 14.
    Busse W, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Cioppa GD, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184–90.CrossRefPubMedGoogle Scholar
  15. 15.
    Bardelas J, Figliomeni M, Kianifard F, Meng X. A 26-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the effect of omalizumab on asthma control in patients with persistent allergic asthma. J Asthma. 2012;49(2):144–52.CrossRefPubMedGoogle Scholar
  16. 16.
    Bousquet J, Cabrera P, Berkman N, Buhl R, Holgate S, Wenzel S, et al. The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma. Allergy. 2005;60(3):302–8.CrossRefPubMedGoogle Scholar
  17. 17.
    Humbert M, Beasley R, Ayres J, Slavin R, Hébert J, Bousquet J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy. 2005;60(3):309–16.CrossRefPubMedGoogle Scholar
  18. 18.
    Holgate ST, Chuchalin AG, Hébert J, Lotvall J, Persson GB, Chung KF, et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy. 2004;34(4):632–8.CrossRefPubMedGoogle Scholar
  19. 19.
    Lanier BQ, Corren J, Lumry W, Liu J, Fowler-Taylor A, Gupta N. Omalizumab is effective in the long-term control of severe allergic asthma. Ann Allergy Asthma Immunol. 2003;91(2):154–9.CrossRefPubMedGoogle Scholar
  20. 20.
    Braunstahl GJ, Chen CW, Maykut R, Georgiou P, Peachey G, Bruce J. The eXpeRience registry: the ‘real-world’ effectiveness of omalizumab in allergic asthma. Respir Med. 2013;107(8):1141–51.CrossRefPubMedGoogle Scholar
  21. 21.
    Barnes N, Menzies-Gow A, Mansur AH, Spencer D, Percival F, Radwan A, et al. Effectiveness of omalizumab in severe allergic asthma: a retrospective UK real-world study. J Asthma. 2013;50(5):529–36.CrossRefPubMedPubMedCentralGoogle Scholar
  22. 22.
    Schumann C, Kropf C, Wibmer T, Rudiger S, Stoiber KM, Thielen A, et al. Omalizumab in patients with severe asthma: the XCLUSIVE study. Clin Respir J. 2012;6(4):215–27.CrossRefPubMedGoogle Scholar
  23. 23.
    Brusselle G, Michils A, Louis R, Dupont L, Van de Maele B, Delobbe A, et al. “Real-life” effectiveness of omalizumab in patients with severe persistent allergic asthma: the PERSIST study. Respir Med. 2009;103(11):1633–42.CrossRefPubMedGoogle Scholar
  24. 24.
    Korn S, Thielen A, Seyfried S, Taube C, Kornmann O, Buhl R. Omalizumab in patients with severe persistent allergic asthma in a real-life setting in Germany. Respir Med. 2009;103(11):1725–31.CrossRefPubMedGoogle Scholar
  25. 25.
    Cazzola M, Camiciottoli G, Bonavia M, Gulotta C, Ravazzi A, Alessandrini A, et al. Italian real-life experience of omalizumab. Respir Med. 2010;104(10):1410–6.CrossRefPubMedGoogle Scholar
  26. 26.
    Korn S, Schumann C, Kropf C, Stoiber K, Thielen A, Taube C, et al. Effectiveness of omalizumab in patients 50 years and older with severe persistent allergic asthma. Ann Allergy Asthma Immunol. 2010;105(4):313–9.CrossRefPubMedGoogle Scholar
  27. 27.
    Grimaldi-Bensouda L, Zureik M, Aubier M, Humbert M, Levy J, Benichou J, et al. Does omalizumab make a difference to the real-life treatment of asthma exacerbations?: results from a large cohort of patients with severe uncontrolled asthma. Chest. 2013;143(2):398–405.CrossRefPubMedGoogle Scholar
  28. 28.
    Vennera MC, Perez De Llano L, Bardagi S, Ausin P, Sanjuas C, Gonzalez H, et al. Omalizumab therapy in severe asthma: experience from the Spanish registry—some new approaches. J Asthma. 2012;49(4):416–22.CrossRefGoogle Scholar
  29. 29.
    Molimard M, de Blay F, Didier A, Le Gros V. Effectiveness of omalizumab (Xolair) in the first patients treated in real-life practice in France. Respir Med. 2008;102(1):71–6.CrossRefPubMedGoogle Scholar
  30. 30.
