209
Views
0
CrossRef citations to date
0
Altmetric
ORIGINAL RESEARCH

Cost-Effectiveness of Lorlatinib for the Treatment of Adult Patients with Anaplastic Lymphoma Kinase Positive Advanced Non-Small Cell Lung Cancer in Spain

ORCID Icon, , , ORCID Icon, , & ORCID Icon show all
Pages 659-671 | Received 16 May 2023, Accepted 15 Aug 2023, Published online: 07 Sep 2023

References

  • 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;21(1):3–17. doi:10.1007/s12094-018-1978-1
  • 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. doi:10.21037/tlcr.2019.08.05
  • Howlader N, Forjaz G, Mooradian MJ, et al. The effect of advances in lung-cancer treatment on population mortality. N Engl J Med. 2020;383(7):640–649. doi:10.1056/NEJMoa1916623
  • Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med. 2017;377(9):829–838. doi:10.1056/NEJMoa1704795
  • Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer. N Engl J Med. 2018;379(21):2027–2039. doi:10.1056/NEJMoa1810171
  • Selvaggi G, Wakelee HA, Mok T, et al. Phase III randomized study of ensartinib vs crizotinib in anaplastic lymphoma kinase (ALK) positive NSCLC patients: EXALT3. Presented at the International Association for the Study of Lung Cancer World Conference on Lung Cancer, Singapore; 2020.
  • Bauer TM, Shaw AT, Johnson ML, et al. Brain penetration of lorlatinib: cumulative incidences of CNS and non-CNS progression with lorlatinib in patients with previously treated ALK-positive non-small-cell lung cancer. Target Oncol. 2020;15(1):55–65. doi:10.1007/s11523-020-00702-4
  • Gainor JF, Chi AS, Logan J, et al. Alectinib dose escalation reinduces central nervous system responses in patients with anaplastic lymphoma kinase-positive non-small cell lung cancer relapsing on standard dose alectinib. J Thorac Oncol. 2016;11(2):256–260. doi:10.1016/j.jtho.2015.10.010
  • Ali A, Goffin JR, Arnold A, Ellis PM. Survival of patients with non-small-cell lung cancer after a diagnosis of brain metastases. Curr Oncol. 2013;20(4):300–306. doi:10.3747/co.20.1481
  • European Medicines Agency. Summary of product characteristics: Lorviqua [homepage on the Internet]. London: European Medicines Agency; 2021. Available from: https://cima.aemps.es/cima/pdfs/es/ft/1191355002/FT_1191355002.pdf. Accessed November, 2021.
  • Johnson TW, Richardson PF, Bailey S, et al. Discovery of (10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo[4,3-h][2,5,11]-benzoxadiazacyclotetradecine-3-carbonitrile (PF-06463922), a macrocyclic inhibitor of anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) with preclinical brain exposure and broad-spectrum potency against ALK-resistant mutations. J Med Chem. 2014;57(11):4720–4744. doi:10.1021/jm500261q
  • European Medicines Agency. Lorviqua® [homepage on the Internet]. London: European Medicines Agency; 2022. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/lorviqua. Accessed March 08, 2022.
  • Shaw AT, Bauer TM, de Marinis F, et al. First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. N Engl J Med. 2020;383(21):2018–2029. doi:10.1056/NEJMoa2027187
  • Solomon B, Bauer T, Mok T, et al. Updated efficacy and safety from the phase 3 CROWN study of first-line lorlatinib vs crizotinib in advanced Anaplastic Lymphoma Kinase (ALK)–positive Non-Small Cell Lung Cancer (NSCLC). Poster presented at American Association for Cancer Research (AACR) Congress; April, 2022. New Orleans, USA.
  • Naik J, Beavers N, Nilsson FOL, et al. Cost‑effectiveness of lorlatinib in first-line treatment of adult patients with Anaplastic Lymphoma Kinase (ALK)‑positive non‑small‑cell lung cancer in Sweden. Appl Health Econ Health Policy. 2023;21(4):661–672. doi:10.1007/s40258-023-00807-7
  • National Institute for Health and Care Excellence. Alectinib for untreated ALK-positive advanced non-small-cell lung cancer (TA536) [homepage on the Internet]. London: National Institute for Health and Care Excellence; 2018. Available from: https://www.nice.org.uk/guidance/ta536. Accessed August 16, 2023.
