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Supplemental materialEstimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer contextPeter P. Toth, Mark Danese, Guillermo Villa, Yi Qian, Anne Beaubrun, Armando Lira and Jeroen P JansenSupplemental Table 1. CV event hospitalization diagnosis codes.CV eventType of codeCodesMIICD-10I21.x or I22.xUAICD-10I20.0, I20.9, I24.0, I24.8, or I24.9ISICD-10I63.xHFICD-10I11.0, I13.0, I13.2, or I50.xCoronary revascularizationOPCS-4K40-K46, K49, K50, or K75CV-related deathICD-10I00-I78CV, cardiovascular; HF, heart failure; ICD-10, International Classification of Diseases, Tenth Revision; IS, ischemic stroke; MI, myocardial infarction; OPCS, Office of Population Censuses and Surveys Classification of Surgical Operations and Procedures, 4th Revision; UA, unstable angina.Supplemental Table 2. FOURIER baseline characteristics from design and methods article.CharacteristicAll randomized subjects(N = 27,564)Age, years, mean (SD)62.5 (9.0)Sex, male, n (%)20,795 (75.4)Race, n (%)White23,426 (85.0)Black or African American699 (2.4)Asian or other3439 (12.5)Region, n (%)North America4571 (16.6)Europe17,335 (62.9)Latin America1823 (6.6)Asia Pacific and South Africa3835 (13.9)Cardiovascular risk factors, n (%)Hypertension22,040 (80.0)Diabetes mellitus9333 (33.9)Current cigarette use7770 (28.2)History of vascular disease, n (%)MI22,356 (81.1)Nonhemorrhagic stroke5330 (19.3)Peripheral artery disease3640 (13.2)Statin use, n (%)High intensity19,082 (69.2)Moderate intensity8390 (30.4)Low intensity, unknown at this time, or no data92 (0.3)Ezetimibe use, n (%)1393 (5.1)Lipid parameters at parent study baseline, mg/dLLDL-C, median (Q1, Q3)91.5 (79.5, 108.0)LDL-C, mean (SD)97.3 (27.9)Total cholesterol, median (Q1, Q3)167.0 (150.5, 188.0)HDL-C, median (Q1, Q3)44.0 (37.0, 52.5)Triglycerides, median (Q1, Q3)133.0 (99.8, 181.0)Based on snapshot of database performed on October 2, 2015. Reprinted with permission from “Rationale and design of the Further cardiovascular OUtcomes Research with PCSK9 Inhibition in subjects with Elevated Risk trial” PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYWJhdGluZTwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+
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ADDIN EN.CITE.DATA [1]. ? 2016 Elsevier.HDL-C, high-density lipoprotein-cholesterol; LDL-C, low-density lipoprotein-cholesterol, MI, myocardial infarction; PCSK9, proprotein convertase subtilisin/kexin type 9; Q1, first quartile; Q3, third quartile; SD, standard deviation.Supplemental Table 3. Cost-effectiveness model input: CV event rates and clinical characteristics of patients on SOC alone used in the cost-effectiveness model.aCohortHistory of CV events at baselineAge at baseline, yearsbLDL-C at baseline, mmol/LEvent countcPatient-yearsRate per 100 patient-years (SE)cPAD12%692.841191930.36.17 (0.57)ACS0%692.84125491.725.42 (2.27)Post-ACS71%86854.110.07 (1.09)IS0%702.7117132.812.80 (3.10)Post-IS17%27238.511.32 (2.18)HF0%702.5576232.132.75 (3.76)Post-HF0%45397.411.32 (1.69)aIn the model, rates were adjusted by age using a rate ratio of 1.03 per year (estimated from pooling data across the cohorts in this table).bIn the model, rates were adjusted by LDL-C levels using a rate ratio of 0.79 per mmol/L PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaG9sZXN0ZXJvbCBUcmVhdG1lbnQgVHJpYWxpc3RzIChD
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ADDIN EN.CITE.DATA [2].cCounts and rates include ACS, IS, HF, and CV death.ACS, acute coronary syndrome; CV, cardiovascular; HF, heart failure; IS, ischemic stroke; LDL-C, low-density lipoprotein-cholesterol; PAD, peripheral artery disease; SE, standard error; SOC, standard of care.Supplemental Table 4. CV event rates with EvoMab added to SOC vs SOC alone.Health stateBaseline LDL-C ≥?70?mg/dLBaseline LDL-C ≥?100?mg/dLEvoMab+ SOC, rateSOC, rateIncre, rate% change% change per mmol/LEvoMab+ SOC, rateSOC, rateIncre, rate% change% change per mmol/LACS0.831.25?0.43?34?260.841.43?0.60?42?26IS0.090.13?0.04?33?250.090.15?0.06?40?25HF0.100.18?0.07?41?320.110.21?0.10?50?32CV-related death0.450.53?0.09?16?120.470.59?0.12?20?12Revascularization0.891.42?0.52?37?290.831.51?0.67?45?28Major CV event1.361.92?0.56?29?221.402.17?0.77?36?22ACS, acute coronary syndrome; CV, cardiovascular; EvoMab, evolocumab; HF, heart failure; incre, incremental; IS, ischemic stroke; LDL-C, low-density lipoprotein-cholesterol; SOC, standard of care. References ADDIN EN.REFLIST 1.Sabatine MS, Giugliano RP, Keech A, et al. Rationale and design of the Further cardiovascular OUtcomes Research with PCSK9 Inhibition in subjects with Elevated Risk trial. Am Heart J. 2016;173:94-101.2.Cholesterol Treatment Trialists (CTT) Collaboration, Fulcher J, O'Connell R, et al. Efficacy and safety of LDL-lowering therapy among men and women: meta-analysis of individual data from 174,000 participants in 27 randomised trials. Lancet. 2015;385(9976):1397-1405. ................
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