Impacto orçamentário da incorporação do sistema de monitoramento intermitente de glicose para indivíduos com Diabetes Mellitus Tipo 1

Abstract

Introduction: Self-monitoring of blood glucose is an important strategy in the management of diabetes with the potential to prevent and control the risk of hypoglycemia and, consequently, delay the onset and progression of complications of the disease. Intermittent glucose monitoring systems are capable of measuring glucose in the interstitial fluid at programmed intervals without the need for finger pricks. These instruments, such as the FreeStyle® Libre, are based on electrochemical operable sensors capable of reading in the range of 40 to 500 mg/dL, with 8-hour memory and 14-day durability. Readings can be performed with a specific reader or smartphone; in the latter case, the device must have Near Field Communication (NFC) technology. The objective of this study is to evaluate the potential budgetary impact (BPI) resulting from the incorporation of the FreeStyle® Libre for individuals with type 1 diabetes mellitus (DM1). Methods: The analyses were performed using the Excel application for a 5-year time horizon from the perspective of the state of Mato Grosso. It was assumed that the FreeStyle® system would be a substitute for self-monitoring with capillary blood glucose and that there would be no introduction of new methods in the time horizon considered. The model did not consider costs with spare strips for possible comparative measurements; nor with sensors lost due to early removal. The cost calculation considered that the use of the technology requires a specific reader made available only once, as well as the supply of 26 sensors/year/individual. The eligible population, individuals aged 18 years or older with T1DM and severe hypoglycemia, was selected with the help of an evidence synthesis that sought to identify among individuals with T1DM those who would benefit most from the technology, considering outcomes related to hypoglycemia. The assumed implementation rates for years 1 to 5 were: 27%; 30%; 33%; 36% and 40%, respectively, based on the frequency with which Brazilian diabetics monitor their glucose; on the acceptance of the technology and on the proportion of diabetics with access to consultation and exams. A bivariate sensitivity analysis was performed by modifying the population and implementation rate parameters, giving rise to an optimistic and a pessimistic scenario. A scenario with the use of smartphones as a replacement for readers was simulated. Results: The eligible population was 2,522 individuals with an annual increase of 2.6% for the subsequent years. The annual cost of sensors/individual was R$7,774.00 and of readers was R$299.00/individual for the entire time horizon. In years 1 and 5, the IO was R$5,497,228.62 and R$8,712,561.00, respectively. Replacing readers with smartphones was not sensitive for the time period considered. The sensitivity analysis showed that in a more optimistic scenario, the IO in the first year could be R$3,763,548.88 and R$5,799,487.72 in the fifth year. For the most pessimistic scenario, the IO would be R$7,348,606.72 and R$11,883,264.640 for years 1 and 5, respectively. Discussions and conclusions: The IO of a possible incorporation of FreeStyle® is significant when compared to the historical spending on analog insulins made available to the DM1 population in the state of Mato Grosso. In the period from 2018 to 2022, the state disbursed from R$3,547,953.77 to R$5,116,775.92 with the provision of insulin glargine and ultra-rapid insulin, benefiting up to 3,663 individuals.