ATMPs in Germany - Holoclar®

Holoclar – the longest approved tissue engineered product that is still available in Germany
Holoclar (active substance: ex vivo expanded autologous human corneal epithelial cells containing stem cells) was approved for treatment of limbal stem cell deficiency due to physical or chemical ocular burns in February 2015. The efficacy and safety of Holoclar was evaluated in several retrospective, non-randomized, non-controlled studies and case-series. Holoclar is a tissue engineered product and currently available in Germany.

🏆German HTA rating:
No assessment (like MACI, Holoclar was defined as being “part of a method”).

💵 Launch price: assumed to be € 120,000 per treatment (according to publication “Stammzelltransplantat bei schweren Verätzungen” by Norbert Schrage, price officially listed with € 0 in Germany). Reimbursement price: not applicable (no HTA)

📘 Special features of reimbursement:
Costs are not included in any DRG for ophthalmology. Reimbursement is subject to a case-by-case decision by the respective health insurance company.

💡 The ATMP Holoclar was classified as being “part of a method”. As a result, Holoclar was not assessed in HTA and is reimbursed in case-by-case decisions.