Abstract
The objective of this article is to analyze the ratio of cost-effectiveness and budgetary impact of lenalidomide treatment in patients with multiple myeloma who have undergone autologous transplant in Spain. The analyses were based on clinical trials CALGB 100104 and IFM 2005-02, from the perspective of the National Health System. The alternatives compared were the treatment with lenalidomide against maintenance without treatment (MwT). Efficiency measures used were years of life gained (YGs) and quality-adjusted life years (QALYs). According to the CALGB 100104 trial data, the average health costs of patients who were treated with lenalidomide for 120 months was €836,534.31 and without treatment was €528,963.63. The effectiveness of the lenalidomide group was 7.59YGs (5.72 QALY) against 6.58 of MwT (4.61 QALY). The incremental cost-utility ratio (ICUR) was €277,456.72/QALY and the incremental cost-effectiveness ratio was €303,191.05/YGs. From the analysis, the IFM2005-02 trial obtained 5.13 QALY in the lenalidomide group against the 4.98 QALY in the MwT group, with an ICUR of €1,502,780.55/QALY. In terms of budgetary impact, a range between 799 and 1452 patients susceptible to receive treatment with lenalidomide was assumed in Spain. In conclusion, the results show a high ICUR and budgetary impact, which adds uncertainty about the maximum prudent duration of the treatment.
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 12 print issues and online access
$259.00 per year
only $21.58 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
Similar content being viewed by others
References
Agencia española de medicamentos y productos sanitarios. Informe de Posicionamiento Terapéutico de lenalidomida nuevo diagnóstico en pacientes no candidatos a trasplante. 2015. p . 1–9. https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-lenalidomida-Revlimid.pdf. Accessed 10 Mar 2018.
Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013;49:1374–403. https://doi.org/10.1016/j.ejca.2012.12.027
Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013;132:1133–45. https://doi.org/10.1002/ijc.27711
McCarthy PL, Owzar K, Hofmeister CC, Hurd DD, Hassoun H, Richardson PG, et al. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366:1770–81. https://doi.org/10.1056/NEJMoa1114083
Holstein SA, Jung SH, Richardson PG, Hofmeister CC, Hurd DD, Hassoun H, et al. Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial. Lancet Haematol. 2017;4:e431–e442. https://doi.org/10.1016/S2352-3026(17)30140-0
Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, et al. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366:1782–91. https://doi.org/10.1056/NEJMoa1114138
Fonseca R, Abouzaid S, Bonafede M, Cai Q, Parikh K, Cosler L, et al. Trends in overall survival and costs of multiple myeloma, 2000-2014. Leukemia. 2017;31:1915–21. https://doi.org/10.1038/leu.2016.380
Teitelbaum A, Ba-Mancini A, Huang H, Henk HJ. Health care costs and resource utilization, including patient burden, associated with novel-agent-based treatment versus other therapies for multiple myeloma: findings using real-world claims data. Oncologist. 2013;18:37–45. https://doi.org/10.1634/theoncologist.2012-0113
Woods B, Sideris E, Palmer S, Latimer N, Soares M. NICE DSU technical support document 19: partitioned survival analysis for decision modelling in health care: a critical review report by the decision support unit. 2017. p . 1–72. http://scharr.dept.shef.ac.uk/nicedsu/wp-content/uploads/sites/7/2017/06/Partitioned-Survival-Analysis-final-report.pdf
Fleurence RL, Hollenbeak CS. Rates and Probabilities in Economic Modelling. Pharmacoeconomics. 2007;25:3–6. https://doi.org/10.2165/00019053-200725010-00002
European Medicines Agency. Assessment report Revlimid. 2017;44. https://www.ema.europa.eu/en/medicines/human/EPAR/revlimid
Guyot P, Ades AE, Ouwens MJNM, Welton NJ. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan–Meier survival curves. BMC Med Res Method. 2012;12:9. https://doi.org/10.1186/1471-2288-12-9.
Williams C, Lewsey JD, Mackay DF, Briggs AH. Estimation of survival probabilities for use in cost-effectiveness analyses: a comparison of a multi-state modeling survival analysis approach with partitioned survival and Markov decision-analytic modeling. Med Decis Mak. 2017;37:427–39.
