CurrentAnthemPolicy CC-0085

Actimmune (interferon gamma-1b) — Clinical Criteria

Clinical criteria governing prior authorization and medical necessity determinations for Actimmune (interferon gamma-1b) under the medical benefit; applies to members and providers seeking coverage for the drug.

Policy Summary

PayerAnthem

PolicyActimmune (interferon gamma-1b) — Clinical Criteria

Policy CodePolicy CC-0085

Change TypeCoding and administrative (non-material)

Effective Date12/22/2025

Next Review Date

Key ActionSubmit prior authorization; approval requires the patient be under 19 years of age and/or meet an approved diagnosis per the criteria.

SourceLink

POLICY UPDATE CHANGES

Coding update: Removed ICD-10-CM D71 effective 9/30/25 and added D71.8, D71.9 effective 10/1/25.

Administrative update for age noted at 11/14/2025 annual review (No clinical changes).

2FDA-approved indications listed

1NCCN off-label recommendation

10Not-approved indications

Coverage and Medical Necessity Criteria

Approval criteria

Requests for Actimmune (interferon gamma-1b) may be approved if the following are met:

Primary approval paths: Approval allowed if ANY of the following paths is met:

Age criterion: Individual is under 19 years of age<19 years

Listed as an approval criterion

Diagnosis-based approvals

Chronic granulomatous disease: Diagnosis: Chronic granulomatous disease

Policy Summary

PayerAnthem

PolicyActimmune (interferon gamma-1b) — Clinical Criteria

Policy CodePolicy CC-0085

Change TypeCoding and administrative (non-material)

Effective Date12/22/2025

Next Review Date

Key ActionSubmit prior authorization; approval requires the patient be under 19 years of age and/or meet an approved diagnosis per the criteria.

SourceLink

On This Page

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Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for Actimmune (interferon gamma-1b). Approval is limited to pediatric patients under 19 years of age or when the member has a covered diagnosis (chronic granulomatous disease, severe malignant osteopetrosis, or mycosis fungoides including Sezary syndrome).

Prior authorization required for all requests for Actimmune (interferon gamma-1b).
Approved age/indication constraints: Age < 19 years OR diagnosis of chronic granulomatous disease, severe malignant osteopetrosis, or mycosis fungoides (including Sezary syndrome).
Requests for indications listed as not approved (see clinical criteria) — e.g., advanced ovarian or primary peritoneal cancer, atopic dermatitis, brain tumors, chronic hepatitis C, Friedreich's ataxia, idiopathic pulmonary fibrosis, invasive fungal infection post-transplantation, metastatic renal cell cancer, pulmonary tuberculosis, and other non-listed indications — will be denied.

Step Therapy

No step therapy or sequencing requirements are specified for Actimmune (interferon gamma-1b). There are no mandated trials of alternative agents prior to approval.

Documentation Required

Documentation Requirements

Documentation submitted with the prior authorization request must clearly demonstrate the patient's age and supporting clinical information that meets the approved criteria. Include relevant diagnostic records, specialist notes, and chart documentation of diagnosis and rationale for therapy.

For age-based approvals: documentation of date of birth or age in the medical record.
For diagnosis-based approvals: problem list, relevant specialist consultation notes (e.g., immunology, hematology, dermatology), pathology reports if applicable (for mycosis fungoides/Sezary syndrome), and any imaging or laboratory data that support the diagnosis.
Provide prior treatment history and clinical rationale if prescribing for an approved indication.
Specify the requested dose, frequency, and duration of therapy and attach the prescriber's plan of care.

Denial Risk

Common Denial Triggers

Common denial triggers include missing or insufficient documentation, requests for non‑covered indications, and adults without an approved diagnosis.

