CurrentBlue Cross Blue Shield - South DakotaPolicy N/A

Pluvicto (Lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive mCRPC - Coverage Criteria

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Policy governs medical necessity and coverage for therapeutic radiopharmaceutical Lu-177-PSMA-617 (Pluvicto) in adults with PSMA-positive metastatic castration-resistant prostate cancer, specifying clinical eligibility, dosing, monitoring, and discontinuation criteria for Blue Cross Blue Shield - South Dakota members.

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CurrentBlue Cross Blue Shield - South DakotaPolicy N/A

Pluvicto (Lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive mCRPC - Coverage Criteria

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Policy Summary

PayerBlue Cross Blue Shield - South Dakota

PolicyPluvicto (Lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive mCRPC - Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateMar 1, 2023

Last ReviewDec 1, 2025

Next Review DateN/A

Key ActionObtain and document PSMA-positive status by an approved PSMA PET radiotracer and prior AR-directed therapy with taxane exposure or documented rationale to delay taxane before seeking authorization for Lu-177-PSMA-617.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7.4 GBqrecommended dose per administration

up to 6maximum number of doses

15.3 vs 11.3mmedian OS (VISION)

8.7 vs 3.4mmedian rPFS (VISION)

52.7% vs 38.0%Grade ≥3 AEs (VISION)

A9607HCPCS therapeutic code

Coverage Criteria for Lu-177-PSMA-617 (Pluvicto)

inv-01: Medically Necessary Indications — Covered when ALL of the following are met

ALL of the following

The individual is an adult with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
Imaging documents one or more PSMA-positive metastatic lesion(s), or metastatic disease that is predominantly PSMA-positive with no dominant PSMA-negative metastatic lesions.
The individual has been treated with androgen receptor (AR) pathway inhibition AND a taxane-based chemotherapy; OR the individual has received AR pathway inhibition and is considered appropriate to delay taxane-based chemotherapy.

inv-03: Coverage criteria for Lu-177-PSMA-617 — Covered when ALL of the following are met

ALL of the following

Treatment is with lutetium Lu 177 vipivotide tetraxetan (Lu-177-PSMA-617; Pluvicto) administered per recommended dosing: 7.4 GBq (200 mCi) IV every ~6 weeks for up to 6 doses, with dose modifications per prescribing information.
PSMA-positive status has been documented using an approved PSMA PET radiotracer (e.g., Ga-68 PSMA-11, F-18 piflufolastat, or F-18 flotufolastat).
Treatment is delivered by or under the supervision of appropriately trained physicians authorized to handle radiopharmaceuticals.

inv-04: Coverage criteria for Lu-177-PSMA-617 — Covered when ALL of the following are met (evidence supports use in these populations):

ALL of the following

Use in taxane‑naive patients who are PSMA‑positive and who have progressed on prior AR pathway inhibition may be considered when supported by clinical trial evidence (e.g., PSMAfore).
Treatment decisions should consider trial inclusion/exclusion features (such as prior therapies and PSMA imaging methods) and the potential for crossover effects on survival analyses.

inv-05: Initial therapy eligibility — Covered when ALL of the following are met

ALL of the following

Baseline evaluation documents PSMA‑positive disease as defined above and excludes predominant PSMA‑negative metastatic disease (PSMA‑negative lesions defined per NCCN: bone with soft tissue components >1.0 cm, lymph nodes >2.5 cm short axis, or solid organ metastases >1.0 cm).
Patient clinical status and prior treatment history align with populations studied in pivotal trials (e.g., prior ARPI ± taxane as specified) or with guideline recommendations (ASCO, NCCN).
Prescriber will follow dosing, hydration, monitoring, and toxicity management guidance consistent with the product labeling, including dose reduction to 5.9 GBq (160 mCi) once if required and permanent discontinuation criteria for specified toxicities.

Investigational: Therapeutic radiopharmaceuticals for prostate cancer using Lu-177-PSMA-617 (Pluvicto) is considered investigational and not covered when the coverage criteria above are not met. This includes, but is not limited to: PSMA‑negative or predominantly PSMA‑negative disease; missing documented PSMA‑positive status by an appropriate PSMA PET radiotracer; use as first‑line therapy outside of clinical trials in populations not represented in supportive randomized data; or when prior therapy requirements (as specified in the medically necessary criteria) have not been satisfied. Evidence does not support routine use of PSMA PET for response assessment; PSMA PET is currently recommended to determine eligibility for Lu-177-PSMA-617 rather than routine response monitoring per ASCO guidance.

