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Int J Womens Health. 2016 Dec 07;8:683-689. doi: 10.2147/IJWH.S118687. eCollection 2016.

A cost-effectiveness evaluation comparing originator follitropin alfa to the biosimilar for the treatment of infertility.

International journal of women's health

Salvatore Gizzo, Juan A Garcia-Velasco, Franca Heiman, Claudio Ripellino, Klaus Bühler

Affiliations

  1. Department of Woman and Child Health, University of Padua, Padua, Italy.
  2. Department of Obstetrics and Gynecology, Rey Juan Carlos University Madrid, Madrid, Spain.
  3. IMS Health Information Solutions Italy Srl, Milan, Italy.
  4. Centre for Gynaecology, Endocrinology, and Reproductive Medicine, Ulm and Stuttgart, Germany.

PMID: 27994486 PMCID: PMC5153281 DOI: 10.2147/IJWH.S118687

Abstract

OBJECTIVES: To perform a cost-effectiveness evaluation comparing the originator follitropin alfa (Gonal-f

METHODS: Starting from the study by Rettenbacher et al, a cost-effectiveness model was developed in the Italian and Spanish contexts. Clinical data on subjects, doses of gonadotropin, pregnancies, live-born children, and ovarian hyperstimulation syndrome were used to feed the model. Costs related to drugs, hospitalizations, specialist visits, and examinations were retrieved from Italian and Spanish tariffs. Gonadotropin acquisition costs for Germany and the UK were also taken into account to expand the economical assessment to the other countries. The evaluation was done based on the National Health Service perspective. Sensitivity analyses, both univariate and probabilistic, as long as scenario analyses, tested the robustness of the model.

RESULTS: Originator follicle-stimulating hormone (FSH) costs were €3,663 and €6,387 in Italy and Spain, respectively, whereas biosimilar FSH costs were €3,483 and €6,342. The efficacy was found to be 0.52 for the originator and 0.47 for the biosimilar. The average cost per live birth was estimated to be €7,044 and €12,283 for the originator FSH and €7,411 and €13,494 for the biosimilar for Italy and Spain, respectively. Furthermore, the originator FSH generated an incremental cost-effectiveness ratio of €3,600 for Italy and €900 for Spain compared to the biosimilar. Sensitivity analyses confirmed the results of the base case model.

CONCLUSION: This analysis indicated that the originator FSH is a cost-efficient treatment strategy for Italian and Spanish health services compared to the biosimilar and it would be worthwhile extending this evaluation to other countries.

Keywords: FSH; biosimilar; follitropin alfa; infertility

Conflict of interest statement

CR and FH are employees of IMS Health Information Solutions Italy Srl, and SG and KB have received honoraria from Merck Serono Spa. The other authors report no conflicts of interest in this work.

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