Table 2. Key Inputs in the Model.
| Input | Value (95% CI) | Source |
|---|---|---|
| Event rate per 100 patient-years, clinical practice population | ||
| Nonfatal myocardial infarction | 2.3 (2.2-2.4) | US Claims Data, NHANES, NVS15 |
| Nonfatal ischemic stroke | 2.1 (2.0-2.2) | |
| Cardiovascular-related death | 2.0 (1.9-2.1) | |
| Coronary revascularizationa | 3.3 (3.1-3.4) | |
| Event rate per 100 patient-years, trial population | ||
| Nonfatal myocardial infarction | 2.5 (2.2-2.7) | FOURIER14 |
| Nonfatal ischemic stroke | 0.9 (0.8-1.1) | |
| Cardiovascular-related death | 0.8 (0.7-1.0) | |
| Coronary revascularizationa | 3.9 (3.6-4.3) | |
| Intervention effect, hazard ratiob | ||
| Nonfatal myocardial infarction, 1 y/beyond 1 y | 0.79 (0.67-0.93)/0.64 (0.54-0.76) | FOURIER14 |
| Nonfatal ischemic stroke, 1 y/beyond 1 y | 0.74 (0.55-1.00)/0.75 (0.58-0.98) | |
| Coronary revascularization,a 1 y/beyond 1 y | 0.84 (0.74-0.96)/0.72 (0.63-0.82) | |
| Intervention effect, rate ratio per 38.67 mg/dL LDL-C reduction | ||
| Nonfatal myocardial infarction, 1 y/beyond 1 y | 0.84 (0.75-0.95)/0.72 (0.64-0.82) | FOURIER, CTTC (2010)8,14 |
| Nonfatal ischemic stroke, 1 y/beyond 1 y | 0.80 (0.65-1.00)/0.81 (0.67-0.99) | |
| Coronary revascularization,a 1 y/beyond 1 y | 0.88 (0.80-0.97)/0.79 (0.72-0.87) | |
| Cardiovascular-related death, up to y 5/beyond 5 y | NAc/0.90 (0.85-0.95) | |
| Direct cost, $ | ||
| Other ASCVD | 8501 (7870-9132) | US Claims Data23,24 |
| Nonfatal myocardial infarction, year 1/beyond 1 y | 52 084 (50 659-53 510)/8501 (7870-9132) | |
| Nonfatal ischemic stroke, year 1/beyond 1 y | 46 207 (44 063-48 351)/8816 (7573-10 058) | |
| Cardiovascular-related death | 76 537 (75 405-77 669) | |
| Coronary revascularizationa | 59 384 (58 463-60 306) | |
| Indirect cost, $ | ||
| Nonfatal myocardial infarction | 57 936 (56 351-59 522) | AHA Cardiovascular Disease Burden Report25 |
| Nonfatal ischemic stroke | 37 465 (35 727-39 204) | |
| Utilityd | ||
| Established ASCVD | 0.824 (0.800-0.848) | Time Tradeoff Study26 |
| Nonfatal myocardial infarction, 1 y/beyond 1 y | 0.672 (0.625-0.719)/0.824 (0.800-0.848) | |
| Nonfatal ischemic stroke, 1 y/beyond 1 y | 0.327 (0.264-0.390)/0.524 (0.472-0.576) | |
| Injection site reaction, disutility | 0.0003 | |
| Discontinuation, % | 15 over 3 y | FOURIER14 |
Abbreviations: AHA, American Heart Association; ASCVD, atherosclerotic cardiovascular disease; CTTC, Cholesterol Treatment Trialists Collaboration; FOURIER, Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk; NHANES, National Health and Nutrition Examination Surveys; NVS, Novartis, LDL-C, low-density lipoprotein cholesterol.
Coronary revascularization was defined as percutaneous coronary intervention or coronary artery bypass graft.
Hazard ratios are converted to rate ratios per 38.67 mg/dL using: rate ratio per 38.67 mg/dL = exp(LN[hazard ratio]/[53.36/38.67]) or equivalently: rate ratio per 38.67 mg/dL = hazard ratio^(1/[53.36/38.67]), where 53.36 is the LDL-C reduction in mg/dL observed in FOURIER.
No reduction in cardiovascular mortality in first 5 years assumed in the base case.
In utilities, 0 represents death, and 1 represents perfect health.