Pluvicto prior authorization and approval quantities

If initial Pluvicto criteria are met, approve four doses. If renewal criteria are met (patient tolerated medication and demonstrated evidence of response by PSA response OR radiologic response on CT and NM bone scan OR clinical benefit per treating physician), approve two additional doses. Total treatment greater than six doses is considered investigational and not approved.

• Initial approval: 4 doses
• Renewal approval (if renewal criteria met): 2 doses
• Maximum total doses per FDA regimen: 6 (>6 investigational)

Pre-authorization required for listed HCPCS codes

Pre-authorization is required for the listed HCPCS codes when criteria are met; providers must verify authorization requirements for a specific code and plan via the Pre-authorization Code Check.

• A9513 — Lutetium Lu 177, dotatate, therapeutic, 1 mCi
• A9607 — Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 mCi

Lutathera step therapy requirement

Lutathera candidates must have progressive disease while on somatostatin analog therapy (SSA) and SSA must be interrupted per protocol prior to administration (short-acting SSA stopped 24 hours before; LAR SSA interrupted at least 4 weeks prior; short-acting SSA may be used as a bridge but stopped 24 hours before treatment).

• Progressive disease on SSA required
• Interrupt short-acting SSA ≥24 hours before Lutathera
• Interrupt long-acting (LAR) SSA ≥4 weeks before initiation
• Short-acting SSA may be used as bridge but stopped 24 hours before treatment

Step therapy / sequencing note

Revision history documents that the medical policy committee approved adoption of hybrid medical necessity criteria for Pluvicto (Lutetium Lu 177 vipivotide tetraxetan); see revision history for sequencing and step therapy adoption details.

• 07/07/2026: MPC approved to adopt hybrid medical necessity criteria for Pluvicto; effective 12/01/2026
• Revision history notes clarifications to renewal radiologic response language

Lutathera required documentation

Document metastatic or locally advanced unresectable GEP‑NET, Ki‑67 ≤20% (patients with higher-grade disease evaluated case-by-case), progressive disease on somatostatin analog therapy, age ≥18, and somatostatin receptor overexpression on 68Ga-DOTATATE PET/CT within the prior 3 months; monitoring labs must be performed at baseline within 4 weeks, 4–6 weeks after each injection, and 2 days prior to subsequent injections.

• Diagnosis: metastatic or locally advanced unresectable GEP‑NET
• Ki‑67 protein ≤20% (higher-grade evaluated case-by-case)
• Evidence of progressive disease on SSA
• Age ≥18 years
• 68Ga-DOTATATE PET/CT showing somatostatin receptor overexpression within 3 months
• Monitoring labs: baseline within 4 weeks; 4–6 weeks after each injection; 2 days prior to subsequent injections

Pluvicto required documentation

For Pluvicto, provide baseline CT and/or bone scan of chest/abdomen/pelvis within the prior 2 months showing at least one visible lesion, and a PSMA PET within the past 3 months demonstrating at least one lesion with uptake greater than normal liver; document required laboratory thresholds and ECOG performance status per criteria.

• Baseline CT/bone scan of chest/abdomen/pelvis within prior 2 months with ≥1 visible lesion
• PSMA PET within past 3 months with ≥1 lesion uptake > normal liver
• Document labs (WBC, ANC, Hgb, platelets, bilirubin, AST/ALT, creatinine/CrCl, albumin) and ECOG PS 0–2

Authorization verification and code documentation

Verify authorization requirements for the specific code and plan using the Pre-authorization Code Check, and document the CPT/HCPCS code(s) used for the service (e.g., A9513, A9607).

• Use Pre-authorization Code Check to confirm authorization requirements by plan
• Document HCPCS codes A9513 or A9607 as applicable

Lutathera coverage exclusions

Lutathera is not covered if the patient had recent surgery, radioembolization, chemoembolization, radiofrequency ablation, or chemotherapy within 4 weeks prior to initiation; other exclusions include untreated brain metastases, uncontrolled CHF (NYHA II–IV), inability to interrupt SSA as specified, prior external beam radiation to >25% of bone marrow, and current spontaneous urinary incontinence making administration unsafe.

• No recent (within 4 weeks) surgery, radioembolization, chemoembolization, radiofrequency ablation, or chemotherapy
• No known brain metastases unless treated and stabilized
• No uncontrolled CHF (NYHA II–IV)
• Must be able to interrupt SSA per protocol
• No prior external beam radiation to >25% of bone marrow
• No current spontaneous urinary incontinence that makes administration unsafe

Pluvicto initial criteria failure

Do not approve Pluvicto if the initial criteria are not met — examples include age <18, no baseline CT/bone scan within prior 2 months, no prior androgen‑receptor pathway inhibitor, no prior taxane chemotherapy, absence of a PSMA‑positive lesion (uptake greater than liver), or presence of PSMA‑negative lesions exceeding size criteria.

• Age <18 years — not approved
• No baseline CT/bone scan of chest/abdomen/pelvis within prior 2 months showing a visible lesion
• No prior androgen‑receptor pathway inhibitor treatment
• No prior taxane-based chemotherapy for mCRPC (≥2 cycles)
• No PSMA-positive lesion with uptake > normal liver within past 3 months
• PSMA‑negative lesions exceeding size criteria (visceral ≥1 cm; lymph node ≥2.5 cm; bone ≥1 cm)

Denial risk for unsupported codes

Lack of documentation that the requested HCPCS/CPT code(s) meet the applicable policy statements (e.g., for A9513 or A9607) may result in claim or authorization denial; verify policy criteria and pre-authorization requirements before billing.

• Failure to meet applicable policy statements for A9513 or A9607 may trigger denial
• Verify criteria and pre-authorization requirements prior to submission