ModifiedColorado Rocky Mountain Health Plans | UnitedHealthcare Pharmacy Clinical Pharmacy ProgramsPolicy 2026 P 3179-3

Akeega™ (niraparib and abiraterone acetate) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Defines step therapy requirements for coverage of Akeega for UnitedHealthcare Commercial Plans: requires prior trial or contraindication to olaparib (Lynparza) for new members with BRCA-mutated mCRPC, allows continuation for current claim-documented users, and auto-approves prescriptions for members under 19.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Pharmacy Clinical Pharmacy Programs

PolicyAkeega™ (niraparib and abiraterone acetate) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2026 P 3179-3

Change TypeAnnual review (2026) — updated manufacturer savings program name and references

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionFor members new to therapy, require documentation of trial and failure, contraindication, or intolerance to olaparib (Lynparza) in combination with abiraterone and prednisone/methylprednisolone before approving Akeega; members currently on Akeega as documented in claims may continue without meeting step criteria.

SourceLink

POLICY UPDATE CHANGES

3/2026 annual review updated name of manufacturer savings program and updated references.

3/2025 annual review with updated references.

3/2024 new step therapy program established requiring trial of olaparib before Akeega.

1Step therapy required prior agent

12Authorization duration (months)

<19

Pediatric auto-approval

BRCA-m mCRPCPrimary covered indication

What is changing & scope

Defines step therapy requirements for coverage of Akeega for UnitedHealthcare Commercial Plans: requires prior trial of or contraindication to Lynparza (olaparib) before coverage of Akeega for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCA m) metastatic castration-resistant prostate cancer (mCRPC); members currently on Akeega as documented in claims may continue without meeting step criteria; prescriptions for members under 19 years will auto-process and be authorized for 12 months. Effective date: 2026-06-01. Policy number: 2026 P 3179-3. Coverage stance: mixed.

Primary covered indicationBRCA-m mCRPC

Authorization duration12 months

Pediatric auto-approval populationAge <19 (auto-approve)

Step therapy required prior agentOlaparib (Lynparza) — trial or contraindication required

Coverage criteria

Prostate Cancer (deleterious or suspected deleterious BRCA-mutated mCRPC)

Akeega will be approved based on all of the following:

ALL of the following

Diagnosis of deleterious or suspected deleterious BRCA-mutated (BRCA m) metastatic castration-resistant prostate cancer (mCRPC)
Used in combination with prednisone
ONE of the following
- History of failure, contraindication, or intolerance to Lynparza (olaparib) in combination with abiraterone and prednisone or methylprednisolone
- Both of the following
  - As continuation of therapy

Diagnosis & codes

ICD-10 Diagnosis (referenced for automated approval)ICD-10

No codes listed

What providers must do

Step Therapy

Step therapy requirement for new members

For members new to therapy, require documentation of trial and failure, contraindication, or intolerance to olaparib (Lynparza) in combination with abiraterone and prednisone/methylprednisolone before approving Akeega; members currently on Akeega as documented in claims may continue without meeting step criteria.

Applies to members new to therapy
Members currently on Akeega as documented in claims may continue without meeting step criteria

Documentation Required

Continuation documentation / manufacturer assistance exclusion

For continuation approvals, confirm patient has not been established on Akeega via manufacturer supplied sample or J&J withME Savings Program assistance; patients established by such samples/assistance must meet initial authorization criteria as new to therapy.

Definitions & evidence

Step therapy encourages use of lower-cost alternatives by requiring a trial of or contraindication to the alternative agent before covering a higher-cost therapy. In this program, a trial of Lynparza (olaparib) in combination with abiraterone and prednisone/prednisolone is required prior to approval of Akeega (niraparib and abiraterone acetate). Akeega is indicated with prednisone for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

mCRPC: metastatic castration-resistant prostate cancer.

BRCA m: deleterious or suspected deleterious BRCA-mutated.

P&T approval dates3/2024, 3/2025, 3/2026

ReferencesAkeega PI Dec 2025; Lynparza PI Jul 2025; NCCN Drugs and Biologics Compendium accessed Jan 15, 2026

Policy changes & timeline

3/2024added

Program created: new step therapy program established requiring trial of olaparib (Lynparza) before Akeega for BRCA-mutated mCRPC; members currently on Akeega may continue as documented in claims; pediatric auto-approval for <19 with 12-month authorization. (Material change.)

3/2025revised

Annual review with no changes to step criteria; updated references.

3/2026revisedLatest

Annual review with updated name of manufacturer savings program and updated references.

Administrative details

Policy number2026 P 3179-3

Policy titleAkeega (niraparib and abiraterone acetate) step therapy program

PayerColorado Rocky Mountain Health Plans (UnitedHealthcare Commercial Plans)

Effective date2026-06-01

Last review2026-03-01

Next review

StatusMODIFIED

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Pharmacy Clinical Pharmacy Programs

PolicyAkeega™ (niraparib and abiraterone acetate) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2026 P 3179-3

Change TypeAnnual review (2026) — updated manufacturer savings program name and references

Effective DateJun 1, 2026

Next Review DateN/A

SourceLink

On This Page

Patient has not received a manufacturer supplied sample at no cost in prescriber office, or any form of assistance from the Johnson & Johnson sponsored J&J withME Savings Program (e.g., sample card which can be redeemed at a pharmacy for a free supply of medication) as a means to establish as a current user of Akeega

Patients requesting initial authorization who were established on therapy via manufacturer supplied sample or J&J withME Savings Program assistance must meet initial authorization criteria as new to therapy.

Patients less than 19 years of age

Akeega will be approved based on the following criterion:

Patient is less than 19 years of age

Authorization will be issued for 12 months.

Other Indications

Akeega will be approved

State mandates, federal regulatory requirements, and member-specific benefit plan coverage may impact coverage criteria

Other policies and utilization management programs may apply; automated approval and claim-based approvals may be used per program rules.

Excludes establishment via manufacturer-supplied samples in prescriber office
Excludes assistance from the Johnson & Johnson J&J withME Savings Program (e.g., sample card redeemed at a pharmacy)
If patient was established on therapy via such samples/assistance, they must meet initial authorization criteria as new to therapy

Prior Authorization

Pediatric auto-approval

For members under age 19, the prescription will automatically process without a coverage review and authorization will be issued for 12 months.

Automatic processing for patients <19 years
Authorization duration: 12 months

Denial Risk

Automated approval caveat

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated approval varies by program and supply limits/notification may be in place.

Automated approvals may rely on claims/ICD-10 and claim logic
Program varies by therapeutic class and may include supply limits or notifications