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Updated clinical and economic analysis of using follitropin alfa in combination with assisted reproductive technologies in 2022

https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.180

Abstract

Objective: to perform a clinical and economic analysis of using drugs containing follitropin alfa as an active substance and to assess the impact of the studied drugs on the budget of the state healthcare system of the Russian Federation considering cost data for 2022 in the population of women with infertility and poor ovarian response who are undergoing treatment with the use of assisted reproductive technologies (ART).
Material and methods. Clinical and economic evaluation of follitropin alfa use in patients with infertility and poor ovarian response was performed by a cost minimization method, using data from the Uniform Information System for Procurement for the period from July to December 2022 inclusive. The budget impact analysis model compared the costs required for ovarian stimulation of patients with poor ovarian response receiving only a fixed dose combination (FDC) of follitropin alfa + lutropin alfa with the expected practice of switching 25% of these patients to follitropin alfa with a modeling time horizon of 1 year.
Results. A cost analysis of an ovarian stimulation course using biosimilar follitropin alfa showed cost savings of 17% compared with the cost of therapy using the original follitropin alfa. Also, cost minimization analysis per cycle of ovarian stimulation demonstrated that the use of the biosimilar follitropin alfa was characterized by cost savings of 24,420 rubles (32.37%) compared to FCD of follitropin alfa + lutropin alfa. Compared to the 2021 data, in the current study based on 2022 data and including only biosimilar follitropin alfa, there was a 103% increase in savings. Budget impact analysis determined that switching 25% of the population from FCD of follitropin alfa + lutropin alfa to follitropin alfa would reduce direct medical costs by 17.3 million rubles (8.1%) per year. Savings in direct medical costs in the current study compared to 2021 increased by 117%.
Conclusion. The clinical and economic analysis, as well as the budget impact analysis of using biosimilar follitropin alfa for ovarian stimulation in a population of women with infertility and poor ovarian response, confirm the economic expediency revealed in 2021. Moreover, according to 2022 data, the use of biosimilar follitropin alfa results in additional budgetary savings.

About the Authors

D. G. Shchurov
Center for Healthcare Quality Assessment and Control
Russian Federation

Dmitry G. Shchurov – MD, PhD, Deputy Head of Development and External Communications Departmen

Scopus Author ID: 57222291235

10/5 Khokhlovskiy Passage, Moscow 109028



D. V. Blinov
Sechenov University; Institute for Preventive and Social Medicine
Russian Federation

Dmitry V. Blinov – MD, PhD, MBA, Assistant Professor, Chair of Sports Medicine and Medical Rehabilitation, Sklifosovsky Institute of Clinical Medicine; Head of Medical and Scientific Affairs

WoS Researcher ID: E-8906-2017; Scopus Author ID: 6701744871

8/2 Trubetskaya Str., Moscow 119991

4/10 Sadovaya-Triumfalnaya Str., Moscow 127006



N. V. Bashmakova
Ural Scientific Research Institute of Maternity and Infancy Protection
Russian Federation

Nadezhda V. Bashmakova – Dr. Med. Sc., Professor, Chief Researcher

 Scopus Author ID: 57191610753

1 Repin Str., Ekaterinburg 620014



M. A. Polzikov
IVFarma LLC
Russian Federation

Mikhail A. Polzikov – PhD (Chem.), Director  General

Scopus Author ID: 10139451800; WoS Researcher ID: GRY-3996-2022

20 bldg 2 Nauchnyy Drive, Moscow 117246



A. S. Semikhin
National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya
Russian Federation

Alexander S. Semikhin – PhD (Biol.), Leading Researcher

WoS ResearcherID: R-6760-2019; Scopus Author ID; 34972055600

18 Gamaleya Str., Moscow 123098



References

1. Malyshkina A.I., Dolgushina N.V., Pesikin O.N., Kuligina M.V. Methodological approaches to evaluating the efficiency of using assisted reproductive technologies at the regional level. Akusherstvo i ginekologiya / Obstetrics and Gynecology. 2022; 11: 148–54 (in Russ.).https://doi.org/10.18565/aig.2022.11.148-154.

2. Novoselova E.N. Social aspects of reproductive health among the female population in Russia. Moscow State University Bulletin. Series 18. Sociology and Political Science. 2018; 24 (2): 121–38 (in Russ.). https://doi.org/10.24290/1029-3736-2018-24-2-121-138.

3. Philippov O.S., Radionchenko A.A., Bolotova V.P., et al. Estimation of the prevalence and causes of infertility in western Siberia. Bull World Health Organ. 1998; 76 (2): 183–7.

