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BACKGROUND: Health economic evaluations require cost data as key inputs. Many countries do not have standardized reference costs so costs used often vary between studies, thereby reducing transparency and transferability. The present review provided a comprehensive overview of cost sources and suggested unit costs for France, Germany and Italy, to support health economic evaluations in these countries, particularly in the field of diabetes. METHODS: A literature review was conducted across multiple databases to identify published unit costs and cost data sources for resource items commonly used in health economic evaluations of antidiabetic therapies. The quality of unit cost reporting was assessed with regard to comprehensiveness of cost reporting and referencing as well as accessibility of cost sources from published cost-effectiveness analyses (CEA) of antidiabetic medications. RESULTS: An overview of cost sources, including tariff and fee schedules as well as published estimates, was developed for France, Germany and Italy, covering primary and specialist outpatient care, emergency care, hospital treatment, pharmacy costs and lost productivity. Based on these sources, unit cost datasets were suggested for each country. The assessment of unit cost reporting showed that only 60% and 40% of CEAs reported unit costs and referenced them for all pharmacy items, respectively. Less than 20% of CEAs obtained all pharmacy costs from publicly available sources. CONCLUSIONS: This review provides a comprehensive account of available costs and cost sources in France, Germany and Italy to support health economists and increase transparency in health economic evaluations in diabetes.
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Diabetes Mellitus , Análisis Costo-Beneficio , Francia , Alemania , Humanos , ItaliaRESUMEN
Aims: The efficacy and safety of oral semaglutide, the first glucagon-like peptide-1 (GLP-1) receptor agonist developed for oral administration for the treatment of type 2 diabetes, was evaluated in the PIONEER clinical trial program, and a recently published network meta-analysis allowed comparison with further injectable GLP-1 receptor agonists. The present study aimed to assess the short-term cost- effectiveness of oral semaglutide 14 mg versus subcutaneous once-weekly dulaglutide 1.5 mg, once-weekly exenatide 2 mg, twice-daily exenatide 10 µg, once-daily liraglutide 1.8 mg, once-daily lixisenatide 20 µg, and once-weekly semaglutide 1 mg, in terms of the cost per patient achieving glycated hemoglobin (HbA1c) targets (cost of control).Materials and methods: Cost of control was calculated by dividing the annual treatment costs associated with an intervention by the proportion of patients achieving the treatment target with an intervention, with outcomes calculated for targets of HbA1c ≤6.5% and HbA1c <7.0% for all included GLP-1 receptor agonists. Annual treatment costs were accounted in 2019 United States dollars (USD), based on 2019 wholesale acquisition cost.Results: For the treatment target of HbA1c ≤6.5%, once-weekly semaglutide 1 mg and oral semaglutide 14 mg were associated with the lowest costs of control, at USD 15,430 and USD 17,383 per patient achieving target, respectively. Similarly, the cost of control was lowest with once-weekly semaglutide 1 mg at USD 12,627 per patient achieving target, followed by oral semaglutide 14 mg at USD 13,493 per patient achieving target for the target of HbA1c <7.0%. All other interventions were associated with higher cost of control values for both targets.Conclusions: Oral semaglutide 14 mg is likely to be cost-effective versus dulaglutide, exenatide (once weekly and twice daily), liraglutide, and lixisenatide in terms of bringing people with type 2 diabetes to glycemic control targets of HbA1c ≤6.5% and HbA1c <7.0% in the US.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Receptor del Péptido 1 Similar al Glucagón/agonistas , Péptidos Similares al Glucagón/economía , Péptidos Similares al Glucagón/uso terapéutico , Hipoglucemiantes/economía , Hipoglucemiantes/uso terapéutico , Administración Oral , Análisis Costo-Beneficio , Esquema de Medicación , Exenatida/uso terapéutico , Péptidos Similares al Glucagón/administración & dosificación , Péptidos Similares al Glucagón/efectos adversos , Péptidos Similares al Glucagón/análogos & derivados , Hemoglobina Glucada , Humanos , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Fragmentos Fc de Inmunoglobulinas/uso terapéutico , Inyecciones Subcutáneas , Liraglutida/uso terapéutico , Péptidos/uso terapéutico , Proteínas Recombinantes de Fusión/uso terapéuticoRESUMEN
BACKGROUND: Compared with basal-bolus insulin therapy (insulin glargine U100 plus insulin aspart), IDegLira has been shown to be associated with similar improvements in HbA1c, with superior weight loss and reduced hypoglycemia in patients with type 2 diabetes. The present analysis evaluated the cost per patient with type 2 diabetes achieving HbA1c-focused and composite treatment targets with IDegLira and insulin glargine U100 plus insulin aspart (≤4 times daily). METHODS: The proportions of patients achieving treatment targets were obtained from the treat-to-target, non-inferiority DUAL VII study (NCT02420262). The annual cost per patient achieving target (cost of control) was analyzed from a US healthcare payer perspective. The annual cost of control was assessed for eight prespecified endpoints and four post-hoc endpoints. RESULTS: The number needed to treat to bring one patient to targets of HbA1c <7.0% and HbA1c ≤6.5% was similar with IDegLira and insulin glargine U100 plus insulin aspart. However, when weight gain and/or hypoglycemia were included, the number needed to treat was lower with IDegLira. IDegLira and insulin glargine U100 plus insulin aspart had similar costs of control for HbA1c <7.0%. However, cost of control values were substantially lower with IDegLira when the more stringent target of HbA1c ≤6.5% was used, and when patient-centered outcomes of hypoglycemia risk and impact on weight were included. CONCLUSION: IDegLira was shown to be a cost-effective treatment vs insulin glargine U100 plus insulin aspart for patients with type 2 diabetes not achieving glycemic targets on basal insulin in the USA.
