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AIMS: To evaluate the short-term cost-effectiveness of insulin degludec (degludec) vs insulin glargine 100 units/mL (glargine U100) from a Canadian public healthcare payer perspective in patients with type 2 diabetes (T2D) who are at high risk of cardiovascular events and hypoglycaemia. MATERIALS AND METHODS: A decision analytic model was developed to estimate costs (2017 Canadian dollars [CAD]) and clinical outcomes (quality-adjusted life years [QALYs]) with degludec vs glargine U100 over a 2-year time horizon. The model captured first major adverse cardiovascular event, death, severe hypoglycaemia and insulin dosing. Clinical outcomes were informed by a post hoc subgroup analysis of the DEVOTE trial (NCT01959529), which compared the cardiovascular safety of degludec and glargine U100 in patients with T2D who are at high cardiovascular risk. High hypoglycaemia risk was defined as the top quartile of patients (n = 1887) based on an index of baseline hypoglycaemia risk factors. RESULTS: In patients at high hypoglycaemia risk, degludec was associated with mean cost savings (CAD 129 per patient) relative to glargine U100, driven by a lower incidence of non-fatal myocardial infarction, non-fatal stroke and severe hypoglycaemia, which offset the slightly higher cost of treatment with degludec. A reduced risk of cardiovascular death and severe hypoglycaemia resulted in improved effectiveness (+0.0132 QALYs) with degludec relative to glargine U100. In sensitivity analyses, changes to the vast majority of model parameters did not materially affect model outcomes. CONCLUSION: Over a 2-year period, degludec improved clinical outcomes at a lower cost as compared to glargine U100 in patients with T2D at high risk of cardiovascular events and hypoglycaemia.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Hipoglicemia , Hipoglicemiantes , Insulina Glargina , Idoso , Canadá , Doenças Cardiovasculares/complicações , Doenças Cardiovasculares/epidemiologia , Redução de Custos , Análise Custo-Benefício , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/mortalidade , Feminino , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Insulina Glargina/efeitos adversos , Insulina Glargina/economia , Insulina Glargina/uso terapêutico , Insulina de Ação Prolongada/efeitos adversos , Insulina de Ação Prolongada/economia , Insulina de Ação Prolongada/uso terapêutico , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
INTRODUCTION: The negative impact of hypoglycaemic events on health-related quality of life (HRQoL) may be evaluated by attaching published disutilities to these events. It is suggested that the marginal negative impact of individual hypoglycaemic events on HRQoL may decrease as the overall frequency increases. METHODS: Using disutility values from a large-scale (>8,000 respondents), time trade-off (TTO) study, nonlinear regression curves were fitted to the total disutility of different frequencies of non-severe daytime and nocturnal hypoglycaemic events. Nonparametric bootstrapping was applied to characterise the uncertainty of the marginal disutility. RESULTS: Power function regression curves were estimated at U d = 0.0141x (0.3393) and U d = 0.0221x (0.3277). An increase from 0 to 1 hypoglycaemic event per year produced a utility decrease of 0.0141 and 0.0221 for non-severe daytime and nocturnal events, respectively. An increase from 25 to 26 events per year produced a marginal impact of 0.0006 and 0.0008 for non-severe daytime and nocturnal events, respectively. DISCUSSION: These data concur with the noted phenomenon of "first being worst" as regards hypoglycaemic events. This finding may reflect a coping mechanism on the part of patients, a maximum limit for trading off remaining lifetime or the nature of the study. CONCLUSION: Applying nonlinear functions to the TTO data might improve the precision of the measured impact of hypoglycaemic events.
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Complicações do Diabetes/psicologia , Nível de Saúde , Hipoglicemia/psicologia , Qualidade de Vida , Idoso , Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Feminino , Inquéritos Epidemiológicos , Humanos , Hipoglicemia/etiologia , Hipoglicemiantes/efeitos adversos , Masculino , Pessoa de Meia-Idade , Estatísticas não ParamétricasRESUMO
OBJECTIVE: The aim of this study was to investigate the impact of hypoglycemia according to severity and time of onset on health-related quality of life (HRQoL) in a Canadian population. METHODS: Time trade-off (TTO) methodology was used to estimate health utilities associated with hypoglycemic events in a representative sample of the Canadian population. A global analysis conducted in the United Kingdom, Canada, Germany and Sweden has been published. The present Canadian analysis focuses on 3 populations: general, type 1 and type 2 diabetes. Using a web-based survey, participants (>18 years) assessed the utility of 13 different health states (severe, non-severe, daytime and nocturnal hypoglycemia at different frequencies) using a scale from 1 (perfect health) to 0 (death). The average disutility value for each type of event was calculated. RESULTS: Of 2258 participants, 1696 completers were included in the analysis. A non-severe nocturnal hypoglycemic event was associated with a significantly greater disutility than a non-severe daytime event (-0.0076 vs. -0.0056, respectively; p=0.05), while there was no statistically significant difference between severe nocturnal and severe daytime events (-0.0616 vs. -0.0592; p=0.76). Severe hypoglycemia was associated with greater disutility than non-severe hypoglycemia (p<0.0001). Similar trends were reported in participants with diabetes. CONCLUSIONS: The findings presented here show that any form of hypoglycemia had a negative impact on HRQoL in a Canadian population. Nocturnal and/or severe hypoglycemia had a greater negative impact on HRQoL compared with daytime and/or non-severe events. This highlights the importance of preventing the development and nocturnal manifestation of hypoglycemia in patients with diabetes.
