MEDICAL DEVICES FOR BLOOD GLUCOSE SELF-MONITORING: COMMODITY AND ECONOMIC ASPECTS

Authors

DOI:

https://doi.org/10.11603/1811-2471.2025.v.i4.15769

Keywords:

test strips, glucose level, type 1 diabetes mellitus, commodity analysis, pharmaceutical supply, "Affordable Medicines" state program

Abstract

SUMMARY. The relevance of the study lies in the need for scientific substantiation of the effectiveness of the state reimbursement program for medical devices intended for self-monitoring of blood glucose levels under the conditions of healthcare system reform in Ukraine. The program aims to improve accessibility, quality of life, and pharmaceutical care for patients with type 1 diabetes mellitus.

The aim – to examine the commodity characteristics of test strips for self-monitoring of blood glucose levels and to analyze their economic accessibility within the framework of the “Available Medicines” state reimbursement program.

Material and Methods. The research object comprised medical devices included in the reimbursement lists of the National Health Service of Ukraine for the period from August 2023 to March 2025. A comparative commodity analysis, content analysis of regulatory legal acts of the Ministry of Health of Ukraine, and a retrospective analysis of data from NHSU analytical dashboards were conducted. Statistical and analytical methods, along with graphical data interpretation, were applied to summarize the research findings.

Results. It has been established that test strips for blood glucose determination are single-use medical devices that are sensitive to external factors, thus requiring specific storage conditions (temperature 4–30 °C, relative humidity ≤65%). The packaging serves both protective and informational functions: the primary packaging is a hermetically sealed tube containing a desiccant; the secondary packaging consists of a cardboard box with labeling and instructions; and the transport packaging is a corrugated container.

A retrospective analysis revealed an expansion in the range of medical devices subject to reimbursement – from 23 items in 2023 to 43 in 2024, along with an increase in the proportion of fully reimbursed products. According to the National Health Service of Ukraine (NHSU), there has been a growth in the number of redeemed e-prescriptions in 2025, indicating improved physical and financial accessibility of medical devices for patients with type 1 diabetes mellitus.

Conclusions. The conducted study confirmed that the expansion of the reimbursement program enhances the accessibility of test strips for blood glucose self-monitoring, contributes to improving patients’ quality of life, supports the prevention of complications, and promotes the rationalization of healthcare system expenditures. It is considered advisable to further improve the assortment policy and state reimbursement mechanisms, taking into account the needs of different age groups of patients.

References

President of Ukraine. Pro Tsili staloho rozvytku Ukrainy na period do 2030 roku: Ukaz Prezydenta Ukrainy vid 20.09.2019 No. 722/2019 [On Sustainable Development Goals of Ukraine until 2030: Presidential Decree No. 722/2019]. Ukrainian. URL: https://zakon.rada.gov.ua/laws/show/722/2019#Text

Cabinet of Ministers of Ukraine. Deiaki pytannia reimbursatsii likarskykh zasobiv ta medychnykh vyrobiv za prohramoiu derzhavnykh harantii medychnoho obsluhovuvannia [Some issues of reimbursement of medicines and medical devices under the state program of medical guarantees]. Postanova vid 28.07.2021 No. 854 Ukrainian. [cited 2025 Sep 27]. URL: https://zakon.rada.gov.ua/laws/show/854-2021-%D0%BF#Text

Abankina A. Prohrama medychnykh harantii – 2025: perelik posluh, taryfy, pakety, osoblyvosti [Medical Guarantees Program – 2025: list of services, tariffs, packages, features]. Medychna sprava. 2025. Ukrainian. [cited 2025 Oct 25]. URL: https://medplatforma.com.ua/article/15737-programa-medichnikh-garantiy-2023-perelik-poslug-osoblivosti

Pokotylo OO, Aleshchenko OYu. Analiz realizatsii derzhavnoi prohramy reimbursatsii, yak skladovoi protsesu zabezpechennia dostupnosti farmatsevtychnoi dopomohy naselenniu [Analysis of the implementation of the state reimbursement program as a component of ensuring the availability of pharmaceutical care]. Farmatsevtychnyi chasopys. 2023;(2):13–22. Ukrainian. DOI: 10.11603/2312-0967.2023.2.13870 DOI: https://doi.org/10.11603/2312-0967.2023.2.13870

