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Table 2 Assignment to study design

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

Additive study design

Substitutive study design

Orphan drug with competition

Orphan drug soloist

Added benefit not proven

Added benefit proven palliative ACT (BSC)

Added benefit proven curative ACT

Added benefit not proven

Added benefit proven

Added benefit proven by law

Pertuzumab 1. Ind 2. SG

Regorafenib new EBA

Pertuzumab 2. Ind

Cabazitaxel 1. SG

Ipilimumab 1. Ind

Abiraterone 1. Ind

Vandetanib new EBA

Enzalutamid 1. Ind

Regorafenib 1. Ind

Radium-223- dichloride 2. SG

Ruxolitinib new EBA

Aflibercept

Pertuzumab 1. SG

Nintedanib

Dabrafenib

Eribulin 1. SG

Vemurafenib

Axitinib 2. SG

Crizotinib 1. SG

Vemurafenib new EBA

Afatinib 1. SG

Trastuzumab 2. SG

Ruxolitinib

Afatinib new EBA

Nivolumab 2. SG

Pembrolizumab 2./3. SG

Trametinib

Abiraterone 2. Ind

Eribulin 2. Ind

Enzalutamide 2. Ind

Decitabin

Bosutinib

Ponatinib

Cabozantinib

Obinutuzumab

Ibrutinib

Lenvatinib

Ruxolitinib

Brentuximab Vedotin

Ramucirumab

Olaparib

  1. EBA Early Benefit Assessment, Ind Indication, SG Subgroup