CurrentUnitedHealthcarePolicy 2025 P 3179-2

Step Therapy for Akeega (niraparib and abiraterone acetate)

This program defines step therapy prior authorization requirements for coverage of Akeega for members, including pediatric automatic approvals and requirements for prior trial or contraindication to Lynparza for mCRPC. It applies to UnitedHealthcare pharmacy benefit enrollees.

Policy Summary

PayerUnitedHealthcare

PolicyStep Therapy for Akeega (niraparib and abiraterone acetate)

Policy CodePolicy 2025 P 3179-2

Change TypeClarificationadded program (Step Therapy)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document trial or contraindication to Lynparza (olaparib) before requesting coverage for Akeega, unless continuation criteria are met.

SourceLink

POLICY UPDATE CHANGES

Program created as a Step Therapy program for Akeega; P&T Approval dated 3/2024 and 3/2025 with effective date 6/1/2025.

Members currently on Akeega will be allowed to continue therapy without meeting new criteria.

12 moinitial/reauthorization approval length

Stepprogram type

3/2024, 3/2025P&T approval dates

2025-06-01effective date

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Coverage Criteria

Covered when criteria below are met

Pediatric (age <19): Patient is less than 19 years of ageage < 19 years

Authorization will be issued for 12 months

Adult mCRPC initial therapy: Diagnosis of deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (BRCAm mCRPC) AND used in combination with prednisoneBRCAm mCRPC; concomitant prednisone

AND one of: history of failure/contraindication/intolerance to Lynparza plus abiraterone and prednisone/methylprednisolone OR continuation criteria

Adult mCRPC prior therapy/continuation logic: (1) History of failure, contraindication, or intolerance to Lynparza (olaparib) in combination with abiraterone and prednisone or methylprednisolone OR (2) Both continuation conditions below

See continuation node for conditions

Patients who were established on Akeega solely through receipt of a manufacturer‑supplied sample in the prescriber's office or via assistance from the Janssen CarePath program (for example, a sample card redeemable for free medication) are not considered established users for continuation purposes. Such patients must meet the initial authorization criteria as if they were new to therapy.

Provider Actions & Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Akeega (niraparib + abiraterone) when prescribed for adult patients with deleterious or suspected deleterious BRCA‑mutated (BRCAm) metastatic castration‑resistant prostate cancer (mCRPC). Members currently documented on Akeega in claims history may continue therapy; new starts require meeting coverage criteria and authorization.

Applies to adults with BRCAm mCRPC
Continuation allowed if documented in claims history

Step Therapy

Step Therapy: Lynparza Trial Required

A step‑therapy requirement mandates a trial of (or documented contraindication/intolerance to) Lynparza (olaparib) in combination with abiraterone and prednisone (or methylprednisolone) before Akeega will be approved for new therapy starts.

Trial of Lynparza (olaparib) in combination with abiraterone + prednisone/prednisolone OR documented contraindication/intolerance
If trial not completed and no contraindication, Akeega initial approval will be denied

Definitions

BRCAm mCRPC — definition and context

TermBRCAm mCRPC

DefinitionMetastatic castration‑resistant prostate cancer (mCRPC) with a deleterious or suspected deleterious BRCA mutation

Indication contextAkeega is indicated for adults with deleterious or suspected deleterious BRCA‑mutated (BRCAm) mCRPC when used with prednisone

Step therapy implicationTrial of or contraindication to Lynparza (olaparib) is required before coverage of Akeega for BRCAm mCRPC patients unless continuation criteria are met

Continuation noteMembers currently on Akeega as documented in claims history will be allowed to continue therapy

Initial Therapy

Initial authorization for adults with BRCAm mCRPC

Initial adult authorization: Diagnosis of deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (BRCAm mCRPC); used in combination with prednisoneBRCAm mCRPC; concomitant prednisone

Authorization issued for 12 months; and patient must meet one of the prior therapy or continuation clauses

Prior therapy or continuation options: (1) History of failure, contraindication, or intolerance to Lynparza (olaparib) in combination with abiraterone and prednisone or methylprednisolone OR (2) Both continuation conditions

If relying on continuation, see continuation criteria

Continuation of Therapy

Continuation of therapy is allowed for members currently on Akeega as documented in claims history.

Continuation conditions: Patient is continuing Akeega therapy AND patient has not received a manufacturer supplied sample at no cost in the prescriber's office, nor any form of assistance from the Janssen CarePath program to establish current use

Patients established via manufacturer sample or Janssen CarePath assistance must meet initial authorization criteria as if new to therapy

Step Therapy Requirements

Step	Required trial or documentation	Coverage implication
1	Trial of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone, or documentation of a contraindication, intolerance, or history of failure to Lynparza in that combination.	Coverage of Akeega is allowed after member has completed the required trial or has documented contraindication/intolerance/failure to Lynparza; members already on Akeega as documented in claims may continue therapy.

Background

Akeega is a fixed‑dose combination of niraparib and abiraterone acetate intended for use in combination with prednisone for adults with deleterious or suspected deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer (BRCAm mCRPC). Prior authorization is required for Akeega in this indication unless the member has a documented history of failure, contraindication, or intolerance to Lynparza (olaparib) used in combination with abiraterone and prednisone/methylprednisolone, or the member meets continuation criteria documented in claims history.