CurrentCignaPolicy N/A

Oncology (Oral - Poly [ADP-Ribose] Polymerase Inhibitor) - Rubraca Prior Authorization Policy

Prior authorization policy for oral PARP inhibitor Rubraca (rucaparib) covering FDA-approved indications and other uses with supportive evidence (pancreatic adenocarcinoma, uterine leiomyosarcoma) for Cigna-administered health benefit plans. Defines clinical criteria for approval (age, diagnosis, mutation status, prior therapies) and duration of approval.

Policy Summary

PayerCigna

PolicyOncology (Oral - Poly [ADP-Ribose] Polymerase Inhibitor) - Rubraca Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMultiple annual/selected updates

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; provide documentation of age, cancer type/stage/response, mutation status, prior therapies, and use of GnRH analog or bilateral orchiectomy as applicable.

SourceLink

POLICY UPDATE CHANGES

Pancreatic Adenocarcinoma indication and criteria were added to Other Uses with Supportive Evidence.

Condition of approval and criteria were removed from 'Other Uses with Supportive Evidence' for ovarian/fallopian tube/primary peritoneal cancer treatment.

Prostate Cancer: removed requirement for prior taxane-based (docetaxel) chemotherapy or intolerance to it.

Uterine Leiomyosarcoma: wording clarified to 'patient has tried at least one systemic regimen.'

Policy name was updated to 'Oncology (Oral - Poly [ADP-Ribose] Polymerase Inhibitor) - Rubraca PA Policy'.

Overview updated due to change in FDA labeled indication.

Prostate Cancer: removed wording 'germline and/or somatic' from BRCA mutation requirement.

Coverage Summary & Scope

This prior authorization policy applies to oral PARP inhibitor Rubraca (rucaparib) for Cigna-administered health benefit plans and covers FDA-approved indications and other uses with supportive evidence (pancreatic adenocarcinoma and uterine leiomyosarcoma). It defines clinical criteria for approval including patient age, diagnosis, mutation status, and prior therapies. Approvals are typically granted for 1 year for patients aged ≥ 18 who meet the applicable criteria.

Quick facts

Covered Indications4

Typical Approval Duration1 year

Age threshold (years)18

Last review date2026-01-28

FDA-Approved Indications — Ovarian / Fallopian Tube / Primary Peritoneal (Maintenance)

FDA-Approved Indications - Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (Maintenance Therapy)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ALL of the following

ALL of the following
- Patient is ≥ 18 years of age
- Patient is in complete or partial response after a platinum-based chemotherapy regimen
  Note: Examples of platinum-based chemotherapy regimen include carboplatin with gemcitabine, carboplatin with paclitaxel, cisplatin with gemcitabine.
- C) Patient meets ONE of the following (i or ii):
  - i.
    a):

COVERAGE — FDA-Approved Indication: Prostate (mCRPC)

FDA-Approved Indications - Prostate Cancer (metastatic castration-resistant)

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, and E):

ALL of the following

Patient is ≥ 18 years of age
Patient has metastatic castration resistant prostate cancer
Patient has BRCA mutation-positive disease
D) Patient meets ONE of the following (i or ii):
- i.: The medication is used concurrently with a gonadotropin-releasing hormone (GnRH) analog

OTHER USES WITH SUPPORTIVE EVIDENCE — Pancreatic Adenocarcinoma

Other Uses with Supportive Evidence - Pancreatic Adenocarcinoma

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ALL of the following

Patient is ≥ 18 years of age
Patient has a BRCA mutation or PALB2 mutation
C) Patient meets BOTH of the following (i and ii):
- i.: Patient has tried platinum-based chemotherapy
- ii.:

OTHER USES WITH SUPPORTIVE EVIDENCE — Uterine Leiomyosarcoma

Other Uses with Supportive Evidence - Uterine Leiomyosarcoma

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ref

title

criteria_group

Other Uses with Supportive Evidence - Uterine Leiomyosarcoma

b4_0

Operational note: policy wording was clarified to state the patient must have 'tried at least one systemic regimen' for uterine leiomyosarcoma.

Exclusions / Not Medically Necessary

Conditions Not Covered

Not medically necessary

Rubraca is considered not medically necessary for ANY other use(s) (i.e., uses not specified above)

Denial Risk

Denial for non-specified uses

Claims for Rubraca billed for indications other than the listed approved or supported uses will be denied as not covered.

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Rubraca; approvals are provided for 1 year when clinical criteria are met.

Documentation Required

Document mutation and prior therapies

Providers must document patient age; cancer type, stage, and response status; BRCA or PALB2 mutation status (as applicable); prior platinum-based chemotherapy and lack of progression when required; prior androgen receptor-directed therapy for prostate cancer; and concurrent use of a GnRH analog or history of bilateral orchiectomy where applicable.

Applicable Codes

DrugNDCCovered

No codes listed

Clinical Evidence & Guidelines

Evidence references: NCCN guideline recommendations include ovarian cancer (NCCN version 3.2025), pancreatic adenocarcinoma (NCCN version 2.2025), prostate cancer (NCCN version 5.2026), and uterine neoplasms (NCCN version 2.2026). The FDA-labeled indications include maintenance treatment for BRCA-mutated ovarian/fallopian tube/primary peritoneal cancer and treatment of BRCA-mutated mCRPC after androgen receptor-directed therapy.

Definitions

Platinum-based chemotherapy: examples include carboplatin with gemcitabine, carboplatin with paclitaxel, and cisplatin with gemcitabine.

Androgen receptor-directed therapy: examples include abiraterone, enzalutamide (Xtandi), darolutamide (Nubeqa), and apalutamide (Erleada).

GnRH analog: examples include leuprolide acetate (Lupron Depot), triptorelin (Trelstar), goserelin (Zoladex), degarelix (Firmagon), relugolix (Orgovyx), and histrelin (Vantas).

Rubraca (rucaparib) is a PARP inhibitor with FDA indications for maintenance treatment of BRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who respond to platinum-based chemotherapy, and for treatment of deleterious BRCA-mutated metastatic castration-resistant prostate cancer after androgen receptor-directed therapy. NCCN guidance also supports use in pancreatic adenocarcinoma with BRCA or PALB2 mutations and in selected uterine leiomyosarcoma scenarios.

Revision History

02/07/2024added

Pancreatic Adenocarcinoma indication and criteria were added to Other Uses with Supportive Evidence based on NCCN guideline updates.

06/05/2024removed

Condition of approval and criteria were removed from 'Other Uses with Supportive Evidence' for ovarian/fallopian tube/primary peritoneal cancer treatment in a prior selected revision.

02/12/2025revised

Prostate Cancer: removed requirement for prior taxane-based chemotherapy or intolerance to it.