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Cost-Effectiveness Of Recombinant Human Follicle Stimulating Hormone Biosimilars In Portugal

2016; Elsevier BV; Volume: 19; Issue: 7 Linguagem: Inglês

10.1016/j.jval.2016.09.323

1524-4733

N Silverio, F Botica, A Diaz Batista,

Health Systems, Economic Evaluations, Quality of Life

To estimate the cost-effectiveness of the original r-hFSH (Gonal-f) when compared with one biosimilar (Ovaleap) using the evidence from a head-to-head registration trial. A TreeAge Pro decision-tree model was developed depicting the different relevant outcomes that result from fertility treatment with r-hFSH. Probabilities were populated using the data from a head-to-head trial used by the biosimilar for its registration at EMA, using as relevant outcome the take-away baby rates found in the trial. Costs were populated from Portuguese official sources and include the cost of the two drugs, as well as the costs related with treatment, such as costs for IVF, ICSI, child delivery and abortion. The analysis was performed from a societal perspective including only direct medical costs. According to the model, treatment of 1.000 women with Gonal-f will result in a total number of 356 pregnancies, with 322 women achieving a new-born child. Total cost for this will be 3.023.350 €, for a cost per woman achieving a new-born child of 9.391,67 €. Respective values for Ovaleap were 281 pregnancies and 268 women with new-born children. Total cost for this alternative is 2.941.660 €, resulting in a cost per new-born child of 10.977,42 €. Incremental cost-effectiveness ratio obtained for Gonal-f vs Ovaleap is 1.514,24 € per woman with a new-born child. Sensitivity analysis did not change the hierarchy in the results except on extreme values. The biossimilar Ovaleap is extendedly dominated by Gonal-f, with its cost-effectiveness ratio being higher than the one found for Gonal-f. Under the current scenario the use of the biossimilar is not a cost-effective alternative to the use of Gonal-f and thus should be avoided.