OBJECTIVES: Recombinant follicle-stimulating hormone (rFSH) is used in controlled ovarian stimulation (COS) for ART. Follitropin delta offers a personalized dosing regimen based on patient's ovarian reserve profile (using anti-Müllerian hormone (AMH) levels) and body weight, achieving consistent daily dosing and reducing the risk of ovarian hyperstimulation syndrome (OHSS) while maintaining efficacy. This study evaluates the cost-effectiveness of follitropin delta compared with follitropins alfa and beta in women undergoing COS.

METHODS: A decision-tree model was developed comparing the outcomes of treatment with follitropin delta versus other follitropins through ongoing pregnancy (OP) and live birth (LB) in fresh cycles, using pooled data from the pivotal clinical trials: ESTHER-1 (global), GRAPE (Pan-Asia), and STORK (Japan). The analyses were stratified by age and ovarian reserve profile and reflected a single COS cycle. Costs were estimated from the healthcare perspective in France, and uncertainty was assessed through sensitivity analyses.

RESULTS: Follitropin delta achieved higher rates of OP (34.1%) and LB (29.5%) compared with follitropins alfa/beta (OP: 32.8% and LB: 26.8%). Additionally, treatment with follitropin delta was associated with fewer miscarriages and lower OHSS incidence (4.6% and 6.2%, respectively) compared with other follitropins (5.9% and 8.3%, respectively). Total treatment cycle cost with/without delivery cost was €5,310/€4,125 for follitropin alfa, €5,361/€4,176 for follitropin beta and €5,381/€4,083 for follitropin delta. The incremental cost-effectiveness ratio was €2,637/LB for follitropin delta vs follitropin alfa. Follitropin beta was dominated (less efficient, more costly). Excluding the delivery cost follitropin delta was the dominant treatment option (more efficient, lower costs) versus follitropins alfa and beta. Probabilistic sensitivity analyses supported the deterministic results, showing 65% probability of follitropin delta being dominant when assessing cost per OP.

CONCLUSIONS: Follitropin delta is cost-effective compared with follitropins alfa and beta in ART for women undergoing COS protocols from French health care perspective. This is attributed to improved OP and LB rates.