Akeega (niraparib and abiraterone) - PA, NF
Indications for Prior Authorization
Akeega (niraparib and abiraterone)
-
For diagnosis of Metastatic castration-resistant prostate cancer (mCRPC)
In combination with prednisone, indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for Akeega.
Criteria
Akeega
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Metastatic castration-resistant prostate cancer (mCRPC)
- Diagnosis of prostate cancer AND
- Disease is all of the following:
- Metastatic
- Castration-resistant
- Deleterious or suspected deleterious BRCA-mutated (BRCAm)
- Used in combination with prednisone AND
- One of the following:
- Used in combination with a gonadotropin-releasing hormone (GnRH) analog
- Patient has had a bilateral orchiectomy
- One of the following:
- Trial and failure, contraindication, or intolerance to Lynparza (olaparib) OR
- For continuation of prior therapy
Akeega
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Metastatic castration-resistant prostate cancer (mCRPC)
- Patient does not show evidence of progressive disease while on therapy
Akeega
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Metastatic castration-resistant prostate cancer (mCRPC)
- Submission of medical records (e.g., chart notes) confirming a diagnosis of prostate cancer AND
- Disease is all of the following:
- Metastatic
- Castration-resistant
- Deleterious or suspected deleterious BRCA-mutated (BRCAm)
- Used in combination with prednisone AND
- One of the following:
- Used in combination with a gonadotropin-releasing hormone (GnRH) analog
- Patient has had a bilateral orchiectomy
- One of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Lynparza (olaparib) OR
- For continuation of prior therapy
P & T Revisions
2024-10-23, 2024-03-24, 2024-01-03, 2023-11-01, 2023-11-01, 2023-11-01, 2023-03-13, 2022-08-11, 2022-03-14, 2021-12-16, 2021-11-04, 2021-09-30, 2021-08-13, 2021-05-05, 2021-03-22, 2020-12-14, 2020-08-10, 2020-04-09, 2020-02-20, 2019-08-24
References
- Akeega prescribing information. Janssen Biotech, Inc. Horsham, PA. August 2024.
Revision History
- 2024-10-23: 2024 Annual Review. Background updates only
- 2024-03-24: Addition of NF criteria; added EHB formulary
- 2024-01-03: Addition of a step through Lynparza
- 2023-11-01: New program
- 2023-11-01: New program
- 2023-11-01: New program
- 2023-03-13: Annual review: No criteria changes. Updated references.
- 2022-08-11: 2023 Medicare Implementation - No Changes
- 2022-03-14: Annual review: No changes to criteria. Updated references.
- 2021-12-16: 2022 Formulary Note update - no changes to criteria
- 2021-11-04: 2022 formulary note addition - no changes to criteria
- 2021-09-30: 2022 formulary note addition - no changes to criteria
- 2021-08-13: 2022 Medicare Implementation - No Changes
- 2021-05-05: Updated guideline to add eff date/P&T date/P&T revision date under Guideline Details section.
- 2021-03-22: Updated guideline to add GPIs for 40 mg and 80 mg tablets to already existing indications.
- 2020-12-14: Update to remove prescriber requirement
- 2020-08-10: 2021 Implementation no changes
- 2020-04-09: Annual Review: Updated background and references
- 2020-02-20: Revised guideline to add new indication of metastatic castration-sensitive prostate cancer (mCSPC)
- 2019-08-24: 2020 Migration Upload - criteria changes from May 2019 P&T.
HEALTHY LIVING