ATMPs in Germany - ChondroCelect®
ChondroCelect® (characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins)
ChondroCelect (active substance: characterized viable autologous cartilage cells expanded ex vivo expressing specific marker proteins) was the first authorized ATMP under the current European ATMP legislation. The tissue engineered product ChondroCelect was authorized in October 2009 for the repair of single symptomatic cartilage defects of the femoral condyle of the knee. The pivotal study compared ChondroCelect vs. the procedure of microfracture. The authorization was withdrawn in July 2016. Consequently, ChondroCelect is no longer available in Germany.
🏆German HTA rating:
Not applicable. German HTA under the current legislation (AMNOG: “Arzneimittelmarktneuordnungsgesetz”) was not in force at this time.
💵 Launch price: € 19,837 per vial. One vial could be used for treatment of cartilage lesions of up to a size of 5 cm2. Reimbursement price: not applicable (no HTA rating).
📘 Special features of reimbursement:
Of note: In 2022, well after withdrawal of authorization of ChondroCelect, the German HTA body excluded the ACI procedure (in which ChondroCelect was used) from reimbursement in inpatient care, as there is no potential being a necessary alternative treatment option. Outpatient reimbursement also does not exist.
💡 The Regulation (EC) No 1394/2007 provides the overall framework on ATMPs. ChondroCelect was the first ATMP being authorized under this regulation.