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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-fa.html
URL: http://jrhms.thums.ac.ir/article-1-144-fa.html
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. عنوان نشریه. 1404; 4 (2) :1-10
چکیده: (35 مشاهده)
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.
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دریافت: 1405/2/15 | پذیرش: 1405/2/21 | انتشار: 1405/3/31
دریافت: 1405/2/15 | پذیرش: 1405/2/21 | انتشار: 1405/3/31
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