OBJECTIVES: Bioequivalence of the two recent Biosimilars of recombinant human FSH (r-hFSH) has been demonstrated on the number of oocytes retrieved but not on the final outcome of interest for women concerned, the number of live births. Objective of this analysis is to assess the cost-effectiveness (CE) of the originator r-hFSH compared to the two biosimilars available in producing live births in patients undergoing a medically assisted reproduction program from a French perspective.

METHODS: An Excel-based decision-tree model depicting the different relevant outcomes of fertility treatment with r-hFSH over the 1st cycle was developed (including ovarian hyperstimulation syndrome, OHSS). Clinical and safety outcomes were derived from head-to-head clinical trials evidence provided for the 2 new Biosimilars of r-hFSH European registrations. Resources considered were based on French Health Insurance data; on French comprehensive national hospital database analysis and on French clinical experts opinions through a management questionnaire. A National Health Insurance perspective using official French tariffs (€2017) were considered. In order to test the robustness of results, deterministic sensitivity analyses were carried out on the main variables.

RESULTS: Treating 100 women with originator r-hFSH resulted in 5 to 9 additional live births compared to the two biosimilars (6 if pooled data are considered). The additional total cost per woman treated with originator r-hFSH ranged from +€259 (for one biosimilar and pooled) to +€279 (for the other biosimilar).The incremental CE ratio (€ per additional live birth) ranged from 3275, 4352 to 4804 (versus1st biosimilar, pooled and 2nd biosimilar respectively). Analysis included OHSS. All sensitivity analyses carried out support these results.

CONCLUSIONS: Originator r-hFSH is a cost-effective strategy compared to biosimilars whatever the consideration or not of OHSS. This present CE model is based on clinical trials evidence. It would be of interest to carry out further investigations using French real world evidence (RWE) to confirm these results.