RESUMO
Background: There is limited real-world data of lipid control and healthcare costs among patients with and without Atherosclerotic Cardiovascular Disease (ASCVD) in Latin America. Methods: A retrospective cohort study including patients with LDL-cholesterol (LDL-C) assessment from 2015 to 2017 was performed in a health insurance database. Patient characteristics, comorbidities and laboratory data were collected, and International Classification of Diseases (ICD) codes were used to identify a subcohort of patients with ASCVD (secondary prevention) and assess the proportion of these patients with LDL-C controlled. Lipid control among patients without ASCVD (primary prevention) and healthcare costs in one year in the overall population were also assessed. Results: From the 17,434 patients selected, 5,208 (29.8%) had ASCVD. The mean age of these patients in secondary prevention was 68.9 (±12.3) years and 47.8% were male patients. LDL-C < 70 mg/dL was identified in 19.1% of the ASCVD population and only 4.1% had an LDL-C < 50 mg/dL. LDL control was worse in women compared to men (13.1% vs. 25.7%; P < 0.01). The average cost in one year was 3,591 American dollars (USD) per patient in primary prevention compared to 8,210 dollars per year for patients in secondary prevention (P < 0.01). While outpatient costs accounted for 59.8% of the total cost in the primary prevention group, the main cost of the secondary prevention population was related to hospital costs (54.1%). Conclusion: Despite the favorable evidence for intensive cholesterol reduction, the evaluation of large real-world database with more than 17,000 individuals showed that the targets of guideline recommendations have not yet been adequately incorporated into clinical practice. Average annual cost per patient in secondary prevention is more than twice compared to primary prevention. Hospital expenses account for most of the cost in the secondary prevention group, while outpatient costs predominate in primary prevention.
Assuntos
Aterosclerose , Custos de Cuidados de Saúde , Humanos , Masculino , Feminino , Estudos Retrospectivos , Idoso , Aterosclerose/economia , Aterosclerose/epidemiologia , Aterosclerose/prevenção & controle , Custos de Cuidados de Saúde/estatística & dados numéricos , Brasil/epidemiologia , Pessoa de Meia-Idade , LDL-Colesterol/sangue , Seguimentos , Prevenção Secundária/economiaRESUMO
OBJECTIVE: Population-based national data on the trends in expenditures related to coexisting atherosclerotic cardiovascular diseases (ASCVD) and diabetes is scarce. We assessed the trends in direct health care expenditures for ASCVD among individuals with and without diabetes, which can help to better define the burden of the co-occurrence of diabetes and ASCVD. METHODS: We used 12-year data (2008-2019) from the US national Medical Expenditure Panel Survey including 28,144 U.S individuals aged ≥ 18 years. Using a two-part model (adjusting for demographics, comorbidities and time), we estimated mean and adjusted incremental medical expenditures by diabetes status among individuals with ASCVD. The costs were direct total health care expenditures (out-of-pocket payments and payments by private insurance, Medicaid, Medicare, and other sources) from various sources (office-based visits, hospital outpatient, emergency room, inpatient hospital, pharmacy, home health care, and other medical expenditures). RESULTS: The total direct expenditures for individuals with ASCVD increased continuously by 30% from $14,713 (95% confidence interval (CI): $13,808-$15,619) in 2008-2009 to $19,145 (95% CI: $17,988-$20,301) in 2008-2019. Individuals with diabetes had a 1.5-fold higher mean expenditure that those without diabetes. A key driver of the observed increase in direct costs was prescription drug costs, which increased by 37% among all individuals with ASCVD. The increase in prescription drug costs was more pronounced among individuals with ASCVD and diabetes, in whom a 45% increase in costs was observed, from $5184 (95% CI: $4721-$5646) in 2008-2009 to $7501 (95% CI: $6678-$8325) in 2018-2019. Individuals with ASCVD and diabetes had $5563 (95% CI: $4643-$6483) higher direct incremental expenditures compared with those without diabetes, after adjusting for demographics and comorbidities. Among US adults with ASCVD, the estimated adjusted total direct excess medical expenditures were $42 billion per year among those with diabetes vs. those without diabetes. CONCLUSIONS: In the setting of ASCVD, diabetes is associated with significantly increased health care costs, an increase that was driven by marked increase in medication costs.
