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DrugsBesponsa™ (inotuzumab ozogamicin) [Pfizer Inc.]

July 2018

Therapeutic area - Oncology

Approval criteria

  • Patient must be 18 years of age or older AND
  • Patient has relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) AND
    • Patient is Philadelphia chromosome (Ph)-negative OR
    • Patient is Philadelphia chromosome (Ph)-positive and failed previous therapy with a tyrosine kinase inhibitor (e.g., imatinib, dasatinib, ponatinib, etc.) AND
  • Patient has not previously received inotuzumab ozogamicin AND
  • Has baseline electrocardiogram (ECG) is within normal limits AND
  • Prescriber attests that patient will be monitored closely for signs and symptoms of Hepatic Veno-occlusive Disease (VOD) (Sinusoidal Obstruction Syndrome) or other severe liver toxicity AND
  • Besponsa will be used as single agent therapy
  • Initial approval is for 3 months

Renewal criteria

  • Patient must not have unacceptable toxicity from the drug AND
  • Not have documented antibodies to inotuzumab ozogamicin AND
  • Has complete remission (CR) or complete remission with incomplete hematologic recovery (Cri) and not proceeding to post-hematopoietic stem cell transplant (HSCT) AND
  • Not have low absolute neutrophil count (ANC) or low platelet count persisting for greater than 28 days suspected to be related to Besponsa
  • Renewal approval is for 3 months

Quantity limits

  • 1.8 mg/m2/cycle; maximum of 6 cycles


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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