#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

The Pharmacoeconomic Analysis of Cetuximab and Panitumumab in the 1st Line Treatment of mCRC in Real Clinical Practice in the Czech Republic


Authors: Irena Sehnalová 1;  Barbora Říhová 1;  Radim Němeček 2;  Kateřina Kintrová 3;  Regina Demlová 1
Authors‘ workplace: Farmakologický ústav, LF MU, Brno 1;  Klinika komplexní onkologické péče LF MU a Masarykův onkologický ústav, Brno 2;  Ústav botaniky a zoologie, PřF MU, Brno 3
Published in: Klin Onkol 2019; 32(4): 288-293
Category: Original Articles
doi: https://doi.org/10.14735/amko2019288

Overview

Background: The anti-epidermal growth factor receptor (EGFR) drugs cetuximab and panitumumab are currently reimbursed when administered during the first and subsequent lines of treatment of patients in the Czech Republic with metastatic colorectal cancer (mCRC). Because cetuximab and panitumumab do not show significant differences in efficacy, their choice may be dependent on cost. This retrospective study analyzed the costs of first-line treatment with cetuximab and panitumumab of patients with mCRC and wild type KRAS, as well as evaluated the correlations between costs and effectiveness, as determined by progression-free survival (PFS) and overall survival (OS).

Patients and methods: This analysis included 51 patients with mCRC and confirmed wild type KRAS treated at the comprehensive cancer centre in the Czech Republic between November 2011 and April 2018. Of these 51 patients, 22 were treated with cetuximab and 29 with panitumumab. Direct medical costs (medications, clinical examinations and procedures, and hospitalization) were evaluated from the initiation of treatment with anti-EGFR drug to disease progression and death. Mean follow-up was 21 months in the cetuximab group and 19 months in the panitumumab group.

Results: Reimbursement for anti-EGFR drugs until disease progression accounted for 71% (mean, 964,288 CZK per patient) of total costs in the cetuximab group and 77% (mean, 1,003,229 CZK per patient) of total costs in the panitumumab group, with median PFS in these two groups being 10.7 months and 8.1 months, respectively. Reimbursement of expensive center drugs from the start of anti-EGFR treatment to patient death accounted for 55% of total costs in the cetuximab group (mean, 1,752,702 CZK per patient) and 63% of total costs in the panitumumab group (mean, 1,596,919 CZK per patient), with median OS in these two groups being 20.2 months and 19.8 months, respectively. No significant between-group differences in clinical effectiveness and costs of treatment were observed (p > 0.05 each).

Conclusion: Reimbursement for biological agents is the most expensive item in the first-line treatment of mCRC patients with wild type KRAS, both to disease progression and death. The clinical effectiveness and costs of cetuximab and panitumumab did not differ significantly.

Supported by CZECRIN (identification code LM2015090); CZECRIN_4 PACIENTY (No. CZ.02.1.01/0.0/0.0/16_013/0001826).

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE recommendation for biomedical papers.

Submitted: 30. 4. 2019

Accepted: 17. 6. 2019

Keywords:

cetuximab – panitumumab – cost analysis


Sources

1. van Cutsem E, Cervantes A, Adam R et al. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol 2016; 27 (8): 1386–1422. doi: 10.1093/annonc/mdw235.

2. Ústav zdravotnických informací a statistiky ČR. Novotvary. [online]. Dostupné z: http: //www.uzis.cz/katalog/zdravotnicka-statistika/novotvary.

3. Linkos.cz. Modrá kniha České onkologické společnosti ČLS JEP. [online]. Dostupné z: https: //www.linkos.cz/lekar-a-multidisciplinarni-tym/diagnostika-a-lecba/modra-kniha-cos/aktualni-vydani-modre-knihy/.

4. Giantonio BJ, Catalano PJ, Meropol NJ et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007; 25 (12): 1539–1544. doi: 10.1200/JCO.2006.09.6305.

5. Hurwitz H, Fehrenbacher L, Novotny W et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350 (23): 2335–2342. doi: 10.1056/NEJMoa032691.

6. Douillard JY, Siena S, Cassidy J et al. Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol 2014; 25 (7): 1346–1355. doi: 10.1093/annonc/mdu141.

7. Bokemeyer C, Bondarenko I, Hartmann JT et al. Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study. Ann Oncol 2011; 22 (7): 1535–1546. doi: 10.1093/annonc/mdq632.

8. Cutsem EV, Tabernero J, Lakomy R et al. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase iii randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol 2012; 30 (28): 3499–3506. doi: 10.1200/JCO.2012.42.8201.

