ATMPs in Germany - Strimvelis®

Strimvelis^® (autologous CD34+ cells that contain human adenosine deaminase (ADA) cDNA)

▶️ Reimbursement of Strimvelis is subject to case-by-case decisions as treatment is only possible outside of Germany.

Strimvelis (active substance: autologous CD34+ cells that contain ADA cDNA) was approved as a gene therapy for treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID) in May 2016. The pivotal study was a single arm trial with 12 patients treated with Strimvelis. Strimvelis is not available in Germany, because it can only be used in a single hospital in Milan, Italy.

🏆German HTA rating: 

No HTA, as the ATMP Strimvelis was not launched in Germany. 

💵 Launch price: assumed to be € 594,000 per treatment (according to the Drug-Future-Report by Techniker Krankenkasse from 2019, as Strimvelis is not available in Germany, the price is not officially listed in Germany). Reimbursement price: not applicable (no HTA)

📘 Special features of reimbursement:

As Strimvelis is not available in Germany, reimbursement is subject to a case-by-case decision by the respective health insurance company.

According to the Drug-Future-Report, the costs of Strimvelis are refunded in case the therapy does not cure the patient.

💡Even though not available in Germany, Strimvelis can be reimbursed by German health insurances. It is agreed upon with the health insurance companies that in case Strimvelis does not cure the patient, the costs are refunded.