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Vol. 100. Núm. 9.
Páginas 792-803 (noviembre 2009)
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Vol. 100. Núm. 9.
Páginas 792-803 (noviembre 2009)
Original articles
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Efficiency of Biologic Agents in the Treatment of Moderate to Severe Psoriasis
Eficiencia de los Agentes Biológicos en el Tratamiento de la Psoriasis Moderada-Grave
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6285
A.J. Blascoa,
Autor para correspondencia
ablasco@taiss.com

Correspondence: Técnicas Avanzadas de Investigación en Servicios de Salud (TAISS), Cambrils, 41-2, 28034 Madrid, Spain.
, P. Lázaroa, C. Ferrándizb, A. García-Díezc, J. Lisod
a Técnicas Avanzadas de Investigación en Servicios de Salud, Madrid, Spain
b Servicio de Dermatología, Hospital Universitario Germans Trias i Pujol, Universidad Autónoma de Barcelona, Barcelona, Spain
c Servicio de Dermatología, Hospital Universitario de La Princesa, Madrid, Spain
d Servicio de Atención Farmacéutica Especializada, Complejo Hospitalario Universitario de Badajoz, Spain
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Abstract
Background

In the treatment of psoriasis, biologic agents are more expensive than conventional therapy while showing similar or superior efficacy. However, their efficiency in terms of cost/efficacy (cost per responder in clinical trial conditions) is unknown.

Objective

To estimate the cost/efficacy ratios of adalimumab, etanercept, infliximab, and efalizumab in the management of moderate to severe psoriasis.

Material and Methods

A model for costs analysis was elaborated by building a decision tree for each of the treatments for which scientific evidence was available. The payer perspective (Spanish national health system) was used, only considering drug costs. The efficacy (proportion of patients who respond according to Psoriasis Area and Severity Index [PASI] 75 criterion) was assigned according to the results of the clinical trials. When more than 1 trial was available per treatment, a meta-analysis was undertaken. In the case of weight-dependent dosing, the weight of the study participants was adjusted by age and sex to the standard Spanish population with correction for increased weight in individuals with psoriasis. Uncertainty was investigated with a sensitivity analysis.

Results and Conclusions

Assigning the efficacy reported in the 15 published clinical trials, the most efficient biologic agent in terms of the cost/efficacy ratio was adalimumab, with one PASI75 response at a cost of €8013.

For the remaining biologic agents and with different regimens, the cost per responder ranged from €9370 to €17 112. The sensitivity analysis confirmed the robustness of these figures.

Key words:
psoriasis
efficiency
biologic agents
meta-analysis
Resumen
Introducción

Los agentes biológicos en el tratamiento de la psoriasis son más caros y, en general, de eficacia similar o superior que la terapia clásica. Sin embargo, se desconoce su eficiencia en términos de coste/eficacia (coste por cada paciente que responde en las condiciones de los ensayos clínicos).

Objetivo

Estimar los cocientes de coste/eficacia de adalimumab, etanercept, infliximab y efalizumab en el manejo de la psoriasis moderada-grave.

Material y métodos

Modelo de evaluación económica, construyendo un árbol de decisión para cada uno de los tratamientos sobre los que existe evidencia científica. Se ha usado la perspectiva del financiador (Sistema Nacional de Salud), considerando sólo los costes del fármaco. La eficacia (proporción de pacientes que responden con el criterio PASI-75) asignada es la que consta en los ensayos clínicos. Cuando había más de un ensayo para cada tratamiento se han realizado metanálisis. Cuando la dosis depende del peso, este último en los sujetos del estudio se ha estandarizado por edad y sexo a la población española, corregido por el incremento de peso de los sujetos con psoriasis. La incertidumbre se ha manejado mediante análisis de sensibilidad.

Resultados y conclusiones

Asignando en los modelos la eficacia de los 15 ensayos clínicos publicados, el agente biológico más eficiente en términos de coste/eficacia es adalimumab, con el que se consigue un respondedor PASI75 a un coste de 8.013 euros. Con el resto de los biológicos y con diferentes pautas el coste/respondedor osciló entre 9.370 € y 17.112 €. El análisis de sensibilidad confirma la robustez de estos hallazgos.

