👉 RCTs for CAR-T cell therapies are becoming more and more common – an RCT is also conducted for Carvykti

Carvykti (active substance: ciltacabtagene autoleucel) is a CAR-T cell therapy and currently authorized for treatment of patients with multiple myeloma after at least 1 prior therapy. The initial authorization (May 2022) was treatment after at least 3 prior therapies. The pivotal study was the single-arm study CARTITUDE-1. Extension of indication was authorized in April 2024 and was based on the RCT CARTITUDE-4, which compares Carvykti to daratumumab-based and pomalidomide-based triplet regimes. Carvykti is available in Germany.

🏆German HTA rating:

[die Zahl sollen weiß auf blauem Grund sein]

To date 2 German HTAs began for Carvykti. The first HTA rating from August 2023 resulted in a non-quantifiable additional benefit, only because of the orphan drug status. The HTA resolution is limited until July 2026, as final results of CARTITUDE-4 also need to be submitted to EMA on basis of the conditional marketing authorization. Reasons for conditional marketing authorization were the lack of comprehensiveness as well as limited patient numbers and duration of follow-up.

The second HTA started in June 2024 because of the extension of indication. However, as the annual sales exceeded the € 30 million threshold already in March 2024, this HTA was suspended to allow for a later HTA comparing Carvykti vs. the appropriate comparator (not yet defined by the German HTA body).

💵 Launch price: € 420,000. Carvykti is used as a one-time treatment. Reimbursement price: € 285,000 (one price reduction). Rebate: 32 %.

Like Abecma, an arbitration award for Carvykti determined the retroactive effect of the reimbursement price. This provides further clarity on the point of time CAR-T-cell therapies are considered “to be launched” from a payer’s perspective.

📘 Special features of reimbursement:

Carvykti is reimbursed. Like other CAR-T cell therapies, Carvykti is reimbursed via NUB fees in hospitals, which meet all requirements of the ATMP Quality Assurance Guideline.

Already one month after launch in Germany and before price negotiation, the rebate contract coverage was above 92 % to facilitate market entry.

💡 Carvykti is the sixth authorized CAR-T cell therapy. The previously supposed special status for CAR-T cell therapies seems to become more and more obsolete.