Lutetium 177Initial TreatmentLutetium 177 (Lu 177) dotatate treatment is considered medically necessary when conditions 1 through 8 are met:
Individual is an adult (≥18 years of age).
Individual has documented low or intermediate grade (Ki-67 index ≤20%), locally advanced or metastatic, gastroenteropancreatic (including foregut, midgut, and hindgut) or metastatic bronchopulmonary or thymus neuroendocrine tumor.
Individual has documented somatostatin receptor expression of a neuroendocrine tumor as detected by somatostatin receptor-based imaging (see Policy Guidelines).
Individual has documented disease progression while on octreotide long-acting release or lanreotide therapy.
Individual is not receiving long-acting somatostatin analogues (e.g., octreotide long-acting release or lanreotide) for at least 4 weeks prior to initiating Lu 177 dotatate and has discontinued use of short-acting octreotide for at least 24 hours prior to initiating Lu 177 dotatate.
Individual does not have severe renal impairment (creatinine clearance <30 mL/min). Individual has adequate bone marrow and hepatic function as determined by the treating physician. Individual has documented Karnofsky Performance Status score of 60 or greater. Continuation of Treatment Continuation of Lu 177 dotatate is considered medically necessary when conditions 1 through 5 are met: No recurrent grade 2, 3, or 4 thrombocytopenia (see Table PG1). No recurrent grade 3 or 4 anemia and neutropenia (see Table PG1). No recurrent hepatotoxicity (see definition of hepatotoxicity in the Policy Guidelines section). No recurrent grade 3 or 4 nonhematologic toxicity (see Table PG1). No renal toxicity requiring a treatment delay of 16 weeks or longer (see definition of renal toxicity in the Policy Guidelines section). Lu 177 dotatate treatment is considered investigational in all other situations in which the above criteria are not met. Lu 177 dotatate treatment greater than a total of 4 doses as per the U.S. Food and Drug Administration (FDA)-approved regimen is considered investigational. Lu 177 dotatate treatment is considered investigational for all other indications including pheochromocytoma and paraganglioma. Iobenguane I 131 Iobenguane I 131 is considered medically necessary when conditions 1 through 5 are met: Individual has documented iobenguane scan positive, locally advanced or metastatic pheochromocytoma and paraganglioma. Individual is 12 years or older. Individual has progressed on prior therapy for pheochromocytoma or paraganglioma OR is not a candidate for chemotherapy. Individual does not have severe renal impairment (creatinine clearance <30 mL/min). Individual has platelet count greater than 80,000/mcL OR absolute neutrophil count greater than 1,200/mcL. Iobenguane I 131 treatment is considered investigational for all other indications including neuroblastoma and gastroenteropancreatic neuroendocrine tumors. Use of iobenguane I 131 not in accordance with FDA approved dosing (first dosimetric dose followed by 2 therapeutic doses administered 90 days apart) is considered investigational. See Policy Guidelines below.