ATMPs in Germany - Spherox®
👉 Spherox is currently the only ATMP of the ACI procedures with a valid, centralized, EU marketing authorization.
Spherox (active substance: spheroids of human autologous matrix-associated chondrocytes) was approved as a tissue engineered therapy for the repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee in July 2017. The pivotal study was an RCT comparing the efficacy and safety of the treatment of cartilage defects in the knee joint with Spherox vs. microfracture treatment.
🏆German HTA rating:
No HTA under AMNOG, as Spherox is considered being “part of a method” (like MACI and Holoclar). However, Spherox (cod16HS13) was assessed in the IQWiG assessment N19-02 on autologous chondrocyte implantation in the knee joint. The study on Spherox was included in the IQWiG assessment, which ultimately lead to the conclusion by the German HTA body that M-ACI (to which Spherox belongs) is reimbursed.
💵 Launch price: € 12.800 per 10–70 spheroids/cm2 implantation suspension. 10–70 spheroids are applied per cm2 defect, Spherox is approved for treatment of defect sizes up to 10 cm2. Reimbursement price: not applicable (no HTA under AMNOG).
📘 Special features of reimbursement:
Reimbursement in hospitals via “Zusatzentgelt“ ZE126 in addition to the DRG.
💡 Spherox is currently the only ATMP of the ACI procedures with a valid, centralized, EU marketing authorization. Authorization of previous ATMPs of the ACI procedures were withdrawn.