CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1001-13

Actimmune (interferon gamma-1b) prior authorization/notification policy

Defines prior authorization and reauthorization criteria for Actimmune (interferon gamma-1b) including approved indications: chronic granulomatous disease (CGD), severe malignant osteopetrosis (SMO), and oncology indications mycosis fungoides (MF) and Sézary syndrome (SS); includes age-specific oncology requirement for patients <19 and reference to NCCN-recognized regimens.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyActimmune (interferon gamma-1b) prior authorization/notification policy

Policy CodePolicy 2025 P 1001-13

Change TypeAnnual review (6/2025) — no coverage changes; historical revisions in 8/2015 and 6/2016

Effective DateSep 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Actimmune; approvals issued for 12 months when coverage criteria are met.

POLICY UPDATE CHANGES

Annual review 6/2025: Annual review with no changes to coverage criteria; updated references.

8/2015: Added oncology indication requirement to age <19 criteria and increased authorization and reauthorization from 6 months to 12 months for all indications.

6/2016: Added reauthorization criteria for CGD.

3Covered Indications

12 monthsAuthorization Duration

NCCN 1/2A/2BOncology Evidence Categories Accepted

Scope: This policy defines prior authorization and reauthorization criteria for Actimmune (interferon gamma-1b) for the approved indications chronic granulomatous disease (CGD) and severe malignant osteopetrosis (SMO), and for oncology indications mycosis fungoides (MF) and Sézary syndrome (SS). For pediatric oncology use, patients must be <19 years of age to meet the pediatric approval criteria. Authorizations and reauthorizations are issued for 12 months. The policy notes that state mandates and the member-specific benefit plan may supersede or modify the criteria in this document.

Coverage stance: Covered with criteria — coverage is provided when the specified diagnostic and reauthorization criteria are met (e.g., diagnosis of CGD, SMO, MF or SS with pediatric age requirement for oncology), and when NCCN recognition is used for oncology regimens as applicable. Effective date: 2025-09-01. Last review: 2025-06.

Initial Therapy Criteria

Patients less than 19 years of age

Actimmune will be approved based on both of the following criteria:

ALL of the following

Patient has oncology diagnosis
Patient is less than 19 years of age

Chronic Granulomatous Disease (Initial Authorization)

Actimmune will be approved based on the following criterion:

ALL of the following

Diagnosis of chronic granulomatous disease

Severe Malignant Osteopetrosis (Initial Authorization)

Actimmune will be approved based on the following criterion:

ALL of the following

Diagnosis of severe, malignant osteopetrosis

Mycosis Fungoides or Sézary Syndrome (Initial Authorization)

Actimmune will be approved based on the following criterion:

ALL of the following

Patient has one of the following diagnoses: Mycosis fungoides (MF) OR Sézary syndrome (SS)

NCCN Recommended Regimens

Recognition for oncology indication:

ANY of the following

The drug has been recognized for treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Reauthorization / Continuation Therapy Criteria

Chronic Granulomatous Disease (Reauthorization)

Actimmune will be approved for reauthorization when:

ALL of the following

Patient does not show evidence of progressive disease while on Actimmune

Severe Malignant Osteopetrosis (Reauthorization)

Actimmune will be approved for reauthorization when:

ALL of the following

Patient does not show evidence of progressive disease while on Actimmune

Mycosis Fungoides or Sézary Syndrome (Reauthorization)

Actimmune will be approved for reauthorization when:

ALL of the following

Patient does not show evidence of progressive disease while on Actimmune

Provider Actions & Operational Requirements

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Actimmune. When coverage criteria are met, approvals are issued for 12 months.

Documentation Required

Reauthorization documentation

For reauthorization, document that the patient does not show evidence of progressive disease while on Actimmune.

Documentation Required

Pediatric oncology requirement

For patients less than 19 years of age, document an oncology diagnosis in addition to age to meet approval criteria.

Billing Rule

Authorization duration

Authorizations and reauthorizations are issued for 12 months.

Documentation Required

NCCN regimen recognition

For oncology indications, coverage may be based on recognition in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B.

Denial Risk

State mandates and benefit plan impact

State mandates and the member-specific benefit plan may supersede or modify the policy language and affect coverage.

Billing Rule

Automated approval processes

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic via automated processes; supply limits may apply.

Background & Clinical Evidence

Background: Actimmune (interferon gamma-1b) is indicated to reduce the frequency and severity of serious infections in chronic granulomatous disease (CGD) and to delay time to disease progression in severe, malignant osteopetrosis (SMO). The National Comprehensive Cancer Network (NCCN) recommends Actimmune in mycosis fungoides (MF) and Sézary syndrome (SS).

Operational and policy notes: State mandates and member benefit plans may supersede the policy language and can affect coverage for off-label or compendium-referenced uses.

References: Package Insert — Actimmune [Package Insert], Horizon Therapeutics USA Inc.; December 2024. NCCN Compendium — The NCCN Drugs and Biologics Compendium; accessed April 28, 2025.

Revision History

08/2015operational_change

Added oncology indication requirement to age <19 criteria and increased authorization and reauthorization from 6 months to 12 months for all indications.

06/2016policy_added

Added reauthorization criterion for chronic granulomatous disease requiring that the patient not show evidence of progressive disease while on Actimmune.

06/2025annual_reviewLatest

Annual review with no changes to coverage criteria; updated references.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyActimmune (interferon gamma-1b) prior authorization/notification policy

Policy CodePolicy 2025 P 1001-13

Change TypeAnnual review (6/2025) — no coverage changes; historical revisions in 8/2015 and 6/2016

Effective DateSep 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Actimmune; approvals issued for 12 months when coverage criteria are met.

On This Page

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Actimmune (interferon gamma-1b) prior authorization/notification policy

Coverage Summary

Initial Therapy Criteria

Reauthorization / Continuation Therapy Criteria

Provider Actions & Operational Requirements

Applicable Codes

Background & Clinical Evidence

Definitions

Revision History