CurrentUnitedHealthcarePolicy 2025 P 1117-15

Xtandi (enzalutamide) prior authorization / coverage criteria

Defines prior authorization/notification criteria for enzalutamide (Xtandi) for treatment of prostate cancer (CRPC, mCSPC, nmCSPC high‑risk BCR) for UnitedHealthcare pharmacy programs; applies nationally except where state mandates supersede.

Policy Summary

PayerUnitedHealthcare

PolicyXtandi (enzalutamide) prior authorization / coverage criteria

Policy CodePolicy 2025 P 1117-15

Change TypeCriteria revised and references updated

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of prostate cancer diagnosis, castration and metastatic status, orchiectomy or concurrent GnRH use when applicable, and evidence of no progression for reauthorization; authorizations are typically issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Updated criteria in 6/2024 to reflect that for non-metastatic castration-sensitive prostate cancer concomitant use with GnRH is not required.

Annual reviews documented through 6/2025 with updates to background and references; 6/2025 review reported no change to coverage criteria.

12authorization duration (initial and reauthorization)

<19prescriptions for members under 19 process without coverage review

3primary labeled prostate cancer settings (CRPC, mCSPC, nmCSPC high-risk BCR)

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Authorization Criteria for Xtandi (enzalutamide)

Patients under 19 years of age

Xtandi will be approved when the following criterion is met:

ALL of the following

Patient is less than 19 years of age

Authorization duration = 12 months

Initial Authorization (adult members)

Xtandi will be approved when ALL of the following are met:

ALL of the following

Diagnosis of prostate cancer
One of the following disease-state scenarios
- Castration-resistant prostate cancer (CRPC)
  - Disease is castration-resistant
  - ANY of the following
    Used in combination with a gonadotropin-releasing hormone (GnRH) analog (e.g., leuprolide, goserelin, triptorelin, histrelin, degarelix)
    Patient has had bilateral orchiectomy
- Metastatic castration-sensitive prostate cancer (mCSPC)
  - Disease is metastatic castration-sensitive
  - ANY of the following

Authorization duration = 12 months

Reauthorization / Continuation Criteria

Xtandi will be approved for reauthorization when the following is met:

ALL of the following

Patient does not show evidence of progressive disease while on Xtandi therapy

Authorization duration = 12 months

NCCN Recommended Regimens

Recognition criterion that may support coverage:

ANY of the following

The drug is recognized for the treatment of the cancer indication by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

What Providers Must Do

Prior Authorization

Prior authorization required

Members must meet the policy's specified clinical criteria (diagnosis of prostate cancer and the applicable disease-state requirements) for prior authorization; authorizations are typically issued for 12 months.

Authorization duration = 12 months

Documentation Required

Clinical documentation to support disease state

Document the clinical details supporting the disease state for the request, including castration status, metastatic status, prior orchiectomy or concurrent GnRH analog use when applicable; for reauthorization, document lack of disease progression while on therapy.

Diagnosis of prostate cancer
Castration status (castration-resistant vs castration-sensitive)
Metastatic status
Prior bilateral orchiectomy or concurrent GnRH analog use when applicable
Documentation of no evidence of progressive disease for reauthorization

Step Therapy

Step therapy / supply limits may apply

Plan-level supply limits and/or step therapy programs may apply; UnitedHealthcare may use automated prior authorization processes based on prior claim or medication history, diagnosis codes, or claim logic.

Automated approval/re-approval may be based on prior claims/medication history, diagnosis codes, or claim logic

Denial Risk

State mandates override criteria

State mandates and other regulatory requirements may supersede this policy and can change coverage determinations or required documentation.

Check state-specific mandates and the member's benefit plan, which may override these criteria

Clinical and Policy Background

Enzalutamide (Xtandi) is an androgen receptor inhibitor indicated for treatment of castration‑resistant prostate cancer (CRPC), metastatic castration‑sensitive prostate cancer (mCSPC), and non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high‑risk BCR). The policy aligns coverage with the product label and recognizes NCCN Drugs & Biologics Compendium recommendations for these prostate cancer indications.

The policy history documents label- and guidance-driven updates over time. Notably, the criteria were updated in 6/2024 to reflect a labeling change removing the requirement for concurrent gonadotropin‑releasing hormone (GnRH) analog use in the nmCSPC high‑risk BCR setting. References and background material were refreshed during annual reviews through 6/2025.

Scope, Durations, and Notes

Scope, Authorization, Automation, and Policy

Scope SummaryDefines prior authorization/notification criteria for enzalutamide (Xtandi) for treatment of prostate cancer (CRPC, mCSPC, nmCSPC high‑risk BCR) for UnitedHealthcare pharmacy programs; applies nationally except where state mandates supersede.

Authorization Duration12 months (initial and reauthorization).

Automated Approval for <19Prescriptions for members under 19 automatically process without coverage review; an authorization will be issued for 12 months.

Policy Number2025 P 1117-15

Authorizations for initial and continued therapy are typically issued for 12 months. For members under 19 years of age, prescriptions will automatically process without a coverage review and an authorization will be issued for 12 months.

UnitedHealthcare may use automated approval or re‑approval processes based solely on prior claims/medication history, diagnosis codes, and/or claim logic; implementation of automated approval varies by program and therapeutic class. Supply limits and/or step therapy programs may apply and applicable state mandates or federal requirements can affect coverage and requirements.

Policy Summary

PayerUnitedHealthcare

PolicyXtandi (enzalutamide) prior authorization / coverage criteria

Policy CodePolicy 2025 P 1117-15

Change TypeCriteria revised and references updated

Effective DateSep 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Xtandi (enzalutamide) prior authorization / coverage criteria

Authorization Criteria for Xtandi (enzalutamide)

What Providers Must Do

Relevant Diagnostic Codes

Clinical and Policy Background

Defined Terms

Policy Changes

Scope, Durations, and Notes