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1.
Curr Probl Cardiol ; 49(8): 102684, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38821231

RESUMO

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.


Assuntos
Insuficiência Cardíaca , Humanos , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/economia , Estados Unidos , Medicare Part D/economia , Guias de Prática Clínica como Assunto , Combinação de Medicamentos , Antagonistas de Receptores de Angiotensina/uso terapêutico , Antagonistas de Receptores de Angiotensina/economia , Compostos Benzidrílicos/uso terapêutico , Compostos Benzidrílicos/economia , Valsartana , Glucosídeos/uso terapêutico , Glucosídeos/economia , Aminobutiratos/uso terapêutico , Aminobutiratos/economia , Compostos de Bifenilo/economia , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose/economia , Custos de Medicamentos , Bases de Dados Factuais , Antagonistas de Receptores de Mineralocorticoides/uso terapêutico , Antagonistas de Receptores de Mineralocorticoides/economia
2.
JAMA Cardiol ; 8(11): 1041-1048, 2023 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-37755814

RESUMO

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 $40 892 compared with RASi, yielding an ICER of $76 852 per QALY. In a probabilistic sensitivity analysis, 95% of the values of the ICER occurred between $71 516 and $82 970 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 <$180 000 per QALY) at a sacubitril-valsartan cost of $10 242 or less per year, of high economic value (ICER <$60 000 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 $67 331 per QALY, $59 614 per QALY, and $56 786 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 $127 172 per QALY gained; treatment was more cost-effective in those at the lower end of this range (ICER of $100 388 per QALY gained for those with EFs of 45%-55%; ICER of $84 291 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.


Assuntos
Insuficiência Cardíaca , Neprilisina , Estados Unidos , Humanos , Análise Custo-Benefício , Neprilisina/uso terapêutico , Angiotensinas/farmacologia , Angiotensinas/uso terapêutico , Volume Sistólico/efeitos dos fármacos , Antagonistas de Receptores de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Tetrazóis/economia , Insuficiência Cardíaca/mortalidade , Anti-Hipertensivos/uso terapêutico
3.
JAMA Cardiol ; 5(11): 1236-1244, 2020 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-32785628

RESUMO

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 $21 532 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.


Assuntos
Aminobutiratos/farmacologia , Efeitos Psicossociais da Doença , Insuficiência Cardíaca/tratamento farmacológico , Hospitalização/economia , Qualidade de Vida , Volume Sistólico/fisiologia , Tetrazóis/farmacologia , Aminobutiratos/economia , Antagonistas de Receptores de Angiotensina/economia , Antagonistas de Receptores de Angiotensina/farmacologia , Compostos de Bifenilo , Análise Custo-Benefício , Combinação de Medicamentos , Feminino , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Estudos Retrospectivos , Tetrazóis/economia , Valsartana , Função Ventricular Esquerda/fisiologia
4.
Expert Rev Pharmacoecon Outcomes Res ; 20(2): 199-205, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31219361

RESUMO

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.


Assuntos
Aminobutiratos/administração & dosagem , Enalapril/administração & dosagem , Insuficiência Cardíaca/tratamento farmacológico , Anos de Vida Ajustados por Qualidade de Vida , Tetrazóis/administração & dosagem , Aminobutiratos/economia , Antagonistas de Receptores de Angiotensina/administração & dosagem , Antagonistas de Receptores de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/administração & dosagem , Inibidores da Enzima Conversora de Angiotensina/economia , Compostos de Bifenilo , Análise Custo-Benefício , Combinação de Medicamentos , Enalapril/economia , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/fisiopatologia , Hospitalização/economia , Humanos , Expectativa de Vida , Cadeias de Markov , Portugal , Volume Sistólico , Tetrazóis/economia , Valsartana
5.
Pharmacoepidemiol Drug Saf ; 29(2): 141-149, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31797484

RESUMO

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.


Assuntos
Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/economia , Guias de Prática Clínica como Assunto/normas , Fatores Socioeconômicos , Antagonistas Adrenérgicos beta/economia , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Antagonistas de Receptores de Angiotensina/economia , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Estudos de Coortes , Feminino , Humanos , Masculino , Infarto do Miocárdio/epidemiologia , Quebeque/epidemiologia , Estudos Retrospectivos
6.
JAMA Cardiol ; 5(3): 336-339, 2020 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-31738371

RESUMO

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 35 423 to 90 606 (156% increase from 2016 to 2017). Medicare beneficiaries prescribed ivabradine increased from 15 856 to 23 213 (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.


Assuntos
Aminobutiratos/economia , Uso de Medicamentos/estatística & dados numéricos , Ivabradina/economia , Medicaid/economia , Medicare Part D/economia , Tetrazóis/economia , Antagonistas de Receptores de Angiotensina/economia , Compostos de Bifenilo , Fármacos Cardiovasculares/economia , Combinação de Medicamentos , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Estados Unidos , Valsartana
7.
Value Health ; 22(10): 1119-1127, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31563254

RESUMO

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.


