ATMPs in Germany - Abecma®
👉 Although an RCT was submitted for Abecma, no additional benefit was granted by the German HTA body.
Abecma (active substance: idecabtagene vicleucel) is a CAR-T cell therapy and authorized for treatment of patients with multiple myeloma. Initially, Abecma was authorized for treatment after at least 3 prior therapies in August 2021, after extension of indication in March 2024, Abecma can also be used after only 2 prior therapies. Initial marketing authorization is based on the single-arm study KarMMa, the extension of indication is based on the RCT KarMMa-3, comparing Abecma to “investigator´s choice”. 🔎 Of note: KarMMa-3 is one of the first multi-comparator RCTs for CAR-T cell therapies in multiple myeloma. Abecma is available in Germany
🏆German HTA rating:
To date Abecma was assessed in 2️⃣ German HTAs. First HTA rating from June 2022 resulted in a hint for a non-quantifiable additional benefit, only because of the orphan drug status of Abecma.
In June 2023 Abecma exceeded annual sales of € 30 million and reassessment started in March 2024 (📍 see previous post on orphan drug reassessment). In the same month Abecma was granted the extension of indication. The according HTA started in April 2024. As this HTA covers also patients with 3 prior therapies, the HTA from March 2024 was suspended.
Reassessment and simultaneous assessment of the new indication was based on the RCT KarMMa-3, comparing Abecma versus “investigator´s choice. The HTA rating from September 2024 resulted in no additional benefit, because Abecma did not show significant advantages in overall survival.
💵 Launch price: € 350,000. Abecma is used as a one-time treatment. Reimbursement price: € 240,000 (so far one price reduction, price negotiation after the latest HTA is not completed, yet). Current rebate: 31 %. An arbitration award for Abecma determined the retroactive effect of the reimbursement price and an extended refund period.
📘 Special features of reimbursement:
Abecma is reimbursed. Like other CAR-T cell therapies, Abecma is reimbursed via NUB fees in hospitals, which meet all requirements of the ATMP Quality Assurance Guideline.