CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rubraca (rucaparib)

Defines accepted indications, continuation, exclusions, coding, and applicable lines of business for Rubraca (rucaparib) use in cancer treatment, including FDA-approved and supported off-label uses per recognized compendia/guidelines. Applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island members across listed lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRubraca (rucaparib)

Policy CodePolicy N/A

Change TypeRevised (template conversion; coding/limits updates)

Effective Date

Next Review Date

Key ActionPrescriber must support use by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS manual standards; document BRCA testing as specified.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1301 Rubraca policy; updated exclusion criteria and references.

Added coding information with HCPCS code and updated maximum dosage form quantities in exclusion criteria.

2Covered Indications (ovarian, prostate)

7+Key references cited

1Drug code listed

Coverage Summary & Indications

Ovarian cancer — Covered indications

Rubraca (rucaparib) may be used when ANY of the following are met:

Ovarian covered indications

Newly diagnosed maintenance: Single agent maintenance therapy after complete or partial response to first line platinum-based therapy for BRCA 1 or 2 positive newly diagnosed stage II-IV ovarian cancer.
Recurrent platinum-sensitive maintenance: Single agent maintenance therapy in a member with stage II-IV ovarian carcinoma with recurrent platinum-sensitive disease, with a deleterious germline BRCA 1 or 2 mutation, after a complete or partial response to platinum-based therapy.

Prostate cancer — Covered indication

Rubraca (rucaparib) may be used as a single agent when ALL of the following criteria are met:

Prostate covered indication

Disease state: Member has metastatic castration-resistant prostate cancer.
Prior therapies: Member has experienced disease progression on an Androgen Receptor Directed therapy (e.g., abiraterone and/or enzalutamide) AND a taxane-based chemotherapy (e.g., docetaxel, cabazitaxel + steroid).
Biomarker: Member's cancer is positive for BRCA 1 or 2 mutation (germline testing on the member and/or somatic testing on the tumor tissue).

This policy applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island members across the listed lines of business (Commercial, Exchange/Marketplace, Medicaid). It defines accepted indications for Rubraca (rucaparib), including FDA-approved settings and off-label uses supported by CMS-recognized compendia or authoritative guidelines (e.g., NCCN, ASCO) as described in the policy.

Continuation Therapy & Exemptions

Continuation requests for not-approvable medication (exemption)

Continuation requests for a not-approvable medication are exempt from this Evolent policy when ALL of the following are met:

Continuation exemption

No progression: The member has not experienced disease progression on the requested medication.
Recent prior use: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No added medications: Additional medication(s) are not being added to the continuation request.

Operational note: Evolent is responsible for processing all medication requests and enforces prior authorization and documentation requirements; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Continuation requests for previously authorized (not-approvable) therapy may be exempt when all of the following are met: no disease progression on the medication, the medication was used within the last year without a lapse >30 days of active authorization, and no additional medications are being added to the continuation request.

Exclusion Criteria and Investigational Uses

Ovarian cancer — Not supported

Monotherapy not supported when ANY of the following apply:

Ovarian not supported

Monotherapy after multiple lines: Persistent disease or recurrence in members (with or without deleterious germline BRCA mutation) who have been treated with two or more lines of chemotherapy — monotherapy not supported based on FDA withdrawal after ARIEL-4 findings.
ARIEL-4 showed lack of overall survival benefit with rucaparib versus chemotherapy in relapsed BRCA-mutated high-grade ovarian cancers.

