Prior Authorization Required

Prior authorization is required for Lutathera, Pluvicto (Lu-177-PSMA-617), and Xofigo. Approvals are limited to durations and total dose counts consistent with the policy and FDA prescribing information; requests exceeding dose limits will be considered investigational / not medically necessary.

• Initial and non‑formulary exception approvals may be issued for up to 12 months.
• Dose limits: Lutathera — up to 4 total doses; Pluvicto — up to 6 total doses (administered once every 6 weeks); Xofigo — up to 6 total doses (typically every 4 weeks).
• Requests for treatment greater than the specified total doses are investigational / not medically necessary.

Prior Authorization and Indication Note

These radiopharmaceutical therapies are specialized and require coordination of diagnostic PSMA or somatostatin receptor imaging, prior systemic therapies where applicable, and documentation of organ function and performance status. Prior authorization requests should reference the specific indication and supporting diagnostic imaging used to select patients (e.g., Ga‑68 PSMA‑11 or F‑18 piflufolastat for Pluvicto; 68Ga-/64Cu‑dotatate or somatostatin receptor scintigraphy for Lutathera).

• Pluvicto requires demonstration of PSMA‑positive disease by an approved PET agent (e.g., Locametz, Illuccix, Pylarify).
• Lutathera requires somatostatin receptor expression confirmed by receptor‑based imaging (68Ga‑dotatate, 64Cu‑Dotatate, 68Ga‑Dotatoc PET or somatostatin receptor scintigraphy).
• Prior systemic therapy requirements for Pluvicto: previous treatment with an androgen‑receptor (AR) pathway inhibitor and a taxane‑based chemotherapy (or documentation that deferring taxane chemotherapy is appropriate).

Imaging, Prior Therapy, and Organ Function Documentation

Documentation expectations for prior authorization include diagnostic imaging reports confirming target receptor expression, records of prior therapies received, and laboratory/organ function results demonstrating adequate marrow, renal, and hepatic function. Absence of required imaging or prior therapy documentation may result in denial.

• Imaging: PET/CT reports showing PSMA‑positive or somatostatin receptor–positive lesions as appropriate.
• Prior therapy: medical records confirming prior AR pathway inhibitor and taxane chemotherapy for Pluvicto (or clinical justification to delay taxane).
• Organ function: recent creatinine clearance (Cockcroft‑Gault), complete blood count, liver function tests, and performance status (Karnofsky ≥60 or ECOG ≤2).
• Adverse event history: documentation showing no recurrent Grade 3–4 hematologic or nonhematologic toxicities that would preclude retreatment.

Prior Authorization and HCPCS Coding

Billing and coding must use the appropriate HCPCS codes for the specific radiopharmaceutical when submitting authorization or claims. Use up‑to‑date HCPCS coding consistent with the policy history and payer updates.

• HCPCS: A9513 — Lutetium Lu‑177 dotatate (Lutathera).
• A9607 — Lutetium Lu‑177 vipivotide tetraxetan (Pluvicto).
• A9606 — Radium Ra‑223 dichloride (Xofigo).
• Verify current HCPCS codes at the time of claim submission; codes have changed over prior updates and removals.

Dose Limits Trigger Noncoverage

Dose limits described in the policy are enforced. Requests for dosing beyond the FDA‑recommended total number of administrations will be considered investigational and are not covered.

• Lutathera: recommended 7.4 GBq (200 mCi) every 8 weeks for total of 4 doses; >4 doses = investigational.
• Pluvicto: recommended 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses; >6 doses = investigational.
• Xofigo: typically given every 4 weeks for up to 6 doses; >6 doses = investigational.

Triggers for Permanent Discontinuation of Lu‑177 Therapies

Specific triggers require permanent discontinuation of therapy with Lu‑177 agents. Authorization and clinical management should reflect these safety stop rules from the prescribing information.