VISION trial context: In the VISION randomized trial, comparators excluded concurrent chemotherapy or radium‑223; standard‑of‑care (SOC) therapies were investigator‑determined and non‑standardized across sites. The trial required PSMA‑positive status by Ga‑68 PSMA‑11 imaging and disallowed patients with dominant PSMA‑negative lesions. When applying trial results to coverage decisions, concurrent administration of prohibited therapies (eg, cytotoxic chemotherapy during Lu‑177‑PSMA-617) should be avoided unless supported by clinical justification or trial protocols.

Requirement for documented PSMA‑positive status: Eligible patients must have documentation of PSMA‑positive disease using an accepted PSMA PET radiotracer (Ga‑68 PSMA‑11, F‑18 piflufolastat, or F‑18 flotufolastat). Patients with PSMA‑negative or predominantly PSMA‑negative disease are excluded from coverage. Patients with discordant FDG‑avid/PSMA‑negative lesions (as evaluated in some trials) may be inappropriate candidates for therapy outside of clinical trials.

PSMA‑negative or predominantly PSMA‑negative disease: Lu-177-PSMA-617 is not covered for individuals whose disease is PSMA‑negative or predominantly PSMA‑negative, given lack of evidence of benefit in these populations and exclusion from pivotal trials.

Investigational when prerequisites not met: Use of Lu-177-PSMA-617 is investigational if essential prerequisites are missing (eg, absent documented PSMA‑positivity, absence of required prior therapies when applicable, or use in unstudied populations). Coverage may be considered within approved indications or within clinical trials for other populations.

Use in populations without demonstrated PSMA‑positivity or as first‑line therapy outside of trials: The evidence base is limited for treating patients without documented PSMA expression or for routine first‑line use outside of clinical studies; such uses are considered investigational.

Not covered for PSMA‑negative or unrepresented populations: Lu-177-PSMA-617 is not covered for patients with PSMA‑negative disease or for populations not represented in the evidence base (eg, certain PSMA‑discordant or FDG‑positive/PSMA‑negative patients) outside of a clinical trial.

PSMA PET for response assessment: Per ASCO guidance, PSMA PET is not currently recommended for routine response assessment; its use is limited to identifying PSMA‑expressing tumors for patient selection.

Dosing regimen summary
No results

Coding and Billing Codes

Codes table referencedmixed

No codes listed

Coding references in excerptmixed

not specified

No explicit CPT/HCPCS/ICD-10 codes provided in this document excerpt

Therapeutic HCPCSHCPCSCovered

A9607

Lutetium lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie.

inv-17: Dose interval and maximum doses

Recommended dose and interval7.4 GBq (200 mCi) administered every 6 weeks

Maximum doses per treatment courseUp to 6 doses (cycles)

Dose reduction optionSingle 20% dose reduction to 5.9 GBq (160 mCi) permitted; dose should not be re‑escalated

inv-18: Maximum treatment cycles

Maximum treatment cyclesUp to 6 cycles

Trial administration intervalAdministered approximately every 6 weeks in pivotal trials (VISION, TheraP)

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization (prior approval) is required for Lu-177-PSMA-617 (Pluvicto) for treatment of adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Authorization must confirm medical necessity per policy criteria before treatment is initiated.

Prior authorization is required for FDA-indicated use (Lu-177-PSMA-617) for adults with PSMA-positive mCRPC who meet medical necessity criteria.
Expected billing HCPCS: A9607 (Lutetium lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie).

Prior Authorization

Prior Authorization — FDA-Indicated Use and Therapy Sequencing

Authorization requests must document that the patient has PSMA-positive mCRPC and has received prior androgen receptor pathway inhibition (ARPI). For patients treated per the original FDA label, prior taxane-based chemotherapy is required; for patients meeting updated FDA/NCCN guidance, documentation that the patient is appropriate to delay taxane chemotherapy (with clinical rationale) is acceptable.

Confirm prior treatment with AR-directed therapy (ARPI) is documented.