Assuntos
Aminobutiratos/economia , Antagonistas de Receptores de Angiotensina/economia , Análise Custo-Benefício , Tetrazóis/economia , Aminobutiratos/administração & dosagem , Compostos de Bifenilo , Combinação de Medicamentos , Alemanha , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Tetrazóis/administração & dosagem , Resultado do Tratamento , Valsartana
10.
Clin Ther ; 41(6): 1066-1079, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31101372

RESUMO

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 ∼8- 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.


Assuntos
Aminobutiratos , Antagonistas de Receptores de Angiotensina , Insuficiência Cardíaca , Tetrazóis , Aminobutiratos/economia , Aminobutiratos/uso terapêutico , Antagonistas de Receptores de Angiotensina/economia , Antagonistas de Receptores de Angiotensina/uso terapêutico , Compostos de Bifenilo , Doença Crônica , Análise Custo-Benefício , Combinação de Medicamentos , Custos de Cuidados de Saúde , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Modelos Estatísticos , República da Coreia , Tetrazóis/economia , Tetrazóis/uso terapêutico , Valsartana , Disfunção Ventricular Esquerda
11.
PLoS One ; 14(2): e0212832, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30817790

RESUMO

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.


Assuntos
Antagonistas de Receptores de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/economia , Anti-Hipertensivos/economia , Análise Custo-Benefício , Custos de Cuidados de Saúde , Adulto , Antagonistas de Receptores de Angiotensina/farmacologia , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/farmacologia , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Anti-Hipertensivos/farmacologia , Anti-Hipertensivos/uso terapêutico , Orçamentos , Estudos de Coortes , Comorbidade , Redução de Custos , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/economia , Diabetes Mellitus Tipo 2/epidemiologia , Nefropatias Diabéticas/economia , Nefropatias Diabéticas/etiologia , Nefropatias Diabéticas/prevenção & controle , Progressão da Doença , Humanos , Hipertensão/tratamento farmacológico , Hipertensão/economia , Hipertensão/epidemiologia , Incidência , Malásia/epidemiologia , Modelos Econômicos , Prevalência , Sistema Renina-Angiotensina/efeitos dos fármacos
12.
J Hypertens ; 37(6): 1285-1293, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30601319

RESUMO

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 (n = 470) 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 (n = 369) and ACEIs-monotherapy (n = 101) 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 (PDC < 80%) (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 1.2 mmHg) and mean DBP (mean difference: -1.9; 95% CI: -2.6 to -1.2 mmHg). 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.


Assuntos
Antagonistas de Receptores de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/economia , Anti-Hipertensivos/uso terapêutico , Hipertensão/tratamento farmacológico , Hipertensão/economia , Adulto , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Anti-Hipertensivos/economia , Substituição de Medicamentos/economia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
13.
J Public Health Policy ; 39(3): 268-282, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30013135

RESUMO

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.


Assuntos
Medicamentos Genéricos/uso terapêutico , Doença pelo Vírus Ebola/tratamento farmacológico , Influenza Humana/prevenção & controle , Terapia de Alvo Molecular , Pandemias/prevenção & controle , Antagonistas de Receptores de Angiotensina/economia , Antagonistas de Receptores de Angiotensina/uso terapêutico , Ensaios Clínicos como Assunto , Combinação de Medicamentos , Medicamentos Genéricos/economia , Medicamentos Genéricos/provisão & distribuição , Saúde Global , Doença pelo Vírus Ebola/epidemiologia , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Influenza Humana/epidemiologia , Análise de Sobrevida
14.
Pharmacoeconomics ; 36(10): 1285-1296, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30054868

RESUMO

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.


Assuntos
Aminobutiratos/economia , Análise Custo-Benefício/estatística & dados numéricos , Insuficiência Cardíaca/economia , Tetrazóis/economia , Idoso , Idoso de 80 Anos ou mais , Aminobutiratos/uso terapêutico , Antagonistas de Receptores de Angiotensina/economia , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Compostos de Bifenilo , Orçamentos , Combinação de Medicamentos , Enalapril/economia , Enalapril/uso terapêutico , Feminino , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econômicos , Método de Monte Carlo , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Tetrazóis/uso terapêutico , Valsartana
15.
Pharmacotherapy ; 38(5): 520-530, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29601093

RESUMO

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.


Assuntos
Aminobutiratos/uso terapêutico , Antagonistas de Receptores de Angiotensina/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Anos de Vida Ajustados por Qualidade de Vida , Tetrazóis/uso terapêutico , Aminobutiratos/economia , Antagonistas de Receptores de Angiotensina/economia , Compostos de Bifenilo , Estudos de Coortes , Análise Custo-Benefício , Combinação de Medicamentos , Custos de Medicamentos , Insuficiência Cardíaca/fisiopatologia , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Humanos , Cadeias de Markov , Volume Sistólico , Tetrazóis/economia , Valsartana
16.
Basic Clin Pharmacol Toxicol ; 122(1): 9-18, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28944989

RESUMO

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.


