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1.
BMC Endocr Disord ; 19(1): 132, 2019 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-31796048

RESUMO

BACKGROUND: This analysis evaluates the cost-effectiveness of insulin degludec (degludec) versus biosimilar insulin glargine U100 (glargine U100) in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM) in Bulgaria. METHODS: A simple, short-term model was used to compare the treatment costs and outcomes associated with hypoglycaemic events with degludec versus glargine U100 in patients with T1DM and T2DM from the perspective of the Bulgarian National Health Insurance Fund. Cost-effectiveness was analysed over a 1-year time horizon using data from clinical trials. The incremental cost-effectiveness ratio (ICER) was the main outcome measure. RESULTS: In Bulgaria, degludec was highly cost-effective versus glargine U100 in people with T1DM and T2DM. The ICERs were estimated to be 4493.68 BGN/quality-adjusted life year (QALY) in T1DM, 399.11 BGN/QALY in T2DM on basal oral therapy (T2DMBOT) and 7365.22 BGN/QALY in T2DM on basal bolus therapy (T2DMB/B), which are below the cost-effectiveness threshold of 39,619 BGN in Bulgaria. Degludec was associated with higher insulin costs in all three patient groups; however, savings from a reduction in hypoglycaemic events with degludec versus glargine U100 partially offset these costs. Sensitivity analysis demonstrated that the results were robust and largely insensitive to variations in input parameters. At a willingness-to-pay threshold of 39,619 BGN/QALY, the probability of degludec being cost-effective versus glargine U100 was 60.0% in T1DM, 99.4% in T2DMBOT and 91.3% in T2DMB/B. CONCLUSION: Degludec is a cost-effective alternative to biosimilar glargine U100 for patients with T1DM and T2DM in Bulgaria. Degludec could be of particular benefit to those patients suffering recurrent hypoglycaemia and those who require additional flexibility in the dosing of insulin.


Assuntos
Análise Custo-Benefício , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Insulina Glargina/uso terapêutico , Insulina de Ação Prolongada/uso terapêutico , Adulto , Idoso , Medicamentos Biossimilares/economia , Bulgária/epidemiologia , Custos de Cuidados de Saúde , Humanos , Hipoglicemia/epidemiologia , Hipoglicemiantes/uso terapêutico , Insulina Glargina/economia , Insulina de Ação Prolongada/economia , Pessoa de Meia-Idade , Resultado do Tratamento
2.
Adv Ther ; 36(8): 2034-2051, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31168765

RESUMO

INTRODUCTION: Glucagon-like peptide-1 (GLP-1) receptor agonists represent a class of treatments for type 2 diabetes that offer multifactorial benefits, including glycemic control, weight loss and low hypoglycemia risk. Once-weekly semaglutide is a novel GLP-1 analog that has been associated with improved glycemic control and reduced body mass index (BMI) versus once-weekly GLP-1 receptor agonist dulaglutide in SUSTAIN 7, which is reimbursed in patients with a BMI > 35 kg/m2 in Slovakia. The aim of the present study was to evaluate the long-term cost-effectiveness of once-weekly semaglutide 0.5 mg and 1 mg versus dulaglutide 1.5 mg in Slovakia. METHODS: Clinical and cost outcomes were projected over patient lifetimes using the IQVIA CORE Diabetes Model. Baseline cohort characteristics and treatment effects were based on the sub-group of patients with a BMI > 35 kg/m2 in SUSTAIN 7. Patients were modeled to receive once-weekly semaglutide or dulaglutide for 3 years, after which treatment was intensified to basal insulin. Treatment effects associated with once-weekly semaglutide and dulaglutide were maintained for the first 3 years before HbA1c increased to 7.0% and BMI reverted to baseline. Costs were accounted from a healthcare payer perspective in Slovakia and expressed in euros (EUR). Utilities relating to quality of life were taken from published sources. RESULTS: Once-weekly semaglutide 0.5 mg and 1 mg were associated with improvements in quality-adjusted life expectancy of 0.04 and 0.07 quality-adjusted life years (QALYs), respectively, versus dulaglutide 1.5 mg. Lifetime medical costs were similar, with cost savings of EUR 20 and EUR 140 per patient with once-weekly semaglutide 0.5 mg and 1 mg, respectively, versus dulaglutide 1.5 mg. Both doses of once-weekly semaglutide were therefore considered dominant versus dulaglutide 1.5 mg. CONCLUSION: Both doses of once-weekly semaglutide represent cost-saving treatment options versus dulaglutide 1.5 mg for obese patients with type 2 diabetes in Slovakia. FUNDING: Novo Nordisk A/S.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/economia , Esquema de Medicação , Peptídeos Semelhantes ao Glucagon/economia , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Humanos , Hipoglicemiantes/administração & dosagem , Masculino , Pessoa de Meia-Idade , Eslováquia/epidemiologia
3.
Diabetes Ther ; 10(2): 493-508, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30706364