Line of Therapy and Sequencing

second-line | later

Second‑line or later use: Lu‑177‑PSMA‑617 may be used in patients who have progressed after androgen receptor pathway inhibition and taxane‑based chemotherapy (post‑taxane mCRPC), consistent with pivotal RCT evidence demonstrating improved OS and rPFS (eg, VISION)

chunks 4,35

second-line | alternative to chemotherapy

Alternative to chemotherapy: Lu‑177‑PSMA‑617 was evaluated as an alternative to cabazitaxel in the TheraP trial and may be considered in later‑line settings where chemotherapy is an alternative; prior AR pathway inhibitor exposure requirements differ by trial

chunks 36,35

first-line | second-line | salvage

PSMA Biomarker Requirements and Definitions

inv-50: PSMA — key definition and context for PSMA biomarker

Biomarker identityProstate-specific membrane antigen (PSMA) is a transmembrane glutamate carboxypeptidase highly expressed on prostate cancer cells

Clinical rolePSMA expression identifies tumors amenable to PSMA-targeted radioligand therapy such as Lu-177-PSMA-617

Imaging for detectionPatients should be selected using PSMA-targeted PET imaging (e.g., Ga-68 PSMA-11 or approved alternatives)

inv-51: PSMA (prostate-specific membrane antigen) — demonstrated PSMA-positivity on PSMA-targeted PET imaging (e.g., gallium Ga 68 gozetotide or PSMA11)

Definition of PSMA-positivityDemonstrated PSMA-positivity on PSMA-targeted PET imaging (e.g., gallium Ga 68 gozetotide/PSMA-11)

Trial imaging standard

Definitions

inv-37: PSMA-positive mCRPC — definition of metastatic castration-resistant prostate cancer with PSMA expression

DefinitionMetastatic castration-resistant prostate cancer (mCRPC) with PSMA expression on metastatic lesions despite ongoing androgen-deprivation therapy

Clinical significancePSMA-positive mCRPC is the population targeted by PSMA-directed radioligand therapy such as Lu-177-PSMA-617

Selection methodPSMA expression should be demonstrated by PSMA-targeted PET imaging prior to therapy

inv-38: Grade 3 or higher adverse event — definition per Common Terminology Criteria for Adverse Events

Grade 3+ definitionSevere or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling (CTCAE v4.03)

Grade 2 vs 3 distinction

Background and Evidence Summary

Lu-177-PSMA-617 is a PSMA‑targeted radioligand therapeutic composed of a PSMA‑binding ligand conjugated to radioactive lutetium‑177 that delivers targeted beta radiation to PSMA‑expressing prostate cancer cells. It is indicated for adults with PSMA‑positive metastatic castration‑resistant prostate cancer and has been studied in randomized trials demonstrating improvements in radiographic progression‑free survival and, in VISION, overall survival in selected, PSMA‑positive populations.

Policy Summary

PayerBlue Cross Blue Shield - South Dakota

PolicyPluvicto (Lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive mCRPC - Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateMar 1, 2023

Last ReviewDec 1, 2025

Next Review DateN/A

SourceLink

On This Page

Safety data for >4 cyclesNo additional safety concerns reported for patients receiving more than 4 cycles (VISION follow-up)

inv-19: Size criteria for PSMA-negative lesions (used for eligibility exclusions)

Bone metastases with soft tissue component> 1.0 cm

Lymph node metastases (short axis)> 2.5 cm

Solid organ metastases> 1.0 cm

If taxane chemotherapy was given, document regimen and dates; if taxane is delayed, include clinical justification for delaying taxane-based chemotherapy (e.g., patient preference, contraindication, comorbidity).

For FDA label cohort: ARPI plus taxane-based chemotherapy required. For updated indication: ARPI plus clinical justification to delay taxane is acceptable.

Documentation Required

Confirm PSMA Positivity and Imaging Requirements

Authorization must confirm PSMA positivity using an approved PSMA PET radiotracer and absence of dominant PSMA-negative metastatic lesions. PSMA PET imaging must be available in the chart and used to support eligibility.

Acceptable radiotracers per trials and guidelines include Ga-68 PSMA-11, F-18 piflufolastat, or F-18 flotufolastat (ASCO/NCCN guidance supports these agents).
PSMA-positive disease defined as one or more PSMA-avid metastatic lesions or predominantly PSMA-positive metastatic disease without dominant PSMA-negative lesions.
If PSMA PET was not performed with an approved radiotracer, authorization may be denied.

