RESUMEN
BACKGROUND: Guideline Directed Medical Therapy (GDMT) has been revolutionary in improving outcomes of heart failure patients. However, with the addition of more medication classes, the annual cost of these medications on the US healthcare system needs further evaluation. OBJECTIVES: We aim to evaluate the trend of annual cost of GDMT from 2013 to 2021 using the Medicare-part D Database. METHODS: Using Medicare Part D database (2013-2021), we determined the number of beneficiaries receiving these drugs, the total number of 30-day fills for each medication, and the total annual spending on these medications. Linear regression was used to analyze data using Python Programming Language. P value of less than 0.05 was considered to be statistically significant. RESULTS: The estimated annual Medicare- part D spending on empagliflozin had a 50 % increase in cost between 2020 and 2021, which could be attributed to its FDA approval for heart failure with reduced ejection fraction. Empagliflozin cost Medicare 3.73 billion USD in 2021 alone. In addition, sacubitril-valsartan had a strong trajectory since its introduction to the market in 2015. Since its approval in July 2015, it cost Medicare 4.51 billion USD. The Mineralocorticoid Receptor Antagonist class was the least costly class of GDMT. CONCLUSION: The rise in the cost of GDMT is not proportionate amongst the different classes of GDMT. Newer classes of medications cast a significant cost on Medicare in recent years.
Asunto(s)
Insuficiencia Cardíaca , Humanos , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/economía , Estados Unidos , Medicare Part D/economía , Guías de Práctica Clínica como Asunto , Combinación de Medicamentos , Antagonistas de Receptores de Angiotensina/uso terapéutico , Antagonistas de Receptores de Angiotensina/economía , Compuestos de Bencidrilo/uso terapéutico , Compuestos de Bencidrilo/economía , Valsartán , Glucósidos/uso terapéutico , Glucósidos/economía , Aminobutiratos/uso terapéutico , Aminobutiratos/economía , Compuestos de Bifenilo/economía , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Inhibidores del Cotransportador de Sodio-Glucosa 2/economía , Costos de los Medicamentos , Bases de Datos Factuales , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Antagonistas de Receptores de Mineralocorticoides/economíaRESUMEN
BACKGROUND: Three medications are now guideline-recommended treatments for heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF), however, the cost-effectiveness of these agents in combination has yet to be established. OBJECTIVES: The purpose of this study was to determine the cost-effectiveness of mineralocorticoid receptor antagonists (MRA), angiotensin receptor-neprilysin inhibitors (ARNIs), and sodium glucose co-transporter 2 inhibitors (SGLT2is) in individuals with HFmrEF/HFpEF. METHODS: Using a 3-state Markov model, we performed a cost-effectiveness study using simulated cohorts of 1,000 patients with HFmrEF and HFpEF. Treatment with 1-, 2-, and 3-drug combinations was modeled. Based on a United States health care sector perspective, outcome data was used to calculate incremental cost-effectiveness ratios (ICERs) in 2023 United States dollars based on a 30-year time horizon. RESULTS: Treatment with MRA, MRA+SGLT2i, and MRA+SGLT2i+ARNI therapy resulted in an increase in life years of 1.04, 1.58, and 1.80 in the HFmrEF subgroup, respectively, and 0.99, 1.54, and 1.77 in the HFpEF subgroup, respectively, compared with placebo. At a yearly cost of $18, MRA therapy resulted in ICERs of $10,000 per quality-adjusted life year (QALY) in both subgroups. The ICER for the addition of SGLT2i therapy ($4,962 per year) was $113,000 per QALY in the HFmrEF subgroup and $141,000 in the HFpEF subgroup. The addition of ARNI therapy ($5,504 per year) resulted in ICERs >$250,000 per QALY in both subgroups. If SGLT2i and ARNI were available at generic pricing the ICERs become <$10,000 per QALY in both EF subgroups. Outcomes were highly sensitive to assumed benefit in cardiovascular death. CONCLUSIONS: For patients with heart failure, MRA was of high value, SGLT2i was of intermediate value, and ARNI was of low value in both HFmrEF and HFpEF subgroups. For patients with HFmrEF/HFpEF increased use of MRA and SGLT2i therapies should be encouraged and be accompanied with efforts to lower the cost of SGLT2i and ARNI therapies.
