RESUMEN
PURPOSE: The purpose of this study is to evaluate the pattern, appropriateness, and cost of antidiabetic drugs prescribed for patients with Type 2 diabetes at primary healthcare facilities (PHFs) in China. METHODS: We collected outpatient-visit prescriptions from 363 PHFs in 31 cities covering eastern, central, and western regions of China. The visits of adult patients with Type 2 diabetes diagnosis were collected and classified the antidiabetic medication pattern of each patient use as recommended or non-recommended according to Chinese guidelines. We then calculated the proportion of guideline-recommended patterns and the average monthly cost for each pattern, overall and by region. RESULTS: Of 33 519 prescriptions for Type 2 diabetes, most (73.9%) were for guideline-recommended antidiabetic treatments. The proportion of guideline-recommended prescriptions varied by region (eastern [75.9%], central [87.5%], and western [59.7%]). Metformin monotherapy was the most common guideline-recommended treatment in all three regions (eastern [20.1%], central [28.0%], and western [24.6%]). The most common non-guideline-recommended treatments were monotherapy of insulin (eastern [16.5%], central [5.1%], and western [25.7%]) and traditional Chinese antidiabetic medicines (eastern [5.6%], central [5.7%], and western [11.1%]). The average monthly costs were lower for guideline-recommended treatments compared to non-recommended treatments in all regions (eastern [13.6 ± 15.4 USD vs. 28.1 ± 22.0 USD], central [9.8 ± 10.9 USD vs. 28.7 ± 19.4 USD], and western [17.9 ± 21.4 USD vs. 30.3 ± 23.6 USD]). CONCLUSIONS: The majority of patients with Type 2 diabetes received guideline-recommended antidiabetic medications at PHFs in China, with only half of the prescriptions containing guideline-recommended metformin. Utilization of guideline-recommended therapies differed across regions. Tailored interventions to promote evidence-based antidiabetic prescribing are urgently needed, especially in the undeveloped western region.
Asunto(s)
Diabetes Mellitus Tipo 2 , Hipoglucemiantes , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina , Atención Primaria de Salud , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , China , Atención Primaria de Salud/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Pautas de la Práctica en Medicina/normas , Persona de Mediana Edad , Masculino , Femenino , Anciano , Adhesión a Directriz/estadística & datos numéricos , Adulto , Costos de los Medicamentos , Metformina/uso terapéutico , Prescripciones de Medicamentos/estadística & datos numéricosRESUMEN
This cross-sectional study examines trends in US prescription fills for semaglutide products by payment method between January 2021 and December 2023.
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Péptidos Similares al Glucagón , Hipoglucemiantes , Humanos , Péptidos Similares al Glucagón/uso terapéutico , Péptidos Similares al Glucagón/economía , Hipoglucemiantes/economía , Hipoglucemiantes/uso terapéutico , Estados Unidos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/economíaRESUMEN
In 2020, Colorado became the first state to cap out-of-pocket spending for insulin prescriptions, requiring fully insured health plans to cap out-of-pocket spending at $100 for a thirty-day supply. We provide the first evidence on the association of Colorado's Insulin Affordability Program with patient out-of-pocket spending, the amounts paid by plans per insulin prescription, and prescription filling. Using statewide claims data from the period 2018-21, we focused on the first two years that the copay cap law was in effect. We found that Colorado's Insulin Affordability Program was associated with significant reductions in out-of-pocket spending for insulin prescriptions, with the mean out-of-pocket payment per thirty-day supply falling nearly in half (from $62.59 to $35.64). Average plan payments increased slightly more ($31.39) than the decrease in out-of-pocket spending, as the total amount paid per prescription increased by about 1 percent. The average insulin user realized annual savings of $184, while the mean number of fills and the mean days' supply per year increased by 4.2 percent and 11.4 percent, respectively.
Asunto(s)
Gastos en Salud , Insulina , Humanos , Colorado , Insulina/economía , Insulina/uso terapéutico , Gastos en Salud/estadística & datos numéricos , Hipoglucemiantes/economía , Hipoglucemiantes/uso terapéutico , Femenino , Masculino , Persona de Mediana Edad , Seguro de Costos Compartidos , Costos de los Medicamentos , AdultoRESUMEN
During the past five years, many states have imposed out-of-pocket spending caps on insulin. In most cases, these reforms have had limited impact, in part because of the limits of state authority. Meanwhile, changes at the federal level and actions by manufacturers and commercial plans have made some of the caps nonbinding. It is not surprising that efforts to measure the impact of these caps yield conflicting results.