  • National Institute for Health and Care Excellence. Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor (TA670) [homepage on the Internet]. London; National Institute for Health and Care Excellence; 2021. Available from: https://www.nice.org.uk/guidance/ta670. Accessed November, 2021.
  • 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. Spanish. doi:10.1016/j.gaceta.2019.06.007
  • Vallejo-Torres L, García-Lorenzo B, Serrano-Aguilar P. Estimating a cost-effectiveness threshold for the Spanish NHS. Health Econ. 2018;27(4):746–761. doi:10.1002/hec.3633
  • López Bastida J, Oliva J, Antoñanzas F, et al. Propuesta de guía para la evaluación económica aplicada a las tecnologías sanitarias [Guide proposal for economic evaluation applied to health technologies]. Gac Sanit. 2010;24(2):154–170. Spanish. doi:10.1016/j.gaceta.2009.07.011
  • Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making. 1993;13(4):322–338. doi:10.1177/0272989X9301300409
  • Ortega A, Marín R, Fraga MD, López-Briz E, Puigventós F. Guía de evaluación económica e impacto presupuestario en los informes de evaluación de medicamentos. Guía práctica asociada al programa MADRE v 4.0 [Economic evaluation and budgetary impact guide in drug evaluation reports. Practical guide associated with the MADRE v 4.0 program] [homepage on the Internet]. Madrid: Sociedad Española de Farmacia Hospitalaria; 2017. Spanish. Available from: http://gruposdetrabajo.sefh.es/genesis. Accessed February 23, 2021.
  • Latimer N NICE DSU Technical Support Document 14: undertaking survival analysis for economic evaluations alongside clinical trials - extrapolation with patient-level data. 2011[homepage on the Internet]. London: National Institute for Health and Care Excellence; 2013. Available from: http://nicedsu.org.uk/wp-content/uploads/2016/03/NICE-DSU-TSD-Survival-analysis.updated-March-2013.v2.pdf. Accessed September 16, 2019.
  • National Statistics Institute. Population mortality tables for Spain by year, sex, age and functions [homepage on the Internet]. Madrid: National Statistics Institute; 2019. Available from: https://www.ine.es/jaxiT3/Tabla.htm?t=27153&L=0. Accessed February 14, 2022.
  • Van Hout B, Janssen M, Feng Y-S, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012;15(5):708–715. doi:10.1016/j.jval.2012.02.008
  • Roughley A, Damonte E, Taylor-Stokes G, Rider A, Munk VC. Impact of brain metastases on quality of life and estimated life expectancy in patients with advanced non-small cell lung cancer. Value Health. 2014;17(7):A650. doi:10.1016/j.jval.2014.08.2364
  • Botplus web 2.0 [homepage on the Internet]. Madrid: General Council of Pharmacists Official College; 2021. Available from: www.portalfarma.com. Accessed November, 2021.
  • Real Decreto-ley 8/2010, de 20 de mayo, por el que se adoptan medidas extraordinarias para la reducción del déficit público [Royal Decree-law] [homepage on the Internet]. Madrid: BOE de; 2010:126. Available from: www.boe.es/boe/dias/2010/05/24/pdfs/BOE-A-2010-8228.pdf. Accessed November, 2021.
  • Rodríguez-Abreu D, Powell SF, Hochmair MJ, et al. Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC: protocol-specified final analysis from KEYNOTE-189. Ann Oncol. 2021;32(7):881–895. doi:10.1016/j.annonc.2021.04.008
  • Felip E, Shaw AT, Bearz A, et al. Intracranial and extracranial efficacy of lorlatinib in patients with ALK-positive non-small-cell lung cancer previously treated with second-generation ALK TKIs. Ann Oncol. 2021;32(5):620–630. doi:10.1016/j.annonc.2021.02.012
  • Gridelli C, Baas P, Barlesi F, et al. Second-line treatment options in non-small-cell lung cancer: report from an international experts panel meeting of the Italian Association of Thoracic Oncology. Clin Lung Cancer. 2018;19(4):301–314. doi:10.1016/j.cllc.2017.12.010
  • Huber RM, Hansen KH, Paz-Ares Rodríguez L, et al. Brigatinib in crizotinib-refractory ALK+ NSCLC: 2-Year follow-up on systemic and intracranial outcomes in the Phase 2 ALTA trial. J Thorac Oncol. 2020;15(3):404–415. doi:10.1016/j.jtho.2019.11.004
  • Ou SH, Ahn JS, De Petris L, et al. Alectinib in crizotinib-refractory ALK-rearranged non-small-cell lung cancer: a Phase II Global Study. J Clin Oncol. 2016;34(7):661–668. doi:10.1200/JCO.2015.63.9443
  • Oblikue Consulting [homepage on the Internet]. Barcelona: base de datos de costes sanitarios eSalud; 2021. Available from: http://www.oblikue.com/bddcostes/. Accessed January 31, 2022.
