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

Gizzo, Salvatore; García-Velasco, Juan A.; Heiman, Franca; Ripellino, Claudio; Bühler, K.

doi:10.2147/ijwh.s118687

Cited by 17 publications

(12 citation statements)

References 6 publications

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“…However, assuming similar effectiveness between corifollitropin alfa and rFSH is supported by other studies ( Devroey et al, 2009 , Obruca et al, 2010 ) and recent meta-analyses ( Fensore et al, 2015 , Griesinger et al, 2016 , Pouwer et al, 2016 ). As regards comparing similar effectiveness between different rFSH, Gizzo et al (2016) considered follitropin alfa biosimilar_B to be less effective than follitropin alfa, which is in contrast to the findings of this study.…”

Section: Discussioncontrasting

confidence: 99%

Comparative economic study of the use of corifollitropin alfa and daily rFSH for controlled ovarian stimulation in older patients: Cost-minimization analysis based on the PURSUE study

Barrenetxea¹,

García-Velasco²,

Aragón³

et al. 2018

Reproductive Biomedicine & Society Online

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This study presents an economic assessment of controlled ovarian stimulation in assisted reproductive technology procedures in Spain, comparing the use of corifollitropin alfa and various forms of recombinant follicle-stimulating hormone (rFSH) in women of advanced maternal age. A cost-minimization analysis (CMA) was performed to assess the cost per cycle of controlled controlled ovarian stimulation, including only direct costs associated with the stimulation phase. The CMA was based on the population characteristics, the protocol, and the results obtained from the PURSUE study, taking into account 9 days of controlled controlled ovarian stimulation and 300 IU rFSH/day. The primary analysis included pharmacological costs alone. Different scenarios were evaluated including various doses and possible additional days (0–5) for rFSH. For the alternative analyses, the total costs (direct pharmacological costs, costs of visits and follow-up tests, and any additional pharmacological costs) were considered in both the private and public sectors. Treatment with corifollitropin alfa resulted in a lower pharmacological cost compared with rFSH (€757.25 and €950.30, respectively), creating a saving of approximately -20%. The results of the scenario analyses showed that corifollitropin alfa reduced the pharmacological cost of controlled ovarian stimulation in comparison with daily administration of doses ≥ 250 IU rFSH (considering same daily dose for all days), regardless of the additional days required (7–12 days) (average -€223; range -€488 to -€44). In conclusion, in addition to the efficacy shown in the PURSUE study, the use of corifollitropin alfa results in a decrease in the direct costs associated with controlled ovarian stimulation in older women in Spain.

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Section: Discussioncontrasting

confidence: 99%

Comparative economic study of the use of corifollitropin alfa and daily rFSH for controlled ovarian stimulation in older patients: Cost-minimization analysis based on the PURSUE study

Barrenetxea¹,

García-Velasco²,

Aragón³

et al. 2018

Reproductive Biomedicine & Society Online

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“…Gizzo et al (2016) estimated the cost-effectiveness of the Originator compared to Biosimilar 1 over two treatment cycles in Italy and Spain. The cost per live birth was also estimated to be lower for Originator in Italy and Spain, €7,044 and €12,283 respectively, compared to €7,411 and €13,494 for Biosimilar 1 23. Like the analysis presented in the current study, the analyses by Silverio et al (2015) and Gizzo et al (2016) were based on clinical evidence reported by Rettenbacher et al14.…”

Section: Discussionmentioning

confidence: 50%

<p>A cost-effectiveness evaluation of the originator follitropin alpha compared to the biosimilars for assisted reproduction in Germany</p>

