Cost-utility analysis of a flash continuous glucose monitoring system in the management of people with type 2 diabetes mellitus on basal insulin therapy-An Italian healthcare system perspective.

AIMS: To assess the cost-utility of the FreeStyle Libre flash continuous glucose monitoring (CGM) system from an Italian healthcare system perspective, when compared with self-monitoring of blood glucose (SMBG) in people living with type 2 diabetes mellitus (T2DM) receiving basal insulin. MATERIALS AND METHODS: A patient-level microsimulation model was run using Microsoft Excel for 10 000 patients over a lifetime horizon, with 3.0% discounting for costs and utilities. Inputs were based on clinical trials and real-world evidence, with patient characteristics reflecting Italian population data. The effect of flash CGM was modelled as a persistent 0.8% reduction in glycated haemoglobin versus SMBG. Costs (€ 2023) and disutilities were applied to glucose monitoring, diabetes complications, severe hypoglycaemia, and diabetic ketoacidosis. The health outcome was measured as quality-adjusted life-years (QALYs). RESULTS: Direct costs were €5338 higher with flash CGM than with SMBG. Flash CGM was associated with 0.51 more QALYs than SMBG, giving an incremental cost-effectiveness ratio (ICER) of €10 556/QALY. Scenario analysis ICERs ranged from €3825/QALY to €26 737/QALY. In probabilistic analysis, flash CGM was 100% likely to be cost effective at willingness-to-pay thresholds > €20 000/QALY. CONCLUSIONS: From an Italian healthcare system perspective, flash CGM is cost effective compared with SMBG for people living with T2DM on basal insulin.

Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.

AIMS: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

Cost of hospitalisation and length of stay due to hypoglycaemia in patients with diabetes mellitus: a cross-sectional study

OBJECTIVE: This study aims to estimate the length of stay and hospitalisation cost of hypoglycaemia, and to identify determinants of variation in the length of stay and hospitalisation cost among individual patients with type 1 or 2 diabetes mellitus. METHODS: A cross-sectional study was conducted using inpatients records for patients with diabetes mellitus who had been hospitalised due to hypoglycaemic events in two private hospitals in Amman, Jordan between January 2009 and May 2017. All hospitalisation costs were inflated to the equivalent costs in 2017. Hospitalisation cost was estimated from the patient's perspective in Jordanian dinars (JOD). Descriptive analyses and correlation between sociodemographic or clinical characteristics with the cost and length of stay were explored. Predictors of hypoglycaemic hospitalisation cost and length of stay were determined using logistic regression. RESULTS: During the study period a total of 126 patients with diabetes mellitus were hospitalised due to an incident of hypoglycaemia. The mean patient age was 64.2 (SD=19.6) years; half were male. Patients admitted for hypoglycaemia stayed in hospital for a median duration of two days (IQR=2 days). The median cost of hospitalisation for hypoglycaemia was 163.2 JOD (USD 230.1) (IQR=216.3 JOD). We found that the Glasgow coma score was positively associated with length of stay (0.345, p = 0.008), and older age was correlated with higher hospitalisation cost (0.207, p = 0.02). Patients with a family history of diabetes had higher hospitalisation costs and longer duration of stay (0.306 and 0.275, p < 0.05). In addition, being a male patient (0.394, p < 0.05) and with an absence of smoking history was associated with longer duration of stay (0.456, p < 0.01), but not with higher hospitalisation cost. CONCLUSIONS: Costs associated with the incidence of hypoglycaemic events are not low and constitute a large cost component of managing and treating diabetes mellitus. Male patients and patients having a family history of diabetes should receive extra care and education on the prevention of hypoglycaemic events, and a treatment de-intensification approach should be considered if necessary, so we can prevent its associated hospitalisation costs and length of stay

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Cost-effectiveness analysis of sensor-augmented pump therapy with low glucose-suspend in patients with type 1 diabetes mellitus and high risk of hypoglycemia in Spain / Análisis coste-utilidad del sistema integrado con suspensión en hipoglucemia en pacientes con diabetes tipo 1 y alto riesgo de hipoglucemias en España

