Research in Health and Medical Sciences
Thu, Jun 25, 2026
[Archive]
Volume 4, Issue 2 (4-2025)
JRHMS 2025, 4(2): 1-10 |
Back to browse issues page
Download citation:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:
Arghavani Nia M, Yousefi A M. Comparative analysis of regulatory, insurance and subsidy policies for continuous glucose monitoring devices with a health technology assessment approach: Comparison of selected countries and Iran. JRHMS 2025; 4 (2) :1-10
URL: http://jrhms.thums.ac.ir/article-1-144-en.html
URL: http://jrhms.thums.ac.ir/article-1-144-en.html
1- Department of Health Management and Economics, School of Public Health, Health Information Management Research Center, Tehran University of Medical Sciences, Tehran, Iran
2- Department of Operating Room, Operating Room Department, Faculty of Paramedical Sciences, Semnan University of Medical Sciences, Semnan, Iran
2- Department of Operating Room, Operating Room Department, Faculty of Paramedical Sciences, Semnan University of Medical Sciences, Semnan, Iran
Abstract: (39 Views)
Continuous Glucose Monitoring (CGM) is an emerging and transformative technology in diabetes management that has gained a special place in global health systems in recent years. By providing the possibility of continuous measurement of interstitial glucose, this technology allows patients to observe their blood sugar fluctuations in real time and have better control over their disease. Despite proven clinical effectiveness and improving patients’ quality of life, regulatory pathways, health technology assessment (HTA), and related insurance policies differ significantly across countries. The aim of this study is to conduct a comparative analysis of the regulatory and insurance pathways related to CGM technology in five selected countries—the United Kingdom, Germany, France, Canada, and Australia—and compare it with the current situation in Iran. The role of health technology assessment (HTA) in insurance decision-making and subsidy policies of these countries is also examined. This study is an analytical and policy-oriented review. Data were collected and analyzed from official documents, HTA reports, and regulatory guidelines published up to 2025. The focus of the analysis was on the relationship between HTA systems, the technical licensing process, and insurance coverage of CGM technology. The results showed that countries that benefit from a coherent HTA system have a more transparent and coherent decision-making process between technical licensing, cost-effectiveness assessment, and insurance coverage. In contrast, in Iran, despite the issuance of technical licensing by the Food and Drug Administration, there is no effective organizational connection between HTA, insurance institutions, and subsidy policies. As a result, some technologies have not yet achieved insurance coverage despite the high need of patients. The experience of selected countries shows that integrating HTA results into insurance and subsidy policies can lead to fairer decision-making and more sustainable access of Iranian patients to new technologies such as CGM.
Establishing an institutional mechanism to link HTA with insurance and regulatory processes is an essential step towards improving the health decision-making system in Iran.
Establishing an institutional mechanism to link HTA with insurance and regulatory processes is an essential step towards improving the health decision-making system in Iran.
Keywords: Health Technology Assessment, Glucose Monitoring, Reimbursement Policy, Regulatory Pathway, Diabetes
Type of Study: Systematic Review Article |
Subject:
General
Received: 2026/05/5 | Accepted: 2026/05/11 | Published: 2026/06/21
Received: 2026/05/5 | Accepted: 2026/05/11 | Published: 2026/06/21
References
1. NICE. Medical technologies guidance: Continuous glucose monitoring. London: NICE; 2022.
2. World Health Organization. Global report on diabetes. Geneva: WHO; 2021.
3. Battelino T, et al. Continuous glucose monitoring and clinical outcomes. Diabetes Care. 2019;42(8):1593-1600. [DOI:10.2337/dci19-0028]
4. NICE. Methods guide for health technology evaluation. 2022.
5. Ministry of Health, Iran. National HTA framework. Tehran: MoHME; 2020.
6. CADTH. Environmental scan: Funding of CGM systems in Canada. Ottawa: CADTH; 2023.
7. MHRA. Medical Device Regulations (UK). 2021.
8. Claxton K, et al. Thresholds for cost-effectiveness in the NHS. Health Econ. 2015;24(10):1242-1250.
9. NICE TA944. Continuous glucose monitoring for people with diabetes. 2022.
10. IQWiG. Assessment of continuous glucose monitoring systems. Cologne: IQWiG; 2016.
11. G-BA. CGM coverage decision. Berlin; 2017.
12. Akturk HK, Dowd R, Shankar K, Derdzinski M. Real-World Evidence and Glycemic Improvement Using Dexcom G6 Features. Diabetes Technol Ther. 2021;23(1):1-9. doi:10.1089/dia.2020.0654. [DOI:10.1089/dia.2020.0654]
13. HAS. Evaluation of medical devices: Methodological guide. Paris: HAS; 2021.
14. LPPR reimbursement list. French Ministry of Health; 2023.
15. CADTH. Health Technology Assessment for CGM devices. 2023.
16. Diabetes Canada. CGM coverage across provinces. Toronto; 2023.
17. PBAC. Public summary documents for CGM. Canberra; 2022.
18. NDSS. CGM subsidy program. Australian Government; 2023.
19. IFDA. List of approved medical devices. Tehran; 2024.
20. Iranian Diabetes Society. Status of CGM accessibility in Iran. Tehran; 2024.
21. Oortwijn W, et al. How HTA can support equitable access. Int J Technol Assess Health Care. 2020;36(5):425-433.
22. NHS England. Continuous glucose monitoring implementation guidance. 2022.
23. G-BA & IQWiG Joint Decision Report. CGM for diabetes. 2018.
24. HAS. ASA grading of diabetes devices. 2022.
25. CADTH. Provincial differences in CGM reimbursement. 2023.
26. HTA International. Lifecycle approach to medical device assessment. 2021.
27. Central Bank of Iran. Medical device foreign exchange allocations. 2023.
28. Parliament Research Center. Evaluation of health subsidies in Iran. 2022.
29. Iranian Food and Drug Organization. Regulatory guidance on diabetes devices. 2023.
30. Rezapour A, Alipour V, Arabloo J, Safari H, Teshnizi SH. Economic evaluation of medical devices and health technologies in Iran: challenges and recommendations. Cost Eff Resour Alloc. 2021; 19:65. [DOI:10.1186/s12962-021-00334-z]
31. Drummond M, et al. Principles of HTA for policy decisions. Oxford Univ Press; 2020.
32. WHO EMRO. Strengthening HTA in Eastern Mediterranean Region. 2023.
33. International Diabetes Federation. Diabetes Atlas (10th ed.). Brussels; 2021.
34. Mohammadi A, Darvishi A, Heshmat R, Nasli Esfahani E, Shafiee G, Ostovar A, Daroudi R. Economic burden of type 2 diabetes in Iran: A cost-of-illness study. Health Sci Rep. 2023;6(2):e1120.
35. Beck RW, Riddlesworth TD, Ruedy KJ, et al. Effect of continuous glucose monitoring on glycemic control. JAMA. 2017;317(4):371-378. [DOI:10.1001/jama.2016.19975]
36. PBAC. (2021). Public Summary Document: Continuous glucose monitoring subsidy. Pharmaceutical Benefits Advisory Committee Report, 1-35.
| Rights and permissions | |
 |
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