Asunto(s)
Análisis Costo-Beneficio , Insuficiencia Cardíaca , Antagonistas de Receptores de Mineralocorticoides , Años de Vida Ajustados por Calidad de Vida , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Volumen Sistólico , Humanos , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/fisiopatología , Volumen Sistólico/fisiología , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Inhibidores del Cotransportador de Sodio-Glucosa 2/economía , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Antagonistas de Receptores de Mineralocorticoides/economía , Masculino , Femenino , Anciano , Estados Unidos , Cadenas de Markov , Neprilisina/antagonistas & inhibidores , Antagonistas de Receptores de Angiotensina/uso terapéutico , Antagonistas de Receptores de Angiotensina/economía , Persona de Mediana Edad , Quimioterapia CombinadaRESUMEN
Importance: The US Food and Drug Administration expanded labeling of sacubitril-valsartan from the treatment of patients with chronic heart failure (HF) with reduced ejection fraction (EF) to all patients with HF, noting the greatest benefits in those with below-normal EF. However, the upper bound of below normal is not clearly defined, and value determinations across a broader EF range are unknown. Objective: To estimate the cost-effectiveness of sacubitril-valsartan vs renin-angiotensin system inhibitors (RASis) across various upper-level cutoffs of EF. Design, Setting, and Participants: This economic evaluation included participant-level data from the PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and the PARAGON-HF (Prospective Comparison of ARNi with ARB Global Outcomes in HF With Preserved Ejection Fraction) trials. PARADIGM-HF was conducted between 2009 and 2014, PARAGON-HF was conducted between 2014 and 2019, and this analysis was conducted between 2021 and 2023. Main Outcomes and Measures: A 5-state Markov model used risk reductions for all-cause mortality and HF hospitalization from PARADIGM-HF and PARAGON-HF. Quality-of-life differences were estimated from EuroQol-5D scores. Hospitalization and medication costs were obtained from published national sources; the wholesale acquisition cost of sacubitril-valsartan was $7092 per year. Risk estimates and treatment effects were generated in consecutive 5% EF increments up to 60% and applied to an EF distribution of US patients with HF from the Get With the Guidelines-Heart Failure registry. The base case included a lifetime horizon from a health care sector perspective. Incremental cost-effectiveness ratios (ICERs) were estimated at EFs of 60% or less (base case) and at various upper-level EF cutoffs. Results: Among 13 264 total patients whose data were analyzed, for those with EFs of 60% or less, sacubitril-valsartan was projected to add 0.53 quality-adjusted life-years (QALYs) at an incremental lifetime cost of $40â¯892 compared with RASi, yielding an ICER of $76â¯852 per QALY. In a probabilistic sensitivity analysis, 95% of the values of the ICER occurred between $71â¯516 and $82â¯970 per QALY. Among patients with chronic HF and an EF of 60% or less, treatment with sacubitril-valsartan vs RASis would be at least of economic intermediate value (ICER <$180â¯000 per QALY) at a sacubitril-valsartan cost of $10â¯242 or less per year, of high economic value (ICER <$60â¯000 per QALY) at a cost of $3673 or less per year, and cost-saving at a cost of $338 or less per year. The ICERs were $67â¯331 per QALY, $59â¯614 per QALY, and $56â¯786 per QALY at EFs of 55% or less, 50% or less, and 45% or less, respectively. Treatment with sacubitril-valsartan in only those with EFs of 45% or greater (up to ≤60%) yielded an ICER of $127â¯172 per QALY gained; treatment was more cost-effective in those at the lower end of this range (ICER of $100â¯388 per QALY gained for those with EFs of 45%-55%; ICER of $84â¯291 per QALY gained for those with EFs of 45%-50%). Conclusions and Relevance: Cost-effectiveness modeling provided an ICER for treatment with sacubitril-valsartan vs RASis consistent with high economic value for patients with reduced and mildly reduced EFs (≤50%) and at least intermediate value at the current undiscounted wholesale acquisition cost price at an EF of 60% or less. Treatment was more cost-effective at lower EF ranges. These findings may have implications for coverage decisions and value assessments in contemporary clinical practice guidelines.
Asunto(s)
Insuficiencia Cardíaca , Neprilisina , Estados Unidos , Humanos , Análisis Costo-Beneficio , Neprilisina/uso terapéutico , Angiotensinas/farmacología , Angiotensinas/uso terapéutico , Volumen Sistólico/efectos de los fármacos , Antagonistas de Receptores de Angiotensina/economía , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Tetrazoles/economía , Insuficiencia Cardíaca/mortalidad , Antihipertensivos/uso terapéuticoRESUMEN
Importance: Sacubitril-valsartan use reduces mortality and hospitalizations compared with enalapril among patients with chronic heart failure with reduced ejection fraction (HFrEF); however, the cost-effectiveness of these treatments when initiated during hospitalization for HF is unknown. Objective: To estimate the cost-effectiveness of inpatient initiation of sacubitril-valsartan vs enalapril compared with no initiation or posthospitalization initiation of sacubitril-valsartan among stabilized patients with HFrEF. Design, Setting, and Participants: This economic evaluation included data on US patients with HFrEF who were eligible for sacubitril-valsartan treatment from December 8, 2009, to May 15, 2018. Main Outcomes and Measures: A 5-state Markov model with all-cause mortality, HF, and non-HF hospitalization probabilities was used. Quality of life was estimated using Euro-QoL EQ-5D scores. Hospitalization, long-term care, and medication costs for sacubitril-valsartan and enalapril were modeled with a discount rate of 3%. The base-case analysis included a lifetime horizon from a health care and societal perspective. Results: Modeled patients were a mean (SD) age of 63.8 (11.5) years. Inpatient treatment with sacubitril-valsartan ($5628 per year) was associated with 62 fewer HF-related admissions per 1000 patients compared with outpatient initiation or 116 fewer HF-related admissions compared with continuation of enalapril treatment. From a health care system perspective, initiation of sacubitril-valsartan during hospitalization saved $452 per year compared with continuing enalapril and $811 per year compared with initiation at 2 months after hospitalization and was associated with an incremental cost-effectiveness ratio of $21â¯532 per quality-adjusted life-year compared with continued enalapril treatment over a lifetime. From a societal perspective, inpatient initiation was estimated to save $460 per year per patient compared with no initiation of sacubitril-valsartan and $813 per year per patient compared with initiation after hospitalization. In a budget analysis, inpatient initiation of sacubitril-valsartan was estimated to save up to $449 per person for 1 year or $2550 per person over 5 years compared with continuation of enalapril. Conclusions and Relevance: The findings suggest that, for patients with HFrEF, initiation of sacubitril-valsartan during hospitalization may be associated with reduced hospitalizations, increased quality-adjusted life expectancy, and cost savings compared with no initiation or initiation after hospitalization.
