Lutathera

Drug - Lutathera® (lutetium lu 177 dotatate) [Advanced Accelerator Applications USA, Inc.]

March 2019

Therapeutic area - Oncology

Approval Criteria

Patient is at least 18 years old AND
Patient has a negative pregnancy test (in females) AND
Patient has progressive locally advanced or metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) AND
Patient disease has progressed on long-acting octreotide or lanreotide AND
Patient’s disease is somatostatin receptor-positive in all tumor lesions (OctreoScan uptake ≥ normal liver) AND
Patient has well-differentiated disease with a Ki67 labeling index score of ≤ 20% AND
Patient has not received any long-acting octreotides within the previous 4 weeks OR short-acting octreotide within 24 hours prior to therapy AND
Lutathera will be used in combination with long-acting octreotide given as a single-injection (between 4 to 24 hours) following each Lutathera infusion
Approval is limited to one year and may NOT be renewed

Lutathera must be billed as a medical claim.

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