Assuntos
Aterosclerose , Comorbidade , Diabetes Mellitus , Custos de Cuidados de Saúde , Gastos em Saúde , Humanos , Estados Unidos/epidemiologia , Masculino , Feminino , Pessoa de Meia-Idade , Diabetes Mellitus/economia , Diabetes Mellitus/epidemiologia , Diabetes Mellitus/terapia , Diabetes Mellitus/diagnóstico , Idoso , Gastos em Saúde/tendências , Adulto , Aterosclerose/economia , Aterosclerose/epidemiologia , Aterosclerose/terapia , Custos de Cuidados de Saúde/tendências , Fatores de Tempo , Adulto Jovem , Adolescente , Custos de Medicamentos/tendênciasRESUMO
BACKGROUND: The study aims to compare cost and non-cost factors associated with delays in receiving medical care in adults with atherosclerotic cardiovascular disease (ASCVD). METHODS: Using 2014-2018 data from the Centers for Disease Control and Prevention (CDC) Behaviour Risk Factor Surveillance System (BRFSS) survey (N = 508,203), multivariate logistic regression models were developed to compute the adjusted odds ratio of reasons for delays in medical care in adults with ASCVD. RESULTS: Our study population of 61,227 adults with ASCVD (9.1%) had higher odds of any medical care delay (aOR 1.50, 95% CI 1.43-1.57), delay due to cost (aOR 1.55, 95% CI 1.45-1.65), long clinic wait times (aOR 1.21, 95% CI 1.04-1.39) and lack of transportation (aOR 1.64, 95% CI 1.47-1.84) than those without ASCVD. CONCLUSION: Novel public health and health policy approaches are urgently needed to reduce the cost- and non-cost-related barriers that adults with ASCVD encounter when accessing healthcare services.
Assuntos
Aterosclerose , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Aterosclerose/economia , Idoso , Adulto , Acessibilidade aos Serviços de Saúde/economia , Tempo para o Tratamento/economia , Tempo para o Tratamento/estatística & dados numéricos , Estados Unidos , Sistema de Vigilância de Fator de Risco Comportamental , Custos de Cuidados de Saúde/estatística & dados numéricos , Modelos LogísticosRESUMO
AIM: In 2022, in Italy, general practitioners (GPs) have been allowed to prescribe SGLT2i in Type 2 Diabetes (T2D) under National Health Service (NHS) reimbursement. In the pivotal clinical trial named DECLARE-TIMI 58, dapagliflozin reduced the risk of hospitalization for heart failure, CV death and kidney disease progression compared to placebo in a population of T2D patients. This study evaluated the health and economic impact of dapagliflozin for T2D patients who had or were at risk for atherosclerotic cardiovascular disease in the Italian GPs setting. METHODS: A budget impact model was developed to assess the health and economic impact of introducing dapagliflozin in GPs setting. The analysis was conducted by adopting the Italian NHS perspective and a 3-year time horizon. The model estimated and compared the health outcomes and direct medical costs associated with a scenario with dapagliflozin and other antidiabetic therapies available for GPs prescription (scenario B) and a scenario where only other antidiabetic therapies are available (scenario A). Rates of occurrence of cardiovascular and renal complications as well as adverse events were captured from DECLARE-TIMI 58 trial and the literature, while cost data were retrieved from the Italian tariff and the literature. One-way sensitivity analyses were conducted to test the impact of model parameters on the budget impact. RESULTS: The model estimated around 442.000 patients eligible for the treatment with dapagliflozin in the GPs setting for each simulated year. The scenario B compared to scenario A was associated with a reduction in the occurrence of cardiovascular and renal complication (-1.83%) over the 3 years simulated. Furthermore, the scenario A allowed for an overall cost saving of 102,692,305: 14,521,464 in the first year, 33,007,064 in the second and 55,163,777 in the third. The cost of cost of drug acquisition, the probability of cardiovascular events and the percentage of patients potentially eligible to the treatment were the factor with largest impact on the results. CONCLUSIONS: The use of dapagliflozin in GPs setting reduce the number of CVD events, kidney disease progression and healthcare costs in Italy. These data should be considered to optimize the value produced for the T2D patients who had or were at risk for atherosclerotic cardiovascular disease.
Assuntos
Aterosclerose , Compostos Benzidrílicos , Diabetes Mellitus Tipo 2 , Glucosídeos , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/economia , Diabetes Mellitus Tipo 2/complicações , Compostos Benzidrílicos/economia , Compostos Benzidrílicos/uso terapêutico , Itália/epidemiologia , Glucosídeos/uso terapêutico , Glucosídeos/economia , Aterosclerose/economia , Aterosclerose/tratamento farmacológico , Clínicos Gerais/estatística & dados numéricos , Clínicos Gerais/economia , Orçamentos/estatística & dados numéricos , Análise Custo-Benefício , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/prevenção & controle , Doenças Cardiovasculares/epidemiologia , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose/economia , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Masculino , Feminino , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Raised low-density lipoprotein cholesterol (LDL-C) in young adulthood (aged 18-39 years) is associated with atherosclerotic cardiovascular disease (ASCVD) later in life. Most young adults with elevated LDL-C do not currently receive lipid-lowering treatment. OBJECTIVES: This study aimed to estimate the prevalence of elevated LDL-C in ASCVD-free U.S. young adults and the cost-effectiveness of lipid-lowering strategies for raised LDL-C in young adulthood compared with standard care. METHODS: The prevalence of raised LDL-C was examined in the U.S. National Health and Nutrition Examination Survey. The CVD Policy Model projected lifetime quality-adjusted life years (QALYs), health care costs, and incremental cost-effectiveness ratios (ICERs) for lipid-lowering strategies. Standard care was statin treatment for adults aged ≥40 years based on LDL-C, ASCVD risk, or diabetes plus young adults with LDL-C ≥190 mg/dL. Lipid lowering incremental to standard care with moderate-intensity statins or intensive lifestyle interventions was simulated starting when young adult LDL-C was either ≥160 mg/dL or ≥130 mg/dL. RESULTS: Approximately 27% of ASCVD-free young adults have LDL-C of ≥130 mg/dL, and 9% have LDL-C of ≥160 mg/dL. The model projected that young adult lipid lowering with statins or lifestyle interventions would prevent lifetime ASCVD events and increase QALYs compared with standard care. ICERs were US$31,000/QALY for statins in young adult men with LDL-C of ≥130 mg/dL and US$106,000/QALY for statins in young adult women with LDL-C of ≥130 mg/dL. Intensive lifestyle intervention was more costly and less effective than statin therapy. CONCLUSIONS: Statin treatment for LDL-C of ≥130 mg/dL is highly cost-effective in young adult men and intermediately cost-effective in young adult women.