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Diabetes Mellitus Tipo 1/psicologia , Diabetes Mellitus Tipo 2/psicologia , Hipoglicemia/psicologia , Qualidade de Vida , Adulto , Canadá , Estudos Transversais , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Feminino , Nível de Saúde , Humanos , Hipoglicemia/fisiopatologia , Masculino , Pessoa de Meia-Idade , Inquéritos e QuestionáriosRESUMO
BACKGROUND: The clinical meaningfulness of the effects of recently approved disease-modifying treatments (DMT) in Alzheimer's disease is under debate. Available evidence is limited to short-term effects on clinical rating scales which may be difficult to interpret and have limited intrinsic meaning to patients. The main value of DMTs accrues over the long term as they are expected to cause a delay or slowing of disease progression. While awaiting such evidence, the translation of short-term effects to time delays or slowing of progression could offer a powerful and readily interpretable representation of clinical outcomes. METHODS: We simulated disease progression trajectories representing two arms, active and placebo, of a hypothetical clinical trial of a DMT. The placebo arm was simulated based on estimated mean trajectories of clinical dementia rating scale-sum of boxes (CDR-SB) recordings from amyloid-positive subjects with mild cognitive impairment (MCI) from Alzheimer's Disease Neuroimaging Initiative (ADNI). The active arm was simulated to show an average slowing of disease progression versus placebo of 20% at each visit. The treatment effects in the simulated trials were estimated with a progression model for repeated measures (PMRM) and a mixed model for repeated measures (MMRM) for comparison. For PMRM, the treatment effect is expressed in units of time (e.g., days) and for MMRM in units of the outcome (e.g., CDR-SB points). PMRM results were implemented in a health economics Markov model extrapolating disease progression and death over 15 years. RESULTS: The PMRM model estimated a 19% delay in disease progression at 18 months and 20% (~ 7 months delay) at 36 months, while the MMRM model estimated a 25% reduction in CDR-SB (~ 0.5 points) at 36 months. The PMRM model had slightly greater power compared to MMRM. The health economic model based on the estimated time delay suggested an increase in life expectancy (10 months) without extending time in severe stages of disease. CONCLUSION: PMRM methods can be used to estimate treatment effects in terms of slowing of progression which translates to time metrics that can be readily interpreted and appreciated as meaningful outcomes for patients, care partners, and health care practitioners.
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Doença de Alzheimer , Disfunção Cognitiva , Humanos , Doença de Alzheimer/diagnóstico por imagem , Doença de Alzheimer/tratamento farmacológico , Disfunção Cognitiva/diagnóstico por imagem , Disfunção Cognitiva/tratamento farmacológico , Progressão da Doença , Testes de Estado Mental e Demência , Projetos de Pesquisa , Ensaios Clínicos como Assunto , Modelos TeóricosRESUMO
OBJECTIVE: To estimate clinical and social benchmarks for interpretation of score differences on the Short-Form 36 Health Survey, and apply these benchmarks to populations with diabetes mellitus (DM). METHODS: Using survival and logistic regression models, we reanalyzed data from three US cohorts: the Medical Outcomes Study (N = 3,445; 541 patients with DM), the Medicare Health Outcomes Survey (N = 78,183; 16,388 patients with DM), and the QualityMetric 2009 Norming Study (N = 4,040; 580 patients with DM). Outcome variables were mortality, hospitalization, current inability to work, and loss of ability to work. RESULTS: Benchmarks were robust across disease groups, but varied according to age and score level. A 1-point lower score on the Physical Function, General Health, and Physical Component Summary scales was associated with a 1.05 to 1.09 relative risk (RR) of mortality for the typical patient with DM, with stronger associations in the younger age groups. For several scales (Physical Function, Role Physical, Bodily Pain, General Health, Vitality, Social Function, and Role Emotional), the associations with mortality also depended on score level, with stronger associations in the lower score ranges (i.e., patients in worse health). A 1-point lower score on the Physical Function, Role Physical, Bodily Pain, General Health, Vitality, Social Function, and Physical Component Summary scales implied a 1.02 to 1.04 RR of hospitalization, a 1.07 to 1.12 RR of being unable to work, and a 1.04 to 1.07 RR of losing the ability to work. CONCLUSIONS: A 1-point lower score on selected Short-Form 36 Health Survey scales is associated with an excess risk of up to 9% for mortality and 12% for inability to work.
