CurrentAetnaPolicy N/A

PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) Medication Precertification Request

Aetna precertification request form governing authorization submissions for PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) for eligible patients, including initiation and continuation of therapy; intended for prescribers and providers submitting requests.

Policy Summary

PayerAetna

PolicyPLUVICTO (lutetium Lu 177 vipivotide tetraxetan) Medication Precertification Request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit precertification using the provided form (use the Medicare request form for Medicare Advantage Part B) and include required clinical documentation such as PSMA status and prior AR-pathway inhibitor and taxane therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 pageform length

PSMA requiredbiomarker field

AR + taxaneprior therapy fields

phone/faxcontact info

Coverage Criteria for PLUVICTO

inv-01: Initiation Therapy — Covered when ALL of the following are documented

Covered when ALL of the following are documented

Initiation criteria: Patient has metastatic castration-resistant prostate cancer AND documentation of prior treatment with an androgen receptor (AR) pathway inhibitor (e.g., abiraterone) AND prior taxane-based chemotherapy (e.g., docetaxel) AND PSMA positive disease

Form explicitly requests each element; all are required for initiation requests per form fields.

inv-02: Continuation Therapy — Covered for continuation when ALL of the following are documented

Covered for continuation when ALL of the following are documented

Continuation criteria: Number of prior doses of the requested drug is provided AND documentation addressing whether there is unacceptable toxicity or disease progression while on the current regimen

Form requests dose count and whether there is evidence of unacceptable toxicity or disease progression.

Policy Summary

PayerAetna

PolicyPLUVICTO (lutetium Lu 177 vipivotide tetraxetan) Medication Precertification Request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

The precertification form includes a specific field to record PSMA status with discrete options: PSMA positive, PSMA negative, or Unknown. This allows the requesting clinician to indicate absence of PSMA expression on imaging when applicable.

Because the initiation criteria for PLUVICTO rely on documentation of PSMA positive disease, selecting PSMA negative on the form may affect authorization. The form captures PSMA negativity as an explicit response and absence of PSMA positivity can be considered an exclusion for therapy authorization depending on medical review of the submission.

Regimen	Indication	Dose / Frequency (to be specified by prescriber)	Coverage status
PLUVICTO (lutetium Lu 177 vipivotide tetraxetan)
Metastatic castration‑resistant prostate cancer after prior androgen receptor (AR) pathway inhibitor and taxane‑based chemotherapy with PSMA positive disease
Dose and frequency to be specified by the prescriber (Dose: __________; Frequency: __________)
Covered with criteria

Line of Therapy

inv-13: second-line — Prior systemic therapy requirement

Prior systemic therapy requirement: Documentation of prior androgen receptor pathway inhibitor and prior taxane-based chemotherapy

Form queries prior AR-pathway inhibition (e.g., abiraterone) and taxane chemotherapy (e.g., docetaxel).

Biomarker Requirements (PSMA)

PSMA — requirement for PSMA positive disease

RequirementPSMA positive disease is required for initiation assessment (form requests PSMA status and lists 'PSMA positive' as an option).

ContextPSMA status is one of the required clinical fields to be completed for initiation requests for PLUVICTO.

ImplicationAbsence of PSMA positivity (PSMA negative or unknown) may preclude authorization pending medical review as indicated by the form's explicit PSMA field.

PSMA status — required field for initiation assessment

Field capturedPSMA status must be indicated on the form as one of: PSMA positive, PSMA negative, or Unknown.

Use in assessmentPSMA status is required for initiation requests to evaluate eligibility for PLUVICTO.

Documentation noteThe form explicitly asks the provider to indicate PSMA status when submitting initiation clinical information.

Administration and Billing Codes

Administration CPT CodesCPT

Administration code(s) (CPT)

Field for CPT administration codes as applicable

Provider Actions and Submission Requirements

Denial Risk

Incomplete clinical documentation

Incomplete or missing clinical documentation may delay or result in denial of the precertification request. Commonly missing items include PSMA status, documentation of prior AR-pathway inhibitor therapy and taxane chemotherapy, and details on prior doses/toxicity for continuation requests. Ensure all required clinical fields are complete before submission.

PSMA status (positive/negative/unknown)
Prior AR-pathway inhibitor therapy (e.g., abiraterone) documented
Prior taxane chemotherapy (e.g., docetaxel) documented
For continuation: number of doses received and evidence of unacceptable toxicity or disease progression when applicable

Documentation Required

Required clinical documentation

Submit the following clinical documentation with all initiation and continuation precertification requests. For initiation: confirm diagnosis of prostate cancer and that disease is metastatic castration‑resistant; documentation that the patient has received an AR‑pathway inhibitor and taxane‑based chemotherapy (or note bilateral orchiectomy status); indicate whether treatment will be combined with a GnRH agonist or degarelix; and provide PSMA status. For continuation: document number of doses received and whether there is unacceptable toxicity or disease progression on current regimen.

Diagnosis: Prostate cancer
Metastatic castration‑resistant prostate cancer: Yes/No
Prior therapy: AR‑pathway inhibitor (e.g., abiraterone) — Yes/No; specify agent and dates
Prior therapy: Taxane‑based chemotherapy (e.g., docetaxel) — Yes/No; specify agent and dates
Bilateral orchiectomy: Yes/No
Concomitant GnRH agonist or degarelix use: Yes/No
PSMA status: Positive / Negative / Unknown
For continuation requests: number of doses received; evidence of unacceptable toxicity or disease progression

Documentation Required

Administrative and dispensing information

Complete administrative and dispensing fields on the precertification form to avoid processing delays. Include full patient demographics, prescriber identifiers, and precise dispensing/administration details.

Patient demographics: name, DOB, address, contact information, weight, height, allergies
Prescriber information: name, credentials, address, phone, fax, state license #, NPI, DEA, UPIN, specialty
Place of administration and dispensing provider: facility name, address, phone, TIN/PIN, and checkboxes for site type (physician office, outpatient infusion center, home infusion, specialty/retail pharmacy)
Administration codes (CPT) if applicable, and selected product (PLUVICTO) dose and frequency

Covered Regimens

Regimen detail	Required documentation on form	Prescriber action (dose specification)	Coverage status
PLUVICTO for patients with mCRPC following AR pathway inhibitor and taxane chemotherapy
Documentation of metastatic castration‑resistant prostate cancer; prior treatment with an AR pathway inhibitor (e.g., abiraterone) and taxane‑based chemotherapy (e.g., docetaxel); PSMA status documented as PSMA positive; for continuation requests, number of prior doses and evidence regarding unacceptable toxicity or disease progression
Prescriber must specify the intended dose and frequency on the request form (Dose: ______; Frequency: ______)
Covered with criteria

Definitions

PLUVICTO — product name and prescriber-specified dose/frequency

ProductPLUVICTO (lutetium Lu 177 vipivotide tetraxetan)

Prescriber responsibilityPrescriber must specify the requested dose for PLUVICTO on the form.

FrequencyPrescriber must specify the requested dosing frequency on the form.

Form locationDose and Frequency fields are captured under the 'E. PRODUCT INFORMATION' section of the precertification request.

Background

This precertification request form is used to request authorization for PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) and collects the clinical details necessary to evaluate either initiation or continuation of radioligand therapy.

For initiation requests the form requires documentation that the patient has metastatic castration-resistant prostate cancer, prior treatment with an androgen receptor (AR) pathway inhibitor and taxane-based chemotherapy, and the patient’s PSMA status. For continuation requests the form requests the number of prior doses and whether there is evidence of unacceptable toxicity or disease progression on the current regimen.