Assuntos
Aterosclerose/sangue , LDL-Colesterol/sangue , Análise Custo-Benefício , Lipídeos/química , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aterosclerose/economia , Aterosclerose/prevenção & controle , Doenças Cardiovasculares/metabolismo , Estudos de Coortes , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/farmacologia , Estilo de Vida , Pessoa de Meia-Idade , Inquéritos Nutricionais , Probabilidade , Anos de Vida Ajustados por Qualidade de Vida , Risco , Adulto JovemRESUMO
BACKGROUND: People living with HIV (PLHIV) have an elevated risk of atherosclerotic cardiovascular disease (ASCVD) compared to their uninfected peers. Expanding statin use may help alleviate this burden. We evaluated the cost-effectiveness of reducing the recommend statin initiation threshold for primary ASCVD prevention among PLHIV in Thailand. METHODS: Our decision analytic microsimulation model randomly selected (with replacement) individuals from the TREAT Asia HIV Observational Database (data collected between 1/January/2013 and 1/September/2019). Direct medical costs and quality-adjusted life-years were assigned in annual cycles over a lifetime horizon and discounted at 3% per year. We assumed the Thai healthcare sector perspective. The study population included PLHIV aged 35-75 years, without ASCVD, and receiving antiretroviral therapy. Statin initiation thresholds evaluated were 10-year ASCVD risk ≥10% (control), ≥7.5% and ≥5%. RESULTS: A statin initiation threshold of ASCVD risk ≥7.5% resulted in accumulation of 0.015 additional quality-adjusted life-years compared with an ASCVD risk threshold ≥10%, at an extra cost of 3,539 Baht ($US113), giving an incremental cost-effectiveness ratio of 239,000 Baht ($US7,670)/quality-adjusted life-year gained. The incremental cost-effectiveness ratio comparing ASCVD risk ≥5% to ≥7.5% was 349,000 Baht ($US11,200)/quality-adjusted life-year gained. At a willingness-to-pay threshold of 160,000 Baht ($US5,135)/quality-adjusted life-year gained, a 30.8% reduction in the average cost of low/moderate statin therapy led to the ASCVD risk threshold ≥7.5% becoming cost-effective compared with current practice. CONCLUSIONS: Reducing the recommended 10-year ASCVD risk threshold for statin initiation among PLHIV in Thailand would not currently be cost-effective. However, a lower threshold could become cost-effective with greater preference for cheaper statins.
Assuntos
Aterosclerose/tratamento farmacológico , Doenças Cardiovasculares/tratamento farmacológico , Infecções por HIV/tratamento farmacológico , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Aterosclerose/complicações , Aterosclerose/economia , Aterosclerose/epidemiologia , Doenças Cardiovasculares/complicações , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/epidemiologia , Análise Custo-Benefício/economia , Custos de Medicamentos , Feminino , Infecções por HIV/complicações , Infecções por HIV/economia , Infecções por HIV/epidemiologia , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Masculino , Anos de Vida Ajustados por Qualidade de Vida , Tailândia/epidemiologiaRESUMO
BACKGROUND: Multiple barriers exist for appropriate use of the proprotein convertase subtilisin/kexin type 9 enzyme inhibitors (PCSK9i) in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) with inadequately controlled hypercholesterolemia despite standard therapies. Among these barriers, high payer rejection rates and inadequate prior authorization (PA) documentation by providers hinder optimal use of PCSK9i. OBJECTIVES: To (a) identify and discuss provider and payer discordances on barriers to authorization and use of PCSK9i based on clinical and real-world evidence and (b) align understanding and application of clinical, cost, safety, and efficacy data of PCSK9i. METHODS: Local groups of 3 payers and 3 providers met in 6 separate locations across the United States through a collaborative project of AMCP and PRIME Education. Responses to selected pre- and postmeeting survey questions measured changes in attitudes and beliefs regarding treatment barriers, lipid thresholds for considering PCSK9i therapy, and tactics for improving PA processes. Statistical analysis of inter- and intragroup changes in attitudes were performed by Cox proportional hazards test and Fisher's exact test for < 5 variables. RESULTS: The majority of providers and payers (67%-78%) agreed that high patient copayments and inadequate PA documentation were significant barriers to PCSK9i usage. However, payers and providers differed on beliefs that current evidence does not support PCSK9i cost-effectiveness (6% providers, 56% payers; P = 0.003) and that PA presents excessive administrative burden (72% providers, 44% payers; P = 0.09) Average increases pre- to postmeeting were noted in provider beliefs that properly documented PA forms expedite access to PCSK9i (22%-50% increase) and current authorization criteria accurately distinguish patients who benefit most from PCSK9i (6%-22%). Payers decreased in their belief that current authorization criteria accurately distinguish benefiting patients (72%-50%). Providers and payers increased in their belief that PCSK9i are