Vlasenko IO, Kubarieva IV, Davtian LL, Korzh YuV. Doslidzhennia suchasnykh aspektiv vyznachennia vartosti samokontroliu tsukrovoho diabetu [Research on modern aspects of determining the cost of diabetes self-monitoring]. Social Pharmacy in Health Care. 2022;8(2):19–27. Ukrainian. DOI: 10.24959/sphhcj.22.259 DOI: https://doi.org/10.24959/sphhcj.22.259

Ministry of Health of Ukraine. Pro zatverdzhennia Perelikiv likarskykh zasobiv i medychnykh vyrobiv, yaki pidliahaiut reimbursatsii za prohramoiu derzhavnykh harantii medychnoho obsluhovuvannia naselennia, stanom na 10 serpnia 2023 roku [On approval of the Lists of medicines and medical devices subject to reimbursement under the program of state guarantees of medical care for the population, as of August 10, 2023]. Nakaz vid 21.08.2023 No. 1495. Ukrainian. [cited 2025 Sep 25]. URL: https://zakon.rada.gov.ua/rada/show/v1495282-23#Text

Reimbursatsiia test-smuzhok: alhorytm dlia farmatsevtiv [Reimbursement of test strips: algorithm for pharmacists]. Shchotyzhnevyk Apteka. 2023;(41):1412. Ukrainian. [cited 2025 Sep 25]. URL: https://www.apteka.ua/article/677772

Callea G, Armeni P, Marsilio M, Jommi C, Tarricone R. The impact of HTA and procurement practices on the selection and prices of medical devices. Soc Sci Med. 2017;174:89–95. DOI: 10.1016/j.socscimed.2016.11.038 DOI: https://doi.org/10.1016/j.socscimed.2016.11.038

World Health Organization. Noncommunicable diseases. [cited 2025 Sep 25]. URL: https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases

Yermak KE, Kostiuk IA. Analiz pereliku medychnykh vyrobiv v Uriadovii prohrami “Dostupni liky”: kvalifikatsiina robota [Analysis of the list of medical devices in the Government “Affordable Medicines” program: qualification paper]. Kyiv; 2024. 42 p. Ukrainian. [cited 2025 Sep 25]. URL: http://ir.librarynmu.com/handle/123456789/11868

Ministry of Health of Ukraine. Nakaz No. 279 vid 20.02.2024. Perelik medychnykh vyrobiv, yaki pidliahaiut reimbursatsii za prohramoiu derzhavnykh harantii medychnoho obsluhovuvannia naselennia, stanom na 12 liutoho 2024 roku [On approval of the List of medical devices subject to reimbursement under the program of state guarantees of medical care for the population, as of February 12, 2024]. Ukrainian. [cited 2025 Sep 25]. URL: https://moz.gov.ua/uploads/10/53742-dn_279_20022024_dod_2.pdf

Ministry of Health of Ukraine. Nakaz No. 1537 vid 04.09.2024. Perelik medychnykh vyrobiv, yaki pidliahaiut reimbursatsii stanom na 23 serpnia 2024 roku [On approval of the List of medical devices subject to reimbursement under the program of state guarantees of medical care for the population, as of August 23, 2024]. Ukrainian. [cited 2025 Sep 25]. URL: https://moz.gov.ua/storage/uploads/ 135668ba-63ee-493f-8477-8a59ec2cfe66/dn_1537_ 04092024_dod_2.pdf

Ministry of Health of Ukraine. Nakaz No. 440 vid 13.03.2025. Perelik medychnykh vyrobiv, yaki pidliahaiut reimbursatsii stanom na 26 liutoho 2025 roku [On approval of the List of medical devices subject to reimbursement under the program of state guarantees of medical care for the population, as of February 26, 2025]. Ukrainian. [cited 2025 Sep 25]. URL: https://moz.gov.ua/storage/uploads/ 0ff673ad-91df-44c8-a25d-6261a8d915ac/dn_440_ 13032025_dod.pdf

