Rituximab Cost Analysis for Maintenance Treatment of Patients With Follicular Lymphoma

Rubio Terrés, C.

doi:10.1016/S2173-5085(08)70026-1

Farmacia Hospitalaria

ISSN: 1130-6343

Farmacia Hospitalaria (Farm Hosp) is the official publication of the Spanish Society of Hospital Pharmacists (SEFH), a professional and scientific organization that currently has about 4.351 members.

The Mission of Farm Hosp is to be the support for health professionals for expanding the influence of projects, publications, and training programs, and to promote the exchange of experiences.

Vision Farm Hosp is:
- to increase the state of knowledge about the hospital pharmacy and whose actions should increase the adequate and safe use of medicines and health products.
- to be an instrument of exchange and dissemination of scientific knowledge of pharmacy practice through the best use and safe medication and health outcomes.

It is a peer-reviewed double-blind scientific journal aimed at publishing in the broad field of Hospital Pharmacy advances in Pharmacy Services. This journal included the following topics: Drug evaluation. Quality of life. Patient Reported Outcome Measures (PROMs), and Patient Reported Experience Measures (PREMs) in the use of drugs. Monitoring medication. Pharmaceutical compounding. Medication administration. Management of Pharmacy Services (logistics, quality control). Technologies and information systems in the process of using medication. Medical devices. Patient Education. Pharmacist´s role in the society and /or in the Health System in Spain, and other topics related to clinical, scientific, and institutional role of hospital pharmacists.

Farmacia Hospitalaria publishes bimonthly (6 issues yearly) originals, short originals, reviews, clinical cases, special articles, protocols, consensus documents, clinical guidelines, letters to the editor, editorials.

All the articles are published in Spanish and English language regardless of the language in which they are received.

Farmacia Hospitalaria is an Open Access journal, whose content is available free of charge to users or their institutions. Users are authorised to read, download, copy, distribute, print, search, or link to entire texts of the articles in this journal without prior permission from the editor or author, according to the BOAI definition of Open Access. The papers may be re-used under the terms of the Creative Commons 4.0 license. (CC BY-NC-ND). Such use shall be subject to authorisation from SEFH, the journal owner.

Farmacia Hospitalaria journal charges no fees for submission of papers or publication of articles.

Adherence to international ethics recommendations

Manuscripts must follow the most recent recommendations of the International Committee of Medical Journal Editors (available at http://www.icmje.org).

The articles published in Farmacia Hospitalaria are indexed in PubMed and other 17 date bases:
- Evaluation databases: MEDLINE, DOAJ, Scopus, Latindex y Scimago Journal and Country Rank (SJR). Índice H: 18, quartile 3 (Medicine, miscellaneous / Pharmacology)
- Bibliographic databases: CINHAL, EMBASE Excerpta Medica, Índice Bibliográfico Español en Ciencias de la Salud (IBECS), Índice Español de Ciencia Y Tecnología (ICyT), Índice Médico Español (IME), International Pharmaceutical Abstracts (IPA).
- Journal collections: Dialnet, Medes, Scientific Electronic Library Online (SciELO), REDIB, ScienceDirect, ClinicalKey.

Farmacia Hospitalaria ha recibido Factor de Impacto (JCR) por primera vez en 2023.
Guía para autores - Envío de manuscritos

Farmacia Hospitalaria has received its first journal Impact Factor (JCR) in 2023.
Instructions for authors - Submit an article

Indexed in:

Web of Science, Scopus, Scimago Journal and Country Rank (SJR), Índice H: 18, CINHAL, EMBASE Excerpta Medica, Índice Bibliográfico Español en Ciencias de la Salud (IBECS), Índice Español de Ciencia Y Tecnología (ICyT), Índice Médico Español (IME), International Pharmaceutical Abstracts (IPA), MEDLINE, DOAJ, Dialnet, Latindex, Medes, Scientific Electronic Library Online (SciELO), REDIB.

Population: the EORTC 20981 clinical trial population. Perspective: Spanish National Health System (direct healthcare costs). Design: Incremental cost-effectiveness analysis, with a transition model between states of health. Main variables: cost of gaining a quality-adjusted life year (QALY), per life year gained (LYG) and per progression-free LYG. Premises of the basic case: Weibull distribution for survival extrapolation, 5 year duration of the benefits of the treatment, time horizon of 10 years, and annual discount rate (costs and benefits) of 3.5%. These premises were modified in the sensitivity analyses.

Results

Deterministic analysis: the cost per QALY gained was €9358, €8493 per LYG, and €5485 per progression-free LYG. Probabilistic and sensitivity analysis: they confirmed the stability of the deterministic analysis results.