cost-effective (44%-61% and 28%-50%, respectively) and were more willing to consider PCSK9i at the low-density lipoprotein cholesterol threshold of > 70 mg/dL for patients with ASCVD (78%-83% and 44%-67%, respectively) or FH (22%-39% and 22%-33%). Payers were more agreeable to less stringent PA requirements for patients with FH (33%-72%, P = 0.019) and need for standardized PA requirements (50%-83%, P = 0.034); these considerations remained high (89%) among providers after the meeting. Most participants supported educational programs for patient treatment adherence (83%) and physician/staff PA processes (83%-94%). CONCLUSIONS: Provider and payer representatives in 6 distinct geographic locations provided recommendations to improve quality of care in patients eligible for PCSK9i. Participants also provided tactical recommendations for streamlining PA documentation processes and improving awareness of PCSK9i cost-effectiveness and clinical efficacy. The majority of participants supported development of universal, standardized patient eligibility criteria and PA forms. DISCLOSURES: The study reported in this article was part of a continuing education program funded by an independent educational grant awarded by Sanofi US and Regeneron Pharmaceuticals to PRIME Education. The grantor had no role in the study design, execution, analysis, or reporting. AMCP received grant funding from PRIME to assist in the study, as well as in writing the manuscript. McCormick, Bhatt, Bays, Taub, Caldwell, Guerin, Steinhoff, and Ahmad received an honorarium from PRIME for serving as faculty for the continuing education program. McCormick, Bhatt, Bays, Taub, Caldwell, Guerin, Steinhoff, and Ahmad were involved as participants in the study. Bhatt discloses the following relationships: Advisory board: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences; Board of directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data monitoring committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research funding: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site co-investigator: Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded research: FlowCo, Merck, Novo Nordisk, Takeda. Bays' research site has received research grants from 89Bio, Acasti, Akcea, Allergan, Alon Medtech/Epitomee, Amarin, Amgen, AstraZeneca, Axsome, Boehringer Ingelheim, Civi, Eli Lilly, Esperion, Evidera, Gan and Lee, Home Access, Janssen, Johnson and Johnson, Lexicon, Matinas, Merck, Metavant, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Selecta, TIMI, and Urovant. Bays has served as a consultant/advisor for 89Bio, Amarin, Esperion, Matinas, and Gelesis, and speaker for Esperion. McCormick, Caldwell, Guerin, Ahmad, Singh, Moreo, Carter, Heggen, and Sapir have nothing to disclose.
Assuntos
Anticolesterolemiantes/administração & dosagem , Doenças Cardiovasculares/tratamento farmacológico , Hiperlipoproteinemia Tipo II/tratamento farmacológico , Inibidores de PCSK9 , Anticolesterolemiantes/efeitos adversos , Anticolesterolemiantes/economia , Aterosclerose/tratamento farmacológico , Aterosclerose/economia , Doenças Cardiovasculares/economia , Análise Custo-Benefício , Documentação , Custos de Medicamentos , Grupos Focais , Humanos , Hiperlipoproteinemia Tipo II/economia , Adesão à Medicação , Qualidade da Assistência à Saúde , Inquéritos e Questionários , Resultado do Tratamento , Estados UnidosRESUMO
Atherosclerotic cardiovascular disease (ASCVD) has posed an increasing burden on Americans and the United States healthcare system for decades. In addition, ASCVD has had a substantial economic impact, with national expenditures for ASCVD projected to increase by over 2.5-fold from 2015 to 2035. This rapid increase in costs associated with health care for ASCVD has consequences for payers, healthcare providers, and patients. The issues to patients are particularly relevant in recent years, with a growing trend of shifting costs of treatment expenses to patients in various forms, such as high deductibles, copays, and coinsurance. Therefore, the issue of "financial toxicity" of health care is gaining significant attention. The term encapsulates the deleterious impact of healthcare expenditures for patients. This includes the economic burden posed by healthcare costs, but also the unintended consequences it creates in form of barriers to necessary medical care, quality of life as well tradeoffs related to non-health-related necessities. While the societal impact of rising costs related to ASCVD management have been actively studied and debated in policy circles, there is lack of a comprehensive assessment of the current literature on the financial impact of cost sharing for ASCVD patients and their families. In this review we systematically describe the scope and domains of financial toxicity, the instruments that measure various facets of healthcare-related financial toxicity, and accentuating factors and consequences on patient health and well-being. We further identify avenues and potential solutions for clinicians to apply in medical practice to mitigate the burden and consequences of out-of-pocket costs for ASCVD patients and their families.
