What Is the CADTH Reimbursement Recommendation for Tecartus?: CADTH recommends that Tecartus be reimbursed by public drug plans for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) if certain conditions are met.

Which Patients Are Eligible for Coverage?: Tecartus should only be covered to treat adult patients who have B-cell precursor ALL whose disease never achieved remission from previous treatments, returned within 1 year after the first remission, returned or did not respond after 2 or more treatments, or returned or did not respond after an allogeneic stem cell transplant (alloSCT).

What Are the Conditions for Reimbursement?: Tecartus should only be reimbursed for patients who have not already received a chimeric antigen receptor (CAR) T-cell therapy, are in relatively good health, do not have leukemia in the central nervous system (CNS), and the cost of Tecartus is reduced. Tecartus should be prescribed and administered by clinicians with expertise in leukemia and cellular therapy or SCT in a hospital setting with adequate resources to perform the procedure and manage side effects.

Why Did CADTH Make This Recommendation?:

1. In adult patients with relapsed or refractory B-cell precursor ALL, evidence from a clinical trial demonstrated that treatment with Tecartus may be associated with meaningful improvements in remission rates compared to past studies for other treatments, as well as the time until patients experienced disease relapse or died.

2. Tecartus may be an effective treatment option for patients who are seeking new treatments with a high complete remission rate, and this treatment may prolong survival.

3. Based on CADTH’s assessment of the health economic evidence, Tecartus does not represent good value to the health care system at the public list price. A price reduction is therefore required.

4. Based on public list prices, Tecartus is estimated to cost the public drug plans approximately $17 million over the next 3 years.

What Is B-Cell Precursor ALL?: B-cell precursor ALL is a rare, aggressive leukemia in adults in which too many B-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. It is estimated that 1,148 people living in Canada have relapsed or refractory B-cell precursor ALL.

Unmet Needs in B-Cell Precursor ALL: Patients with B-cell precursor ALL have a poor prognosis and limited treatment options. Furthermore, not all patients benefit from currently available treatments. Additional treatments that can prolong survival, cure the disease, and improve quality of life are needed.

How Much Does Tecartus Cost?: Treatment with Tecartus is expected to cost approximately $533,500 per infusion.