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BACKGROUND AND AIMS: IDegLira, a fixed ratio combination of insulin degludec and glucagon-like peptide-1 receptor agonist liraglutide, utilizes the complementary mechanisms of action of these two agents to improve glycemic control with low risk of hypoglycemia and avoidance of weight gain. The aim of the present analysis was to assess the long-term cost-effectiveness of IDegLira vs liraglutide added to basal insulin, for patients with type 2 diabetes not achieving glycemic control on basal insulin in the US setting. METHODS: Projections of lifetime costs and clinical outcomes were made using the IMS CORE Diabetes Model. Treatment effect data for patients receiving IDegLira and liraglutide added to basal insulin were modeled based on the outcomes of a published indirect comparison, as no head-to-head clinical trial data is currently available. Costs were accounted in 2015 US dollars ($) from a healthcare payer perspective. RESULTS: IDegLira was associated with small improvements in quality-adjusted life expectancy compared with liraglutide added to basal insulin (8.94 vs 8.91 discounted quality-adjusted life years [QALYs]). The key driver of improved clinical outcomes was the greater reduction in glycated hemoglobin associated with IDegLira. IDegLira was associated with mean costs savings of $17,687 over patient lifetimes vs liraglutide added to basal insulin, resulting from lower treatment costs and cost savings as a result of complications avoided. CONCLUSIONS: The present long-term modeling analysis found that IDegLira was dominant vs liraglutide added to basal insulin for patients with type 2 diabetes failing to achieve glycemic control on basal insulin in the US, improving clinical outcomes and reducing direct costs.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/economía , Hipoglucemiantes/uso terapéutico , Insulina de Acción Prolongada/economía , Insulina de Acción Prolongada/uso terapéutico , Liraglutida/economía , Liraglutida/uso terapéutico , Glucemia/efectos de los fármacos , Presión Sanguínea , Índice de Masa Corporal , Análisis Costo-Beneficio , Complicaciones de la Diabetes/economía , Complicaciones de la Diabetes/prevención & control , Método Doble Ciego , Combinación de Medicamentos , Quimioterapia Combinada , Hemoglobina Glucada/efectos de los fármacos , Humanos , Hipoglucemia/inducido químicamente , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Insulina/economía , Insulina/uso terapéutico , Insulina de Acción Prolongada/administración & dosificación , Insulina de Acción Prolongada/efectos adversos , Lípidos/sangre , Liraglutida/administración & dosificación , Liraglutida/efectos adversos , Cadenas de Markov , Modelos Económicos , Método de Montecarlo , Años de Vida Ajustados por Calidad de Vida , Estados Unidos , Aumento de PesoRESUMEN
BACKGROUND: The National Institute for Health and Clinical Excellence (NICE) recommended the Oncotype DX® Breast Recurrence Score® (RS) assay as an option for informing adjuvant chemotherapy decisions in node-negative, oestrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer assessed to be at intermediate risk of recurrence based on clinicopathological factors. We evaluated the impact of RS testing on adjuvant chemotherapy decision-making in routine clinical practice in a UK Cancer Network. METHODS: RS testing was performed in 201 females with newly diagnosed, ER+, HER2-negative, invasive breast cancer who underwent breast surgery with curative intent, were calculated to have a >3% overall survival benefit at 10 years from adjuvant chemotherapy based on PREDICT, and were considered for adjuvant chemotherapy. The impact of RS testing on adjuvant treatment decisions/associated cost was assessed. RESULTS: In all patients, the multi-disciplinary team recommended chemotherapy but the RS result allowed 127/201 patients (63.2%) to avoid unnecessary adjuvant chemotherapy. Amongst ER+, HER2-negative, node-negative patients (eligible for Oncotype DX testing in UK guidelines), 60.3% were spared chemotherapy. In node-positive patients, the assay reduced the use of chemotherapy by 69.2%. The use of RS testing to guide treatment in these 201 patients was associated with significant cost saving (when considering the cost of RS testing for all patients plus chemotherapy and its associated cost for 74 patients). CONCLUSIONS: Incorporating RS testing into routine clinical practice for selected node-negative and node-positive breast cancer patients significantly reduces the use of chemotherapy (p < 0.001) with its associated morbidity and costs.
