Coste-efectividad de exenatida en comparación con insulina glargina en pacientes con obesidad y diabetes mellitus tipo 2 en España / Cost-effectiveness of exenatide versus insulin glargine in Spanish patients with obesity and type 2 diabetes mellitus

Antecedentes y objetivos Exenatida es un agonista del receptor de GLP-1 empleado como tratamiento adyuvante en la diabetes mellitus tipo 2 (DM2), que ha demostrado ser tan eficaz como insulina glargina (IG) reduciendo la concentración de hemoglobina glucosilada, cuando se administra en combinación con metformina o/y sulfonilureas. Exenatida se asocia a una reducción de peso y a una mayor incidencia de acontecimientos adversos de tipo gastrointestinal. El objetivo de este estudio fue evaluar el coste-efectividad de exenatida frente a IG en pacientes obesos con DM2, que no alcanzan un control glucémico adecuado, desde la perspectiva del sistema nacional de salud. Material y métodos Se utilizó un modelo farmacoeconómico que incluyó información procedente de un ensayo clínico internacional, aleatorizado y controlado, que comparaba exenatida con IG, en pacientes con un inadecuado control de la glucosa, en concreto de la subpoblación de pacientes obesos (IMC ≥ 30 k/m2), y de datos específicos del país. Resultados Exenatida se asocia con un incremento de años de vida ganados y años de vida ajustados por calidad (AVAC) (0,11 y 0,62, respectivamente), frente a IG. Los costes directos se incrementaron 9.306 € en comparación con IG (47.010 frente a 37.704 €) siendo los costes farmacológicos los más importantes. Esto se tradujo en un coste-efectividad incremental de 15.068 €/AVAC de exenatida frente a IG. Conclusiones En pacientes obesos con DM2, exenatida se asocia con mayores beneficios clínicos y mayores costes que IG. Considerando el umbral de disposición a pagar de 30.000 € /AVAC para España, exenatida representa una opción eficiente en comparación con IG (AU)

Background and objectives: Exenatide, a GLP-1 receptor agonist for adjuvant treatment of type2 diabetes mellitus (T2DM), has been shown to be as effective as insulin glargine (IG) for reducingglycated hemoglobin levels combined with metformin or/and sulphonylureas. Exenatide isassociated to weight reduction and a higher incidence of gastrointestinal adverse events. The objective of this study was to assess the cost-effectiveness of exenatide as comparedto IG in obese patients with T2DM not achieving an adequate blood glucose control from the perspective of the Spanish healthcare system. Methods: Pharmacoeconomic model inputs were obtained from an obese subpopulation (BMI ≥30 k/m2) of an international, randomized, controlled clinical trial comparing exenatide with IGin poorly controlled T2DM patients, and were supplemented with country-specific data.Results: Exenatide was associated to improvements in life-years gained and quality-adjusted life years (QALYs) by 0.11 and 0.62 respectively versus IG. Direct costs were D 9,306 higher as compared to IG (D 47,010 versus D 37,704, with increased pharmacy costs as the main driver).Exenatideís incremental cost-effectiveness ratio was D 15,068 per QALY gained versus IG. Conclusions: Exenatide was associated to greater clinical benefits and higher costs in obeseT2DM patients as compared to IG. Considering a willingness-to-pay threshold of D 30,000 perQALY gained in the Spanish setting, exenatide represents an efficient option in comparison withIG (AU)

[Cost-effectiveness of exenatide versus insulin glargine in Spanish patients with obesity and type 2 diabetes mellitus]. / Coste-efectividad de exenatida en comparación con insulina glargina en pacientes con obesidad y diabetes mellitus tipo 2 en España.

BACKGROUND AND OBJECTIVES: Exenatide, a GLP-1 receptor agonist for adjuvant treatment of type 2 diabetes mellitus (T2DM), has been shown to be as effective as insulin glargine (IG) for reducing glycated hemoglobin levels combined with metformin or/and sulphonylureas. Exenatide is associated to weight reduction and a higher incidence of gastrointestinal adverse events. The objective of this study was to assess the cost-effectiveness of exenatide as compared to IG in obese patients with T2DM not achieving an adequate blood glucose control from the perspective of the Spanish healthcare system. METHODS: Pharmacoeconomic model inputs were obtained from an obese subpopulation (BMI ≥ 30 k/m(2)) of an international, randomized, controlled clinical trial comparing exenatide with IG in poorly controlled T2DM patients, and were supplemented with country-specific data. RESULTS: Exenatide was associated to improvements in life-years gained and quality-adjusted life years (QALYs) by 0.11 and 0.62 respectively versus IG. Direct costs were € 9,306 higher as compared to IG (€ 47,010 versus € 37,704, with increased pharmacy costs as the main driver). Exenatideís incremental cost-effectiveness ratio was € 15,068 per QALY gained versus IG. CONCLUSIONS: Exenatide was associated to greater clinical benefits and higher costs in obese T2DM patients as compared to IG. Considering a willingness-to-pay threshold of € 30,000 per QALY gained in the Spanish setting, exenatide represents an efficient option in comparison with IG.