RESUMO

INTRODUCTION: Few patients with type 2 diabetes mellitus (T2DM) achieve recommended glycemic control targets in the Czech Republic. Novel therapies, such as fixed-ratio combinations of basal insulin plus glucagon-like peptide-1 receptor agonists, may contribute to better glycemic control. In the analysis presented here, the present analysis assessed the long-term cost-effectiveness of two fixed-ratio combinations, IDegLira (insulin degludec/liraglutide) and iGlarLixi (insulin glargine/lixisenatide), for the treatment of patients with T2DM inadequately controlled with basal insulin from a healthcare payer perspective in the Czech Republic. METHODS: A cost-effectiveness analysis was performed over patient lifetimes using the IQVIA CORE Diabetes Model. Treatment effects were obtained from an indirect treatment comparison as no head-to-head data for IDegLira versus iGlarLixi are currently available. IDegLira was compared with two iGlarLixi pens (100 U/mL insulin glargine + 33 µg/mL and 50 µg/mL of lixisenatide, respectively). Direct medical costs associated with pharmaceutical interventions, screening and diabetes-related complications were captured. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: IDegLira was associated with gains in life expectancy of 0.11 years and in quality-adjusted life expectancy of 0.14 quality-adjusted life-years (QALYs) versus iGlarLixi, due to a lower cumulative incidence and delayed onset of diabetes-related complications. IDegLira was also associated with higher projected costs due to higher acquisition costs; however, these were partially offset by cost savings from avoided complications. IDegLira was associated with incremental cost-effectiveness ratios of Czech Koruna (CZK) 695,998 and CZK 348,323 per QALY gained versus iGlarLixi pens containing 33 and 50 µg/mL of lixisenatide, respectively. These ratios were below the commonly used willingness-to-pay threshold of CZK 1,200,000 per QALY gained. CONCLUSION: The present analysis indicated that IDegLira was associated with clinical benefits relative to iGlarLixi over patient lifetimes and was likely to be cost-effective in the treatment of patients with T2DM uncontrolled on basal insulin in the Czech Republic. FUNDING: Novo Nordisk. Plain language summary is available for this article.

4.
Diabetes Ther ; 10(1): 159-176, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30535837

RESUMO

INTRODUCTION: Once-weekly semaglutide is a novel glucagon-like peptide-1 (GLP-1) analogue for the treatment of type 2 diabetes that was associated with greater reductions in glycated hemoglobin (HbA1c) and body mass index (BMI) versus once-daily GLP-1 analogue liraglutide in a recent network meta-analysis (NMA). The aim of the present study was to assess the long-term cost-effectiveness of once-weekly semaglutide 1 mg versus liraglutide 1.2 mg in Estonia. METHODS: Outcomes were projected over patient lifetimes using the IQVIA CORE Diabetes Model (version 9.0), with baseline cohort characteristics sourced from SUSTAIN 3 and changes in HbA1c, systolic blood pressure (SBP), and BMI associated with once-weekly semaglutide and liraglutide derived from the NMA. Patients were assumed to receive once-weekly semaglutide or liraglutide for 5 years before intensifying to basal insulin. Treatment effects were applied for the first 5 years, after which HbA1c increased to 7.0%, SBP followed a natural progression, and BMI reverted to baseline for the remainder of the analysis. Costs were expressed in euros (EUR) and estimated from a healthcare payer perspective. Utilities associated with diabetes and diabetes-related complications were taken from published sources. RESULTS: Once-weekly semaglutide 1 mg was associated with improvements in quality-adjusted life expectancy of 0.13 quality-adjusted life years (QALYs) versus liraglutide 1.2 mg. Direct costs were EUR 67 higher with once-weekly semaglutide, due to the increased acquisition cost, but this was mostly offset by cost savings due to avoidance of diabetes-related complications. Once-weekly semaglutide 1 mg was therefore associated with an incremental cost-effectiveness ratio of EUR 523 per QALY gained versus liraglutide 1.2 mg, which falls well below a willingness-to-pay threshold of EUR 52,390 per QALY gained (three times the Estonian GDP per capita). CONCLUSION: Once-weekly semaglutide was considered highly cost-effective versus liraglutide 1.2 mg for the treatment of patients with type 2 diabetes in Estonia. FUNDING: Novo Nordisk A/S. Plain language summary available for this article.

