CurrentUnitedHealthcarePolicy N/A

Orgovyx (relugolix) prior authorization

Criteria and authorization rules for coverage of Orgovyx (relugolix) for treatment of adult patients with advanced prostate cancer; applies to UnitedHealthcare clinical pharmacy programs and affected members/prescribers.

Policy Summary

PayerUnitedHealthcare

PolicyOrgovyx (relugolix) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionSubmit prior authorization documenting diagnosis of advanced prostate cancer; for reauthorization, document no evidence of disease progression.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization duration

Age <19auto-process for age <19

Category 1/2A/2BNCCN recognition

2021-2025P&T review history

Coverage Criteria for Orgovyx (relugolix)

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Initial Authorization: Diagnosis of advanced prostate cancer

Orgovyx indicated for adult patients with advanced prostate cancer

Age <19 auto-process: Prescriptions for members under the age of 19 will automatically process without a coverage review

Orgovyx will be approved for patients less than 19 years of age

Reauthorization requirement: Patient does not show evidence of progressive disease while on Orgovyx therapy

Requirement for continuation of therapy

NCCN recognition: Drug recognized by the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B

Supportive recognition may guide coverage

Member-specific benefit plan exclusions, state mandates, federal regulatory requirements, and other utilization management programs may affect coverage decisions. Some states mandate benefit coverage for certain off-label medication uses or require use of particular compendia, and where such mandates apply they supersede language in the benefit document or notification criteria. Providers should refer to the member's plan specifics to determine exclusion status and any applicable state or federal requirements.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization criteria — Initial and reauthorization

Prior authorization required. Initial authorization will be approved only when the patient has a diagnosis of advanced prostate cancer. Reauthorization will be approved only when documentation shows the patient does not have evidence of progressive disease while on Orgovyx (relugolix) therapy.

Initial authorization: Diagnosis = advanced prostate cancer
Reauthorization: Documentation of no progressive disease while on therapy

Note

Automated approval and supply limits

Automated approval or reapproval may be used based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic. Supply limits may apply. Check program-specific processes for automated workflows.

Automated approvals based on claim/medication history and ICD-10 diagnosis codes
Supply limits may be in place

Denial Risk

Denial risk due to plan or mandate

Coverage may be impacted by member-specific benefit plan exclusions, state mandates, or other utilization management programs. Where state mandates require coverage or use of alternate Compendia, those mandates supersede the criteria below. Refer to the member’s plan specifics to determine exclusion status.

Plan exclusions and benefit design may deny coverage
State mandates or other utilization management programs may alter coverage requirements

Documentation Required

Supporting references

Refer to the product prescribing information and the NCCN Compendium for supporting clinical documentation as needed when submitting prior authorization requests.

Background

Orgovyx (relugolix) is an oral gonadotropin‑releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer. The policy recognizes NCCN Compendium recommendations and aligns coverage to that indication while noting that program-specific rules and state mandates may modify coverage determinations.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization/continuation criteria

Continuation: Patient does not show evidence of progressive disease while on Orgovyx therapy

Authorization may be renewed if no progression is documented

Quantity Limits and Supply

Orgovyx (relugolix) — Supply limits and approval rules

Automated approval pathwaysUnitedHealthcare may approve initial and reauthorization based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic

Supply limitsSupply limits may be in place

Program variationUse of automated approval and re-approval processes varies by program and/or therapeutic class

Plan-specific exclusionsRefer to member’s plan specifics to determine exclusion status