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Antineoplásicos/uso terapéutico , Neoplasias de la Mama/genética , Neoplasias de la Mama/terapia , Perfilación de la Expresión Génica , Adulto , Anciano , Antineoplásicos/economía , Neoplasias de la Mama/química , Neoplasias de la Mama/patología , Quimioterapia Adyuvante/economía , Quimioterapia Adyuvante/estadística & datos numéricos , Toma de Decisiones Clínicas , Femenino , Estudios de Seguimiento , Perfilación de la Expresión Génica/economía , Perfilación de la Expresión Génica/métodos , Genómica , Humanos , Metástasis Linfática , Persona de Mediana Edad , Invasividad Neoplásica , Guías de Práctica Clínica como Asunto , Receptor ErbB-2/análisis , Receptores de Estrógenos/análisis , Tasa de Supervivencia , Reino Unido , Adulto JovenRESUMEN
AIMS: The aim of the analysis was to investigate whether insulin intensification, based on the use of intensive insulin regimens as recommended by the current standard of care in routine clinical practice, would be cost-effective for patients with type 2 diabetes in the UK. METHODS: Clinical data were derived from a retrospective analysis of 3185 patients with type 2 diabetes on basal insulin in The Health Improvement Network (THIN) general practice database. In total, 48% (614 patients) intensified insulin therapy, defined by adding bolus or premix insulin to a basal regimen, which was associated with a reduction in HbA1c and an increase in body mass index. Projections of clinical outcomes and costs (2011 GBP) over patients' lifetimes were made using a recently validated type 2 diabetes model. RESULTS: Immediate insulin intensification was associated with improvements in life expectancy, quality-adjusted life expectancy and time to onset of complications versus no intensification or delaying intensification by 2, 4, 6, or 8 years. Direct costs were higher with the insulin intensification strategy (due to the acquisition costs of insulin). Incremental cost-effectiveness ratios for insulin intensification were GBP 32,560, GBP 35,187, GBP 40,006, GBP 48,187 and GBP 55,431 per QALY gained versus delaying intensification 2, 4, 6 and 8 years, and no intensification, respectively. CONCLUSIONS: Although associated with improved clinical outcomes, insulin intensification as practiced in the UK has a relatively high cost per QALY and may not lead to cost-effective outcomes for patients with type 2 diabetes as currently defined by UK cost-effectiveness thresholds.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/economía , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/economía , Insulina/administración & dosificación , Insulina/economía , Nivel de Atención/economía , Anciano , Índice de Masa Corporal , Análisis Costo-Beneficio , Costos y Análisis de Costo , Diabetes Mellitus Tipo 2/epidemiología , Femenino , Humanos , Esperanza de Vida , Masculino , Persona de Mediana Edad , Calidad de Vida , Estudios Retrospectivos , Reino Unido/epidemiologíaRESUMEN
AIMS: The Associazione Medici Diabetologi-annals initiative is a physician-led quality-of-care improvement scheme that has been shown to improve HbA1c concentration, blood pressure, lipid profiles and BMI in enrolled people with Type 2 diabetes. The present analysis investigated the long-term cost-effectiveness of enrolling people with Type 2 diabetes in the Associazione Medici Diabetologi-annals initiative compared with conventional management. METHODS: Long-term projections of clinical outcomes and direct costs (in 2010 Euros) were made using a published and validated model of Type 2 diabetes in people with Type 2 diabetes who were either enrolled in the Associazione Medici Diabetologi-annals initiative or who were receiving conventional management. Treatment effects were based on mean changes from baseline seen at 5 years after enrolment in the scheme. Costs and clinical outcomes were discounted at 3% per annum. RESULTS: The Associazione Medici Diabetologi-annals initiative was associated with improvements in mean discounted life expectancy and quality-adjusted life expectancy of 0.55 years (95% CI 0.54-0.57) years and 0.48 quality-adjusted life years (95% CI 0.46-0.49), respectively, compared with conventional management. Whilst treatment costs were higher in the Associazione Medici Diabetologi-annals arm, this was offset by savings as a result of the reduced incidence and treatment of diabetes-related complications. The Associazione Medici Diabetologi-annals initiative was found to be cost-saving over patient lifetimes compared with conventional management [ 37,289 (95% CI 37,205-37,372) vs 41,075 (95% CI 40,956-41,155)]. CONCLUSIONS: Long-term projections indicate that the physician-led Associazione Medici Diabetologi-annals initiative represents a cost-saving method of improving long-term clinical outcomes compared with conventional management of people with Type 2 diabetes in Italy.
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Análisis Costo-Beneficio/métodos , Diabetes Mellitus Tipo 2/economía , Diabetes Mellitus Tipo 2/terapia , Manejo de la Enfermedad , Calidad de la Atención de Salud/economía , Calidad de la Atención de Salud/tendencias , Anciano , Complicaciones de la Diabetes/epidemiología , Femenino , Costos de la Atención en Salud/estadística & datos numéricos , Costos de la Atención en Salud/tendencias , Humanos , Incidencia , Italia , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud/economía , Evaluación de Resultado en la Atención de Salud/tendencias , Años de Vida Ajustados por Calidad de Vida , Factores de TiempoRESUMEN
OBJECTIVE: To evaluate the annual cost-utility of insulin degludec compared with glargine in patients with: type 1 diabetes (T1D), type 2 diabetes receiving basal-only therapy (T2D-BOT), and type 2 diabetes receiving basal-bolus therapy (T2B-BB) in Sweden. METHODS: A cost-utility model was programmed in Microsoft Excel to evaluate clinical and economic outcomes. The clinical trials were designed as treat-to-target, with insulin doses adjusted in order to achieve similar glycemic control between treatments, thus long-term modeling is not meaningful. Basal and bolus insulin doses, incidence of hypoglycemic events, frequency of self-monitoring of blood glucose, and possibility for flexibility in timing of dose administration were specified for each insulin in three diabetes populations, based on data collected in Swedish patients with diabetes and a meta-analysis of clinical trials with degludec. Using these characteristics, the model estimated costs from a societal perspective and quality-adjusted life years (QALYs) in the two scenarios. RESULTS: Use of degludec was associated with a QALY gain compared with glargine in T1D (0.31 vs 0.26 QALYs), T2D-BOT (0.76 vs 0.69 QALYs), and T2D-BB (0.56 vs 0.47 QALYs), driven by reduced incidence of hypoglycemia and possibility for flexibility around timing of dose administration. Therapy regimens containing degludec were associated with increased costs compared to glargine-based regimens, driven by the increased pharmacy cost of basal insulin, but partially offset by other cost savings. Based on estimates of cost and clinical outcomes, degludec was associated with incremental cost-effectiveness ratios of SEK 19,766 per QALY gained, SEK 10,082 per QALY gained, and SEK 36,074 per QALY gained in T1D, T2-BOT, and T2-BB, respectively. LIMITATIONS: The hypoglycemic event rates in the base case analysis were derived from a questionnaire-based study that relied on patient interpretation and recall of hypoglycemic symptoms. The relative rates of hypoglycemia with degludec compared to glargine were derived from a meta-analysis of phase III trials, which may not reflect the relative rates observed in real-world clinical practice. Both of these key limitations were explored in one-way sensitivity analyses. CONCLUSIONS: Based on reduced incidence of hypoglycemia and possibility for flexibility around timing of dose administration, use of degludec is likely to be cost-effective compared to glargine from a societal perspective in T1D, T2-BOT, and T2-BB in Sweden over a 1-year time horizon.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/economía , Insulina de Acción Prolongada/economía , Costo de Enfermedad , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 1/economía , Diabetes Mellitus Tipo 2/economía , Humanos , Hipoglucemia/economía , Hipoglucemia/epidemiología , Hipoglucemiantes/administración & dosificación , Insulina Glargina , Insulina de Acción Prolongada/administración & dosificación , Modelos Económicos , Años de Vida Ajustados por Calidad de Vida , SueciaRESUMEN