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Benchmarking , Interpretação Estatística de Dados , Diabetes Mellitus , Nível de Saúde , Qualidade de Vida , Inquéritos e Questionários/normas , Adulto , Idoso , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados UnidosRESUMO
BACKGROUND: Hypoglycaemic events, particularly nocturnal, affect health-related quality of life (HRQoL) via acute symptoms, altered behaviour and fear of future events. We examined the respective disutility associated with a single event of daytime, nocturnal, severe and non-severe hypoglycaemia. METHODS: Representative samples were taken from Canada, Germany, Sweden, the United States and the United Kingdom. Individuals completed an internet-based questionnaire designed to quantify the HRQoL associated with different diabetes- and/or hypoglycaemia-related health states. HRQoL was measured on a utility scale: 1 (perfect health) to 0 (death) using the time trade-off method. Three populations were studied: 8286 respondents from the general population; 551 people with type 1 diabetes; and 1603 with type 2 diabetes. Respondents traded life expectancy for improved health states and evaluated the health states of well-controlled diabetes and diabetes with non-severe/severe and daytime/nocturnal hypoglycaemic events. RESULTS: In the general population, non-severe nocturnal hypoglycaemic events were associated with a 0.007 disutility compared with 0.004 for non-severe daytime episodes, equivalent to a significant 63% increase in negative impact. Severe daytime and nocturnal events were associated with a 0.057 and a 0.062 disutility, respectively, which were not significantly different. CONCLUSIONS: This study applies an established health economic methodology to derive disutilities associated with hypoglycaemia stratified by onset time and severity using a large multinational population. It reveals substantial individual and cumulative detrimental effects of hypoglycaemic events - particularly nocturnal - on HRQoL, reinforcing the clinical imperative of avoiding hypoglycaemia.
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Diabetes Mellitus Tipo 1/psicologia , Diabetes Mellitus Tipo 2/psicologia , Hipoglicemia/etiologia , Qualidade de Vida , Adulto , Idoso , Canadá , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Suécia , Fatores de Tempo , Reino Unido , Estados UnidosRESUMO
INTRODUCTION: Real-world evidence has demonstrated improved glycemic control and insulin management following introduction of smart insulin pens in a Swedish type 1 diabetes (T1D) population. To understand the implications for healthcare costs and expected health outcomes, this analysis evaluated the long-term cost-effectiveness of introducing smart insulin pens to standard-of-care T1D treatment (standard care) from a Swedish societal perspective. METHODS: Clinical outcomes and healthcare costs (in 2018 Swedish krona, SEK) were projected over patients' lifetimes using the IQVIA CORE Diabetes Model to estimate cost-effectiveness. Clinical data and baseline characteristics for the simulated cohort were informed by population data and a prospective, noninterventional study of a smart insulin pen in a Swedish T1D population. This analysis captured direct and indirect costs, mortality, and the impact of diabetes-related complications on quality of life. RESULTS: Over patients' lifetimes, smart insulin pen use was associated with per-patient improvements in mean discounted life expectancy (+ 0.90 years) and quality-adjusted life expectancy (+ 1.15 quality-adjusted life-years), in addition to mean cost savings (direct, SEK 124,270; indirect, SEK 373,725), versus standard care. A lower frequency and delayed onset of complications drove projected improvements in quality-adjusted life expectancy and lower costs with smart insulin pens versus standard care. Overall, smart insulin pens were a dominant treatment option relative to standard care across all base-case and sensitivity analyses. CONCLUSIONS: Use of smart insulin pens was projected to improve clinical outcomes at lower costs relative to standard care in a Swedish T1D population and represents a good use of healthcare resources in Sweden.