Asunto(s)
Aminobutiratos/farmacología , Costo de Enfermedad , Insuficiencia Cardíaca/tratamiento farmacológico , Hospitalización/economía , Calidad de Vida , Volumen Sistólico/fisiología , Tetrazoles/farmacología , Aminobutiratos/economía , Antagonistas de Receptores de Angiotensina/economía , Antagonistas de Receptores de Angiotensina/farmacología , Compuestos de Bifenilo , Análisis Costo-Beneficio , Combinación de Medicamentos , Femenino , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Años de Vida Ajustados por Calidad de Vida , Estudios Retrospectivos , Tetrazoles/economía , Valsartán , Función Ventricular Izquierda/fisiologíaRESUMEN
BACKGROUND: Inequities between guideline-recommended drugs (GRD) exposure and socioeconomic status might exist. The objective was to assess the association between a material and a social deprivation index and GRD exposure following a first acute myocardial infarction (AMI) in older adults in the province of Quebec. METHODS: We conducted a retrospective cohort study using the Quebec Integrated Chronic Disease Surveillance System. Elderly ≥66 years, hospitalized for a first AMI between January 1, 2006, and December 31, 2011 and covered by the public drug plan were identified. Exposure to GRD (i.e. simultaneous use of 1) antiplatelet, 2) beta-blocker, 3) lipid-lowering and 4) angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker drugs) was assessed 30 and 365 days following hospital discharge. Associations between deprivation index and GRD exposure were estimated with log-binomial regressions adjusting for potential confounders. RESULTS: Exposure to GRD was 52.2% and 48.0%, 30 and 365 days after hospital discharge, respectively. No statistically significant association was observed in multivariate analysis for both time points. Thirty days post hospital discharge, adjusted prevalence ratio of non-exposure to GRD was 0.98 (95% confidence interval [CI]: 0.95-1.02) for most materially deprived vs. least deprived and 1.04 (95% CI: 0.99-1.08) for most socially deprived vs. least deprived. Similar results were observed for 365 days. CONCLUSION: Exposure to GRD after a first urgent AMI among older adults insured by the public drug plan in the province of Quebec is relatively low. Reasons and risk groups for this low exposure should be studied to improve secondary prevention. However, results suggest equitable access to GRD, regardless of deprivation.
Asunto(s)
Infarto del Miocardio/tratamiento farmacológico , Infarto del Miocardio/economía , Guías de Práctica Clínica como Asunto/normas , Factores Socioeconómicos , Antagonistas Adrenérgicos beta/economía , Antagonistas Adrenérgicos beta/uso terapéutico , Anciano , Anciano de 80 o más Años , Antagonistas de Receptores de Angiotensina/economía , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/economía , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Estudios de Cohortes , Femenino , Humanos , Masculino , Infarto del Miocardio/epidemiología , Quebec/epidemiología , Estudios RetrospectivosRESUMEN
Objectives: This study assesses the cost-effectiveness of sacubitril/valsartan versus enalapril in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).Methods: We used a previously developed Markov model calibrated with patient-level data from the PARADIGM-HF trial, adapted to the Portuguese setting. The model considers two health states (alive or dead) and uses regression analyzes to estimate hospitalizations and deaths over time. A panel of experts estimated resource consumption in the outpatient setting. To estimate resource consumption with hospitalizations, the National Health Service Diagnosis Related Groups database was used. Unit costs were based on national legislation, and on the Infomed database. The model considers a societal perspective, a time horizon of 30-years, and a 5% annual discount rate. Sensitivity analyses assessed the robustness of results.Results: Sacubitril/valsartan increases life expectancy by 0.5 life-years, corresponding to 0.4 incremental quality adjusted life-years (QALY) versus enalapril. The estimated incremental cost-effectiveness ratio (ICER) is 22,702/QALY. Sensitivity analysis shows that results are robust, but sensitive to the parameter estimates of the cardiovascular survival curve.Conclusion: Sacubitril/valsartan is a cost-effective therapeutic option in the treatment of Portuguese patients with HFrEF and translate into significant health gains and increased life expectancy versus the current standard of care.
