210
Views
0
CrossRef citations to date
0
Altmetric
Original Research

Lorlatinib as a first-line treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer: Α cost-effectiveness analysis in Greece

Pages 375-385 | Received 03 Aug 2023, Accepted 07 Nov 2023, Published online: 25 Nov 2023

References

  • Global Cancer Observatory (GCO). New global cancer data GLOBOCAN. 2020
  • Sun S, Schiller JH, Gazdar AF. Lung cancer in never smokers–a different disease. Nat Rev Cancer. 2007 Oct;7(10):778–790. doi: 10.1038/nrc2190. PubMed PMID: 17882278.
  • Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014 Dec 4;371(23): 2167–2177. doi: 10.1056/NEJMoa1408440. PubMed PMID: 25470694; eng.
  • Iyer S, Roughley A, Rider A, et al. The symptom burden of non-small cell lung cancer in the USA: a real-world cross-sectional study. Support Care Cancer. 2014 Jan;22(1):181–187. doi: 10.1007/s00520-013-1959-4. PubMed PMID: 24026981; eng.
  • Chia PL, Mitchell P, Dobrovic A, et al. Prevalence and natural history of ALK positive non-small-cell lung cancer and the clinical impact of targeted therapy with ALK inhibitors. Clin Epidemiol. 2014;6:423–432. doi: 10.2147/clep.S69718. PubMed PMID: 25429239; PubMed Central PMCID: PMCPMC4242069. eng.
  • Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007 Aug 2;448(7153): 561–566. doi: 10.1038/nature05945. PubMed PMID: 17625570; eng.
  • Grande E, Bolós MV, Arriola E. Targeting oncogenic ALK: a promising strategy for cancer treatment. Mol Cancer Ther. 2011 Apr;10(4):569–579. doi: 10.1158/1535-7163.Mct-10-0615. PubMed PMID: 21474455; eng.
  • Gainor JF, Varghese AM, Ou SH, et al. ALK rearrangements are mutually exclusive with mutations in EGFR or KRAS: an analysis of 1,683 patients with non-small cell lung cancer. Clin Cancer Res. 2013 Aug 1;19(15): 4273–4281. doi: 10.1158/1078-0432.CCR-13-0318. PubMed PMID: 23729361; PubMed Central PMCID: PMCPMC3874127.
  • Wong DW, Leung EL, So KK, et al. The EML4-ALK fusion gene is involved in various histologic types of lung cancers from nonsmokers with wild-type EGFR and KRAS. Cancer. 2009 Apr 15;115(8): 1723–1733. doi: 10.1002/cncr.24181. PubMed PMID: 19170230.
  • Chatziandreou I, Tsioli P, Sakellariou S, et al. Comprehensive molecular analysis of NSCLC; clinicopathological associations. PLoS One. 2015;10(7):e0133859. doi: 10.1371/journal.pone.0133859
  • Toyokawa G, Seto T, Takenoyama M, et al. Insights into brain metastasis in patients with ALK+ lung cancer: is the brain truly a sanctuary? Cancer metastasis reviews. PubMed PMID: 26342831; PubMed Central PMCID: PMCPMC4661196. eng. 2015 Dec;34(4):797–805. DOI:10.1007/s10555-015-9592-y
  • Leighl NB, Rekhtman N, Biermann WA, et al. Molecular testing for selection of patients with lung cancer for epidermal growth factor receptor and anaplastic lymphoma kinase tyrosine kinase inhibitors: American Society of clinical oncology endorsement of the College of American Pathologists/International Association for the study of lung cancer/Association for Molecular Pathology guideline. J Clin Oncol. 2014 Nov 10;32(32): 3673–3679. doi: 10.1200/jco.2014.57.3055. PubMed PMID: 25311215; eng.