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OBJECTIVES: The present cost-consequence analysis compared estimated hospitalization costs in a Canadian setting with insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) in patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk. METHODS: Medical terms were mapped across the different vocabularies, in order to assign unit costs from eligible hospital abstracts in Canadian Institute for Health Information data (International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Canada) to serious adverse events (SAEs; Medical Dictionary for Regulatory Activities) from the randomized DEVOTE trial comparing the two insulins degludec and glargine. Mean annual costs of SAE-related hospitalizations were estimated by treatment, the cost difference (degludec - glargine U100) was bootstrapped to compute confidence intervals (CIs) and p-values, and the cost ratio (degludec/glargine U100) was estimated using a Tweedie distribution. RESULTS: The mean annual cost per patient for SAE-related hospitalizations was 4,074 CAD with degludec and 4,569 CAD with glargine U100 (cost difference: -495, 95% confidence interval [CI]: -966; -24, p = .039), for a cost ratio of 0.89 (95% CI: 0.81; 0.98, p = .016). Overall, cost ratios from sensitivity analyses varying individual methodological assumptions were consistent with the main analysis. Of the system organ classes from DEVOTE SAEs, cardiac disorders were the largest contributor to the costs savings with degludec versus glargine U100. CONCLUSIONS: In patients with T2D at high CV risk, our findings suggest that there are likely to be lower hospitalization costs with degludec versus glargine U100 based on the SAEs observed in DEVOTE and in a Canadian setting.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Hipoglicemia , Glicemia , Canadá , Doenças Cardiovasculares/induzido quimicamente , Redução de Custos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobinas Glicadas/análise , Fatores de Risco de Doenças Cardíacas , Hospitalização , Humanos , Hipoglicemiantes/uso terapêutico , Insulina Glargina/efeitos adversos , Insulina de Ação Prolongada , Fatores de RiscoRESUMO
AIMS: To investigate the relationship between potential explanatory factors (socio-economic factors and health) and non-response in two general population health interview surveys (face-to-face and telephone), and to compare the effects of the two interview modes on non-response patterns. METHODS: Data derives from The Danish Health Interview Survey 2000 (face-to-face interview) and The Funen County Health Survey 2000/2001 (telephone interview). Data on all invited individuals were obtained from administrative registers and linked to survey data at individual level. Multiple logistic regression analyses were used to examine associations between potential explanatory factors and non-response. RESULTS: The overall response rate was higher in the face-to-face interview survey (74.5%) than in the telephone survey (69.2%). Refusal was the most common reason for non-response and the same factors were generally associated with non-response in both modes of interview. The non-response rate was high among persons with low socio-economic position. No significant associations between health and non-response were found. CONCLUSIONS: Health status does not play a systematic role for non-response rates in health interview surveys, but the non-response rate is higher in lower socio-economic groups. Analyses of non-response should be performed to understand the implications of survey findings.
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Participação da Comunidade/estatística & dados numéricos , Coleta de Dados/métodos , Nível de Saúde , Inquéritos Epidemiológicos , Recusa de Participação/estatística & dados numéricos , Adolescente , Adulto , Idoso , Dinamarca , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Fatores Socioeconômicos , Inquéritos e Questionários , Telefone , Adulto JovemRESUMO
BACKGROUND: Economic modeling is widely used in estimating cost-effectiveness in type 2 diabetes mellitus. Because type 2 diabetes is complex and patients are heterogenous, the cohort modeling approach may generate biased estimates of costeffectiveness. The IHE Diabetes Cohort Model (IHE-DCM) was constructed using the cohort approach as an alternative for stakeholders with limited resources, some of whom have voiced reasonable concerns about a lack of transparency with type 2 diabetes micro-simulation models and long run times. OBJECTIVES: The objective of this study was to inform decision makers by investigating the direction and magnitude of bias of IHE-DCM cost-effectiveness estimates that can be attributed to the cohort modeling approach. METHODS: Simulation scenarios inspired by the 9th Mount Hood Diabetes Challenge were simulated with IHE-DCM and with a micro-simulation model, the Economic and Health Outcomes Model of T2DM (ECHO-T2DM), and key metrics (absolute and incremental costs and quality-adjusted life-years, event rates, and cost-effectiveness) were compared for evidence of systematic differences. The models were harmonized to the extent possible to ensure that differences were driven primarily by the unit of observation and not by other model differences. RESULTS: IHE-DCM run times were faster and IHE-DCM produced uniformly larger estimates of absolute life-years, quality-adjusted life-years, and costs than ECHO-T2DM but smaller between-arm (incremental) differences. Estimated incremental cost-effectiveness ratios and net monetary benefits varied similarly and predictably across the scenarios. On average, IHE-DCM estimates of incremental cost-effectiveness ratios and net monetary benefits were CAN$269 (3%) and CAN$2935 (10%) smaller, respectively, than ECHO-T2DM. CONCLUSIONS: There was little evidence that estimated cost-effectiveness metrics, the outcomes that matter most to stakeholders, differed systematically.
