Cost-Consequence Model Comparing the Originator r-hFSH-alfa and Its Biosimilar for ≤4 Complete Ovarian Stimulation Cycles During Assisted Reproductive Technology Treatment in Spain, France, and Germany

OBJECTIVES: Studies show that originator recombinant human follicle‑stimulating hormone-alfa (r‑hFSH-alfa) is associated with higher cumulative live birth rates (CLBR) than biosimilars, reducing costs per live birth (LB). Evidence regarding the most cost-effective treatment pathway is limited as most women undergo multiple ovarian stimulation (OS) cycles for Assisted Reproductive Technology treatment. This study evaluated clinical and economic outcomes of initiating OS with either originator r-hFSH-alfa or biosimilars, and consider implications of continuing or switching treatments based on published data.

METHODS: A decision-tree model assessed outcomes (CLBR, total costs per LB, time to LB, ICER) using real world (Grynberg 2022) and a meta-analysis of RCT data (Chua 2021). It compared originator r-hFSH-alfa versus biosimilars in Spain, France and Germany (Matorras 2023) considering ≤4 complete OS cycles, each with 1 fresh and ≤3 frozen embryo transfers (FET). Treatment started with originator r-hFSH-alfa or its biosimilar. If no LB occurred, women either continued with FET or initiated a new OS. Outcomes were assessed when switching treatment between originator and biosimilar after first, second, or third cycle without a LB. Model structure and assumptions were validated.

RESULTS: In the analysis originator r-hFSH-alfa showed a higher CLBR (58.2% versus 50.8%) and a shorter time to LB (936 days versus 980 days) compared to biosimilars. Costs per LB associated with originator r-hFSH-alfa versus biosimilars were lower in all countries: France (€16,187 versus €18,932), Spain (€17,174 versus €20,828), and Germany (€17,007 versus €19,367). Scenarios with early switch to originator r-hFSH-alfa ranged from being cost-saving (all scenarios for Spain) to being more effective at slightly higher costs (Germany): (ICER: €285 for switch to biosimilars after first versus after second; €4,149 for switch after second versus after third OS).

CONCLUSIONS: Starting and continuing OS with originator r-hFSH-alfa may save time and costs in achieving LB compared to biosimilars.