  • Rekhtman N, Leighl NB, Somerfield MR. Molecular testing for selection of patients with lung cancer for epidermal growth factor receptor and anaplastic lymphoma kinase tyrosine kinase inhibitors: American Society of clinical oncology endorsement of the College of American Pathologists/International Association for the study of lung cancer/Association for Molecular Pathology guideline. J Oncol Pract. 2015 Mar;11(2):135–136. doi: 10.1200/JOP.2014.002303. PubMed PMID: 25515718.
  • Addeo A, Tabbò F, Robinson T, et al. Precision medicine in ALK rearranged NSCLC: A rapidly evolving scenario. Crit Rev Oncol Hematol. 2018 Feb;122:150–156. doi: 10.1016/j.critrevonc.2017.12.015. PubMed PMID: 29458783; eng
  • Blackhall F, Ross Camidge D, Shaw AT, et al. Final results of the large-scale multinational trial PROFILE 1005: efficacy and safety of crizotinib in previously treated patients with advanced/metastatic ALK-positive non-small-cell lung cancer. ESMO Open. 2017;2(3):e000219. doi: 10.1136/esmoopen-2017-000219. PubMed PMID: 29209525; PubMed Central PMCID: PMCPMC5703388. eng.
  • Khozin S, Blumenthal GM, Zhang L, et al. FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer. Clin Cancer Res. 2015 Jun 1;21(11): 2436–2439. 10.1158/1078-0432.ccr-14-3157. PubMed PMID: 25754348; eng.
  • Camidge DR, Kim HR, Ahn M-J, 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. PubMed PMID: 30280657
  • 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 Aug;31(8):1056–1064. doi: 10.1016/j.annonc.2020.04.478. PubMed PMID: 32418886; eng
  • Page S, Milner-Watts C, Perna M, et al. Systemic treatment of brain metastases in non-small cell lung cancer. Eur J Cancer. 2020 Jun;132:187–198. doi: 10.1016/j.ejca.2020.03.006. PubMed PMID: 32380429; eng
  • Burudpakdee C, Wong W, Seetasith A, et al. Economic impact of preventing brain metastases with alectinib in ALK-positive non-small cell lung cancer. Lung Cancer. 2018 May;119:103–111. doi: 10.1016/j.lungcan.2018.03.008. PubMed PMID: 29656744; eng
  • Chan PC, Rodrigues MM, Lim FM, et al. Economic burden of brain metastases in patients with non-small cell lung cancer: costs and implications. Ann Palliat Med. 2019 Apr;8(2):210–214. doi: 10.21037/apm.2018.12.03. PubMed PMID: 30691277; eng.
  • Cagney DN, Martin AM, Catalano PJ, et al. Incidence and prognosis of patients with brain metastases at diagnosis of systemic malignancy: a population-based study. Neuro Oncol. 2017 Oct 19;19(11):1511–1521. doi: 10.1093/neuonc/nox077. PubMed PMID: 28444227; PubMed Central PMCID: PMCPMC5737512. eng
  • Roughley A, Damonte E, Taylor-Stokes G, et al. Impact of brain metastases on quality of life and estimated life expectancy in patients with advanced non-small cell lung cancer. Value Health. 2014 Nov;17(7):A650. doi: 10.1016/j.jval.2014.08.2364. PubMed PMID: 27202347; eng
  • Shaw AT, Solomon BJ, Besse B, et al. ALK resistance mutations and efficacy of lorlatinib in advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer. J Clin Oncol. 2019 Jun 1;37(16): 1370–1379. 10.1200/jco.18.02236. PubMed PMID: 30892989; PubMed Central PMCID: PMCPMC6544460. eng.