Assuntos
Aterosclerose , Doenças Cardiovasculares , Efeitos Psicossociais da Doença , Estresse Financeiro , Gastos em Saúde/tendências , Qualidade de Vida , Aterosclerose/economia , Aterosclerose/epidemiologia , Aterosclerose/psicologia , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/psicologia , Humanos , Estados Unidos/epidemiologiaRESUMO
INTRODUCTION: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are proven to have profound lowering of low-density lipoprotein cholesterol (LDL-C) in patients with clinical atherosclerotic cardiovascular disease or familial hypercholesterolemia. AIM: The primary purpose of this study was to evaluate PCSK9i utilization in older adults, with a focus on efficacy outcomes within 6 months of initiation. Secondary outcomes included tolerability, out-of-pocket expenses (OPE), and barriers to initiation of therapy. METHODS: We conducted a retrospective chart review of patients ≥ 65 years prescribed PCSK9i therapy by a pharmacist-run lipid clinic within a cardiology practice. RESULTS: A total of 136 older adults were prescribed PCSK9i therapy for a Food and Drug Administration-approved indication between September 2015 and March 2019 with 98 patients included in the analyses. In terms of efficacy, 51 patients who took ≥ 3 doses of PCSK9i with baseline and follow-up lipid panels were assessed. On average, LDL-C reduced by 60% (169-67 mg/dL, p < 0.001). For tolerability, 15 patients reported treatment-emergent side effects, resulting in 10 therapy discontinuations. For the cost analysis, 72 patients reported anticipated OPE for 1 month of therapy. Ultimately 17 patients were approved for manufacturer patient assistance with $0 OPE and 31 patients utilized insurance coverage to obtain therapy reporting a median OPE of $9 United States Dollars ($0-$450). The main barrier to initiation was high OPE. CONCLUSIONS: PCSK9i are effective at lowering LDL-C in older adults. Tolerability was high among patients without a history of statin intolerance. PCSK9i remain high-cost medications to both insurance companies and patients in terms of cost-sharing responsibilities.
Assuntos
Anticolesterolemiantes/economia , Anticolesterolemiantes/uso terapêutico , Aterosclerose/tratamento farmacológico , Aterosclerose/economia , LDL-Colesterol/sangue , Custos de Medicamentos , Hiperlipoproteinemia Tipo II/tratamento farmacológico , Hiperlipoproteinemia Tipo II/economia , Inibidores de PCSK9 , Inibidores de Serina Proteinase/economia , Inibidores de Serina Proteinase/uso terapêutico , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anticolesterolemiantes/efeitos adversos , Aterosclerose/sangue , Aterosclerose/diagnóstico , Biomarcadores/sangue , Regulação para Baixo , Feminino , Gastos em Saúde , Humanos , Hiperlipoproteinemia Tipo II/sangue , Hiperlipoproteinemia Tipo II/diagnóstico , Seguro de Serviços Farmacêuticos/economia , Masculino , Pró-Proteína Convertase 9/metabolismo , Estudos Retrospectivos , Inibidores de Serina Proteinase/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
Background Atherosclerotic cardiovascular disease (ASCVD) has a strong association with diabetes mellitus (DM), accounting for approximately two thirds of deaths in this patient population. Many individuals with ASCVD and DM are vulnerable to financial hardship associated with treatment-related expenses. Therefore, we examined the burden of financial hardship from medical bills across the spectrum of ASCVD status with and without DM. Methods and Results Using data from the National Health Interview Survey from 2013 to 2017, we used logistic regression analysis to examine the association of ASCVD and DM status with financial hardship and an inability to pay medical bills from a representative sample of non-elderly adults in the United States. Our study population consisted of 121 672 individuals. Approximately 3.1% of the weighted population had ASCVD, 5.6% had DM, and 1.3% had both ASCVD and DM. Nearly 50% of individuals with ASCVD and DM reported financial hardship from medical bills (23% being unable to pay medical bills at all), whereas ≈28% of those with neither ASCVD nor DM reported financial hardship from medical bills (8% being unable to pay medical bills at all). Individuals with concurrent ASCVD and DM had the highest relative odds of expressing an inability to pay at all when compared with those with neither condition (odds ratio, 2.69; 95% CI, 2.21-3.28). Conclusions Individuals with concurrent ASCVD and DM are at a disproportionately high risk of being unable to pay their medical bills. The findings provide strong evidence for developing more effective public health policies that protect vulnerable populations from financial hardship.