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Insulina , Insulina/economía , Humanos , Estados Unidos , Gastos en Salud , Gobierno Estatal , Costos de los Medicamentos , Hipoglucemiantes/economía , Hipoglucemiantes/uso terapéuticoRESUMEN
Nearly all patients with type 1 diabetes and 20-30 percent of patients with type 2 diabetes use insulin to manage glycemic control. Approximately one-quarter of patients who use insulin report underuse because of cost. In response, more than twenty states have implemented monthly caps on insulin out-of-pocket spending, ranging from $25 to $100. Using a difference-in-differences approach, this study evaluated whether state-level caps on insulin out-of-pocket spending change insulin usage among commercially insured enrollees. The study included 33,134 people ages 18-64 who had type 1 diabetes or who used insulin to manage type 2 diabetes with commercial insurance coverage that was subject to state-level oversight and was included in the 25 percent sample of the IQVIA PharMetrics database during 2018-21. Insulin out-of-pocket caps did not significantly increase quarterly insulin claims for enrollees who had type 1 diabetes or who used insulin to manage type 2 diabetes. State-level caps on insulin out-of-pocket spending for commercial enrollees did not significantly increase insulin use; that may be in part because of out-of-pocket expenses being lower than cap amounts.
Asunto(s)
Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Gastos en Salud , Hipoglucemiantes , Insulina , Humanos , Insulina/uso terapéutico , Insulina/economía , Femenino , Persona de Mediana Edad , Adulto , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/economía , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/economía , Masculino , Estados Unidos , Gastos en Salud/estadística & datos numéricos , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , Adolescente , Revisión de Utilización de Seguros , Cobertura del Seguro/estadística & datos numéricos , Adulto Joven , Seguro de Salud/economía , Seguro de Salud/estadística & datos numéricos , Costos de los Medicamentos/estadística & datos numéricosRESUMEN
BACKGROUND: Use of Continuous Subcutaneous Insulin Infusion (CSII) has been shown to improve glycemic outcomes in Type 1 Diabetes (T1D), but high costs limit accessibility. To address this issue, an inter-operable, open-source Ultra-Low-Cost Insulin Pump (ULCIP) was developed and previously shown to demonstrate comparable delivery accuracy to commercial models in standardised laboratory tests. This study aims to evaluate the updated ULCIP in-vivo, assessing its viability as an affordable alternative for those who cannot afford commercially available devices. METHODS: This first-in-human feasibility study recruited six participants with T1D. During a nine-hour inpatient stay, participants used the ULCIP under clinical supervision. Venous glucose, insulin, and ß-Hydroxybutyrate were monitored to assess device performance. RESULTS: Participants displayed expected blood glucose and blood insulin levels in response to programmed basal and bolus insulin dosing. One participant developed mild ketosis, which was treated and did not recur when a new pump reservoir was placed. All other participants maintained ß-Hydroxybutyrate < 0.6 mmol/L throughout. CONCLUSION: The ULCIP safely delivered insulin therapy to users in a supervised inpatient environment. Future work should focus on correcting a pump hardware issue identified in this trial and extending device capabilities for use in closed loop control. Longer-term outpatient studies are warranted. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623001288617) on the 11 December 2023.
