Table 1.
Key model input parameters
| Variable | Base case | Range | Reference |
|---|---|---|---|
| Cost in 2017 monthly (US $) | |||
| Brand dabigatran | 296.23 | — | 29, 31 |
| Generic dabigatran | 257.72 | — | 29, 30, 31 |
| Rate of ischemic stroke on brand dabigatran for different patient subgroups (%/year) | |||
| Low stroke risk subgroup (CHA2DS2‐VASc score 2–3) | 0.721 | 0.569–0.930 | IBM11 |
| Medium stroke risk subgroup (CHA2DS2‐VASc score 4) | 1.082 | 0.854–1.396 | IBM11 |
| High stroke risk subgroup (CHA2DS2‐VASc score ≥ 5) | 1.942 | 1.533–2.300 | IBM11 |
| Rate of minor bleeding on brand dabigatran for different patient subgroup (%/year) | |||
| Low bleed risk subgroup (HAS‐BLED score 0–1) | 7.361 | 6.876–7.846 | IBM11 |
| Medium bleed risk subgroup (HAS‐BLED score 2) | 9.183 | 8.577–9.788 | IBM11 |
| High bleed risk subgroup (HAS‐BLED score ≥ 3) | 13.151 | 12.029–14.018 | IBM11 |
| Rate of ICH on brand dabigatran for different patient subgroup (%/year) | |||
| Low bleed risk subgroup (HAS‐BLED score 0–1) | 0.199 | 0.167–0.298 | IBM11 |
| Medium bleed risk subgroup (HAS‐BLED score 2) | 0.248 | 0.167–0.372 | IBM11 |
| High bleed risk subgroup (HAS‐BLED score ≥ 3) | 0.355 | 0.239–0.532 | IBM11 |
| Rate of ECH on brand dabigatran for different patient subgroup (%/year) | |||
| Low bleed risk subgroup (HAS‐BLED score 0–1) | 2.050 | 1.494–2.395 | IBM11 |
| Medium bleed risk subgroup (HAS‐BLED score 2) | 2.557 | 1.864–2.9875 | IBM11 |
| High bleed risk subgroup (HAS‐BLED score ≥ 3) | 3.662 | 2.670–4.279 | IBM11 |
| Efficacy and safety of F = 1.25 generic dabigatran | |||
| HR for ischemic stroke, F = 1.25 generic vs. brand | 0.934 | NA | S. Kim and S. Schmidt (personal communication) |
| HR for bleeding event (minor bleeding, ICH, ECH), F = 1.25 generic vs. brand | 1.211 | NA | S. Kim and S. Schmidt (personal communication) |
| HR for MI, F = 1.25 generic vs. brand | 1.062 | NA | 34 |
| Efficacy and safety of F = 0.8 generic dabigatran | |||
| HR for ischemic stroke, F = 0.8 generic vs. brand | 1.066 | NA | S. Kim and S. Schmidt (personal communication) |
| HR for bleeding (minor bleeding, ICH, ECH), F = 0.8 generic vs. brand | 0.842 | NA | S. Kim and S. Schmidt (personal communication) |
| HR for MI, F = 0.8 generic vs. brand | 0.951 | NA | 34 |
| Efficacy and safety of F = 1.125 generic dabigatran | |||
| HR for ischemic stroke, F = 1.125 generic dabigatran vs. brand | 0.967 | NA | S. Kim and S. Schmidt (personal communication) |
| HR for bleeding (minor bleeding, ICH, ECH), F = 1.125 dabigatran vs. brand | 1.1055 | NA | S. Kim and S. Schmidt (personal communication) |
| HR for MI, F = 1.125 generic vs. brand | 1.031 | NA | 34 |
| Efficacy and safety of F = 0.9 generic dabigatran | |||
| HR for ischemic stroke, F = 0.9 generic dabigatran vs. brand | 1.033 | NA | S. Kim and S. Schmidt (personal communication) |
| HR for bleeding (minor bleeding, ICH, ECH), F = 0.9 generic dabigatran vs. brand | 0.921 | NA | S. Kim and S. Schmidt (personal communication) |
| HR for MI, F = 0.9 generic vs. brand | 0.976 | NA | 34 |
ECH, extracranial hemorrhage; F, bioavailability ratio vs. reference brand; HR, hazard ratio; ICH, intracranial hemorrhage; MI, myocardial infarction; NA, not applicable.