Cost-utility of exenatide once weekly compared with insulin glargine in patients with type 2 diabetes in the UK.

OBJECTIVE: To compare the cost-utility of exenatide once weekly (EQW) and insulin glargine in patients with type 2 diabetes in the United Kingdom (UK). RESEARCH DESIGN AND METHODS: The IMS CORE Diabetes Model was used to project clinical and economic outcomes for patients with type 2 diabetes treated with EQW or insulin glargine. Treatment effects and patient baseline characteristics (mean age: 58 years, mean glycohaemoglobin: 8.3%) were taken from the DURATION-3 study. Unit costs and health state utility values were derived from published sources. As the price of EQW is not yet known, the prices of two currently available glucagon-like peptide-1 products were used as benchmarks. To reflect diabetes progression, patients started on EQW switched to insulin glargine after 5 years. The analysis was conducted from the perspective of the UK National Health Service over a time horizon of 50 years with costs and outcomes discounted at 3.5%. Sensitivity analyses explored the impact of changes in input data and assumptions and investigated the cost utility of EQW in specific body mass index (BMI) subgroups. MAIN OUTCOME MEASURES: Incremental cost-effectiveness ratio (ICER) for EQW compared with insulin glargine. RESULTS: At a price equivalent to liraglutide 1.2 mg, EQW was more effective and more costly than insulin glargine, with a base case ICER of £10,597 per quality-adjusted life-year (QALY) gained. EQW was associated with an increased time to development of any diabetes-related complication of 0.21 years, compared with insulin glargine. Three BMI subgroups investigated (<30, 30-35 and >35 kg/m(2)) reported ICERs for EQW compared with insulin glargine ranging from £9425 to £12,956 per QALY gained. CONCLUSIONS: At the prices investigated, the cost per QALY gained for EQW when compared with insulin glargine in type 2 diabetes in the UK setting, was within the range normally considered cost effective by NICE. Cost effectiveness in practice will depend on the final price of EQW and the extent to which benefits observed in short-term randomised trials are replicated in long-term use.

Cost-effectiveness of duloxetine: the Stress Urinary Incontinence Treatment (SUIT) study.

OBJECTIVE: To assess the cost-effectiveness of duloxetine compared with conservative therapy in women with stress urinary incontinence (SUI). METHODS: Cost and outcome data were taken from the Stress Urinary Incontinence Treatment (SUIT) study, a 12-month, prospective, observational, naturalistic, multicenter, multicountry study. Costs were assessed in UK pound and outcomes in quality adjusted life years using responses to the EuroQol (EQ-5D); numbers of urine leaks were also estimated. Potential selection bias was countered using multivariate regression and propensity score analysis. RESULTS: Duloxetine alone, duloxetine in combination with conservative treatment, and conservative treatment alone were associated with roughly two fewer leaks per week compared with no treatment. Duloxetine alone and with conservative treatment for SUI were associated with incremental quality-adjusted life-years (QALYs) of about 0.03 over a year compared with no treatment or with conservative treatment alone. Conservative treatment alone did not show an effect on QALYs. None of the interventions appeared to have marked impacts on costs over a year. Depending on the form of matching, duloxetine either dominated or had an incremental cost-effectiveness ratio (ICER) below pound900 per QALY gained compared with no treatment and with conservative treatment alone. Duloxetine plus conservative therapy had an ICER below pound5500 compared with no treatment or conservative treatment alone. Duloxetine compared with duloxetine plus conservative therapy showed similar outcomes but an additional cost for the combined intervention. CONCLUSIONS: Although the limitations of the use of SUIT's observational data for this purpose need to be acknowledged, the study suggests that initiating duloxetine therapy in SUI is a cost-effective treatment alternative.

Patient reported outcomes tools in an observational study of female stress urinary incontinence.

