CurrentBlue Cross Blue Shield - North CarolinaPolicy N/A

Therapeutic Radiopharmaceuticals in Oncology (Lutathera, Pluvicto, Xofigo) Coverage Criteria

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.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyTherapeutic Radiopharmaceuticals in Oncology (Lutathera, Pluvicto, Xofigo) Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial updates (additions and revisions)

Effective DateJul 1, 202616d

Next Review DateN/A

Key ActionSubmit prior authorization with required imaging/pathology, prior therapy documentation, and adherence to lifetime dosing limits tied to HCPCS codes.

SourceLink

POLICY UPDATE CHANGES

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.

3therapeutic radiopharmaceuticals covered

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Coverage Criteria for Therapeutic Radiopharmaceuticals

Lutathera (initial therapy)

Covered when ALL of the following are met:

Lutathera eligibility: Request is for Lutathera; patient is ≥ 12 years of age; diagnosis of somatostatin receptor–positive gastroenteropancreatic (GEP) NET or somatostatin receptor–positive bronchopulmonary or thymus neuroendocrine tumor; disease is unresectable, locally advanced, or metastatic; documented over‑expression of somatostatin receptors on target lesions by appropriate imaging (medical record documentation required); well‑differentiated disease with Ki‑67 index ≤ 20% as documented in pathology (medical record documentation required); ONE of the following: (i) disease progression despite somatostatin analog therapy (e.g., octreotide LAR or lanreotide) or molecularly targeted therapy (e.g., everolimus) (medical record documentation required), OR (ii) for well‑differentiated gastrointestinal or pancreatic NETs BOTH: Ki‑67 10–20% AND clinically significant tumor burden (medical record documentation required); patient will NOT be treated for pheochromocytomas or paragangliomas; patient will NOT receive more than 4 doses (one treatment course) total during the patient’s lifetime.

Pluvicto (initial therapy)

Covered when ALL of the following are met:

Pluvicto eligibility: Request is for Pluvicto; patient is ≥ 18 years of age; diagnosis of PSMA‑positive metastatic castration‑resistant prostate cancer; unresectable metastatic disease; at least one PSMA‑positive lesion and/or predominantly PSMA‑positive disease without dominant PSMA‑negative metastatic lesions as determined by gallium‑68 PSMA‑11 PET/CT (medical record documentation required); disease progression despite advanced androgen therapy with at least one androgen receptor pathway inhibitor, demonstrated by PSA progression after at least 4 weeks (medical record documentation required); ONE of the following: (i) progression after at least one taxane‑based chemotherapy regimen, OR (ii) patient is appropriate to delay taxane chemotherapy (medical record documentation required); patient has had bilateral orchiectomy OR will use Pluvicto in combination with an LHRH agonist or antagonist (medical record documentation required); patient will NOT receive more than 6 doses (one treatment course) total during the patient’s lifetime.

Xofigo (initial therapy)

Covered when ALL of the following are met:

Xofigo eligibility: Request is for Xofigo; patient is ≥ 18 years of age; diagnosis of castration‑resistant prostate cancer; presence of symptomatic bone metastases; no known visceral metastatic disease; patient has had bilateral orchiectomy OR will use Xofigo with an LHRH agonist or antagonist (medical record documentation required); disease progression despite castrate serum testosterone < 50 ng/dL (medical record documentation required); Xofigo will NOT be used in combination with abiraterone plus prednisone/prednisolone, cytotoxic chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy (use with ADT and denosumab or zoledronic acid is permitted); patient will NOT receive more than 6 doses (one treatment course) total during the patient’s lifetime.

NCCN compendia coverage

Additional coverage provision:

NCCN-supported indications: Agent may be covered when the patient’s indication and all associated requirements specified in the NCCN 'Recommended Use' box are met at category 1 or 2A (i.e., the indication must be supported by ALL requirements such as performance status, disease severity, prior therapy failures, and monotherapy vs combination therapy).

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:

Prescriber and dosing: Prescriber must be a specialist in the area of the patient’s diagnosis (e.g., oncologist, radiation oncologist, nuclear medicine physician) or must have consulted with such a specialist; requested quantity (dose) and treatment duration must be within FDA‑labeled dosing for the requested indication or NCCN 1/2A compendia supported dosing and must not exceed the maximum units allowed for the duration of approval; maximum lifetime doses: Lutathera — 4 doses (maximum units 800), Pluvicto — up to 6 doses (maximum units 1,200), Xofigo — up to 6 doses (maximum units 894).

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

Lutathera HCPCSHCPCSCovered

A9513

lutetium Lu 177 dotatate (Lutathera) HCPCS

Pluvicto HCPCSHCPCSCovered

A9607

lutetium Lu 177 vipivotide tetraxetan (Pluvicto) HCPCS

Xofigo HCPCSHCPCSCovered

A9606

radium Ra 223 dichloride (Xofigo) HCPCS

Maximum lifetime doses

Lutathera (lutetium Lu 177 dotatate)Maximum 4 doses per lifetime — Maximum units: 800 (4 doses; IV: 7.4 GBq/200 mCi every 8 weeks)

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)Maximum 6 doses per lifetime — Maximum units: 1,200 (6 doses; IV: 7.4 GBq/200 mCi every 6 weeks)

Xofigo (radium Ra 223 dichloride)Maximum 6 doses per lifetime — Maximum units: 894 (6 doses; IV: 55 kBq/kg every 4 weeks)

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for Lutathera (A9513), Pluvicto (A9607), and Xofigo (A9606). Submit the request to Blue Cross Blue Shield - North Carolina before administration.

Prior authorization is required for: A9513 (lutetium Lu 177 dotatate, Lutathera®); A9607 (lutetium Lu 177 vipivotide tetraxetan, Pluvicto®); A9606 (radium Ra 223 dichloride, Xofigo®).
Include HCPCS code on the prior authorization request and claims.

Documentation Required

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.

Key Definitions

Well-differentiated NET (Ki-67) — definitions and guidance

DefinitionWell-differentiated neuroendocrine tumors include low-grade (G1) and intermediate-grade (G2) tumors determined by Ki-67 proliferation index via immunohistochemistry.

Ki-67 thresholds by gradeG1: Ki-67 < 3%; G2: Ki-67 3–20%.

Policy eligibility criterionPolicy requires documented Ki-67 ≤ 20% for Lutathera eligibility; for certain well-differentiated GI/pancreatic NETs, Ki-67 10–20% may qualify when coupled with clinically significant tumor burden.

PSMA-positive disease — definition and interpretation guidance

DefinitionPSMA-positive disease is presence of at least one PSMA-positive lesion and/or predominantly PSMA-positive disease without dominant PSMA-negative metastatic lesions as determined by gallium-68 PSMA-11 PET/CT.

Required imaging

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.