Rubraca (rucaparib)
Indications for Prior Authorization
Rubraca (rucaparib)
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For diagnosis of Maintenance Treatment of BRCA-mutated Recurrent Ovarian cancer
Indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. -
For diagnosis of Metastatic Castration-Resistant Prostate Cancer with BRCA Mutations
Indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Criteria
Rubraca
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Ovarian Cancer
- Diagnosis of one of the following:
- Epithelial ovarian cancer
- Fallopian tube cancer
- Primary peritoneal cancer
- One of the following:
- Trial and failure, contraindication, or intolerance to Lynparza OR
- For continuation of prior therapy
Rubraca
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Prostate Cancer
- Diagnosis of castration-resistant prostate cancer (CRPC) AND
- One of the following:
- Trial and failure, contraindication, or intolerance to Lynparza OR
- For continuation of prior therapy
Rubraca
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of All Indications Listed Above
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2024-07-01, 2023-07-06, 2023-06-05, 2023-03-03, 2023-03-03, 2022-08-02, 2022-07-08, 2021-07-23, 2021-05-21, 2020-06-30
References
- Rubraca Prescribing Information. Clovis Oncology, Inc. Boulder, CO. December 2022.
- U.S. Food and Drug Administration [website]: List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Available at https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm Accessed July 9, 2021.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Ovarian Cancer - v.1.2022. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed June 15, 2022.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Prostate Cancer v.2.2021. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed July 9, 2021.
Revision History
- 2024-07-01: Annual Review - No criteria changes
- 2023-07-06: Annual Review - Removal of specialist requirement.
- 2023-06-05: Program update to remove disease severity, mutation status, prior treatment history criterion.
- 2023-03-03: Updated criteria for ovarian cancer
- 2023-03-03: Addition of COT language to step requirements
- 2022-08-02: created separate EHB guideline
- 2022-07-08: Updated background and criteria due to recent FDA withdrawn indication for BRCA mutated-associated ovarian cancer
- 2021-07-23: 2021 Annual Review, no changes to criteria.
- 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
- 2020-06-30: Updated for new indication mCRPC and 2020 annual review
HEALTHY LIVING