CurrentUnitedHealthcarePolicy 2025 P 1244-9

Erleada (apalutamide) prior authorization / coverage criteria

UnitedHealthcare prior authorization criteria for coverage of Erleada (apalutamide) for treatment of prostate cancer, including initial and reauthorization requirements and special handling for members under 19 years of age.

Policy Summary

PayerUnitedHealthcare

PolicyErleada (apalutamide) prior authorization / coverage criteria

Policy CodePolicy 2025 P 1244-9

Change TypeAnnual reviewreferences updated

Effective DateFeb 15, 2026

Next Review Date

Key ActionObtain prior authorization demonstrating the patient meets labeled disease-state criteria and concurrent androgen deprivation therapy or prior bilateral orchiectomy; reauthorization requires no evidence of progressive disease.

SourceLink

POLICY UPDATE CHANGES

Annual reviews through 11/2025 indicate no changes to clinical coverage criteria; references updated.

12Authorization period for initial and reauthorization approvals

Age <19Prescriptions for members under 19 process without coverage review

2FDA-labeled indications referenced (non-metastatic CRPC, metastatic CSPC)

Erleada (apalutamide) Coverage Criteria

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Patients less than 19 years of age

Erleada will be approved based on the following criterion:

ALL of the following

Patient is less than 19 years of age

Reauthorization Criteria

Erleada will be approved for reauthorization when the following criterion is met:

ALL of the following

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

NCCN Recommendation

Supporting guidance

ALL of the following

The drug is recognized 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 for Erleada

Providers must obtain prior authorization for Erleada and demonstrate the patient meets the labeled disease‑state criteria (non‑metastatic castration‑resistant prostate cancer or metastatic castration‑sensitive prostate cancer) and is receiving concurrent androgen deprivation therapy (GnRH analog) or has had a bilateral orchiectomy for initial approvals. Reauthorization requires documentation that there is no evidence of progressive disease while on Erleada therapy.

Documentation Required

Documentation of disease status and ADT

Document the prostate cancer diagnosis, whether the disease is metastatic or non‑metastatic, castration sensitivity or resistance, and either concurrent GnRH analog therapy (e.g., leuprolide, goserelin, triptorelin, histrelin, degarelix) or a history of bilateral orchiectomy. UnitedHealthcare may use previous claim/medication history, diagnosis codes, and automated processes to approve initial or reauthorizations.

Prior Authorization

Authorization duration

Authorizations for Erleada—both initial approvals and reauthorizations—are issued for a 12‑month period.

Authorization duration: 12 months

Denial Risk

Reauthorization denial risk

Reauthorization may be denied if there is evidence of progressive disease while the patient is receiving Erleada therapy.

Clinical Background

Erleada (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer and for patients with metastatic castration-sensitive prostate cancer. Patients receiving Erleada should receive concurrent gonadotropin-releasing hormone (GnRH) analog therapy (for example, leuprolide, goserelin, triptorelin, histrelin, or degarelix) while on therapy or should have had a bilateral orchiectomy.

Scope, Limitations, and Operational Notes

UnitedHealthcare prior authorization criteria for coverage of Erleada (apalutamide) apply to its FDA‑labeled indications for prostate cancer and specify initial and reauthorization requirements, including special handling for members under 19 years of age (prescriptions for members under 19 will automatically process without a coverage review). State mandates and member-specific benefit plans may supersede or modify these criteria. UnitedHealthcare may use prior claim/medication history, diagnosis codes and automated processes to approve initial authorizations or reauthorizations, and supply limits may apply.

Key Facts

Authorization period for initial and reauthorization approvals12 months

Prescriptions for members under 19 process without coverage reviewAge <19 auto-approve

FDA-labeled indications referenced (non-metastatic CRPC, metastatic CSPC)2 indications

Policy Summary

PayerUnitedHealthcare

PolicyErleada (apalutamide) prior authorization / coverage criteria

Policy CodePolicy 2025 P 1244-9

Change TypeAnnual reviewreferences updated

Effective DateFeb 15, 2026

Next Review Date

SourceLink

On This Page

OpenPayer

Erleada (apalutamide) prior authorization / coverage criteria

Erleada (apalutamide) Coverage Criteria

What Providers Must Do

Relevant Codes

Clinical Background

Defined Terms

Policy Changes

Scope, Limitations, and Operational Notes