Modern Pediatrics. Ukraine. (2025).2(146): 57-67. doi: 10.15574/SP.2025.2(146).5767
Wolf O. O.^1,2, Auhunas S. V.¹, Kyryk O. V.¹, Korniychuk I. Yu.^3
1Shupyk National Healthcare University of Ukraine, Kyiv
²Сharity organization “Association of Palliative and Hospice Medicine”, Kyiv, Ukraine
³Danylo Halytsky Lviv National Medical University, Ukraine

For citation: Wolf OO, Auhunas SV, Kyryk OV, Korniychuk IYu. (2025). Analysis of the effectiveness of botulinum toxin type A procurement and access to tiered injections for children with spastic cerebral palsy in Ukraine. Modern Pediatrics. Ukraine. 2(146): 57-67. doi: 10.15574/SP.2025.2(146).5767.
Article received: Nov 24, 2024. Accepted for publication: Mar 18, 2025.

The relevance of the study is determined by global changes in medicine, where an important request is to find effective methods of treatment of pediatric diseases, in particular cerebral palsy (CP), which is the main cause of pediatric disability. According to the World Health Organization, CP is common in 2-5 cases per 1,000 children, and 75% of them have a spastic form, which requires a special approach to treatment. Injections of botulinum toxin type A are one of the most effective methods of reducing spasticity. However, there are problems with access to these drugs in Ukraine, which emphasizes the need to analyze their supply and use in regions.
The aim of the study was to analyze the provision, availability, and use of medicines for the treatment of a spastic form of CP in Kyiv, Zhytomyr, Kharkiv, Dnipro, Zaporizhzhia regions and the city of Kyiv.
Materials and methods. The study covered the monitoring of botulinum toxin type A supply for the period 2019-2023. It consisted of two parts: data were obtained from open databases and official websites, including the Ministry of Health of Ukraine and medical institutions. To assess the drugs prescribed to patients and the level of satisfaction with the supply, surveys and interviews were conducted with patients and healthcare professionals. The survey covered 530 patients with a response rate of over 90%.
Results. The study showed that 40% of respondents complained about the lack of free medicines, and 20% noted their absence in medical facilities. A decrease in delays in supply and problems with treatment interruption were noted by 5% of respondents. Successful public procurement related to the increase in the volume of medicines procured has reduced costs during tenders.
Conclusions. The main factors limiting the provision of medicines for the treatment of children with CP are insufficient funding and an inefficient procurement system in Ukraine.
The authors declare no conflict of interest.
Keywords: health care facility, cerebral palsy, spastic form, botulinum toxin type A, botulinum therapy, supply monitoring.
REFERENCES

1. Angulo-Parker FJ, Adkinson JM. (2018). Common etiologies of upper extremity spasticity. Hand Clinics. 34(4): 437-442. https://doi.org/10.1016/j.hcl.2018.06.001; PMid:30286958

2. Bhimani R, Anderson L. (2014). Clinical understanding of spasticity: Implications for practice. Rehabilitation Research and Practice. 2014: 279175. https://doi.org/10.1155/2014/279175; PMid:25276432 PMCid:PMC4168242

3. Dorf SR, Fonseca AR, Sztajnbok FR, Oliveira TRD, Basttistella LR. (2024). The state of the art in therapeutic administration of botulinum toxin in children with cerebral palsy: An integrative review. Revista Paulista de Pediatria. 42: e2023093. https://doi.org/10.1590/1984-0462/2024/42/2023093; PMid:38537033 PMCid:PMC10962635

4. Expert Group on Botulinum Toxin Treatment, Chinese Society of Parkinson's Disease, Movement Disorders. (2018). Chinese expert consensus document on the therapeutic uses of botulinum toxin 2018. Chinese Journal of Neurology. 51(10): 779-786. https://doi.org/10.3760/cma.j.issn.1006-7876.2018.10.002.

5. Glinac A, Tahirović H, Delalić A. (2013). Family socioeconomic status and health-related quality of life in children with cerebral palsy: Assessing differences between clinical and healthy samples. The Central European Journal of Paediatrics. 9: 183-191. https://doi.org/10.5457/p2005-114.74

6. Hull M, Anupindi VR, DeKoven M, He J, Bouchard J. (2023). Botulinum toxin utilization, treatment patterns, and healthcare costs among patients with spasticity or cervical dystonia in the US. Advances in Therapy. 40(9): 3986-4003. https://doi.org/10.1007/s12325-023-02563-5; PMid:37414904 PMCid:PMC10427537

7. Jacinto J, Varriale P, Pain E, Lysandropoulos A, Esquenazi A. (2020). Patient perspectives on the therapeutic profile of botulinum neurotoxin type A in spasticity. Frontiers in Neurology. 11: 388. https://doi.org/10.3389/fneur.2020.00388; PMid:32477251 PMCid:PMC7233119