4. Clinical guidelines. Female infertility (CG 641). Developers: Russian Society of Obstetricians and Gynecologists, LLC “Russian Association of Human Reproduction” (RAHR). 2023. Available at: https://cr.minzdrav.gov.ru/schema/641_1 (in Russ.) (accessed 24.01.2023).

5. Perminova S.G., Nazarenko Т.А., Korneeva I.Е., et al. Comparative study of the equivalence of the biosimilar follitropin alpha preparation (solution for subcutaneous injection) and the original follitropin alpha preparation (lyophilisate for preparation of solution for subcutaneous administration) in women with different responses to ovarian stimulation in an in vitro fertilization program: results of a phase IV clinical trial. Akusherstvo i ginekologiya / Obstetrics and Gynecology. 2022; 10: 138–49 (in Russ.). https://doi.org/10.18565/aig.2022.10.138-149.

6. Mochtar M.H., Danhof N.A., Ayeleke R.O., et al. Recombinant luteinizing hormone (rLH) and recombinant follicle stimulating hormone (rFSH) for ovarian stimulation in IVF/ICSI cycles. Cochrane Database Syst Rev. 2017; 5 (5): CD005070. https://doi.org/10.1002/14651858.CD005070.pub3.

7. Alviggi C., Conforti A., Esteves S.C., et al. Recombinant luteinizing hormone supplementation in assisted reproductive technology: a systematic review. Fertil Steril. 2018; 109 (4): 644–64. https://doi.org/10.1016/j.fertnstert.2018.01.003.

8. State Register of Medicines. Instructions for the medical use of the medicinal product Pergoveris® (LP-005826). Available at: https://grls.rosminzdrav.ru (in Russ.) (accessed 13.01.2023).

9. Humaidan P., Chin W., Rogoff D., et al. Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders. Hum Reprod. 2017; 32 (3): 544–55. https://doi.org/10.1093/humrep/dew360.

10. Budani M.C., Fensore S., Di Marzio M., Tiboni G.M. Efficacy and safety of follitropin alpha biosimilars compared to their reference product: a meta-analysis. Gynecol Endocrinol. 2021; 37 (5): 406–14. https://doi.org/10.1080/09513590.2020.1792437.

11. Budani M.C., Fensore S., Di Marzio M., Tiboni G.M. An updated meta-analysis comparing the efficacy and safety of biosimilar medicinal products to the original follitropin alfa. Minerva Obstet Gynecol. 2022; Dec 19. https://doi.org/10.23736/S2724-606X.22.05175-2.

12. IVFarma LLC in cooperation with Zavod Medsintez LLC extend production of biotechnological drugs for infertility treatment. Obstetrics, Gynecology and Reproduction. 2022; 16 (6): 749–55 (in Russ.). https://doi.org/10.17749/2313-7347/ob.gyn.rep.2022.375.

13. Podkorytov A.B., Zhilyaev O.V., Polzikov M.A. A pen injector for self-administration of follitropin alpha solution with a minimal dose increment of 5 IU. Obstetrics, Gynecology and Reproduction. 2017; 11 (4): 35–42 (in Russ.). https://doi.org/10.17749/2313-7347.2017.11.4.035-042.

14. Orlova N., Kovnir S., Khodak Y., et al. High-level expression of biologically active human follicle stimulating hormone in the Chinese hamster ovary cell line by a pair of tricistronic and monocistronic vectors. PLoS One. 2019; 14 (7): e0219434. https://doi.org/10.1371/journal.pone.0219434.

15. Advisory Board on potential import substitution of follitropin alfa preparations in IVF cycles. Obstetrics, Gynecology and Reproduction. 2021; 15 (4): 470–92 (in Russ.). https://doi.org/10.17749/2313-7347/ob.gyn.rep.2021.246.

16. Sinegubova M., Vorobiev I., Klishin A., et al. Purification process of a recombinant human follicle stimulating hormone biosimilar (Primapur®) to yield a pharmaceutical product with high batch-to-batch consistency. Pharmaceutics. 2022; 14 (1): 96. https://doi.org/10.3390/pharmaceutics14010096.

17. Vorob’ev I.I., Proskurina O.V., Khodak Yu.A., et al. Physicochemical properties, toxicity, and specific activity of a follitropin alpha biosimilar. Pharm Chem J. 2017; 50 (11): 753–60. https://doi.org/10.1007/s11094-017-1525-3.