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Diabetes Mellitus Tipo 2 , Análise Custo-Benefício , Humanos , Hipoglicemiantes , Avaliação de Resultados em Cuidados de Saúde , Anos de Vida Ajustados por Qualidade de VidaRESUMO
Aims: The costs associated with insulin therapy and diabetes-related complications represent a significant and growing economic burden for healthcare systems. The aim of this study was to evaluate the cost-effectiveness of switching to insulin degludec (degludec) vs continuing previous basal insulin, in Italian patients with type 1 (T1D) or type 2 (T2D) diabetes, using a long-term economic model.Materials and methods: Data were retrieved from a real-world population of patients from clinical practice in Italy. Clinical parameters included in the base-case model were change from baseline in HbA1c, rates of hypoglycemia, and basal and bolus insulin dose, at 6 months following switch to degludec. Costs of treatments were taken from official Italian pharmaceutical list prices and costs of hypoglycemia were based on the literature. The data were used to populate a long-term (lifetime) IQVIA CORE Diabetes Model to evaluate the incremental cost-effectiveness ratio (ICER) - cost per quality-adjusted life-year (QALY). The robustness of these results was tested with extensive sensitivity analyses by varying the time horizons and abolishing each of the treatment differences and previous basal insulins.Results: The total incremental cost for degludec vs previous basal insulin was -6,310 and -2,682 for patients with T1D and T2D, respectively; the switch to degludec resulted in a QALY gain of 0.781 and 0.628. The long-term ICER for degludec vs continuing the previous basal insulin regimen showed that degludec was dominant for both T1D and T2D, meaning that patient health was improved in terms of QALYs with lower healthcare costs. Sensitivity analyses showed that degludec remained dominant in most scenarios including after elimination of any benefit in non-severe hypoglycemia and insulin dose, in both T1D and T2D.Conclusions: Under routine care, switching to degludec is dominant, compared with continuing previous basal insulin, in Italian patients with T1D or T2D.
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Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Insulina de Ação Prolongada/economia , Insulina de Ação Prolongada/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Relação Dose-Resposta a Droga , Feminino , Hemoglobinas Glicadas , Gastos em Saúde/estatística & dados numéricos , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Insulina de Ação Prolongada/administração & dosagem , Insulina de Ação Prolongada/efeitos adversos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Estudos RetrospectivosRESUMO
INTRODUCTION: This study aimed to evaluate the short-term cost-effectiveness of insulin degludec 200 units/mL (degludec) versus insulin glargine 300 units/mL (glargine U300) from a Dutch societal perspective. METHODS: A previously published model estimated costs [2018 euros (EUR)] and effectiveness [quality-adjusted life years (QALYs)] with degludec compared with glargine U300 over a 1-year time horizon. The model captured hypoglycaemia rates and insulin dosing. Clinical outcomes were informed by CONCLUDE (NCT03078478), a head-to-head randomised controlled trial in insulin-experienced patients with type 2 diabetes. RESULTS: Treatment with degludec was associated with mean annual cost savings (EUR 24.71 per patient) relative to glargine U300, driven by a lower basal insulin dose and lower severe hypoglycaemia rate with degludec compared with glargine U300. Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300. In sensitivity analyses, changes to the vast majority of model parameters did not materially affect model outcomes. CONCLUSIONS: This short-term analysis, informed by the latest clinical trial evidence, demonstrated that degludec was a cost-effective treatment option relative to glargine U300. As such, our modelling analysis suggests that degludec would represent an efficient use of Dutch public healthcare resources in this patient population.
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Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina Glargina/uso terapêutico , Insulina de Ação Prolongada/uso terapêutico , Análise Custo-Benefício , Relação Dose-Resposta a Droga , Etnicidade , Feminino , Gastos em Saúde/estatística & dados numéricos , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/economia , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/economia , Insulina Glargina/efeitos adversos , Insulina Glargina/economia , Insulina de Ação Prolongada/efeitos adversos , Insulina de Ação Prolongada/economia , Modelos Econométricos , Países Baixos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND AND AIMS: The ReFLeCT study demonstrated that switching to insulin degludec from other basal insulins was associated with reductions in glycated hemoglobin and hypoglycemic events in type 1 (T1D) and type 2 diabetes (T2D), and reductions in insulin doses in T1D. The aim of the present analysis was to assess the short- and long-term cost-effectiveness of switching to insulin degludec in Sweden. METHODS: Short-term outcomes were evaluated over 1 year in a Microsoft Excel model, while long-term outcomes were projected over patient lifetimes using the IQVIA CORE Diabetes Model. Cohort characteristics and treatment effects were sourced from the ReFLeCT study. Costs (in 2018 Swedish krona [SEK]) encompassed direct medical expenditure and indirect costs from loss of workplace productivity. In the long-term analyses, patients were assumed to receive insulin degludec or continue prior insulin therapy (primarily insulin glargine U100) for 5 years, before all patients intensified to once-daily degludec and mealtime aspart. RESULTS: Switching to insulin degludec was associated with improved quality-adjusted life expectancy of 0.04 and 0.02 quality-adjusted life years (QALYs) over 1 year, and 0.16 and 0.08 QALYs over patient lifetimes, in T1D and T2D. Combined costs in T1D and T2D were estimated to be SEK 1,249 lower and SEK 1,181 higher over the short-term, and SEK 157,258 and SEK 2,114 lower over the long-term. Benefits were due to lower insulin doses in T1D, reduced rates of hypoglycemia, and lower incidences of diabetes-related complications. Insulin degludec was associated with an incremental cost-effectiveness ratio of SEK 64,298 per QALY gained for T2D over 1 year and considered dominant for T1D and T2D in all other comparisons. CONCLUSIONS: Insulin degludec was projected to be cost-effective or dominant versus other basal insulins for the treatment of T1D and T2D in Sweden.