8. Kumar D, Kumar R, Mudgal SK, Ranjan P, Kumar S. (2023). The effects of botulinum toxin and casting in spastic children with cerebral palsy: A systematic review and meta-analysis. Cureus. 15(3): e36851. https://doi.org/10.7759/cureus.36851

9. Ministerstvo okhorony zdorov'ia Ukrainy. (2016). Pro zdiisnennia zakhodiv z kontroliu za vykorystanniam likars'kykh zasobiv ta medychnykh vyrobiv, zakuplenykh za biudzhetni koshty. Nakaz vid 02.06.2016 No. 509. URL: http://www.moz.gov.ua.

10. Ministerstvo okhorony zdorov'ia Ukrainy. (2019). Pro rozpodil likars'koho zasobu «BOTOKS®» dlia likuvannia ditei, khvorykh na dytiachyi tserebral'nyi paralich, zakuplenoho za koshty Derzhavnoho biudzhetu Ukrainy na 2018 rik za biudzhetnuiu prohramu KPKVK 2301400 «Zabezpechennia medychnykh zakhodiv okremykh derzhavnykh prohram ta kompleksnykh zakhodiv prohramnoho kharakteru». Nakaz vid 08.01.2019 No.26. URL: https://moz.gov.ua/uploads/1/9685-dn_20190108_26_dod.pdf.

11. Ministerstvo okhorony zdorov'ia Ukrainy. (2019). Pro rozpodil likars'koho zasobu «BOTOKS®» dlia likuvannia ditei, khvorykh na dytiachyi tserebral'nyi paralich, zakuplenoho za koshty Derzhavnoho biudzhetu Ukrainy na 2018 rik. Nakaz vid 09.07.2019 No. 1580. URL: http://www.moz.gov.ua.

12. Ministerstvo okhorony zdorov'ia Ukrainy. (2018). Pro rozpodil likars'koho zasobu «DYSPORT®» dlia likuvannia ditei, khvorykh na dytiachyi tserebral'nyi paralich, zakuplenoho za koshty Derzhavnoho biudzhetu Ukrainy na 2018 rik. Nakaz vid 09.11.2018 No. 2054. URL: http://www.moz.gov.ua.

13. Ministerstvo okhorony zdorov'ia Ukrainy. (2019). Pro vnesennya zmin do rozpodilu likarsʹkoho zakhvoryuvannya "DYSPORT" dlya likuvannya ditey, khvorykh na dytyachu tserebralʹnu paralich, zakuplenoho za koshty Derzhavnoho byudzhetu Ukrayiny na 2016 rik, zatverdzhenoho nakazom Ministerstva okhorony zdorov'ya Ukrayiny vid 23 lyutoho 2018 roku No. 334: Nakaz vid 23.07. 2018 No. 1371. URL: http://www.moz.gov.ua.

14. National Collaborating Centre for Women's and Children's Health (UK). (2012). Spasticity in children and young people with non-progressive brain disorders: Management of spasticity and co-existing motor disorders and their early musculoskeletal complications. London: RCOG Press.

15. Natsionalna sluzhba zdorovia Ukrainy. (2021). Dopomoha novonarodzhenym ta reabilitatsiyi ditey z tserebralnym paralichem u 2022 rotsi URL: https://nszu.gov.ua/likar-2020.

16. Olver J, Esquenazi A, Fung VS, Singer BJ, Ward AB. (2010). Botulinum toxin assessment, intervention and aftercare for lower limb disorders of movement and muscle tone in adults: International consensus statement. European Journal of Neurology. 17; Suppl 2: 57-73. https://doi.org/10.1111/j.1468-1331.2010.03128.x; PMid:20633179

17. Suputtitada A. (2000). Managing spasticity in pediatric cerebral palsy using a very low dose of botulinum toxin type A: Preliminary report. American Journal of Physical Medicine & Rehabilitation. 79(4): 320-326. https://doi.org/10.1097/00002060-200007000-00002; PMid:10892617

18. World Health Organization. (2020). Children: Improving survival and well-being. URL: https://www.who.int/news-room/fact-sheets/detail/children-reducing-mortality.

19. World Health Organization. (2023). Disability. URL: https://www.who.int/news-room/fact-sheets/detail/disability-and-health.

20. Hull M, Danchenko N, Anupindi VR, DeKoven M, He J, Bouchard J, et al. Health care resource utilization and costs among patients with spasticity or cervical dystonia. Journal of Managed Care & Specialty Pharmacy. 30(1): 40: 3986-4003. https://doi.org/10.18553/jmcp.2023.22205; PMid:38055046 PMCid:PMC10775770