CurrentHealth NetPolicy CP PHAR.582

Clinical Policy: Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)

Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, exclusions, diagnostic requirements, and coding implications for Pluvicto for metastatic castration-resistant prostate cancer (mCRPC) across commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)

Policy CodePolicy CP PHAR.582

Change TypeAnnual review updates; coding and criteria clarifications

Effective DateJun 1, 2022

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, imaging) showing the member meets all approval criteria; prior authorization may be required for concomitant/previous agents.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code A9607.

Clarified approval duration is for up to a total of 6 doses and revised continued therapy approval duration from 12 to 6 months.

Added F-18 flotufolastat as an additional option to confirm PSMA-positive disease.

Revised FDA-approved indications to include use in those considered appropriate to delay taxane-based chemotherapy.

2Q 2025 annual review noted no significant changes; references reviewed and updated.

6Maximum doses authorized

7.4 GBqPer-dose maximum

18+

Coverage Summary

Policy CP PHAR.582: covered_with_criteria for Pluvicto (lutetium Lu 177 vipivotide tetraxetan). Scope summary: Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, exclusions, diagnostic requirements, and coding implications for Pluvicto for metastatic castration-resistant prostate cancer (mCRPC) across commercial, HIM, and Medicaid lines of business. Subject: Lutetium Lu 177 vipivotide tetraxetan (Pluvicto). Effective date: 06.01.22. Status: CURRENT.

Initial Therapy Criteria

Initial Approval Criteria

Pluvicto is medically necessary when ALL of the following criteria are met:

ALL of the following

Diagnosis of metastatic castration-resistant prostate cancer (mCRPC).
Documentation of disease progression despite bilateral orchiectomy or other androgen deprivation therapy (ADT).
See Appendix D for examples of ADT; ADT should be continued during therapy per NCCN guidance.
Prescribed by or in consultation with an oncologist or urologist.
PSMA imaging: Positive PSMA imaging using piflufolastat (F-18), F-18 flotufolastat, or other PSMA PET/CT (e.g., F-18 agents).
Policy lists piflufolastat and F-18 flotufolastat as acceptable diagnostic agents.
Age > 18 years.
Failure of both of the following unless contraindicated or intolerant (a AND b required unless clinically significant adverse effects or contraindications):
- a: Taxane-based chemotherapy (e.g., docetaxel, cabazitaxel) OR member is considered appropriate to delay taxane-based chemotherapy per updated prescribing information.
  Prior authorization may be required for docetaxel and cabazitaxel.
- b: Androgen receptor pathway inhibition with both of the following agents (unless contraindicated or intolerant): abiraterone (Zytiga or Yonsa) AND enzalutamide (Xtandi).
  Prior authorization may be required for Zytiga, Yonsa, and Xtandi.
ADT requirement: Member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy.
Concurrent therapy exclusions: Pluvicto is NOT prescribed concurrently with cytotoxic chemotherapy, immunotherapy, other radioligand therapy, or investigational therapy.
Dose limits: Dose does not exceed 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses.7.4 GBq (200 mCi) every 6 weeks; up to 6 doses
HCPCS A9607 denotes 1 millicurie unit for lutetium Lu 177 vipivotide tetraxetan.
Regimen support: Prescribed regimen must be FDA‑approved or recommended by NCCN; for off-label regimens, dose must be supported by practice guidelines or peer-reviewed literature with prescriber-submitted evidence.

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Continuation (Renewal) Therapy Criteria

Continued therapy is authorized when ALL of the following are met:

ALL of the following

Current receipt: Member is currently receiving Pluvicto via Centene benefit or documentation supports current receipt of Pluvicto for a covered indication and has received the medication for at least 30 days.≥ 30 days
Response: Member is responding positively to therapy.
Dose count limit: Member has not received 6 doses (infusions) of Pluvicto previously.< 6 total doses

Diagnoses / Indications Not Authorized

Diagnoses/Indications Not Authorized

Coverage not authorized for:

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per line-of-business off-label use policies (refer to CP.CPA.09, HIM.PA.154, CP.PMN.53 or other applicable off-label policies).

Operational exclusion in initial criteria: Pluvicto is NOT to be prescribed concurrently with cytotoxic chemotherapy, immunotherapy, other radioligand therapy, or investigational therapy. Requests that include concurrent administration with those modalities will not meet initial approval criteria and are subject to denial.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization and documentation

Provider must submit documentation (office chart notes, lab results, imaging) supporting that member meets all approval criteria. Prior authorization may be required for concomitant or prior agents including docetaxel, cabazitaxel, abiraterone, and enzalutamide.

Documentation Required

PSMA imaging confirmation

Provider must supply PSMA-positive imaging results demonstrating PSMA-positive disease using piflufolastat (F-18) or F-18 flotufolastat PET/CT.

Applicable Codes

HCPCS - Radiopharmaceutical unit measurementHCPCS

A9607

Lutetium Lu 177 vipivotide tetraxetan, 1 millicurie

Clinical Evidence & Guidelines

Primary evidence supporting the policy criteria includes: Pluvicto Prescribing Information, Novartis, March 2025 (prescribing information); NCCN Prostate Cancer Version 1.2025 (guideline); and the pivotal trial Sartor et al., N Engl J Med 2021 (Lutetium-177-PSMA-617 for mCRPC). These are the principal references for the approval criteria.

6Maximum total doses authorized (up to)

7.4 GBqPer-dose maximum (200 mCi) every 6 weeks

30 daysMinimum therapy duration before renewal consideration

Background

Background: Pluvicto is an FDA-approved radioligand therapeutic for adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor (AR) pathway inhibition and have received taxane-based chemotherapy, with allowance for delaying taxane-based chemotherapy in patients considered appropriate per updated labeling. Per NCCN guidance, androgen deprivation therapy (ADT) should be continued during additional therapies, including radiopharmaceuticals such as Pluvicto.

Revision History

2022-06-01added

Added HCPCS code A9607. HCPCS A9607 denotes 1 millicurie unit for lutetium Lu 177 vipivotide tetraxetan.

2023-01-06revised

Clarified approval duration is for up to a total of 6 doses and revised continued therapy approval duration from 12 to 6 months; added requirement that member has not received 6 doses for continued therapy; added piflufolastat F-18 as an additional radioactive diagnostic agent.

2024-01-10added

Added F-18 flotufolastat as an additional option to confirm PSMA-positive disease; references reviewed and updated.