ModifiedmhnPolicy CP.PHAR.582

Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) for PSMA-positive mCRPC

Defines medical necessity, approval criteria, dosing limits, and prior authorization requirements for Pluvicto in adults with PSMA-positive metastatic castration-resistant prostate cancer for Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyLutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) for PSMA-positive mCRPC

Policy CodePolicy CP.PHAR.582

Change TypeAnnual review with material updates (2Q 2025: taxane-delay indication clarifiedprior updates added diagnostic agents and dosing clarifications)

Effective DateJun 1, 2022

Next Review Date

Key ActionObtain prior authorization and submit documentation confirming metastatic CRPC, PSMA-positive PET/CT, prior AR pathway therapy and taxane status, and dosing plan within policy limits.

SourceLink

POLICY UPDATE CHANGES

2Q 2025 annual review: revised FDA-approved indications to include use in those that are considered appropriate to delay taxane-based chemotherapy per updated prescribing information; updated criteria requiring use of taxane to allow bypass in those where delay may be appropriate.

2Q 2023 annual review: clarified approval duration is for up to a total of 6 doses; revised continued therapy approval duration from 12 to 6 months; added requirement that member has not received ≥ 6 doses of Pluvicto; added piflufolastat F-18 as an additional radioactive diagnostic agent for identification of PSMA-positive disease.

2Q 2024 annual review: added F-18 flotufolastat as an additional option to confirm PSMA-positive disease; references reviewed and updated.

Up to 6max doses

7.4 GBqmax dose/admin

≥18

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Coverage Criteria for Pluvicto (Lutetium Lu 177 vipivotide tetraxetan)

inv-01: Initial Therapy - Metastatic Castration-Resistant Prostate Cancer

Covered when ALL of the following are met

Initial Approval - Metastatic CRPC: 1. Diagnosis of metastatic castration-resistant prostate cancer (mCRPC). 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. Patient age ≥ 18 years. 6. Concurrent use of a gonadotropin-releasing hormone (GnRH) analog or prior bilateral orchiectomy. 7. Failure of BOTH of the following unless contraindicated or intolerant: (a) a taxane-based regimen (e.g., docetaxel, cabazitaxel) — unless the member is considered appropriate to delay taxane-based chemotherapy; AND (b) abiraterone (unless the member previously failed Yonsa or enzalutamide). 8. Not prescribed concurrently with cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. 9. Request meets ONE of the following dosing conditions: (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 the relevant off-label use with prescriber-submitted supporting evidence. 10. Prescribed regimen must be FDA-approved or recommended by NCCN.dose ≤ 7.4 GBq q6w; ≤ 6 doses

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

inv-02: Continuation Therapy

Covered when ALL of the following are met for continuation/renewal

Continuation Therapy - Metastatic CRPC: 1. Member is currently receiving Pluvicto via the Centene benefit or has documentation of receiving Pluvicto for a covered indication for at least 30 days. 2. Member is responding positively to therapy. 3. Member has not received ≥ 6 doses (infusions) of Pluvicto. 4. If request is for a dose increase, ONE of the following must be met: (a) the new dose does not exceed 7.4 GBq (200 mCi) IV every 6 weeks for up to 6 doses; OR (b) the new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use with submitted supporting evidence. 5. Prescribed regimen must be FDA-approved or recommended by NCCN.

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

inv-03: Coverage criteria (high-level extract)

Covered when criteria in the main policy are met (see full policy); recent revisions clarify dose limits and options to delay taxane chemotherapy

Dose and therapy limits: Approval duration clarified for up to a total of 6 doses; continued therapy approval duration revised from 12 to 6 months; continued therapy requires member has not received ≥ 6 doses of Pluvicto.≤6 doses

From 2Q 2023 annual review and retained in subsequent reviews

Diagnostic confirmation: PSMA-positive disease may be confirmed using F-18 piflufolastat or F-18 flotufolastat (in addition to Ga-68-PSMA-11) as acceptable radioactive diagnostic agents.

Added in 2Q 2023 and 2Q 2024 reviews

Taxane chemotherapy requirement: FDA-approved indications revised to allow use in patients considered appropriate to delay taxane-based chemotherapy; criteria updated to allow bypassing prior taxane use where delay is appropriate.

2Q 2025 annual review

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 in accordance with applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for Marketplace, CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents.

The presence or absence of a code in this clinical policy is for informational purposes only and does not guarantee coverage. Providers must reference current professional coding guidance and the member’s plan documents to determine coverage and reimbursement.

Requests for Pluvicto that are for non‑FDA‑approved diagnoses or indications not covered by this policy will be denied unless the requestor provides sufficient off‑label evidence of efficacy and safety consistent with the applicable off‑label use policies. Additionally, dose or regimen deviations for off‑label use must be supported by practice guidelines or peer‑reviewed literature with submitted supporting evidence.