Assuntos
Aminobutiratos/farmacologia , Antagonistas de Receptores de Angiotensina/farmacologia , Anti-Hipertensivos/farmacologia , Insuficiência Cardíaca/tratamento farmacológico , Hipertensão/tratamento farmacológico , Tetrazóis/farmacologia , Aminobutiratos/economia , Aminobutiratos/uso terapêutico , Antagonistas de Receptores de Angiotensina/economia , Antagonistas de Receptores de Angiotensina/uso terapêutico , Anti-Hipertensivos/economia , Anti-Hipertensivos/uso terapêutico , Compostos de Bifenilo , Pressão Sanguínea/efeitos dos fármacos , Ensaios Clínicos como Assunto , Combinação de Medicamentos , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/mortalidade , Humanos , Hipertensão/etiologia , Hipertensão/mortalidade , Imidazóis/farmacologia , Imidazóis/uso terapêutico , Peptídeos Natriuréticos/metabolismo , Neprilisina/antagonistas & inibidores , Sistema Renina-Angiotensina/efeitos dos fármacos , Tetrazóis/economia , Tetrazóis/uso terapêutico , Resultado do Tratamento , Valsartana
17.
Pharmacotherapy ; 38(2): 284-298, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29265423

RESUMO

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.


Assuntos
Aminobutiratos/administração & dosagem , Antagonistas de Receptores de Angiotensina/administração & dosagem , Ensaios Clínicos como Assunto/métodos , Insuficiência Cardíaca/tratamento farmacológico , Tetrazóis/administração & dosagem , Aminobutiratos/economia , Antagonistas de Receptores de Angiotensina/economia , Compostos de Bifenilo , Análise Custo-Benefício/métodos , Combinação de Medicamentos , Enalapril/administração & dosagem , Enalapril/economia , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/epidemiologia , Humanos , Estudos Prospectivos , Tetrazóis/economia , Valsartana
19.
Value Health ; 20(10): 1260-1269, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-29241885

RESUMO

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.


Assuntos
Aminobutiratos/uso terapêutico , Antagonistas de Receptores de Angiotensina/uso terapêutico , Farmacoeconomia , Insuficiência Cardíaca/tratamento farmacológico , Modelos Econômicos , Tetrazóis/uso terapêutico , Idoso , Aminobutiratos/economia , Antagonistas de Receptores de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Compostos de Bifenilo , Doença Crônica , Análise Custo-Benefício , Combinação de Medicamentos , Enalapril/economia , Enalapril/uso terapêutico , Feminino , Guias como Assunto , Insuficiência Cardíaca/economia , Humanos , Masculino , Pessoa de Meia-Idade , Neprilisina/antagonistas & inibidores , Países Baixos , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Volume Sistólico/efeitos dos fármacos , Tetrazóis/economia , Valsartana
20.
Am J Prev Med ; 53(6S2): S131-S142, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29153114

RESUMO

CONTEXT: Hypertension affects one third of the U.S. adult population. Although cost-effectiveness analyses of antihypertensive medicines have been published, a comprehensive systematic review across medicine classes is not available. EVIDENCE ACQUISITION: PubMed, Embase, Cochrane Library, and Health Technology Assessment were searched to identify original cost-effectiveness analyses published from 1990 through August 2016. Results were summarized by medicine class: angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), thiazide-type diuretics, ß-blockers, and others. Incremental cost-effectiveness ratios (ICERs) were adjusted to 2015 U.S. dollars. EVIDENCE SYNTHESIS: Among 76 studies reviewed, 14 compared medicines with no treatment, 16 compared medicines with conventional therapy, 29 compared between medicine classes, 13 compared within medicine class, and 11 compared combination therapies. All antihypertensives were cost effective compared with no treatment (ICER/quality-adjusted life year [QALY]=dominant-$19,945). ARBs were more cost effective than CCBs (ICER/QALY=dominant-$13,016) in nine comparisons, whereas CCBs were more cost effective than ARBs (ICER/QALY=dominant) in two comparisons. ARBs were more cost effective than ACEIs (ICER/QALY=dominant-$34,244) and ß-blockers (ICER/QALY=$1,498-$18,137) in all eight comparisons. CONCLUSIONS: All antihypertensives were cost effective compared with no treatment. ARBs appeared to be more cost effective than CCBs, ACEIs, and ß-blockers. However, these latter findings should be interpreted with caution because these findings are not robust due to the substantial variability across the studies, including study settings and analytic models, changes in the cost of generic medicines, and publication bias.


Assuntos
Anti-Hipertensivos/economia , Análise Custo-Benefício , Medicamentos Genéricos/economia , Hipertensão/tratamento farmacológico , Antagonistas Adrenérgicos beta/economia , Antagonistas Adrenérgicos beta/uso terapêutico , Antagonistas de Receptores de Angiotensina/economia , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Bloqueadores dos Canais de Cálcio/economia , Bloqueadores dos Canais de Cálcio/uso terapêutico , Medicamentos Genéricos/uso terapêutico , Humanos , Hipertensão/economia , Anos de Vida Ajustados por Qualidade de Vida , Inibidores de Simportadores de Cloreto de Sódio/economia , Inibidores de Simportadores de Cloreto de Sódio/uso terapêutico
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