Documentation Required

Required Documentation for Authorization

Authorization requests must include the following clinical documentation to support medical necessity; missing documentation is a common denial trigger.

Baseline PSMA PET report and images (e.g., Ga-68 PSMA-11, or an accepted F-18 tracer) demonstrating PSMA-positive disease and noting any PSMA-negative or discordant lesions.
Documentation of prior systemic therapies: ADT history, ARPI (agent names and dates), and taxane-based chemotherapy history or documentation justifying delay of taxane.
Clinical notes describing extent of disease and confirmation that there are no dominant PSMA-negative metastatic lesions (definitions per NCCN: bone lesions with soft tissue >1.0 cm, lymph nodes >2.5 cm short axis, solid organ metastases >1.0 cm).
Provider attestation that therapy will be administered by qualified clinicians experienced in radiopharmaceuticals, and planned Lu-177-PSMA-617 dosing schedule (7.4 GBq every 6 weeks, up to 6 doses) if applicable.

Denial Risk

Denial Triggers and Risk

Denial risk is elevated when PSMA-positive status is not documented, when dominant PSMA-negative lesions are present, or when prior therapy requirements are unmet or undocumented.

Denials likely if PSMA PET is absent, performed with an unapproved tracer without justification, or does not demonstrate PSMA-avid disease.
Denials likely if dominant PSMA-negative metastatic lesions are present (see NCCN size-based definition) or if prior ARPI and taxane (or documented rationale to delay taxane) are not shown.
Denials may occur if concurrent prohibited therapies (per trials/guidance) are planned; include notes on intended concurrent systemic therapy.

Note

Consideration of Alternative Therapies and Sequencing

Consideration of alternative systemic therapies and sequencing should be documented when applicable. The TheraP and PSMAfore trials and ASCO/NCCN guidance inform sequencing choices between Lu-177-PSMA-617, cabazitaxel, and changes in AR-directed therapy.

If cabazitaxel (or other chemotherapy) is an alternative, document prior exposure to cabazitaxel and clinical rationale for selecting Lu-177-PSMA-617 instead (e.g., expected benefit, toxicity concerns).
If choosing Lu-177-PSMA-617 over a change in ARPI, document the rationale referencing trial evidence (PSMAfore, TheraP) and patient-specific factors.
When delaying taxane chemotherapy, include explicit clinical justification and planned monitoring or trigger points for reconsideration of chemotherapy.

Billing Rule

Billing/Coding and Administration Notes

Billing and operational notes: include expected HCPCS code(s) and treatment administration details to support claims processing.

HCPCS A9607 — Lutetium lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie (report per millicurie administered).
Specify place of service (inpatient vs outpatient) and planned number of cycles (up to 6 doses at 7.4 GBq every 6 weeks) in the authorization request.

Line of therapy considerations:

Evidence supports use in (1) patients previously treated with AR pathway inhibitors and taxane chemotherapy (post‑taxane) and (2) patients previously treated with AR pathway inhibition who are taxane‑naive and appropriate to delay taxane therapy (trials include PSMAfore and RESIST‑PC contexts)

second-line or later

Second‑line or later consistency with guidelines: Use in second‑line or later settings is aligned with FDA indication and guideline recommendations: indicated for adults with PSMA‑positive mCRPC after AR pathway inhibition and taxane chemotherapy, with the 2025 update permitting use when delaying taxane is appropriate; ASCO and NCCN provide concordant recommendations for post‑taxane patients

chunks 21,55,35

VISION determined PSMA-positive status using gallium-68-labeled PSMA-11 PET/CT

Guideline-accepted tracersGuidelines note Ga-68 PSMA-11 and certain F-18 tracers (e.g., piflufolastat, flotufolastat) as acceptable for eligibility assessment

inv-52: PSMA — PSMA-positive on PSMA PET as defined in trials; Ga-68 or F-18 tracers accepted by guideline discussion

PSMA PET positivity per trialsPSMA-positive on PSMA PET as defined in pivotal trials (e.g., Ga-68 PSMA-11 used in VISION)