Asunto(s)
Aminobutiratos/administración & dosificación , Enalapril/administración & dosificación , Insuficiencia Cardíaca/tratamiento farmacológico , Años de Vida Ajustados por Calidad de Vida , Tetrazoles/administración & dosificación , Aminobutiratos/economía , Antagonistas de Receptores de Angiotensina/administración & dosificación , Antagonistas de Receptores de Angiotensina/economía , Inhibidores de la Enzima Convertidora de Angiotensina/administración & dosificación , Inhibidores de la Enzima Convertidora de Angiotensina/economía , Compuestos de Bifenilo , Análisis Costo-Beneficio , Combinación de Medicamentos , Enalapril/economía , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/fisiopatología , Hospitalización/economía , Humanos , Esperanza de Vida , Cadenas de Markov , Portugal , Volumen Sistólico , Tetrazoles/economía , ValsartánRESUMEN
Importance: In 2015, the US Food and Drug Administration approved 2 new medications for treatment of heart failure with reduced ejection fraction, sacubitril/valsartan and ivabradine. However, few national data are available examining their contemporary use and associated costs. Objective: To evaluate national patterns of use of sacubitril/valsartan and ivabradine and associated therapeutic spending in Medicare Part D and Medicaid. Design, Setting, and Participants: In this US nationwide claims-based study, we analyzed data from the Medicare Part D Prescription Drug Event and Medicaid Utilization and Spending data sets to compare national patterns of use of sacubitril/valsartan and ivabradine between 2016 and 2017. Main Outcomes and Measures: Changes in total spending, per-beneficiary/claim spending, number of beneficiaries, and number of claims between 2016 and 2017 for sacubitril/valsartan and ivabradine. Results: The number of Medicare beneficiaries prescribed sacubitril/valsartan increased from 35â¯423 to 90â¯606 (156% increase from 2016 to 2017). Medicare beneficiaries prescribed ivabradine increased from 15â¯856 to 23â¯213 (46% increase). In 2017, Medicare Part D spent $227 million and $7.3 million on sacubitril/valsartan and ivabradine, respectively. This represented increases of 241% and 59% compared with 2016 spending, respectively. The annual Medicare per-beneficiary spending on sacubitril/valsartan and ivabradine was $2512 and $2400. Parallel trends in use patterns and spending were observed among Medicaid beneficiaries. Conclusions and Relevance: Although initial experiences suggested slow uptake after regulatory approval, these national data demonstrate an increase in use of sacubitril/valsartan and, to a lesser degree, ivabradine in the United States. Current annual per-beneficiary expenditures remain less than spending thresholds that have been reported to be cost-effective. Ongoing efforts are needed to promote high-value care while improving affordability and access to established and emerging heart failure therapies.
Asunto(s)
Aminobutiratos/economía , Utilización de Medicamentos/estadística & datos numéricos , Ivabradina/economía , Medicaid/economía , Medicare Part D/economía , Tetrazoles/economía , Antagonistas de Receptores de Angiotensina/economía , Compuestos de Bifenilo , Fármacos Cardiovasculares/economía , Combinación de Medicamentos , Insuficiencia Cardíaca/tratamiento farmacológico , Humanos , Estados Unidos , ValsartánRESUMEN
BACKGROUND: To assess the cost-effectiveness of new treatments in Germany, the efficiency frontier (EF) method has been developed. We compared the cost-effectiveness analysis using international standards and the German methodology, using the heart failure drug sacubitril/valsartan as an example. METHODS: A previously developed Markov model was adapted to include 4 treatment options: no treatment, enalapril, candesartan, and sacubitril/valsartan. The internationally used incremental cost-effectiveness ratio (ICER) was calculated, as well as cost-effectiveness acceptability curves. Additionally, EFs, net monetary benefits (NMBs), and price-acceptability curves were created according to German guidelines. All analyses were performed from the perspective of the German Statutory Health Insurance. RESULTS: The base-case ICER for sacubitril/valsartan compared to enalapril is 19 300/quality-adjusted life-year. On the cost-effectiveness acceptability curve, sacubitril/valsartan is most likely to be cost-effective, out of all included comparators, from a hypothetical willingness-to-pay threshold of 18 250/quality-adjusted life-year onward. No EF could be constructed for the base case. Taking the uncertainty of the input parameters into account for the probabilistic sensitivity analysis, a NMB of around -14 000 was calculated, depending on the outcome considered, with the NMB being zero at a daily price for sacubitril/valsartan ranging from 1.52 to 1.67. CONCLUSION: We calculated an ICER for Germany, comparable to previously published cost-effectiveness analyses for Europe, which widely concluded sacubitril/valsartan to be cost-effective. Using the German EF approach, a considerable discount needs to be applied before sacubitril/valsartan can be considered cost-effective.