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Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/economia , Insulina de Ação Prolongada/economia , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Complicações do Diabetes/economia , Complicações do Diabetes/epidemiologia , Relação Dose-Resposta a Droga , Hemoglobinas Glicadas , Gastos em Saúde/estatística & dados numéricos , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/economia , Hipoglicemiantes/uso terapêutico , Insulina de Ação Prolongada/uso terapêutico , Modelos Econométricos , Anos de Vida Ajustados por Qualidade de Vida , Suécia/epidemiologiaRESUMO
Objective: With healthcare systems under increasing financial pressure from costs associated with diabetes care, it is important to assess which treatments provide clinical benefits and represent best value. This study evaluated the annual costs of insulin degludec (degludec) versus insulin detemir (IDet) in children and adolescents with type 1 diabetes (T1D) in the UK. Research design and methods: Using data from a randomized, treat-to-target, non-inferiority trial-BEGIN YOUNG 1-annual costs with degludec versus IDet in children and adolescents aged 1-17 years with T1D were estimated, as costs of these insulins and hyperglycemia with ketosis events. Analyses by age group (1-5, 6-11 and 12-17 years) and scenario (no ketosis benefit, no dose benefit, hyperglycemia with ketones >0.6 and >3.0 mmol/L and the additional costs of twice-daily IDet in 64% of patients) were also performed. Results: The mean annual cost per patient was estimated as £235.16 for degludec vs £382.91 for IDet, resulting in an annual saving of £147.75 per patient. These substantial cost savings were driven by relative reductions in the frequency of hyperglycemia with ketosis and basal insulin dose with degludec versus IDet. Annual savings in favor of degludec were observed across each age group (£122.63, £140.59 and £172.50 for 1-5, 6-11 and 12-17 years age groups, respectively). Five scenario analyses further demonstrated the robustness of the results, which included no ketosis or dose benefits in favor of degludec. Conclusions: Degludec provides appreciable annual cost savings compared with IDet in children and adolescents with T1D in a UK setting. While a cost-effectiveness analysis could incorporate the health impact of treatment complications better than the present cost analysis, the strong generalizability of the data from this study suggests that degludec can help healthcare providers to maximize health outcomes despite increasingly stringent budgets.
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Biomarcadores/sangue , Análise Custo-Benefício , Diabetes Mellitus Tipo 1/economia , Hipoglicemiantes/economia , Insulina Detemir/economia , Insulina de Ação Prolongada/economia , Adolescente , Glicemia/análise , Criança , Pré-Escolar , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/epidemiologia , Feminino , Seguimentos , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes/uso terapêutico , Lactente , Insulina Detemir/uso terapêutico , Insulina de Ação Prolongada/uso terapêutico , Masculino , Prognóstico , Reino Unido/epidemiologiaRESUMO
OBJECTIVES: To evaluate the cost-effectiveness of insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) in basal-bolus regimens for patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk based on the DEVOTE CV outcomes trial. METHODS: A microsimulation model, informed by clinical outcomes from the subgroup of patients using basal-bolus insulin therapy in DEVOTE (NCT01959529) and by the UKPDS Outcomes Model 2 risk equations, was used to model direct costs (2018 GBP) and effectiveness outcomes [quality-adjusted life years (QALYs)] with degludec versus glargine U100 over a 40-year time horizon. The model captured the development of eight diabetes-related complications, death, severe hypoglycemia and insulin dosing. This analysis was conducted from the perspective of National Health Service (NHS) England. RESULTS: Treatment with degludec versus glargine U100 in basal-bolus regimens was associated with improved clinical outcomes at a higher cost per patient [incremental cost effectiveness ratio (ICER): £14,956 GBP/QALY]. Degludec remained cost effective versus glargine U100 in all exploratory sensitivity analyses, with ICERs below the widely accepted willingness-to-pay threshold, although the result was most sensitive to assumptions regarding the persistence of treatment effects. CONCLUSIONS: Our long-term modeling analysis suggested that degludec was cost effective (from the perspective of NHS England) versus glargine U100 in basal-bolus regimens for patients with T2D at high CV risk. Our findings raise important questions regarding how to model the health economics of diabetes therapies.