5.
Diabetes Ther ; 9(3): 1201-1216, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29700772

RESUMO

INTRODUCTION: This study investigates the cost-effectiveness of insulin degludec versus insulin glargine U100 in patients with type 1 and type 2 diabetes mellitus in Serbia. METHODS: A cost-utility analysis, implementing a simple short-term model, was used to compare treatment costs and outcomes with degludec versus glargine U100 in patients with type 1 (T1DM) and type 2 diabetes (T2DM). Cost-effectiveness was analysed in a 1-year setting, based on data from clinical trials. Costs were estimated from the healthcare payer perspective, the Serbian Health Insurance Fund (RFZO). The outcome measure was the incremental cost-effectiveness ratio (ICER) or cost per quality-adjusted life-year (QALY) gained. RESULTS: Degludec is highly cost-effective compared with glargine U100 for people with T1DM and T2DM in Serbia. The ICERs are estimated at 417,586 RSD/QALY gained in T1DM, 558,811 RSD/QALY gained in T2DM on basal oral therapy (T2DMBOT) and 1,200,141 RSD/QALY gained in T2DM on basal-bolus therapy (T2DMB/B). All ICERs fall below the commonly accepted thresholds for cost-effectiveness in Serbia (1,785,642 RSD/QALY gained). In all three patient groups, insulin costs are higher with degludec than with glargine U100, but these costs are partially offset by savings from a lower daily insulin dose in T1DM and T2DMBOT, a reduction in hypoglycaemic events in all three patient groups and reduced costs of SMBG testing in the T2DM groups with degludec versus glargine U100. CONCLUSION: Degludec is a cost-effective alternative to glargine U100 for patients with T1DM and T2DM in Serbia. Degludec may particularly benefit those suffering from hypoglycaemia or where the patient would benefit from the option of flexible dosing. FUNDING: Novo Nordisk.

6.
Pol Merkur Lekarski ; 34(204): 332-8, 2013 Jun.
Artigo em Polonês | MEDLINE | ID: mdl-23882930

RESUMO

UNLABELLED: Standard procedure for cytomegalovirus disease (CMV) prophylaxis in kidney transplant patients was the administration of valganciclovir for up to 110 days after organ transplant. This prophylaxis has been extended up to 200 days in Poland since 2011. The decision was based on the results of clinical trials which showed significant clinical benefit in case of prolonged administration of the drug. The aim of the analysis was to provide the economic evaluation of extending the CMV prophylaxis with co-financed from public funds Valcyte (valganciclovirum; 60 tab. a 450 mg; Roche Polska Sp. z o.o.) from 110 to 200 days, in the high risk patients group after kidney transplant (seronegative recipient and infected donor, D+/R-). The analysis was performed from the Polish healthcare payer's perspective. MATERIAL AND METHODS: All methods used in the following study were consistent with the Requirements of the Polish HTA Agency (AHTAPOL). The cost-effectiveness and the cost-utility analysis were performed on the basis of a randomised study which was identified as a result of the systematic search of the medical databases, comparing 200 days valgancyclovir administration with 100 days drug use as a prophylaxis of CMV disease in the patients group mentioned above. The Markov model was developed, simulating the disease evolution over time considering a high risk patient after kidney transplant treated with valgancicloviras the CMV disease prophylaxis. The disease period was divided into health states that are the most probable for this condition and the transitions probabilities between them were identified and assigned. Based on the clinical trial results, registry database of health conditions usability and experts' opinion, all health states (i.e. death, kidney transplant, CMV disease) were attributed with utilities and costs. The direct costs, important from the Polish healthcare payer's perspective, were included in the analysis. Extension of the proposed model in the series of one month time cycles made it possible to assess long-term (assumed time horizon was median patient's life expectancy--23,5 years) costs and clinical effects of the compared technologies. RESULTS: The Incremental Cost-Effectiveness Ratio (ICER) was 39 669 008 PLN and The Incremental Cost-Utility Ratio (ICUR) was 48 008 PLN in the specified time horizon. The result is well below the accepted threshold of profitability in Poland (assuming tripled GDP per capita cost-utility threshold, i.e. 99 543 PLN), which means that the therapy is cost-effective. CONCLUSIONS: The results of the analysis confirmed that the 200 days use of valganciclovirin the prevention of CMV disease compared to standard 110 days therapy is economically justified from the Polish healthcare payer's perspective.


Assuntos
Antivirais/economia , Infecções por Citomegalovirus/prevenção & controle , Ganciclovir/análogos & derivados , Transplante de Rim/efeitos adversos , Antivirais/uso terapêutico , Análise Custo-Benefício , Infecções por Citomegalovirus/economia , Infecções por Citomegalovirus/etiologia , Ganciclovir/economia , Ganciclovir/uso terapêutico , Humanos , Cadeias de Markov , Modelos Estatísticos , Polônia , Anos de Vida Ajustados por Qualidade de Vida , Valganciclovir , Adulto Jovem
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