    Eisner MD, Zazzali JL, Miller MK, Bradley MS, Schatz M. Longitudinal changes in asthma control with omalizumab: 2-year interim data from the EXCELS Study. J Asthma. 2012;49(6):642–8.CrossRefPubMedGoogle Scholar
  31. 31.
    Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)—explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health. 2013;16(2):231–50.CrossRefPubMedGoogle Scholar
  32. 32.
    Lopez Bastida J, Oliva J, Antoñanzas F, Garcia-Altes A, Gisbert R, Mar J, et al. A proposed guideline for economic evaluation of health technologies [in Spanish]. Gac Sanit. 2010;24(2):154–70.Google Scholar
  33. 33.
    Dal Negro RW, Tognella S, Pradelli L. A 36-month study on the cost/utility of add-on omalizumab in persistent difficult-to-treat atopic asthma in Italy. J Asthma. 2012;49(8):843–8.CrossRefPubMedGoogle Scholar
  34. 34.
    National Institute for Health and Clinical Excellence (NICE). Omalizumab for treating severe persistent allergic asthma (review of technology appraisal guidance 133 and 201). NICE 2013. Available at: Accessed 8 Oct 2014.
  35. 35.
    Dewilde S, Turk F, Tambour M, Sandstrom T. The economic value of anti-IgE in severe persistent, IgE-mediated (allergic) asthma patients: adaptation of INNOVATE to Sweden. Curr Med Res Opin. 2006;22(9):1765–76.CrossRefPubMedGoogle Scholar
  36. 36.
    Levy AN, García a Ruiz AJ, García-Agua Soler N, Sanjuan MV. Cost-effectiveness of omalizumab in severe persistent asthma in Spain: a real-life perspective. J Asthma. 2015;52(2):205–10.Google Scholar
  37. 37.
    Spanish Guidelines for Asthma Management (GEMA) [Guía Española para el Manejo del Asma (GEMA 4.0)]. Editorial: Luzan 5 Madrid; 2015.Google Scholar
  38. 38.
    de Llano LP, Vennera MC, Alvarez FJ, Medina JF, Borderias L, Pellicer C, et al. Effects of omalizumab in non-atopic asthma: results from a Spanish multicenter registry. J Asthma. 2013;50(3):296–301.CrossRefPubMedGoogle Scholar
  39. 39.
    Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, et al. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113(1):59–65.CrossRefPubMedGoogle Scholar
  40. 40.
    Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009;124(4):719–23.CrossRefPubMedGoogle Scholar
  41. 41.
    Gisbert R, Brosa M. Spanish health care costs database: eSalud. Oblikue Consulting, S.L., Barcelona. Updated 2015. Available at: Accessed 15 Mar 2016.
  42. 42.
    Ministry of Health, Social Services and Equality [Ministerio de Sanidad, Servicios Sociales e Igualdad, MSSSI]. Minimum Basic Data Set-Hospital Discharge (MBDS-HD) [Conjunto Mínimo Básico de Datos, CMBD]. Updated 2013. Available at: Accessed 15 Mar 2016.
  43. 43.
    General Council of the Association of Official Pharmacists. General Council of the Association of Official Pharmacists Database: Bot PLUS 2.0. Available at: Accessed 15 Mar 2016.
  44. 44.
    Royal Decree-Law 8/2010. Extraordinary measures to reduce the public deficit. Amended by the Royal Decree-Law 9/2011.Google Scholar
  45. 45.
    Ojeda P, Sanz de Burgoa V, Coste Asma Study. Costs associated with workdays lost and utilization of health care resources because of asthma in daily clinical practice in Spain. J Investig Allergol Clin Immunol. 2013;23(4):234–41.PubMedGoogle Scholar
  46. 46.
    Efron B, Tibshirani R. An introduction to the bootstrap. Boca Raton: Chapman & Hall/CRC; 1993.CrossRefGoogle Scholar
  47. 47.
    Efron B. Better bootstrap confidence intervals. J Am Stat Assoc. 1987;82(397):171–85.CrossRefGoogle Scholar
  48. 48.
    Polsky D, Glick HA, Willke R, Schulman K. Confidence intervals for cost-effectiveness ratios: a comparison of four methods. Health Econ. 1997;6(3):243–52.CrossRefPubMedGoogle Scholar
  49. 49.
    Campbell MK, Torgerson DJ. Bootstrapping: estimating confidence intervals for cost-effectiveness ratios. QJM. 1999;92(3):177–82.CrossRefPubMedGoogle Scholar
  50. 50.