18. Tyulkina E.E., Gordeev I.G., Grebenkin D.Yu., et al. Randomized crossover comparative study of safety, tolerance and pharmacokinetics of Primapur vs. Gonal-f upon single-dose subcutaneous administration in healthy volunteers. Eksperimentalnaya i klinicheskaya farmakologiya / Experimental and Clinical Pharmacology. 2017; 80 (4): 13–7 (in Russ.). https://doi.org/10.30906/0869-2092-2017-80-4-13-17.

19. Barakhoeva Z., Vovk L., Fetisova Y., et al. A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha. Eur J Obstet Gynecol Reprod Biol. 2019; 241: 6–12. https://doi.org/10.1016/j.ejogrb.2019.07.032.

20. Barakhoeva Z.B., Vovk L.A., Zorina I.V., et al. Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®). Obstetrics, Gynecology and Reproduction. 2018; 12 (3): 5–16 (in Russ.). https://doi.org/10.17749/2313-7347.2018.12.3.005-016.

21. Kamilova D.P., Ovchinnikova M.M., Ablyaeva E.S., et al. An observational study “FOLLITROPIN” comparing the efficacy of follitropin alpha biosimilar: the real-world data. Obstetrics, Gynecology and Reproduction. 2021; 15 (1): 5–21 (in Russ.). https://doi.org/10.17749/2313-7347/ob.gyn.rep.2021.212.

22. Kurtser M.A., Kasyanova G.V., Ovchinnikova M.M., Khetagurova D.T. Retrospective comparative study on artificial reproductive technology outcomes in women undergoing in vitro fertilization with recombinant gonadotropins. Obstetrics, Gynecology and Reproduction. 2022; 16 (3): 277–86 (in Russ.). https://doi.org/10.17749/2313-7347/ob.gyn.rep.2022.304.

23. Kirsanova O.V., Omelyanovsky V.V. Options to optimize the access to biosimilars: analysis and solutions. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2018; 11 (1): 50–5 (in Russ.). https://doi.org/10.17749/2070-4909.2018.11.1.050-055.

24. Perova K.A., Shchurov D.G., Blinov D.V., Bashmakova N.V., Musina N.Z. Pharmacoeconomic analysis of the application of follitropin alfa in combination with assisted reproductive technologies. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2022; 15 (1): 40–50 (in Russ.). https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.129.

25. Russian Association of Human Reproduction. ART register. Report for 2020. Available at: https://www.rahr.ru/d_registr_otchet/RegistrVRT_2020.pdf (in Russ.) (accessed 10.01.2023).

26. Interchangeable medicines (Item 4, Part 4, Article 3, Federal Law of 27.12.2019 No. 475-FZ; Item 8, Government Resolution of 05.09.20 No. 1360). Available at: https://grls.rosminzdrav.ru/Forum/Files/243339/ПереченьВЗ(24.01.2022).xlsb (in Russ.) (accessed 10.01.2023).

27. Uniform Information System for Procurement. Available at: https://zakupki.gov.ru/epz/main/public/home.html (in Russ.) (accessed 10.02.2023).

28. Bahadur G., Homburg R., Jayaprakasan K., et al. Correlation of IVF outcomes and number of oocytes retrieved: a UK retrospective longitudinal observational study of 172 341 non-donor cycles. BMJ Open. 2023; 13 (1): e064711. https://doi.org/10.1136/bmjopen-2022-064711.

29. Magnusson Å., Källen K., Thurin-Kjellberg A., Bergh C. The number of oocytes retrieved during IVF: a balance between efficacy and safety. Human Reprod. 2018; 33 (1): 58–64. https://doi.org/10.1093/humrep/dex334.

30. Shuvalova M.P., Yarotskaya E.L., Pismenskaya T.V., et al. Maternity care in Russia: issues, achievements, and potential. J Obstet Gynaecol Can. 2015; 37 (10): 865–71. https://doi.org/10.1016/s1701-2163(16)30019-6.

31. Nohr E.A., Olsen J., Bech B.H., et al. Periconceptional intake of vitamins and fetal death: a cohort study on multivitamins and folate. Int J Epidemiol. 2014; 43 (1): 174–84. https://doi.org/10.1093/ije/dyt214.

32. Polzikov M., Blinov D., Barakhoeva Z., et al. Association of the serum folate and total calcium and magnesium levels before ovarian stimulation with outcomes of fresh in vitro fertilization cycles in normogonadotropic women. Front Endocrinol. 2022; 13: 732731. https://doi.org/10.3389/fendo.2022.732731.


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For citations:


Shchurov D.G., Blinov D.V., Bashmakova N.V., Polzikov M.A., Semikhin A.S. Updated clinical and economic analysis of using follitropin alfa in combination with assisted reproductive technologies in 2022. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2023;16(1):49-59. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.180

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