Proskorovsky I, Lewis P, Williams CD, Jordan K, Kyriakou C, Ishak J, et al. Mapping EORTC QLQ-C30 and QLQ-MY20 to EQ-5D in patients with multiple myeloma. Health Qual Life Outcomes. 2014;12:1–9. https://doi.org/10.1186/1477-7525-12-35
Agencia española de medicamentos y productos sanitarios. Informe de Posicionamiento Terapéutico de daratumumab recaída y refractario. 2017. p. 1–6. https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-daratumumab-Darzalex-mieloma-multiple.pdf. Accessed 17 Feb 2018.
European Medicines Agency. EPAR Darzalex, INN-daratumumab. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/004077/WC500228981.pdf. Accessed 17 Feb 2018.
European Medicines Agency. CHMP-Kyprolis (carfilzomib)-EMA/517040/2016. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003790/human_med_001932.jsp&mid=WC0b01ac058001d124. Accessed 19 Feb 2018.
Agencia española de medicamentos y productos sanitarios. Informe de Posicionamiento Terapéutico de de Pomalidomida (Imnovid®). 2015. p. 1–5. https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-pomalidomida-imnovid.pdf. Accessed 17 Feb 2018.
Real Decreto-ley 8/2010, de 20 de mayo, por el que se adoptan medidas extraordinarias para la reducción del déficit público. Boletín Oficial del estado 2013;126:45070–128.
LeBlanc R, Tay J, Hollmann S, Shustik J. A Canadian cost analysis comparing the use of bortezomib or lenalidomide as maintenance therapies in multiple myeloma patients eligible for autologous stem cell transplant. J Popul Ther Clin Pharm. 2016;23:e013–113.
ORDEN de 14 de octubre de 2005, por la que se fijan los precios públicos de los servicios sanitarios prestados por Centros dependientes del Sistema Sanitario Público de Andalucía. http://juntadeandalucia.es/boja/2005/210/28. Accessed 2 May 2018.
Orden de 8 de noviembre de 2016, por la que se modifica la Orden de 14 de octubre de 2005, por la que se fijan los precios públicos de los servicios sanitarios prestados por centros dependientes del Sistema Sanitario Público de Andalucía. 2016. p. 42–61. http://juntadeandalucia.es/boja/2016/218/1. Accessed 3 May 2018.
Colección Consejo BOT Plus, Consejo General de Colegios Oficiales de Farmacéuticos. https://botplusweb.portalfarma.com/. Accessed 10 Feb 2018.
López Bastida J, Oliva J, Antoñanzas F. Propuesta de guía para la evaluación económica aplicada a las tecnologías sanitarias. Gac Sanit. 2010;24:154–70. https://doi.org/10.1016/j.gaceta.2009.07.011
Agencia española de medicamentos y productos sanitarios. Informe de Posicionamiento Terapéutico de de Revlimid en mantenimiento. https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-lenalidomida-Revlimid-mantenimiento-mieloma-multiple.pdf. Accessed 17 Feb 2018.
Chen Y, Lairson DR, Chan W, Huo J, Du XL. Cost-effectiveness of novel agents in medicare patients with multiple myeloma: findings from a U.S. payer’s perspective. J Manag Care Spec Pharm. 2017;23:831–43. https://doi.org/10.18553/jmcp.2017.23.8.831
Gonzalez-McQuire S, Yong K, Leleu H, Mennini FS, Flinois A, Gazzola C, et al. Healthcare resource utilization among patients with relapsed multiple myeloma in the UK, France, and Italy. J Med Econ. 2018;21:450–67.
Aguiar PM, Lima TM, Storpirtis S. Systematic review of the economic evaluations of novel therapeutic agents in multiple myeloma: what is the reporting quality? J Clin Pharm Ther. 2016;41:189–97. https://doi.org/10.1111/jcpt.12384
Jackson G, Dutton R, Zamagni E, Hughes R, Dhanasiri S. Lenalidomide maintenance therapy post-autologous stem cell transplant: a healthcare cost-impact analysis in Europe. Blood. 2017;130:3405.
Xie J, Parikh K, Chen C, Yang C, Farruth A, Cockrum P, et al. Impact of FDA approval of lenalidomide maintenance therapy in the first-line treatment of multiple myeloma after autologous stem cell transplant on total healthcare costs. J Clin Oncol. 2017;35 Suppl 15:e19509–e19509.
Gao M, Gao L, Yang G, Tao Y, Tompkins VS, Wu X, et al. Lenalidomide after stem-cell transplantation for multiple myeloma: a meta-analysis of randomized controlled trials. Int J Clin Exp Pathol. 2014;7:3073–80.