Coding lists in this policy are informational; inclusion or exclusion of any procedure or supply codes does not guarantee coverage. Final medical necessity and coverage determinations are subject to the terms of the member’s benefit plan and applicable contract or evidence of coverage documents.

Covered Regimens and Administration

Regimen	Notes
7.4 GBq (200 mCi) IV every 6 weeks for up to 6 doses
Alternative dosing supported if dose is supported by practice guidelines or peer‑reviewed literature with submitted supporting evidence; approval duration: 6 months (up to a total of 6 doses)

HCPCS / Drug	Administration limits
A9607 Lutetium Lu 177 vipivotide tetraxetan
Administered per policy dosing: dose does not exceed 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses (approval duration: 6 months; total ≤ 6 doses)

Coding and Billing

Coding referencesmixed

Not listed in this section of document

No explicit CPT/HCPCS/ICD-10/NDC codes provided in these chunks.

HCPCS CodesHCPCSCovered

A9607

Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie

inv-10: Maximum dose per administration

Maximum dose per administration7.4 GBq (200 mCi)

Dose routeIntravenous (IV)

Indication contextMetastatic castration-resistant prostate cancer dosing regimen

inv-11: Dosing interval

Dosing intervalEvery 6 weeks

Typical scheduleAdministered q6w between doses

Maximum administrations per interval guidance

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must follow plan-specific prior authorization processes and submit clinical documentation to support that the member meets all approval criteria.

Prior authorization required prior to initiation of Pluvicto.
Follow the payer’s prior authorization submission process; referencing HCPCS A9607 on the request/claim may be required or helpful.

Documentation Required

Documentation Required to Support Approval

Providers must submit supporting clinical documentation (for example: office chart notes, relevant lab results, imaging reports including PSMA-positive PET/CT, pathology reports, and prior therapy records) demonstrating the member meets all approval criteria.

Failure to submit required documentation may result in denial of the request.
Documentation should clearly show diagnosis, evidence of PSMA-positive disease, prior therapies tried and responses or contraindications, and rationale if taxane chemotherapy is being delayed or bypassed.

Line of Therapy and Prior Treatment Requirements

inv-26: second-line

Line of therapy: Indicated for patients who have been treated with AR pathway inhibition and either are appropriate to delay taxane-based chemotherapy (prior taxane not required) OR have received prior taxane-based chemotherapy.

Captures both post-AR-inhibition patients delaying taxane and those post-taxane.

inv-27: second-line

Line of therapy (updated): Revised FDA-approved indications include use in patients who are appropriate to delay taxane-based chemotherapy; allows bypassing prior taxane requirement where delay is appropriate.

2Q 2025 update

Biomarker and Imaging Requirements

inv-28: PSMA

Required diagnostic confirmationPSMA-positive on Ga-68-PSMA-11 PET/CT

Alternative PET agentsF-18 piflufolastat PET/CT

Additional option addedF-18 flotufolastat PET/CT (added in 2Q 2024)

inv-29: PSMA expression

PSMA requirementDocumentation of PSMA-positive disease confirmed on Ga-68-PSMA-11, F-18 piflufolastat, or F-18 flotufolastat PET/CT

PurposeConfirmation of PSMA expression required prior to Pluvicto administration

Policy history

Definitions and Terminology

inv-23: Castration-resistant prostate cancer (CRPC)

Definition of CRPCProstate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone (< 50 ng/dL)

Clinical evidence of progressionProgression despite bilateral orchiectomy or other ADT documented in policy initial approval criteria

ContextRequired diagnosis for Pluvicto coverage in metastatic disease

inv-24: ADT (androgen deprivation therapy)

Definition of ADTTherapies that lower or block androgens, including bilateral orchiectomy, LHRH agonists/antagonists, and anti-androgens

Examples of ADTBilateral orchiectomy; LHRH agonists (goserelin, leuprolide, triptorelin); anti-androgens (bicalutamide, flutamide, nilutamide, enzalutamide, apalutamide, darolutamide); LHRH antagonists (degarelix, relugolix)

Background

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a PSMA‑targeted radioligand therapy indicated for adult patients with PSMA‑positive metastatic castration‑resistant prostate cancer who have had androgen receptor pathway inhibition and either are appropriate to delay taxane‑based chemotherapy or have received prior taxane‑based chemotherapy. Androgen deprivation therapy should be continued during treatment. The policy specifies dosing of 7.4 GBq (200 mCi) IV every 6 weeks for up to 6 doses or alternative dosing supported by guidelines or peer‑reviewed literature with submitted evidence.

Revision History and Policy Changes

2022-09-09code addition

HCPCS code A9607 (Lutetium Lu 177 vipivotide tetraxetan) was added to the policy coding section.

2023-01-06dose & diagnostic update

2Q 2023 annual review clarified approval duration as up to a total of 6 doses, revised continued therapy approval duration from 12 to 6 months, added requirement that member has not received ≥ 6 doses, and added piflufolastat F‑18 as an additional diagnostic option.

2024-01-10diagnostic option added