Table 4. Sensitivity and Scenario Analyses.
| Scenario | Base-Case Assumption | Scenario Assumption | ICER, $ | VBP, $a | |
|---|---|---|---|---|---|
| List Price | Discounted Net Price | ||||
| Intervention effect | Individual end point for nonfatal MI, nonfatal IS, and RV from FOURIER; benefit less in first year and greater in second year and beyond; 5-year delay in CV mortality benefit | A reduction of 6.4% in CV mortality per 38.67 mg/dL LDL-C reduction | 313 163 | 191 539 | 8872 |
| Intervention effect | Individual end point for nonfatal MI, nonfatal IS, and RV from FOURIER; benefit less in first year and greater in second year and beyond; 5-year delay in CV mortality benefit | A reduction of 14.0% in CV mortality per 38.67 mg/dL LDL-C reduction | 225 575 | 140 688 | 10 773 |
| Intervention effect | Individual end point for nonfatal MI, nonfatal IS, and RV from FOURIER; benefit less in first year and greater in second year and beyond; 5-year delay in CV mortality benefit | 3-y delay in CV mortality benefit | 245 066 | 151 983 | 10 221 |
| Intervention effect | Individual end point for nonfatal MI, nonfatal IS, and RV from FOURIER; benefit less in first year and greater in second year and beyond; 5-year delay in CV mortality benefit | 7-y delay in CV mortality benefit | 293 720 | 180 258 | 9188 |
| Intervention effect | Individual end point for nonfatal MI, nonfatal IS, and RV from FOURIER; benefit less in first year and greater in second year and beyond; 5-year delay in CV mortality benefit | No CV mortality benefit | 483 800 | 290 601 | 7246 |
| Intervention effect | Individual end point for nonfatal MI, nonfatal IS, and RV from FOURIER; benefit less in first year and greater in second year and beyond; 5-year delay in CV mortality benefit | Key secondary end point in FOURIER | 160 934 | 106 567 | 13 676 |
| Intervention effect | Individual end point for nonfatal MI, nonfatal IS, and RV from FOURIER; benefit less in first year and greater in second year and beyond; 5-year delay in CV mortality benefit | Individual end point for nonfatal MI and nonfatal IS with benefit the same in all years | 286 577 | 182 226 | 9010 |
| Intervention effect | Individual end point for nonfatal MI, nonfatal IS, and RV from FOURIER; benefit less in first year and greater in second year and beyond; 5-year delay in CV mortality benefit | All HRs varied 1 SE lower simultaneously | 193 260 | 114 202 | 12 218 |
| Intervention effect | Individual end point for nonfatal MI, nonfatal IS, and RV from FOURIER; benefit less in first year and greater in second year and beyond; 5-year delay in CV mortality benefit | All HRs varied 1 SE higher simultaneously | 429 364 | 275 893 | 6856 |
| Price of ezetimibe, $ | Net price, 2780 | Net price, 68 | 268 441 | 165 493 | 9677 |
| Ezetimibe use in all patients | Ezetimibe use in 7% | All patients treated with statin and ezetimibe as background therapy | 271 313 | 168 365 | 9560 |
| Annual event rates from FOURIER | Annual event rate of 6.4 per 100 patient-years | Annual event rate of 4.2 per 100 patient-years | 413 579 | 270 192 | 6780 |
| Annual event rates 25% lower US practice | Annual event rate of 6.4 per 100 patient-years | Annual event rate of 4.8 per 100 patient-years | 341 974 | 216 762 | 8065 |
| Annual event rates 25% higher US practice | Annual event rate of 6.4 per 100 patient-years | Annual event rate of 8.0 per 100 patient-years | 224 401 | 134 510 | 11 037 |
| Annual event rates 50% lower US practice | Annual event rate of 6.4 per 100 patient-years | Annual event rate of 3.2 per 100 patient-years | 488 642 | 318 010 | 6164 |
| Annual event rates 50% higher US practice | Annual event rate of 6.4 per 100 patient-years | Annual event rate of 9.6 per 100 patient-years | 194 551 | 113 142 | 12 218 |
| Perspective | Societal | Payer (exclude indirect cost) | 304 392 | 201 444 | 8206 |
| LDL-C threshold, mg/dL | LDL-C ≥70 | LDL-C ≥100 (mean, 130) | 172 194 | 100 193 | 13 225 |
| Annual event rate threshold | Annual event rate of 6.4 per 100 patient-years | Annual event rate to be cost-effective at current list price, 13.5 per 100 patient-years | 150 000 | 80 210 | 14 523 |
| Annual event rate threshold | Annual event rate of 6.4 per 100 patient-years | Annual event rate to be cost-effective at current list price 7.1 per 100 patient-years | 246 303 | 150 000 | 10 311 |
Abbreviations: CV, cardiovascular; FOURIER, Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk; HR, hazard ratio; ICER, incremental cost-effectiveness ratio; IS, ischemic stroke; LDL-C, low-density lipoprotein cholesterol; MI, myocardial infarction; RV, coronary revascularization; VBP, value-based price.
SI conversion factor: To convert LDL-C to millimoles per liter, multiply by 0.0259.
a
Value-based price is net annual price to achieve an incremental cost-effectiveness ratio of $150 000 per quality-adjusted life-years.