👉 Breyanzi is the first CAR-T cell therapy without an orphan drug status ‒ nevertheless, a considerable additional benefit was granted by the German HTA body

Breyanzi (active substance: lisocabtagene maraleucel) is a CAR-T cell therapy and authorized for the treatment of patients with DLBCL, PMBCL and FL3B after at least 2 prior therapies (initial authorization: April 2022) and for treatment of patients with DLBCL, HGBCL, PMBCL and FL3B after 1 prior therapy (authorization: April 2023). Initial authorization was based on single arm trials only; the authorization for extension of indication was based on the RCT TRANSFORM. Breyanzi is available in Germany.

🏆German HTA rating:

To date Breyanzi was assessed in 2️⃣ German HTAs. As Breyanzi has no orphan drug status, comparisons vs. the appropriate comparator were required for HTA. German HTA rating in April 2023 for treatment after at least 2 prior therapies resulted in no additional benefit, because the German HTA body did not assess the submitted indirect comparisons.

For the HTA on the extension of indication (resolution: September 2023) the German HTA body granted a considerable additional benefit for Breyanzi, because the comparator in the study TRANSFORM was the correct implementation of the appropriate comparator and Breyanzi showed significant advantages in event-free survival.

💵 Launch price: € 345,000. Breyanzi is used as a one-time treatment. Reimbursement price: € 233,750. Rebate: 32 %.

Only one price reduction was observed. Assumably, the results of both HTAs were negotiated simultaneously. Under this assumption, the positive results of the second HTA resolution might have compensated for the negative results of the first HTA.

📘 Special features of reimbursement:

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

💡 Breyanzi has the greatest additional benefit among CAR-T cell therapies so far.

Interestingly, Breyanzi is now defined to be the appropriate comparator in its indications, even for non-CAR-T cell therapies (compare HTA resolution for Polivy from June 2024). What remains an intriguing question is how CAR-T cell therapies can actually be implemented as comparators in clinical trials.