Asunto(s)
Aminobutiratos/economía , Antagonistas de Receptores de Angiotensina/economía , Análisis Costo-Beneficio , Tetrazoles/economía , Aminobutiratos/administración & dosificación , Compuestos de Bifenilo , Combinación de Medicamentos , Alemania , Insuficiencia Cardíaca/tratamiento farmacológico , Humanos , Tetrazoles/administración & dosificación , Resultado del Tratamiento , ValsartánAsunto(s)
Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Antihipertensivos/uso terapéutico , Sustitución de Medicamentos/economía , Medicamentos Genéricos/uso terapéutico , Hipertensión/tratamiento farmacológico , Antagonistas de Receptores de Angiotensina/economía , Inhibidores de la Enzima Convertidora de Angiotensina/economía , Antihipertensivos/economía , Ahorro de Costo , Medicamentos Genéricos/economía , Humanos , Medicare , Estados UnidosAsunto(s)
Aminobutiratos/economía , Aminobutiratos/uso terapéutico , Antagonistas de Receptores de Angiotensina/economía , Antagonistas de Receptores de Angiotensina/uso terapéutico , Gastos en Salud , Insuficiencia Cardíaca/tratamiento farmacológico , Cobertura del Seguro/economía , Medicare Part D , Tetrazoles/economía , Tetrazoles/uso terapéutico , Compuestos de Bifenilo , Combinación de Medicamentos , Humanos , Estados Unidos , ValsartánRESUMEN
PURPOSE: Sacubitril/valsartan, the first-in-class angiotensin receptor neprilysin inhibitor (ARNI), is a possible treatment option for chronic heart failure patients with reduced ejection fraction (HFrEF). The aim of this study was to estimate the cost-effectiveness of sacubitril/valsartan use in South Korea for treating patients with HFrEF compared with that of enalapril, an angiotensin-converting enzyme inhibitor, and with angiotensin receptor blockers (ARBs). METHODS: A Markov model was designed to estimate the lifetime cost-effectiveness of treatment for patients with HFrEF. Cohorts in the alive-state incurred a monthly risk of hospitalization because of deteriorated HF, adverse events (AEs), or death. Transition probabilities of sacubitril/valsartan and enalapril were estimated by using data from the PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. The effectiveness of ARBs (eg, reduction in mortality and hospitalization rates) was assumed to be identical to that of enalapril, according to the results of the meta-analysis. However, there was no comparative evidence for AEs. We therefore conducted a Bayesian network meta-analysis and adjusted the incidence rate of AEs for ARBs. The utility for estimating quality-adjusted life years (QALYs) was elicited by the survey of the general South Korean population by using EuroQol-5 dimensions. We calculated the medical costs, including medication, monitoring, hospitalization, AEs, and terminal care, from the health care sector perspective. Costs and effectiveness were discounted by 5%. One-way sensitivity analyses and a probabilistic sensitivity analysis were conducted to determine the model robustness. FINDINGS: The total cost per patient for sacubitril/valsartan and enalapril was $25,832 and $18,295, respectively. Sacubitril/valsartan was associated with an â¼8- month longer life expectancy compared with enalapril and a QALY gain of 0.59. As a result, the incremental cost-effectiveness ratio for sacubitril/valsartan versus enalapril was $12,722 per QALY. The incremental cost-effectiveness ratio of sacubitril/valsartan versus ARB was $11,970 with an incurred cost of $18,741 for the ARB group. The main results and those of various sensitivity analyses were lower than a threshold of $20,000. IMPLICATIONS: From a health care sector perspective, sacubitril/valsartan is a cost-effective treatment for HFrEF compared with enalapril and ARBs. This finding could be helpful for cardiologists or decision makers in reaching cost-effective choices regarding the treatment selection process.
Asunto(s)
Aminobutiratos , Antagonistas de Receptores de Angiotensina , Insuficiencia Cardíaca , Tetrazoles , Aminobutiratos/economía , Aminobutiratos/uso terapéutico , Antagonistas de Receptores de Angiotensina/economía , Antagonistas de Receptores de Angiotensina/uso terapéutico , Compuestos de Bifenilo , Enfermedad Crónica , Análisis Costo-Beneficio , Combinación de Medicamentos , Costos de la Atención en Salud , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/fisiopatología , Humanos , Modelos Estadísticos , República de Corea , Tetrazoles/economía , Tetrazoles/uso terapéutico , Valsartán , Disfunción Ventricular IzquierdaRESUMEN
INTRODUCTION: Renin-angiotensin system inhibitors (RAS) drugs have a proteinuria-reducing effect that could prevent the progression of kidney disease in diabetic patients. Our study aimed to assess the budget impact based on healthcare payer perspective of increasing uptake of RAS drugs into the current treatment mix of standard anti-hypertensive treatments to prevent progression of kidney disease in patient's comorbid with hypertension and diabetes. METHODS: A Markov model of a Malaysian hypothetical cohort aged ≥30 years (N = 14,589,900) was used to estimate the total and per-member-per-month (PMPM) costs of RAS uptake. This involved an incidence and prevalence rate of 9.0% and 10.53% of patients with diabetes and hypertension respectively. Transition probabilities of health stages and costs were adapted from published data. RESULTS: An increasing uptake of RAS drugs would incur a projected total treatment cost ranged from MYR 4.89 billion (PMPM of MYR 27.95) at Year 1 to MYR 16.26 billion (PMPM of MYR 92.89) at Year 5. This would represent a range of incremental costs between PMPM of MYR 0.20 at Year 1 and PMPM of MYR 1.62 at Year 5. Over the same period, the care costs showed a downward trend but drug acquisition costs were increasing. Sensitivity analyses showed the model was minimally affected by the changes in the input parameters. CONCLUSION: Mild impact to the overall healthcare budget has been reported with an increased utilization of RAS. The long-term positive health consequences of RAS treatment would reduce the cost of care in preventing deterioration of kidney function, thus offsetting the rising costs of purchasing RAS drugs. Optimizing and increasing use of RAS drugs would be considered an affordable and rational strategy to reduce the overall healthcare costs in Malaysia.
