CurrentUnitedHealthcarePolicy N/A

Erleada (apalutamide) prior authorization

Prior authorization and notification requirements for Erleada (apalutamide) for treatment of castration-resistant and castration-sensitive prostate cancer for UnitedHealthcare members. Specifies initial and reauthorization clinical criteria and special handling for members under 19.

Policy Summary

PayerUnitedHealthcare

PolicyErleada (apalutamide) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 15, 2026

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis, castration and metastatic status, and concurrent GnRH therapy or orchiectomy to obtain approval for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration typically issued

ages <19automatic processing without coverage review

2 indicationsapproved indications noted

NCCNrecognized compendium

Coverage and Authorization Criteria

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.

Provider Responsibilities & Prior Authorization

Prior Authorization

Prior authorization required; approval when criteria met

Prior authorization is required for Erleada (apalutamide). Requests meeting the documented initial authorization criteria will be approved and authorization will be issued for 12 months.

Step Therapy

Supply limits and automated approvals may apply

Supply limits may apply and automated approval/re-approval processes may be used depending on program or therapeutic class; UnitedHealthcare may approve based solely on prior claim/medication history, diagnosis codes (ICD-10) or claim logic.

Supply limits may be in place.
Use of automated approval and re-approval processes varies by program and/or therapeutic class.
UHC may approve based on previous claim/medication history or diagnosis codes.

Documentation Required

Required clinical documentation

Document the diagnosis of prostate cancer, castration status (castration‑resistant vs castration‑sensitive/naive), metastatic status (non‑metastatic vs metastatic), and either concurrent use of a GnRH analog or history of bilateral orchiectomy. For reauthorization, document absence of progressive disease while on therapy; prior medication/claim history and ICD‑10 codes may be used.

Diagnosis of prostate cancer.
Castration status (resistant vs sensitive/naive).
Metastatic status (non‑metastatic vs metastatic).
Concurrent GnRH analog use (examples: leuprolide, goserelin, triptorelin, histrelin, degarelix) or bilateral orchiectomy.
For reauthorization: no evidence of progressive disease while on Erleada.

Denial Risk

Denial risk if clinical criteria not met

Requests that do not meet the initial authorization criteria (missing required diagnosis, correct castration or metastatic status, or lack of concurrent GnRH analog use / bilateral orchiectomy) or the reauthorization criterion (evidence of disease progression on therapy) risk denial.

Missing diagnosis of prostate cancer.
Disease not documented as the required castration-resistant/non‑metastatic or castration‑sensitive/metastatic state.
No documentation of concurrent GnRH analog therapy or bilateral orchiectomy.
Evidence of progressive disease for reauthorization requests.

Key Definitions

Castration status — definitions and related terms

Castration-resistant (CRPC)Disease that progresses or recurs despite androgen deprivation therapy (i.e., progression while on castration), typically described as castration-resistant or recurrent.

Castration-sensitive (also called castration‑naive)Disease that remains responsive to androgen deprivation therapy; when described as castration-sensitive or naive, the disease is not progressing despite castration and may be metastatic.

Concurrent castration therapy requirementErleada should be used in combination with a GnRH analog (examples: leuprolide, goserelin, triptorelin, histrelin, degarelix) or the patient must have had bilateral orchiectomy.

Non‑metastatic vs metastatic distinctionNon‑metastatic castration‑resistant: disease is castration‑resistant or recurrent AND non‑metastatic. Metastatic castration‑sensitive: disease is castration‑sensitive or naive AND metastatic.

Clinical documentation to support statusProviders should document castration status (castration‑resistant vs castration‑sensitive), metastatic status (non‑metastatic vs metastatic), and concurrent GnRH analog use or history of bilateral orchiectomy.

Clinical Background

Apalutamide (Erleada) is an androgen receptor inhibitor indicated for treatment of both non‑metastatic castration‑resistant prostate cancer (nmCRPC) and metastatic castration‑sensitive prostate cancer (mCSPC). Use of apalutamide is expected to be in combination with continued androgen‑deprivation therapy (concurrent GnRH analog) or in patients who have undergone bilateral orchiectomy. Authorization decisions follow criteria that confirm the prostate cancer diagnosis, the required castration status and metastatic status, and appropriate concurrent or prior castration therapy.