ModifiedmhnPolicy CP.PHAR.582

Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)

Medical necessity and prior authorization criteria for use of Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in adult patients with PSMA-positive metastatic castration‑resistant prostate cancer across commercial and Medicaid lines of business.

Policy Summary

Payermhn

PolicyLutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)

Policy CodePolicy CP.PHAR.582

Change TypeMaterial updates to indications, diagnostics, dosing limits, and coding

Effective DateJun 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation of metastatic CRPC, PSMA-positive PET/CT, prior AR pathway inhibition and required prior therapies or justification to delay taxane chemotherapy.

SourceLink

POLICY UPDATE CHANGES

FDA indication language updated to include patients considered appropriate to delay taxane-based chemotherapy.

Continued therapy approval duration revised from 12 to 6 months and approval limited to up to a total of 6 doses.

Expanded list of diagnostic PSMA PET agents to include F-18 piflufolastat and F-18 flotufolastat.

Added HCPCS code A9607 and removed inactive HCPCS code A9699.

Expanded list of androgen receptor pathway inhibitors to include Erleada and Nubeqa for prior therapy qualification.

7.4 GBqrecommended dose every 6 weeks

Up to 6maximum number of infusions authorized

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minimum patient age for coverage

A9607drug billing code (per mCi)

Coverage Criteria for Pluvicto (Lutetium Lu 177 vipivotide tetraxetan)

Initial Therapy

Covered when ALL of the following are met

Initial Approval for mCRPC: Initial Approval Criteria for Metastatic Castration‑Resistant Prostate Cancer (must meet all): (1) Diagnosis of metastatic CRPC; (2) Documentation of disease progression despite bilateral orchiectomy or other androgen deprivation therapy (ADT); (3) PSMA‑positive disease confirmed on a Ga‑68‑PSMA‑11, F‑18 piflufolastat, or F‑18 flotufolastat PET/CT; (4) Prescribed by or in consultation with an oncologist or urologist; (5) Age ≥ 18 years; (6) Member will use a gonadotropin‑releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy; (7) Failure of both: (a) a taxane‑based regimen (e.g., docetaxel, cabazitaxel), unless member is considered appropriate to delay taxane‑based chemotherapy; and (b) abiraterone, unless clinically significant adverse effects are experienced or all are contraindicated (examples of AR pathway inhibitors include enzalutamide, apalutamide, darolutamide, and others); (8) Not prescribed concurrently with cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy; (9) Member has not received ≥ 6 doses (infusions) of Pluvicto; (10) Request meets one of: (a) dose does not exceed 7.4 GBq (200 mCi) IV every 6 weeks for up to 6 doses; or (b) dose is supported by practice guidelines or peer‑reviewed literature for relevant off‑label use (prescriber must submit supporting evidence).up to 6 doses

Approval duration: 6 months (up to a total of 6 doses)

Continuation Therapy

Covered when ALL of the following are met

Continued Therapy for mCRPC: Continued Therapy Criteria (must meet all): (1) Currently receiving medication via Centene benefit, or documentation supports member has received Pluvicto for a covered indication for at least 30 days; (2) Member is responding positively to therapy; (3) Member continues to use a GnRH analog concurrently or has had a bilateral orchiectomy; (4) Member has not received ≥ 6 doses (infusions) of Pluvicto; (5) If request is for a dose increase, new dose must either (a) not exceed 7.4 GBq (200 mCi) IV every 6 weeks for up to 6 doses, or (b) be supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).up to 6 doses

Approval duration: 6 months (up to a total of 6 doses)

Coverage — Initial and continuation therapy criteria

Covered when ALL of the following are met (summary from document updates and approvals):

Pluvicto coverage core criteria: Member has documented PSMA‑positive disease by an approved PSMA PET agent (examples include Ga‑68‑PSMA‑11, F‑18 piflufolastat, or F‑18 flotufolastat); member meets the FDA‑approved indication (treated with AR pathway inhibition and either have received prior taxane‑based chemotherapy or are considered appropriate to delay taxane‑based chemotherapy per updated prescribing information); prior therapy requirements are satisfied (examples of AR pathway inhibitors include enzalutamide, apalutamide/Erleada, darolutamide/Nubeqa, abiraterone as applicable); total planned/received doses do not exceed 6; for continuation, member has not received ≥ 6 doses and either continues concurrent GnRH analog therapy or has had bilateral orchiectomy.

This node summarizes policy updates and continuation limits.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for ICHRA/marketplace, or CP.PMN.53 for Medicaid) or the member’s evidence of coverage explicitly allows the requested use.

