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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.


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

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