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Therapeutic Radiopharmaceuticals in Oncology

Lutetium 177Initial Treatment
Lutetium 177 (Lu 177) dotatate treatment is considered medically necessary when conditions 1 through 8 are met:

Patient is an adult (≥18 years of age).

Patient has documented low or intermediate grade (Ki-67 index ≤20%), locally advanced or metastatic, gastroenteropancreatic (including foregut, midgut, and hindgut) or bronchopulmonary or thymus neuroendocrine tumor.

Patient has documented somatostatin receptor expression of a neuroendocrine tumor as detected by somatostatin receptor-based imaging (68Ga-dotate positron emission tomography or computed tomography, which is preferred) or somatostatin receptor scintigraphy.

Patient has documented disease progression while on octreotide long-acting release therapy.

Patient is not receiving long-acting somatostatin analogues for at least 4 weeks prior to initiating Lu 177 dotatate.

Patients does not have severe renal impairment (creatinine clearance, <30 mL/min). Patient has adequate bone marrow and hepatic function as determined by the treating physician. Patient 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-approved regimen is considered investigational. Iobenguane I 131 Iobenguane I 131 is considered medically necessary when conditions 1 through 5 are met: Patient has documented iobenguane scan positive, locally advanced or metastatic pheochromocytoma and paraganglioma. Patient is 12 years or older. Patient has progressed on prior therapy for pheochromocytoma or paraganglioma OR is not a candidate for chemotherapy. Patient does not have severe renal impairment (creatinine clearance <30 mL/min). Patient 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.

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