AIMS: To determine which patient characteristics, incontinence and non-incontinence related, are associated with the symptom severity scores of the Urogenital Distress Inventory (UDI) and the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI); and to determine the association of both patient characteristics and symptom severity scores with quality-of-life scores of the Incontinence Impact Questionnaire (IIQ) and the Incontinence-Quality of Life (I-QOL) questionnaire. METHODS: Women presenting with stress urinary incontinence (SUI) symptoms in primary and secondary care entered the Stress Urinary Incontinence Treatment Study (SUIT), an observational study evaluating the cost-effectiveness of duloxetine compared to other non-surgical treatments for SUI. At enrollment patients completed the UDI-6, the short form ICIQ-UI, the IIQ-7 and the I-QOL. Multivariate linear regressions were performed with the UDI-6, ICIQ-UI SF, IIQ-7, and I-QOL as outcomes. RESULTS: The total number of incontinence episodes is the most significant explanatory variable of the two symptom questionnaire scores, but the UDI-6 score also reflects the type of incontinence. The variability of the condition-specific quality-of-life questionnaires is primarily explained by the symptom severity questionnaire scores. Although there is a high intercorrelation, both these symptom questionnaires independently contributed significantly to the IIQ-7 and I-QOL total scores. CONCLUSIONS: The UDI-6 and ICIQ-UI SF can be regarded as scientifically sound symptom questionnaires in UI evaluation; but they have differences. Since the UDI-6 and ICIQ-UI SF independently contribute to the quality-of-life scores, this suggests that in incontinence research symptom questionnaires should not focus only on incontinence, but on a broader range of urogenital symptoms.

Patient characteristics impacting health state index scores, measured by the EQ-5D of females with stress urinary incontinence symptoms.

OBJECTIVE: To describe the characteristics of women seeking treatment for symptoms of stress urinary incontinence (SUI) and to investigate the association of SUI symptoms with generic health-related quality of life (HRQoL) as measured by the EuroQol (EQ-5D) instrument. METHODS: The Stress Urinary Incontinence Treatment (SUIT) study was a 12-month observational study in four European countries that evaluated the cost-effectiveness of duloxetine compared with other forms of nonsurgical intervention in the treatment of the symptoms of SUI. Four hundred thirty-one physicians observed women seeking treatment for their SUI, and recorded the care provided and the outcomes of that care at enrollment and at 3, 6 and 12 months afterward The impact of SUI on baseline HRQoL as expressed by the EQ-5D index score was assessed by linear and logistic regression. RESULTS: Three thousand seven hundred sixty-two women were enrolled into SUIT, with the largest patient group from Germany. Overall, the majority of women were postmenopausal, had a mean age of 58.0 years, were not current smokers, and tended to be overweight (mean body mass index [BMI]=27.7 kg/m2), with at least one comorbidity. The health state index scores were significantly and independently influenced by the presence of comorbidity(ies) affecting quality of life, total number of stress and urge incontinence episodes, urinary incontinence subtype, comorbidity(ies) affecting incontinence, BMI, socioeconomic status, educational status, age, and country. CONCLUSION: This article describes the characteristics of patients at the SUIT enrollment visit, and demonstrates that the number of incontinence episodes has a significant impact on the EQ-5D index score.

Characteristics of patients with type 2 diabetes mellitus initiating insulin therapy: baseline data from the INSTIGATE study.

OBJECTIVE: To describe the characteristics at baseline of patients with type 2 diabetes mellitus who are initiating insulin. METHODS: Prospective, observational multi-centre, open-label study in five European countries of patients with type 2 diabetes who were initiating insulin as part of their usual care. RESULTS: A total of 1172 patients were enrolled, with mean age 63.3 years and body mass index 29.9 kg/m(2). The majority (90%) of patients were taking one or more oral anti-diabetic agents; the percentage not taking anti-diabetic medication in the previous four weeks was highest in Germany (23.4%) and Spain (15.1%). The prevalence of microvascular diseases (range: 16.1%-36.1%) varied considerably between countries but for macrovascular (30.4%-38.6%) and other diabetes-related diagnoses (72.6%-76.6%) such as hypertension and dyslipidaemia the differences were less pronounced. In Germany, reported use of lipid-lowering (26.7%) and anti-platelet (27.1%) therapies was much less than in other countries (ranges: 53.2%-78.1% and 48.3%-61.1%, respectively). The majority of evaluable patients in each country had demonstrated poor control over a long period of time. Prior to initiating insulin, the most recent mean (+/-SD) HbA1(c) was 9.58 +/- 1.81%, fasting plasma glucose was 12.18 +/- 4.32 mmol/L and 78.5% had metabolic syndrome. IDF targets for HDL- and LDL-cholesterol, and blood pressure were met in 76.8%, 33.1% and 18.9% of patients, respectively. CONCLUSIONS: Insulin treatment was only initiated after HbA1(c) values were considerably higher than recommended in treatment guidelines for a sustained period of time.