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Antagonistas de Receptores de Angiotensina/economía , Inhibidores de la Enzima Convertidora de Angiotensina/economía , Antihipertensivos/economía , Análisis Costo-Beneficio , Costos de la Atención en Salud , Adulto , Antagonistas de Receptores de Angiotensina/farmacología , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/farmacología , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Antihipertensivos/farmacología , Antihipertensivos/uso terapéutico , Presupuestos , Estudios de Cohortes , Comorbilidad , Ahorro de Costo , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/economía , Diabetes Mellitus Tipo 2/epidemiología , Nefropatías Diabéticas/economía , Nefropatías Diabéticas/etiología , Nefropatías Diabéticas/prevención & control , Progresión de la Enfermedad , Humanos , Hipertensión/tratamiento farmacológico , Hipertensión/economía , Hipertensión/epidemiología , Incidencia , Malasia/epidemiología , Modelos Económicos , Prevalencia , Sistema Renina-Angiotensina/efectos de los fármacosRESUMEN
OBJECTIVE: To evaluate the clinical and cost impact of switching angiotensin receptor blockers (ARBs) to angiotensin-converting enzyme inhibitors (ACEIs) in patients with hypertension. METHODS: This study used the UK Clinical Practice Research Datalink, linking with the Hospital Episode Statistics (April 2006 to March 2012). Adults with hypertension (nâ=â470) were followed from the first ARB prescription date to the switching date (preswitching period); then from the switching date to the date when study ended, patient left the dataset or died (postswitching period). Patients were divided into ACEIs-combined (nâ=â369) and ACEIs-monotherapy (nâ=â101) groups by whether additional antihypertensive drugs were prescribed with ACEIs in the postswitching period. Proportion of days covered (PDC), clinical outcomes and costs were compared between the preswitching and postswitching periods using a multilevel regression. RESULTS: Overall, in the postswitching period, there was a significant increase in the proportion of nonadherence (PDCâ<â80%) (OR: 2.4; 95% CI: 1.6-3.7), but a significant reduction in mean SBP (mean difference: -2.3; 95 CI: -3.4 to 1.2âmmHg) and mean DBP (mean difference: -1.9; 95% CI: -2.6 to -1.2âmmHg). However, these results were only observed in the ACEIs-combined group. There was no postswitching significant difference in either the incidence of individual or composite hypertension-related complications (OR: 0.9; 95% CI: 0.4-2.0). There was a significant reduction in the overall annual medical cost per patient by £329 (95% CI: -534 to -205). CONCLUSION: Switching of ARBs to ACEIs monotherapy appeared to be clinically effective and a cost-saving strategy. The observed changes in the ACEIs-combined group are assumed to be related to factors other than the ARBs switching.
Asunto(s)
Antagonistas de Receptores de Angiotensina/economía , Inhibidores de la Enzima Convertidora de Angiotensina/economía , Antihipertensivos/uso terapéutico , Hipertensión/tratamiento farmacológico , Hipertensión/economía , Adulto , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Antihipertensivos/economía , Sustitución de Medicamentos/economía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Heart failure affects over 1 million people in Germany and contributes to morbidity, mortality, and high healthcare costs. A recent large randomized controlled trial compared the novel compound sacubitril/valsartan (LCZ696) with the angiotensin-converting enzyme (ACE) inhibitor enalapril and found a 16% reduction in mortality hazard. In Germany, sacubitril/valsartan was launched at the beginning of 2016. OBJECTIVE: The purpose of this study was to conduct a post hoc analysis of the cost effectiveness, budget impact, and disease burden reduction of sacubitril/valsartan compared with ACE inhibitors for patients with heart failure from the perspective of the German social health insurance (SHI), based on the results of this trial. METHODS: A Markov (cohort) state transition model was constructed to simulate treatment over a remaining lifetime. Based on the Markov model, a dynamic population model was developed that projects the incidence, prevalence, mortality, and healthcare costs of heart failure in the SHI population from 2017 to 2060. The population model follows prevalent and incident cohorts over time. Each year a new cohort is added, while the existing cohorts age by 1 year or die. To test for sensitivity of results, a Monte Carlo simulation was run. RESULTS: Based on the price negotiated between manufacturer and representatives of the SHI, the base-case incremental cost-effectiveness ratio (ICER) of sacubitril/valsartan versus ACE inhibitors is 23,401 per life-year gained (in 2018 Euros). At a price of zero, the cost-effectiveness ratio is already 9594 per life-year gained due to high background costs of heart failure. Annual budget impact and reduction of disease burden reach a maximum at 4-8 years after launch (221 million and 2.9%, respectively, in the base case). CONCLUSIONS: The ICER of sacubitril/valsartan is projected to be at or below the level of other accepted interventions for the treatment of asymptomatic to severe heart failure in Germany. Projected budget impact leads to an increase in SHI expenditures by < 0.04% per year.
Asunto(s)
Aminobutiratos/economía , Análisis Costo-Beneficio/estadística & datos numéricos , Insuficiencia Cardíaca/economía , Tetrazoles/economía , Anciano , Anciano de 80 o más Años , Aminobutiratos/uso terapéutico , Antagonistas de Receptores de Angiotensina/economía , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/economía , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Compuestos de Bifenilo , Presupuestos , Combinación de Medicamentos , Enalapril/economía , Enalapril/uso terapéutico , Femenino , Insuficiencia Cardíaca/tratamiento farmacológico , Humanos , Masculino , Cadenas de Markov , Persona de Mediana Edad , Modelos Económicos , Método de Montecarlo , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Tetrazoles/uso terapéutico , ValsartánRESUMEN
Almost all new treatments being developed for the next influenza pandemic target the virus. During the Ebola crisis in West Africa, patients were treated with an inexpensive generic statin/angiotensin receptor blocker combination that appeared to greatly improve survival. These drugs target the host response, not the virus, and probably reverse endothelial dysfunction. Scientists and health officials have shown little interest in this idea. Yet, during the early months of the next pandemic, vaccines will be unavailable and treatment options will be limited. Physicians should be prepared to undertake clinical trials of widely available generic drugs to determine whether they improve survival in patients with seasonal influenza, other emerging virus diseases, and other forms of acute critical illness. Public health officials should give these studies their strong support. If successful, they will suggest a 'bottom up' approach to patient care that could be implemented worldwide on the first pandemic day.
