ATMPs in Germany - Imlygic®

Imlygic^® (talimogene laherparepvec)

▶️ Imlygic was the first ATMP, which reimbursement price was set by the arbitration board after HTA.

Imlygic (active substance: talimogene laherparepvec) was approved as a gene therapy for treatment of adults with unresectable melanoma in December 2015. Imlygic is available in Germany.

🏆German HTA rating: 

The randomized, pivotal study OPTiM was submitted for HTA, which compared Imlygic to GM-CSF. However, GM-CSF did not match the defined appropriate comparator by the German HTA body. Depending on prior treatments and BRAF V600-status the appropriate comparators were vemurafenib, vemurafenib in combination with cobimetinib, dabrafenib in combination with trametinib, pembrolizumab, nivolumab or therapy according to physician’s choice.

Consequently, the additional benefit of Imlygic was not proven, due to the lack of HTA relevant evidence.

💵 Launch price: € 2,398.50 per vial. Continuous treatment with up to 4 vials in a 14-day cycle. Reimbursement price: €1,220.52 per vial. Rebate: 52 %

📘 Special features of reimbursement:

Imlygic is reimbursed.

The reimbursement price was set by the arbitration board. The reimbursement price contract contains a clause, which stipulates that if the median treatment duration of Imlygic is longer than 4.1 months, the reimbursement price would increase to € 1,526.33. However, an increase was never listed. 

💡 Although an RCT for the ATMP Imlygic was submitted for HTA, no additional benefit could be achieved due to the wrong comparator in the pivotal trial. The arbitration board designed the reimbursement price contract as a kind of “pay for performance” contract.