Table 1.
Example of calculation of drug cost avoidance per clinical trial.
| Characteristic | |
|---|---|
| Clinical trial protocol’s code | BO29159 |
| Arms Single-arm |
Trastuzumab SC 600 mg day 1 + Pertuzumab 420 mg day 1 (loading dose: 840 mg) + Docetaxel according to clinical practice day 1. A cycle of 21 days. |
| Investigational treatment information | |
| Drugs provided by the sponsor | Trastuzumab SC and Pertuzumab (docetaxel is not provided) |
| Duration of treatment | Until tumor progression |
| Standard treatment information | |
| Best Standard of Care | Trastuzumab IV 6 mg/kg (loading dose: 8 mg/kg) + Pertuzumab 420 mg (loading dose: 840 mg) + Docetaxel 75 mg/m2. A cycle of 21 days. |
| Reference | NCCN guidelines (20) |
| Duration of treatment | Until tumor progression |
| No. of cycles according to bibliography | 24 |
| Reference | CLEOPATRA study (N Engl J Med 2015; 372: 724-734) |
| Scenario from the decision algorithm | 2 |
| Cost to the pharmacy department of a patient enrolled in the clinical trial | |
| Docetaxel | |
| Cost/mg Dose Cost/dose Cost/cycle Cost/patient |
€1.1432 75 mg * 1.70 m2 = 127.5 mg 127.5 * €1.1432 = €145.76 €145.76 €145.76 * 24 = €3,498.19 |
| Cost to the pharmacy department of a patient treated with the local standard treatment | |
| Trastuzumab IV | |
| Cost/mg Dose Cost/dose Cost/cycle Cost/patient |
€2.8952 6 mg * 70 kg = 420 mg (loading dose: 560 mg) 420 * €2.8952 = €1,215.97 (loading dose: €1,621.29) €1,215.97 €1,621.29 + 23 * €1,215.97 = €29,588.55 |
| Pertuzumab | |
| Cost/mg Dose Cost/dose Cost/cycle Cost/patient |
€6.9333 420 mg (loading dose: 840 mg) 420 * €6.9333 = €2,911.98 (loading dose: €5,823.95) €2,911.98 €5,823.95 + 23 * €2,911.98 = €72,799.35 |
| Docetaxel Cost/patient |
€3,498.19 |
| Total | €29,588.55 + €72,799.35 + €3,498.19 = €105,886.10 |
| Drug cost avoidance | €105,886.10 – €3,498.19 = €102,387.91 |
IV, intravenous; SC, subcutaneous.