OBJECTIVES: Colorectal cancer, the third most common cancer in the world, has different treatments. The most important is chemotherapy. FOLFIRI regimen (Folinic acid, 5Fluorouracil, Irinotecan) is one of the effective chemotherapy regimens for colorectal patients that is commonly used in Iran. Cetuximab is a monoclonal EGFR inhibitor introduced to the market to improve these patients’ treatments. However, the high price of these new medicines is always a concern for health systems. this study evaluates cost-effectiveness of adding Cetuximab to FOLFIRI regimen in metastatic colorectal carcinoma patients with different KRAS gene Statuses

METHODS:

Using a Markov model, the analysis was performed from the Healthcare perspective over lifetime horizon in a cohort of 1000 hypothetical patients received Cetuximab with FOLFIRI regimen versus FOLFRI regimen alone in two scenarios with and without KRAS gene screening. The measure for efficacy was reported as Quality Adjusted Life Year (QALY) and the costs were retrieved from literature, clinicians’ routine practice, and Iran tariff book.

RESULTS:

In both scenarios adding Cetuximab to FOLFRI regimen increase the QALY. However, the mean discounted QALY’s in the KRAS-WT(wild type) population were higher than without screening (0.193 versus 0.069). In the case of costs, the mean discounted costs per patient in the group who received Cetuximab and FOLFIRI were higher than in whom received FOLFIRI alone (20,767 versus 56,985 US$); moreover, the total cost in the KRAS group was more than the group without of screening (20,258 US$). Finally, the incremental cost-effective ratio in scenario with KRAS gene screening was 292,768 US$/QALY, which was lower than the base scenario without screening which was 520,771US$/QALY.

CONCLUSIONS:

According to the willingness-to-pay threshold in the Iranian health system, which is 1GDP/capita ($2,422), Cetuximab is not a cost-effective intervention in Iran, even for KRAS-WT patients. So, Risk-sharing agreements would be the best solution for patient access to this medicine.