Exclusion criteria (conditions that make use not covered)

Use is excluded when ANY of the following apply:

Exclusion criteria

Progression on PARP: Disease progression while receiving Rubraca (rucaparib) or another PARP inhibitor (e.g., Zejula (niraparib) or Lynparza (olaparib)).
Exceeds maintenance lines: Use of Rubraca (rucaparib) exceeding more than 1 line of maintenance therapy for recurrent ovarian cancer.
Lack of BRCA testing: Lack of documented BRCA 1 or 2 testing: germline testing required for members with ovarian cancer AND germline and/or somatic mutation testing on the tumor tissue.
Concurrent chemo: Concurrent use with chemotherapy.
Single dose limit: Dosing exceeds single dose limit of Rubraca (rucaparib) 600 mg.600 mg
Monthly tablet limits: Treatment exceeds the maximum limit of 120 (300 mg), 120 (250 mg), or 120 (200 mg) tablets/month.120 tablets/month by strength
Investigational off-label: Investigational use with an off-label indication that lacks sufficient evidence or is not generally accepted by the medical community (insufficient CMS compendia support or acceptable peer-reviewed literature).
Investigational evidence considerations
- Clinical characteristics representation: Whether the clinical characteristics of the patient and the cancer are adequately represented in the published evidence.
- Therapy regimen representation: Whether the administered oncologic therapy regimen is adequately represented in the published evidence.
- Clinically meaningful outcomes: Whether reported study outcomes represent clinically meaningful outcomes (ASCO guidance: e.g., Hazard Ratio < 0.80 and OS/PFS benefit at least 3 months).HR < 0.80; OS/PFS ≥ 3 months
- Appropriate experimental design: Whether the experimental design is appropriate to address the investigative question (randomization, blinding, placebo, crossover as relevant).
Non-randomized trials: Non-randomized clinical trials with a significant number of subjects may be supportive evidence but are not sufficient alone (listed as exclusion considerations).
Case reports/abstracts: Case reports and meeting abstracts without full peer-reviewed articles lack adequate evidence for accepted uses of drugs.

Platinum-sensitive: Implied recurrence after response to platinum-based therapy (policy references platinum-sensitive recurrent disease for ovarian cancer).

Prior Authorization, Documentation & Billing Rules

Prior Authorization

Prior authorization processing

All medication requests for rucaparib (Rubraca) are processed by Evolent. Prescribers must submit prior authorization requests to Evolent using the listed drug code. HCPCS/J‑code: J8999.

Documentation Required

Support for drug use

Prescribers must support use with one of the following sources: FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature that meets CMS standards. Document BRCA testing per indication: germline BRCA testing is required for members with ovarian cancer; for prostate cancer, germline testing and/or somatic tumor testing for BRCA 1/2 is required.

Accepted evidence sources: FDA labeling, CMS‑recognized compendia, NCCN, ASCO, or acceptable peer‑reviewed literature meeting CMS manual standards.
BRCA testing: germline required for ovarian cancer; germline and/or somatic tumor testing acceptable for prostate cancer.

Billing Rule

Dose and quantity limits enforcement

Do not exceed single dose of 600 mg. Monthly tablet maximums are limited to 120 tablets per month at the listed strengths: 300 mg, 250 mg, or 200 mg. Billing and claims must reflect dosing and quantity that comply with these limits.

Single dose limit: 600 mg
Maximum tablets per month: 120 (300 mg), 120 (250 mg), or 120 (200 mg)
Billing must reflect compliant dosing and quantities

Denial Risk

Denial risk for excluded situations

Claims may be denied when use meets exclusion criteria, including disease progression while on a PARP inhibitor, exceeding allowed maintenance therapy lines, lack of required BRCA testing, concurrent chemotherapy, or dosing/quantity that exceed specified limits.

Progression while receiving Rubraca or another PARP inhibitor
Use exceeding more than one line of maintenance therapy for recurrent ovarian cancer
Lack of documented BRCA 1 or 2 testing (germline required for ovarian; germline and/or somatic for prostate)
Concurrent use with chemotherapy
Dosing exceeds single dose 600 mg or monthly tablet limits

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRubraca (rucaparib)

Policy CodePolicy N/A

Change TypeRevised (template conversion; coding/limits updates)

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Rubraca (rucaparib)

Coverage Summary & Indications

Continuation Therapy & Exemptions

Exclusion Criteria and Investigational Uses

Applicable Codes

Prior Authorization, Documentation & Billing Rules

Key Evidence & Trial Findings

Background & Purpose

Policy Changes & Revision History