Centene Rubraca Coverage Update: Prior Auth

Coverage Criteria for Rucaparib (Rubraca)

inv-01: Initial Therapy — Ovarian Cancer

Covered when ALL of the following are met for Ovarian Cancer (Initial Approval):

Ovarian Cancer initial: 1. Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For brand Rubraca requests, member must use generic rucaparib if available unless contraindicated or clinically significant adverse events are experienced; 5. Prescribed as a single agent; 6. Member meets one of the following (a or b): (a) Documentation of deleterious or suspected deleterious BRCA mutation AND completed platinum-based chemotherapy with complete or partial response, OR (b) Newly diagnosed stage II–IV disease AND completed first-line platinum-based chemotherapy with complete or partial response; 7. Member has not previously received a PARP inhibitor; 8. Request does not exceed health-plan approved quantity limit; 9. Request meets one of the following: (a) Dose does not exceed 1,200 mg per day and 4 tablets per day, OR (b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

See Appendices B, D, F for examples and details.

inv-02: Initial Therapy — Prostate Cancer (mCRPC)

Covered when ALL of the following are met for Prostate Cancer (Initial Approval):

Prostate Cancer initial: 1. Diagnosis of metastatic castration-resistant prostate cancer (mCRPC) with progression despite androgen deprivation therapy (ADT); 2. Prescribed by or in consultation with an oncologist or urologist; 3. Age ≥ 18 years; 4. Documented deleterious germline and/or somatic BRCA1/2 mutation; 5. For Rubraca requests, member must use generic rucaparib if available unless contraindicated or clinically significant adverse events are experienced; 6. Prescribed concurrently with systemic ADT or member has had bilateral orchiectomy; 7. Failure of an androgen receptor-directed therapy (e.g., abiraterone, enzalutamide, darolutamide, apalutamide), unless contraindicated or not tolerated; 8. Member has not previously received a PARP inhibitor; 9. Request does not exceed health-plan approved quantity limit; 10. Request meets one of the following: (a) Dose does not exceed 1,200 mg per day and 4 capsules per day, OR (b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Select patients based on documented deleterious BRCA mutation and prior AR-directed therapy per updated labeling/NCCN.

inv-03: Off-label — NCCN Recommended Indications

Covered when ALL of the following are met for NCCN Compendium Recommended Off-label Indications:

Off-label NCCN indications: 1. Diagnosis of pancreatic adenocarcinoma or uterine sarcoma; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For Rubraca requests, member must use generic rucaparib if available unless contraindicated or clinically significant adverse events are experienced; 5. For pancreatic adenocarcinoma: deleterious germline and/or somatic BRCA mutation OR deleterious germline PALB2 mutation; for uterine sarcoma: BRCA2 mutation as specified by compendium; 6. Prescribed as a single-agent subsequent therapy; 7. Member has not previously received a PARP inhibitor; 8. Request does not exceed health-plan approved quantity limit; 9. Dose is within FDA maximum limit for any FDA-approved indication (or supported by practice guidelines/peer-reviewed literature with prescriber evidence).

NCCN Drugs & Biologics Compendium recommendation required; prescriber must submit supporting evidence when dose exceeds standard.

inv-04: Continuation/Renewal Criteria

Covered when ALL of the following are met for Continuation Therapy (Renewal):

Continuation: 1. Member is currently receiving medication via Centene benefit or documentation supports member has received rucaparib for at least 30 days; 2. For ovarian cancer: if request is for an adult with deleterious BRCA mutation who has been treated with two or more chemotherapies, provider attestation acknowledging manufacturer withdrawal due to potential overall survival detriment; 3. For ovarian cancer maintenance in nondeleterious BRCA, provider attestation acknowledging possible OS detriment; 4. Member is responding positively to therapy per treating clinician documentation; 5. For Rubraca requests, member must use generic rucaparib if available unless contraindicated or clinically significant adverse events are experienced; 6. Request does not exceed health-plan approved quantity limit; 7. If request is for a dose increase, new dose must not exceed 1,200 mg per day and 4 tablets per day unless supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

See Appendices E and F for attestation language and rationale.

inv-05: Coverage criteria (dosing, indications, and restrictions)

Covered when ALL of the following are met for the respective indication

Ovarian cancer - maintenance (second-line): Patient has epithelial ovarian, fallopian tube, or primary peritoneal cancer receiving second-line maintenance and tumor is BRCA-mutated (restriction based on ARIEL3 and FDA request).BRCA mutation positive

Second-line maintenance restricted to BRCA-mutated patients per Appendix F; prescriber documentation required.