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Glucemia , Diabetes Mellitus Tipo 1 , Estudios de Factibilidad , Hipoglucemiantes , Sistemas de Infusión de Insulina , Insulina , Humanos , Sistemas de Infusión de Insulina/economía , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/economía , Masculino , Femenino , Insulina/administración & dosificación , Insulina/economía , Adulto , Glucemia/análisis , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/economía , Persona de Mediana EdadRESUMEN
Importance: Many insulin users ration doses due to high out-of-pocket costs. Starting January 2020 with Colorado, 25 states and the District of Columbia enacted laws that cap insulin copayments. Objective: To estimate the association of Colorado's $100 copayment cap with out-of-pocket spending, medication adherence, and health care services utilization for diabetes-related complications. Design, Setting, and Participants: In this cohort study using Colorado's All-Payer Claims Database, nonelderly insulin users with type 1 diabetes were analyzed from January 2019 to December 2020. Outcome changes were compared in the prepolicy and postpolicy period among individuals continuously enrolled in state-regulated and non-state-regulated plans using difference-in-differences regressions. Subgroup analyses were conducted based on individuals' prepolicy spending (low: never ≥$100 out-of-pocket vs high: ≥$100 out-of-pocket cost at least once). Data were analyzed from June 2023 to May 2024. Exposure: Enrollment in state-regulated health insurance plans subject to the copayment cap legislation. Main Outcomes and Measures: Adherence to basal and bolus insulin treatment was evaluated using the proportion of days covered measure, out-of-pocket spending reflected prescription cost for a 30-day supply, and health care utilization for diabetes-related complications was identified using primary diagnosis codes from medical claims data. Results: The panel included 1629 individuals with type 1 diabetes (39â¯096 person-months), of which 924 were male (56.7%), 540 (33.1%) had 1 or more comorbidities, and the mean (SD) age was 40.6 (15.9) years. Overall, the copayment cap was associated with out-of-pocket spending declines of $17.3 (95% CI, -$27.3 to -$7.3) for basal and $11.5 (95% CI, -$24.7 to $1.7) for bolus insulins and increases in adherence of 3.2 (95% CI, 0.0 to 6.5) percentage points for basal and 3.3 (95% CI, 0.3 to 6.4) percentage points for bolus insulins. Changes in adherence were associated with increases within the prepolicy high-spending group (basal, 9.9; 95% CI, 2.4 to 17.4 percentage points; bolus, 13.0; 95% CI, 5.1 to 20.9 percentage points). The policy was also associated with a mean reduction of -0.09 (95% CI, -0.16 to -0.02) medical claims for diabetes-related complications per person per month among high spenders, a 30% decrease. Conclusions and Relevance: In this cohort study of Colorado's insulin copayment cap among individuals with type 1 diabetes, the policy was associated with an overall decline in out-of-pocket spending, an increase in medication adherence, and a decline in claims for diabetes-related complications only among insulin users who spent more than $100 in the prepolicy period at least once.
Asunto(s)
Diabetes Mellitus Tipo 1 , Gastos en Salud , Hipoglucemiantes , Insulina , Humanos , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/economía , Masculino , Femenino , Adulto , Insulina/economía , Insulina/uso terapéutico , Colorado/epidemiología , Gastos en Salud/estadística & datos numéricos , Hipoglucemiantes/economía , Hipoglucemiantes/uso terapéutico , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Estudios de Cohortes , Deducibles y Coseguros/estadística & datos numéricos , Deducibles y Coseguros/economía , Seguro de Salud/economía , Seguro de Salud/estadística & datos numéricos , Seguro de Costos Compartidos/estadística & datos numéricos , Seguro de Costos Compartidos/economía , Aceptación de la Atención de Salud/estadística & datos numéricosRESUMEN
BACKGROUND: Western guidelines often recommend biguanides as the first-line treatment for diabetes. However, dipeptidyl peptidase-4 (DPP-4) inhibitors, alongside biguanides, are increasingly used as the first-line therapy for type 2 diabetes (T2DM) in Japan. However, there have been few studies comparing the effectiveness of biguanides and DPP-4 inhibitors with respect to diabetes-related complications and cardio-cerebrovascular events over the long term, as well as the costs associated. OBJECTIVE: We aimed to compare the outcomes of patients with T2DM who initiate treatment with a biguanide versus a DPP-4 inhibitor and the long-term costs associated. METHODS: We performed a cohort study between 2012 and 2021 using a new-user design and the Shizuoka Kokuho database. Patients were included if they were diagnosed with T2DM. The primary outcome was the incidence of cardio-cerebrovascular events or mortality from the initial month of treatment; and the secondary outcomes were the incidences of related complications (nephropathy, renal failure, retinopathy, and peripheral neuropathy) and the daily cost of the drugs used. Individuals who had experienced prior events during the preceding year were excluded, and events within 6 months of the start of the study period were censored. Propensity score matching was performed to compare between two groups. RESULTS: The matched 1:5 cohort comprised 529 and 2,116 patients who were initially treated with a biguanide or a DPP-4 inhibitor, respectively. Although there were no significant differences in the incidence of cardio-cerebrovascular events or mortality and T2DM-related complications between the two groups (p = 0.139 and p = 0.595), daily biguanide administration was significantly cheaper (mean daily cost for biguanides, 61.1 JPY; for DPP-4 inhibitors, 122.7 JPY; p<0.001). CONCLUSION: In patients with T2DM who initiate pharmacotherapy, there were no differences in the long-term incidences of cardio-cerebrovascular events or complications associated with biguanide or DPP-4 use, but the former was less costly.
