Relapsed/metastatic head and neck squamous cell cancer patients are offered a combination of platinum-based chemotherapy (PF, cisplatin-fluorouracil) plus cetuximab regimen (PF+C) according to results of the EXTREME trial (1). However, two economic evaluations showed that addition of cetuximab was not cost-effective.

This study aimed to evaluate the cost-effectiveness of a putative predictive molecular test (MT) to identify and treat only patients potentially responsive to cetuximab when added to PF.

A Markov model was developed to compare both health and economic outcomes of PF+C regimen administered to all patients (PF+C ALL) versus the regimen administered only to MT-positive patients (PF+C POS).

The model considered the following health states: partial/complete response with/out mild/severe adverse events (AEs), progression and death. Rates of progression and survival, response rates to systemic treatment and adverse events were retrieved from the EXTREME trial (1). According to Mesía et al. (2), we assumed that addition of cetuximab to PF would not negatively affect life quality compared to PF alone, and the baseline utility coefficients for disease control and progression were assumed as .67 and .52, respectively.

Only direct costs estimated from the Italian Health Service perspective were included (tariffs and Diagnosis Related Group - DRG - reimbursements).

The model was evaluated according to a cut-off of sensitivity at 85 percent and specificity at 70 percent. A 3 years horizon was chosen. Life expectancy, quality-adjusted life years (QALYs) and costs were discounted at 3.5 percent annually.

Applying the World Health Organization (WHO) cost-effectiveness threshold of 3 times the gross domestic product for Italy (EUR66,402), PF+C POS resulted a cost-effective choice in comparison to PF+C ALL for a MT cost lower than EUR5,750.

Adding cetuximab to PF only to patients positive to a predictive test may be cost-effective. Efforts should be spent to build such a test upon existing evidences in order to save resources for the health systems and spare unnecessary toxicities to patients.