Bluebird to Withdraw Zynteglo from Germany After Price Negotiations Failed to Recognize Drug’s Value

CAMBRIDGE, MA, United States, and BERLIN, Germany – bluebird bio has announced it will be withdrawing Zynteglo (betibeglogene autotemcel) for transfusion-dependent β-thalassemia (TDT) from the German market after reimbursement negotiations failed.

Zynteglo was launched in Germany in January of this year and made available thanks to value-based payment agreements with multiple statutory health insurers under which payers only pay if the therapy delivers on its promise. Specifically, the model was limited to five payments in equal installments: an initial payment at the time of infusion and four additional payments if no transfusions for TDT are required for the patient.

In May of this year, German assessor the Federal Joint Committee (G-BA) found Zynteglo to offer unquantifiable added benefit for the treatment of patients aged 12 years and up with TDT who do not have a β0/β0 genotype and for whom allogeneic hematopoietic stem cell transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available, as data available (from HGB-202, -205, -207, and -212, as well as LTF203) did not allow for any quantification.

According to bluebird, the negotiations “did not result in a price for Zynteglo that reflects the value of this one-time gene therapy with potential life-long benefit for people living with TDT.” The company added that Germany’s proposed price for the gene therapy failed to recognize the innovativeness and benefit Zynteglo provides to patients living with this disease, which is severely burdensome.

Reimbursement negotiations continue across Europe, the company said, and it will provide an update on this process in the second half of 2021. However, failed negotiations in Germany have led bluebird to reduce and reshape its workforce in Europe.

Andrew Obenshain, President, Severe Genetic Diseases, bluebird bio, commented, “…Through our continued engagement across Europe, we are optimistic that countries will reach pricing decisions that recognize the value of one-time gene therapies and provide the necessary access to the people who need them.”