In order to evaluate the impact of these uncertainties upon the results of the model, we conducted extensive sensitivity analyses, as mentioned previously. Under these analyses, GClb showed favorable cost-effectiveness results and remained within the limits of acceptable willingness to pay thresholds in Spain.
Disclosure
Continue Reading
J Orofino was an employee of the company Roche Farma SA, and T Krivasi was an employee of the company F Hoffmann-La Roche Ltd. at the time of preparation of this manuscript. C Rubio-Terres and D Rubio-Rodríguez received an honorarium from Roche Farma SA in connection with the development of this manuscript. L Felipe Casado, A Burgos, E González-Haba, and J Loscertales do not have any conflicts of interest in this work.
References
1. García Marco JA, Giraldo Castellano P, López Jiménez J, Ríos Herranz E, Sastre Moral JL, Terol Casterá MJ, Bosch Albareda F. [National guidelines for the management of patients with chronic lymphocytic leukemia. Sociedad Española de Hematología y Hemoterapia and Grupo Español de Leucemia Linfocítica Crónica]. Med Clin (Barc). 2013;141(4):175, e1–e8. Spanish.
2. Grupo Cooperativo del REL. Resultados del Registro Español de Leucemias (REL) 2002 [Spanish Leukemias Registry Results (REL) 2002]. Madrid: Aula Médica; 2003. Spanish.
3. González Rodríguez AP, González García E, Fernández Alvarez C, González Huerta AJ, González Rodríguez S. [B-chronic lymphocytic leukemia: epidemiological study and comparison of MDACC and GIMENA pronostic indexes]. Med Clin (Barc). 2009;133(5):161–166. Spanish.
4. Hernández JA, González M, Hernández JM. [Chronic lymphocytic leukemia]. Med Clin (Barc). 2010;135(4):172–178. Spanish.
5. Terol MJ. ¿Deben tratarse todos los pacientes con leucemia linfática crónica (LLC) “Sin mutaciones”? ¿Cuándo y cómo? Haematologica (ed. esp.) [Should all patients treated with Chronic lymphatic leukemia(CLL) “No mutations”? When and how?]. 2003;87(Suppl 6):387–392. Spanish.
6. Shanafelt T. Treatment of older patients with chronic lymphocytic leukemia: key questions and current answers.Hematology Am Soc Hematol Educ Program. 2013;2013:158–167.
7. Goede V, Fischer K, Busch R, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014;370(12):1101–1110.
8. U.S. Food and Drug Administration (FDA). Medical Review. 2013 [April 23, 2014]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125486Orig1s000MedR.pdf. Accessed March 16, 2016.
9. Summary of Product Characteristics. Gazyvaro 1,000 mg concentrate for solution for infusion. Available from: http://www.ema.europa.eu/docs/es_ES/document_library/EPAR_-_Product_Information/human/002799/WC500171594.pdf. Accessed February 19, 2016.
10. Recommendation for maintenance of orphan designation at the time of marketing authorisation Gazyvaro (obinutuzumab) for the treatment of chronic lymphocytic leukaemia. EMA/COMP/345188/2014 Committee for Orphan Medicinal Products. August 21, 2014. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2012/11/human_orphan_001129.jsp&mid=WC0b01ac058001d12b. Accessed February 19, 2016.
11. Dervaux B, Lenne X, Theis D, et al. Cost effectiveness of oral fludarabine in chronic lymphocytic leukaemia: the French case. J Med Econ. 2007;10(4):339–354.
12. Scott WG, Scott HM. Economic evaluation of third-line treatment with alemtuzumab for chronic lymphocytic leukaemia. Clin Drug Investig. 2007;27(11):755–764.
13. Hornberger J, Reyes C, Shewade A, et al. Cost-effectiveness of adding rituximab to fludarabine and cyclophosphamide for the treatment of previously untreated chronic lymphocytic leukemia. Leuk Lymphoma. 2012;53(2):225–234.
14. Mittmann N, Isogai PK, Connors JM, Rebeira M, Cheung MC. Economic analysis of alemtuzumab (MabCampath®) in fludarabine-refractory chronic lymphocytic leukemia. Open Pharmacoecon Health Econ J. 2012;4(1):18–25.
15. Briggs A, Claxton K, Sculpher M. Decision Modelling for Health Economic Evaluation. Oxford: Oxford University Press; 2006.
16. Atlas de la Sanidad en España. Índice general de Población.Talla y peso medio, según grupo de edad y sexo. Ministerio de Sanidad, Servicios Sociales e Igualdad [General Index of Population. Height and Average body weight, by age, group and sex. Ministry of Health, Social Services and Equality.]. Available from: http://www.msssi.gob.es/estadEstudios/estadisticas/inforRecopilaciones/atlas/atlasDatos.htm. Accessed January 19, 2016. Spanish.
17. Goede V, Fischer K, Bosch F, t al. Updated survival analysis from the CLL11 study: Obinutuzumab versus rituximab in chemoimmunotherapy-treated patients with chronic lymphocytic leukemia. Blood. 2015;126(23):1733. Poster session presented at 57th American Society of Hematology Annual Meeting and Exposition, Orlando, FL.
18. Cavanaugh JE. 171:290 Model Selection Lecture II: The Akaike Information Criterion. Available from: http://myweb.uiowa.edu/cavaaugh/ms_lec_2_ho.pdf. Accessed January 25, 2016.
19. Eichhorst BF, Busch R, Stilgenbauer S, et al. First-line therapy with fludarabine compared with chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia. Blood. 2009;114(16):3382–3391.
20. Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet.2010;376(9747):1164–1174.