F-18 tracer acceptanceASCO and NCCN note that select F-18 tracers (piflufolastat, flotufolastat) are acceptable alternatives to Ga-68 PSMA-11 for determining eligibility

Selection requirementPSMA PET imaging should demonstrate uptake consistent with PSMA expression sufficient to target radioligand therapy

inv-53: PSMA — PSMA-positive disease without dominant PSMA-negative metastatic lesions (size criteria as defined)

Eligibility requirementPSMA-positive disease without dominant PSMA-negative metastatic lesions as defined by size criteria

Source of size definitionsNCCN defines PSMA-negative lesions as bone with soft tissue >1.0 cm, lymph nodes >2.5 cm short axis, or solid organ metastases >1.0 cm

Implication for coveragePredominantly PSMA-positive metastatic disease with no dominant PSMA-negative lesions is required for treatment eligibility per guidelines and trials

Grade 2: moderate; limiting instrumental activities of daily living; Grade 3: limits self-care activities of daily living

Highest gradesGrade 4: life-threatening; Grade 5: death related to adverse event

inv-39: Castration-Resistant Prostate Cancer (CRPC) — definition

DefinitionProstate cancer that progresses while the individual is on androgen-deprivation therapy (ADT)

Management implicationContinued ADT is generally used in conjunction with other treatments after progression

Therapeutic optionsOptions include AR pathway inhibitors, taxane chemotherapy, and other agents depending on clinical context

inv-40: PSMA-positive — definition for imaging-based PSMA expression sufficient for targeting

Imaging-based definitionTumors demonstrating uptake on PSMA-targeted PET imaging consistent with PSMA expression sufficient to target PSMA-directed radioligand therapy

Use for eligibilityPSMA-positive status on PET is required to select patients for Lu-177-PSMA-617 per trials and guidelines

Common tracersGa-68 PSMA-11 commonly used in trials; guideline-accepted F-18 tracers are also noted

inv-41: Lu-177-PSMA-617 — drug definition (lutetium-177 conjugated PSMA ligand)

Drug identityLutetium Lu 177 vipivotide tetraxetan (Lu-177-PSMA-617; Pluvicto) — a PSMA-targeting ligand (PSMA617) conjugated to radioactive lutetium-177

MechanismBinds PSMA on cancer cells and delivers beta radiation from lutetium-177 to induce DNA damage and cell death

Administration settingRadiopharmaceutical to be administered by qualified physicians experienced in radiopharmaceutical handling

inv-42: PSA response — ≥50% reduction from baseline PSA

PSA response definitionA reduction of ≥50% from baseline PSA

Use in trialsPrimary endpoint in TheraP (PSA response achieved in 66% with Lu-177-PSMA-617 vs 37% with cabazitaxel)

Clinical relevanceUsed as a marker of biochemical response in RCTs evaluating Lu-177-PSMA-617

inv-43: PSA PFS — definition used in trials (≥25% increase and ≥2 ng/mL after 12 weeks)

PSA PFS definitionInterval from randomization to first evidence of PSA progression, defined by an increase of ≥25% and ≥2 ng/mL after 12 weeks

Trial usePSA PFS was used as an outcome in TheraP and other RCT analyses

Measurement timingRequires at least 12 weeks post-randomization to define progression per trials

inv-44: rPFS — radiographic progression-free survival definition

rPFS definitionRadiographic progression-free survival as defined in trials; time to radiographic progression per trial protocols (VISION/other RCTs)

Trial specificsrPFS in VISION was an alternate primary outcome (added Jan 2019) analyzed for patients randomized on or after March 5, 2019

Clinical importancerPFS improvements were observed in VISION (8.7 vs 3.4 months)

inv-45: PSMA-negative lesions — size-based definition used to identify dominant PSMA-negative disease

Definition of PSMA-negative lesionsMetastatic disease that lacks PSMA uptake; includes bone lesions with soft tissue components >1.0 cm, lymph nodes >2.5 cm short axis, and solid organ metastases >1.0 cm

Use for exclusionsPresence of dominant PSMA-negative lesions as defined may render patient ineligible for Lu-177-PSMA-617 based on NCCN guidance and trial criteria

Documentation implicationPSMA PET imaging should be reviewed to identify discordant or dominant PSMA-negative disease prior to treatment