Gizzo Salvatore, Garcia-Velasco Juan A, Heiman Franca, Ripellino Claudio, Bühler Klaus
Department of Woman and Child Health, University of Padua, Padua, Italy.
Department of Obstetrics and Gynecology, Rey Juan Carlos University Madrid, Madrid, Spain.
Int J Womens Health. 2016 Dec 7;8:683-689. doi: 10.2147/IJWH.S118687. eCollection 2016.
To perform a cost-effectiveness evaluation comparing the originator follitropin alfa (Gonal-f) to the biosimilar (Bemfola) in the Italian and Spanish contexts, with an assessment of the German and UK backgrounds.
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.
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.
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.
在意大利和西班牙背景下，对原研促卵泡素α（果纳芬）与生物类似药（倍美安）进行成本效益评估，并评估德国和英国的情况。
以雷滕巴赫等人的研究为基础，在意大利和西班牙背景下建立了成本效益模型。使用关于受试者、促性腺激素剂量、妊娠、活产儿和卵巢过度刺激综合征的临床数据来输入模型。与药物、住院、专科门诊和检查相关的成本从意大利和西班牙的收费标准中获取。还考虑了德国和英国的促性腺激素采购成本，以便将经济评估扩展到其他国家。评估是从国民医疗服务体系的角度进行的。单变量和概率敏感性分析以及情景分析测试了模型的稳健性。
在意大利和西班牙，原研促卵泡激素（FSH）的成本分别为3663欧元和6387欧元，而生物类似药FSH的成本分别为3483欧元和6342欧元。发现原研药的疗效为0.52，生物类似药为0.47。在意大利和西班牙，原研FSH每例活产的平均成本估计分别为7044欧元和12283欧元，生物类似药分别为7411欧元和13494欧元。此外，与生物类似药相比，原研FSH在意大利产生的增量成本效益比为3600欧元，在西班牙为900欧元。敏感性分析证实了基础案例模型的结果。
该分析表明，与生物类似药相比，原研FSH对意大利和西班牙的医疗服务而言是一种具有成本效益的治疗策略，将该评估扩展到其他国家是值得的。
