Pharmacy Prior Authorization Criteria

Rubraca (rucaparib) - PA, NF

Indications for Prior Authorization

Rubraca (rucaparib)

• For diagnosis of Maintenance Treatment of BRCA-mutated Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal 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 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal 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 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• Submission of medical records (e.g., chart notes) confirming diagnosis of one of the following:
• Epithelial ovarian cancer
• Fallopian tube cancer
• Primary peritoneal cancer
AND
• One of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming a trial and failure, contraindication, or intolerance to BOTH of the following:
• Lynparza
• Zejula
OR
• BOTH of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy for continuation of therapy
• Patient demonstrates positive clinical response to therapy

Rubraca

Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming diagnosis of castration-resistant prostate cancer (CRPC)
AND
• One of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming a trial and failure, contraindication, or intolerance to Lynparza
OR
• BOTH of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy for continuation of therapy
• Patient demonstrates positive clinical response to therapy

P & T Revisions

2025-07-29, 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.

---

End Notes

1. In clinical trials for mCRPC, patients received concomitant GnRH analog or had prior bilateral orchiectomy. This PA criterion requirement has been removed from other prostate cancer drugs as part of PA criteria optimization initiative as it was being approved 100% of the time.

---

Revision History

• 2025-07-29: Annual Review 2025 - Program update to NF criteria for standard UM verbiage to require submission of records for diagnosis & attestation for positive clinical response for continuation for therapy.
• 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

---