Over 4 million patients suffer nosocomial infections annually in the European Union. This study aimed to estimate the healthcare burden associated with healthcare-associated infections (HAIs) following surgery in France, and explore the potential impact of infection control strategies and interventions on the clinical and economic burden of disease. Data on the frequency of HAIs were gathered from the 2010 Programme de Médicalisation des Systèmes d'Information (PMSI), and cost data were taken from the 2009 Echelle Nationale de Coûts à Méthodologie Commune (ENCC). It was estimated that 3% of surgical procedures performed in 2010 in France resulted in infection, resulting in an annual cost of 57 892 715. Patients experiencing a HAI had a significantly increased mortality risk (4.15-fold) and an increased length of hospital stay (threefold). Scenario analysis in which HAI incidence following surgery was reduced by 8% (based on a study of the effectiveness of triclosan-coated sutures), suggested that, annually, 20 205 hospital days and 4 588 519 could be saved. Analyses of 20% and 30% reductions in incidence (based on an estimate of the number of preventable nosocomial infections) suggested that annual savings of 11 548 057 and 17 334 696, respectively, could be made. New infection control interventions which reduce HAI incidence during hospitalization for surgery have the potential to provide valuable cost savings to healthcare providers.
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Infección Hospitalaria/economía , Infección Hospitalaria/epidemiología , Infección de la Herida Quirúrgica/economía , Infección de la Herida Quirúrgica/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Francia/epidemiología , Costos de la Atención en Salud , Humanos , Incidencia , Control de Infecciones/economía , Control de Infecciones/métodos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Análisis de Supervivencia , Adulto JovenRESUMEN
AIM: To evaluate the cost-effectiveness of laparoscopic adjustable gastric banding (LAGB) versus standard medical management (SMM) in obese patients with type 2 diabetes from a UK healthcare payer perspective. METHODS: A validated computer model of diabetes was used to project outcomes reported from a randomized clinical trial of LAGB versus SMM in obese patients with type 2 diabetes. Two-year follow-up data from the trial were projected over a 40-year time horizon and cost-effectiveness was assessed from the perspective of the National Health Service. Future costs and clinical outcomes were discounted at 3.5% annually and all costs were reported in 2010 pounds sterling. A series of sensitivity analyses were performed. RESULTS: LAGB was associated with benefits in HbA1c, systolic blood pressure, body mass index and serum lipid concentrations, which led to significant increases in discounted life expectancy (an increase of 0.64 years) and quality-adjusted life expectancy (an increase of 0.92 quality-adjusted life years, QALYs) and reduced incidence of diabetes complications relative to SMM. Treatment costs in the LAGB arm increased by 4552 Great British Pounds (GBP), but this was partially offset by cost savings resulting from a reduction in the incidence of all modelled diabetes complications. The incremental cost-effectiveness ratio of GBP 3602 per QALY in the base case fell well below commonly quoted willingness-to-pay thresholds in the UK setting. CONCLUSIONS: On the basis of data from a recent randomized controlled trial, LAGB is likely to be considered cost-effective from the healthcare payer perspective when compared with SMM of obesity in patients with type 2 diabetes in the UK setting.
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Diabetes Mellitus Tipo 2/economía , Diabetes Mellitus Tipo 2/terapia , Angiopatías Diabéticas/prevención & control , Gastroplastia/economía , Hipoglucemiantes/economía , Obesidad/economía , Obesidad/cirugía , Adolescente , Adulto , Índice de Masa Corporal , Comorbilidad , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/epidemiología , Angiopatías Diabéticas/economía , Angiopatías Diabéticas/epidemiología , Femenino , Gastroplastia/métodos , Hemoglobina Glucada/metabolismo , Humanos , Hipoglucemiantes/uso terapéutico , Masculino , Persona de Mediana Edad , Modelos Económicos , Obesidad/complicaciones , Obesidad/epidemiología , Obesidad/terapia , Selección de Paciente , Guías de Práctica Clínica como Asunto , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Reino Unido/epidemiologíaRESUMEN
OBJECTIVE: The 21-gene assay (Oncotype DX Breast Cancer Test (Genomic Health Inc., Redwood City, CA)) is a well validated test that predicts the likelihood of adjuvant chemotherapy benefit and the 10-year risk of distant recurrence in patients with ER+, HER2- early-stage breast cancer. The aim of this analysis was to evaluate the cost-effectiveness of using the assay to inform adjuvant chemotherapy decisions in Germany. METHODS: A Markov model was developed to make long-term projections of distant recurrence, survival, quality-adjusted life expectancy, and direct costs for patients with ER+, HER2-, node-negative, or up to 3 node-positive early-stage breast cancer. Scenarios using conventional diagnostic procedures or the 21-gene assay to inform treatment recommendations for adjuvant chemotherapy were modeled based on a prospective, multi-center trial in 366 patients. Transition probabilities and risk adjustment were based on published landmark trials. Costs (2011 Euros ()) were estimated from a sick fund perspective based on resource use in patients receiving chemotherapy. Future costs and clinical benefits were discounted at 3% annually. RESULTS: The 21-gene assay was projected to increase mean life expectancy by 0.06 years and quality-adjusted life expectancy by 0.06 quality-adjusted life years (QALYs) compared with current clinical practice over a 30-year time horizon. Clinical benefits were driven by optimized allocation of adjuvant chemotherapy. Costs from a healthcare payer perspective were lower with the 21-gene assay by â¼561 vs standard of care. Probabilistic sensitivity analysis indicated that there was an 87% probability that the 21-gene assay would be dominant (cost and life saving) to standard of care. LIMITATIONS: Country-specific data on the risk of distant recurrence and quality-of-life were not available. CONCLUSIONS: Guiding decision-making on adjuvant chemotherapy using the 21-gene assay was projected to improve survival, quality-adjusted life expectancy, and be cost saving vs the current standard of care women with ER+, HER2- early-stage breast cancer.
