CurrentUnitedHealthcarePolicy 2026 P 1421-4

Akeega (niraparib and abiraterone acetate) prior authorization

Defines UnitedHealthcare prior authorization and reauthorization criteria for Akeega for members (with automatic processing for those under 19). Applies to prescribers seeking coverage for Akeega for prostate cancer indications under UnitedHealthcare benefit plans.

Policy Summary

PayerUnitedHealthcare

PolicyAkeega (niraparib and abiraterone acetate) prior authorization

Policy CodePolicy 2026 P 1421-4

Change TypeAdded coverage for mCSPCbackground updated

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization showing diagnosis of mCRPC or mCSPC, documented deleterious or suspected deleterious BRCA mutation, and use with prednisone.

SourceLink

POLICY UPDATE CHANGES

Added criteria for metastatic castration-sensitive prostate cancer (mCSPC).

Updated background and references.

mCRPC, mCSPCCovered diagnoses (listed)

12 monthsAuthorization duration

BRCAmRequired biomarker

11/2023–2/2026P&T reviews

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Initial Authorization

Covered when ALL of the following are met

Initial Authorization: (a) Diagnosis of one of the following: (1) metastatic castration-resistant prostate cancer (mCRPC) OR (2) metastatic castration-sensitive prostate cancer (mCSPC); AND (b) deleterious or suspected deleterious BRCA-mutated (BRCAm); AND (c) used in combination with prednisone.

Authorization issued for 12 months.

Reauthorization

Reauthorization is approved when the following is met

Reauthorization: Patient does not show evidence of progressive disease while on Akeega therapy.

Authorization issued for 12 months.

Patients less than 19 years of age

Patients <19 years: Member is less than 19 years of age; prescription will automatically process without a coverage review.

Authorization issued for 12 months.

Some states mandate benefit coverage for off-label use of medications or require use of specific compendium references. Where such state mandates apply, they supersede the criteria in this policy and the member’s benefit plan.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Akeega per Program 2026 P 1421-4. Initial authorization requires a documented diagnosis of metastatic castration-resistant prostate cancer (mCRPC) or metastatic castration-sensitive prostate cancer (mCSPC), evidence of deleterious or suspected deleterious BRCA mutation, and use in combination with prednisone. Select patients for therapy based on an FDA-approved test for Akeega. For members under 19 years the prescription will automatically process without a coverage review. UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; automated approval processes vary by program.

Program: UnitedHealthcare Pharmacy Clinical Pharmacy Programs — Prior Authorization/Notification (2026 P 1421-4)
Initial approval requires: diagnosis of mCRPC or mCSPC; deleterious or suspected deleterious BRCAm; used with prednisone
Select patients based on an FDA-approved test for Akeega
Members <19 years: prescription auto-processes without coverage review
UnitedHealthcare may use prior claim/medication history, ICD-10 diagnosis codes, and claim logic for approvals
Supply limits may apply

Step Therapy

No step therapy requirements are specified for Akeega in this program.

Documentation Required

Required Clinical Documentation

Select patients for therapy based on an FDA‑approved test for Akeega. Documentation submitted for authorization should support the diagnosis (mCRPC or mCSPC), presence of deleterious or suspected deleterious BRCA mutation, and that Akeega will be used in combination with prednisone. Retain clinical records to demonstrate these criteria in case of review.

Documented diagnosis: mCRPC or mCSPC
Documented deleterious or suspected deleterious BRCA mutation (FDA‑approved test preferred)
Medication plan showing Akeega will be used in combination with prednisone

Denial Risk

Denial Risk if Criteria Not Met

Coverage may be denied if the member does not meet the Coverage Information and Initial Authorization criteria (e.g., diagnosis not mCRPC/mCSPC, no evidence of deleterious/suspected deleterious BRCAm, or not used with prednisone). Additionally, approvals or reauthorizations based solely on prior claims or diagnosis codes may not be available in all cases.

Denial risk if documentation does not confirm mCRPC or mCSPC diagnosis
Denial risk if no evidence of deleterious or suspected deleterious BRCA mutation
Denial risk if Akeega is not prescribed in combination with prednisone
Automated claim-based approvals may not apply in all situations

Definitions

mCRPC / mCSPC — definitions

mCRPCMetastatic castration-resistant prostate cancer.

mCSPCMetastatic castration-sensitive prostate cancer.

Clinical noteAkeega is indicated for adult patients with these diagnoses when they have a deleterious or suspected deleterious BRCAm and are selected using an FDA‑approved test.

BRCAm — definition

BRCAm definitionIndicates a deleterious or suspected deleterious BRCA mutation.

TestingPatients should be selected for Akeega therapy based on an FDA‑approved test for Akeega.

RelevancePresence of BRCAm is required for coverage of Akeega for the labeled prostate cancer indications.

OpenPayer

Akeega (niraparib and abiraterone acetate) prior authorization

Coverage Criteria

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Provider Actions & Requirements

Background

Definitions

Quantity Limits