Ovarian cancer - third-line BRCA-mutated: Physicians should not initiate new treatment with rucaparib for adult patients with deleterious BRCA mutation who have been treated with two or more chemotherapies due to voluntary withdrawal after ARIEL4 overall survival detriment.N/A

Manufacturer withdrawal effective June 10, 2022 (Appendix E).

mCRPC indication: Patient has metastatic castration-resistant prostate cancer and has progressed after an androgen receptor-directed therapy (e.g., abiraterone, enzalutamide); patient is on concurrent ADT or has had bilateral orchiectomy; dosing up to 600 mg PO BID (maximum 1,200 mg/day).

Non–FDA–approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (for example, CP.CPA.09 for commercial lines, HIM.PA.154 for Marketplace, and CP.PMN.53 for Medicaid) or other approved evidence‑of‑coverage documents. Prior authorization requests for such off‑label uses must include supporting clinical information per those off‑label policies.

Clovis Oncology voluntarily withdrew the Rubraca indication for treatment of adult patients with a deleterious BRCA (germline and/or somatic)‑associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received two or more chemotherapies; the withdrawal was effective June 10, 2022. This action followed ARIEL4 results showing an overall survival detriment for rucaparib versus chemotherapy. Consequently, physicians should not initiate new treatment with rucaparib in this third‑line BRCA‑mutated ovarian cancer setting.

Uses of rucaparib outside FDA‑approved indications or those listed in the NCCN Compendium that lack sufficient supporting evidence are considered not authorized. Requests for such indications should be evaluated under the plan’s off‑label use policies and require submission of adequate documentation of clinical benefit and safety to be considered for coverage.

Second‑line maintenance use of rucaparib for epithelial ovarian, fallopian tube, or primary peritoneal cancer is restricted to patients with a deleterious BRCA mutation. This restriction was requested by the FDA based on ARIEL3 data showing increased risk of death in non‑BRCA patients; therefore rucaparib maintenance in the second‑line setting is authorized only for BRCA‑mutated tumors.

Approved and Recommended Regimens

Regimen	Coverage status	Notes / limits
Rucaparib as a single agent; dosing up to 1,200 mg/day (maximum 4 tablets/capsules per day)		Prescribed regimen must be FDA‑approved or recommended by NCCN; dose may exceed limits only if supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence). Request must not exceed health‑plan approved quantity limit.

Dosing	Maximum daily dose	Product strengths available
Standard dosing — 600 mg orally twice daily (600 mg PO BID)	1,200 mg/day	Tablets: 200 mg, 250 mg, 300 mg

Line of Therapy Guidance

inv-25: maintenance

Maintenance use:

Maintenance therapy after response to platinum-based chemotherapy for eligible ovarian cancer patients (including newly diagnosed stage II–IV after first-line platinum-based chemotherapy when criteria met); standard maintenance dosing is 600 mg PO BID (maximum 1,200 mg/day).600 mg PO BID; max 1,200 mg/day

Second-line maintenance restricted to BRCA-mutated tumors per Appendix F.

inv-26: second-line

Second-line - Prostate: Treatment for metastatic castration-resistant prostate cancer after failure of an androgen receptor-directed therapy; must be given with concurrent ADT or after bilateral orchiectomy; standard regimen 600 mg PO BID (max 1,200 mg/day).Prior AR-directed therapy failure

Updated to require prior AR-directed therapy per 1Q2024 review.

Biomarker Requirements and Testing

BRCA (germline and/or somatic) — biomarker requirement for certain FDA indications

BiomarkerDeleterious germline and/or somatic BRCA1/2 mutation required for FDA-approved indications (e.g., ovarian maintenance, mCRPC).

