01Already effective September 17, 2026: Claims for Xofigo (A9606) need documentation that the patient has medically or surgically castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease or bulky regional lymph nodes greater than three cm on imaging performed within the past 30 days.
02Claims for Pluvicto (A9607) need documentation that the patient is PSMA-positive with metastatic castration-resistant prostate cancer, has been treated with at least one androgen-receptor pathway inhibitor (enzalutamide and/or abiraterone), has been treated with one or two taxane-based regimens or is considered appropriate to delay taxane-based chemotherapy, and has at least one PSMA-positive metastatic lesion and no PSMA-negative lesions on a PSMA PET/CT scan.
03Claims for Lutathera (A9513) need documentation of an eligible SSTR-positive tumor type, a Ki-67 below 20% for well-differentiated G1 or G2 tumors or below 55% for well-differentiated G3 tumors, positive somatostatin receptor scintigraphy with correlative CT or MRI, or a positive gallium-68 Dotate PET scan, and progression after somatostatin analogs.
04Documentation must also show the absence of these contraindications: serum creatinine of 1.7 mg per deciliter or greater or creatinine clearance below 50 mL per minute, hemoglobin of 8.0 g/dL or less, white blood cell count below 2000/mm3, and platelets below 75,000/mm3.
05For Lutathera without metastatic disease, documentation should include a surgical or medical consult and the reason for inoperability.
06Claims for strontium-89 chloride (A9600) need documentation of bone pain in patients with confirmed skeletal metastases.
07Claims for HICON (A9517, A9530) need documentation of one of the thyroid carcinoma criteria in the policy, such as remnant ablation after surgery in T1b/T2 localized disease, adjuvant therapy under the listed circumstances, or proven unresectable or metastatic disease.
08Treatment regimens in excess of the FDA approved regimen are considered investigational.