OBJECTIVES

A recent meta-analysis based on data from Randomized Controlled Trails (RCTs) demonstrated higher probability of live birth (LB) and pregnancy (ongoing) in couples treated with the reference follitropin alfa product (GONAL-f) compared with biosimilar follitropin alfa preparations (Chua et al, 2021). It is not known to which extent this better clinical outcome is associated with improved cost-effectiveness. The objective of this study is to perform a Cost-Effectiveness Analysis (CEA), using clinical outcomes from the published meta-analysis.

METHODS

A decision tree model was developed in MSExcel®. Relative risk from the meta-analysis provide the clinical inputs. Costs were sourced from a Spanish perspective. The proportion of patients at the end of each treatment pathway was multiplied by the relevant direct cost. The analysis comprised one stimulation cycle with fresh embryo transfer. Outputs included LB rates, total direct costs, and cost per LB. The incremental cost-effectiveness ratio (ICER) was calculated as the difference in total costs divided by the difference in LB rates. One-way sensitivity analysis (OWSA) and Probabilistic sensitivity analysis (PSA) were conducted.

RESULTS

Gonal-f was associated with an increased LB rate (26,4%) versus biosimilars (21,9%). Total cost per patient was marginally higher in the Gonal-f group (€4,789) versus biosimilars (€4,465), related to the costs associated with the higher number of pregnancies and live births observed for GONAL-f. Cost per LB was lower (€18,138) with Gonal-f versus the biosimilars (€20,377), with an ICER of €7,208. Results of OWSA showed that probability of pregnancy/LB and costs following successful pregnancy had the greatest impact on the ICER. The PSA confirmed the robustness of the analysis.

CONCLUSIONS

This is the first CEA utilising a recently published meta-analysis which compared Gonal-f versus biosimilars. Gonal-f was found to be a cost-effective treatment option by international threshold standards. Cost per LB was found to be lower for Gonal-f versus biosimilars.