Palabras clave:
psoriasis
eficiencia
terapia biológica
metanálisis
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References
[1.]
Lodeiro C, Peña J, del Pozo J. Guía Clínica de Psoriasis. Fisterra. Atención Primaria en la Red. http://www.fisterra.com/guias2/psoriasis.asp. [Accessed October 10, 2008].
[2.]
C. Ferrándiz, X. Bordas, V. García-Patos, S. Puig, R. Pujol, A. Smandía.
Prevalence of psoriasis in Spain (Epiderma Project: phase I).
J Eur Acad Dermatol Venereol, 15 (2001), pp. 20-23
[3.]
The Psoriasis Association. What is psoriatic arthritis? http://www.psoriasis-association.org.uk/arthritis.html. [Accessed October 10, 2008].
[4.]
S.R. Feldman, G.G. Krueger.
Psoriasis assessment tools in clinical trials.
Ann Rheum Dis, 64 (2005), pp. 65-68
[5.]
C.H. Smith, A.V. Anstey, J.N.W.N. Barker, A.D. Burden, R.J.G. Chalmers, D. Chandler, et al.
British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005.
Br J Dermatol, 153 (2005), pp. 486-497
[6.]
A. Nast, I. Kopp, M. Augustin, K.B. Banditt, W.H. Boehncke, M. Follmann, et al.
German evidence-based guidelines for the treatment of psoriasis vulgaris (short version).
Arch Dermatol Res, 299 (2007), pp. 111-138
[7.]
N. Woolacott, N. Hawkins, A. Mason, A. Kainth, Z. Khadjesari, Y. Bravo Vergel, et al.
Etanercept and efalizumab for the treatment of psoriasis: a systematic review.
Health Technol Assess, 10 (2006), pp. 1-233
[8.]
J. Schmitt, Z. Zhang, G. Wozel, M. Meurer, W. Kirch.
Efficacy and tolerability of biologic and nonbiologic systemic treatments for moderate-to-severe psoriasis: meta-analysis of randomized controlled trials.
Br J Dermatol, 159 (2008), pp. 513-526
[9.]
J.H. Saurat, G. Stingl, L. Dubertret, K. Papp, R.G. Langley, J.P. Ortonne, et al.
Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION).
Br J Dermatol, 158 (2008), pp. 558-566
[10.]
A. Menter, S.K. Tyring, K. Gordon, A.B. Kimball, C.L. Leonardi, R.G. Langley, et al.
Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial.
JAm Acad Dermatol, 58 (2008), pp. 106-115
[11.]
C.L. Leonardi, J.L. Powers, R.T. Matheson, B.S. Goffe, R. Zitnik, A. Wang, et al.
Etanercept as monotherapy in patients with psoriasis.
N Engl J Med, 349 (2003), pp. 2014-2022
[12.]
K.A. Papp, S. Tyring, M. Lahfa, J. Prinz, C.E.M. Griffiths, A.M. Nakanishi, et al.
A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction.
Br J Dermatol, 152 (2005), pp. 1304-1312
[13.]
A.B. Gottlieb, R.T. Matheson, N. Lowe, G.G. Krueger, S. Kang, B.S. Goffe, et al.
A randomized trial of etanercept as monotherapy for psoriasis.
Arch Dermatol, 139 (2003), pp. 1 627-1632
[14.]
S. Tyring, A. Gottlieb, K. Papp, K. Gordon, C. Leonardi, A. Wang, et al.
Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial.
[15.]
K. Reich, F.O. Nestle, K. Papp, J-P. Ortonne, R. Evans, C. Guzzo, et al.
Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial.
Lancet, 366 (2005), pp. 1367-1374
[16.]
A. Menter, S.R. Feldman, G.D. Weinstein, K. Papp, R. Evans, C. Guzzo, et al.
A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis.
J Am Acad Dermatol, 56 (2007), pp. 31.e1-31.e15
[17.]
U. Chaudhari, P. Romano, L.D. Mulcahy, L.T. Dooley, D.G. Baker, A.B. Gottlieb.
Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial.
Lancet, 357 (2001), pp. 1842-1847
[18.]
A.B. Gottlieb, R. Evans, S. Li, L.T. Dooley, C.A. Guzzo, D. Baker, et al.
Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, doubleblind, placebocontrolled trial.
J Am Acad Dermatol, 51 (2004), pp. 534-542
[19.]
C.L. Leonardi, K.A. Papp, K.B. Gordon, A. Menter, S.R. Feldman, I. Caro, et al.
Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial.
J Am Acad Dermatol, 52 (2005), pp. 425-433
[20.]
K.B. Gordon, K.A. Papp, T.K. Hamilton, P.A. Walicke, W. Dummer, N. Li, et al.
Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial.
JAMA, 290 (2003), pp. 3073-3080
[21.]
L. Dubertret, W. Sterry, J.D. Bos, S. Chimenti, S. Shumack, C.G. Larsen, et al.
Clinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: results from a phase III international randomized, placebo-controlled trial.
Br J Dermatol, 155 (2006), pp. 170-181
[22.]
K.A. Papp, R. Bressinck, S. Fretzin, B. Goffe, S. Kempers, K.B. Gordon, et al.
Safety of efalizumab in adults with chronic moderate to severe plaque psoriasis: a phase IIIb, randomized, controlled trial.
Int J Dermatol, 45 (2006), pp. 605-614
[23.]
M. Lebwohl, S.K. Tyring, T.K. Hamilton, D. Toth, S. Glazer, N.H. Tawfik, et al.
A novel targeted T-cell modulator, efalizumab, for plaque psoriasis.
N Engl J Med, 349 (2003), pp. 2004-2013
[24.]
J.L. Fleiss.
Statistical methods for rates and proportions.
2nd ed., John Wiley & Sons, (1981),
[25.]
R. DerSimonian, N. Laird.
Meta-analysis in clinical trials.
Control Clin Trials, 7 (1986), pp. 177-188
[26.]
J.P.T. Higgins, S.G. Thompson, J. Jonathan, J.J. Deeks, D.G. Altman.
Measuring inconsistency in meta-analyses.
[27.]
Organización Farmacéutica Colegial. Base de datos de medicamentos. http://pfarmals.portalfarma.com/default.asp. [Accessed May 20, 2008].
[28.]
Nota informativa sobre los factores de PVL a PVP y PVPIVA2005 y 2006. BOE, Real Decreto 2402/2004; 31 de diciembre de 2004.
[29.]
Instituto Nacional de Estadística. Encuesta sobre Discapacidades, Deficiencias y Estado de Salud. http://www.ine.es/prodyser/pubweb/disc_inf05/discapa_inf.htm. [Accessed May 20, 2008].
[30.]
M.D. Herron, M. Hinckley, M.S. Hoffman, J. Papenfuss, C.B. Hansen, K.P. Callis, et al.
Impact of obesity and smoking on psoriasis presentation and management.
Arch Dermatol, 141 (2005), pp. 1527-1534
[31.]
CASPe. Critical Appraisal Skill Program in Spanish. http://www.redcasoe.org. [Accessed May 26, 2008].
[32.]
Agencia Española de Medicamentos y Productos Sanitarios. Adalimumab. Anexo I. Ficha técnica o resumen de las características del producto. http://www.emea.europa.eu/humandocs/PDFs/EPAR/humira/H-481-PI-es.pdf [Accessed May 20, 2008].
[33.]
Agencia Española de Medicamentos y Productos Sanitarios. Etanercept. Anexo I. Ficha técnica o resumen de las características del producto. http://www.emea.europa.eu/humandocs/PDFs/EPAR/Enbrel/H-262-PI-es.pdf. [Accessed May 20, 2008].
[34.]
Agencia Española de Medicamentos y Productos Sanitarios. Infliximab. Anexo I. Ficha técnica o resumen de las características del producto. http://www.emea.europa.eu/humandocs/P DFs/EPAR/Remic ade/H-240-PI-es.pdf. [Accessed May 20, 2008].
[35.]
Agencia Española de Medicamentos y Productos Sanitarios. Efalizumab. Anexo I. Ficha técnica o resumen de las características del producto. http://www.emea.europa.eu/humandocs/PDFs/EPAR/raptiva/H-542-PI-es.pdf. [Accessed May 20, 2008].
[36.]
A.K. Brimhall, L.N. King, J.C. Licciardone, H. Jacobe, A. Menter.
Safety and efficacy of alefacept, efalizumab, etanercept and infliximab in treating moderate to severe plaque psoriasis: a meta-analysis of randomised controlled trials.
Br J Dermatol, 159 (2008), pp. 274-285
[37.]
National Institute for Health and Clinical Excellence. Technology appraisal guidance 146: Adalimumab for the treatment of adults with psoriasis. London, July, 2008.
[38.]
L. Naldi, L. Chatenoud, D. Linder, A.B. Fortina, A. Peserico, A.R. Virgili, et al.
Cigarette smoking, body mass index, and stressful life events as risk factors for psoriasis: results from an Italian Case-Control Study.
J Invest Dermatol, 125 (2005), pp. 61-67
[39.]
A.B. Gottlieb, C. Chao, F. Dann.
Psoriasis comorbidities.
J Dermatolog Treat, 19 (2008), pp. 5-21
[40.]
K. Buesch, J. Chapnick, S. Gupta, R. Bergemann.
Health-Related Quality of Life (HRQOL) and work productivity outcomes for psoriasis patients in Europe.
Oral presentation at the 17th annual congress of the European Academy of Dermatology and Venereology,
Copyright © 2009. Academia Española de Dermatología y Venereología and Elsevier España, S.L.
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