Asunto(s)
Biguanidas , Diabetes Mellitus Tipo 2 , Retinopatía Diabética , Inhibidores de la Dipeptidil-Peptidasa IV , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Biguanidas/efectos adversos , Biguanidas/economía , Biguanidas/uso terapéutico , Enfermedades Cardiovasculares/economía , Enfermedades Cardiovasculares/tratamiento farmacológico , Estudios de Cohortes , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/economía , Nefropatías Diabéticas/tratamiento farmacológico , Nefropatías Diabéticas/economía , Neuropatías Diabéticas/tratamiento farmacológico , Neuropatías Diabéticas/economía , Retinopatía Diabética/tratamiento farmacológico , Retinopatía Diabética/economía , Inhibidores de la Dipeptidil-Peptidasa IV/uso terapéutico , Inhibidores de la Dipeptidil-Peptidasa IV/economía , Inhibidores de la Dipeptidil-Peptidasa IV/efectos adversos , Hipoglucemiantes/economía , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/efectos adversos , Japón , Resultado del TratamientoRESUMEN
Importance: For people with type 2 diabetes (T2D), out-of-pocket medication costs may influence medication choice, adherence, and overall diabetes management and progression. Little is known about how these costs change as insured people enter Medicare at age 65 years, when coinsurance in the coverage gap and catastrophic phases of Part D coverage can be increased greatly by use of insulin and newer, branded medications (eg, dipeptidyl peptidase 4 inhibitors, glucagon-like peptide 1 agonists, and sodium-glucose cotransporter 2 inhibitors). Objective: To identify whether reaching age 65 years is associated with T2D medication out-of-pocket costs and utilization. Design, Setting, and Participants: This retrospective cohort study (2012-2020) featuring 7 years of follow-up used prescription drug claims data from the TriNetX Diamond Network. Participants included people in the US with diagnosed T2D, and claims for T2D medications were observed both before and after age 65 years. Data analysis was performed from October 2022 to September 2023. Exposure: Reaching age 65 years, according to participants' year of birth. Main Outcomes and Measures: The primary outcome was patient out-of-pocket costs for T2D drugs per quarter (inflation adjusted to 2020 dollars). Utilization, measured as binary utilization of specific classes, and the number of claims for mutually exclusive classes and combinations of classes were also examined. All outcomes were examined using regression discontinuity design. Results: In claims data for 129â¯997 individuals with T2D diagnosed at ages 58 to 72 years (mean [SD] age, 65.50 [2.95] years; 801â¯235 female [50.9%]), reaching age 65 years was associated with an increase of $23.04 (95% CI, $19.86-$26.22) in mean quarterly out-of-pocket costs for T2D drugs, and an increase of $56.36 (95% CI, $51.48-$61.23) at the 95th percentile of spending, after utilization adjustment. Utilization decreased by 5.3% at age 65 years, from 3.40 claims per quarter (95% CI, 3.38-3.42 claims per quarter) to 3.22 claims per quarter (95% CI, 3.21-3.24 claims per quarter), but a shift in composition of utilization, including increased insulin use, was associated with additional increases in patient costs. Conclusions and Relevance: In this cohort study of individuals with T2D, the increase in spending upon reaching age 65 years (when most people enroll in Medicare) was associated with patient coinsurance in the coverage gap and catastrophic coverage phases of Medicare Part D. The increased patient cost burden at age 65 years and a modest reduction in overall T2D drug utilization suggest that as people with T2D age into Medicare, there is potentially an increase in nonadherence and diabetes complications.