21. Kosmas CE, Shingler SL, Samanta K, Wiesner C, Moss PA, Becker U, Lloyd AJ. Health state utilities for chronic lymphocytic leukemia: importance of prolonging progression-free survival. Leuk Lymphoma. 2015;56(5):1320–1326.
22. Isla D, González-Rojas N, Nieves D, Brosa M, Finnern HW. Treatment patterns, use of resources, and costs of advanced non-small-cell lung cancer patients in Spain: results from a Delphi panel. Clin Transl Oncol. 2011;13(7):460–471.
23. Ojeda B, de Sande LM, Casado A, Merino P, Casado MA. Cost-minimisation analysis of pegylated liposomal doxorubicin hydrochloride versus topotecan in the treatment of patients with recurrent epithelial ovarian cancer in Spain. Br J Cancer. 2003;89(6):1002–1007.
24. Listado de medicamentos afectados por las deducciones del Real Decreto-ley 8/2010. Ministerio de Sanidad, Servicios Sociales e Igualdad [List of drugs affected by the Royal Decree deductions. Law 8/2010. Ministry of Health, Social Services and Equality]. Available from: https://www.msssi.gob.es/profesionales/farmacia/notasInfor.htm. Accessed March 15, 2016. Spanish.
25. Casado LF, García JA, Gilsanz F, et al. [Economic evaluation of rituximab added to fludarabine plus cyclophosphamide versus fludarabine plus cyclophosphamide for the treatment of chronic lymphocytic leukemia]. Gac Sanit. 2011;25(4):274281. Spanish.
26. Herring W, Pearson I, Purser M, Nakhaipour HR, Haiderali A, Wolowacz S, Jayasundara K. Cost effectiveness of ofatumumab plus chlorambucil in first-line chronic lymphocytic leukaemia in Canada. Pharmacoeconomics. 2016;34(1):77–90.
27. Rai KR, Peterson BL, Appelbaum FR, Tallman MS, Belch A, Morrison VA, Larson RA. Long-term survival analysis of the North American Intergroup Study C9011 comparing fludarabine (F) and chlorambucil (C) in previously untreated patients with chronic lymphocytic leukemia (CLL). Blood. 2009;114(22):536.
28. Guía y recomendaciones para la realización y presentación de evaluaciones económicas y análisis de impacto presupuestario de medicamentos en el ámbito de CatSalut [Guidance and recommendations to perform and present economic assessments and budget impact analysis of drugs in CatSalut.]. Barcelona: CatSalut, marzo de 2014. Available from: http://static.correofarmaceutico.com/docs/2014/03/19/guia_cat.pdf. Accessed March 25, 2016. Spanish.
29. CHMP assessment report. Gazyvaro. EMA/CHMP/231450/2014. May 22, 2014. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002799/human_med_001780.jsp&mid=WC0b01ac058001d124. Accessed January 25, 2016.
30. Kaplan RM. The minimally clinically important difference in generic utility-based measures. COPD. 2005;2(1):91–97.
31. Wee HL, Machin D, Loke WC, et al. Assessing differences in utility scores: a comparison of four widely used preference-based instruments. Value Health. 2007;10(4):256–265.
32. De Cock E, Miravitlles M, Gonzalez J, Azanza P. [Threshold value of the cost for life-years gained by adopting health technologies in Spain: Evidence from a literature review]. Pharmacoeconomics. 2007;4(3):97–107. Spanish.
33. Mar J, Antoñanzas F, Pradas R, Arrospide A. [Probabilistic Markov models in economic evaluation of health technologies: a practical guide]. Gac Sanit. 2010;24(3):209–214. Spanish.
34. Rubio-Terrés C, Cobo E, Sacristán JA, Prieto L, del Llano J, Badia X; Grupo ECOMED. [Analysis of uncertainty in the economic assessment of health interventions]. Med Clin (Barc). 2004;122(17):668–674. Spanish.
35. Marsh K, Xu, P, Orfanos P, Gordon J, Griebsch I. Model-based cost-effectiveness analyses for the treatment of chronic lymphocytic leukaemia: a review of methods to model disease outcomes and estimate utility.PharmacoEconomics. 2014;32(10):981–993.
36. Real Decreto-ley 16/2012, de 20 de abril, de medidas urgentes para garantizar la sostenibilidad del Sistema Nacional de Salud y mejorar la calidad y seguridad de sus prestaciones [Royal Decree-Law 16/2012, of 20 April, on urgent measures to ensure the sustainability of the National Health System and improve quality and safety of its services.]. BOE Nº 98, 24 de abril de 2012. Spanish.
37. BotPlus 2.0. Consejo General de Colegios Oficiales de Farmacéuticos [Bot Plus 2.0. General Council of Official Colleges of Pharmacists.]. Available from: https://botplusweb.portalfarma.com/. Accessed March 16, 2016. Spanish.
38. Beusterein KM, Davies J, Leach M, Meiklejohn D, Grinspan JL, O’Toole A, Bramham-Jones S. Population preference values for treatment outcomes in chronic lymphocytic leukaemia: a cross-sectional utility study.Health Qual Life Outcomes. 2010;8:50.
39. Ferguson J, Tolley K, Gilmour L, Priaulx J. Health state preference study mapping the change over the course of the disease process in chronic lymphocytic leukaemia (CLL). Value Health. 2008;11(6):A485.
40. Holzner B, Kemmler G, Sperner-Unterweger B, et al. Quality of life measurement in oncology – a matter of the assessment instrument? Eur J Cancer. 2001;37(18):2349–2356.
41. Greiner W, Weiinen T, Nieuwenhuizen M, et al. A single European currency for EQ-5D health states. Results from a six-country study. Eur J Health Econ. 2003;4(3):222–231.
Source: ClinicoEconomics and Outcomes Research
Originally published September 21, 2016.