Conclusions

According to this model, maintenance treatment with rituximab is cost-effective (cost per LYG <€30 000) in patients with resistant or recurrent follicular lymphoma responding to induction treatment, in comparison to the usual practice of observing patients’ evolution.

Key words:

Cost analysis

Rituximab

Observation

Lymphoma, Follicular

Resumen

Introducción

En pacientes con linfoma folicular refractario o en recaída que responden a terapia de inducción con CHOP o rituximab + CHOP, el tratamiento de mantenimiento con rituximab frente a la opción de “observar” mejora la supervivencia global y la supervivencia libre de progresión.

Objetivo

Estimar si el tratamiento de mantenimiento con rituximab es una intervención coste-efectiva en comparación con la práctica clínica de “observar” su evolución.

Método

Población: la del ensayo clínico EORTC 20981. Perspectiva: Sistema Nacional de Salud Español (costes directos sanitarios). Diseño: Análisis coste-efectividad incremental, con un modelo de transición entre estados de salud. Variables principales: coste de ganar un año de vida ajustado por su calidad (AVAC), por año de vida ganado (AVG) y por AVG libre de progresión. Premisas del caso básico: distribución de Weibull para extrapolación de supervivencia, 5 años de duración del beneficio del tratamiento, horizonte temporal de 10 años y tasa anual de descuento (costes y beneficios) del 3,5%. Estas premisas se modificaron en los análisis de sensibilidad.

Resultados

Análisis determinístico: el coste por AVAC ganado fue de 9.358 €, por AVG de 8.493 € y por AVG libre de progresión de 5.485 €. Análisis probabilístico y de sensibilidad: confirmaron la estabilidad de los resultados del análisis determinístico.

Conclusiones

Según este modelo, el tratamiento de mantenimiento con rituximab es coste-efectivo (coste por AVG < 30.000 €) en los pacientes con linfoma folicular resistente o en recaída que responden al tratamiento de inducción, en comparación con la práctica habitual de observar la evolución de los pacientes.

Palabras clave:

Análisis de costes

Rituximab

Observación

Linfoma folicular

Full text is only aviable in PDF

References

[1.]

Centro Nacional de Epidemiología.

La situación del cáncer en España.

Ministerio de Sanidad y Consumo, (2005),

[2.]

J. Gómez Codina.

Linfomas B y T. Biología, clínica y tratamiento.

Nova Sidonia, (2002),

[3.]

S.M. Ansell, J. Armitage.

Non-Hodgkin lymphoma: diagnosis and treatment.

Mayo Clin Proc, 80 (2005), pp. 1087-1097

http://dx.doi.org/10.4065/80.8.1087 | Medline

[4.]

Resumen de las características del producto: Mabthera 100 mg (rituximab). Roche; 2003.

[5.]

M.H. van Oers, R. Klasa, R.E. Marcus, M. Wolf, E. Kimby, R.D. Gascoyne, et al.

Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial.

Blood, 108 (2006), pp. 3295-3301

http://dx.doi.org/10.1182/blood-2006-05-021113 | Medline

[6.]

R. Gisbert, M. Brosa.

Base de datos de costes sanitarios.

Versión 2.2, Soikos, (2005),

[7.]

C. Rubio-Terrés, J.A. Sacristán, X. Badía, E. Cobo, F. García Alonso, por el Grupo ECOMED.

Métodos utilizados para realizar evaluaciones económicas de intervenciones sanitarias.

Medicina Clínica, 122 (2004), pp. 578-583

Medline

[8.]

C. Rubio-Terrés, A. Echevarría.

La herramienta clave: modelos de Markov.

Pharmacoeconomics–Spanish Research Articles, 3 (2006), pp. 71-78

[9.]

D. Wild, M. Tabberer.

Utility values in follicular lymphoma.

Oxford Outcomes, (2005),

[10.]

Chapman and Hall. Applied Survival Analysis. New York: John Wiley & Sons, Inc; 1984.

[11.]

NICE.

Guide to the methods of technology appraisal.

National Institute for Clinical Excellence, (2004),

[12.]

Guideline for the economic evaluation of health technologies: Canada. 3th edition. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2006.

[13.]

M.C. Weinstein, B. O'Brien, J. Hornberger, J. Jackson, M. Johannesson, C. McCabe, et al.

Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on good research practices – modeling studies.

Value in Health, 6 (2003), pp. 9-17

Medline

[14.]

Base de datos de medicamentos. Consejo General de Colegios Oficiales de Farmacéuticos. Available from:http://www.portalfarma.com/home.nsf (consulted: July, 2006).

[15.]

Ministerio de Sanidad y Consumo. Talla y peso medios de los españoles (año 2001). Available from: http://www.msc.es/gl/estadEstudios/estadisticas/docs/Cap._1_Poblaci_n.xls#’Talla y peso’!A1 (consulted: July, 2006).

