CurrentCignaPolicy N/A

Oncology - Rubraca Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for Rubraca (rucaparib) for FDA-approved indications and select supportive-evidence uses in adults.

Policy Summary

PayerCigna

PolicyOncology - Rubraca Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClinical criteria updates and additions

Effective DateN/A

Next Review DateFeb 12, 2025

Key ActionSubmit prior authorization with documentation of diagnosis, age (≥18), required biomarker status (BRCA and/or PALB2 where applicable), prior platinum-based chemotherapy and response, and prior therapies as specified.

SourceLink

POLICY UPDATE CHANGES

Ovarian maintenance criterion changed from response after at least two platinum-based regimens to response after a platinum-based chemotherapy regimen.

Added criteria allowing approval for patients with recurrent disease and a BRCA mutation, or for patients in response to first-line primary treatment for ovarian/fallopian tube/primary peritoneal cancer.

Pancreatic adenocarcinoma indication and criteria were added as an other use with supportive evidence.

3FDA-approved indications listed

1 yearTypical approval duration

4Other uses with supportive evidence

NCCN cited

Policy Summary

PayerCigna

PolicyOncology - Rubraca Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClinical criteria updates and additions

Effective DateN/A

Next Review DateFeb 12, 2025

SourceLink

On This Page

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Coverage and Medical Necessity Criteria

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

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

Ovarian maintenance criteria: A) Patient is ≥ 18 years of age;

Ovarian maintenance criteria: B) Patient is in complete or partial response after a platinum-based chemotherapy regimen;

Examples of platinum-based chemotherapy regimen include carboplatin with gemcitabine, carboplatin with paclitaxel, cisplatin with gemcitabine.

Ovarian maintenance criteria

ONE of: i) Patient meets BOTH of the following: a) Patient has recurrent disease; AND b) Patient has a BRCA mutation; OR ii) Patient is in complete or partial response to first-line primary treatment.

Prostate Cancer - Metastatic Castration-Resistant (FDA-approved)

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

Prostate criteria: A) Patient is ≥ 18 years of age;

Prostate criteria: B) Patient has metastatic castration resistant prostate cancer;

Prostate criteria: C) Patient has BRCA mutation-positive (germline and/or somatic) disease;

Prostate criteria

ONE of: i) The medication is used concurrently with a gonadotropin-releasing hormone (GnRH) analog; OR ii) Patient has had a bilateral orchiectomy;
Examples of GnRH analogs include leuprolide acetate, Lupron Depot, Trelstar, Vantas, Firmagon, Zoladex, degarelix, Orgovyx.

Pancreatic Adenocarcinoma - Other Uses with Supportive Evidence (NCCN)

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

Pancreatic criteria: A) Patient is ≥ 18 years of age;

Pancreatic criteria: B) Patient has a BRCA mutation or PALB2 mutation;

Pancreatic criteria: C) Patient meets BOTH of the following: i) Patient has tried platinum-based chemotherapy; AND ii) Patient has not had disease progression following the most recent platinum-based chemotherapy.

NCCN lists this as 'Useful in Certain Circumstances' for metastatic disease post-platinum.

Uterine Leiomyosarcoma - Other Uses with Supportive Evidence (NCCN)

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

Uterine leiomyosarcoma criteria: A) Patient is ≥ 18 years of age;

Uterine leiomyosarcoma criteria: B) Patient has BRCA2-altered disease;

Uterine leiomyosarcoma criteria: C) Patient has tried one systemic regimen.

Examples of a systemic regimen include dacarbazine, docetaxel, doxorubicin, gemcitabine, ifosfamide, trabectedin (Yondelis).

Rubraca (rucaparib) is considered experimental, investigational, or unproven for any indications not specifically listed in this policy. Requests for uses outside the enumerated coverage criteria may be denied and will be reviewed only as new published evidence becomes available.

Prior Authorization and Provider Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Rubraca; approvals are provided for the durations specified (typically 1 year).

Step Therapy

Required prior therapies

For certain indications, the patient must have prior exposure to platinum-based chemotherapy or at least one prior systemic regimen before approval.

