Analysis of the availability of therapy for multiple sclerosis with immunomodulators and immunosuppressants in Ukraine

Authors

DOI:

https://doi.org/10.24959/uekj.19.35

Keywords:

multiple sclerosis, glatiramer acetate, fingolimod, alemtuzumab, осrеlіzumаb

Abstract

Multiple sclerosis is predominantly affected by young people, usually beginning at the age of 20 to 40 years and is the most common cause of non-traumatic disability in the adult population.
The aim of the work is the analysis and systematization of literature data on the the availability of therapy for multiple sclerosis with immunomodulators and immunosuppressants in Ukraine.
Results. Presented on the world and domestic pharmaceutical market multiple sclerosis disease modifying drugs, the first and second generation are not able to completely cure the patient, but their use can significantly slow the progression of multiple sclerosis. Analysis of the cost of purchasing first-line drugs for the treatment of patients with multiple sclerosis, which are purchased from the State Budget in Ukraine according to 2018 data, revealed a lack of funding. Studies have shown that the cost of an annual course of treatment with first-line drugs, which are widely used by most patients with multiple sclerosis, is 70-510 thousand UAH. Second-line drugs have an extremely high cost – over 1 million UAN for a year.
Conclusions. Thus, to increase the availability of multiple sclerosis disease modifying drugs with immunosuppressive or immunomodulatory properties, it is necessary to increase funding for public programs aimed at the treatment of this disease. This will further reduce the costs associated with the disability of such patients. It is also advisable to use the international flexible mechanisms of the agreement on trade-related aspects of intellectual property rights.

Author Biographies

O. V. Litvinova, National University of Pharmacy

доктор фармацевтичних наук, доцент кафедри управління та економіки підприємства

O. V. Posilkina, National University of Pharmacy

доктор  фармацевтичних наук, професор, завідувачка кафедри управління та економіки підприємства

References

Montalban, X., Gold, R., Thompson, A. J., Otero-Romero, S., Amato, M. P., Chandraratna, D., … Zipp, F. (2018). ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis.Multiple Sclerosis Journal, 24(2), 96–120. https://doi.org/10.1177/1352458517751049

Scalfari, A., Neuhaus, A., Daumer, M., Muraro, P. A., & Ebers, G. C. (2013). Onset of secondary progressive phase and long-term evolution of multiple sclerosis. Journal of Neurology, Neurosurgery & Psychiatry, 85(1), 67–75. https://doi.org/10.1136/jnnp-2012-304333

Antoniuk, T. (2018). NeiroNews: psykhonevrolohiia ta neiropsykhiatriia, 3(96), 6–9.

Voloshina, N. P., Egorkina, O. V. (2012). Ukrainskyi medychnyi chasopys, 4, 32–37.

Alifirova, V. M., Bisaga, G. N., Boyko, A. N., Bryukhov, V. V., Davydovskay, M. V., Zakharova, M. N., … Schmidt, T. E. (2017). Clinical recommendations on the use of alemtuzumab (lemtrada). Zhurnal Nevrologii i Psikhiatrii Im. S.S. Korsakova, 117(2. Vyp. 2), 115. https://doi.org/10.17116/jnevro201711722115-126

Popova, E. V. (2017). Monoclonal antibody for multiple sclerosis treatment. Medical Council, 10, 65–68.

Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy Press release, 26.07.2019. (2019). Available at: https://www.ema.europa.eu/en/news/updated-restrictions-gilenya-multiple-sclerosis-medicine-not-be-used-pregnancy

Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing, 11.04.2019 (2019). Available at: https://www.ema.europa.eu/en/medicines/human/referrals/lemtrada

EMA review of Zinbryta confirms medicine’s risks outweigh its benefits, 02.03.2018. (2018). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/zinbryta

Tramacere, I., Del Giovane, C., Salanti, G., D’Amico, R., & Filippini, G. (2015). Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis. Cochrane Database of Systematic Reviews, 9. https://doi.org/10.1002/14651858.CD011381.pub2

Riera, R., Porfírio, G. J., & Torloni, M. R. (2016). Alemtuzumab for multiple sclerosis. Cochrane Database of Systematic Reviews, 4. https://doi.org/10.1002/14651858.CD011203.pub2

La Mantia, L., Di Pietrantonj, C., Rovaris, M., Rigon, G., Frau, S., Berardo, F., … Vaona, A. (2016). Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis. Cochrane Database of Systematic Reviews. https://doi.org/10.1002/14651858.CD009333.pub3

Hartung, D. M. (2017). Economics and Cost-Effectiveness of Multiple Sclerosis Therapies in the USA. Neurotherapeutics, 14(4), 1018–1026. https://doi.org/10.1007/s13311-017-0566-3

Nakaz MOZ Ukrainy vid 11.04.2019 № 820. (2019). «Pro vnesennia zmin do nakazu Ministerstva okhorony zdorovia Ukrainy vid 28 sichnia 2019 roku № 204. Available at: https://moz.gov.ua/article/ministrymandates/nakaz-moz-ukraini-vid-11042019--820-pro-vnesennja-zmin-do-nakazu-ministerstva-ohoroni-zdorovja-ukraini-vid-28-sichnja-2019-roku--204

British National Formulary 74: September 2017-March 2018. (2018). London: Pharmaceutical Press, 799–807.

Bell, C., Anderson, J., Ganguly, T., Prescott, J., Capila, I., Lansing, J. C., … Glajch, J. (2017). Development of Glatopa® (Glatiramer Acetate): The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis. Journal of Pharmacy Practice, 31(5), 481–488. https://doi.org/10.1177/0897190017725984

Published

2019-11-27

Issue

Section

Marketing, logistics, pharmacoeconomic research