Cost-benefit analysis of ALK diagnosis vs. non-diagnosis in patients with advanced non–small cell lung cancer in Spain

Authors

DOI:

https://doi.org/10.33393/grhta.2022.2449

Keywords:

ALK, Cost-benefit, Cost-effectiveness, Economic evaluation, Lung cancer, Non–small cell lung cancer

Abstract

Introduction: In recent years, target therapies to specific molecular alterations in advanced non–small cell lung cancer (NSCLC) have been identified and have shown superior efficacy compared to non-targeted treatments. Anaplastic lymphoma kinase (ALK) is one of the therapeutic targets; nevertheless, ALK diagnosis is not performed in all NSCLC patients in Spain. The objective of this study is to estimate in monetary terms the benefit for the Spanish society of ALK diagnosis in advanced NSCLC patients. 

Methods: A cost-benefit analysis of ALK diagnosis vs. non-diagnosis in advanced NSCLC patients was carried out from the Spanish social perspective, with a time horizon of 5 years. Costs, benefits and the cost-benefit ratio weremeasured. The analysis has considered the overall survival in advanced NSCLC patients treated with the ALKtyrosine kinase inhibitor (TKI) alectinib. The natural history of NSCLC was simulated using a Markov model. A 3% discount rate was applied to both costs and benefits. The result was tested using a deterministic sensitivity analysis.

Results: The cost of ALK diagnosis vs. non-diagnosis in the base case would be €10.19 million, generating benefits of €11.71 million. The cost-benefit ratio would be €1.15. In the sensitivity analysis, the cost-benefit ratio could range from €0.89 to €2.10.

Conclusions: The results justify the universal application of ALK diagnosis in advanced NSCLC, which generates a benefit for Spanish society that outweighs its costs and allows optimal treatment with targeted therapies for these patients.

References

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. https://doi.org/10.3322/caac.21492PMID:30207593

Sociedad Española de Oncología Médica (SEOM). Las cifras del cáncer en España. 2021. Accessed April 2021. Online: https://seom.org/images/Cifras_del_cancer_en_Espnaha_2021.pdf

SEER. National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer Statistics Review, 1975-2016. Accessed May 2021. Online: https://seer.cancer.gov/csr/1975_2016/index.html

Majem M, Juan O, Insa A, et al. SEOM clinical guidelines for the treatment of non-small cell lung cancer (2018). Clin Transl Oncol. 2019 Jan;21(1):3-17. https://doi.org/10.1007/s12094-018-1978-1 PMID: 30446985

Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010 Oct 28;363(18):1693-1703. https://doi.org/10.1056/nejmoa1006448 PMID: 20979469

Mok T, Camidge DR, Gadgeel SM, et al. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020;31(8):1056-1064 https://doi.org/10.1016/j.annonc.2020.04.478 PMID: 32418886

Zhu QG, Zhang SM, Ding XX, He B, Zhang HQ. Driver genes in non-small cell lung cancer: characteristics, detection methods, and targeted therapies. Oncotarget. 2017;8(34):57680-57692. https://doi.org/10.18632/oncotarget.17016 PMID:28915704

European Medicines Agency (EMA). Medicines [Internet]. European Medicines Agency. Accessed March 2020. Online: https://www.ema.europa.eu/en/medicines/human

Update to the “Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors” [Internet]. IASLC. Accessed May 2021. Online: https://www.iaslc.org/iaslc-news/ilcn/update-molecular-testing-guideline-selection-lung-cancer-patients-egfr-and-alk

López Bastida J, Oliva J, Antoñanzas F, et al. Propuesta de guía para la evaluación económica aplicada a las tecnologías sanitarias [A proposed guideline for economic evaluation of health technologies]. Gac Sanit. 2010;24(2):154-170. https://doi.org/10.1016/j.gaceta.2009.07.011 PMID: 19959258

National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Non-small cell lung cancer. Version 3. 2020. Accessed May 2022. Online https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf

Planchard D, Popat S, Kerr K, et al. Metastatic non-small-cell lung cancer. ESMO Clinical Practice Guidelines for diagnosis, treatment and follow up. Updated version published 18 September 2019 by ESMO Guidelines Committee. European Society for Medical Oncology; 2019:71.