  • 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. PubMed PMID: 33207094
  • Solomon BJ, Bauer TM, Mok TSK, et al. Efficacy and safety of first-line lorlatinib versus crizotinib in patients with advanced, ALK-positive non-small-cell lung cancer: updated analysis of data from the phase 3, randomised, open-label CROWN study. Lancet Respir Med. 2023;11(4):354–366. doi: 10.1016/S2213-2600(22)00437-4
  • 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 Jul;21(4):661–672. doi: 10.1007/s40258-023-00807-7
  • National Institute for Health and Care Excellence (NICE). 2021. Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor (TA670) 28 Jan 2023. Available from: https://www.nice.org.uk/guidance/ta670 Accessed 06 Mar 2023
  • Gourzoulidis G, Zisimopoulou O, Boubouchairopoulou N, et al. Cost-effectiveness analysis of lorlatinib in patients Previously treated with anaplastic lymphoma kinase inhibitors for non-small cell lung cancer in Greece. J Health Econ Outcomes Res. 2022;9(1):50–57. doi: 10.36469/jheor.2022.32983. PubMed PMID: 35620456; PubMed Central PMCID: PMCPMC8853822. eng.
  • National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal. Available from: https://wwwniceorguk/process/pmg9/chapter/involvement-and-participation. Accessed 6 Mar 2023
  • Gourzoulidis G, Barmpouni M, Kossyvaki V, et al. Health and economic outcomes of 20-valent pneumococcal conjugate vaccine compared to 15-valent pneumococcal conjugate vaccine strategies for adults in Greece. Front Public Health PubMed PMID: 37841729; PubMed Central PMCID: PMCPMC10570410. eng. 2023;11:1229524. doi: 10.3389/fpubh.2023.1229524
  • Hendriks LE, Kerr KM, Menis J, et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Jan 23;34(4): 358–376. 10.1016/j.annonc.2022.12.013. PubMed PMID: 36872130; eng.
  • Hellenic Ministry of Health. Guidelines- Lung Cancer. Available from: https://wwwmohgovgr/. Accessed 4 Apr 2023
  • Hellenic Society of Medical Oncology. Guidelines- Lung Cancer. Available from:https://wwwhesmogr/en/. Accessed 4 Apr 2023
  • Greek Ministry of Health. Latest positive list 2023. Available from: https://www.moh.gov.gr/articles/times-farmakwn/epitroph-aksiologhshs-kai-apozhmiwshs-farmakwn/11255-anathewrhsh-katalogoy-apozhmioymenwn-farmakwn-toy-arthroy-251-toy-n-4512-2018-opws-tropopoihthhke-me-to-arthro-24-toy-n-4633-2019 Accessed 6 Mar 2023
  • van Hout B, Janssen MF, Feng YS, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012 Jul;15(5):708–715. doi: 10.1016/j.jval.2012.02.008. PubMed PMID: 22867780; eng.
  • Ara R, Brazier JE. Populating an economic model with health state utility values: moving toward better practice. Value Health. 2010 Aug;13(5):509–518. doi: 10.1111/j.1524-4733.2010.00700.x. PubMed PMID: 20230546; eng.
  • Greek Ministry of Health. Drug price bulletin 2023. Available from: https://wwwmohgovgr/articles/times-farmakwn/deltia-timwn Accessed 6 Mar 2023
  • National Organisation for Healthcare Services Provision. Official web site of EOPYY 2023. Available from: https://www.eopyy.gov.gr/ Accessed 6 Mar 2023
  • Gourzoulidis G, Maniadakis N, Petrakis D, et al. Economic evaluation of trifluridine and tipiracil hydrochloride in the treatment of metastatic colorectal cancer in Greece. J Comp Eff Res. 2019 Feb;8(3):133–142. doi: 10.2217/cer-2018-0076. PubMed PMID: 30547679; eng.
