CurrentMedical Mutual - OhioPolicy N/A

Actimmune (interferon gamma-1b) coverage

Defines prior authorization, coverage criteria, and approval durations for Actimmune (interferon gamma-1b) for treatment of chronic granulomatous disease and severe malignant infantile osteopetrosis for Medical Mutual - Ohio members.

Policy Summary

PayerMedical Mutual - Ohio

PolicyActimmune (interferon gamma-1b) coverage

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateAug 21, 2025

Key ActionPrior authorization is recommended for pharmacy benefit coverage of Actimmune and approval is granted only when policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA‑approved indications listed

365Initial approval duration

365Extended approval duration

PA recommendedAuthorization requirement

YesSpecialist prescriber required

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FDA-Approved Indications

Coverage of Actimmune is recommended in those who meet the following criteria:

Chronic Granulomatous Disease (CGD)

CGD A: Diagnosis established by a molecular genetic test identifying a gene-related pathogenic variant linked to chronic granulomatous disease
Examples include biallelic pathogenic variants in CYBA, CYBB, NCF1, NCF2, and NCF4.
CGD B: Medication prescribed by, or in consultation with, an immunologist, a hematologist or an infectious disease specialist

Malignant Osteopetrosis, Severe Infantile

Osteopetrosis A: Diagnosis by either i. radiographic (X-ray) imaging demonstrating skeletal features related to osteopetrosis OR ii. molecular genetic test identifying a gene-related pathogenic variant linked to severe, infantile malignant osteopetrosis
Examples of pathogenic variants include CA2, CLCN7, IKBLG, ITGB3, LRP5, OSTM1, PLEKHM1, SNX10, TCIRG1, TNFRSF11A, and TNFSF11.
Osteopetrosis B: Medication prescribed by, or in consultation with, an endocrinologist

The criteria listed in this policy define the circumstances under which Actimmune (interferon gamma-1b) is recommended for coverage. These criteria are not exhaustive; coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. The policy will be updated as new published data become available, and additional exclusions or restrictions may apply based on emerging evidence or safety concerns.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for pharmacy benefit coverage of Actimmune; approval is recommended only when criteria in the policy are met. Because of the specialized skills and monitoring required, initial approval requires prescription by or in consultation with a specialist who treats the condition.

Prior authorization recommended for Actimmune
Initial prescription must be by or in consultation with a specialist

Step Therapy

No step therapy requirements are specified in this policy.

Documentation Required

Documentation May Be Requested

Additional documentation supporting medical necessity (patient records, test results, provider credentials) may be requested and must be provided upon request.

Patient records
Relevant test results
Provider credentials

Denial Risk

Denial Conditions

The Company may deny reimbursement when the drug or services were not medically necessary, were investigational or experimental, not within the scope of benefits, or when a pattern of inappropriate or excessive billing/practice is identified.

Background and Definitions

Actimmune (interferon gamma-1b) is indicated to reduce the frequency and severity of serious infections in chronic granulomatous disease (CGD) and to delay disease progression in severe malignant infantile osteopetrosis (SMO). The mechanism by which interferon gamma-1b provides benefit is not fully established. For CGD, coverage is recommended when a molecular genetic test identifies a pathogenic variant linked to CGD and the medication is prescribed by or in consultation with an immunologist, hematologist, or infectious disease specialist. For SMO, coverage is recommended when diagnosis is established by radiographic imaging or a molecular genetic test identifying a pathogenic variant linked to severe infantile malignant osteopetrosis and the medication is prescribed by or in consultation with an endocrinologist. Initial and extended approvals are each granted for 365 days when criteria are met.

Chronic granulomatous disease (CGD) — key facts

DefinitionChronic granulomatous disease (CGD) — a genetic immunodeficiency disorder for which Actimmune is indicated to reduce the frequency and severity of serious infections.

Diagnostic evidence (policy requirement)Diagnosis established by a molecular genetic test identifying a pathogenic variant linked to CGD (examples: biallelic pathogenic variants in CYBA, CYBB, NCF1, NCF2, NCF4).

Prescriber requirementMedication must be prescribed by, or in consultation with, an immunologist, hematologist, or infectious disease specialist for initial approval.

Rationale/notesActimmune reduces frequency and severity of serious infections in CGD; mechanism not fully established and superoxide changes do not predict efficacy.

Severe, malignant osteopetrosis (SMO) — key facts

DefinitionSevere, malignant osteopetrosis (SMO) — a severe infantile form of osteopetrosis for which Actimmune is indicated to delay disease progression.

Diagnostic evidence (policy requirement)Diagnosis by radiographic imaging demonstrating skeletal features of osteopetrosis OR molecular genetic testing identifying a pathogenic variant linked to severe infantile malignant osteopetrosis (examples include CA2, CLCN7, IKBLG, ITGB3, LRP5, OSTM1, PLEKHM1, SNX10, TCIRG1, TNFRSF11A, TNFSF11).

Prescriber requirementMedication must be prescribed by, or in consultation with, an endocrinologist for initial approval.

Rationale/notesActimmune is indicated to delay time to disease progression in SMO; exact mechanism of treatment effect not established.