Assuntos
Aterosclerose/economia , Aterosclerose/terapia , Efeitos Psicossociais da Doença , Diabetes Mellitus/economia , Diabetes Mellitus/terapia , Estresse Financeiro/economia , Financiamento Pessoal/economia , Custos de Cuidados de Saúde , Gastos em Saúde , Adolescente , Adulto , Aterosclerose/epidemiologia , Diabetes Mellitus/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Estados Unidos/epidemiologia , Adulto JovemRESUMO
AIMS: To assess longitudinal risk for atherosclerotic cardiovascular disease (ASCVD) and cost of healthcare resource utilization over 9â¯years in patients with or without newly diagnosed type 2 diabetes (T2DM) who had no ASCVD at baseline. METHODS: This retrospective, longitudinal analysis of a large, nationwide US administrative claims database compared adults with newly diagnosed T2DM (nâ¯=â¯22,468) and a propensity score matched non-T2DM cohort (nâ¯=â¯22,468). Longitudinal risk of ASCVD and total annual healthcare costs were determined. Subgroup analysis was conducted for 3 age categories: 18-44, 45-64, and 65+ years. RESULTS: From 2006 to 2015, ASCVD was identified in a significantly greater percentage of patients in the T2DM versus non-T2DM cohort (43.2% vs 32.3%; Hazard ratio [HR]â¯=â¯1.45, Pâ¯<â¯0.001). Total annual healthcare cost was markedly higher in T2DM versus non-T2DM cohorts (48.4% higher at year 9). The differences between cohorts were most pronounced in patients aged 18-44â¯years. CONCLUSIONS: This 9-year claims-based retrospective, longitudinal analysis showed a higher risk of ASCVD and higher healthcare costs in newly diagnosed T2DM patients versus those without T2DM, with highest relative risk and cost differences observed in younger patients.
Assuntos
Aterosclerose/epidemiologia , Diabetes Mellitus Tipo 2/epidemiologia , Adolescente , Adulto , Fatores Etários , Idoso , Aterosclerose/economia , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/epidemiologia , Bases de Dados Factuais , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/economia , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Pontuação de Propensão , Estudos Retrospectivos , Risco , Estados Unidos/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Medication nonadherence is associated with worse outcomes in patients with atherosclerotic cardiovascular disease (ASCVD), a group who requires long-term therapy for secondary prevention. It is important to understand to what extent drug costs, which are potentially actionable factors, contribute to medication nonadherence. METHODS: In a nationally representative survey of US adults in the National Health Interview Survey (2013-2017), we identified individuals ≥18 years with a reported history of ASCVD. Participants were considered to have experienced cost-related nonadherence (CRN) if in the preceding 12 months they reported skipping doses to save money, taking less medication to save money, or delaying filling a prescription to save money. We used survey analysis to obtain national estimates. RESULTS: Of the 14 279 surveyed individuals with ASCVD, a weighted 12.6% (or 2.2 million [95% CI, 2.1-2.4]) experienced CRN, including 8.6% or 1.5 million missing doses, 8.8% or 1.6 million taking lower than prescribed doses, and 10.5% or 1.9 million intentionally delaying a medication fill to save costs. Age <65 years, female sex, low family income, lack of health insurance, and high comorbidity burden were independently associated with CRN, with >1 in 5 reporting CRN in these subgroups. Survey respondents with CRN compared with those without CRN had 10.8-fold higher odds of requesting low-cost medications and 8.9-fold higher odds of using alternative, nonprescription, therapies. CONCLUSIONS: One in 8 patients with ASCVD reports nonadherence to medications because of cost. The removal of financial barriers to accessing medications, particularly among vulnerable patient groups, may help improve adherence to essential therapy to reduce ASCVD morbidity and mortality.
Assuntos
Aterosclerose/tratamento farmacológico , Aterosclerose/economia , Adesão à Medicação/psicologia , Honorários por Prescrição de Medicamentos/tendências , Inquéritos e Questionários , Adolescente , Adulto , Idoso , Aterosclerose/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Distribuição Aleatória , Estados Unidos/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Hypertriglyceridemia (HTG) is associated with increased cardiovascular disease (CVD) risk. However, the cost burden of HTG-related CVD in high-risk US adults on statins has not been well characterized. OBJECTIVE: We estimated the HTG-related health care cost burden among US adults with CVD or diabetes taking statin therapy. METHODS: We estimated population sizes and annual health care costs among US adults aged ≥45 years with diabetes or CVD taking statin therapy with normal triglycerides (TGs) defined as TG < 150 mg/dL compared with those with HTG defined as TG ≥ 150 mg/dL. Population sizes were estimated from the 2007-2014 National Health and Nutrition Examination Surveys. Adjusted mean total annual health care costs in 2015 US dollars were estimated using the Optum Research Database. The annual total health care cost burden was estimated by multiplying the population size by the mean annual total incremental health care costs overall and within subgroups. RESULTS: There were 6.2 (95% confidence interval [CI], 5.4 - 7.1) million and 12.0 (95% CI, 11.1 - 12.9) million US adults aged ≥45 years with diabetes and/or CVD on statin therapy with TG ≥ 150 mg/dL and TG < 150 mg/dL, respectively. The mean adjusted incremental total one-year health care costs in adults with TG ≥ 150 mg/dL compared with those with TG < 150 mg/dL was $1730 (95% CI, $1160 - $2320). This leads to a projected annual incremental cost burden associated with HTG in patients with diabetes or CVD on statins of $10.7 billion (95% CI, $6.8 B - $14.6 B). CONCLUSION: In US adults on statins and at high risk for CVD, the health care costs associated with HTG are substantial.