Syed YY. Lenalidomide: a review in newly diagnosed multiple myeloma as maintenance therapy after ASCT. Drugs. 2017;77:1473–80. https://doi.org/10.1007/s40265-017-0795-0
Pulte ED, Dmytrijuk A, Nie L, Goldberg KB, McKee AE, Farrell AT, et al. FDA approval summary: lenalidomide as maintenance therapy after autologous stem cell transplant in newly diagnosed multiple myeloma. Oncologist. 2018;23:734–9. https://doi.org/10.1634/theoncologist.2017-0440
Al-Ani F, Louzada M. Post-transplant consolidation plus lenalidomide maintenance vs lenalidomide maintenance alone in multiple myeloma: a systematic review. Eur J Haematol. 2017;99:479–88. https://doi.org/10.1111/ejh.12961
Williams C, Lewsey JD, Mackay DF, Briggs AH. Estimation of survival probabilities for use in cost-effectiveness analyses: a comparison of a multi-state modeling survival analysis approach with partitioned survival and Markov decision-analytic modeling. Med Decis Mak. 2017;37:427–39. https://doi.org/10.1177/0272989X16670617
Longworth L, Yang Y, Young T, Mulhern B, Hernández Alava M, Mukuria C, et al. Use of generic and condition-specific measures of health-related quality of life in NICE decision-making: a systematic review, statistical modelling and survey. Health Technol Assess. 2014;18:1–224. https://doi.org/10.3310/hta18090
Teckle P, Peacock S, McTaggart-Cowan H, van der Hoek K, Chia S, Melosky B, et al. The ability of cancer-specific and generic preference-based instruments to discriminate across clinical and self-reported measures of cancer severities. Health Qual Life Outcomes. 2011;9:106. https://doi.org/10.1186/1477-7525-9-106
Crott R, Briggs A. Mapping the QLQ-C30 quality of life cancer questionnaire to EQ-5D patient preferences. Eur J Health Econ. 2010;11:427–34. https://doi.org/10.1007/s10198-010-0233-7
Kharroubi SA, Edlin R, Meads D, McCabe C. Bayesian statistical models to estimate EQ-5D utility scores from EORTC QLQ data in myeloma. Pharm Stat. 2018;1–14. https://doi.org/10.1002/pst.1853.
Oddershede L, Petersen KD. Adjustment of foreign EQ-5D-3L utilities can increase their transferability. Clin Outcomes Res. 2015;7:629–36. https://doi.org/10.2147/CEOR.S93280
Fuchida SI, Sunami K, Matsumoto M, Okumura H, Murayama T, Miyamoto T, et al. A phase II study of lenalidomide consolidation and maintenance therapy after autologous PBSCT in patients with multiple myeloma. Int J Hematol. 2018. https://doi.org/10.1007/s12185-018-2543-y.
Berenson JR, Crowley JJ, Grogan TM, Zangmeister J, Briggs AD, Mills GM, et al. Maintenance therapy with alternate-day prednisone improves survival in multiple myeloma patients. Blood. 2002;99:3163–8.
Agencia española de medicamentos y productos sanitarios.Informe de Posicionamiento Terapéutico de lenalidomida (Revlimid®) en mantenimiento en mieloma múltiple. https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-lenalidomida-Revlimid-mantenimiento-mieloma-multiple.pdf. Accessed 23 May 2018.
Vallejo‐Torres L, García‐Lorenzo B, Serrano‐Aguilar P. Estimating a cost‐effectiveness threshold for the Spanish NHS. Health Econ. 2017;27:1–16.
Author information
Authors and Affiliations
Contributions
All authors have made substantial contributions to all of the following: (1) the conception and design of the study, acquisition of data, analysis, and interpretation of data, (2) drafting the article and revising it critically, and (3) final approval of the version to be submitted.
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflict of interest relating to the subject matter that may affect the design, analysis, or presentation of results.
Additional information
Publisher’s note: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary information
Rights and permissions
About this article
Cite this article
Olry de Labry Lima, A., Gimeno-Ballester, V., Ríos Tamayo, R. et al. Cost-effectiveness of lenalidomide maintenance in patients with multiple myeloma who have undergone autologous transplant of hematopoietic progenitor cells. Bone Marrow Transplant 54, 1908–1919 (2019). https://doi.org/10.1038/s41409-019-0574-5
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1038/s41409-019-0574-5
This article is cited by
-
Cost-effectiveness of lenalidomide
Bone Marrow Transplantation (2020)