CurrentUnitedHealthcarePolicy 2025 P 3127-7

Step therapy program for Rubraca (rucaparib)

UnitedHealthcare step therapy policy requiring trials of Lynparza (olaparib) or Zejula (niraparib) before coverage of Rubraca for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer; also addresses continuation therapy and members <19 years. Affects prescribers and members under UnitedHealthcare pharmacy benefits.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy program for Rubraca (rucaparib)

Policy CodePolicy 2025 P 3127-7

Change TypeWording clarificationsprogram addition

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain and document trial of Lynparza or Zejula (or documented contraindication/intolerance or provider attestation) before requesting Rubraca; submit prior authorization for approved indications.

SourceLink

POLICY UPDATE CHANGES

Revised wording without change to clinical intent; updated references.

Program effective date 7/1/2025 documented.

2required prior step therapy alternatives (Lynparza or Zejula)

12 moauthorization duration when approved

≤19patients under age 19 auto-approve

2019-2025P&T approval history range

Coverage Criteria

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy program for Rubraca (rucaparib)

Policy CodePolicy 2025 P 3127-7

Change TypeWording clarificationsprogram addition

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

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Maintenance Treatment of Recurrent Ovarian Cancer

Covered when ONE of the following sets of conditions is met:

Primary approval paths: (1) Patient has a contraindication or history of intolerance to Lynparza (olaparza) OR Zejula (niraparib); OR (2) Provider attests patient is not an appropriate candidate for either Lynparza (olaparib) or Zejula (niraparib) based on clinical status or comorbidities; OR (3) Both continuation conditions are met: (a) request is for continuation of therapy AND (b) patient has not received manufacturer-supplied samples, assistance (e.g., sample card redeemable at pharmacy), or a 30-day free trial from a pharmacy to establish current user status.

Authorization will be issued for 12 months.

Patients less than 19 years of age

Covered when the following is met:

Pediatrics auto-approval: Member is less than 19 years of age.

Prescription will automatically process without a coverage review for members under 19.

Other Indications

Other indications: Rubraca will be approved for other indications per state mandates and member-specific benefit plan coverage.

Authorization will be issued for 12 months. State mandates and federal regulatory requirements may impact coverage.

Coverage decisions in this policy may be affected by statutory or regulatory requirements. State mandates that require coverage for specific off‑label medication uses or impose different compendium references take precedence and supersede the provisions of this document where they apply. Additionally, actual coverage for any individual depends on the member’s specific benefit plan; patient‑specific plan terms may restrict or alter coverage compared with the policy.

Initial Therapy Criteria

Initial Therapy

Initial coverage requirement for Rubraca:

Initial therapy step: Member new to therapy must trial Lynparza (olaparib) or Zejula (niraparib) prior to Rubraca unless there is documented contraindication or history of intolerance to those agents, or provider attests the patient is not an appropriate candidate.

Members currently on Rubraca per claims will be allowed to continue therapy.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rubraca (rucaparib) for maintenance treatment of recurrent ovarian cancer for all members age 19 and older. Authorization, when approved, will be issued for 12 months. Note: Members currently documented on Rubraca in claims history may be allowed to continue therapy.

Authorization duration: 12 months
Members with prior claims for Rubraca may continue without meeting step requirements

Step Therapy

Step Therapy Requirement

Step therapy is required for members new to therapy. Member must have tried and had contraindication or intolerance to Lynparza (olaparib) or Zejula (niraparib), or the provider must attest the patient is not an appropriate candidate for both agents, before Rubraca will be approved.

Step agents: Lynparza (olaparib); Zejula (niraparib)

Documentation Required

Providers must document prior therapy history demonstrating trial and intolerance or contraindication to Lynparza or Zejula, or provide a clinical attestation that the patient is not an appropriate candidate for those agents. For continuation requests, document that the patient is currently on Rubraca and has not used manufacturer or pharmacy-supplied free samples or assistance programs to establish current use.

Required documentation: prior therapy history showing trial and intolerance/contraindication to Lynparza or Zejula, or provider attestation of inappropriateness
For continuation: claims history or documentation showing active use and no reliance on manufacturer/pharmacy free samples or assistance programs

Denial Risk

Prior Step Not Met / Denial Risk

If the prior step is not met — i.e., failure to document a trial and intolerance/contraindication to Lynparza or Zejula and no provider attestation that both are inappropriate — coverage of Rubraca may be denied. UnitedHealthcare may also approve based solely on prior claims/medication history, diagnosis codes, or claim logic per program rules.

Denial risk if trial/intolerance/contraindication not documented and no attestation provided
Automated approvals may occur based on claims history or diagnosis codes in specific programs

Step Therapy Requirements

Step	Requirement	Exception criteria / notes
1	Member must trial Lynparza (olaparib) or Zejula (niraparib) prior to initiation of Rubraca (rucaparib) for maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer	Authorization will be issued for 12 months; members currently on Rubraca per claims may continue therapy
2	If patient has a documented contraindication or history of intolerance to Lynparza (olaparib) or Zejula (niraparib), Rubraca may be approved	Provider must document contraindication/intolerance; authorization issued for 12 months
3	Provider attestation that patient is not an appropriate candidate for Lynparza or Zejula based on clinical status/comorbidities	Provider attestation acceptable in lieu of prior trial; authorization issued for 12 months
4	Continuation exception: request is for continuation of Rubraca therapy	Patient must not have received manufacturer samples, assistance programs, or a 30‑day pharmacy free trial to establish current use; authorization issued for 12 months

Background

Rubraca (rucaparib), Lynparza (olaparib), and Zejula (niraparib) are members of the PARP inhibitor drug class used as maintenance therapy for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have responded to platinum‑based chemotherapy. These agents have overlapping indications for maintenance treatment, with differences in labeling (for example, language regarding BRCA mutation status varies by product). Clinical guidance such as NCCN supports use of all three agents for BRCA‑associated recurrent disease. For members under 19 years of age, prescriptions will automatically process without a coverage review per the benefit rules.

Definitions

Maintenance treatment of recurrent ovarian cancer — definition/key attributes

DefinitionTreatment given to patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy to delay progression.

Included agents (context)PARP inhibitors referenced in this program: Rubraca (rucaparib), Lynparza (olaparib), Zejula (niraparib).

Target populationAdult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer responding to platinum-based chemotherapy; BRCA mutation language varies by agent (germline and/or somatic for Rubraca).

Program intentUse of step therapy to encourage trial of lower-cost alternatives (Lynparza or Zejula) prior to coverage of Rubraca for maintenance treatment of recurrent disease.

Continuation allowanceMembers currently on Rubraca per claims history are permitted to continue therapy (new members must meet criteria).

OpenPayer