Therapeutic Radiopharmaceuticals in Oncology (Lutathera, Pluvicto, Xofigo) Coverage Criteria
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Defines medical necessity criteria, dosing limits, and documentation requirements for lutetium Lu 177 dotatate (Lutathera), lutetium Lu 177 vipivotide tetraxetan (Pluvicto), and radium Ra 223 dichloride (Xofigo) for Blue Cross NC members; applies to providers requesting coverage for these agents.
Xofigo (radium Ra 223 dichloride) and associated criteria were added to the policy for treatment of castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.
Lutathera age eligibility was extended to patients 12 years and older per the FDA label.
For Pluvicto, requirement added that the patient has had a bilateral orchiectomy or will use the agent with an LHRH agonist or antagonist.
Requirement that the prescriber is a relevant specialist or has consulted with one was added.
Maximum units (lifetime dose limits) for each agent were added to the policy.
Policy now requires documented imaging or pathology (e.g., PSMA PET for Pluvicto, somatostatin receptor imaging for Lutathera) as part of medical record documentation.
Coverage Criteria for Therapeutic Radiopharmaceuticals
Lutathera (initial therapy)
Covered when ALL of the following are met:
Pluvicto (initial therapy)
Covered when ALL of the following are met:
Xofigo (initial therapy)
Covered when ALL of the following are met:
NCCN compendia coverage
Additional coverage provision:
References to NCCN versions are included in the policy and FDA/NCCN‑supported dosing should be used when applicable.
Prescriber and dosing constraints
Provider and dosing requirements:
Medical record documentation required for indication, imaging/pathology (e.g., somatostatin receptor imaging for Lutathera; Ki‑67 for NETs; PSMA PET/CT for Pluvicto), prior therapies and progression, and castration status when applicable.
Excluded uses and prohibited combinations are specified for each agent. Lutathera must not be used for treatment of pheochromocytomas or paragangliomas; documentation in the medical record must support that the requested use is not for these diagnoses. Xofigo must not be given in combination with abiraterone plus prednisone/prednisolone, with cytotoxic chemotherapy (for example, docetaxel or cabazitaxel), with other systemic radioisotopes, or with hemibody external radiotherapy. Use of Xofigo with androgen deprivation therapy and with bone-modifying agents such as denosumab or zoledronic acid is permitted. Additionally, each agent is subject to its respective lifetime dose limit (Lutathera ≤4 doses; Xofigo ≤6 doses), and requests exceeding those limits are not allowed.
Requests that do not meet the specified indications, required imaging or pathology documentation, prior therapy or progression requirements, prescriber specialty requirements, or that exceed the stated lifetime dose limits are considered not medically necessary. Examples include absence of documented somatostatin receptor over-expression or Ki-67 reporting for Lutathera, lack of gallium-68 PSMA-11 PET/CT demonstrating PSMA-positive disease for Pluvicto, missing evidence of prior androgen receptor pathway inhibitor therapy or PSA progression for Pluvicto, or failure to document castration status/serum testosterone for Xofigo. The policy also requires that the prescriber be a specialist in the area of the patient’s diagnosis or have consulted such a specialist; failure to meet that prescriber requirement may lead to denial.
Billing Codes and Dose Limits
| A9513 | lutetium Lu 177 dotatate (Lutathera) HCPCS |
| A9607 | lutetium Lu 177 vipivotide tetraxetan (Pluvicto) HCPCS |
| A9606 | radium Ra 223 dichloride (Xofigo) HCPCS |
Provider Actions and Prior Authorization Requirements
Documentation Requirements and Denial Risk
Required clinical documentation must be included with the prior authorization request. Missing imaging or pathology documentation, or requests that exceed lifetime dose limits, may result in denial.
- Receptor imaging: For Lutathera — documentation of somatostatin receptor–positive target lesions (appropriate imaging study). For Pluvicto — Gallium-68 PSMA-11 PET/CT showing at least one PSMA-positive lesion and no dominant PSMA-negative lesions.
- Pathology: For Lutathera — pathology report documenting well-differentiated disease and Ki-67 index (≤20% for eligibility; 10–20% has specific criteria).
- Prior treatments: Documentation of prior therapies and progression (e.g., somatostatin analog therapy or molecularly targeted therapy for Lutathera; advanced androgen therapy and prior taxane chemotherapy or rationale to delay taxane for Pluvicto).
- Clinical notes: Disease stage (unresectable, locally advanced, or metastatic), symptomatic status (e.g., symptomatic bone metastases for Xofigo), and treatment intent.
- Dosing/lifetime limits: Documentation must support that the patient will not exceed lifetime dose limits (Lutathera: max 4 doses per lifetime; Pluvicto: max 6 doses per lifetime; Xofigo: max 6 doses per lifetime).
Prior Therapy Requirements
Prior therapy requirements — include explicit prior therapy history and progression evidence. Requests missing prior therapy documentation or not meeting prior therapy rules risk denial.
- Lutathera: Evidence of disease progression despite somatostatin analog therapy (e.g., octreotide LAR or lanreotide) OR for well‑differentiated GI/pancreatic NETs with Ki‑67 10–20% both (a) Ki‑67 10–20% documented and (b) clinically significant tumor burden.
- Pluvicto: Progression despite advanced androgen therapy with at least one androgen receptor pathway inhibitor (document PSA progression after ≥4 weeks). Also document prior taxane-based chemotherapy OR documentation that patient is appropriate to delay taxane chemotherapy.
- Xofigo: Document castration-resistant status, symptomatic bone metastases, absence of known visceral metastatic disease, and prior castrate levels of serum testosterone (<50 ng/dL).
Dosing Limits and Billing/Coding Guidance
Dosing and lifetime limits are enforced. Requests that propose doses beyond the policy limits or lack documentation justifying deviations will be denied.
- Lutathera dosing per label: 7.4 GBq (200 mCi) IV every 8 weeks (±1 week) for a total of 4 doses. HCPCS A9513. Maximum units = 800 (4 doses per lifetime).
- Pluvicto dosing per label: 7.4 GBq (200 mCi) IV every 6 weeks for up to 6 doses. HCPCS A9607. Maximum units = 1,200 (6 doses per lifetime).
- Xofigo dosing per label: 55 kBq/kg IV every 4 weeks for 6 doses. HCPCS A9606. Maximum units = 894 (6 doses per lifetime).
- Operational notes: Discontinue long-acting somatostatin analogs ≥4 weeks prior to Lutathera initiation; short-acting octreotide withheld ≥24 hours prior. Document scheduled octreotide administration during and after treatment as applicable.
Key Definitions
Background
These therapeutic radiopharmaceuticals are indicated for specific advanced malignancies: Lutathera for somatostatin receptor–positive gastroenteropancreatic and certain bronchopulmonary neuroendocrine tumors (well-differentiated, Ki-67 ≤20%), Pluvicto for PSMA-positive metastatic castration‑resistant prostate cancer after progression on an androgen receptor pathway inhibitor (with castration by orchiectomy or concurrent LHRH agonist/antagonist), and Xofigo for castration‑resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease. FDA‑approved dosing schedules and maximum lifetime dose limits are specified in the policy (for example, Lutathera ≤4 doses, Pluvicto ≤6 doses, Xofigo ≤6 doses), and required clinical documentation (imaging, pathology, prior therapies, and castration status) must be provided with prior authorization requests.
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