Dataset Information

Cost-effectiveness of Low-density Lipoprotein Cholesterol Level-Guided Statin Treatment in Patients With Borderline Cardiovascular Risk.

ABSTRACT: Importance:American College of Cardiology/American Heart Association cholesterol guidelines prioritize primary prevention statin therapy based on 10-year absolute risk (AR10) of atherosclerotic cardiovascular disease (ASCVD). However, given the same AR10, patients with higher levels of low-density lipoprotein cholesterol (LDL-C) experience greater absolute risk reduction from statin therapy. Objectives:To estimate the cost-effectiveness of expanding preventive statin treatment eligibility from standard care to patients at borderline risk (AR10, 5.0%-7.4%) for ASCVD and with high levels of LDL-C and to estimate cost-effectiveness of statin treatment across ranges of age, sex, AR10, and LDL-C levels. Design, Setting, and Participants:This study evaluated 100 simulated cohorts, each including 1 million ASCVD-free survey respondents (50% men and 50% women) aged 40 years at baseline. Cohorts were created by probabilistic sampling of the 1999-2014 US National Health and Nutrition Examination Surveys from the perspective of the US health care sector. The CVD Policy Model microsimulation version projected lifetime health and cost outcomes. Probability of first-ever coronary heart disease or stroke event was estimated by analysis of 6 pooled US cohort studies and recalibrated to match contemporary event rates. Other model variables were derived from national surveys, meta-analyses, and published literature. Data were analyzed from May 15, 2018, through June 10, 2019. Exposures:Four statin treatment strategies were compared: (1) treat all patients with AR10 of at least 7.5%, diabetes, or LDL-C of at least 190 mg/dL (standard care); (2) add treatment for borderline risk and LDL-C levels of 160 to 189 mg/dL; (3) add treatment for borderline risk and LDL-C levels of 130 to 159 mg/dL; and (4) add treatment for remainder of patients with AR10 of at least 5.0%. Statin treatment was also compared with no statin treatment in age, sex, AR10, and LDL-C strata. Main Outcomes and Measures:Lifetime quality-adjusted life-years (QALYs) and costs (2019 US dollars) were projected and discounted 3.0% annually. The primary outcome was the incremental cost-effectiveness ratio. Results:In these 100 simulated cohorts, each with 1 million patients aged 40 years at baseline (50% women and 50% men), adding preventive statins to individuals with borderline AR10 and LDL-C levels of 160 to 189 mg/dL would be cost-saving; further treating borderline AR10 and LDL-C levels of 130 to 159 mg/dL would also be cost-saving; and treating all individuals with AR10 of at least 5.0% would be highly cost-effective ($33?558/QALY) and would prevent the most ASCVD events. Within age, AR10, and sex categories, individuals with higher baseline LDL-C levels gained more QALYs from statin therapy. Cost-effectiveness increased with LDL-C level and AR10. Conclusions and Relevance:In this study, lifetime statin treatment of patients in a hypothetical cohort with borderline ASCVD risk and LDL-C levels of 160 to 189 mg/dL was found to be cost-saving. Results suggest that treating all patients at borderline risk regardless of LDL-C level would likely be highly cost-effective.

SUBMITTER: Kohli-Lynch CN

PROVIDER: S-EPMC6714024 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Cost-effectiveness of Low-density Lipoprotein Cholesterol Level-Guided Statin Treatment in Patients With Borderline Cardiovascular Risk.

