Gastric cancer (GC) is one of the most common malignancy and the third leading cause of cancer mortality worldwide. Currently, platinum-based and fluoropyrimidine-based combinations represent the milestone of front-line drug regimens. Unfortunately, there are few treatment options after failure of first-line therapy. Ramucirumab, a human IgG1 monoclonal antibody to VEGFR-2, has been recently approved in the European Union (EU) for use as monotherapy or in combination with paclitaxel as second-line treatment in patients with advanced GC with progressed disease. We performed a cost-effectiveness analysis of the Ramucirumab plus paclitaxel doublet versus paclitaxel alone in patients with previously treated advanced GC, based on results of the RAINBOW trial (1).

A Markov model has been developed in order to estimate the Life Years Gained (LYGs) and the incremental cost-effectiveness ratio (ICER) for both treatments. The model adopted the Italian healthcare system perspective and the time horizon is that of the lifetime of a patient with an advanced GC. The model considered three distinct health states: stable, progression or death. Transition probabilities were extracted from the Kaplan-Meier curves provided in the trial and cubic/spline function was used to approximate the extrapolation of survival curves for each treatment cycle. An internal model validation was performed to validate the Overall Survival (OS) curves generated by our model simulation. We based our economic analysis on clinical data and resource consumption (drugs, drug administration, supportive care medications, disease monitoring and graded 3 or 4 adverse events) on the Italian setting (2,3). All costs were expressed in euros. Sensitivity analysis also have been performed.

This cost-effectiveness study demonstrated that, in 2nd-line therapy, the combination of ramucirumab with paclitaxel provides an incremental benefit (+1.54) at high incremental cost (EUR41,616) per LYGs.

At a threshold of EUR5,000 for LYGs, based on Italian perspective, ramucirumab plus paclitaxel had less probability of being cost-effective. To our knowledge, our study is the first modeling study from an Italian payer perspective and the first worldwide to examine ramucirumab as a 2nd-line treatment.