CurrentBlue Cross Blue Shield - WisconsinPolicy CC-0085

Actimmune (interferon gamma-1b) — Clinical Drug Coverage Criteria

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Clinical coverage criteria for use of Actimmune (interferon gamma-1b) under the medical benefit, including indications, age limitations, and non‑approved uses for Blue Cross Blue Shield - Wisconsin members.

Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyActimmune (interferon gamma-1b) — Clinical Drug Coverage Criteria

Policy CodePolicy CC-0085

Change TypeNo material changes

Effective Date12/22/2025

Last ReviewNov 14, 2025

Next Review Date

Key ActionSubmit prior authorization — requests will be reviewed against clinical criteria and approval is limited to patients under 19 years or those with specified diagnoses.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA indications listed

<19Age criterion

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CurrentBlue Cross Blue Shield - WisconsinPolicy CC-0085

Actimmune (interferon gamma-1b) — Clinical Drug Coverage Criteria

Customize your policy alerts

Sign up for Blue Cross Blue Shield - Wisconsin Policy CC-0085 alerts

Get alerted when Policy CC-0085 changes without checking for updates manually.

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Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyActimmune (interferon gamma-1b) — Clinical Drug Coverage Criteria

Policy CodePolicy CC-0085

Change TypeNo material changes

Effective Date12/22/2025

Last ReviewNov 14, 2025

Next Review Date

Key ActionSubmit prior authorization — requests will be reviewed against clinical criteria and approval is limited to patients under 19 years or those with specified diagnoses.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA indications listed

<19Age criterion

Coverage Criteria for Actimmune (interferon gamma-1b)

Approval Criteria

Requests for Actimmune may be approved if ONE of the following is met:

Approval criteria: (A) Individual is under 19 years of age

Criterion I from policy

Approval criteria: (B) Individual has a diagnosis of chronic granulomatous disease

Criterion II.A from policy

Approval criteria: (C) Individual has a diagnosis of severe malignant osteopetrosis

Criterion II.B from policy

Approval criteria: (D) Individual has a diagnosis of mycosis fungoides, including Sezary syndrome (NCCN 2A)

Criterion II.C from policy

Use of Actimmune (interferon gamma-1b) may not be approved for the following indications: advanced ovarian or primary peritoneal cancer; atopic dermatitis; brain tumors; chronic hepatitis C; Friedreich’s ataxia; idiopathic pulmonary fibrosis; invasive fungal infection post-transplantation (for example after hematopoietic stem cell or solid organ transplantation); metastatic renal cell cancer; and pulmonary tuberculosis.

Requests for Actimmune that do not meet the listed approval criteria or that are submitted for any of the excluded indications above will not be approved and are considered not medically necessary.

Billing and Diagnosis Codes

HCPCSHCPCS

J9216

Injection, interferon, gamma-1b, 3 million units [Actimmune]

ICD-10 DiagnosisICD-10

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

Provider Requirements and Authorization

Prior Authorization

Prior authorization required; approvals limited by age/diagnosis

Prior authorization is required for Actimmune (interferon gamma-1b). Requests will be reviewed against the clinical criteria and approvals are limited to individuals under 19 years of age or those meeting the specified diagnoses (chronic granulomatous disease; severe malignant osteopetrosis; or mycosis fungoides including Sézary syndrome).

Provider must submit a prior authorization request for HCPCS J9216 when billing under the medical benefit.

Note

Include specific diagnosis code and age on PA submission

When submitting a request, include the specific diagnosis code that corresponds to the covered indication (for example, C84.00–C84.19 for mycosis fungoides / Sézary disease, D71.8/D71.9 for chronic granulomatous disease, or Q78.2 for osteopetrosis) and the patient's age to demonstrate eligibility under the age-based criterion.

Use HCPCS code J9216 on claims for Actimmune.
Document patient age (<19 years) or one of the approved diagnoses on the prior authorization submission.

Background on Actimmune

Actimmune (interferon gamma-1b) is a biologic response modifier with FDA‑listed indications and roles in select rare disorders. The policy identifies primary approved diagnoses such as chronic granulomatous disease, severe malignant osteopetrosis, and mycosis fungoides (including Sézary syndrome) and limits approval accordingly.

Definitions and Condition Summaries

Chronic Granulomatous Disease

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 featuresRecurrent bacterial and fungal infections and abnormal inflammatory responses; granuloma formation can be prominent.

Relevance to policyListed as an approved diagnosis for Actimmune (interferon gamma‑1b) coverage in the policy criteria.

Mycosis Fungoides

DefinitionA sub‑type 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 features

Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyActimmune (interferon gamma-1b) — Clinical Drug Coverage Criteria

Policy CodePolicy CC-0085

Change TypeNo material changes

Effective Date12/22/2025

Last ReviewNov 14, 2025

Next Review Date

Key ActionSubmit prior authorization — requests will be reviewed against clinical criteria and approval is limited to patients under 19 years or those with specified diagnoses.

SourceLink

On This Page

Documentation Required

Document medical necessity per clinical criteria

Clinical documentation must demonstrate that medical necessity criteria are met: either the individual is under 19 years of age or has one of the listed diagnoses (chronic granulomatous disease; severe malignant osteopetrosis; or mycosis fungoides including Sézary syndrome).

Provide clinical records, diagnostic evidence, and rationale tying the request to the approved indication.
Reference NCCN 2A for mycosis fungoides / Sézary syndrome when applicable.

Denial Risk

Denial risk: listed non‑covered indications

Requests will not be approved for a defined list of non‑covered indications; submitting for these will risk denial.

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
Any use not meeting the approval criteria or for all other indications

Skin erythema and/or plaques; potential spread to lymph nodes, blood, and internal organs.

Relevance to policyIncluded as an approved indication for Actimmune (interferon gamma‑1b).

Sézary Syndrome

DefinitionA sub‑type of cutaneous T‑cell lymphoma characterized by intense itching and redness with associated T‑cell leukemia; circulating T cells clonally match those invading the skin.

Clinical featuresPruritus and erythroderma with malignant T‑cell leukemia component; historically more difficult to treat than mycosis fungoides.

Relevance to policyListed in the policy as an approved indication (Sézary syndrome) for Actimmune; considered alongside mycosis fungoides (NCCN 2A).

Severe Malignant Osteopetrosis

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

Clinical featuresAbnormal bone development with risk of fractures, vision and hearing problems, and characteristic facial and head appearance.

Relevance to policyIdentified as an approved diagnosis for Actimmune (interferon gamma‑1b) coverage in the policy criteria.