Leukine (Sargramostim) — Medical Mutual

Initial criteria

• Treatment of chemotherapy-induced febrile neutropenia: Used in patients who have not received prophylactic therapy with a granulocyte colony stimulating factor; AND patient has one or more of the following risk factors for developing infection-related complications: Sepsis syndrome; OR age > 65 years; OR absolute neutrophil count [ANC] < 100/mcL; OR duration of neutropenia expected to be > 10 days; OR pneumonia or other clinically documented infections; OR invasive fungal infection; OR hospitalization at the time of fever; OR prior episode of febrile neutropenia
• Neuroblastoma: Used in combination with a regimen containing a GD2-binding monoclonal antibody (i.e., naxitamab, dinutuximab, etc.) for the treatment of high-risk neuroblastoma

Reauthorization criteria

• Neuroblastoma: Use in combination with dinutuximab and isotretinoin-based regimens may not be renewed.
• Neuroblastoma: Used in combination with a naxitamab-based regimen, or in combination with dinutuximab, temozolomide, and irinotecan; AND patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in initial criteria; AND absence of unacceptable toxicity from the drug (examples of unacceptable toxicity include severe hypersensitivity reactions, severe effusions and capillary leak syndrome, severe supraventricular arrhythmias, etc.).
• All other indications: Refer to initial prior authorization criteria.

Approval duration

Neuroblastoma with dinutuximab + isotretinoin: 5 months, not renewable; Neuroblastoma other regimens: 6 months, renewable; All other indications: 4 months, renewable