Objective: To compare the cost-effectiveness of sensor-augmented pump therapy (SAP) [continuous subcutaneous insulin infusion (CSII) plus real-time continuous glucose monitoring (RT-CGM)] with low glucose suspend (MiniMed(TM) Veo(TM)) and CSII alone in patients with type 1 diabetes mellitus (T1DM) at high risk of hypoglycemia in Spain. Methods: The IQVIA CORE Diabetes Model was used to estimate healthcare outcomes as life-years gained (LYGs) and quality-adjusted life years (QALYs), and to project lifetime costs. Information about efficacy, resource utilization, and unit costs (€2016) was taken from published sources and validated by an expert panel. Analyses were performed from both the Spanish National Health System (NHS) perspective and the societal perspective. Results: From the NHS perspective, SAP with low glucose suspend was associated to a €47,665 increase in direct healthcare costs and to increases of 0.19 LYGs and 1.88 QALYs, both discounted, which resulted in an incremental cost-effectiveness ratio (ICER) of €25,394/QALY. From the societal perspective, SAP with low glucose suspend increased total costs (including direct and indirect healthcare costs) by €41,036, with a resultant ICER of €21,862/QALY. Considering the willingness-to-pay threshold of €30,000/QALY in Spain, SAP with low glucose suspend represents a cost-effective option from both the NHS and societal perspectives. Sensitivity analyses confirmed the robustness of the model. Conclusions: From both the Spanish NHS perspective and the societal perspective, SAP with low glucose suspend is a cost-effective option for the treatment of T1DM patients at high risk of hypoglycemia

Objetivo: Evaluar la relación coste-utilidad del sistema integrado (MiniMed(R) Veo(R)) con suspensión en hipoglucemia frente a la infusión subcutánea continua de insulina (ISCI) en el tratamiento de pacientes con diabetes tipo 1 (DM1) y alto riesgo de hipoglucemias en España. Métodos: Se utilizó el modelo de diabetes IQVIA CORE para estimar los resultados en salud expresados como años de vida ganados (AVG) y años de vida ajustados por calidad (AVAC) y los costes a lo largo de la vida de los pacientes. La información sobre la eficacia, el consumo de recursos y los costes unitarios (2016€) fue obtenida de fuentes publicadas y validadas por un panel de expertos. En el escenario principal se consideró la perspectiva del Sistema Nacional de Salud (SNS) y, en un escenario alternativo, la de la sociedad en general. Resultados: Bajo la perspectiva del SNS el tratamiento con el sistema integrado con suspensión en hipoglucemia se asoció con mayores costes sanitarios directos (47.665€) y un incremento de 0,19 AVG y 1,88 AVAC, resultando en un ratio coste-utilidad incremental (RCUI) de 25.394€/AVAC. Considerando la perspectiva de la sociedad, los costes totales (sanitarios directos e indirectos) se incrementaron en 41.036€, siendo el RCUI resultante de 21.862€/AVAC. Los análisis de sensibilidad confirmaron la robustez de los resultados en todos los escenarios evaluados. Conclusión: Considerando el umbral de máxima disposición a pagar para España de 30.000€/AVAC, el sistema integrado con suspensión en hipoglucemia representa una opción eficiente en comparación con la ISCI tanto desde la perspectiva del SNS como de la sociedad en su conjunto

Impacto presupuestario de la infusión subcutánea continua de insulina en el tratamiento de pacientes con diabetes tipo 1 que presentan episodios de hipoglucemia grave recurrente en España / Budget impact of continuous subcutaneous insulin infusion therapy in patients with type 1 diabetes who experience severe recurrent hypoglycemic episodes in Spain

Objetivo: Las hipoglucemias suponen una de las complicaciones más habituales para alcanzar un buen control metabólico y figuran entre las indicaciones comúnmente aceptadas por diferentes sociedades para iniciar tratamiento con infusión subcutánea continua de insulina (ISCI). La utilización de ISCI en España es aún residual en comparación con países de nuestro entorno, siendo el coste de adquisición una de las principales motivaciones. Este trabajo estima el impacto presupuestario asociado a ISCI frente a múltiples dosis de insulina en pacientes con diabetes mellitus tipo 1 e hipoglucemias graves recurrentes desde la perspectiva del Sistema Nacional de Salud. Métodos: El impacto presupuestario está basado en los resultados de un estudio observacional que evaluó la efectividad de ISCI en el Hospital Clínic i Universitari de Barcelona, donde el promedio anual de hipoglucemias graves en los dos años anteriores al inicio con ISCI fue 1,33 y 0,08 en los últimos dos años de seguimiento (p=0,003). Se contemplaron los costes asociados al tratamiento y al manejo de hipoglucemias graves durante cuatro años. Los costes unitarios (euros, 2016) fueron obtenidos de bases de datos nacionales. Resultados: El coste del tratamiento con ISCI resultó en un incremento de 9.509euros/paciente frente a múltiples dosis de insulina (11.902euros-2.393euros). El coste asociado a las hipoglucemias graves disminuyó 19.330euros/paciente en aquellos tratados con ISCI (1.371euros-20.701euros). Los resultados indican un ahorro medio de 9.821euros/paciente para el SNS en los cuatro años de estudio. Conclusión: El incremento asociado al coste del tratamiento podría quedar totalmente compensado gracias a los episodios de hipoglucemia grave evitados (AU)