Tykhonova TM, Smilka YuM, Khyzhniak OO. Suchasni vymohy do indyvidualnykh zasobiv vymiriuvannia hlikemii [Modern requirements for individual glycemia measuring devices]. Problemy endokrynnoi patolohii. 2018;(2):93–98. Ukrainian. DOI: 10.21856/ j-PEP.2018.2.11

Tykhonova TM, Smilka YuM, Khyzhniak OO. Tochne vymiriuvannia hlikemii – osnovna skladova samokontroliu tsukrovoho diabetu [Accurate glucose measurement as the main component of diabetes self-monitoring]. Problemy endokrynnoi patolohii. 2018;(1):42–48. Ukrainian. DOI: 10. 21856/j-PEP.2018.1.05

Reckers-Droog V, Federici C, Brouwer W, Drummond M. Challenges with coverage with evidence development schemes for medical devices: a systematic review. Health Policy Technol. 2020;9(2):146–56. DOI: 10. 1016/j.hlpt.2020.02.006 DOI: https://doi.org/10.1016/j.hlpt.2020.02.006

Tai MHY. Drug and Medical Device Reimbursement. In: Lee PC, Wang JTH, Chen TY, Peng Ch, editors. Digital Health Care in Taiwan. Cham: Springer; 2022. p. 153–70. DOI: 10.1007/978-3-031-05160-9_8 DOI: https://doi.org/10.1007/978-3-031-05160-9_8

Kalushka OB, Hroshovyi TA, Znayevska AV, Demchuk MB. Medychne ta farmatsevtychne tovaroznavstvo [Medical and Pharmaceutical Commodity Science]. Ternopil: Ukrmedknyha; 2017. 484 p. Ukrainian.

Cabinet of Ministers of Ukraine. Pro zatverdzhennia Tekhnichnoho rehlamentu shchodo medychnykh vyrobiv [On approval of the Technical Regulation on medical devices]. Postanova vid 02.10.2013 No. 753 Ukrainian. [cited 2025 Sep 25]. URL: https://zakon.rada.gov.ua/laws/show/753-2013-%D0%BF#Text

National Health Service of Ukraine. Analitychni paneli (dashbordy): Elektronnyi retsept na medychni vyroby – detalizatsiia pohashennia [Analytical dashboards: electronic prescription for medical devices]. Ukrainian. [cited 2025 Sep 25]. URL: https://nszu.gov.ua/dashboards/elektronnii-recept-na-medicni-virobi-detalizaciia

Koval VM, Kryvoviaz OV, Kudria VV. Otsinka dynamiky stanu farmatsevtychnoi dopomohy v Ukraini ta Respublitsi Polshcha z ohliadu na ekonomichnu dostupnist naselennia do likarskykh zasobiv ta medychnykh vyrobiv, vartist yakykh pidliahaie vidshkoduvanniu [Assessment of the dynamics of pharmaceutical care in Ukraine and Poland regarding economic access to reimbursable medicines and devices]. Zdobutky klinichnoi i eksperymentalnoi medytsyny. 2024;(3):5-12. Ukrainian. DOI: 10.11603/1811-2471. 2024.v.i3.14703 DOI: https://doi.org/10.11603/1811-2471.2024.v.i3.14703

Daubner-Bendes R, Kovács S, Niewada M, et al. Quo Vadis HTA for medical devices in Central and Eastern Europe? Recommendations to address methodological challenges. Front Public Health. 2021;8:612410. DOI: 10.3389/fpubh.2020.612410 DOI: https://doi.org/10.3389/fpubh.2020.612410

Maresova P, Hajek L, Krejcar O, Storek M, Kuca K. New regulations on medical devices in Europe: are they an opportunity for growth? Adm Sci. 2020;10(1):16. DOI: 10.3390/admsci10010016 DOI: https://doi.org/10.3390/admsci10010016

Downloads

Published

2026-01-02

How to Cite

Pokotylo, O. O., Demchuk, M. B., Budniak L. І., Basaraba, R. Y., & Dub, A. I. (2026). MEDICAL DEVICES FOR BLOOD GLUCOSE SELF-MONITORING: COMMODITY AND ECONOMIC ASPECTS. Achievements of Clinical and Experimental Medicine, (4), 19–29. https://doi.org/10.11603/1811-2471.2025.v.i4.15769

Issue

Section

Original research articles