ATMPs in Germany - MACI

▶️ MACI was not assessed in German HTA because it was defined as being “part of a method” – this alters options for reimbursement

MACI (active substance: autologous cultured chondrocytes) was the second ATMP authorized as a tissue engineered product in the EU. It was authorized for the repair of symptomatic cartilage defects of the knee in June 2013. The pivotal study compared MACI vs. the procedure of microfracture. The marketing authorization for MACI expired in July 2018 following the decision of the marketing authorization holder. Consequently, MACI is no longer available in Germany.

🏆German HTA rating:

No assessment

💵 Launch price: unknown. Reimbursement price: not applicable (no HTA rating)

📘 Special features of reimbursement:

Other than the ACI procedure and ChondroCelect, the German HTA body concluded that M‑ACI (which also accounts for MACI^, before its marketing authorization was expired) is an “adequate, appropriate and economical” treatment alternative, and thus will be continued to be reimbursed in inpatient care and can also be used as an outpatient treatment option.

💡 The German HTA body defines an ATMP either as “medicinal product” or “part of a method”. Within this definition “medicinal products” are reimbursed but must go through HTA and price negotiation. “Methods” have more complex routes to reimbursement (e. g. reimbursement within hospital DRGs) but no price negotiations resulting in listed reimbursement prices. “Medicinal products” exerts effects via the pharmacological properties, while the therapeutic effect of “methods” highly depends on the complex intervention in which the ATMP is used. MACI was classified as being “part of a method”. As a result, MACI was not assessed in HTA and was not reimbursed at time of launch.