CurrentUnitedHealthcarePolicy N/A

Ogsiveo (nirogacestat) prior authorization

Prior authorization and coverage criteria for Ogsiveo (nirogacestat) for treatment of progressing desmoid tumors in UnitedHealthcare members; applies to pharmacy benefit and affects prescribers requesting coverage. Pediatric prescriptions (<19 years) auto-process without review per this document.

Policy Summary

PayerUnitedHealthcare

PolicyOgsiveo (nirogacestat) prior authorization

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Ogsiveo for adults meeting all coverage criteria; pediatric patients under 19 auto-process without review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period for initial and reauthorization

age <19automatic approval without coverage review

desmoid tumorcovered diagnosis

P&T 1/2025policy approval

Coverage Criteria for Ogsiveo (nirogacestat)

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Initial Authorization

Covered when ALL of the following are met

Initial Authorization for adults: Diagnosis of desmoid tumor AND Disease is progressive AND Patient requires systemic treatment

Authorization will be issued for 12 months

Reauthorization

Covered for reauthorization when the following is met

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

Authorization will be issued for 12 months

Patients less than 19 years of age

Automatic authorization for pediatric members

Members <19 years: Patient is less than 19 years of age. Prescription will automatically process without a coverage review.

Authorization will be issued for 12 months

Some states mandate benefit coverage for off-label use of medications for certain diagnoses or circumstances and may require use of specific compendium references. Where such state mandates or federal regulatory requirements apply, they supersede the coverage criteria and notification language in this document.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ogsiveo for members aged 19 and older. For members under 19 years of age, prescriptions will automatically process without a coverage review and do not require prior authorization. When required, prior authorization may be issued for up to 12 months for initial and continuation therapy when clinical criteria are met.

Prior authorization required for members ≥19 years
Auto-process (no coverage review) for members <19 years
Typical authorization duration: up to 12 months

Denial Risk

Coverage Variations and Triggers for Denial

Coverage may vary by state mandate, federal requirement, or the member's specific benefit plan. State mandates can require coverage for off-label uses or reference different compendia, and where such mandates apply they supersede this policy language. Coverage decisions may be limited or denied if the member's benefit plan does not include the service, if state/federal mandates do not apply, or if required clinical criteria are not met.

State or federal mandates may alter coverage or reference requirements
Member-specific benefit plan exclusions or limits can trigger denials
Lack of required clinical criteria in the prior authorization request may result in denial

Documentation Required

Permission for Automated Approval and Documentation Expectations

UnitedHealthcare may use automated approval or re-authorization processes based on prior claims/medication history, submitted diagnosis codes (ICD-10), and claim logic. Use of these automated processes varies by program and therapeutic class. Providers should ensure claims and prior-medication history are accurate and include required diagnosis codes and supporting documentation when requested to avoid delays or denials.

Automated approval may be granted using prior claims/medication history and diagnosis codes
Ensure accurate ICD-10 coding and complete claims history to support automated reviews
Supply limits and/or step therapy may apply and affect authorization

Step Therapy

Step Therapy / Supply Limits

Supply limits and/or step therapy may apply to Ogsiveo. Specific step therapy requirements or quantity limits are program-dependent and may not be detailed here; providers should check the member's benefit plan and any program-specific rules.

Step therapy or supply limits may be enforced depending on program or benefit plan
Verify member-specific step therapy and quantity limits prior to prescribing

Note
Supply limits and/or Step Therapy may be in place; specific step therapy requirements are not detailed in this document.

Definitions

Disease is progressive — definition key/value

DefinitionDisease is progressive — disease demonstrating objective clinical or radiographic evidence of worsening over time (i.e., not stable or improving).

Policy usageRequired as criterion (must be met) for initial authorization of Ogsiveo: 'Disease is progressive' is listed as criterion (2) in initial authorization.

Authorization impactWhen documented, contributes to issuance of authorization for 12 months if all initial criteria are met.

Patient requires systemic treatment — definition key/value

DefinitionPatient requires systemic treatment — the patient’s desmoid tumor necessitates systemic therapy rather than local measures (listed as criterion (3) for initial authorization).

Policy usageRequired as criterion (must be met) for initial authorization of Ogsiveo: 'Patient requires systemic treatment' is listed as criterion (3) in initial authorization.

Authorization impactWhen documented, contributes to issuance of authorization for 12 months if all initial criteria are met.

Policy Summary

PayerUnitedHealthcare

PolicyOgsiveo (nirogacestat) prior authorization

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Ogsiveo for adults meeting all coverage criteria; pediatric patients under 19 auto-process without review.

SourceLink

On This Page

OpenPayer

Ogsiveo (nirogacestat) prior authorization

Coverage Criteria for Ogsiveo (nirogacestat)

Initial Therapy

Continuation / Reauthorization Criteria

Provider Actions and Authorization Requirements

Step Therapy and Supply Limits

Site of Care

Background

Definitions