The inclusion or exclusion of specific procedure or billing codes in this policy is for information only and does not guarantee coverage. Providers must follow the member’s benefit documents, state and federal requirements, and current professional coding guidance when submitting claims.

Requests for Pluvicto that would result in a total of more than 6 doses are not authorized. Pluvicto must not be prescribed concurrently with cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy; concurrent use in those settings is not permitted under this policy.

Coverage determinations are subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents and applicable law. This clinical policy is a guide to medical necessity but does not guarantee payment; providers remain responsible for confirming eligibility, benefits, and any plan‑level requirements prior to delivering or billing for services.

Coding and Billing Information

Referenced HCPCS CodesHCPCS

A9607

Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie

Covered HCPCS CodesHCPCSCovered

A9607

Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie

Removed/Inactive HCPCSHCPCS

A9699

Noted as inactive HCPCS code removed from policy

inv-11: Dose per administration

Recommended dose per administration7.4 GBq (200 mCi) IV every 6 weeks

Allowed dosing intervalEvery 6 weeks

Dose unitGigabecquerel (GBq) and millicurie (mCi)

Maximum per-administration statementDose does not exceed 7.4 GBq (200 mCi) every 6 weeks unless supported by guidelines or peer‑reviewed literature (prescriber must submit supporting evidence)

inv-12: Maximum total doses

Policy maximum total dosesUp to a total of 6 doses (member has not received ≥ 6 doses)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Pluvicto (lutetium Lu 177 vipivotide tetraxetan). Requests must document metastatic castration‑resistant prostate cancer (mCRPC), confirmation of PSMA‑positive disease by an approved PET/CT agent, and that the member meets prior therapy requirements or has a clinical justification for bypassing them. Dosing limits apply: members must not have received ≥ 6 total doses (infusions); dosing should not exceed 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses unless an alternative dose is supported by practice guidelines or peer‑reviewed literature (supporting evidence must be submitted). Approval duration: up to 6 months (up to a total of 6 doses).

Prior authorization required for Pluvicto (A9607).
Dose limit: ≤ 7.4 GBq (200 mCi) every 6 weeks, up to 6 doses (total).
Member must not have received ≥ 6 doses (infusions) of Pluvicto.

Documentation Required

Pluvicto — Required Clinical Documentation

Background and Drug Information

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate‑specific membrane antigen (PSMA)-targeted radioligand therapeutic approved for adults with PSMA‑positive metastatic castration‑resistant prostate cancer. The FDA‑approved dosing regimen is 7.4 GBq (200 mCi) IV every 6 weeks for up to 6 doses. Use requires confirmation of PSMA‑positive disease by an approved PET agent and adherence to prior therapy and concurrent androgen‑deprivation requirements as specified in the policy.

Definitions

inv-22: CRPC

DefinitionCastration‑resistant prostate cancer (CRPC) — prostate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone (< 50 ng/dL)

Clinical contextProgression despite bilateral orchiectomy or other androgen deprivation therapy (ADT) required for documentation

ADT guidancePer NCCN, ADT should be continued in patients with metastatic CRPC while additional therapies are applied

inv-23: PSMA‑positive

Definition of PSMA‑positivePSMA‑positive disease confirmed on a Ga‑68‑PSMA‑11, F‑18 piflufolastat, or F‑18 flotufolastat PET/CT

Acceptable PET agents (examples)Ga‑68 PSMA‑11; F‑18 piflufolastat (piflufolastat F‑18); F‑18 flotufolastat

Line of Therapy Specification

second-line | later

Line of therapy: Patients must have been treated with androgen receptor (AR) pathway inhibition and either have received prior taxane‑based chemotherapy or are considered appropriate to delay taxane‑based chemotherapy per updated FDA indication.

second-line

Line of therapy context: Policy updated to permit use in patients where delaying taxane‑based chemotherapy is considered appropriate per updated prescribing information; prior therapy with AR pathway inhibitors or taxane may be required depending on indication and clinical judgment.

Biomarker and Imaging Requirements

inv-27: PSMA

PSMA positivity criteriaPSMA‑positive on Ga‑68‑PSMA‑11, F‑18 piflufolastat, or F‑18 flotufolastat PET/CT

Required before therapyDocumentation of PSMA‑positive disease on an approved PSMA PET scan is required prior to initiation

Examples of approved agentsGa‑68 PSMA‑11; F‑18 piflufolastat; F‑18 flotufolastat

inv-28: PSMA

Positive PSMA PET imagingPositive PSMA PET imaging by an approved agent (e.g., piflufolastat F‑18, F‑18 flotufolastat)

DocumentationEvidence of PSMA positivity by an approved PET agent must be provided with prior authorization