Xue¹,

Lloyd²,

Falla³

et al. 2019

IJWH

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Background and objectives: Demand for assisted reproduction technology (ART) in Germany is high, with 100,844 treatment cycles during 2016. Many ART procedures involve ovarian stimulation with follicle stimulating hormone (FSH). Recently, biosimilar FSH products have become available. The objective of this study was to evaluate the cost-effectiveness of the recombinant FSH Gonal-f ® (Originator) in comparison to biosimilar follitropin alfa, Bemfola ® (Biosimilar 1) and Ovaleap ® (Biosimilar 2), from a German payer perspective in terms of cost per live birth. Methods: A decision tree model was developed, based on one cycle of assisted reproduction, to compare the original product to biosimilars. Clinical inputs, including live birth rates and adverse event rates were obtained from published randomized trials. Cost inputs were obtained from publicly available German sources. Clinical inputs, model structure and methodology were based on previous publications and validated by a clinical expert. Results: Results indicated that the live birth rate is higher for the Originator compared to Biosimilar 1 (40.7% vs 32.1% respectively), and Biosimilar 2 (32.2% vs 26.8%). The average cost per live birth for women treated with the Originator was estimated to be lower than those who were treated with biosimilars: Originator vs Biosimilar 1 (€10,510 vs €12,192), Originator vs Biosimilar 2 (€12,590 vs €13,606). The analysis also found that the Originator is associated with an incremental cost-effectiveness of €4,168 and €7,540 per additional live birth versus Biosimilar 1 and Biosimilar 2 respectively. Sensitivity analysis indicated probabilities of pregnancy, embryo transfer and live birth, were key drivers of model costs. Scenario analysis confirmed the robustness of the model outcomes. Conclusion: This study suggests that treatment with the Originator could result in a lower cost per live birth in comparison to biosimilars. Further analysis using real-world data, when available, is recommended to validate the results of the present study.

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“…A cost-effectiveness evaluation comparing the originator follitropin α Gonal-F ® to the biosimilar Bemfola ® , based on data derived from the registration study by Rettenbacher [ 65 ], established that the originator r-hFSH is more cost-efficient than the biosimilar relative to the conditions of medical reimbursement existing in Italian and Spanish health systems. All clinical data and the costs of the procedure, including the overall r-hFSH dose and the costs related to drugs, hospitalizations and examinations were taken into account and related to the number of live births; compared to the originator, the biosimilar generated an higher cost of € 3600 for Italy and € 900 for Spain [ 70 ].…”

Section: Cost-effectiveness Evaluation Of Follitropin α mentioning

confidence: 99%

Human Recombinant FSH and Its Biosimilars: Clinical Efficacy, Safety, and Cost-Effectiveness in Controlled Ovarian Stimulation for In Vitro Fertilization

et al. 2020

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Exogenous human follicle-stimulating hormone (hFSH), either derived from extraction and purification from the urine or obtained by recombinant technology in the form of follitropin α, β and δ (rFSH), has been used for decades in the treatment of infertility. The main applications of FSH treatment in the woman have been, and still are, ovulation induction in oligo-anovulatory subjects, and stimulation of the development of a cohort of follicles in patients undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF). In the last years, two biosimilars of follitropin alfa, rFSH compounds structurally and functionally similar to the originator, have been approved and marketed for clinical use in Europe. Moreover, some other rFSH biosimilars are currently under investigation. The objective of this article is to review the available evidences comparing the efficacy, safety, and cost-effectiveness of rFSH follitropin alpha originator with its biosimilars, discussing the clinical trials that allowed biosimilars to get registration and marketing authorization.

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

Cited by 17 publications

References 6 publications

Comparative economic study of the use of corifollitropin alfa and daily rFSH for controlled ovarian stimulation in older patients: Cost-minimization analysis based on the PURSUE study

Comparative economic study of the use of corifollitropin alfa and daily rFSH for controlled ovarian stimulation in older patients: Cost-minimization analysis based on the PURSUE study

<p>A cost-effectiveness evaluation of the originator follitropin alpha compared to the biosimilars for assisted reproduction in Germany</p>

Human Recombinant FSH and Its Biosimilars: Clinical Efficacy, Safety, and Cost-Effectiveness in Controlled Ovarian Stimulation for In Vitro Fertilization

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