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New HTA Decisions in England
March 2021
Drug name
TECARTUS (autologous anti-CD19-transduced CD3+ cells)
Company
Kite
Decision date
19/01/2021
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood and bone marrow cancers
Decision
Recommended (CDF)
Indication
Treatment with autologous anti-CD19-transduced CD3+ cells is recommended for use within the Cancer Drugs Fund as an option for relapsed or refractory mantle cell lymphoma in adults who have previously had a Bruton's tyrosine kinase (BTK) inhibitor.
Decision Detail
It is only recommended if the conditions in the managed access agreement for autologous anti‑CD19‑transduced CD3+ cells treatment are followed (the company has a commercial arrangement (simple discount patient access scheme and a managed access agreement including a commercial access agreement)).
Summary
Clinical evidence for autologous anti CD19 transduced CD3+ cells came from ZUMA 2, an ongoing, phase 3, multicentre, open label, single-arm study. The committee concluded that treatment is clinically effective, but the benefit cannot be quantified because of the immature survival data and lack of trial data compared with standard care. Long-term survival data were consistent with the possibility of a cure, but the data are too immature to establish this. Autologous anti-CD19-transduced CD3+ cells meet both criteria to be considered a life-extending treatment at the end of life. There are a range of possible cost-effectiveness estimates because the final survival data are not yet available. However, the treatment had the plausible potential to satisfy the criteria for routine use if this uncertainty could be reduced. The committee recognised that more data on long-term survival and post-progression survival for treatment with autologous anti CD19 transduced CD3+ cells would allow for a more robust cost-effectiveness estimate. It agreed that the treatment met the criteria to be considered for inclusion in the Cancer Drugs Fund for treating relapsed or refractory mantle cell lymphoma.