Asunto(s)
Diabetes Mellitus Tipo 2 , Gastos en Salud , Hipoglucemiantes , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/economía , Anciano , Estados Unidos , Masculino , Femenino , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , Estudios Retrospectivos , Gastos en Salud/estadística & datos numéricos , Medicare/economía , Persona de Mediana Edad , Costos de los Medicamentos/estadística & datos numéricos , Medicare Part D/economía , Medicare Part D/estadística & datos numéricosRESUMEN
AIMS: To describe healthcare resource utilization (HCRU) and associated costs after initiation of injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy by adult patients with type 2 diabetes (T2D) in the prospective, observational, 24-month TROPHIES study in France, Germany, and Italy. MATERIALS AND METHODS: HCRU data for cost calculations were collected by treating physicians during patient interviews at baseline and follow-up visits approximately 6, 12, 18, and 24 months after GLP-1 RA initiation with once-weekly dulaglutide or once-daily liraglutide. Costs were evaluated from the national healthcare system (third-party payer) perspective and updated to 2018 prices. RESULTS: In total, 2,005 patients were eligible for the HCRU analysis (1,014 dulaglutide; 991 liraglutide). Baseline patient characteristics were generally similar between treatment groups and countries. The largest proportions of patients using ≥2 oral glucose-lowering medications (GLMs) at baseline (42.9-43.4%) and month 24 (44.0-45.1%) and using another injectable GLM at month 24 (15.3-23.2%) were in France. Mean numbers of primary and secondary healthcare contacts during each assessment period were highest in France (range = 4.0-10.7) and Germany (range = 2.9-5.7), respectively. The greatest proportions (≥60%) of mean annualized costs per patient comprised medication costs. Mean annualized HCRU costs per patient varied by treatment cohort and country: the highest levels were in the liraglutide cohort in France (909) and the dulaglutide cohort in Germany (883). LIMITATIONS: Limitations included exclusion of patients using insulin at GLP-1 RA initiation and collection of HCRU data by physician, not via patient-completed diaries. CONCLUSIONS: Real-world HCRU and costs associated with the treatment of adults with T2D with two GLP-1 RAs in TROPHIES emphasize the need to avoid generalization with respect to HCRU and costs associated with a particular therapy when estimating the impact of a new treatment in a country-specific setting.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have become frequent treatments of hyperglycemia in type-2 diabetes (T2D). Not all types of clinical study provide information about the cost of these treatments or the effects they might have on use of other medicines and equipment to control T2D or the need for visits to a doctor or nurse and different types of treatment in hospital. This study collected this information during the regular care of adults in France, Germany, or Italy who were prescribed either dulaglutide or liraglutide (both types of GLP-1 RAs) by their family doctor or a specialist in T2D. There were differences in costs and the need for other medicines and medical services between people using either dulaglutide or liraglutide and for people who were using the same GLP-1 RA in each of the three countries. The information from this study could be used to more accurately understand the overall costs and medical care needed when patients use dulaglutide or liraglutide in France, Germany, or Italy.
Asunto(s)
Diabetes Mellitus Tipo 2 , Péptidos Similares al Glucagón , Hipoglucemiantes , Fragmentos Fc de Inmunoglobulinas , Liraglutida , Proteínas Recombinantes de Fusión , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/economía , Liraglutida/uso terapéutico , Liraglutida/economía , Péptidos Similares al Glucagón/análogos & derivados , Péptidos Similares al Glucagón/uso terapéutico , Péptidos Similares al Glucagón/economía , Péptidos Similares al Glucagón/administración & dosificación , Fragmentos Fc de Inmunoglobulinas/uso terapéutico , Fragmentos Fc de Inmunoglobulinas/economía , Proteínas Recombinantes de Fusión/economía , Proteínas Recombinantes de Fusión/uso terapéutico , Proteínas Recombinantes de Fusión/administración & dosificación , Masculino , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , Femenino , Estudios Prospectivos , Persona de Mediana Edad , Anciano , Recursos en Salud/estadística & datos numéricos , Recursos en Salud/economía , Modelos EconométricosRESUMEN
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.
Asunto(s)
Automonitorización de la Glucosa Sanguínea , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2 , Hipoglucemiantes , Años de Vida Ajustados por Calidad de Vida , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/economía , Italia , Automonitorización de la Glucosa Sanguínea/economía , Automonitorización de la Glucosa Sanguínea/instrumentación , Automonitorización de la Glucosa Sanguínea/métodos , Femenino , Masculino , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , Persona de Mediana Edad , Insulina/uso terapéutico , Insulina/economía , Insulina/administración & dosificación , Glucemia/análisis , Glucemia/metabolismo , Anciano , Hemoglobina Glucada/análisis , Hemoglobina Glucada/metabolismo , Hipoglucemia/inducido químicamente , Hipoglucemia/economía , Hipoglucemia/prevención & control , Monitoreo Continuo de GlucosaRESUMEN
Over the past two decades, diabetes pharmacopoeia has flourished, with new drugs that, on top of their glucose-lowering efficacy, have been shown to protect the heart and the kidney. Despite these new opportunities, metformin retains a pivotal role among glucose-lowering agents. As one of the few available insulin sensitizers, metformin is an effective, safe, and overall well-tolerated drug backed by over 60 years of clinical experience, including evidence for potential benefits beyond glucose reduction across different ages, sexes, genetic backgrounds, geographical areas, and stages of disease. Although there is some discussion of whether metformin offers the most effective front-line option in newly diagnosed type 2 diabetes (T2D), it remains a natural companion to all other glucose-lowering agents. Furthermore, metformin comes at a very low cost and, as such, it has extremely high cost-effectiveness, particularly given the serious economic burden associated with diabetes complications. This financial advantage is particularly relevant in resource-constrained healthcare systems, where the affordability of metformin may be instrumental in implementing an effective treatment in an evergrowing number of individuals. We present here compelling real-world evidence in support of the clinical efficacy and cost-effectiveness of metformin across different patient populations, highlighting areas where more population-based studies are needed to further incorporate and consolidate its use in the pharmacological management of T2D.