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Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/genética , Quimioterapia Adyuvante/economía , Adulto , Factores de Edad , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Ensayos Clínicos como Asunto , Análisis Costo-Beneficio , Toma de Decisiones , Femenino , Perfilación de la Expresión Génica , Alemania , Gastos en Salud/estadística & datos numéricos , Humanos , Esperanza de Vida , Cadenas de Markov , Persona de Mediana Edad , Modelos Econométricos , Estudios Multicéntricos como Asunto , Recurrencia Local de Neoplasia/economía , Recurrencia Local de Neoplasia/epidemiología , Años de Vida Ajustados por Calidad de Vida , Receptor ErbB-2/genética , Reacción en Cadena de la Polimerasa de Transcriptasa InversaRESUMEN
OBJECTIVE: To evaluate the financial consequences of using laparoscopic adjustable gastric banding (LAGB) in place of standard medical management (SMM) in obese patients with type 2 diabetes from a UK healthcare payer perspective. DESIGN AND METHODS: A budget impact model was constructed to evaluate the budgetary implications of LAGB in obese patients with type 2 diabetes in the UK. For patients undergoing LAGB, the model captured pre-, peri-, and post-operative costs including consultations with physicians, psychologists, nurses, and dieticians, the cost of surgery, and costs associated with post-surgical complications. The model also captured costs associated with medication for diabetes, asthma, hypertension, and hyperlipidemia, costs of diabetes complications, sleep apnea, and asthma, and costs of diagnostic tests. The SMM arm also captured costs associated with very low calorie diet products. Costs were modeled in a simulated UK cohort of 100 obese patients with newly-diagnosed diabetes. Future costs were discounted at 3.5% per annum and all costs were reported in 2010 pounds sterling. RESULTS: Over the 5-year time horizon, the cohort of 100 patients who underwent LAGB incurred costs £91,287 lower than an equivalent cohort receiving SMM (£818,668 and £909,955, respectively). Costs of surgery and post-surgical complications (£254,000 and £40,981, respectively) were more than offset by savings arising from reduced diabetes, asthma, and sleep apnea medication costs, reduced incidence of diabetes complications, and fewer healthcare professional contacts. Sensitivity analysis (SA) showed that the model was most sensitive to assumptions around diabetes medication use, although none of the SA findings showed LAGB to be more costly than SMM. LIMITATIONS: In order to capture the diverse resource use and medical care costs arising in obese patients with type 2 diabetes, the analysis made use of a range of heterogeneous data sources. While the vast majority of data were applicable to obese patients with recently-diagnosed diabetes in the UK setting, some surrogate data (e.g. from different geographies) were used in cases where data in the target population were unavailable. Additionally, given the largely uncharacterized long-term risk profile in patients with remission of type 2 diabetes, remission was captured using a transparent and highly conservative approach. CONCLUSIONS: Based on the findings of the present analysis, the high initial costs of performing LAGB are offset within 5 years after surgery when compared with SMM in a population of obese patients with type 2 diabetes. The high up-front costs associated with surgery should not therefore be a barrier to its reimbursement in this patient group.
