BESPONSA (inotuzumab ozogamicin IV)

BESPONSA (inotuzumab ozogamicin IV) 

OFFICE ADMINISTRATION

Indications for Prior Authorization:

• Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Patients must meet the following criteria for the indication(s) above:

• Prescribed by an oncologist, AND
• Patient is 18 years or older, AND
• Confirmed relapse or refractory Philadelphia chromosome positive ALL who are TKI-intolerant/refractory (B-cell acute lymphoblastic leukemia (B-ALL)), OR relapsed or refractory Philadelphia chromosome-negative ALL (B-ALL)

Dosing:

• Pre-medicate before each dose
• First cycle:
  • 1.8 mg/m² , administered as 3 divided doses on Day 1 (0.8 mg/m²), Day 8 (0.5 mg/m²), and Day 15 (0.5mg/m²)
  • Cycle 1 is 3 weeks in duration but may extend to 4 weeks if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow recovery from toxicity
• Subsequent Cycles:
  • If CR or CRi is achieved: The recommended total dose is 1.5 mg/m² per cycle, administered as 3 divided doses on Day 1 (0.5 mg/m²), Day 8 (0.5 mg/m²), and Day 15 (0.5 mg/m²). Subsequent cycles are 4 weeks in duration
  • If CR or CRi is not achieved: The recommended total dose is 1.8 mg/m² given as 3 divided doses on Day 1 (0.8 mg/m²), Day 8 (0.5 mg/m²), and Day 15 (0.5 mg/m²). Subsequent cycles are 4 weeks in duration. Treatment should be discontinued if CR or CRi is not achieved within 3 cycles
• Hematooietic stem cell transplant (HSCT) patients: The recommended duration is 2 cycles. A 3rd cycle may be considered for those who do not achieve CR or CRi and minimal residual disease (MRD) negativitiy after 2 cycles
• Patients not proceeding to HSCT: Additional cycles of treatment, up to a maximum of 6 cycles, may be administered

Approval:

• Initial approval: 1 cycle
• First renewal: 1 or 2 cycles (depending if the patient is to proceed to HSCT or not)
• Subsequent renewal: 1 more approval up to a maximum of 6 total cycles if the patient has achieved CR or CRi
• Total maximum allowed cycles: 6 cycles