Objective: Hypoglycemia is one of the most common complications to achieve a good metabolic control, and has been listed by several scientific associations as a common indication to start treatment with continuous subcutaneous insulin infusion (CSII). Use of CSII is still residual in Spain as compared to neighbouring countries, and cost of acquisition cost is one of the main reasons. This study estimates the budget impact of treatment with CSII, as compared to multiple daily insulin injections, of patients with type 1 diabetes mellitus who experience recurrent severe hypoglycemia episodes from the National Healthcare System perspective. Methods: Budget impact was based on a retrospective, observational study evaluating the efficacy of CSII in patients with type 1 diabetes mellitus conducted at Hospital Clínic i Universitari in Barcelona, where one of the main indications for switching to CSII were recurrent severe hypoglycemia episodes. The mean number of annual episodes was 1.33 in the two years prior to CSII start and 0.08 in the last two years of follow up (p=0.003). Costs of treatment and major hypoglycemic events over a four-year period were considered. Costs were taken from different Spanish data sources and expressed in euros of 2016. Results: Treatment with CSII increased costs by euros9,509 per patient as compared to multiple daily insulin injections (euros11,902-euros2,393). Cost associated to severe hypoglycemic events decreased by euros19,330 per patient treated with CSIII (euros1,371-euros20,701). Results suggest mean total savings of euros9,821 per patient during the four-year study period. Conclusion: The higher costs associated to CSII therapy may be totally offset by the severe hypoglycemic events prevented (AU)

Hospitalizaciones por hipoglucemia grave en pacientes con diabetes mellitus en España / Hospitalizations due to severe hypoglycemia in patients with diabetes mellitus in Spain

Antecedentes y objetivo. Una de las complicaciones terapéuticas más importantes en los pacientes con diabetes mellitus (DM) es la hipoglucemia. Hemos estimado el número de hospitalizaciones por hipoglucemia grave en los pacientes con DM tipo 1 (DM1) y tipo 2 (DM2). Pacientes y métodos. El universo hospitalario se definió a partir del Catálogo Nacional de Hospitales (CNH) de 2007 (últimos datos disponibles), y se incluyeron 260 hospitales generales del Sistema Nacional de Salud. El número de hospitalizaciones por hipoglucemia grave fue extraído del Conjunto Mínimo Básico de Datos (CMBD) para 183 hospitales. Para los 77 restantes se estimó a partir de la información disponible. Resultados. En el año 2007 se produjeron un total de 26.701 (0,82%) hospitalizaciones con hipoglucemia. En los enfermos con DM2 se reportaron 8.242 (0,25%) ingresos como diagnóstico principal y 16.649 (0,51%) como secundario. En los pacientes con DM1 se reportaron 1.157 (0,04%) y 653 (0,02%) ingresos como diagnóstico principal y secundario, respectivamente. La incidencia global en DM2 fue de 1,82 episodios/10.000 habitantes/año, y osciló entre los 1,10 episodios/10.000 habitantes/año en Canarias y los 3,37 episodios en Castilla y León. Conclusiones. La hipoglucemia grave es una causa importante de hospitalización en los pacientes con DM en España, con una gran variabilidad entre CCAA (AU)

Background and objectives One of the most important therapeutic complications in patients with diabetes mellitus (DM) is hypoglycemia. This study has estimated the number of hospitalizations due to severe hypoglycemia in patients with type DM1 and DM2. Patients and methods. The study hospital population was defined using the National Catalogue of Hospitals (CNH) 2007 (last available data), and has included 260 general hospitals of the National Health System. The number of hospitalizations due to severe hypoglycemia was obtained from the Basic Minimum Data Set (BMDS) for the 183 hospitals. For the remaining 77 hospitals, this number was estimated based on the available information. Results. In 2007, there were 26,701 (0.82%) hospitalizations with hypoglycemia. In DM2 patients, 8,242 (0.25%) episodes were reported as primary diagnosis and 16,649 (0.51%) as secondary. In DM1 patients, 1,157 (0.04%) and 653 (0.02%) episodes were reported as primary and secondary diagnosis, respectively. Overall incidence in DM2 was 1.82 episodes/10,000 inhabitants-year, this ranging between 1.10 episodes/10,000 inhabitants-year in the Islas Canarias to 3.37 in Castilla y León. Conclusions. Severe hypoglycemia is an important reason for hospitalization of patients with DM in Spain, there being great variability according to the Autonomous Regions (AU)