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Presupuestos , Diabetes Mellitus Tipo 2 , Gastroplastia/economía , Laparoscopía/métodos , Obesidad/cirugía , Adulto , Estudios de Cohortes , Costos y Análisis de Costo , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/epidemiología , Femenino , Gastroplastia/métodos , Humanos , Masculino , Persona de Mediana Edad , Modelos Econométricos , Obesidad/complicaciones , Obesidad/economía , Atención Perioperativa/economía , Medicina Estatal/economía , Reino Unido/epidemiologíaRESUMEN
AIM: To evaluate the cost-effectiveness of insulin detemir vs. NPH insulin once daily, in patients with type 2 diabetes in the Swedish setting based on clinical data from a published randomized controlled trial. METHODS: Projections of long-term outcomes were made using the IMS CORE Diabetes Model (CDM), based on clinical data from a 26-week randomized controlled trial that compared once daily insulin detemir and NPH insulin, when used to intensify insulin treatment in 271 patients with type 2 diabetes and body mass index (BMI) 25-40 kg/m(2). Trial results showed that insulin detemir was associated with a significantly lower incidence of hypoglycemic events and significantly less weight gain in comparison with NPH insulin. The analysis was conducted from a third party payer perspective and the base case analysis was performed over a time horizon of 40 years and future costs and clinical outcomes were discounted at a rate of 3% per year. RESULTS: Insulin detemir was associated with higher mean (SD) quality-adjusted life expectancy (5.42 [0.10] vs. 5.31 [0.10] quality-adjusted life years [QALYs]) and lower overall costs (SEK 378,539 [10,372] vs. SEK 384,216 [11,230]; EUR 33,794 and EUR 34,300, respectively, where 1 EUR=11.2015 SEK) compared with NPH insulin. Sensitivity analysis showed that the principal driver of the benefits associated with insulin detemir was the lower rate of hypoglycemic events (major and minor events) vs. NPH insulin, suggesting that detemir might also be cost-saving over a shorter time horizon. Limitations of the analysis include the use of data from a trial outside Sweden in the Swedish setting. CONCLUSIONS: Based on clinical input data derived from a previously published randomized controlled trial, it is likely that in the Swedish setting insulin detemir would be cost-saving in comparison with NPH insulin for the treatment of patients with type 2 diabetes.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/economía , Insulina Isófana/economía , Insulina de Acción Prolongada/economía , Adulto , Anciano , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2/complicaciones , Femenino , Humanos , Hipoglucemiantes/administración & dosificación , Insulina Detemir , Insulina Isófana/administración & dosificación , Insulina de Acción Prolongada/administración & dosificación , Masculino , Persona de Mediana Edad , Modelos Teóricos , Evaluación de Resultado en la Atención de Salud , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Suecia , Resultado del TratamientoRESUMEN
AIMS: To estimate short-term cost-effectiveness of insulin detemir vs. NPH insulin based on the incidence of mild hypoglycaemia in subjects with Type 1 diabetes in Denmark, Sweden, Finland and the Netherlands. METHODS: A model was developed to evaluate cost-effectiveness based on mild (self-treated) hypoglycaemia and pharmacy costs over 1 year. Published rates of mild hypoglycaemia were used for NPH insulin and insulin detemir. Effectiveness was calculated in terms of quality-adjusted life expectancy. Pharmacy costs were accounted using published prices and defined daily doses for both insulins. Costs were expressed in 2010 euros (). RESULTS: Treatment with insulin detemir was associated with fewer mild hypoglycaemic events than NPH insulin (mean rates of 26.3 vs. 35.5 events per person-year), leading to an improvement in mean quality-adjusted life expectancy of approximately 0.019 (0.030) quality-adjusted life years (standard deviation). Annual costs were 573.55 (110.42) vs. 332.76 (62.18) in Denmark for insulin detemir and NPH insulin, respectively. These values were 545.79 (106.54) vs. 306.12 (57.78) in Sweden, 720.10 (140.74) vs. 408.73 (78.61) in Finland and 584.01 (109.47) vs. 359.60 (64.84) in the Netherlands. Incremental cost-effectiveness ratios were approximately 12,644 (Denmark), 12,612 (Sweden), 16,568 (Finland) and 12,216 (the Netherlands) per quality-adjusted life year gained for insulin detemir vs. NPH insulin. CONCLUSIONS: Insulin detemir is likely to be cost-effective vs. NPH insulin in subjects with Type 1 diabetes in Denmark, Sweden, Finland and the Netherlands. Increased pharmacy costs with insulin detemir should not be a barrier to therapy based on these findings.
Asunto(s)
Diabetes Mellitus Tipo 1/economía , Hipoglucemia/economía , Hipoglucemiantes/economía , Insulina Isófana/economía , Insulina de Acción Prolongada/economía , Farmacias/economía , Análisis Costo-Beneficio , Dinamarca , Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Femenino , Finlandia , Humanos , Hipoglucemia/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Insulina Detemir , Insulina Isófana/uso terapéutico , Insulina de Acción Prolongada/uso terapéutico , Masculino , Países Bajos , Años de Vida Ajustados por Calidad de Vida , SueciaRESUMEN
AIM: To investigate the cost-effectiveness of liraglutide as add-on to metformin vs. glimepiride or sitagliptin in patients with Type 2 diabetes uncontrolled with first-line metformin. METHODS: Data were sourced from a clinical trial comparing liraglutide vs. glimepiride, both in combination with metformin, and a clinical trial comparing liraglutide vs. sitagliptin, both as add-on to metformin. Only the subgroup of patients in whom liraglutide was added to metformin monotherapy was included in the cost-utility analysis. The CORE Diabetes Model was used to simulate outcomes and costs with liraglutide 1.2 and 1.8 mg vs. glimepiride and vs. sitagliptin over patients' lifetimes. Treatment effects were taken directly from the trials. Costs and outcomes were discounted at 3.5% per annum and costs were accounted from a third-party payer (UK National Health System) perspective. RESULTS: Treatment with liraglutide 1.2 and 1.8 mg resulted, respectively, in mean increases in quality-adjusted life expectancy of 0.32 ± 0.15 and 0.28 ± 0.14 quality-adjusted life years vs. glimepiride, and 0.19 ± 0.15 and 0.31 ± 0.15 quality-adjusted life years vs. sitagliptin, and was associated with higher costs of £ 3003 ± £ 678 and £ 4688 ± £ 639 vs. glimepiride, and £ 1842 ± £ 751 and £ 3224 ± £ 683 vs. sitagliptin, over a patient's lifetime. Both liraglutide doses were cost-effective, with incremental cost-effectiveness ratios of £ 9449 and £ 16,501 per quality-adjusted life year gained vs. glimepiride, and £ 9851 and £ 10,465 per quality-adjusted life year gained vs. sitagliptin, respectively. CONCLUSIONS: Liraglutide, added to metformin monotherapy, is a cost-effective option for the treatment of Type 2 diabetes in a UK setting.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Péptido 1 Similar al Glucagón/análogos & derivados , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/economía , Metformina/administración & dosificación , Pirazinas/economía , Compuestos de Sulfonilurea/economía , Triazoles/economía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Índice de Masa Corporal , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/economía , Femenino , Péptido 1 Similar al Glucagón/administración & dosificación , Péptido 1 Similar al Glucagón/economía , Humanos , Liraglutida , Masculino , Metformina/economía , Persona de Mediana Edad , Pirazinas/administración & dosificación , Años de Vida Ajustados por Calidad de Vida , Fosfato de Sitagliptina , Compuestos de Sulfonilurea/administración & dosificación , Resultado del Tratamiento , Triazoles/administración & dosificación , Reino Unido , Adulto JovenRESUMEN
