ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 3179-2

Step Therapy Program for Akeega (niraparib and abiraterone acetate)

Defines a step therapy requirement requiring trial of or contraindication/intolerance to Lynparza (olaparib) before coverage of Akeega for members (with special automatic approval for <19). Applies to UnitedHealthcare Pharmacy Clinical Pharmacy Programs, effective 6/1/2025.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep Therapy Program for Akeega (niraparib and abiraterone acetate)

Policy CodePolicy 2025 P 3179-2

Change TypeProgram added; annual review (no criteria changes)

Effective DateJun 1, 2025

Next Review Date

Key ActionMembers new to Akeega must have trial and failure, contraindication, or intolerance to Lynparza (olaparib) in combination with abiraterone and prednisone/methylprednisolone prior to approval; members currently on Akeega per claims history may continue without meeting step criteria.

POLICY UPDATE CHANGES

New program created 3/2024.

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

1Step therapy requirement (requires Lynparza trial)

12 monthsAuthorization duration

<19Pediatric automatic processing

What is changing & scope

A Step Therapy program requires a trial of or documented contraindication/intolerance to Lynparza (olaparib) before coverage of Akeega (niraparib and abiraterone acetate) for adult patients with deleterious or suspected deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer (mCRPC). This requirement applies to UnitedHealthcare Pharmacy Clinical Pharmacy Programs and becomes effective 2025-06-01.

Coverage criteria for Akeega

Prostate Cancer (deleterious or suspected deleterious BRCAm mCRPC)

Akeega will be approved based on all of the following: Authorization duration: 12 months.

ALL of the following

Diagnosis of deleterious or suspected deleterious BRCA-mutated (BRCAm) 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
  - Patient has not received a manufacturer supplied sample at no cost in prescriber office, or any form of assistance from the Janssen sponsored Janssen CarePath 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 receipt of a manufacturer supplied sample or Janssen CarePath assistance must meet initial authorization criteria as if new to therapy

ref": "b1_0", "title": "Prostate Cancer (deleterious or suspected deleterious BRCAm mCRPC)"}

This line should not be present

Patients less than 19 years of age

Authorization will be issued for 12 months.

Patient is less than 19 years of age12 months

Other Indications

Akeega will be approved (coverage for other indications subject to state mandates and member-specific benefit plan coverage).

Coverage may be approved for other indications (subject to state mandates and member-specific benefit plan coverage)

Referenced products and definitions

Referenced product names (not billing codes)mixed

Akeega	niraparib and abiraterone acetate (combination product)
Lynparza	olaparib (required step therapy agent)

Akeega: combination of niraparib and abiraterone acetate indicated with prednisone for adult patients with deleterious or suspected deleterious BRCA‑mutated mCRPC.

Lynparza: olaparib, a PARP inhibitor used as the required step therapy agent (in combination with abiraterone and prednisone/prednisolone for the same mCRPC population).

mCRPC: metastatic castration‑resistant prostate cancer.

Evidence/references: Akeega PI Aug 2024; Lynparza PI Nov 2023; NCCN Compendium accessed Jan 29, 2025.

What providers must do

Step Therapy

Step therapy prior authorization required for new starts

Members new to Akeega must have trial and failure, contraindication, or intolerance to Lynparza (olaparib) in combination with abiraterone and prednisone/methylprednisolone prior to approval; members currently on Akeega per claims history may continue without meeting step criteria.

Documentation Required

Documentation of prior therapy or contraindication

Document history of failure, contraindication, or intolerance to Lynparza when requesting authorization; if patient was established on therapy via free manufacturer sample or Janssen CarePath assistance, they must meet initial authorization criteria as if new.

Billing Rule

Authorization duration

Authorizations will be issued for 12 months.

Prior Authorization

Automatic processing for pediatric members

For members under age 19, the prescription will automatically process without a coverage review.

Policy update changes

3/2024added

Program established as Step Therapy for Akeega requiring trial of or contraindication to Lynparza (olaparib) prior to coverage; new program created 3/2024.

3/2025revisedLatest

Annual review with no changes to step criteria; updated references. Effective date 2025-06-01.

The 3/2025 annual review documented no changes to the step criteria; the program effective date is 2025-06-01.