Cost-Consequence Analysis Comparing Originator r-hFSH-alfa and Biosimilars for =4 Complete Ovarian Stimulation Cycles During Assisted Reproductive Technology Treatment: A Multi-Country Perspective

Assisted reproductive technology (ART) demand is increasing, raising questions about the cost-effectiveness of ovarian stimulation (OS) treatments. This study evaluates the clinical and economic outcomes of originator recombinant human follicle-stimulating hormone (r-hFSH-alfa) compared with its biosimilars across multiple ART cycles and countries.

A cost-consequence analysis was conducted using a decision-tree model simulating up to four complete OS cycles in women undergoing ART across seven countries (Spain, France, Germany, the United Kingdom, Denmark, Australia, and South Korea). The analysis incorporated both fresh and frozen embryo transfers within each cycle and included base-case and scenario analyses, including treatment-switching strategies.

Theoretical model corresponding to women undergoing ART and receiving originator r-hFSH-alfa or a biosimilar for OS.

Clinical inputs were derived from published real-world data and a meta-analysis. Economic inputs were estimated from public payer perspectives and included drug acquisition, ART procedures, embryo transfer, pregnancy, and delivery costs. Outcomes included cumulative live birth rate (CLBR), total costs, and cost per LB. Base-case and scenario analyses, including treatment-switching strategies, were conducted alongside deterministic sensitivity analyses.

Originator r-hFSH-alfa was associated with a higher CLBR compared with biosimilars (58.2% vs 50.8%). This advantage persisted across scenarios and time horizons. Despite slightly higher drug acquisition costs, originator r-hFSH-alfa resulted in lower cost per LB across all countries, with savings ranging from approximately €2,900 to over €8,000 per LB. Strategies initiating treatment with biosimilars were consistently dominated (less effective and more costly) compared to strategies starting with r-hFSH-alpha. Results were robust to sensitivity analyses, with LB rate differences being the primary driver of outcomes.

This model included limited national clinical data and reliance on modeled assumptions. Other studies are needed to further establish the robustness of the effectiveness data used here. Indirect societal costs and the emotional burden associated with unsuccessful ART cycles were not included. Additionally, costs related to ovarian hyperstimulation syndrome were excluded because rates are very similar between both treatment arms.

Across multiple countries and healthcare systems and based on the available effectiveness evidence, initiating ART with originator r-hFSH-alfa improves clinical outcomes and reduces cost per live birth compared with biosimilars. These findings highlight the importance of evaluating ART strategies based on overall treatment pathway value rather than drug acquisition cost alone and support prioritizing more effective treatments in clinical and reimbursement decision-making.