CurrentUnitedHealthcarePolicy N/A

Xtandi (enzalutamide) prior authorization

Prior authorization and notification requirements for enzalutamide (Xtandi) for treatment of prostate cancer indications, applied to UnitedHealthcare benefit plans; members under 19 process without review. Affects prescribers and pharmacy/prior authorization staff.

Policy Summary

PayerUnitedHealthcare

PolicyXtandi (enzalutamide) prior authorization

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for enzalutamide; prescriptions for members under 19 will auto-process without coverage review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

patients <19 auto-processauto-process <19

categories 1/2A/2BNCCN recognition

2025-09-01effective

Coverage Criteria for Xtandi (enzalutamide)

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.

Initial Authorization: Diagnosis of prostate cancer

Permitted disease states: One of the following disease-specific paths must be met:

Path A - Castration-resistant disease: Disease is castration-resistant AND one of the following: (a) used in combination with a gonadotropin-releasing hormone (GnRH) analog (examples: leuprolide, goserelin, triptorelin, histrelin, degarelix) OR (b) patient has had bilateral orchiectomy.

Path B - Metastatic castration-sensitive disease: Disease is metastatic castration-sensitive AND one of the following: (a) used in combination with a gonadotropin-releasing hormone (GnRH) analog (examples: leuprolide, goserelin, triptorelin, histrelin, degarelix) OR (b) patient has had bilateral orchiectomy.

Path C - Non-metastatic castration-sensitive disease: Disease is non-metastatic castration-sensitive with biochemical recurrence at high risk for metastasis

Pediatric (<19 years) Authorization

Special pediatric rule:

Patients <19: Patient is less than 19 years of age

Authorization will be issued for 12 months and prescriptions for members under 19 will process without coverage review.

Some state mandates and compendia requirements may supersede the policy language in this document. Where state law requires coverage for off‑label medication use or mandates the use of a particular compendium, those mandates take precedence over the benefit document or notification criteria.

Coverage is also subject to the terms of the member's federal and plan benefit documents; federal requirements and member‑specific benefit plan provisions may affect whether a prescription is covered under this policy.

Initial Therapy Requirements

Initial Therapy

Initial therapy coverage requirements

Diagnosis requirement: Diagnosis of prostate cancer

Disease-state specific conditions: Meet one disease-state path: (a) castration-resistant with concurrent GnRH analog use or bilateral orchiectomy; OR (b) metastatic castration-sensitive with concurrent GnRH analog use or bilateral orchiectomy; OR (c) non-metastatic castration-sensitive with high-risk biochemical recurrence

Policy provides GnRH analog examples: leuprolide, goserelin, triptorelin, histrelin, degarelix.

Provider Actions and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xtandi except for members less than 19 years of age. For patients under 19, authorization will be issued for 12 months. For all other members, prior authorization approvals and reauthorizations are issued for 12 months when criteria are met.

Prior authorization required for adults and members ≥19 years of age
Members <19 years: authorization issued for 12 months when criterion met

Step Therapy

Potential Step Therapy / Supply Limits

Supply limits and/or step therapy may apply to this medication. Confirm member-specific program rules for quantity limits or required step edits prior to prescribing.

Supply limits may be enforced
Step therapy edits may be in place

Documentation Required

Documentation and Automated Review

Decisions may be determined through automated review of prior claims, medication history, diagnosis codes (ICD-10), and claim logic. Providers should ensure accurate and complete claims and medication history to support coverage determinations.

Automated approvals/reauthorizations may use prior claims, medication history, ICD-10 codes, and claim logic
Use of automated processes varies by program and therapeutic class

Denial Risk

Denial Triggers

Denials may occur if required documentation is missing or if the member fails to meet the coverage criteria (including diagnosis, disease state, treatment combination, or evidence of non-progression for reauthorization). Provide complete clinical documentation to reduce the risk of denial.

Missing or insufficient documentation
Failure to meet coverage criteria (e.g., diagnosis, castration status, combination with GnRH analog or bilateral orchiectomy, metastatic status, or lack of response criteria for reauthorization)

Step therapy / supply limits	Details
Presence noted	Policy indicates supply limits and/or step therapy may be in place per program or therapeutic class; specifics are not listed in this document.

Background on Enzalutamide (Xtandi)

Enzalutamide (Xtandi) is an oral androgen receptor inhibitor indicated for treatment of prostate cancer, including castration‑resistant prostate cancer (CRPC), metastatic castration‑sensitive prostate cancer (mCSPC), and non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with high‑risk biochemical recurrence. The policy aligns coverage to labeled indications and clinical guidance recognizing these disease states.

Key Definitions

Castration and related management terms

DefinitionCastration = androgen deprivation achieved either medically (with GnRH agonists/antagonists) or surgically (bilateral orchiectomy)

Medical castration (examples)Gonadotropin-releasing hormone (GnRH) analogs/agents such as leuprolide (Lupron), goserelin (Zoladex), triptorelin (Trelstar), histrelin (Vantas), and the GnRH antagonist degarelix (Firmagon)

Surgical castrationBilateral orchiectomy (documented prior bilateral orchiectomy fulfills the castration requirement)

Policy use of castrationCastration (medical or surgical) is required or paired with disease-state criteria for certain indications (e.g., metastatic castration-sensitive or castration-resistant disease) in initial authorization pathways

Related management term — concurrent usePolicy allows enzalutamide when used in combination with a GnRH analog (concurrent medical castration) as an alternative to prior bilateral orchiectomy