Sociedad Española de Onlología Médica (SEOM). Las cifras del cáncer en España 2020. Accessed April 2021. Online: https://seom.org/seomcms/images/stories/recursos/Cifras_del_cancer_2020.pdf

Vidal J, Clavé S, de Muga S, et al. Assessment of ALK status by FISH on 1000 Spanish non-small cell lung cancer patients. J Thorac Oncol. 2014;9(12):1816-1820. https://doi.org/10.1097/JTO.0000000000000361 PMID:25393795

Provencio M, Carcereny E, Rodríguez-Abreu D, et al. Lung cancer in Spain: information from the Thoracic Tumors Registry (TTR study). Transl Lung Cancer Res. 2019;8(4):461-475. https://doi.org/10.21037/tlcr.2019.08.05 PMID:31555519

de Castro J, Tagliaferri P, de Lima VCC, et al. Systemic therapy treatment patterns in patients with advanced non-small cell lung cancer (NSCLC): PIvOTAL study. Eur J Cancer Care (Engl). 2017;26(6):e12734. https://doi.org/10.1111/ecc.12734 PMID:28748556

Sociedad Española de Anatomía Patológica (SEAP). LungPath. Accessed April 2021. Online: https://www.seap.es/lungpath

Elliott J, Bai Z, Hsieh SC, et al. ALK inhibitors for non-small cell lung cancer: a systematic review and network meta-analysis. PLoS One. 2020;15(2):e0229179. https://doi.org/10.1371/journal.pone.0229179 PMID: 32074131

Instituto Nacional de Estadística (INE). Índice de Precios de Consumo. Base 2016. Medias anuales. Índices nacionales: general y de grupos ECOICOP. INE. Accessed April 2021. Online: https://www.ine.es/jaxiT3/Datos.htm?t=22553

Chouaid C, Dujon C, Do P, et al. Feasibility and clinical impact of re-biopsy in advanced non small-cell lung cancer: a prospective multicenter study in a real-world setting (GFPC study 12-01). Lung Cancer. 2014;86(2):170-173. https://doi.org/10.1016/j.lungcan.2014.08.016PMID:25214431

Sociedad Española de Farmacia Hospitalaria (SEFH). Grupos de trabajo. Docetaxel Monoterapia. 2005 [Internet]. Accessed May 2021. Online: http://gruposdetrabajo.sefh.es/gedefo/images/stories/documentos/protocolod/pulmon/docetaxel%20mono.pdf

Consejo General de Colegios Farmacéuticos. Botplusweb.portalfarma.com. BOT Plus 2. Base de Datos de Medicamentos [Internet]. Accessed May 2021. Online: https://botplusweb.portalfarma.com/

Real Decreto-ley 8/2010, de 20 de mayo, por el que se adoptan medidas extraordinarias para la reducción del déficit público. Agencia Estatal Boletín Oficial del Estado. Accessed March 2020; Online: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2010-8228

Alonso-Babarro A, Astray-Mochales J, Domínguez-Berjón F, et al. The association between in-patient death, utilization of hospital resources and availability of palliative home care for cancer patients. Palliat Med. 2013;27(1):68-75. https://doi.org/10.1177/0269216312442973PMID:22492481

Alonso-Babarro A, Bruera E, Varela-Cerdeira M, et al. Can this patient be discharged home? Factors associated with at-home death among patients with cancer. J Clin Oncol. 2011;29(9):1159-1167. https://doi.org/10.1200/JCO.2010.31.6752 PMID:21343566

Wood R, Taylor-Stokes G, Smith F, Chaib C. The humanistic burden of advanced non-small cell lung cancer (NSCLC) in Europe: a real-world survey linking patient clinical factors to patient and caregiver burden. Qual Life Res. 2019;28(7):1849-1861. https://doi.org/10.1007/s11136-019-02152-6 PMID:30825160

Fundación más que ideas, Asociación Española de Cáncer de Pulmón. La esfera emocional y social del cáncer de pulmón. 2019. Accessed March 2020. Online: https://afectadoscancerdepulmon.com/wp-content/uploads/2022/03/Informe-Esfera-emocional-y-social-del-cancer-de-pulmon.pdf

Nightingale CL, Steffen LE, Tooze JA, et al. Lung cancer patient and caregiver health vulnerabilities and interest in health promotion interventions: an exploratory study. Glob Adv Health Med. 2019;8:2164956119865160. https://doi.org/10.1177/2164956119865160 PMID:31360617

