Lutathera (lutetium Lu 177 dotatate) (Revised)
Summary
This is a revised Lutathera (lutetium Lu 177 dotatate) prior authorization policy effective August 26, 2026, for Medicare and four state Medicaid programs (FL, KY, SC, VA). The policy clarifies three mandatory approval criteria: diagnosis of unresectable/metastatic neuroendocrine tumors, somatostatin receptor-positive imaging, and no prior Lutathera therapy (maximum 4 doses). The revision includes detailed dose modification protocols for adverse reactions (thrombocytopenia, anemia, neutropenia, renal/hepatic toxicity, hypersensitivity), mandatory premedication/concomitant medication requirements (long-acting octreotide timing, amino acid infusions), and comprehensive warnings regarding radiation exposure, myelosuppression, and secondary malignancy risk.
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