A cost-effectiveness analysis of gonadotropins used for ovarian stimulation during assisted reproductive technology based on data from the French nationwide claims database (SNDS)

Objective: Various gonadotropins are used for ovarian stimulation (OS). This study investigated the cost-effectiveness of different gonadotropins based on real-world data from the French National Health Database (SNDS) over a 7-year follow-up of assisted reproductive technology (ART) treatments. Design: Cost-effectiveness analysis of different gonadotropins based on real-world data from the French National Health Database (SNDS). Participants: Women from SNDS undergoing OS leading to oocyte pick-up registered between 31 Jan 2013 and 31 Dec 2018 (N=245,534 stimulations) and receiving either r-hFSH alfa originator (110,439), its biosimilars (12,287), or urinaries (mainly HP-hMG[65,654] and marginally u-hFSH-HP[7,821]) were included (follow-up:31 Dec 2019). Methods: Clinical inputs for this model, including live birth (LB) and cumulative LB (CLB) were calculated from data as published in Grynberg et al. 2022. A decision-tree model was developed comprising pregnancy and live birth rate (LBR) states for a complete ART cycle, including one fresh and ≤4 frozen/thawed embryo transfers and related costs. Cost inputs included those of drugs, ART procedure, pregnancy and delivery, and adverse events. Cost per LB and CLB, and incremental cost-effectiveness ratio (ICER) were assessed. Robustness of results was determined by comprehensive sensitivity analyses. Results: Overall, r-hFSH alfa originator was found to be associated with a lower cost per LB and per CLB (cost per LB: €26,010; CLB: €22,278) versus its biosimilars (cost per LB: €28,037; CLB: €23,807) and versus urinaries (cost per LB: €26,636; CLB: €23,335). Calculated ICERs with r-hFSH alfa for LB were €5,538 and €14,090, whereas for CLB were €1,945 and €13,742 versus biosimilars and urinaries, respectively. Cost-effectiveness acceptability curve showed that in a majority of iterations r-hFSH alfa originator had a probability of being cost-effective at a hypothetical threshold of €20,000/live birth. Sensitivity analyses showed that the most important variable impacting the outcome in fresh transfers was the probability of birth for biosimilars and the probability of pregnancy for urinaries, while for cumulative transfers it was the probability of pregnancy for biosimilars and the probability of birth for urinaries. Limitations: As the clinical data were obtained from a non-interventional study and not a randomised controlled trial, the results may still be susceptible to residual confounding or other biases Conclusions: r-hFSH alfa originator is cost-effective compared to its biosimilars and to urinaries (mainly HP-hMG) and is associated with a lower cost per LB compared to these gonadotropins, where the main driver is the higher live birth efficacy rate achieved with it.