Consecuencias clínicas y económicas de la combinación de metformina con inhibidores de la dipeptidilpeptidasa en pacientes con diabetes tipo 2 / Clinical and economical consequences of the combination of metformin with dipeptidyl peptidase inhibitors in type 2 diabetes patients

ANTECEDENTES Y OBJETIVO: Existen diversos tratamientos farmacológicos hipoglucemiantes de segunda línea cuya eficacia, seguridad y perfil económico no se ha precisado en nuestro medio. Hemos analizado las consecuencias clínicas (adherencia al tratamiento antidiabético, control metabólico, hipoglucemias y complicaciones macrovasculares) y económicas (uso de recursos y costes) de la combinación de metformina con inhibidores de la dipeptidilpeptidasa (IDPP4) en pacientes con diabetes tipo 2 en comparación con metformina y otros fármacos hipoglucemiantes. PACIENTES Y MÉTODOS: Estudio observacional multicéntrico de carácter retrospectivo. Se incluyeron pacientes de ≥30 años tratados con metformina que iniciaron un segundo tratamiento antidiabético durante los años 2008-2009. Se establecieron 2 grupos de pacientes: metformina con IDPP4 y metformina con otros fármacos antidiabéticos. Las principales medidas fueron: la comorbilidad, el cumplimiento/persistencia, el control metabólico (hemoglobina glicosilada<7%), complicaciones (hipoglucemias, macrovasculares) y costes totales. El seguimiento se realizó durante 2 años. RESULTADOS: Se reclutaron 2.067 pacientes (edad media: 66,6 años; 53,1% varones). En el grupo metformina+IDPP4 se analizaron 519 pacientes (25,1%) y en el grupo metformina+otros fármacos antidiabéticos: 1.548 pacientes (74,9%). Los enfermos tratados con IDPP4, en comparación con los que recibieron metformina asociada a otros antidiabéticos, mostraron un mejor cumplimiento (70,3 vs. 59,6%), persistencia (63,4 vs. 51,0%) y control metabólico (64,3 vs. 59,6%) (p < 0,001). También presentaron una menor proporción de hipoglucemias (13,9 vs. 44,3%), eventos cardiovasculares (3,7 vs. 7,6%) y costes totales (2.347 vs. 2.682 €) (p < 0,05) durante los 2 años del estudio. CONCLUSIONES: A pesar de las limitaciones del estudio, los pacientes en tratamiento con metformina asociada a IDPP4 mostraron un mayor cumplimiento terapéutico, control metabólico y menores tasas de hipoglucemias que los enfermos tratados con metformina asociada a otros antidiabéticos

BACKGROUNDS AND OBJECTIVE: There are different second line glucose lowering drugs whose efficacy, safety and economic profile have not been established in our setting. We have analyzed the clinical (diabetic treatment adherence, metabolic control, hypoglycemia and macrovascular complications) and economic (resource use and costs) consequences of the combination of metformin with dipeptidyl peptidase inhibitors (DPPIV) in patients with type 2 diabetes. Patients and methods. We conducted a multicenter, observational and retrospective study. Patients ≥30 years treated with metformin who initiated a second antidiabetic treatment during 2008-2009 were enrolled in the study. Two groups of patients were established: a) metformin with DPPIV and metformin with other diabetic drugs. The main measurements were comorbidity, compliance/persistence, metabolic control (glycosylated hemoglobin <7%), complications (hypoglycemia, macrovascular) and total costs. Patients were followed-up for 2 years. Results. A total of 2,067 patients were enrolled (mean age: 66.6 years, 53.1% male). Of these, 519 patients (25.1%) were analyzed in the metformin+DPPIV group and 1,548 patients (74.9%) in the group metformin+other antidiabetic drug. The DPPIV group patients showed better compliance (70.3 vs. 59.6%), persistence (63.4 vs. 51.0%) and metabolic control (64.3 vs. 59.6%), respectively (P<.001) compared to the other group. They also showed a lower proportion of hypoglycemia (13.9 vs. 44.3%), cardiovascular events (3.7 vs. 7.6%) and total costs (2,347 vs. € 2,682), P<.05. Conclusions. Despite the limitations of the study, patients treated with metformin associated to DPPIV were more likely to show increased adherence, metabolic control and lower rates of hypoglycemia than those treated with metformin associated to other antidiabetics