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Table 1 Premium calculation for Axitinib

From: The impact of additive or substitutive clinical study design on the negotiated reimbursement for oncology pharmaceuticals after early benefit assessment in Germany

1. Estimation of AnTC of the appraised pharmaceutical after negotiation:

Average annual tablet consumption according to the decision of the FJC: 730–1460

Package size: 56 tablets

Annual package consumption: [(730 + 1460)/2]56 = 19.5536

Additional SHI services or other SHI costs: 0 €

Date of FJC decisdion: March 2013 âž” search for price adaptation in German Drug Directory (Lauer) September/October 2013

Date of new price for Inlyta 5 mg 56 tabl.: 01.10.2013

Pharmacy selling price (PSP): 5596.87 €

Mandatory pharmacy rebate: 1.85 €

Mandatory manufacturer rebate: 1941.53 €

Costs after subtraction of statutory mandated rebates: 5596.87–1.85 – 1941.53 = 3653.49 €

AnTC after negotiation = 3653.49 × 19.5536 = 71,438.88 €

2. Estimation of AnTC of the appraised before negotiation:

To estimate costs of Inlyta 5 mg 56 tabl. Before negotiation all the data were extracted from the German Drug Directory (Lauer) the 15th September 2013, so that no bias due to changed statutory manufacturer rebates occur:

PSP: 5596.87 €

Mandatory pharmacy rebate: 1.85 €

Mandatory manufacturer rebate: 723.12 €

Costs after subtraction of statutory mandated rebates: 5596.87 € - 1.85 € - 723.12 € = 4871.90 €

AnTC before negotiation = 4871.90 € ×  19.5536 = 95,263.19 €

3. AnTC of the ACT (added benefit):

Subgroup 1: Everolimus 49,569.47 €; No added benefit

Subgroup 2: Sorafenib 55,314.19 €; Indication for a minor added benefit

4. Estimation of subgroup proportion:

Subgroup 1: 914 patients = 914/920 = 0.99 weighting coefficient SG1

Subgroup 2: 6/920 patients = 0.01 weighting coefficient SG2

5. Calculation of premiums

5.1 Additive premium on subgroup-specific ACT:

Premium2 = (71,438.88 € - 0.99 × 49,569.47 € - 0.01 × 55,314.19 €)/0.01 = 2,181,196.49 €

5.2M ultiplicative premium on subgroup-specific ACT:

Premium2 = (71,438.88 € - (0.99 × 49,569.47 €))/(0.01 × 55,314.19 €) = 40,432.85 €

5.3 Additive premium on weighted ACT

Premium 71,438.88 € - 0.99 × 49,569.47 € - 0.01 × 55,314.19 € = 21,811.96 €

5.4 Multiplicative premium on weighted ACT

71,438.88 €/(0.99 × 49,569.47 € + 0.01 × 55,314.19 €) = 1.4395