• Lu‑177 dotatate (Lutathera): permanently discontinue for hepatotoxicity (bilirubin >3× ULN) or hypoalbuminemia <30 g/L with prothrombin ratio <70%, or renal toxicity defined as creatinine clearance <40 mL/min (Cockcroft‑Gault).
• Lu‑177‑PSMA‑617 (Pluvicto): permanently discontinue for recurrent Grade ≥3 myelosuppression after one dose reduction; Grade ≥3 renal toxicity; recurrent renal toxicity after one dose reduction; recurrent Grade 3 dry mouth after one dose reduction; recurrent Grade ≥3 gastrointestinal toxicity after one dose reduction; AST/ALT >5× ULN in absence of liver metastases; any unacceptable or serious adverse reaction requiring >4 weeks treatment delay; recurrent Grade 3–4 or persistent/intolerable Grade 2 adverse reaction after one dose reduction.

Required Documentation for Initial Treatment

Initial treatment authorization must be supported by specified clinical documents. For continuation or reauthorization, provide interval imaging, toxicity assessments, and justification for further dosing within policy limits.

• Initial documentation: history & physical supporting diagnosis, pathology verification, and receptor‑based imaging confirming target expression.
• Laboratories: creatinine clearance, CBC demonstrating adequate marrow reserve, and liver function tests prior to initiation.
• Performance status: documented Karnofsky ≥60 or ECOG ≤2.
• For reauthorization: evidence of clinical benefit or stability, absence of disqualifying toxicities, and adherence to dose and interval limits.

Administration and Documentation Expectations

Administration and dosing should follow the FDA prescribing information and established procedural steps for radiopharmaceuticals. Dose modifications, interruptions, or permanent discontinuation should follow guidance for adverse reactions and documented in the medical record.

• Lutathera: withhold long‑acting somatostatin analogues 4–6 weeks prior to each dose; stop short‑acting agents 24 hours prior and resume 4–24 hours after treatment.
• Pluvicto: individuals should be well‑hydrated; dose may be reduced once by 20% (to 5.9 GBq / 160 mCi) and should not be re‑escalated; dosing interval may be extended up to every 10 weeks for toxicity management.
• Radiopharmaceuticals must be used by or under supervision of physicians qualified in safe handling and administration of radiopharmaceuticals and within a quality management program.

Required Clinical Documentation

Required clinical documentation to support medical necessity includes pathology confirmation, imaging of target receptor expression, prior therapy verification, organ function tests, and performance status.

• Pathology report confirming diagnosis and tumor grade (e.g., Ki‑67 ≤20% for neuroendocrine tumors).
• Imaging reports: somatostatin receptor PET for Lutathera; PSMA PET for Pluvicto.
• Medical records verifying prior AR pathway inhibitor and taxane chemotherapy for Pluvicto (or clinical rationale for deferring taxane).
• Recent labs: CBC, creatinine clearance (Cockcroft‑Gault), LFTs; documentation of no prohibitive toxicities (see safety criteria).

Prescribing Information and Exception Durations

Policy follows FDA dosing and administration prescribing information. Non‑formulary exception authorizations may be approved up to 12 months consistent with policy history; any exception durations shorter or longer than standard prescribing intervals should be justified in the record.

• Approvals (including non‑formulary exception reviews) may be issued up to 12 months.
• Follow prescribing information for dosing schedules and recommended dose modifications.
• Document any deviations and clinical rationale when requesting exceptions to standard dosing or duration.

Step Therapy Context and Therapy Sequencing

Step therapy context and typical sequencing: these radiopharmaceuticals are generally used after specified prior systemic therapies and occupy a later line of treatment for mCRPC and neuroendocrine tumors per guideline recommendations.

• For mCRPC, Pluvicto is typically used after progression on androgen‑receptor pathway inhibitors and taxane chemotherapy (per NCCN and clinical trial eligibility).
• For neuroendocrine tumors, Lutathera is used for somatostatin receptor–positive, progressive disease after somatostatin analogue therapy.
• No specific step‑therapy program is specified in this excerpt, but clinical sequencing expectations should be documented in the authorization request.

Medicare Coverage Gap

Medicare coverage gap: there is currently no Medicare National Coverage Determination (NCD) for these therapies; this policy does not by itself establish Medicare coverage. Providers should verify local Medicare administrative contractor (MAC) determinations and payer‑specific requirements.

• No national coverage determination exists for these agents.
• This policy does not establish Medicare coverage; check MAC or local coverage articles for Medicare billing and coverage guidance.