CurrentColorado Rocky Mountain Health PlansPolicy 1 = 2026 P 1350-6

Orgovyx (relugolix) prior authorization

Prior authorization/notification criteria for Orgovyx (relugolix) for treatment of adult patients with advanced prostate cancer; applies to Colorado Rocky Mountain Health Plans' clinical pharmacy program and members (automatic processing for patients under 19).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOrgovyx (relugolix) prior authorization

Policy CodePolicy 1 = 2026 P 1350-6

Change TypeNo material changes

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit prior authorization showing diagnosis of advanced prostate cancer; prescriptions for members under 19 will automatically process.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

2021-2026P&T approvals

automaticpatients <19

recognizedNCCN status

Coverage Criteria for Orgovyx (relugolix)

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Patients less than 19 years

Special-case processing for patients under 19:

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

State mandates and member specific benefit plans may still apply.

NCCN Recommended Regimens

Guidance:

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

State mandates may supersede policy language; other utilization management programs may apply.

Some states may mandate coverage for off‑label uses or require use of alternate compendia; where such state mandates apply, they supersede the language in this policy. Plan benefit exclusions and supply limits may also affect coverage determinations—refer to the member's specific plan for exclusion status. In addition, automated approval and re‑approval processes may be used in certain programs; these processes vary by program and therapeutic class and may result in approval decisions that rely on previous claims/medication history, diagnosis codes, and claim logic.

For members under 19 years of age, prescriptions for Orgovyx will automatically process without a coverage review. When prior authorization is required for other members, the policy’s stated clinical criteria apply; if state or federal mandates require different handling, those mandates take precedence.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Orgovyx (relugolix) except for prescriptions for members under 19 years of age, which will automatically process without a coverage review. Initial authorization will be approved for patients with a diagnosis of advanced prostate cancer. Reauthorization will be approved when the patient does not show evidence of progressive disease while on Orgovyx therapy. Providers should be aware that automated approval and re‑approval processes may be used based on prior claim/medication history, diagnosis codes (ICD‑10) and/or claim logic; supply limits may apply and plan exclusions should be checked in plan-specific documents.

Initial authorization: diagnosis of advanced prostate cancer required
Reauthorization: no evidence of progressive disease while on Orgovyx
Members under 19: prescriptions automatically process without coverage review
Automated approvals may occur based on prior claim/medication history, ICD‑10 codes, and claim logic
Supply limits and plan exclusions may apply; check plan specifics

Step Therapy

No step therapy requirements are stated in this document.

Note

References for Providers

Use Orgovyx package insert (Oct 2025) and the NCCN Drugs and Biologics Compendium as reference sources. Change control history and annual reviews are documented (updates through 02/2026).

Background

Orgovyx (relugolix) is a gonadotropin‑releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer. The agent is recognized in the NCCN Drugs and Biologics Compendium with categories of evidence and consensus (Category 1, 2A, or 2B) for the relevant oncology indications.

Authorization for Orgovyx under this policy supports treatment of advanced prostate cancer in adults; initial coverage requires a diagnosis of advanced prostate cancer, and reauthorization requires documentation that the patient does not show evidence of progressive disease while on therapy. References include the Orgovyx package insert (Sumitomo Pharma America; October 2025) and the NCCN Drugs and Biologics Compendium.

Definitions

Advanced prostate cancer — definition/indication

DefinitionAdvanced prostate cancer — the clinical indication for Orgovyx (relugolix) per product labeling (GnRH receptor antagonist indicated for treatment of adult patients with advanced prostate cancer).

Source labelingOrgovyx (relugolix) indicated for treatment of adult patients with advanced prostate cancer (product background).

NCCN recognitionAgent is recognized in the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus 1, 2A, or 2B for this cancer indication.

Age scopeIndication per labeling applies to adult patients; separate automatic processing rules exist for patients under 19 (policy note).