Kohli-Lynch Ciaran N CN Bellows Brandon K BK Thanassoulis George G Zhang Yiyi Y Pletcher Mark J MJ Vittinghoff Eric E Pencina Michael J MJ Kazi Dhruv D Sniderman Allan D AD Moran Andrew E AE

JAMA cardiology 20191001 10

<h4>Importance</h4>American College of Cardiology/American Heart Association cholesterol guidelines prioritize primary prevention statin therapy based on 10-year absolute risk (AR10) of atherosclerotic cardiovascular disease (ASCVD). However, given the same AR10, patients with higher levels of low-density lipoprotein cholesterol (LDL-C) experience greater absolute risk reduction from statin therapy.<h4>Objectives</h4>To estimate the cost-effectiveness of expanding preventive statin treatment eli ...[more]

PMID: 31461121

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Project description:BackgroundInclisiran is a novel, cholesterol-lowering therapy, with a long duration of effect, administered every 6 months (subcutaneously by a healthcare professional). In the ORION-10 trial in US patients with atherosclerotic cardiovascular disease (ASCVD) in addition to maximum tolerated statins, with or without ezetimibe, inclisiran demonstrated statistically significant reductions in low-density lipoprotein cholesterol (LDL-C) of up to 51%. This is the first peer-reviewed publication to investigate the price at which inclisiran is cost effective in the US.ObjectiveThe aim of this study was to determine the maximum price at which inclisiran is cost effective in addition to standard of care, in US patients with ASCVD, versus standard of care alone, at different willingness-to-pay thresholds.Design, setting and participantsA lifetime Markov model from the US health system perspective, including 15 health states, was used to evaluate the cost effectiveness of inclisiran. The following states were separated by time from a previous cardiovascular event (0-1 years, 1-2 years, 2+ years ['stable']): initial, unstable angina, myocardial infarction, and stroke. Additional states included revascularization and death (cardiovascular or non-cardiovascular causes). Baseline risk of cardivoascular events were from US database sources or published literature. Reductions in LDL-C from inclisiran were from the ORION-10 trial. LDL-C reduction was used to adjust baseline risk of cardiovascular events, based on established relationships between 1 mmol/L reduction in LDL-C and decreases in cardiovascular events, from the Cholesterol Treatment Trialists studies. The population included adults with a history of ASCVD, and LDL-C ≥ 70 mg/dL, despite maximum tolerated doses of statin therapy.InterventionsInclisiran as an adjunct to standard of care, compared with standard of care alone.Main outcomes and measuresThe threshold price of inclisiran.ResultsInclisiran as an adjunct to standard of care resulted in threshold annual inclisiran prices of $6383, $9973, and $13,563 at willingness-to-pay thresholds of $50,000, $100,000, and $150,000 per quality-adjusted life-year, respectively. Probabilistic sensitivity analysis showed that at a threshold of $100,000 per QALY, inclisiran had a 100% probability of being cost effective, with an annual price below $9000. At the publicly available price of $3250 per dose, inclisiran was found to have an incremental cost-effectiveness ratio just above the $50,000 per QALY threshold, of $51,686.Conclusions and relevanceThis study identified the price at which inclisiran is cost effective for the US health system, at generally accepted willingness-to-pay thresholds.

Project description:Background Conventional "low-density lipoprotein cholesterol (LDL-C)" assays measure cholesterol content in both low-density lipoprotein and lipoprotein(a) particles. To clarify the consequences of this methodological limitation for clinical care, our study aimed to compare associations of "LDL-C" and corrected LDL-C with risk of cardiovascular disease and to assess the impact of this correction on the classification of patients into guideline-recommended LDL-C categories. Methods and Results Lipoprotein(a) cholesterol content was estimated as 30% of lipoprotein(a) mass and subtracted from "LDL-C" to obtain corrected LDL-C values (LDL-Ccorr30). Hazard ratios for cardiovascular disease (defined as coronary heart disease, stroke, or coronary revascularization) were quantified by individual-patient-data meta-analysis of 5 statin landmark trials from the Lipoprotein(a) Studies Collaboration (18 043 patients; 5390 events; 4.7 years median follow-up). When comparing top versus bottom quartiles, the multivariable-adjusted hazard ratio for cardiovascular disease was significant for "LDL-C" (1.17; 95% CI, 1.05-1.31; P=0.005) but not for LDL-Ccorr30 (1.07; 95% CI, 0.93-1.22; P=0.362). In a routine laboratory database involving 531 144 patients, reclassification of patients across guideline-recommended LDL-C categories when using LDL-Ccorr30 was assessed. In "LDL-C" categories of 70 to <100, 100 to <130, 130 to <190, and ?190 mg/dL, significant proportions (95% CI) of participants were reassigned to lower LDL-C categories when LDL-Ccorr30 was used: 30.2% (30.0%-30.4%), 35.1% (34.9%-35.4%), 32.9% (32.6%-33.1%), and 41.1% (40.0%-42.2%), respectively. Conclusions "LDL-C" was associated with incident cardiovascular disease only when lipoprotein(a) cholesterol content was included in its measurement. Refinement in techniques to accurately measure LDL-C, particularly in patients with elevated lipoprotein(a) levels, is warranted to assign risk to the responsible lipoproteins.

