CurrentUnitedHealthcarePolicy N/A

Actimmune (interferon gamma-1b) prior authorization

Defines prior authorization and reauthorization criteria for Actimmune (interferon gamma-1b) for UnitedHealthcare members, including indications covered (chronic granulomatous disease, severe malignant osteopetrosis, and select oncology diagnoses) and pediatric oncology exception under age 19.

Policy Summary

PayerUnitedHealthcare

PolicyActimmune (interferon gamma-1b) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization; approvals issued for 12 months when criteria for the specific indication are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Primary indications

12 monthsAuthorization period

NCCN recognizedNCCN referenced

Prior Authorization/NotificationProgram type

Coverage Criteria

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Oncology Indications (MF / SS)

Covered when ALL of the following are met for oncology indications:

Oncology diagnoses: Patient has one of: (a) Mycosis fungoides (MF) OR (b) Sézary syndrome (SS)

Authorization issued for 12 months. NCCN recommended regimens referenced.

This policy defines medical necessity and prior authorization criteria for Actimmune (interferon gamma-1b) for covered indications. Providers should be aware that some states mandate coverage for off‑label use of medications or require use of alternative compendia; where such state mandates apply, they supersede the terms of this benefit document and its notification criteria.

The policy applies to the specified indications and authorization requirements described in this document; it does not list every possible exclusion. Coverage determinations remain subject to applicable federal and state laws and the member’s specific benefit plan provisions.

Initial therapy

Initial authorization criteria by indication

CGD initial: Diagnosis of chronic granulomatous disease

Authorization issued for 12 months

SMO initial: Diagnosis of severe, malignant osteopetrosis

Authorization issued for 12 months

Oncology initial: Diagnosis of mycosis fungoides (MF) OR Sézary syndrome (SS); pediatric oncology patients <19 years may be approved for any oncology diagnosis per pediatric exception

Authorization issued for 12 months; NCCN recognized regimens referenced for MF/SS

Initial Therapy Criteria (by indication)

Chronic Granulomatous Disease (Initial Authorization)

Covered when ALL of the following are met:

Chronic granulomatous disease (CGD): Diagnosis of chronic granulomatous disease

Authorization issued for 12 months

Severe Malignant Osteopetrosis (Initial Authorization)

Covered when ALL of the following are met:

Severe malignant osteopetrosis (SMO): Diagnosis of severe, malignant osteopetrosis

Authorization issued for 12 months

Oncology Indications (MF / SS)

Covered when ALL of the following are met for oncology indications:

Oncology diagnoses (MF/SS): Patient has one of: Mycosis fungoides (MF) OR Sézary syndrome (SS); NCCN Drugs & Biologics Compendium recognition applies

Authorization issued for 12 months; NCCN recommended regimens referenced

Reauthorization / Continuation Criteria

Reauthorization (all indications)

Reauthorization covered when the following are met for CGD, MF/SS, and SMO:

Reauthorization criterion: Patient does not show evidence of progressive disease while on Actimmune

Authorization issued for 12 months

Reauthorization

Reauthorization requirement

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

Approvals issued for 12 months

Provider Actions and Authorization Notes

Prior Authorization

Prior Authorization Requirement

Prior Authorization Required — when criteria are met, approvals are issued for 12 months. Providers must request authorization per UnitedHealthcare processes; failure to obtain prior authorization when required may result in claim denial or delayed payment.

Authorization term: 12 months (when criteria met)
Affected populations include: patients <19 with oncology diagnosis; chronic granulomatous disease; severe malignant osteopetrosis; Mycosis fungoides and Sézary syndrome

Note

Automated Approval / Re‑approval

Program may use automated approval and re‑approval processes based on prior claim or medication history, diagnosis codes (ICD‑10), and claim logic. Use of automated processes varies by program and therapeutic class.

Approvals or re‑authorizations may be granted without additional clinical review when prior claims/medication history and diagnosis codes support coverage
Supply limits may apply

Note

Authorization Decision Factors and Supply Limits

Authorization decisions may be based on prior claim/medication history, diagnosis codes, and claim logic. Providers should ensure documentation supports the diagnosis and therapy; state mandates and the member's specific benefit plan may alter coverage requirements.

Decisions may rely on: prior claims, medication history, ICD‑10 diagnosis codes, claim logic
State mandates and member-specific benefits may supersede or modify criteria

Denial Risk

Denial Risk and Missing Provider Actions

Denial Risk — failure to meet specified coverage criteria, not providing required documentation, or conflicts with state‑mandated coverage may result in denial. If provider action is not specified in the request or the submission lacks required information, the request may be denied or returned for more information.

Denial triggers: not meeting coverage criteria, missing provider-specified information, state mandate conflicts

Background

Actimmune (interferon gamma-1b) is indicated to reduce the frequency and severity of serious infections associated with chronic granulomatous disease (CGD) and to delay progression in severe malignant osteopetrosis (SMO). The National Comprehensive Cancer Network (NCCN) also recognizes Actimmune for select oncology indications, specifically mycosis fungoides and Sézary syndrome, which informs coverage for those cancer diagnoses.

Under this policy, Actimmune is a pharmacy/specialty drug requiring prior authorization for covered uses. Approvals are generally issued for 12 months when the patient meets the specific indication criteria. For pediatric oncology patients younger than 19 years, the policy includes a coverage exception permitting authorization when the patient has any oncology diagnosis and is under age 19, consistent with the document’s pediatric oncology provisions.

Quantity Limits

Actimmune (interferon gamma-1b) — supply/quantity notes

Quantity limits statementSupply limits may apply

Program-level approvalsUnitedHealthcare may approve initial and re-authorization based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic

Automation noteUse of automated approval and re-approval processes varies by program and/or therapeutic class

Policy Summary

PayerUnitedHealthcare

PolicyActimmune (interferon gamma-1b) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization; approvals issued for 12 months when criteria for the specific indication are met.

SourceLink

On This Page

OpenPayer

Actimmune (interferon gamma-1b) prior authorization

Coverage Criteria

Initial Therapy Criteria (by indication)

Reauthorization / Continuation Criteria

Provider Actions and Authorization Notes

Definitions and Recognition

Background

Quantity Limits