    R Core Team. R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna; 2015. Available at:
  51. 51.
    Oba Y, Salzman GA. Cost-effectiveness analysis of omalizumab in adults and adolescents with moderate-to-severe allergic asthma. J Allergy Clin Immunol. 2004;114(2):265–9.CrossRefPubMedGoogle Scholar
  52. 52.
    Wu AC, Paltiel AD, Kuntz KM, Weiss ST, Fuhlbrigge AL. Cost-effectiveness of omalizumab in adults with severe asthma: results from the Asthma Policy Model. J Allergy Clin Immunol. 2007;120(5):1146–52.CrossRefPubMedPubMedCentralGoogle Scholar
  53. 53.
    Campbell JD, Spackman DE, Sullivan SD. The costs and consequences of omalizumab in uncontrolled asthma from a USA payer perspective. Allergy. 2010;65(9):1141–8.PubMedGoogle Scholar
  54. 54.
    Brown R, Turk F, Dale P, Bousquet J. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy. 2007;62(2):149–53.CrossRefPubMedGoogle Scholar
  55. 55.
    Dal Negro RW, Pradelli L, Tognella S, Micheletto C, Iannazzo S. Cost-utility of add-on omalizumab in difficult-to-treat allergic asthma in Italy. Eur Ann Allergy Clin Immunol. 2011;43(2):45–53.PubMedGoogle Scholar
  56. 56.
    Campbell JD, McQueen RB, Briggs A. The “e” in cost-effectiveness analyses. A case study of omalizumab efficacy and effectiveness for cost-effectiveness analysis evidence. Ann Am Thorac Soc. 2014;11(Suppl 2):S105–11.Google Scholar
  57. 57.
    van Nooten F, Stern S, Braunstahl GJ, Thompson C, Groot M, Brown RE. Cost-effectiveness of omalizumab for uncontrolled allergic asthma in the Netherlands. J Med Econ. 2013;16(3):342–8.CrossRefPubMedGoogle Scholar
  58. 58.
    Braunstahl GJ, Leo J, Thirlwell J, Peachey G, Maykut R. Uncontrolled persistent allergic asthma in practice: eXpeRience registry baseline characteristics. Curr Med Res Opin. 2011;27(4):761–7.CrossRefPubMedGoogle Scholar
  59. 59.
    Doz M, Chouaid C, Com-Ruelle L, Calvo E, Brosa M, Robert J, et al. The association between asthma control, health care costs, and quality of life in France and Spain. BMC Pulm Med. 2013;13:15.CrossRefPubMedPubMedCentralGoogle Scholar
  60. 60.
    Barnes PJ, Jonsson B, Klim JB. The costs of asthma. Eur Respir J. 1996;9(4):636–42.CrossRefPubMedGoogle Scholar
  61. 61.
    Plaza V, Cobos A, Ignacio-Garcia JM, Molina J, Bergoñon S, Garcia-Alonso F, et al. Cost-effectiveness of an intervention based on the Global INitiative for Asthma (GINA) recommendations using a computerized clinical decision support system: a physicians randomized trial [in Spanish]. Med Clin (Barc). 2005;124(6):201–6.CrossRefPubMedGoogle Scholar
  62. 62.
    Lane S, Molina J, Plusa T. An international observational prospective study to determine the cost of asthma exacerbations (COAX). Respir Med. 2006;100(3):434–50.CrossRefPubMedGoogle Scholar
  63. 63.
    Dominguez-Ortega J, Phillips-Angles E, Barranco P, Quirce S. Cost-effectiveness of asthma therapy: a comprehensive review. J Asthma. 2015;52(6):529–37.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • María del Carmen Vennera
    • 1
    • 2
    • 3
  • Antonio Valero
    • 1
    • 2
    • 3
  • Estefany Uría
    • 4
  • Carles Forné
    • 4
  • César Picado
    • 1
    • 2
    • 3
  1. 1.Department of Pneumology and Respiratory AllergyHospital Clinic, Universitat de BarcelonaBarcelonaSpain
  2. 2.Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)BarcelonaSpain
  3. 3.Centro de Investigaciones Biomédicas en Red de Enfermedades Respiratorias (CIBERES)MadridSpain
  4. 4.Department of Health Economics and Outcome ResearchOblikue Consulting S.L.BarcelonaSpain

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