Assuntos
Aterosclerose/tratamento farmacológico , Aterosclerose/economia , Doenças Cardiovasculares/economia , Efeitos Psicossociais da Doença , Diabetes Mellitus/economia , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipertrigliceridemia/economia , Adulto , Idoso , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Improved survival after a cardiovascular event has led to an expanding patient population at very high risk of recurrent events. Reduction in low-density lipoprotein cholesterol, and thus implicitly non-high-density lipoprotein cholesterol, to guideline-recommended goals is a key tenet of secondary prevention. Yet, standard-of-care treatment with statin (with or without ezetimibe) often leaves a high risk of preventable cardiovascular events. Inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9), highly efficacious lipid-lowering treatments that confer reduction in cardiovascular events and death, clearly have a role in the personalized management of these very-high-risk patients. Given budget constraints, however, their integration into the health care pathway merits health economic considerations. Consequently, it is important to identify challenges at the crossroads of the clinical and economic dimensions. FINDINGS AND CONCLUSION: Health economic analyses involve application of modeling scenarios integrating multiple parameters to ultimately yield values for quality-adjusted life-years and cost-effectiveness ratios. To date, these analyses have led to widely variable estimates of these benchmarks for PCSK9 inhibitors, causing confusion among stakeholders in the health care pathway. Clearly, a consensual approach to the conduct and reporting of health economic analyses involving all players, including noneconomists such as clinicians and patient advocates, is essential to bridge the gap between the clinical needs of patients and financial access to PCSK9 inhibition.
Assuntos
Aterosclerose/tratamento farmacológico , Aterosclerose/economia , Inibidores Enzimáticos/economia , Inibidores Enzimáticos/uso terapêutico , Inibidores de PCSK9 , LDL-Colesterol , Humanos , Modelos Econômicos , Pró-Proteína Convertase 9/metabolismo , Fatores de RiscoRESUMO
Importance: In October 2018, evolocumab was made available at a reduced annual list price of $5850 in the United States. This 60% reduction was aimed at improving patient access by lowering patient copays. Shortly thereafter, the 2018 American College of Cardiology/American Heart Association cholesterol management guideline was released. An updated cost-effectiveness analysis of evolocumab in the United States may be therefore of interest to payers and prescribers. Objective: To present an updated cost-effectiveness analysis of evolocumab added to standard background therapy compared with standard background therapy alone in patients with very high-risk atherosclerotic cardiovascular disease, reflecting the 2018 ACC/AHA guideline definition and using the new evolocumab list price. Design, Setting, and Participants: This study used the Markov model originally used in a previous study by Fonarow et al in 2017. A US societal perspective was considered, and a range of baseline cardiovascular event rates were modeled to reflect varying risk profiles in clinical practice within patients with very high-risk atherosclerotic cardiovascular disease. Exposures: Addition of evolocumab to standard background therapy, including maximally tolerated statin therapy (ie, the maximum intensity of statin therapy a patient can safely receive), with or without ezetimibe. Main Outcomes and Measures: Major cardiovascular events (myocardial infarction, ischemic stroke, and cardiovascular death), costs, quality-adjusted life-years, and incremental cost-effectiveness ratios. Results: Evolocumab was associated with both increased costs and improved outcomes when added to standard background therapy. Incremental costs ranged from $22â¯228 to $3411, depending on the varying level of risk within the defined population. Incremental quality-adjusted life years ranged from 0.39 to 0.44. Incremental cost-effectiveness ratios ranged from $56â¯655 to $7667 per quality-adjusted life-year gained. For a range of baseline cardiovascular event rates in patients with very high-risk atherosclerotic cardiovascular disease, incremental cost-effectiveness ratios were below the generally accepted willingness-to-pay thresholds. Moreover, the ratios were below the threshold of $50â¯000 per quality-adjusted life-years gained for any baseline rate of 6.9 or more events per 100 patient-years. Conclusions and Relevance: At its current list price, the addition of evolocumab to standard background therapy meets accepted cost-effectiveness thresholds across a range of baseline cardiovascular event rates in patients with very high-risk atherosclerotic cardiovascular disease as defined by the 2018 ACC/AHA guideline.
