Pharmacy Prior Authorization Criteria

Rubraca (rucaparib) - PA, NF

Indications for Prior Authorization

Rubraca (rucaparib)

• 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.

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
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to one of the following:
• Lynparza
• Zejula
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
• 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

Rubraca

Non Formulary

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
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to BOTH of the following:
• Lynparza
• Zejula
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

Rubraca

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Prostate Cancer

• Diagnosis of castration-resistant prostate cancer (CRPC)
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to Lynparza
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

P & T Revisions

2024-07-02, 2023-07-06, 2023-06-05, 2023-03-03, 2022-11-30, 2022-08-02, 2022-07-08, 2021-07-23, 2021-05-21, 2020-06-30

References

1. Rubraca Prescribing Information. Clovis Oncology, Inc. Boulder, CO. December 2022.
2. 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 July 1, 2024.
3. 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 1, 2024.

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Revision History

• 2024-07-02: Annual Review - NF Ovarian Cancer update to t/f of both Lynparza and Zejula
• 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
• 2022-11-30: Updated guideline
• 2022-08-02: Addition of NF criteria and embedded step and removed EHB formulary to 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

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