Project description:ImportanceFinancial incentives shared between physicians and patients were shown to significantly reduce low-density lipoprotein cholesterol (LDL-C) levels in a randomized clinical trial, but it is not known whether these health benefits are worth the added incentive and utilization costs required to achieve them.ObjectiveTo evaluate the long-term cost-effectiveness of financial incentives on LDL-C level control.Design, setting, and participantsIn this economic evaluation, a previously validated microsimulation computer model was parameterized using individual-level data from the randomized clinical trial on financial incentives, National Health and Nutrition Examination Surveys for model population inputs, and other published sources. The study was conducted from April 15, 2016, to March 29, 2018.InterventionsThe following interventions were used: (1) usual care, (2) trial control strategy (increased cholesterol level monitoring and use of electronic pill bottles), (3) financial incentives for physicians, (4) financial incentives for patients, and (5) incentives shared between physicians and patients.Main outcomes and measuresDiscounted costs (2017 US dollars), lifetime cardiovascular disease risk, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).ResultsThe model population (n?=?1?000?000 [30.7% women]) had similar mean (SD) age (61.5 [11.9] years) and LDL-C level (153.9 mg/dL) as the observed trial population (n?=?1503 [42.7% women]; age, 62.0 [8.7] years; and LDL-C level, 160.6 mg/dL). Using base-case assumptions (including a 10-year waning period of LDL-C level reductions), the usual-care strategy was dominated (higher costs and lower QALYs) by all other strategies. Strategies for physician- or patient-only incentives were dominated by the shared-incentives strategy, which had an ICER of $60?000/QALY compared with the trial control strategy. In a sensitivity analysis regarding the duration of LDL-C level reductions, the shared-incentives strategy remained cost-effective (ICERs <$100?000/QALY and <$150?000/QALY) for scenarios with LDL-C level reductions lasting, with linear waning, at least 7 and 5 years, respectively. In the 1-way sensitivity analysis for the time horizon of the analysis, the ICER of the shared-incentives strategy exceeded $100?000/QALY at 11 years and $150?000/QALY at 8 years. In probabilistic sensitivity analysis, the shared-incentives intervention was cost-effective in 69% to 77% of iterations using cost-effectiveness thresholds of $100?000 to $150?000/QALY. Cost-effectiveness results were also sensitive to the duration of intervention costs.Conclusions and relevanceThis study suggests that the financial incentives shared between patients and physicians for LDL-C level control meet conventional standards of cost-effectiveness, but these results appeared to be sensitive to assumptions about the durations of LDL-C level reductions and years of intervention costs included, as well as to the choice of time horizon.

Dataset Information

Cost-effectiveness of Low-density Lipoprotein Cholesterol Level-Guided Statin Treatment in Patients With Borderline Cardiovascular Risk.

Publications

Cost-effectiveness of Low-density Lipoprotein Cholesterol Level-Guided Statin Treatment in Patients With Borderline Cardiovascular Risk.

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