CurrentColorado Rocky Mountain Health PlansPolicy N/A

Ogsiveo (nirogacestat) prior authorization

Defines prior authorization and coverage criteria for Ogsiveo (nirogacestat) for members of the plan, including special handling for patients under 19. Applies to pharmacy prior authorization/notification program.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOgsiveo (nirogacestat) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for adult members: confirm diagnosis of desmoid tumor, documented progressive disease, and need for systemic treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

age <19 auto-approvepediatric auto-approve

desmoid tumorcovered indication

1/2024,1/2025,1/2026P&T approvals

Coverage Criteria for Ogsiveo (nirogacestat)

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Initial Authorization for adults: Diagnosis of desmoid tumor

Authorization issued for 12 months

Initial Authorization for adults: Disease is progressive

Authorization issued for 12 months

Initial Authorization for adults: Patient requires systemic treatment

Authorization issued for 12 months

Coverage criteria in this policy apply to Ogsiveo (nirogacestat) subject to the member’s benefit plan and applicable state or federal mandates. State mandates or compendium requirements that require coverage for off‑label uses supersede the criteria described here. Similarly, federal law and any member‑specific benefit plan language take precedence over these criteria.

Providers should also note that plan‑level exceptions may occur based on prior claims or documented medical history; authorization decisions can be affected by existing claim/medication history and claim logic when those data meet program rules.

Provider Actions and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for adults (age 19 and older). For initial approval, submit documentation that demonstrates all required criteria are met: diagnosis of desmoid tumor, evidence of progressive disease, and that the patient requires systemic treatment. Initial authorizations are issued for up to 12 months.

Adults (≥19 years): Prior authorization required for initial and reauthorization
Required for initial approval: diagnosis of desmoid tumor; documentation of progressive disease; clinical rationale that systemic treatment is required
Authorization duration: up to 12 months

Note

Auto-approval for Patients <19

For patients under 19 years of age, authorization is processed automatically when the single-age criterion is met. If approved, authorization will be issued for 12 months.

Patients <19 years: auto-approval when age criterion met
Authorization duration: 12 months

Step Therapy

Possible Step Therapy / Supply Limits

Supply limits or step therapy requirements may apply depending on program rules. Check payer-specific step therapy and quantity limits prior to prescribing to avoid claim denials or delays.

Possible supply limits or step therapy depending on program/therapeutic class
Verify applicable quantity limits and step edits in the payer’s drug management rules before dispensing

Denial Risk

Triggers for Initial Denial

Initial denials commonly occur when required elements are missing or incomplete. Ensure submitted information includes the diagnosis, documentation of progressive disease, and clinical reasoning for systemic therapy. Missing or unclear documentation of any required criterion may result in denial.

Primary triggers for initial denial: missing diagnosis of desmoid tumor
Lack of documentation showing disease progression
No documentation that systemic treatment is required

Documentation Required

Supporting Documentation and References

Acceptable supporting documentation includes prior claims/medication history, relevant ICD-10 diagnosis codes, clinical notes documenting progression, and treatment rationale. UnitedHealthcare may use automated approval based on claims history, ICD-10 codes, and claim logic — include clear, structured clinical documentation to support manual or automated review. Key references: Ogsiveo package insert (April 2024) and the NCCN Drugs and Biologics Compendium.

Acceptable documentation sources: prior claim/medication history, ICD-10 codes, clinic notes documenting progression and systemic therapy need
Automated approval may be granted based on claims and diagnosis codes; include explicit clinical notes when possible
References: Ogsiveo [package insert], April 2024; NCCN Drugs and Biologics Compendium (accessed Nov 24, 2025)

Initial Therapy Requirements

Initial Therapy

Initial authorization requirements

Initial Therapy: Diagnosis of desmoid tumor

Authorization for 12 months

Initial Therapy: Disease is progressive

Authorization for 12 months

Initial Therapy: Patient requires systemic treatment

Authorization for 12 months

Step / Supply Limit	Details
Possible step therapy or supply limits	Supply limits and/or Step Therapy may be in place; specific steps, failure criteria, or quantity limits are not specified in this policy document.

Background

Ogsiveo (nirogacestat) is described in the policy background as a systemic therapy for desmoid tumors. The drug is recognized by the plan for treatment of progressing desmoid tumors that require systemic treatment. For members under 19 years of age, prescriptions for Ogsiveo will automatically process without a coverage review and an authorization will be issued for 12 months.

When reviewing requests for adult members, prior authorization is required and coverage is granted only when the documented clinical criteria are met (for example, diagnosis of desmoid tumor with evidence of progressive disease and a clinical need for systemic therapy).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOgsiveo (nirogacestat) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for adult members: confirm diagnosis of desmoid tumor, documented progressive disease, and need for systemic treatment.

SourceLink

On This Page

OpenPayer

Ogsiveo (nirogacestat) prior authorization

Coverage Criteria for Ogsiveo (nirogacestat)

Provider Actions and Authorization Process

Initial Therapy Requirements

Continuation / Reauthorization Criteria

Step Therapy and Supply Limits

Background

Definitions