Table 4.
Base case and univariate sensitivity analysis
| Base case results | |||
|---|---|---|---|
| Ribociclib + LZE | Palbociclib + LZE | Ribociclib + LZE vs palbociclib + LZE | |
| Cost results | |||
| First-line line treatment (€) | 90,923.49 | 91,895.72 | −972.23 |
| PF state (€) | 4,155.48 | 3,902.99 | 252.49 |
| PD state (€) | 1,798.47 | 1,474.23 | 324.24 |
| Subsequent treatments (€) | 4,925.20 | 3,975.62 | 949.58 |
| AEs (€) | 317.24 | 369.93 | −52.69 |
| End-of-life (€) | 3,458.24 | 3,519.78 | −61.55 |
| Total costs (€) | 105,578.12 | 105,138.26 | 439.86 |
| Health outcomes | |||
| LYG | 4.474 | 4.037 | 0.437 |
| QALY | 3.313 | 3.028 | 0.285 |
| Incremental ratios | |||
| ICER(€/LYG) | - | - | 1,007.69 |
| ICUR (€/QALY gained) | - | - | 1,543.62 |
| Univariate analysis results | |||||
|---|---|---|---|---|---|
| Scenario | Δ Cost (€) | Δ LY | Δ QALY | ICER (€/LYG) | ICUR (€/QALY) |
| Alternative parametric distributions | |||||
| PFS, Weibull distribution | 988.86 | 0.470 | 0.289 | 2,106.07 | 3,421.83 |
| PFS, gamma distribution | 870.70 | 0.460 | 0.288 | 1,892.13 | 3,022.53 |
| PFS, log-normal distribution | 103.74 | 0.424 | 0.302 | 244.65 | 343.39 |
| OS, Gompertz distribution | −468.08 | 0.260 | 0.196 | Ribociclib is dominant | Ribociclib is dominant |
| OS, gamma distribution | 1,945.13 | 0.738 | 0.437 | 2,634.84 | 4,447.75 |
| OS, log-logistic distribution | 2,532.82 | 0.873 | 0.505 | 2,901.96 | 5,012.69 |
| Unadjusted HR (MONALEESA-2; cutoff, January 2017) | |||||
| Ribociclib + LZE | 65.36 | 0.258 | 0.142 | 252.84 | 460.18 |
| PFS HR: 0.568 (0.457 - 0.704) | |||||
| OS HR: 0.746 (0.517 - 1.078) | |||||
| Patient characteristics | |||||
| Patients’ age (+20%) | 439.86 | 0.437 | 0.285 | 1,007.69 | 1,543.62 |
| Patients’ age (−20%) | 439.86 | 0.437 | 0.285 | 1,007.69 | 1,543.62 |
| Quality of life questionnaires | |||||
| Utility PF state (CR/PR) (+20%) | 439.86 | 0.437 | 0.315 | 1,007.69 | 1,396.30 |
| Utility PF state (CR/PR) (−20%) | 439.86 | 0.437 | 0.255 | 1,007.69 | 1,725.69 |
| Utility PF state (SD) (+20%) | 439.86 | 0.437 | 0.288 | 1,007.69 | 1,529.45 |
| Utility PF state (SD) (−20%) | 439.86 | 0.437 | 0.282 | 1,007.69 | 1,558.06 |
| Utility PD state (+20%) | 439.86 | 0.437 | 0.309 | 1,007.69 | 1,422.39 |
| Utility PD state (−20%) | 439.86 | 0.437 | 0.261 | 1,007.69 | 1,687.44 |
| Utility PF and PD states (MONALEESA-2) | 439.86 | 0.437 | 0.352 | 1,007.69 | 1,249.29 |
| Economic parameters | |||||
| Disregarding palbociclib wastage | 722.72 | 0.437 | 0.285 | 1,655.70 | 2,536.26 |
| Price parity between CDK4/6 inhibitors | −16,321.32 | 0.437 | 0.285 | Ribociclib is dominant | Ribociclib is dominant |
| Cost PF state (+20%) | 553.16 | 0.437 | 0.285 | 1,267.25 | 1,941.21 |
| Cost PF state (−20%) | 326.57 | 0.437 | 0.285 | 748.14 | 1,146.03 |
| Cost PD state (+20%) | 631.83 | 0.437 | 0.285 | 1,447.48 | 2,217.30 |
| Cost PD state (−20%) | 247.89 | 0.437 | 0.285 | 567.91 | 869.94 |
| Cost subsequent treatments (+20%) | 629.78 | 0.437 | 0.285 | 1,442.78 | 2,210.10 |
| Cost subsequent treatments (−20%) | 249.95 | 0.437 | 0.285 | 572.61 | 877.14 |
| Cost ribociclib monitoring (+20%) | 517.59 | 0.437 | 0.285 | 1,185.77 | 1,816.40 |
| Cost ribociclib monitoring (−20%) | 362.13 | 0.437 | 0.285 | 829.62 | 1,270.84 |
| Cost palbociclib monitoring (+20%) | 421.64 | 0.437 | 0.285 | 965.95 | 1,479.68 |
| Cost palbociclib monitoring (−20%) | 458.08 | 0.437 | 0.285 | 1,049.44 | 1,607.56 |
| Scenario | Δ Cost (€) | Δ LY | Δ QALY | ICER (€/LYG) | ICUR (€/QALY) |
| Cost AEs (+20%) | 429.32 | 0.437 | 0.285 | 983.55 | 1,506.64 |
| Cost AEs (−20%) | 450.40 | 0.437 | 0.285 | 1,031.83 | 1,580.60 |
| Structural parameters | |||||
| Discount rate (0%) | 467.44 | 0.502 | 0.329 | 931.00 | 1,421.02 |
| Discount rate (5%) | 432.00 | 0.400 | 0.260 | 1,080.89 | 1,658.60 |
| Time horizon: 5 years | −208.42 | 0.235 | 0.151 | Ribociclib is dominant | Ribociclib is dominant |
| Time horizon: 10 years | 395.04 | 0.411 | 0.264 | 960.34 | 1,496.27 |
| Time horizon: 20 years | 459.07 | 0.444 | 0.291 | 1,034.70 | 1,577.98 |
| Time horizon: 30 years | 465.91 | 0.446 | 0.293 | 1,044.63 | 1,590.89 |
Abbreviations: AEs, adverse events; CDK4/6, cyclin-dependent kinase 4 and 6; CR, complete response; HR, hazard ratio; ICER, incremental cost-effectiveness ratio; ICUR, incremental cost-utility ratio; LY, life years; LYG, life-years gained; LZE, letrozole; OS, overall survival; PD, progressed disease; PF, progression-free; PFS, progression-free survival;PR, partial response; QALY, quality-adjusted life years; SD, stable disease; Δ, differential.