Besponsa™

Drugs - Besponsa™ (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

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

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