Asunto(s)
Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2 , Hipoglucemiantes , Metformina , Metformina/uso terapéutico , Metformina/economía , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/economía , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , Femenino , Resultado del Tratamiento , MasculinoAsunto(s)
Costos de los Medicamentos , Péptido 1 Similar al Glucagón , Agonistas Receptor de Péptidos Similares al Glucagón , Adulto , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Péptido 1 Similar al Glucagón/agonistas , Accesibilidad a los Servicios de Salud/economía , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , Estados Unidos/epidemiología , Agonistas Receptor de Péptidos Similares al Glucagón/economía , Agonistas Receptor de Péptidos Similares al Glucagón/uso terapéutico , Obesidad/tratamiento farmacológico , Cobertura del Seguro/economía , Medicare Part D/economía , Enfermedad Crónica/tratamiento farmacológico , Enfermedad Crónica/economíaRESUMEN
BACKGROUND: Deprescribing of medication for cardiovascular risk factors and diabetes has been incorporated in clinical guidelines but proves to be difficult to implement in primary care. Training of healthcare providers is needed to enhance deprescribing in eligible patients. This study will examine the effects of a blended training program aimed at initiating and conducting constructive deprescribing consultations with patients. METHODS: A cluster-randomized trial will be conducted in which local pharmacy-general practice teams in the Netherlands will be randomized to conducting clinical medication reviews with patients as usual (control) or after receiving the CO-DEPRESCRIBE training program (intervention). People of 75 years and older using specific cardiometabolic medication (diabetes drugs, antihypertensives, statins) and eligible for a medication review will be included. The CO-DEPRESCRIBE intervention is based on previous work and applies models for patient-centered communication and shared decision making. It consists of 5 training modules with supportive tools. The primary outcome is the percentage of patients with at least 1 cardiometabolic medication deintensified. Secondary outcomes include patient involvement in decision making, healthcare provider communication skills, health/medication-related outcomes, attitudes towards deprescribing, medication regimen complexity and health-related quality of life. Additional safety and cost parameters will be collected. It is estimated that 167 patients per study arm are needed in the final intention-to-treat analysis using a mixed effects model. Taking loss to follow-up into account, 40 teams are asked to recruit 10 patients each. A baseline and 6-months follow-up assessment, a process evaluation, and a cost-effectiveness analysis will be conducted. DISCUSSION: The hypothesis is that the training program will lead to more proactive and patient-centered deprescribing of cardiometabolic medication. By a comprehensive evaluation, an increase in knowledge needed for sustainable implementation of deprescribing in primary care is expected. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov (identifier: NCT05507177).
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Deprescripciones , Atención Primaria de Salud , Anciano , Femenino , Humanos , Antihipertensivos/uso terapéutico , Antihipertensivos/economía , Factores de Riesgo Cardiometabólico , Enfermedades Cardiovasculares/tratamiento farmacológico , Comunicación , Análisis Costo-Beneficio , Toma de Decisiones Conjunta , Diabetes Mellitus/tratamiento farmacológico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , Países Bajos , Participación del Paciente , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: People with type 2 diabetes (T2D) are at elevated risk of cardiovascular disease (CVD) including stroke, yet existing real-world evidence (RWE) on the clinical and economic burden of stroke in this population is limited. The aim of this cohort study was to evaluate the clinical and economic burden of stroke among people with T2D in France. METHODS: We conducted a retrospective RWE study using data from the nationally representative subset of the French Système National des Données de Santé (SNDS) database. We assessed the incidence of stroke requiring hospitalization between 2012 and 2018 among T2D patients. Subsequent clinical outcomes including CVD, stroke recurrence, and mortality were estimated overall and according to stroke subtype (ischemic versus hemorrhagic). We also examined the treatment patterns for glucose-lowering agents and CVD agents, health care resource utilization and medical costs. RESULTS: Among 45,331 people with T2D without baseline history of stroke, 2090 (4.6%) had an incident stroke requiring hospitalization. The incidence of ischemic stroke per 1000 person-years was 4.9-times higher than hemorrhagic stroke (6.80 [95% confidence interval (CI) 6.47-7.15] versus 1.38 [1.24-1.54]). During a median follow-up of 2.4 years (interquartile range 0.6; 4.4) from date of index stroke, the rate of CVD, stroke recurrence and mortality per 1000 person-years was higher among hemorrhagic stroke patients than ischemic stroke patients (CVD 130.9 [107.7-159.0] versus 126.4 [117.2-136.4]; stroke recurrence: 86.7 [66.4-113.4] versus 66.5 [59.2-74.6]; mortality 291.5 [259.1-327.9] versus 144.1 [134.3-154.6]). These differences were not statistically significant, except for mortality (adjusted hazard ratio 1.95 [95% CI 1.66-2.92]). The proportion of patients prescribed glucagon-like peptide-1 receptor agonists increased from 4.2% at baseline to 6.6% during follow-up. The proportion of patients prescribed antihypertensives and statins only increased slightly following incident stroke (antihypertensives: 70.9% pre-stroke versus 76.7% post-stroke; statins: 24.1% pre-stroke versus 30.0% post-stroke). Overall, 68.8% of patients had a subsequent hospitalization. Median total medical costs were 12,199 (6846; 22,378). CONCLUSIONS: The high burden of stroke among people with T2D, along with the low proportion of patients receiving recommended treatments as per clinical guidelines, necessitates a strengthened and multidisciplinary approach to the CVD prevention and management in people with T2D.