[16.]

Semergen. Calculadora para la estimación de la superficie corporal media según el peso y la talla medios. Available from: http://www.semergen.es/semergen2/cda/documentos/calculadoras/ahcalc.htm (consulted: July, 2006).

[17.]

C. Rubio-Terrés, E. Cobo, J.A. Sacristán, L. Prieto, J. del Llano, X. Badia, por el Grupo ECOMED.

Análisis de la incertidumbre en las evaluaciones económicas de intervenciones sanitarias.

Medicina Clínica, 122 (2004), pp. 668-674

Medline

[18.]

J.A. Sacristán, J. Oliva, J. del Llano, L. Prieto, J.L. Pinto.

¿Qué es una tecnología sanitaria eficiente en España?.

Gac Sanit, 16 (2002), pp. 334-343

Medline

[19.]

C. Rubio Terrés.

Introducción a la utilización de los modelos de Markov en el análisis farmacoeconómico.

Farm Hosp, 24 (2000), pp. 241-247

[20.]

J.D. Hainsworth, S. Litchy, D.W. Shaffer, V.L. Lackey, M. Grimaldi, F.A. Greco.

Maximizing therapeutic benefit of rituximab: maintenance therapy versus re-treatment at progression in patients with indolent non-Hodgkin's lymphoma - a randomized phase II trial of the Minnie Pearl Cancer Research Network.

Journal of Clinical Oncology, 23 (2005), pp. 1088-1095

http://dx.doi.org/10.1200/JCO.2005.12.191 | Medline

[21.]

M. Ghielmini, S.F. Schmitz, S.B. Cogliatti, G. Pichert, J. Hummerjohann, U. Waltzer, et al.

Prolonged treatment with rituximab in patients with follicular lymphoma significantly increases event-free survival and response duration compared with the standard weekly x 4 schedule.

Blood, 103 (2004), pp. 4416-4423

[22.]

M. Dreyling, R. Forstpointner, M. Gramatzki, H. Böck, M. Hänel, J. Seymour, et al.

Rituximab maintenance improves progression-free and overall survival rates after combined immuno-chemotherapy (R-FCM) in patients with relapsed follicular and mantle cell lymphoma: final results of a prospective randomised trial of the German Low Grade Lymphoma Study Group (GLSG).

Journal of Clinical Oncology, 24 (2006), pp. 7502

[23.]

B. Maturi, J.R. Mickhael, W.C.N. Dunlop, D.T. Tilden, L. Wong.

Maintenance Therapy with Rituximab for Follicular Lymphoma Is Cost-Effective. A Canadian Perspective.

Blood, 108 (2006),

http://dx.doi.org/10.1182/blood-2006-03-013334 | Medline

[24.]

P. Plans Rubió.

Cost-effectiveness of pharmacologic treatments for the reduction of blood lipids.

Med Clin (Barc), 105 (1995), pp. 327-333

[25.]

P. Plans-Rubió.

Cost-effectiveness of cardiovascular prevention programs in Spain.

Int J Technol Assess Health Care, 14 (1998), pp. 320-330

Medline

[26.]

P. Plans, P. Garrido, L. Salleras.

Coste-efectividad de la vacunación neumocócica en Cataluña.

Rev Esp Salud Pública, 69 (1995), pp. 409-417

Medline

[27.]

M.J. Martínez-Bengoechea, M.F. Errecalde, N. Jaio, C. Sáiz de Rozas, A. Arana, O. Ibarra.

Coste-efectividad de alteplasa versus estreptocinasa en el infarto de miocardio.

Rev Esp Farmacoeconom, 1 (1995), pp. 23-32

[28.]

Rovira J, Trinxet C. Economic evaluation of hormone replacement therapy. In: Cosséry JM (Ed). Medical-economics aspects of hormone replacement therapy. New York: The Parthenon Publishing Group. p. 131-63.

Follicular Lymphoma Pharmacoeconomics Group: Capote, Francisco J. (Hospital Universitario Puerta del Mar, Cádiz); Conde, Eulogio (Hospital Universitario Marqués de Valdecilla, Santander); Fernández Rañada, Jose Mª (Hospital Universitario de La Princesa, Madrid); Giraldo, Pilar (Hospital Universitario Miguel Servet, Zaragoza); Gómez Codina, José (Hospital Universitario La Fe, Valencia); Provencio, Mariano (Hospital Universitario Puerta de Hierro, Madrid); Ríos, Eduardo (Hospital Virgen del Rocío, Seville); Rubio-Terrés, Carlos (HEALTH VALUE, Madrid); Rueda, Antonio (Hospital Virgen de la Victoria, Málaga); Varela, Cristina (Roche Farma, Madrid).

Tools

Indexed in:

Follow us:

Subscribe to our newsletter