Rucaparib (Rubraca) coverage
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Defines medical necessity and prior authorization criteria for rucaparib (Rubraca) for commercial, HIM, and Medicaid lines of business within Delaware First Health; covers FDA-approved and select NCCN-recommended off-label indications and continuation criteria.
Revised quantity limit to 1,200 mg per day and 4 tablets per day and added requirement that request does not exceed health-plan approved quantity limit.
Treatment of BRCA‑mutated ovarian cancer after two or more therapies was changed to off-label usage due to FDA withdrawal but remains supported by NCCN.
Appendix E documents voluntary withdrawal of Rubraca for third-line BRCA‑mutated ovarian cancer indication effective June 10, 2022.
Appendix F restricts second-line ovarian cancer maintenance indication to BRCA‑mutated patients based on ARIEL3 OS findings.
Coverage Criteria for Rucaparib (Rubraca)
inv-01: Initial Therapy - Ovarian Cancer
Covered when ALL of the following are met for Ovarian Cancer (Initial Approval):
inv-02: Initial Therapy - Prostate Cancer
Covered when ALL of the following are met for Prostate Cancer (Initial Approval):
inv-03: Initial Therapy - Off-label NCCN Indications
Covered when ALL of the following are met for Off-label NCCN Compendium Recommended Indications:
inv-04: Continued Therapy
Continued Therapy (All Indications): must meet all
inv-05: Policy-level coverage conditions
Policy-level coverage stances and limits extracted from appendices and review notes
Patients without BRCA had increased risk of death; FDA requested label revision
Withdrawal effective June 10, 2022 based on ARIEL4 OS detriment
FDA indication updated to permit use earlier after androgen receptor-directed therapy; prior taxane failure removed per review notes
Added in 1Q 2026 review
Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents.
Initiation of rucaparib (Rubraca) for adult patients with a deleterious BRCA mutation (germline and/or somatic) associated with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies should not be started. The manufacturer voluntarily withdrew this third‑line approval effective June 10, 2022 after ARIEL4 results demonstrated a detrimental overall survival (OS) effect (ARIEL4 OS HR 1.31); new treatment starts for this indication are therefore excluded from initiation and may be denied.
Second‑line ovarian maintenance use of rucaparib is restricted to patients with a deleterious BRCA mutation. This label restriction was requested by the FDA after ARIEL3 final OS data showed an increased risk of death for patients without BRCA mutations (observed increases of 28% and 15% in certain subgroups); therefore, rucaparib should be used for second‑line ovarian maintenance only in the BRCA‑mutated population.
Initial Therapy Criteria and Dosing
inv-27: Initial Therapy
Initial therapy criteria by indication
inv-28: Initial therapy dosing
Dosing information and requirements for initiation where applicable
Dose cap 1,200 mg/day
Continuation and Continued Therapy Requirements
inv-29: Continuation Therapy
Continuation requirements for all indications
inv-30: Continued therapy after indication withdrawal
Continued therapy and prescriber attestation requirements added for indications with withdrawn approvals
See Appendix E
Provider Actions, Documentation, and Authorization
Prior authorization required — submit diagnosis, prescriber specialty, age, and BRCA status
Prior authorization is required. Provider must document the member's diagnosis, that the drug was prescribed by or in consultation with an oncologist (or urologist for prostate cancer), the member's age (≥18 years), and documented deleterious or suspected BRCA mutation when required by the indication. Include prior therapies and dosing within plan limits as part of the submission.
- Document diagnosis of relevant cancer (eg, epithelial ovarian, fallopian tube, primary peritoneal, or metastatic CRPC).
- Document prescriber specialty or consultation (oncologist; urologist for prostate cancer).
- Document age (≥ 18 years).
- When required by indication, document deleterious or suspected deleterious BRCA mutation status.
- Document prior therapies and requested dose (must be within plan-approved quantity limits).
Quantity limit — do not exceed plan-approved limits (1,200 mg/day; 4 tablets/day)
Ensure requests do not exceed the health-plan approved quantity limit. The policy's revised quantity limits cap dosing at 1,200 mg per day and a maximum of 4 tablets (or 4 capsules) per day.
- Maximum dose: 1,200 mg per day.
- Maximum tablets/capsules: 4 tablets or 4 capsules per day.
- Request must not exceed the member's health-plan approved quantity limit.
Generic substitution required when available; prior PARP inhibitor use disqualifies initiation
When generic rucaparib is available, providers should use the generic formulation unless contraindicated or clinically significant adverse events occur. Members who have previously received any PARP inhibitor are ineligible to initiate rucaparib for covered indications.
- Use generic rucaparib if available unless contraindicated or adverse events prevent substitution.
- Do not initiate rucaparib if the member has previously received a PARP inhibitor (eg, olaparib, talazoparib, niraparib, berzosertib/Akeega listed as examples).
Prior therapy for mCRPC — document failure of an androgen receptor‑directed therapy
For metastatic castration‑resistant prostate cancer (mCRPC) initial approvals, document prior failure of an androgen receptor‑directed therapy (for example, abiraterone or enzalutamide) unless such therapies are contraindicated or not tolerated.