Asunto(s)
Medicamentos Genéricos/uso terapéutico , Fiebre Hemorrágica Ebola/tratamiento farmacológico , Gripe Humana/prevención & control , Terapia Molecular Dirigida , Pandemias/prevención & control , Antagonistas de Receptores de Angiotensina/economía , Antagonistas de Receptores de Angiotensina/uso terapéutico , Ensayos Clínicos como Asunto , Combinación de Medicamentos , Medicamentos Genéricos/economía , Medicamentos Genéricos/provisión & distribución , Salud Global , Fiebre Hemorrágica Ebola/epidemiología , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/economía , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Gripe Humana/epidemiología , Análisis de SupervivenciaRESUMEN
OBJECTIVE: Sacubitril/valsartan (SAC/VAL) has been shown to reduce mortality and hospitalization in patients with heart failure with reduced ejection fraction (HFrEF) compared with enalapril but at a substantially higher cost. This study evaluates the cost-effectiveness of SAC/VAL versus enalapril in patients with HFrEF over a 5-year time horizon from the U.S. payer perspective. METHODS: A cohort-based Markov model was developed to compare costs and quality-adjusted life years (QALYs) between SAC/VAL and enalapril in patients with HFrEF over a 5-year time horizon. Markov states included New York Heart Association (NYHA) class (II-IV) and death. Treatment discontinuation, HF-related hospitalizations, and NYHA class progression were modeled as transition states based on data from the PARADIGM trial. Other probabilities, costs, and utilities were obtained from published literature and public databases. RESULTS: In the base case analysis, SAC/VAL cost more than enalapril ($81,943 vs $67,287) and was more effective (2.647 QALYs vs 2.546 QALYs), resulting in an incremental cost-effectiveness ratio of $143,891/QALY gained. At a willingness to pay (WTP) of $100,000/QALY, SAC/VAL was cost-effective up to a cost of $298/month. Results were most sensitive to SAC/VAL cost, SAC/VAL mortality benefit, and NYHA progression probability. SAC/VAL had a 10% and 52% probability of being cost-effective at WTP thresholds of $100,000/QALY and $150,000/QALY, respectively. CONCLUSIONS: SAC/VAL is associated with clinical benefit and may be cost-effective compared with the current standard of care over realistic treatment durations from the payer perspective. Results of this analysis can inform discussions on the value and position of SAC/VAL in the current market.
Asunto(s)
Aminobutiratos/uso terapéutico , Antagonistas de Receptores de Angiotensina/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Años de Vida Ajustados por Calidad de Vida , Tetrazoles/uso terapéutico , Aminobutiratos/economía , Antagonistas de Receptores de Angiotensina/economía , Compuestos de Bifenilo , Estudios de Cohortes , Análisis Costo-Beneficio , Combinación de Medicamentos , Costos de los Medicamentos , Insuficiencia Cardíaca/fisiopatología , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Humanos , Cadenas de Markov , Volumen Sistólico , Tetrazoles/economía , ValsartánAsunto(s)
Aminobutiratos/uso terapéutico , Antagonistas de Receptores de Angiotensina/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Tetrazoles/uso terapéutico , Aminobutiratos/efectos adversos , Aminobutiratos/economía , Antagonistas de Receptores de Angiotensina/efectos adversos , Antagonistas de Receptores de Angiotensina/economía , Compuestos de Bifenilo , Toma de Decisiones Clínicas , Análisis Costo-Beneficio , Combinación de Medicamentos , Costos de los Medicamentos , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Humanos , Selección de Paciente , Recuperación de la Función , Factores de Riesgo , Tetrazoles/efectos adversos , Tetrazoles/economía , Factores de Tiempo , Resultado del Tratamiento , ValsartánRESUMEN
Our aim was to summarize published secondary analyses of the PARADIGM-HF trial. In the original trial, published in September 2014, sacubitril/valsartan significantly reduced the primary composite outcome of cardiovascular death or heart failure hospitalization compared to enalapril. This summary provides a resource for clinicians to review subsequent analyses of the landmark trial evaluating the benefit of sacubitril/valsartan in various subgroups and providing information regarding optimal use of this new therapy in the broader heart failure population. A full list of publications of the existing PARDADIGM-HF post hoc analyses was obtained and summarized, grouped by focus (e.g., severity of illness, tolerability). Twenty-six publications and one abstract analyzing the PARADIGM-HF trial were reviewed, summarizing the most important results that compared the benefits of sacubitril/valsartan to enalapril, including pertinent subgroup information from each analysis. Key publications evaluated the treatment effect of sacubitril/valsartan based on heart failure severity (i.e., ejection fraction or heart failure risk scores), impact on alternate outcomes, influence of additional therapies, tolerability in patients with comorbidities (i.e., diabetes), long-term benefits, and cost-effectiveness. In addition, nine ongoing phase III and phase IV clinical trials with sacubitril/valsartan were briefly summarized to address potential future uses in more extensive heart failure settings. The benefit of sacubitril/valsartan over enalapril for the primary endpoint in the PARADIGM-HF trial is maintained throughout numerous secondary analyses. Though the subgroups analyzed are based on participants from a single clinical trial, clinicians can more confidently incorporate this novel therapy into practice with expanded knowledge of these existing analyses as well as ongoing prospective trials.
