Cost-effectiveness of FOLFIRI + cetuximab vs FOLFIRI + bevacizumab in the first-line treatment of RAS wild-type metastatic colorectal cancer in Germany: data from the FIRE-3 (AIO KRK-0306) study.

Aims: This analysis evaluates the cost-effectiveness of first-line treatment with FOLFIRI + cetuximab vs FOLFIRI + bevacizumab for patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in Germany based on the randomized phase 3 FIRE-3 trial. For patients with RAS wt mCRC, FOLFIRI + cetuximab yielded statistically significant median overall survival gains over FOLFIRI + bevacizumab.Materials and methods: A standard 3-state partitioned survival cost-utility model was developed to compare the health benefits and costs of treatment from a German social health insurance perspective using individual patient-level trial data. Health outcomes were reported in life-years (LYs) and quality-adjusted life-years (QALYs) gained. Survival was estimated based on Kaplan-Meier (KM) curves supplemented with best-fitting parametric survival model extrapolations. Subgroup analyses of patients with a left-sided primary tumor location or patients with metastases confined to the liver were performed.Results: In the modified intention-to-treat analysis, FOLFIRI + cetuximab, providing 0.68 additional LYs (0.53 QALYs), yielded incremental cost-effectiveness ratios (ICERs) of €36,360/LY and €47,250/QALY. In subgroup analyses, patients experienced improved survival gains without a corresponding increase in costs, resulting in lower ICERs. Our model was most sensitive to changes in treatment duration across all lines of therapy, utility of progressive disease, as well as patients' weight and body surface area.Limitations: This cost-effectiveness analysis was based on patient-level data from the FIRE-3 trial. Trial outcomes may not adequately reflect those in the real-world setting. Additionally, resource use and costs were obtained from tariff lists, which do not account for differences in treatment practice. These considerations limit generalizability of outcomes to other countries, or within the German healthcare setting.Conclusions: Based on our analyses, FOLFIRI + cetuximab is cost-effective compared with FOLFIRI + bevacizumab in patients with RAS wt mCRC, with ICERs well below willingness-to-pay thresholds for diseases with a high burden.

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

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.