No documentation of age or date of birth to confirm <19 years of age.
Insufficient clinical evidence supporting a covered diagnosis (chronic granulomatous disease, severe malignant osteopetrosis, or mycosis fungoides/Sezary syndrome).
Request for an indication explicitly listed as not approved (e.g., idiopathic pulmonary fibrosis, Friedreich's ataxia, chronic hepatitis C, advanced ovarian cancer, metastatic renal cell cancer, pulmonary tuberculosis, invasive fungal infection post‑transplant).
Requests for adults without an approved diagnosis or where the clinical criteria are not met.
Missing requested dose/frequency/duration or lack of prescriber plan of care.

Condition Definitions

Chronic Granulomatous Disease — key points

DefinitionA heterogeneous group of primary inherited immunodeficiency disorders that increase susceptibility to recurrent, potentially life‑threatening bacterial and fungal infections and cause abnormal inflammatory responses with excessive granuloma formation.

Clinical significanceLeads to recurrent severe infections and granuloma-related inflammation that may require specialized immune-modulating therapy.

Relation to ActimmuneListed as an approval diagnosis for interferon gamma‑1b (Actimmune) under the policy coverage criteria.

Mycosis Fungoides — key points

DefinitionA subtype of cutaneous T‑cell lymphoma in which tumor cells invade the skin causing reddening (erythroderma) and/or plaques; may involve lymph nodes, blood, and internal organs.

Clinical featuresPresents with skin erythema and plaques; possible extracutaneous spread to lymph nodes, blood, or internal organs.

Policy contextIncluded in the document’s definitions as a specific diagnosis; mycosis fungoides (including Sézary syndrome per NCCN 2A) is an approval pathway for Actimmune in the coverage criteria.

Sézary Syndrome — key points

DefinitionA subtype of cutaneous T‑cell lymphoma characterized by itching (pruritus) and redness with circulating malignant T‑cell leukemia whose cells clonally match those invading the skin.

Clinical relevanceHistorically more difficult to treat than mycosis fungoides and associated with circulating malignant T cells.

Policy contextSézary syndrome is recognized separately in the definitions and is encompassed under the mycosis fungoides approval pathway for Actimmune (per NCCN category 2A).

Severe Malignant Osteopetrosis — key points

DefinitionA rare inherited disorder (also called marble bone disease or malignant infantile osteopetrosis) caused by defective osteoclast function leading to abnormal bone development.

Clinical manifestationsResults in bone fractures, vision and hearing problems, and abnormal craniofacial appearance.

Policy contextSevere malignant osteopetrosis is an FDA‑approved indication for Actimmune and is listed as an approval diagnosis in the coverage criteria.

Document History and Changes

2025-11-14administrative updateLatest

Annual review noted an administrative update for age; no clinical changes were made.

2025-09-03coding update

Removed ICD-10-CM D71 effective 2025-09-30 and added D71.8 and D71.9 effective 2025-10-01.

2024-11-15annual review

Annual review completed; no changes and coding reviewed with no changes.

2024-02-23annual review

Annual review completed; no changes and coding reviewed with no changes.

2023-02-24annual review

Annual review completed; no changes and coding reviewed with no changes.

2022-02-25annual review

Annual review with wording and formatting changes; coding reviewed with no changes.

2021-02-19annual review

Annual review completed; no changes and coding reviewed with no changes.

2020-02-21annual review

Annual review with wording and formatting changes; coding reviewed with no changes.

2019-05-17initial review

First review of Actimmune clinical criteria with wording and formatting changes; added reference for off-label criteria and coding reviewed with no changes.

C84.00-C84.09	Mycosis fungoides
C84.10-C84.19	Sézary disease
D71.8	Other functional disorders of polymorphonuclear neutrophils [chronic granulomatous disease]
D71.9	Functional disorders of polymorphonuclear neutrophils, unspecified [chronic granulomatous disease]
Q78.2	Osteopetrosis
C84.00-C84.09	Mycosis fungoides

OpenPayer

Actimmune (interferon gamma-1b) — Clinical Criteria

Coverage and Medical Necessity Criteria

Billing and Diagnosis Codes

Prior Authorization, Documentation, and Denial Risks

Clinical Background

Condition Definitions

Document History and Changes