Asunto(s)
Aminobutiratos/administración & dosificación , Antagonistas de Receptores de Angiotensina/administración & dosificación , Ensayos Clínicos como Asunto/métodos , Insuficiencia Cardíaca/tratamiento farmacológico , Tetrazoles/administración & dosificación , Aminobutiratos/economía , Antagonistas de Receptores de Angiotensina/economía , Compuestos de Bifenilo , Análisis Costo-Beneficio/métodos , Combinación de Medicamentos , Enalapril/administración & dosificación , Enalapril/economía , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/epidemiología , Humanos , Estudios Prospectivos , Tetrazoles/economía , ValsartánRESUMEN
A novel antihypertensive drug, LCZ696 (Entresto®), has recently been introduced, which combines the action of an antagonist of the renin-angiotensin-aldosterone system (RAAS), effectively decreasing the blood pressure, with an inhibition of neprilysin, which is responsible for metabolizing natriuretic peptides exerting antihypertensive and antifibrotic effects. In this MiniReview, we describe the pharmacokinetics and pharmacodynamics, efficacy and side effects of the combined angiotensin receptor antagonist and neprilysin inhibitor LCZ696. We summarize the effect of LCZ696 treatment of patients suffering from hypertension and heart failure (HF) and further highlight the role of this new drug as a treatment option in the future. In the earlier stages of the treatment of patients with heart failure, LCZ696 was superior in lowering the blood pressure compared to olmesartan, while the effect on blood pressure at long-term treatment was comparable for the two drugs. The numbers of adverse effects were comparable. LCZ696 was superior to enalapril in reducing mortality, hospitalizations and HF symptoms. Adverse effects were reduced with a slower up-titrating regimen of 6 weeks. The current results are promising and suggest that LCZ696 will be a new candidate for first-line treatment of HF. However, it needs to be explored whether LCZ696 is safe in pregnant women, what are the effects of long-term LCZ696 treatment on survival and whether the antifibrotic effects can be of major benefit in, for example HF with preserved ejection fraction.
Asunto(s)
Aminobutiratos/farmacología , Antagonistas de Receptores de Angiotensina/farmacología , Antihipertensivos/farmacología , Insuficiencia Cardíaca/tratamiento farmacológico , Hipertensión/tratamiento farmacológico , Tetrazoles/farmacología , Aminobutiratos/economía , Aminobutiratos/uso terapéutico , Antagonistas de Receptores de Angiotensina/economía , Antagonistas de Receptores de Angiotensina/uso terapéutico , Antihipertensivos/economía , Antihipertensivos/uso terapéutico , Compuestos de Bifenilo , Presión Sanguínea/efectos de los fármacos , Ensayos Clínicos como Asunto , Combinación de Medicamentos , Insuficiencia Cardíaca/etiología , Insuficiencia Cardíaca/mortalidad , Humanos , Hipertensión/etiología , Hipertensión/mortalidad , Imidazoles/farmacología , Imidazoles/uso terapéutico , Péptidos Natriuréticos/metabolismo , Neprilisina/antagonistas & inhibidores , Sistema Renina-Angiotensina/efectos de los fármacos , Tetrazoles/economía , Tetrazoles/uso terapéutico , Resultado del Tratamiento , ValsartánRESUMEN
OBJECTIVES: To describe the adaptation of a global health economic model to determine whether treatment with the angiotensin receptor neprilysin inhibitor LCZ696 is cost effective compared with the angiotensin-converting enzyme inhibitor enalapril in adult patients with chronic heart failure with reduced left ventricular ejection fraction in the Netherlands; and to explore the effect of performing the cost-effectiveness analyses according to the new pharmacoeconomic Dutch guidelines (updated during the submission process of LCZ696), which require a value-of-information analysis and the inclusion of indirect medical costs of life-years gained. METHODS: We adapted a UK model to reflect the societal perspective in the Netherlands by including travel expenses, productivity loss, informal care costs, and indirect medical costs during the life-years gained and performed a preliminary value-of-information analysis. RESULTS: The incremental cost-effectiveness ratio obtained was 17,600 per quality-adjusted life-year (QALY) gained. This was robust to changes in most structural assumptions and across different subgroups of patients. Probability sensitivity analysis results showed that the probability that LCZ696 is cost-effective at a 50,000 per QALY threshold is 99.8%, with a population expected value of perfect information of 297,128. On including indirect medical costs of life-years gained, the incremental cost-effectiveness ratio was 26,491 per QALY gained, and LCZ696 was 99.46% cost effective at 50,000 per QALY, with a population expected value of perfect information of 2,849,647. CONCLUSIONS: LCZ696 is cost effective compared with enalapril under the former and current Dutch guidelines. However, the (monetary) consequences of making a wrong decision were considerably different in both scenarios.