Real Decreto BOE. 231/2020, de 4 de febrero, por el que se fija el salario mínimo interprofesional para 2020. [Internet]. Accessed May 2021. Online: https://www.boe.es/buscar/doc.php?id=BOE-A-2020-1652

DOG núm. 96, del 21 de mayo de 2014. DECRETO 56/2014, de 30 de abril, por el que se establecen las tarifas de los servicios sanitarios prestados en los centros dependientes del Servicio Gallego de Salud y en las fundaciones públicas sanitarias. 2014. Accessed March 2020. Online: https://www.xunta.gal/dog/Publicados/2014/20140521/AnuncioC3K1-140514-0001_es.html

DOCM núm. 226, del 21 de noviembre de 2014. Orden de 17/11/2014, de la Consejería de Sanidad y Asuntos Sociales, por la que se establecen los precios públicos de la asistencia sanitaria y de los servicios prestados en la red de centros sanitarios dependientes del Servicio de Salud de Castilla-La Mancha. [2014/15022] [Internet]. Accessed May 2021. Online: https://docm.jccm.es/portaldocm/descargarArchivo.do?ruta=2014/11/21/pdf/2014_15022.pdf&tipo=rutaDocm

BORM núm. 133, del 11 de junio de 2020. Orden de 29 de mayo de 2020 de la Consejería de Presidencia y Hacienda, por la que se publican las tarifas de las tasas y precios públicos aplicables en el año 2020. Accessed March 2020. Online: https://www.borm.es/services/anuncio/ano/2020/numero/2742/pdf?id=785222

BOPA núm. 77, del 4 de abril de 2013. Resolución de 25 de febrero de 2013, de la Consejería de Hacienda y Sector Público, por la que hace pública la relación de las cuantías exigibles por tasas y precios públicos en el ejercicio 2013. Accessed March 2020. Online: https://sede.asturias.es/bopa/disposiciones/repositorio/LEGISLACION39/66/3/001U0051ZD0001.pdf

BOA núm. 156, del 10 de agosto de 2012. RESOLUCIÓN de 30 de julio de 2012, de la Dirección Gerencia del Servicio Aragonés de Salud, sobre revisión de las tarifas a aplicar por la prestación de servicios sanitarios a terceros obligados al pago o a usuarios sin derecho a asistencia sanitaria en la Comunidad Autónoma de Aragón. 2012. Accessed May 2021. Online: http://www.boa.aragon.es/cgi-bin/EBOA/BRSCGI?CMD=VEROBJ&MLKOB=686810581515

Molina Villaverde R, Feliu Batlle J, Jiménez Gordo AM, San José Valiente B. Actividad laboral en una cohorte de pacientes con carcinoma de pulmón. Med segur trab. 2012;58(226):6-12. https://dx.doi.org/10.4321/S0465-546X2012000100002.

Lister J, Stanisic S, Kaier K, Hagist C, Gultyaev D, Walzer S. Societal savings in patients with advanced non-squamous non-small-cell lung cancer receiving bevacizumab-based versus non-bevacizumab-based treatments in France, Germany, Italy, and Spain. Clinicoecon Outcomes Res. 2012;4:299-305. PMID:23071397

Chapple A, Ziebland S, McPherson A. Stigma, shame, and blame experienced by patients with lung cancer: qualitative study. BMJ. 2004;328(7454):1470. https://doi.org/10.1136/bmj.38111.639734.7C PMID:15194599

Sacristán JA, Oliva J, Campillo-Artero C, et al. ¿Qué es una intervención sanitaria eficiente en España en 2020? [What is an efficient health intervention in Spain in 2020?]. Gac Sanit. 2020;34(2):189-193. https://doi.org/10.1016/j.gaceta.2019.06.007 PMID: 31558385

Ortega Eslava A, Marín Gil R, Fraga Fuentes MD, López-Briz E, Puigventós Latorre F. Guía de evaluación económica e impacto presupuestario en los informes de evaluación de medicamentos. GENESIS, Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de Medicamentos. SEFH, Sociedad Española de Farmacia Hospitalaria; 2017. Accessed March 2020. Online: https://gruposdetrabajo.sefh.es/genesis/index.php?option=com_content&view=article&id=11&Itemid=13