- Record specific androgen receptor‑directed therapy tried (eg, abiraterone, enzalutamide, darolutamide, apalutamide).
- If therapies were not used due to contraindication or intolerance, document the clinical rationale.
Clinical documentation — include office notes, labs, and objective evidence
Submit supporting clinical documentation with the prior authorization request such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria.
- Include objective evidence of response or disease status per indication (eg, documentation of complete or partial response to platinum-based chemotherapy for ovarian indications).
- Provide mutation testing results when BRCA or other mutation status is required.
Required clinical documentation — concurrent ADT/orchiectomy and dosing/strengths
For metastatic CRPC patients, prescribers should document concurrent GnRH analog therapy or prior bilateral orchiectomy, and include the prescribed dosing and product strengths (tablets available in 200 mg, 250 mg, 300 mg).
- Document concurrent systemic ADT (GnRH analog) or prior bilateral orchiectomy.
- Document prescribed dose (eg, 600 mg PO twice daily for mCRPC) and tablet strength(s) used.
Documentation requirement — incomplete documentation may trigger denial
Failure to submit required documentation (office notes, labs, or other clinical information) demonstrating that the member meets the approval criteria may result in denial of the request.
- Ensure BRCA/mutation test results, prior therapy history, prescriber consultation notes, and dosing information are included to avoid denial.
Withdrawal-related denial risk — do not initiate for 3rd-line BRCA‑mutated ovarian indication
Do not initiate rucaparib for adult patients with deleterious BRCA‑mutated ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies; the manufacturer voluntarily withdrew this indication effective June 10, 2022 and such requests may be denied.
- Withdrawal effective June 10, 2022 based on ARIEL4 overall survival detriment (HR 1.31).
- Physicians should not start new treatment for this withdrawn third‑line BRCA‑mutated ovarian indication.
Second‑line ovarian maintenance restriction — limited to BRCA‑mutated patients; prescriber attestation may be required
Use of rucaparib as second‑line ovarian maintenance for patients without BRCA mutations is restricted due to an increased risk of death observed in ARIEL3; prescriber attestation acknowledging this risk may be required for continuation or exceptional cases.
- Second‑line maintenance indication is limited to BRCA‑mutated patients per Appendix F.
- Patients without BRCA mutations had increased risk of death; document prescriber attestation if continuation is requested for a patient affected by the restriction.
Dosing Limits and Coding Notes
Step Therapy and Prior Treatment Requirements
| Step | Requirement | Notes |
|---|---|---|
| 1 | Failure of an androgen receptor-directed therapy is required prior to initiation for metastatic castration‑resistant prostate cancer (mCRPC). | Examples include abiraterone, enzalutamide, darolutamide, apalutamide; exceptions for contraindication or intolerability are allowed. (See policy for documentation requirements.) |
| Step prior to rucaparib | Member must have progression despite androgen deprivation therapy and documented failure of an androgen receptor-directed therapy. | Aligned with FDA/NCCN: requirement updated in 1Q2024 to 'androgen receptor‑directed therapy' language; prior taxane failure removed. |
| Documented Item | Required Documentation | Status/Notes |
|---|---|---|
| Type of prior therapy | Name of the androgen receptor‑directed agent(s) previously used (e.g., abiraterone, enzalutamide, darolutamide, apalutamide). | Record must show failure, intolerance, or contraindication to the agent; prior authorization may be required for those therapies. |
| ADT status | Documentation that rucaparib will be prescribed concurrently with systemic ADT or that the member has had bilateral orchiectomy. | Required for mCRPC initiation per policy (Appendix D). |
| Mutation status | Documentation of deleterious germline and/or somatic BRCA1/2 mutation. | Required for prostate indication; include test reports or genetic consultation notes. |
Quantity Limits and Plan Dose Caps
Background on Rucaparib (Rubraca)
Rucaparib (Rubraca) is a PARP inhibitor indicated for maintenance treatment of adult patients with deleterious BRCA‑mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who responded to platinum‑based chemotherapy, and for treatment of adult patients with deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer after an androgen receptor‑directed therapy. The policy also recognizes select NCCN‑recommended off‑label indications with specific mutation requirements. The manufacturer withdrew the third‑line BRCA‑mutated ovarian indication effective June 10, 2022 based on ARIEL4 OS findings, and FDA‑requested label revisions limit second‑line ovarian maintenance to the BRCA‑mutated population.
Definitions and Abbreviations
Policy Revision History
1Q 2026 annual review updated approval language to require requests not exceed the health-plan approved quantity limit and revised the quantity limit to 1,200 mg per day and 4 tablets per day.
Manufacturer voluntarily withdrew Rubraca approval for third-line (after ≥2 chemotherapies) BRCA‑mutated ovarian cancer; policy documents withdrawal effective June 10, 2022 and recommends not initiating new treatment for this indication.
FDA-requested label revision restricted second-line ovarian cancer maintenance indication to BRCA‑mutated patients based on ARIEL3 overall survival findings.
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