9. van Cutsem E, Köhne CH, Láng I et al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol 2011; 29 (15): 2011–2019. doi: 10.1200/JCO.2010.33.5091.

10. Grothey A, van Cutsem E, Sobrero A al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013; 381 (9863): 303–312. doi: 10.1016/S0140-6736 (12) 61900-X.

11. Mayer RJ, van Cutsem E, Falcone A et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med 2015; 372 (20): 1909–1919. doi: 10.1056/NEJMoa1414325.

12. Aghagolzadeh P, Radpour R. New trends in molecular and cellular biomarker discovery for colorectal cancer. World J Gastroenterol 2016; 22 (25): 5678–5693. doi: 10.3748/wjg.v22.i25.5678.

13. Král J, Slyšková J, Vodička P et al. Molecular pathogenesis of colorectal cancer. Klin Onkol 2016; 29 (6): 419–427. doi: 10.14735/amko2016419.

14. ERBITUX, 5MG/ML INF SOL 1X20ML. Státní ústav pro kontrolu léčiv. [online]. Dostupné z: http: //www.sukl.cz/modules/medication/detail.php?code= 0028761&tab=texts.

15. VECTIBIX, 20MG/ML INF CNC SOL 1X5ML. Státní ústav pro kontrolu léčiv. [online]. Dostupné z: http: //www.sukl.cz/modules/medication/detail.php?code=0029248& tab=texts.

16. Chung CH. Managing premedications and the risk for reactions to infusional monoclonal antibody therapy. Oncologist 2008; 13 (6): 725–732. doi: 10.1634/theoncologist.2008-0012.

17. Jean GW, Shah SR. Epidermal growth factor receptor monoclonal antibodies for the treatment of metastatic colorectal cancer. Pharmacotherapy 2008; 28 (6): 742–754. doi: 10.1592/phco.28.6.742.

18. Price TJ, Peeters M, Kim TW et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol 2014; 15 (6): 569–579. doi: 10.1016/S1470-2045 (14) 70118-4.

19. Cutsem EV, Lenz HJ, Köhne CH et al. Fluorouracil, leucovorin, and irinotecan plus cetuximab treatment and RAS mutations in colorectal cancer. J Clin Oncol 2015; 33 (7): 692–700. doi: 10.1200/JCO.2014.59.4812.

20. Bokemeyer C, Cutsem EV, Rougier P et al. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: pooled analysis of the CRYSTAL and OPUS randomised clinical trials. Eur J Cancer 2012; 48 (10): 1466–1475. doi: 10.1016/j.ejca.2012.02.057.

21. Elez E, Argilés G, Tabernero J. First-line treatment of metastatic colorectal cancer: interpreting FIRE-3, PEAK, and CALGB/SWOG 80405. Curr Treat Options Oncol 2015; 16 (11): 52. doi: 10.1007/s11864-015-0369-x.

22. Venook AP, Niedzwiecki D, Lenz HJ et al. CALGB/SWOG 80405: phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum (MCRC). J Clin Oncol 2014; 32 (Suppl 18): LBA3–LBA3.

23. Hradecká I, Říhová B, Horová R et al. Analýza nákladů na 1. linii léčby metastatického kolorektálního karcinomu při podání režimů s bevacizumabem – data z reálné klinické praxe v České republice. Klin Onkol 2014; 27 (4): 255–260. doi: 10.14735/amko2014255.

24. Rautenberg T, Siebert U, Arnold D et al. Economic outcomes of sequences which include monoclonal antibodies against vascular endothelial growth factor and/or epidermal growth factor receptor for the treatment of unresectable metastatic colorectal cancer. J Med Econ 2014; 17 (2): 99–110. doi: 10.3111/13696998.2013.864973.

25. Fínek J, Skoupá J, Jandová P. Cost-effectiveness analysis of panitumumab plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 for first-line treatment of patients with wild-type RAS metastatic colorectal cancer-czech Republic model adaptation. Klin Onkol 2015; 28 (4): 265–272. doi: 10.14735/amko2015265.

26. Schwartzberg LS, Rivera F, Karthaus M et al. PEAK: a randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer. J Clin Oncol 2014; 32 (21): 2240–2247. doi: 10.1200/JCO.2013.53.2473.

Labels
Paediatric clinical oncology Surgery Clinical oncology

Article was published in

Clinical Oncology

Issue 4

2019 Issue 4

Most read in this issue
Login
Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account

#ADS_BOTTOM_SCRIPTS#