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Bases de Datos Factuales , Diabetes Mellitus Tipo 2 , Accidente Cerebrovascular Hemorrágico , Hipoglucemiantes , Accidente Cerebrovascular Isquémico , Humanos , Diabetes Mellitus Tipo 2/epidemiología , Diabetes Mellitus Tipo 2/economía , Diabetes Mellitus Tipo 2/mortalidad , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Femenino , Masculino , Incidencia , Anciano , Estudios Retrospectivos , Persona de Mediana Edad , Francia/epidemiología , Factores de Tiempo , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , Accidente Cerebrovascular Isquémico/epidemiología , Accidente Cerebrovascular Isquémico/mortalidad , Accidente Cerebrovascular Isquémico/economía , Accidente Cerebrovascular Isquémico/terapia , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Hemorrágico/epidemiología , Accidente Cerebrovascular Hemorrágico/mortalidad , Accidente Cerebrovascular Hemorrágico/economía , Accidente Cerebrovascular Hemorrágico/terapia , Accidente Cerebrovascular Hemorrágico/diagnóstico , Medición de Riesgo , Recurrencia , Factores de Riesgo , Costos de la Atención en Salud , Resultado del Tratamiento , Hospitalización/economía , Anciano de 80 o más Años , Fármacos Cardiovasculares/uso terapéutico , Fármacos Cardiovasculares/economía , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/economía , Accidente Cerebrovascular/terapia , Accidente Cerebrovascular/diagnósticoRESUMEN
OBJECTIVE: To examine the association between missed CMS Star Ratings quality measures for medication adherence over 3 years for diabetes, hypertension, and hyperlipidemia medications (9 measures) and health care utilization and relative costs. STUDY DESIGN: Retrospective cohort study. METHODS: The study examined eligible patients who qualified for the diabetes, statin, and renin-angiotensin system antagonist medication adherence measures in 2018, 2019, and 2020 and were continuously enrolled in a Medicare Advantage prescription drug plan from 2017 through 2021. A total of 103,900 patients were divided into 4 groups based on the number of adherence measures missed (3 medication classes over 3 years): (1) missed 0 measures, (2) missed 1 measure, (3) missed 2 or 3 measures, and (4) missed 4 or more measures. To achieve a quality measure, patients had to meet the Pharmacy Quality Alliance 80% threshold of proportion of days covered during the calendar year. RESULTS: The mean age of the cohort was 71.1 years, and 49.9% were female. Compared with patients who missed 0 of 9 adherence measures, those who missed 1 measure, 2 or 3 measures, and 4 or more measures experienced 12% to 26%, 22% to 42%, and 24% to 50% increased risks, respectively, of all-cause and diabetes-related inpatient stays and all-cause and diabetes-related emergency department visits (all P values < .01). Additionally, patients who missed 1, 2 or 3, and 4 or more adherence measures experienced 14%, 19%, and 20% higher monthly medical costs, respectively. CONCLUSIONS: Missing Star Ratings quality measures for medication adherence was associated with an increased likelihood of health care resource utilization and increased costs for patients taking medications to treat diabetes, hypertension, and hyperlipidemia.