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Análise Custo-Benefício , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/economia , Hipoglicemiantes/economia , Insulina Glargina/economia , Insulina de Ação Prolongada/economia , Idoso , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Método de Monte Carlo , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal/economia , Reino UnidoRESUMO
BACKGROUND: Understanding which therapeutic innovations in diabetes represent the best value requires rigorous economic evaluation. Data from randomised controlled trials and observational studies indicate that insulin degludec has a hypoglycemia advantage versus insulin glargine 100 units/mL (glargine U100), the most widely prescribed basal insulin analogue in the UK. This analysis was done to more rigorously assess cost-effectiveness in a UK setting. METHODS: Data from two double-blinded, randomised, two-period crossover trials in type 1 (SWITCH 1) and type 2 (SWITCH 2) diabetes mellitus were used to assess the cost-effectiveness of degludec vs. glargine U100 with an economic model. Cost-effectiveness was analysed over a 1-year time horizon based on the different rates of hypoglycaemia and actual doses of insulin used, rather than glycaemic control due to the treat-to-target trial design. RESULTS: In type 1 diabetes mellitus, degludec was highly cost-effective compared with glargine U100, with an incremental cost-effectiveness ratio of £984 (increased costs of only £23/year and improvement in participant health of 0.0232 quality-adjusted life-years (QALYs)). In type 2 diabetes mellitus, it was estimated that quality of life was improved (0.0065 QALYs gain) with degludec compared with glargine U100 at an increased annual cost of £117 (incremental cost-effectiveness ratio, £17,939). One-way sensitivity analyses showed that the results were robust to changes in parameters in both type 1 and type 2 diabetes mellitus. CONCLUSIONS: The rigorous design of the SWITCH trials, coupled with a representative patient population and a definition of hypoglycaemia that is relevant for real-world patients, makes the results of these trials highly generalisable. The within-trial analysis has the added value of being able to include doses and event rates directly from the trials. This short-term economic analysis estimated that IDeg would be cost-effective relative to IGlar U100 in both type 1 and type 2 diabetes mellitus in the UK. TRIAL REGISTRATION: SWITCH 1 (NCT02034513); SWITCH 2 (NCT02030600). FUNDING: Novo Nordisk, Søborg, Denmark.
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BACKGROUND AND AIMS: Drug rebates are almost universally negotiated privately between the manufacturer and the payer in the US. The aim of the present study was to illustrate the use of a "rebate table" to improve the transparency and utility of published budget impact analyses in the US by modeling ranges of hypothetical rebates for two comparators. Worked examples were conducted to illustrate the budgetary implications of using insulin degludec (IDeg) relative to insulin glargine (IGlar) U100 in patients with type 1 or 2 diabetes. METHODS: A short-term (1-year) budget impact model was developed to evaluate the costs of switching to IDeg from IGlar in patients with type 1 or 2 diabetes on basal-bolus and basal-only insulin, respectively. The analysis used insulin dose and hypoglycemia data from recent randomized trials, data on the prevalence of diabetes, and estimates of the proportion of patients using each insulin regimen. The model was configured to run multiple rebate scenarios to generate a rebate table in a hypothetical 1 million member commercial plan. RESULTS: Relative to IGlar, IDeg resulted in reductions in non-severe and severe hypoglycemia incidence and costs both in patients with type 1 and patients with type 2 diabetes. Insulin acquisition costs were higher, and respective rebates of 7.3% and 10.6% were required for IDeg to break-even with IGlar at the full list price. Incremental per member per month IDeg costs without a rebate were USD 0.04 in type 1 diabetes and USD 0.80 in type 2 diabetes. CONCLUSIONS: Using IDeg instead of IGlar at list price could result in a modest increase in costs when considering insulin and hypoglycemia costs alone, but modest incremental rebates with IDeg would result in cost neutrality relative to IGlar. In addition, IDeg would result in reduced incidence of severe and non-severe hypoglycemia.
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Análise Custo-Benefício , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Insulina Glargina/economia , Insulina de Ação Prolongada/economia , Seguro de Serviços Farmacêuticos/economia , Orçamentos , Redução de Custos , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/economia , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/economia , Custos de Medicamentos , Feminino , Humanos , Insulina Glargina/administração & dosagem , Insulina de Ação Prolongada/administração & dosagem , Seguro de Serviços Farmacêuticos/estatística & dados numéricos , Masculino , Modelos Econômicos , Estados UnidosRESUMO
INTRODUCTION: The aim of this study was to evaluate the short-term cost-utility of insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) for the treatment of type 2 diabetes in the basal-bolus subgroup of the head-to-head cardiovascular (CV) outcome trial, DEVOTE. METHODS: A cost-utility analysis was conducted over a 2-year time horizon using a decision analytic model to compare costs in patients receiving once daily degludec or glargine U100, both as part of a basal-bolus regimen, in addition to standard care. Clinical outcomes and patient characteristics were taken exclusively from DEVOTE, whilst health-related quality of life utilities and UK-specific costs (expressed in 2016 GBP) were obtained from the literature. The analysis was conducted from the perspective of the National Health Service. RESULTS: Degludec was associated with mean cost savings of GBP 28.78 per patient relative to glargine U100 in patients with type 2 diabetes at high CV risk. Cost savings were driven by the reduction in risk of diabetes-related complications with degludec, which offset the higher treatment costs relative to glargine U100. Degludec was associated with a mean improvement of 0.0064 quality-adjusted life-years (QALYs) compared with glargine U100, with improvements driven predominantly by lower rates of severe hypoglycemia with degludec versus glargine U100. Improvements in quality-adjusted life expectancy combined with cost neutrality resulted in degludec being dominant over glargine U100. Sensitivity analyses demonstrated that the incremental cost-utility ratio was stable to variations in the majority of model inputs. CONCLUSION: The present short-term modeling analysis found that for the basal-bolus subgroup of patients in DEVOTE, with a high risk of CV events, degludec was cost neutral (no additional costs) compared with glargine U100 over a 2-year time horizon in the UK setting. Furthermore, there were QALY gains with degludec, particularly due to the reduction in the risk of severe hypoglycemia. FUNDING: Novo Nordisk A/S. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01959529.