  • Llibre-Codina JM, Casado-Gómez MÁ, Sánchez-de la Rosa R, et al. Costes de la toxicidad asociada a los análogos de nucleósidos inhibidores de la transcriptasa inversa en pacientes con infección por el VIH-1 [Costs of toxicity associated with nucleoside reverse transcriptase inhibitors in patients with HIV-1 infection]. Enferm Infecc Microbiol Clin. 2007;25(2):98–107. doi:10.1157/13098570
  • Martín-Escudero V, García-Muro X, Trigo JM, et al. Uso de recursos y costes relacionados con el manejo de los acontecimientos adversos asociados al uso de terapias dirigidas en el tratamiento del carcinoma de células renales metastático en España [Resources use and costs related to the management of adverse events associated with the use of targeted therapies in the treatment of metastatic renal cell carcinoma in Spain]. Póster presentado en las XXX Jornadas de Economía de la Salud Valencia, España; 2010. Spanish.
  • Rivera F, Valladares M, Gea S, López-Martínez N. Cost-effectiveness analysis in the Spanish setting of the PEAK trial of panitumumab plus mFOLFOX6 compared with bevacizumab plus mFOLFOX6 for first-line treatment of patients with wild-type RAS metastatic colorectal cancer. J Med Econ. 2017;20(6):574–584. doi:10.1080/13696998.2017.1285780
  • Wehler E, Zhao Z, Pinar Bilir S, Munakata J, Barber B. Economic burden of toxicities associated with treating metastatic melanoma in eight countries. Eur J Health Econ. 2017;18(1):49–58. doi:10.1007/s10198-015-0757-y
  • Campone M, Yang H, Faust E, et al. Cost of adverse events during treatment with everolimus plus exemestane or single-agent chemotherapy in patients with advanced breast cancer in Western Europe. J Med Econ. 2014;17(12):837–845. doi:10.3111/13696998.2014.959589
  • Instituto Nacional de Estadística. General consumer price index [homepage on the Internet]. Madrid: Instituto Nacional de Estadística; 2022. Spanish. Available from: https://www.ine.es/. Accessed January 31, 2022.
  • Wilking N, Bradvik G, Lindgren P, Svedman C, Jönsson B, Hofmarcher T. A comparative study on costs of cancer and access to medicines in Europe. Ann Oncol. 2020;31(Suppl 4):S1197. doi:10.1016/j.annonc.2020.08.2303
  • Li S, Li J, Peng L, Li Y, Wan X. Cost-effectiveness of lorlatinib as a first-line therapy for untreated advanced anaplastic lymphoma kinase-positive non-small cell lung cancer. Front Oncol. 2021;11:684073. doi:10.3389/fonc.2021.684073
  • Nilsson FOL, Asanin ST, Masters ET, et al. The cost-effectiveness of lorlatinib versus chemotherapy as a second- or third-line treatment in Anaplastic Lymphoma Kinase (ALK)-positive non-small-cell lung cancer in Sweden. Pharmacoeconomics. 2021;39(8):941–952. doi:10.1007/s40273-021-01015-8
  • Jansen JP, Fleurence R, Devine B, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR task force on indirect treatment comparisons good research practices: part 1. Value Health. 2011;14(4):417–428. doi:10.1016/j.jval.2011.04.002
  • Hoaglin DC, Hawkins N, Jansen JP, et al. Conducting indirect-treatment-comparison and network-meta-analysis studies: report of the ISPOR task force on indirect treatment comparisons good research practices: part 2. Value Health. 2011;14(4):429–437. doi:10.1016/j.jval.2011.01.011