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Diabetes Mellitus , Hiperlipidemias , Hipertensión , Cumplimiento de la Medicación , Aceptación de la Atención de Salud , Humanos , Femenino , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Estudios Retrospectivos , Anciano , Estados Unidos , Hipertensión/tratamiento farmacológico , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/economía , Hiperlipidemias/tratamiento farmacológico , Aceptación de la Atención de Salud/estadística & datos numéricos , Medicare Part C/economía , Medicare Part C/estadística & datos numéricos , Anciano de 80 o más Años , Persona de Mediana Edad , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , Antihipertensivos/uso terapéutico , Antihipertensivos/economía , Indicadores de Calidad de la Atención de SaludRESUMEN
BACKGROUND: In 2014, the US Food and Drug Administration approved the first glucagon-like peptide-1 (GLP-1) receptor agonist product, liraglutide injection, for obesity treatment. Many GLP-1 obesity treatment clinical trials report significant weight loss and medication adherence at more than 85%. Little is known about the real-world GLP-1 obesity treatment adherence, persistence, and switch rates. OBJECTIVE: To measure GLP-1 therapy persistence, adherence, and switch rates in a real-world cohort of members without diabetes using these drugs for obesity treatment. METHODS: Integrated pharmacy and medical claims data from 16.5 million average monthly commercially insured membership were used to identify obese members without diabetes newly initiating GLP-1 therapy between January 1, 2021, and December 31, 2021. Members were required to be continuously enrolled 1-year before and after the GLP-1 therapy start date and aged 19 years of age or older. Persistence was measured as no greater than or equal to 60-day gap with allowance for GLP-1 switching. Adherence was measured as the proportion of days covered (PDC) and members with a PDC greater than or equal to 80% were considered adherent. GLP-1 product switching was also assessed descriptively. RESULTS: 4,066 commercially insured obese members without diabetes that newly initiated GLP-1 therapy met all study criteria. The mean age was 46 years, and 81% were female. Overall, GLP-1 persistence was 46.3% at 180 days and 32.3% at 1 year. The highest and lowest persistence rates at 1 year were observed for semaglutide (Ozempic) at 47.1% and liraglutide (Saxenda) 19.2%, respectively. Average PDC during the 1-year assessment was 51.0% with 27.2% adherent to therapy and 11.1% switched GLP-1 drugs. CONCLUSIONS: This GLP-1 weight loss treatment real-world analysis, among obese individuals without diabetes, found poor 1-year persistence and adherence and low rates of switching between products. These findings will aid in assessing products cost-effectiveness, understanding obesity care management program needs, forecasting future GLP-1 use and cost trends, and negotiating GLP-1 pharmaceutical manufacturer value-based purchasing agreements.
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Receptor del Péptido 1 Similar al Glucagón , Liraglutida , Cumplimiento de la Medicación , Obesidad , Humanos , Femenino , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Obesidad/tratamiento farmacológico , Adulto , Receptor del Péptido 1 Similar al Glucagón/agonistas , Persona de Mediana Edad , Liraglutida/uso terapéutico , Adulto Joven , Estados Unidos , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/economía , Estudios Retrospectivos , Seguro de Salud , Anciano , Agonistas Receptor de Péptidos Similares al GlucagónAsunto(s)
Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2 , Hipoglucemiantes , Evaluación de la Tecnología Biomédica , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/economía , Modelos Económicos , Años de Vida Ajustados por Calidad de VidaRESUMEN
BACKGROUND: Newer diabetes medications have cardiorenal benefits beyond blood sugar lowering that make them a preferred treatment option in many patients. Despite this, studies have shown that prescribing of these medications remains suboptimal with medication costs being hypothesized as a reason for underutilization. OBJECTIVE: To understand clinicians' decision-making processes for prescribing diabetes medications in older adults, focusing on higher cost medications. METHODS: Observations of patient encounters and semi-structured interviews were conducted with clinicians from primary care, endocrinology, and geriatrics to elucidate themes into diabetes medication prescribing. A qualitative descriptive approach was used to analyze the data from interviews using an inductive coding scheme with themes derived from the data. RESULTS: Twenty-one interviews were conducted. Five themes were identified: 1) out-of-pocket costs drive prescribing decisions 2) out-of-pocket costs can be variable due to changing insurance plans or changing coverage 3) clinicians have difficulty with determining patient-specific out-of-pocket costs 4) clinicians manage the tradeoffs existing between cost, efficacy, and safety and 5) clinicians can use cost-modifying strategies such as patient assistance. CONCLUSION: Addressing the challenges that medication costs pose to prescribing evidence-based medications for type 2 diabetes is necessary to optimize diabetes care for older adults.