Carlson JJ, Suh K, Orfanos P, Wong W. Cost effectiveness of alectinib vs. crizotinib in first-line anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer. Pharmacoeconomics. 2018;36(4):495-504. https://doi.org/10.1007/s40273-018-0625-6PMID:29488070

Nafees B, Stafford M, Gavriel S, Bhalla S, Watkins J. Health state utilities for non small cell lung cancer. Health Qual Life Outcomes. 2008;6(1):84. https://doi.org/10.1186/1477-7525-6-84PMID:18939982

Roman JG, Flood SM, Genadek KR. Parents’ time with a partner in a cross-national context: a comparison of the United States, Spain, and France. Demogr Res. 2017;36:111-144. https://doi.org/10.4054/DemRes.2017.36.4 PMID:29416440

Masanet E, La Parra D. [Relationship between the number of hours of informal care and the mental health status of caregivers]. Rev Esp Salud Pública. 2011;85(3):257-266. https://doi.org/10.1590/S1135-57272011000300004 PMID:21892550

Grant M, Sun V, Fujinami R, et al. Family caregiver burden, skills preparedness, and quality of life in non-small cell lung cancer. Oncol Nurs Forum. 2013;40(4):337-346. https://doi.org/10.1188/13.ONF.337-346 PMID:23803267

Jassem J, Penrod JR, Goren A, Gilloteau I. Caring for relatives with lung cancer in Europe: an evaluation of caregivers’ experience. Qual Life Res. 2015;24(12):2843-2852. https://doi.org/10.1007/s11136-015-1028-1 PMID:26068731

Gallacher D, Auguste P, Royle P, Mistry H, Armoiry X. A systematic review of economic evaluations assessing the cost-effectiveness of licensed drugs used for previously treated epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) negative advanced/metastatic non-small cell lung cancer. Clin Drug Investig. 2019;39(12):1153-1174. https://doi.org/10.1007/s40261-019-00859-5 PMID: 31583605

Russell LB. The science of making better decisions about health: cost-effectiveness and cost-benefit analysis, Working Paper, No. 2014-06, Rutgers University, Department of Economics, New Brunswick, NJ, 2014. Accessed May 2022. Online: https://www.econstor.eu/bitstream/10419/123823/1/787821322.pdf

Planchard D, Popat S, Kerr K, et al. Metastatic non-small-cell lung cancer. ESMO Clinical Practice Guidelines for diagnosis, treatment and follow up. Updated version published 15 September 2020 by ESMO Guidelines Committee. European Society for Medical Oncology; 2020:64.

Jefatura del Estado. Ley 14/2007, de 3 de julio, de Investigación biomédica. Ley 14/2007 Jul 4, 2007. Accessed March 2020. Online: https://www.boe.es/buscar/act.php?id=BOE-A-2007-12945&tn=1&p=20110602

Jefatura del Estado. Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica. . Sec. Capítulo IV - Artículo 8, Ley 14/2007 Nov 15, 2002. Accessed March 2020. Online: https://www.boe.es/buscar/act.php?id=BOE-A-2002-22188

Instituto Nacional de Estadística (INE). Encuesta Nacional de Salud. Microdatos. INE. Accessed April 2021. Online: https://www.ine.es/dyngs/INEbase/es/operacion.htm?c=Estadistica_C&cid=1254736176783&menu=resultados&secc=1254736195295&idp=1254735573175

Ohara G, Kurishima K, Nakazawa K, et al. Age-dependent decline in renal function in patients with lung cancer. Oncol Lett. 2012;4(1):38-42. https://doi.org/10.3892/ol.2012.672 PMID:22807956

Additional Files

Published

2022-09-12

How to Cite

1.
Majem M, Álvarez R, Ortega AL, Ruiz de Alda L, Gordo R, García JF, Ivanova-Markova Y, González-Domínguez A, Sánchez San Cristóbal R, Rojo F. Cost-benefit analysis of ALK diagnosis vs. non-diagnosis in patients with advanced non–small cell lung cancer in Spain. Grhta [Internet]. 2022 Sep. 12 [cited 2022 Oct. 1];9(1):82-90. Available from: https://journals.aboutscience.eu/index.php/grhta/article/view/2449

Issue

Section

Original Research Articles

Most read articles by the same author(s)