CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy for Rubraca (rucaparib) — maintenance treatment of recurrent ovarian cancer

This clinical pharmacy program governs prior authorization and step-therapy requirements for Rubraca (rucaparib) maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer for Colorado Rocky Mountain Health Plans members; it affects prescribers and pharmacy benefit adjudication.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Rubraca (rucaparib)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateApr 1, 2025

Key ActionObtain prior authorization documenting trial or intolerance/contraindication to Lynparza (olaparib) or Zejula (niraparib), or provider attestation that those agents are not appropriate.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

Step therapyprogram type

Trial of alternativescoverage requirement

Recurrent ovarian cancerindication focus

Coverage Criteria for Rubraca (rucaparib)

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COVERAGE CRITERIA

Covered when ANY of the following are met:

Main approval pathways

Contraindication or intolerance pathway: Patient has a contraindication or history of intolerance to Lynparza (olaparib) OR Zejula (niraparib)
Provider attestation pathway: Provider attests patient is not an appropriate candidate for Lynparza (olaparib) and/or Zejula (niraparib) based on clinical status or comorbidities
Continuation pathway: As continuation of therapy AND patient has not received a manufacturer-supplied sample, access program assistance, or a 30-day free trial from a pharmacy to establish current Rubraca use

Pediatric automatic approval: For members under 19 years of age the prescription will automatically process without coverage review

Patients <19 years

Patients <19 years: Member is less than 19 years of age; prescription will automatically process without a coverage review

Other Indications

Other indications: Rubraca will be approved for other indications; authorization will be issued for 12 months. State mandates, federal requirements, and member-specific benefit plan coverage may affect coverage.

Authorization duration: 12 months

Coverage for Rubraca is subject to member-specific benefit plan terms and applicable state mandates. Some states mandate benefit coverage for off-label use or require use of specific compendia; where such mandates apply they supersede the policy language and criteria set forth in this document. Providers should verify the member’s plan benefits and any state-specific requirements prior to seeking authorization.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rubraca (rucaparib) when used for maintenance treatment of recurrent ovarian cancer. Members currently documented on Rubraca in claims history may continue therapy; new starts require prior authorization.

Authorization duration: up to 12 months
Prior authorization may be approved based on previous claim/medication history and diagnosis codes

Step Therapy

Step Therapy Requirement and Failure Consequences

Step therapy requires trial of Lynparza (olaparib) or Zejula (niraparib) before Rubraca will be approved for new-to-therapy members. If the required trial is not documented and no valid attestation is provided, coverage for Rubraca may be denied.

Step therapy applies to new starts only (members already on Rubraca per claims may continue)
Lack of documented trial or acceptable attestation = potential denial or request for additional information

Documentation Required

Required Documentation for Approval

To obtain approval when bypassing step therapy, the provider must submit documentation showing one of the following: (1) contraindication or history of intolerance to Lynparza (olaparib) or Zejula (niraparib); (2) provider attestation that the patient is clinically unsuitable for both Lynparza and Zejula due to clinical status or comorbidities; or (3) continuation of therapy for a current user who has not used manufacturer samples, access-program assistance, or a pharmacy 30‑day free trial to establish current use.

Acceptable documentation: medical records, prior medication history, allergy/intolerance documentation, provider attestation of clinical unsuitability
Providers should note whether patient received free samples or assistance from Rubraca access programs (this may affect continuation eligibility)

Definitions

Maintenance treatment — definition and key facts

DefinitionMaintenance treatment: therapy given to patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy to prolong disease control

Indication contextApplies to adult patients with recurrent disease; Rubraca indicated for deleterious BRCA mutation (germline and/or somatic)

Related agents (step requirement)Step therapy requires trial of Lynparza (olaparib) or Zejula (niraparib) prior to Rubraca for maintenance treatment

Continuation allowanceMembers currently on Rubraca as documented in claims history may continue their current therapy

Population noteNCCN recommends PARP inhibitors (Lynparza, Zejula, Rubraca) for germline or somatic BRCA1/2 mutation–associated recurrent disease

Initial Therapy Requirements

Initial therapy

Initial therapy requirements for Rubraca maintenance use

Initial approval paths

Contraindication or intolerance: Patient has a contraindication or history of intolerance to Lynparza (olaparib) OR Zejula (niraparib)
Provider attestation: Provider attests patient is not an appropriate candidate for Lynparza (olaparib) and/or Zejula (niraparib) based on clinical status or comorbidities

Step therapy requirement: Member must try Lynparza (olaparib) or Zejula (niraparib) prior to coverage for Rubraca unless documented contraindication/intolerance or provider attestation of unsuitability

Failure to document trial or attestation may trigger denial; document intolerance/contraindication or clinical unsuitability

Continuation of Therapy

Continuation therapy

Continuation of therapy conditions

Continuation of Rubraca: Approved as continuation of therapy provided the patient has not received manufacturer-supplied samples, access program assistance, or a 30-day free trial from a pharmacy to establish current Rubraca use

Authorization will be issued for 12 months

Step Therapy Table

Step	Requirement
1	Member must have tried Lynparza (olaparib) or Zejula (niraparib) prior to coverage for Rubraca (rucaparib) for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer (unless alternative criteria below are met).
2	Exception — Contraindication or intolerance: patient has a documented contraindication or history of intolerance to Lynparza (olaparib) or Zejula (niraparib).
3	Exception — Provider attestation: prescriber attests the patient is not an appropriate candidate for Lynparza and/or Zejula based on clinical status or comorbidities.
4	Continuation exception: approval as continuation of therapy when patient has not received manufacturer-supplied samples, access program assistance, or a 30-day free trial from a pharmacy to establish current Rubraca use; authorization issued for 12 months.

Background

Rubraca (rucaparib), along with Lynparza (olaparib) and Zejula (niraparib), belongs to the class of PARP inhibitors used in the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer for patients who have achieved a complete or partial response to platinum-based chemotherapy. This policy implements a step-therapy approach: for maintenance indications, coverage of Rubraca is contingent on trial and intolerance/contraindication to or clinical unsuitability of the alternative PARP inhibitors (Lynparza or Zejula), unless other approval pathways (such as continuation therapy or pediatric auto‑process for members <19) apply.