OBJECTIVES: The Nippon Ultra-Rapid Insulin and Diabetic Complication Evaluation Study (NICE Study) (NCT00575172) was a 5-year, open-label, randomised controlled trial which compared cardiovascular outcomes in Japanese type 2 diabetes patients intensively treated with regular human insulin or insulin aspart (NovoRapid; Novo Nordisk A/S, Bagsvaerd, Denmark), a rapid-acting insulin analogue. The aim of the present analysis was to evaluate the cost effectiveness of insulin aspart versus regular human insulin from the perspective of a Japanese third-party healthcare payer. RESEARCH DESIGN AND METHODS: A discrete event-simulation model was developed in Microsoft Excel to assess the within-trial cost effectiveness and make longer-term clinical projections in patients treated with regular human insulin or insulin aspart. In addition to severe hypoglycaemia, the model captured myocardial and cerebral infarction events and percutaneous coronary intervention and coronary artery bypass graft procedures. Within-trial mortality, incidence of severe hypoglycaemia and cardiovascular event probabilities were derived from the annual rates observed during the trial period, while post-trial outcomes were calculated using the event rates from the trial, adjusted for increasing patient age. Event costs were accounted from the healthcare payer perspective and expressed in 2008 Japanese yen (JPY), while health-related quality of life (HRQoL) was captured using event and state utilities. Future costs and clinical benefits were discounted at 3% annually. Life expectancy, quality-adjusted life expectancy, cardiovascular event rates and costs were evaluated over 5- and 10-year time horizons and sensitivity analyses were performed to assess variability in model outcomes. RESULTS: Over 5 years of treatment, insulin aspart dominated human insulin both in incremental life expectancy and in incremental quality-adjusted life-years (QALYS). Insulin aspart was associated with a small improvement in discounted life expectancy of 0.005 years (4.688 vs. 4.684 years) and an increase of 0.023 quality-adjusted life-years (QALYs) (3.800 vs. 3.776 QALYs) when compared with regular human insulin. Insulin aspart also incurred lower costs (JPY 481,586 vs. 594,717, difference -113,131) which resulted from the decreased incidence of cardiovascular events with insulin aspart (0.013 events per patient year vs. 0.030 on regular human insulin). Breakdown of costs indicated that pharmacy costs were higher with insulin aspart (JPY 346,608 vs. 278,468), but these costs were more than offset by the reduced costs associated with cardiovascular complications and hypoglycaemia over 5 years of treatment (JPY 134,978 vs. 316,249). Sensitivity analysis showed that insulin aspart was still cost-effective in the case where only 18% of the within-trial cardiovascular and mortality benefit over regular human insulin was captured in the model (assuming a willingness-to-pay threshold of JPY 5,000,000). LIMITATIONS: The NICE study cohort was relatively small (n = 325), meaning that caution should be exercised when calculating and interpreting the incremental cost-effectiveness ratio. Also, despite the differences in cardiovascular risk profile between the Japanese and UK populations, UKPDS-derived risk equations were used to project MI outcomes and PCI and CABG procedures and UKPDS HRQoL scores were applied to all health states. While these risk formulas and HRQoL utilities may not be directly applicable to the Japanese population, no equivalent Japanese-specific data are currently available. CONCLUSIONS: In a Japanese type 2 diabetes population, prescribing rapid-acting insulin aspart significantly reduced cardiovascular complications over 5- and 10-year time horizons, resulting in increased quality of life and decreased costs when compared with human insulin.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/etnología , Hipoglucemiantes/economía , Insulina/análogos & derivados , Insulina/economía , Anciano , Anciano de 80 o más Años , Análisis Costo-Beneficio/economía , Femenino , Humanos , Hipoglucemiantes/farmacología , Hipoglucemiantes/uso terapéutico , Insulina/farmacología , Insulina/uso terapéutico , Insulina Aspart , Reembolso de Seguro de Salud , Japón/etnología , Esperanza de Vida , Masculino , Persona de Mediana EdadRESUMEN
AIMS: To determine the long-term health economic benefits associated with lispro vs. regular human insulin (RHI) in UK Type 1 diabetic (T1DM) patients using the previously published and validated CORE Diabetes Model. METHODS: A literature review designed to capture clinical benefits associated with lispro and T1DM cohort characteristics specific to UK was undertaken. Clinical benefits were derived from a Cochrane meta-analysis. The estimated difference (weighted mean) in glycated haemoglobin (HbA(1c)) was -0.1% (95% confidence interval -0.2 to 0.0%) for lispro vs. RHI. Severe hypoglycaemia rates for lispro and RHI were 21.8 and 46.1 events per 100 patient years, respectively. Costs and disutilities were accounted for severe hypoglycaemia rates. All costs were accounted in 2007 poundUK from a National Health Service (NHS) perspective. Future costs and clinical benefits were discounted at 3.5% annually. RESULTS: In the base-case analysis, lispro was projected to be dominant compared with RHI. Lispro was associated with improvements in quality-adjusted life expectancy (QALE) of approximately 0.10 quality-adjusted life years (QALYs) vs. RHI (7.60 vs. 7.50 QALYs). Lifetime direct medical costs per patient were lower with lispro treatment, pound70 576 vs. pound72 529. Severe hypoglycaemia rates were the key driver in terms of differences in QALE and lifetime costs. Sensitivity analyses with assumptions around time horizon, discounting rates and benefits in terms of glycaemic control or hypoglycaemic event rates revealed that lispro remained dominant. CONCLUSIONS: Our findings suggest that lispro is likely to improve QALE, reduce frequency of diabetes-related complications and lifetime medical costs compared with RHI.
