OBJECTIVES:

Colorectal is currently the third most common cancer in the world. Although the FOLFIRI regimen (Folinic acid, 5Fluorouracil, Irinotecan) is effective in colorectal cancer, adding some new monoclonal antibodies such as Cetuximab, an EGFR inhibitor, show improved efficacy. However, due to resource limitations, the cost-effectiveness of these new and expensive medicines is challenging for several countries, especially developing ones. This research aims to evaluate the cost-effectiveness of cetuximab add-on therapy in FOLFRI regimen patients in two scenarios; with and without RAS gene screening.

METHODS:

The analysis was performed from a health system perspective using a Markov model. The measure for efficacy was reported as Quality Adjusted Life Year (QALY). the costs were retrieved from literature, clinicians’ routine practice, and the Iran tariff book. Two scenarios were applied with and without RAS gene status screening. Costs and outcomes were discounted, and sensitivity analysis was performed to show the robustness of the model.

RESULTS:

Although in both scenarios, with and without screening, when added to the Cetuximab in the FOLFRI regimen, the QALY was increased, the mean discounted QALY’s in the RAS-WT(wild type) population were higher than people without screening (0.285 versus 0.069 QALYS). The discounted costs per patient in patients who received Cetuximab and FOLFIRI were higher than those who received FOLFIRI alone (20,767 versus 56,985 US$). Furthermore, the total cost in the group with RAS gene screening was more than the base scenario without screening(25,648US$). Then, the incremental cost-effective ratio in RAS-WT(wild type) was 217,460 US$/QALY, and ICER without screening was 520,771US$/QALY.

CONCLUSIONS:

So, noting the willingness-to-pay threshold in the Iranian health system, 1GDP/capita ($2,422 ), Cetuximab may not be a cost-effective alternative in treating Metastatic Colorectal Cancer Patients in Iran even for RAS-WT patients. So, managed entry agreement would be the only solution for patient access to this medicine.