ANALYSIS OF THE PHARMACEUTICAL SUPPLY OF THE POPULATION WITH BIOTECHNOLOGICAL PRODUCTS – INSULIN PREPARATIONS AND ITS ANALOGUES
DOI:
https://doi.org/10.11603/2312-0967.2025.4.15766Keywords:
diabetes mellitus, insulin preparations, genetic engineering, ATC/DDD methodology, reimbursement, pharmaceutical supplyAbstract
Aim of the study. To analyze the physical and economic accessibility of insulin preparations and its analogues for the population under the implementation of the governmental reimbursement programme «Affordable Medicines».
Materials and Methods. The study utilized data from the State Register of Medicinal Products of Ukraine, the Registers of Reimbursed Medicines (2022-2025), the ATC classification system, dashboards of the National Health Service of Ukraine; as well as analytical, synthetic, generalisation, content-analysis, marketing, pharmacoeconomic, mathematical-statistical and graphical research methods.
Results and Discussion. The study demonstrated a broad nomenclature of insulin preparations and their analogues presented in the State Register of Ukraine (71 trade names) and included in reimbursement programmes (61 trade names), with a predominance of the Insulin human molecule (62%). A substantial share of the market (82%) is controlled by foreign manufacturers, led by Novo Nordisk (46%) and Sanofi Aventis (13%). Domestic companies JSC «Farmak» and PJSC «Indar» supply in total 12% of the registered trade names and 27% of the positions included in the «Affordable Medicines» programme. Analysis of dosage forms indicated the predominance of modern injectable systems such as cartridges (48%) and prefilled pens (29%), while the share of vials (23%) continues to decline. According to the assessment of the dispersion medium, injectable solutions (48%) and suspensions (39%) constitute the major forms available.
Audit of reimbursement registers for 2022-2025 revealed a sustained contraction in the insulin assortment. Relative to 2022, the size of the register decreased by 5.6% in 2024 and by 15.3% in 2025. Compared with the State Register, the number of reimbursed insulin products is generally 53% lower, and the INN Insulin lispro is entirely absent.
Pharmacoeconomic analysis using the ATC/DDD methodology demonstrated substantial variability in the cost of 1 DDD from 15.12 to 180.19 UAH. The most affordable options were intermediate-acting insulins (15.12-18.87 UAH/DDD): Humodar® B100R, Protaphane® HM, Pharmasulin® H, and Gensulin N. In contrast, long-acting analogues and innovative combination products exhibited the highest DDD cost (108.00-180.19 UAH/DDD): Soliqua® and Xultophy®.
Conclusions. The conducted studies confirmed an overall sufficient level of physical accessibility of insulin products; however, enhancing economic accessibility, particularly to innovative insulin analogues, requires additional socially effective mechanisms within national pharmaceutical policy.
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