  • Gourzoulidis G, Kourlaba G, Giannoulia P, et al. PCN129 - cost-effectiveness of Ponatinib in the treatment of patients with chronic phase- chronic myeloid leukemia in Greece. Value Health. 2017;20(9):A435. doi: 10.1016/j.jval.2017.08.212
  • Greek Ministry of Health. Diagnostic related groups Athens[March 2012]. Available from: http://www.yyka.gov.gr/articles/health/domes-kai-draseis-gia-thn-ygeia/kwdikopoihseis/709-kleista-enopoihmena-noshlia-1 Accessed 26 Mar 2023
  • Gourzoulidis G, Koulentaki M, Koumarianou A, et al. Cost-effectiveness of trifluridine/tipiracil as a third-line treatment of metastatic gastric cancer, including adenocarcinoma of the gastrohesophageal junction, among patients previously treated in Greece. Expert Rev Pharmacoecon Outcomes Res. 2022 Mar;22(2):259–269. doi: 10.1080/14737167.2021.1921576. PubMed PMID: 33900864; eng
  • Kokkotou E, Stefanou G, Syrigos N, et al. End-of-life cost for lung cancer patients in Greece: a hospital-based retrospective study. Comparative Effectiveness Research. 2021.
  • Hellenic Statistical Authority (EL.STAT.). Consumer price index. Available from: http://www.statistics.gr (Latest available). Accessed 16 Mar 2023.
  • Tzanetakos C, Gourzoulidis G. Does a standard cost-effectiveness threshold Exist? The case of Greece. Value Health Reg Issues. 36 2023 Mar 31: 18–26. 10.1016/j.vhri.2023.02.006. PubMed PMID: 37004314; eng
  • Thokala P, Ochalek J, Leech AA, et al. Cost-effectiveness thresholds: the past, the present and the future. PharmacoEconomics. 2018 May;36(5):509–522. doi: 10.1007/s40273-017-0606-1. PubMed PMID: 29427072; eng
  • Woods B, Revill P, Sculpher M, et al. Country-level cost-effectiveness thresholds: initial estimates and the need for further research. Value Health. 2016 Dec;19(8):929–935. doi: 10.1016/j.jval.2016.02.017. PubMed PMID: 27987642; PubMed Central PMCID: PMCPMC5193154. eng
  • International Monetary Fund. World economic outlook database 2022. Available from: https://www.imf.org/external/pubs/ft/weo/2019/02/weodata/index.aspx Accessed 6 Jun 2023
  • Li S, Li J, Peng L, et al. Cost-effectiveness of lorlatinib as a first-line therapy for untreated advanced anaplastic lymphoma kinase-positive non-small cell lung cancer. Front Oncol PubMed PMID: 34136409; PubMed Central PMCID: PMCPMC8203315. eng. 2021;11:684073. doi: 10.3389/fonc.2021.684073
  • National Institute for Health and Care Excellence (NICE). 2018. Alectinib for untreated ALK-positive advanced non-small-cell lung cancer (TA536) 15 March 2023. Available from: https://www.nice.org.uk/guidance/ta536 Accessed 30 Mar 2023
  • Bonetti A, Giuliani J. Implications of drugs with rebate in Europe. Lancet Reg Health Eur. 2021 Apr;3:100060. doi: 10.1016/j.lanepe.2021.100060
  • Giuliani J, Bonetti A. Immunotherapy in first-line for advanced non-small cell lung cancer: a cost-effective choice? Recenti Prog Med. 2019 Mar;110(3):138–143. doi: 10.1701/3132.31141. PubMed PMID: 30968854; eng.
  • Giuliani J, Bonetti A. Pharmacologic costs of tyrosine kinase inhibitors in first-line therapy for advanced non-small-cell lung cancer with activating epidermal growth factor receptor mutations: a review of pivotal phase III randomized controlled trials. Clin Lung Cancer. 2016 Mar;17(2):91–94. doi: 10.1016/j.cllc.2015.12.005. PubMed PMID: 26778441; eng.
  • EUnetHTA. European network for Health technology. Guidelines—comparators & comparisons: direct and indirect comparisons 2015. Available from: https://www.eunethta.eu/wp-content/uploads/2018/01/Comparators-Comparisons-Direct-and-indirect-comparisons_Amended-JA1-Guideline_Final-Nov-2015.pdf Accessed 30 Mar 2023

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.