Blinatumomab

Key Messages

• The Formulary Management Expert Committee (FMEC) recommends that blinatumomab in combination with a tyrosine kinase inhibitor (TKI) not be reimbursed for the first-line treatment of adult and pediatric patients with Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL).
• FMEC reviewed 3 single-arm, open-label phase II trials (GIMEMA LAL2116 D-ALBA, SWOG-1318, and MDACC) in adult patients with Ph-positive ALL, as well as a cost comparison of blinatumomab versus other treatments used in Canada. There was no direct or indirect clinical evidence available that compared blinatumomab with a relevant comparator (e.g., standard of care chemotherapy) as first-line treatment for adult patients with Ph-positive ALL and no evidence that met the inclusion criteria for the pediatric population.
• Patients and clinicians identified a need for first-line treatments that prolong disease remission and survival, reduce toxicities, and maintain health-related quality of life (HRQoL). FMEC agreed that the use of blinatumomab in combination with a TKI may potentially avoid the use of high-dose chemotherapy with or without an allogeneic stem cell transplant (allo-SCT), which are highly toxic. However, based on the available evidence, FMEC concluded that there was significant uncertainty in the clinical value demonstrated by blinatumomab in combination with a TKI due to the limitations of the available evidence (e.g., lack of formal hypothesis testing, small sample size, missing information, and indirectness of the population). The committee recognized that patients want longer survival, less toxicity, and improved HRQoL. However, without direct evidence, FMEC concluded it is uncertain whether blinatumomab in combination with a TKI addresses these significant unmet clinical and nonclinical needs.