Assuntos
Anticorpos Monoclonais Humanizados/economia , Anticolesterolemiantes/economia , Aterosclerose/economia , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticolesterolemiantes/uso terapêutico , Aterosclerose/tratamento farmacológico , Análise Custo-Benefício , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Masculino , Anos de Vida Ajustados por Qualidade de Vida , Fatores de RiscoRESUMO
BACKGROUND: Nearly half of statin users discontinue therapy within the first year of treatment. Nonadherence to statin therapy may lead to an increased risk of atherosclerotic cardiovascular disease and, thus, higher costs due to hospitalizations. Value-based care models, such as accountable care organizations (ACO), are measured on adherence rates to statins through proportion of days covered (PDC). However, there is little research describing pharmacy student-based interventions within value-based care models. OBJECTIVES: To (a) identify mean change in PDC for statins following implementation of a pharmacy student adherence outreach program and (b) identify the proportion of patients converted to PDC ≥ 0.80 following the implementation of the outreach program. METHODS: This single-center retrospective quasi-experimental study included patients actively enrolled in a Humana Medicare Advantage Prescription Drug (MA-PD) plan who completed at least 1 adherence outreach telephone call performed by a pharmacy student between January 1, 2017, and December 31, 2017. RESULTS: 99 patients met inclusion criteria. Atorvastatin was the most commonly prescribed statin (43%), followed by simvastatin (38%). Sixty-four percent of patients had a baseline PDC of < 0.80. Mean (SD) PDC was 0.66 (±0.24) before the pharmacy student adherence outreach intervention, and 0.79 (± 0.23)-a 0.13 increase-after the pharmacy student adherence outreach intervention (P < 0.001). Among patients who had PDC < 0.80 at baseline, 35% of patients (n = 35) were converted to PDC ≥ 0.80 (P < 0.001), and 5% of patients with a baseline PDC ≥ 0.80 had a decrease in PDC to < 0.80 following the intervention. CONCLUSIONS: Among patients enrolled in a Humana MA-PD plan within an ACO, mean PDC for statins increased following exposure to a pharmacy student adherence outreach program. One third of patients converted their PDCs to ≥ 0.80 following the intervention. Value-based care programs may consider incorporating pharmacy student services to improve adherence to statins. DISCLOSURES: No outside funding supported this research. The authors have no financial conflicts of interest to disclose. At the time of conducting this research, all authors were employed at Nova Southeastern University. Preliminary results were presented as a poster at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.
Assuntos
Aterosclerose/prevenção & controle , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Adesão à Medicação/estatística & dados numéricos , Conduta do Tratamento Medicamentoso/organização & administração , Estudantes de Farmácia , Idoso , Idoso de 80 Anos ou mais , Aterosclerose/economia , Feminino , Custos de Cuidados de Saúde , Implementação de Plano de Saúde , Hospitalização/economia , Humanos , Masculino , Programas de Assistência Gerenciada/organização & administração , Medicare Part C/economia , Medicare Part C/estatística & dados numéricos , Conduta do Tratamento Medicamentoso/estatística & dados numéricos , Avaliação de Programas e Projetos de Saúde , Estudos Retrospectivos , Telefone , Estados UnidosAssuntos
Aterosclerose/economia , Aterosclerose/prevenção & controle , Custos de Medicamentos , Dislipidemias/tratamento farmacológico , Dislipidemias/economia , Ácido Eicosapentaenoico/análogos & derivados , Definição da Elegibilidade/economia , Hipolipemiantes/economia , Hipolipemiantes/uso terapêutico , Aterosclerose/sangue , Aterosclerose/epidemiologia , Biomarcadores/sangue , Tomada de Decisão Clínica , Ensaios Clínicos como Assunto , Dislipidemias/sangue , Dislipidemias/epidemiologia , Ácido Eicosapentaenoico/efeitos adversos , Ácido Eicosapentaenoico/economia , Ácido Eicosapentaenoico/uso terapêutico , Humanos , Hipolipemiantes/efeitos adversos , Lipídeos/sangue , Estudos Multicêntricos como Assunto , Seleção de Pacientes , Fatores de Risco , Resultado do Tratamento , Estados Unidos/epidemiologia , United States Department of Veterans Affairs , Serviços de Saúde para Veteranos MilitaresRESUMO
OBJECTIVE: The 2016 Chinese guidelines for the management of dyslipidemia recommended mixed rules that centered around a 10% 10-year risk threshold to initiate statins for the primary prevention of atherosclerotic cardiovascular disease (ASCVD). The present study aimed to evaluate the cost-effectiveness of the guideline statin-initiation strategy and alternative strategies. METHODS: A decision analytic model using discrete event simulation with event probabilities based on a validated ASCVD risk prediction tool for Chinese was constructed. Risk factor inputs were from the dataset of a nationally representative survey of middle-aged and elderly Chinese. Data of statin treatment effectiveness were from a published meta-analysis. Other key input data were identified from the literature or relevant databases. The strategies we evaluated were the guideline strategy, a 15% 10-year risk threshold strategy and a 20% 10-year risk threshold strategy. After excluding any extended dominance strategies, the incremental costs per quality-adjusted life year (QALY) gained of each strategy was calculated. RESULTS: The 20% 10-year risk threshold strategy was an extended dominance option. The incremental costs per QALY gained from the 15% 10-year risk threshold strategy compared with no treatment and the guideline strategy compared with the 15% 10-year risk threshold strategy were CN¥69,309 and CN¥154,944, respectively. The results were robust in most sensitivity analyses. CONCLUSIONS: The guideline strategy and the 15% 10-year risk threshold strategy are optimal when using the three times and the two times the gross domestic product per capita willingness-to-pay standards, respectively.