Covered Regimens and Authorized Use

Indication	Regimen	Coverage Status
Metastatic castration‑resistant prostate cancer (mCRPC)	7.4 GBq (200 mCi) IV every 6 weeks for up to 6 doses	Covered when policy criteria met (dose limit and total doses ≤ 6)

Agent	Regimen / Limits	Continuation Requirements	Coverage Status
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)	Up to 6 doses (dose not to exceed 7.4 GBq [200 mCi] IV every 6 weeks unless supported by guidelines/literature)	Continuation contingent on meeting criteria including documentation of response, member has not received ≥ 6 doses, and concurrent GnRH analog use or prior bilateral orchiectomy	Covered when policy criteria met

Policy Summary

Payermhn

PolicyLutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)

Policy CodePolicy CP.PHAR.582

Change TypeMaterial updates to indications, diagnostics, dosing limits, and coding

Effective DateJun 1, 2022

Next Review Date

SourceLink

On This Page

Approval duration related to total dosesApproval duration: 6 months (up to a total of 6 doses)

Requests exceeding limitRequests exceeding 6 doses are not authorized

Specific documentation for Pluvicto requests must include: diagnosis of metastatic CRPC, evidence of disease progression on ADT (or prior bilateral orchiectomy), PSMA‑positive imaging (Ga‑68‑PSMA‑11, F‑18 piflufolastat, or F‑18 flotufolastat PET/CT), prescriber specialty (oncologist or urologist), age ≥ 18, concurrent use of a GnRH analog or history of bilateral orchiectomy, and prior therapy history (see step therapy callout). If an off‑label dosing regimen is requested, submit peer‑reviewed literature or guideline support.

PSMA‑positive disease confirmation required (Ga‑68‑PSMA‑11, F‑18 piflufolastat, or F‑18 flotufolastat).
Prescriber must be or consult with an oncologist or urologist.
Clinical documentation: office notes, labs, and imaging to support criteria.

Denial Risk

Documentation Insufficiency / Non‑Covered Indications

Requests that lack sufficient documentation to demonstrate the member meets all approval criteria, or requests for non‑FDA indications without adequate off‑label evidence, may be denied. For non‑FDA uses, provide supporting evidence per the applicable off‑label use policies (commercial, HIM.PA.154 for HIX/ICHRA, or Medicaid) to be considered.

Insufficient clinical documentation (eg, missing PET/CT reports, prior therapy records) risks denial.
Non‑FDA indications require supporting evidence per off‑label use policies.

Step Therapy

Step Therapy / Prior Treatment

Prior therapy (step therapy) requirements: member must have failed a taxane‑based regimen (eg, docetaxel, cabazitaxel) and abiraterone unless these are contraindicated or the member experienced clinically significant adverse effects. Per updated prescribing information, bypassing taxane therapy is allowed when delaying taxane chemotherapy is considered appropriate; document the clinical rationale when taxane is not used. Examples of androgen receptor pathway inhibitors that may satisfy prior therapy include abiraterone (Zytiga, Yonsa), enzalutamide (Xtandi), apalutamide (Erleada), and darolutamide (Nubeqa).

Failure of a taxane‑based regimen required unless clinically appropriate to delay taxane (document rationale).
Failure of abiraterone (or alternative AR pathway inhibitors as listed) required unless contraindicated or prior intolerance.
Prior authorization may be required for listed prior therapies (eg, docetaxel, cabazitaxel, Zytiga, Xtandi, Erleada, Nubeqa).

Billing Rule

Coding and Provider Actions

Coding and claim submission: the HCPCS code A9607 (Lutetium Lu 177 vipivotide tetraxetan) is referenced for informational purposes. Inclusion of a code in this policy does not guarantee coverage; providers should reference up‑to‑date professional coding guidance prior to claim submission. Claims may be denied if coding guidance is not followed or if required prior authorization/documentation is not obtained.

HCPCS: A9607 — Lutetium Lu 177 vipivotide tetraxetan (informational).
Policy code inclusion does not guarantee payment — follow current coding guidance and obtain required prior authorization.

Documentation requirementDocumentation of PSMA‑positive disease on an approved PSMA PET scan is required prior to therapy

inv-24: PSMA confirmation

Acceptable agents for PSMA confirmationPiflufolastat F‑18 and F‑18 flotufolastat are acceptable to document PSMA‑positive disease

Policy update notePiflufolastat F‑18 was added as an approved diagnostic agent (2Q 2023); F‑18 flotufolastat added later (2Q 2024)

Use in prior authorizationConfirmation with an approved PSMA PET agent must be submitted as part of prior authorization documentation

Policy examples list piflufolastat F‑18 and F‑18 flotufolastat among acceptable agents