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
Quantity limits
- 7.4 GBq (200 mCi) per dose, given every 8 weeks for 4 doses total
Billing for Lutathera
Lutathera must be billed as a medical claim.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411