Asunto(s)
Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Insulina/análogos & derivados , Insulina/uso terapéutico , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 1/economía , Humanos , Hipoglucemiantes/economía , Insulina/economía , Insulina Lispro , Esperanza de Vida , Años de Vida Ajustados por Calidad de Vida , Estadística como Asunto , Factores de TiempoRESUMEN
OBJECTIVES: To investigate the long-term clinical and economic outcomes associated with exenatide versus insulin glargine as "add-on" treatments to oral therapy in individuals with Type 2 diabetes inadequately controlled with combination oral agents in the Swiss setting. METHODS: A computer simulation model of diabetes was used to project complications, life expectancy, quality-adjusted life expectancy and direct medical costs over a 35-year time horizon. Cohort characteristics and treatment effect data were derived from a 26-week randomized clinical trial comparing exenatide and insulin glargine. Modeled treatment effects included reductions in glycosylated hemoglobin (HbA1c) by -0.99% and -1.07% and in body mass index (BMI) by -0.80 and +0.55 kg/m2 with exenatide and insulin glargine respectively. Changes in systolic blood pressure and serum lipid levels were also captured. Simulations incorporated published quality of life utilities and Swiss costs from 2006. Extensive sensitivity analyses were conducted to assess the robustness of projected outcomes. Future clinical and economic outcomes were discounted at 2.5% per annum. RESULTS: In the base-case analysis exenatide was associated with comparable life expectancy (11,549 years versus 11,468 years) and an improvement in quality-adjusted life expectancy of 0.43 quality-adjusted life years (QALYs) versus insulin glargine over a 35-year time horizon. Exenatide was associated with a reduced cumulative incidence of most diabetes-related complications including an absolute reduction in myocardial infarction by 0.28%. Assuming an annual treatment cost of CHF 2,797.74 for exenatide, direct costs increased by CHF 8,378 per patient over the 35-year time horizon compared to insulin glargine. The resultant incremental cost-effectiveness ratio was CHF 19,450 per QALY gained for exenatide versus insulin glargine. CONCLUSIONS: Exenatide was associated with comparable life expectancy and an improvement in quality-adjusted life expectancy versus insulin glargine over a 35-year time horizon. Based on current standards exenatide would be a cost-effective treatment alternative to insulin glargine in Switzerland for Type 2 diabetes patients inadequately controlled on oral therapy.
Asunto(s)
Diabetes Mellitus Tipo 2/economía , Hipoglucemiantes/economía , Insulina/análogos & derivados , Péptidos/economía , Ponzoñas/economía , Administración Oral , Anciano , Glucemia/efectos de los fármacos , Presión Sanguínea/efectos de los fármacos , Índice de Masa Corporal , Simulación por Computador , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Quimioterapia Combinada , Exenatida , Femenino , Hemoglobina Glucada/análisis , Costos de la Atención en Salud , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/economía , Insulina/uso terapéutico , Insulina Glargina , Insulina de Acción Prolongada , Lípidos/sangre , Masculino , Péptidos/uso terapéutico , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Suiza , Ponzoñas/uso terapéuticoRESUMEN
OBJECTIVES: To evaluate the cost-effectiveness of pioglitazone versus placebo, given in addition to existing treatment regimens, in patients with type 2 diabetes and evidence of macrovascular disease in Switzerland. METHODS: Event rates corresponding to macrovascular outcomes from the PROactive (Prospective Pioglitazone Clinical Trial in Macrovascular Events) trial of pioglitazone were used to project long-term clinical outcomes as part of a modified version of the previously validated CORE Diabetes Model. Direct medical costs associated with treatment regimens, complications and patient management were accounted in 2005 values based on Swiss-specific unit costs. Time horizon was set to lifetime (35 years). Future costs and clinical benefits were discounted at 2.5% annually in line with Swiss recommendations. One-way sensitivity analyses were performed. RESULTS: Addition of pioglitazone was associated with a reduced incidence of most diabetes-related complications, improved life expectancy (0.258 years) and improved quality-adjusted life expectancy (0.180 QALYs) compared with placebo. Pioglitazone treatment increased direct costs by CHF 10,914 per patient over a lifetime horizon. The incremental cost-effectiveness ratio (ICER) of pioglitazone versus placebo was CHF 42,274 per life-year gained and CHF 60,596 per QALY gained. ICERs were sensitive to variation in time horizon and duration of pioglitazone treatment effects. With a willingness to pay of CHF 80,000 per QALY in the Swiss setting, there was a 62.5% chance that pioglitazone would be cost-effective. CONCLUSIONS: Addition of pioglitazone to existing therapy was projected to reduce the long-term cumulative incidence of most diabetes complications and improve quality-adjusted life expectancy. Evaluation of incremental direct medical costs associated with these clinical benefits indicated that pioglitazone is likely to be a cost-effective treatment option in the Swiss setting over patient lifetimes.