LUTATHERA (lutetium 1u 177 dotatate injection)

LUTATHERA (lutetium 1u 177 dotatate injection)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

• Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults

Patients must meet the following criteria for the indication(s) above:

• Prescribed by an oncologist, AND
• Member is 18 years or older, AND
• Diagnosis of gastroenteropancreatic neuroendocrine tumor (GEP-NETs), AND
• Confirmation that tumor is somatostatin receptor-positive by an OctreoScan test, AND
• Member has disease progression on somatostatin analogs (Sandostatin LAR Depot or Somatuline Depot), AND
• Will be used with long-acting octreotide after each Lutathera dose and after completion of therapy

Dosing:

• 7.4 gigabecquerel (GBq) [200 millicuries {mCi}] IV every 8 weeks for a total of 4 doses
• Before starting Lutathera: discontinue long-acting somatostatin analogs (e.g. long-acting octreotide) for at least 4 weeks prior to initiating Lutathera. Administer short-acting octreotide as needed; discontinue at least 24 hours prior to initiating Lutathera
• During Lutathera treatment: Administer long-acting octreotide 30 mg intramuscularly between 4 to 24 hours after each Lutathera dose. Do not administer long-acting octreotide within 4 weeks of each subsequent Lutathera dose. Short-acting octreotide may be given for symptomatic management during Lutathera treatment, but must be withheld for at least 24 hours before each Lutathera dose
• Following Lutathera treatment: continue long-acting octreotide 30 mg IM every 4 weeks after completing Lutathera until disease progression or for up to 18 months following treatment initiation

Approval:

• Limited to 4 total doses per lifetime