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INTRODUCTION: To estimate the cost-effectiveness of insulin degludec (IDeg) versus insulin glargine U100 (IGlar U100) and new-to-market basal insulin analogues in patients with diabetes in order to aid decision-making in a complex basal insulin market. METHODS: A simple, short-term model was used to evaluate the costs and effects of treatment with IDeg versus IGlar U100 over a 12-month period in patients with type 1 (T1DM) and type 2 diabetes (T2DM) from the perspective of the UK National Health Service. New-to-market basal insulin analogues were evaluated in scenario analyses. RESULTS: IDeg is dominant (more effective and less costly) versus IGlar U100 in patients with T1DM and patients with T2DM on a basal-only therapy regimen (T2DMBOT), and is cost-effective versus IGlar U100 in patients with T2DM on a basal-bolus regimen (T2DMB/B). In T1DM, lower costs are primarily driven by lower insulin costs, as a result of a lower daily dose of IDeg. In T2DMBOT, lower overall costs with IDeg are driven by lower costs of severe hypoglycaemic events due to the significant reduction in number of events with IDeg versus IGlar U100. Improvements in clinical outcomes in all three patient groups are a result of the reduced incidence of hypoglycaemic events. Sensitivity analyses demonstrate that the results are robust. Scenario analyses versus two new-to-market basal insulin analogues indicate that in patients with T1DM and T2DMBOT, IDeg is likely to be highly cost-effective versus IGlar biosimilar Abasaglar® and dominant versus IGlar U300 (Toujeo®). In T2DMB/B, IDeg is likely to be cost-effective versus both comparators, with incremental cost-effectiveness ratios (ICERs) below the accepted threshold. CONCLUSION: IDeg is a cost-effective alternative to IGlar U100 for patients with diabetes in the UK, and it also likely to be cost-effective versus two new-to-market basal insulin analogues.
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OBJECTIVES: Health economic analysis from a healthcare and societal point of view was conducted to assess the cost-effectiveness of insulin degludec (IDeg) after switching from other basal insulins in people with type 1 diabetes. MATERIAL AND METHODS: This was a prospective, open-label, single arm, observational follow-up from August 2013 to October 2015 of 476 consecutive patients at Danderyd Hospital (Stockholm, Sweden) who switched to IDeg from other basal insulins (99% basal insulin analogs). The IMS CORE Diabetes Model (CDM) was used to predict the cost-effectiveness of life-long treatment with IDeg vs. other basal insulins, based on a Swedish setting. RESULTS: Mean (SD) duration of follow-up was 21.7 (6.0) weeks. Mean HbA1c decreased by 2.7 mmol/mol, mean basal insulin dose decreased by 13.1% (p < .0001), and mean bolus insulin dose decreased by 7.5% (p < .0001) after switching. Frequencies of non-severe daytime hypoglycemia and non-severe nocturnal hypoglycemia decreased by 12% (p = .0127) and 53% (p < .0001) respectively and severe hypoglycemia was reduced by 62% (p = .0225). The CDM predicted a gain in life expectancy of 0.33 years, a discounted gain in quality-adjusted life-years (QALYs) of 0.54, and lower estimated direct lifetime healthcare costs of SEK 22,757 for patients switching to IDeg. The incremental cost-effectiveness ratio (ICER) showed IDeg as dominant (i.e. higher effectiveness with a lower cost). Sensitivity analyses confirmed the results. CONCLUSION: Based on this prospective, real-world, follow-up and using the CDM, it was estimated that switching to IDeg from other basal insulins translated into QALY gains including improved life expectancy and health-related quality of life, as well as dominant ICER, meaning cost-savings for the healthcare system. However, the study is limited by its observational design. Extrapolation into the future is only estimated since the actual treatment effect cannot be projected with certainty.