Indication linkageRequired for maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in response to platinum-based chemotherapy.

DocumentationProvider must document deleterious or suspected deleterious BRCA mutation in the medical record (see Appendix F/Appendix B references).

PALB2 (germline) — listed biomarker

BiomarkerDeleterious germline PALB2 mutation (germline) accepted for NCCN-compendium pancreatic adenocarcinoma off-label indication.

Use case

Dosing Limits and Quantity Constraints

Maximum daily dose — 1,200 mg per day

Maximum daily dose1,200 mg per day.

Standard regimenTypical dosing is 600 mg PO BID (total 1,200 mg/day).

Dose limit enforcementRequests exceeding 1,200 mg/day may be denied unless supported by guidelines or peer-reviewed literature and documented by prescriber.

Maximum tablets/capsules per day — 4 tablets/capsules per day

Tablet/capsule limit4 tablets/capsules per day.

Typical administrationAdministered as 600 mg PO BID using available tablet strengths (200, 250, 300 mg).

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required and Duration

Prior authorization is required. Initial approvals for maintenance indications (Medicaid and HIM) may be issued for up to 12 months. Requests must not exceed the health-plan approved quantity limit (maximum 1,200 mg per day and 4 tablets/capsules per day unless supported by guideline or peer-reviewed literature).

Initial approval duration: up to 12 months for maintenance (Medicaid/HIM)
Quantity limit: 1,200 mg/day and 4 tablets/capsules per day
Dose exceptions allowed only if supported by practice guidelines or peer-reviewed literature and prescriber provides evidence

Documentation Required

Required Supporting Documentation

Prescribers must submit supporting documentation (office/clinic notes, pathology reports, laboratory results including BRCA testing where applicable, prior therapy records, and any relevant imaging) demonstrating the member meets all applicable criteria.

Background and Drug Information

Rucaparib (Rubraca) is an oral poly(ADP‑ribose) polymerase (PARP) inhibitor indicated for multiple oncology settings. Approved indications include maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients with a deleterious BRCA mutation who responded to platinum‑based chemotherapy, and treatment of BRCA‑mutated metastatic castration‑resistant prostate cancer after prior androgen receptor‑directed therapy. Dosing for approved indications is commonly 600 mg PO twice daily (maximum 1,200 mg/day), with tablets available in 200, 250, and 300 mg strengths. Note that the manufacturer withdrew the third‑line BRCA‑mutated ovarian cancer treatment indication due to an observed overall survival detriment (ARIEL4), and the second‑line ovarian maintenance indication was restricted to BRCA‑mutated patients per FDA request.

Definitions and Abbreviations

androgen deprivation therapy — ADT definition

DefinitionAndrogen deprivation therapy (ADT): interventions that lower androgen levels or block androgen action, including bilateral orchiectomy, LHRH agonists/antagonists, and anti-androgens.

ExamplesExamples include surgical castration (bilateral orchiectomy), LHRH agonists (goserelin, leuprolide, triptorelin), LHRH antagonists (degarelix, relugolix), and anti-androgens (bicalutamide, flutamide, nilutamide).

Clinical noteADT is required to be continued when additional therapies are applied in CRPC per NCCN guidance.

poly (ADP-ribose) polymerase — PARP definition

DefinitionPARP: poly (ADP-ribose) polymerase, a class of enzymes targeted by rucaparib and other PARP inhibitors.

Clinical context

Revision History and Policy Changes

2026-01-05operational revisionLatest

Revised quantity limit to 1,200 mg per day and 4 tablets per day, added requirement that requests do not exceed the health-plan approved quantity limit for all indications, and extended initial approval duration for Medicaid and HIM maintenance coverage from 6 months to 12 months.

2024-10-25clinical alignment update

Updated mCRPC criteria to require failure of an androgen receptor-directed therapy (e.g., abiraterone, enzalutamide) to align with FDA indication and NCCN compendium; removed outdated NCCN ovarian guideline information and updated references.

OpenPayer

Rucaparib (Rubraca) Coverage Criteria