CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy and coverage criteria for Akeega (niraparib + abiraterone acetate)

Defines step therapy and coverage criteria for Akeega (niraparib and abiraterone acetate), primarily for adults with BRCA‑mutated metastatic castration‑resistant prostate cancer (mCRPC); also notes automatic processing for patients under 19. Affects prescribers and pharmacy benefit adjudication.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy and coverage criteria for Akeega (niraparib + abiraterone acetate)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionRequire prior authorization for new Akeega users and document trial or contraindication/intolerance to Lynparza (olaparib) combined with abiraterone and prednisone.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization period

requires prior trialstep therapy requirement

age <19pediatric auto-process

BRCA‑mCRPCprimary indication

Coverage Criteria for Akeega (niraparib + abiraterone acetate)

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Initial coverage criteria

Covered when the following criteria are met

Pediatric auto-approval: Patient is less than 19 years of ageage <19

Authorization issued for 12 months

Adult mCRPC indication requirements: For adult patients: (a) diagnosis of deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC); (b) used in combination with prednisone; AND (c) one of the following: history of failure, contraindication, or intolerance to Lynparza (olaparib) in combination with abiraterone and prednisone or methylprednisolone OR continuation exception for established users who meet continuation criteria

Authorization issued for 12 months

Continuation therapy

Continuation of therapy

Continuation: Request is for continuation of therapy; AND patient has not received a manufacturer supplied sample at no cost in prescriber's office or any form of assistance from the Johnson & Johnson sponsored J&J withME Savings Program to establish current user of Akeega

If patient was established via manufacturer sample or J&J assistance, treat as new and require initial authorization criteria

If a patient was established on Akeega solely through receiving a manufacturer-supplied sample in the prescriber’s office or via assistance from the Johnson & Johnson sponsored J&J withME Savings Program (for example, a sample card redeemable for free medication), that patient is considered new to therapy for authorization purposes. Such patients must meet the initial authorization criteria rather than continuation criteria; in other words, prior receipt of free samples or program assistance does not qualify the patient as an ongoing user for continuation approvals.

Initial Therapy Criteria

Initial therapy criteria

Initial coverage for adult patients

Initial adult coverage: (a) Diagnosis of deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC); (b) Akeega will be used in combination with prednisone; AND (c) either history of failure, contraindication, or intolerance to Lynparza (olaparib) in combination with abiraterone and prednisone or methylprednisolone, OR meet continuation exception for established users

Authorization issued for 12 months

Continuation Criteria

Continuation criteria

Continuation conditions for existing users

Continuation: Request is for continuation of therapy AND patient has not received a manufacturer supplied sample at no cost in the prescriber's office or any form of assistance from the Johnson & Johnson sponsored J&J withME Savings Program to establish current user

Patients established solely via manufacturer sample or J&J assistance are considered new and must meet initial criteria

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required for members new to Akeega. Members currently on Akeega as shown in claims history may continue without new prior auth; members new to therapy must obtain prior authorization. Auto-processing/automated approval may be applied for members under age 19 or when previous claim/medication history supports coverage per plan automation.

Members currently on Akeega per claims history: continuation allowed without new prior authorization
Members new to Akeega: prior authorization required
Automated approval may be used for members <19 or when prior claims/medication history and diagnosis support coverage

Step Therapy

Step Therapy Requirement

Step therapy is required: a trial of Lynparza (olaparib) in combination with abiraterone and prednisone (or documented contraindication or intolerance to that regimen) is required prior to approval of Akeega.

Required prior therapy: Lynparza (olaparib) + abiraterone + prednisone/prednisolone
Documentation of contraindication or intolerance to Lynparza regimen acceptable in lieu of trial

Denial Risk

Step Therapy Enforcement / Denial Risk

Coverage may be denied if step therapy requirements or required documentation (including documentation of contraindication or intolerance to Lynparza) are not met. Members who were established on Akeega via a manufacturer-supplied sample or assistance program must meet initial authorization criteria as if new to therapy unless documented as current users in claims history.

Denial risk if no documented trial of Lynparza regimen and no documented contraindication/intolerance
Patients established by manufacturer samples or J&J assistance programs must meet initial authorization criteria unless claims history shows they are current users

Documentation Required

Required Documentation

Provider must document prior therapy history, reasons for intolerance or contraindication to Lynparza + abiraterone + prednisone (if claimed), and any supporting clinical details to justify bypassing step therapy. For continuation requests, document prior authorization or claims showing ongoing Akeega use. Note that automated approvals may rely on claims/diagnosis history.

Document prior Lynparza trial dates, dose, and reason for discontinuation if applicable
If claiming contraindication/intolerance, provide clinical rationale and supporting records
For continuation, include evidence of prior Akeega fills or prior authorization approvals

Step	Requirement	Notes
1	Trial of Lynparza (olaparib) in combination with abiraterone and prednisone (or documented contraindication or intolerance to this combination)	Required prior to coverage of Akeega for members new to therapy; members currently on Akeega as shown in claims may continue. Authorization issued for 12 months.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy and coverage criteria for Akeega (niraparib + abiraterone acetate)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionRequire prior authorization for new Akeega users and document trial or contraindication/intolerance to Lynparza (olaparib) combined with abiraterone and prednisone.

SourceLink

On This Page

OpenPayer

Step therapy and coverage criteria for Akeega (niraparib + abiraterone acetate)

Coverage Criteria for Akeega (niraparib + abiraterone acetate)

Initial Therapy Criteria

Continuation Criteria

Provider Actions and Prior Authorization

Step Therapy Requirements

Definitions

Background