Ovarian maintenance: patient must be in response after a platinum-based chemotherapy regimen (examples: carboplatin with gemcitabine, carboplatin with paclitaxel, cisplatin with gemcitabine).
Pancreatic adenocarcinoma maintenance: patient must have tried platinum-based chemotherapy and not had disease progression following the most recent platinum-based chemotherapy.
Uterine leiomyosarcoma: patient must have tried one systemic regimen (examples: dacarbazine, docetaxel, doxorubicin, gemcitabine, ifosfamide, trabectedin).

Allowed Regimens and Treatment Settings

Indication	Regimen	Dose / Schedule / Notes	Coverage status
Ovarian, Fallopian Tube, or Primary Peritoneal Cancer — maintenance therapy after platinum-based chemotherapy response
Single‑agent Rubraca (rucaparib) as maintenance therapy
Approve for 1 year when patient is ≥ 18 years, in complete or partial response after a platinum‑based chemotherapy regimen (examples: carboplatin with gemcitabine, carboplatin with paclitaxel, cisplatin with gemcitabine). Approve for either: i) recurrent disease with a BRCA mutation, or ii) response to first‑line primary treatment.
Covered with criteria

Indication	Regimen	Dose / Schedule / Notes	Coverage status
Metastatic castration‑resistant prostate cancer (mCRPC) with deleterious BRCA mutation
Rubraca (rucaparib) single‑agent treatment
Approve for 1 year when patient is ≥ 18 years, has BRCA mutation‑positive (germline and/or somatic) mCRPC, and meets one of: i) used concurrently with a GnRH analog (examples listed in policy) OR ii) has had bilateral orchiectomy. Patient must have been previously treated with at least one androgen receptor‑directed therapy.
Covered with criteria

Treatment Intent and Line Definitions

maintenance

maintenance: Patients should be in complete or partial response following platinum-based chemotherapy (ovarian, pancreatic) or have completed prior therapy with documented response/no progression as specified.

treatment (mCRPC)

mCRPC treatment: For mCRPC with BRCA mutation after androgen receptor-directed therapy (and usually after taxane), Rubraca is indicated as treatment rather than maintenance per FDA labeling; prior androgen receptor-directed therapy is required.

Genomic and Biomarker Testing Requirements

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

MarkerBRCA (germline and/or somatic)

Required forOvarian maintenance (recurrent-disease pathway) and ovarian maintenance in select first-line responders; Prostate mCRPC treatment; Pancreatic maintenance if BRCA-mutated; Uterine leiomyosarcoma when BRCA2-altered (per other-use guidance)

Age requirementPatient must be ≥ 18 years of age for covered indications requiring BRCA status

Clinical contextFor ovarian maintenance: patient must be in complete or partial response after a platinum-based chemotherapy regimen; for prostate mCRPC: BRCA mutation–positive disease in patients previously treated with at least one androgen receptor-directed therapy; for pancreatic maintenance: used after prior platinum with no progression

PALB2 — biomarker requirement for certain indications

Key Terms and Examples

Definition — deleterious BRCA mutation (germline and/or somatic)

Termdeleterious BRCA mutation (germline and/or somatic)

DefinitionA pathogenic BRCA1 or BRCA2 alteration detected in germline and/or somatic testing associated with susceptibility to PARP inhibitor therapy

Policy usesDefines eligibility for Rubraca maintenance in ovarian, and as treatment in metastatic castration-resistant prostate cancer; also referenced for pancreatic and uterine indications where applicable

Examples — androgen receptor-directed therapy

TermAndrogen receptor-directed therapy (examples)

ExamplesAbiraterone; Enzalutamide (Xtandi); Darolutamide (Nubeqa); Apalutamide (Erleada)

Clinical Background

Rubraca (rucaparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor. It is FDA-approved for maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults responding to platinum-based chemotherapy, and for treatment of metastatic castration-resistant prostate cancer with a deleterious BRCA mutation following prior androgen receptor-directed therapy and taxane. The agent has also been discussed in clinical practice guidelines for additional tumor types.