Reimbursement of combined antihypertensive medicenes in Ukraine: aspects of inclusion and external reference pricing

Cardiovascular diseases (CVD), in particular arterial hypertension (AH), are the main causes of morbidity and mortality, Ukraine is on the 1st place in Europe for mortality from these diseases. Modern clinical guidelines emphasize the use of combined antihypertensive drugs, and improving the accessibility of these medicines for Ukrainian patients with hypertension is relevant. In Ukraine, at the end of 2022, there were no combined antihypertensive drugs in the List of reimbursed drugs. Therefore, there is a need to develop scientific and practical approaches to improve the «Affordable Medicines» reimbursement program in accordance with modern trends in the treatment of hypertension. The aim of the study is to formulate scientific and practical proposals for the inclusion of combined antihypertensive drugs in the state reimbursement program «Affordable Medicines» and to improve external reference pricing. Оbjects of the study were Orders of the Ministry of Health of Ukraine, national and international clinical guidelines, WHO ATC/DDD methodology guidelines. The study used content analysis, methods of comparative and logical analysis. At the 1st stage of the study, it was found that the current legislation of Ukraine does not prohibit the inclusion of combined antihypertensive drugs in the National List of Essential Medicines, and it is not limited solely to WHO recommendations. In the second stage of the study, it is proposed to use the data of pharmacoepidemiological studies and data of studies of actual consumption of combinated antihypertensive drugs in Ukraine, for further state HTA assessment and inclusion in the National List of Essential Medicines and «Affordable Medicines» program. The third and fourth stages of the study showed that the mechanism of external reference pricing needs to be improved and an algorithm for conducting external reference pricing for combined antihypertensive drugs, consisting of five consecutive stages, was developed and proposed. The current regulatory framework of Ukraine provides the possibility of including combined antihypertensive drugs in the state program «Affordable Medicines», and the initiation of the inclusion of medicines is within the competence of the Ministry of Health and the NHSU. A scientific and practical approach to the use of pharmaco-epidemiological research data to identify the most used doses of combined antihypertensive drugs as potential candidates for inclusion in the «Affordable Medicines» program is proposed. A scientific and practical algorithm for external reference pricing for combinated antihypertensive drugs was developed, considering current regulatory and methodological aspects.