ModifiedmhnPolicy CP.PHAR.52

ACTIMMUNE (PDF)

Defines medical necessity criteria, prescriber requirements, dosing limits, approval durations, and exclusions for Actimmune (interferon gamma-1b) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyACTIMMUNE (PDF)

Policy CodePolicy CP.PHAR.52

Change TypeAnnual review updates (2025-2026)

Effective DateJun 1, 2010

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

1Q 2025 annual review: for CGD, added immunologist as an additional prescriber specialist option; for mycosis fungoides and Sezary syndrome, added hematologist as an additional prescriber specialist option; references reviewed and updated.

1Q 2026 annual review: for Medicaid and HIM, extended approval durations from 6 to 12 months for this maintenance medication for chronic conditions; references reviewed and updated.

Multiple annual reviews (2021-2024) noted 'no significant changes; references reviewed and updated.'

3Covered Indications (listed)

1Off-label Indication (listed)

1Not Authorized category

Coverage Summary & Indications

Coverage stance: covered_with_criteria. Subject: Interferon gamma-1b (Actimmune). Scope: Defines medical necessity criteria, prescriber requirements, dosing limits, approval durations, and exclusions for Actimmune (interferon gamma-1b) across Commercial, HIM, and Medicaid lines of business. Background: Actimmune is a recombinant interferon gamma-1b indicated to reduce serious infections in chronic granulomatous disease (CGD) and delay progression in severe malignant osteopetrosis (SMO), with certain oncologic/off‑label uses considered (e.g., mycosis fungoides/Sezary syndrome).

Initial Therapy Criteria (by indication)

A. Chronic Granulomatous Disease (CGD) - Initial therapy (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of chronic granulomatous disease (CGD)
Age ≥ 1 year
Prescribed by or in consultation with an immunologist, hematologist, or infectious disease specialist
Dose must not exceed one of the following
- BSA > 0.5 m2: 50 mcg/m2 three times weekly
  dose limit
- BSA ≤ 0.5 m2: 1.5 mcg/kg three times weekly
  dose limit

B. Severe Malignant Osteopetrosis (SMO) - Initial therapy (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of severe malignant osteopetrosis (SMO; autosomal recessive osteopetrosis)
Prescribed by or in consultation with an endocrinologist or rheumatologist
Age ≥ 1 month
Dose must not exceed one of the following
- BSA > 0.5 m2: 50 mcg/m2 three times weekly
  dose limit

C. Mycosis Fungoides / Sezary Syndrome (off-label) - Initial therapy (must meet all)

Covered when ALL of the following are met:

off-label

D. Other diagnoses/indications - Pathway

If not addressed above, follow one of the pathways:

ANY of the following

If drug recently (within last 6 months) had a label change not reflected in this policy and drug is on formulary/PDL, refer to no coverage criteria policy for the line of business (CP.CPA.190 commercial, HIM.PA.33 marketplace, CP.PMN.255 Medicaid)
If drug recently had label change and drug NOT on formulary/PDL, refer to non-formulary policy for the line of business (CP.CPA.190 commercial, HIM.PA.103 marketplace, CP.PMN.16 Medicaid)
If requested use is not specifically listed in section III and criterion 1 above does not apply, refer to off-label use policy for the line of business (CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid)

Continuation Therapy Criteria

Continued Therapy / All Indications (must meet all)

Approval for continued therapy requires ALL of the following:

ALL of the following

Member must meet one of the following
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Documentation supports that member is currently receiving Actimmune for mycosis fungoides or Sezary syndrome and has received this medication for at least 30 days
Member is responding positively to therapy
If request is for a dose increase, new dose must meet one of the following
- BSA > 0.5 m2: new dose does not exceed 50 mcg/m2 three times weekly
- BSA ≤ 0.5 m2: new dose does not exceed 1.5 mcg/kg three times weekly
- New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  prescriber must submit supporting evidence
Prescribed regimen must be FDA-approved or recommended by NCCN

Provider Actions & Authorization Requirements

Documentation Required

Submit supporting documentation

Providers must submit supporting documentation to demonstrate that the member meets all approval criteria. Acceptable documentation includes office chart notes, laboratory results, and other relevant clinical information.

Office notes
Lab results
Other clinical information

Prior Authorization

Specialist prescriber requirement

Prescriptions must be written by or in consultation with the specialist appropriate to the indication. Required specialist by indication: CGD — immunologist, hematologist, or infectious disease specialist; SMO — endocrinologist or rheumatologist; Mycosis Fungoides/Sezary Syndrome — oncologist or hematologist.

CGD: immunologist, hematologist, or infectious disease specialist
SMO: endocrinologist or rheumatologist
Mycosis Fungoides/Sezary: oncologist or hematologist

Billing Rule

Dose limit enforcement

Dose limits are enforced for BSA- or weight-based dosing and affect billing for J9216. Requests for doses above the specified BSA/weight limits require submission of supporting practice guidelines or peer‑reviewed literature to justify the higher dose.

Affected code: J9216
For doses above limits, submit practice guidelines or peer‑reviewed literature

Documentation Required

Continued therapy evidence

For continued therapy, provide documentation showing the member is currently receiving the medication and is responding positively to therapy. For mycosis fungoides or Sezary syndrome specifically, documentation must show the member has received Actimmune for at least 30 days.

Evidence of current receipt (30 days for MF/Sezary)
Documentation of positive response to therapy

Clinical Evidence & References

Actimmune Prescribing Information. Horizon Pharma; December 2024.

NCCN Drugs and Biologics Compendium; Interferon Gamma-1b entry.

Immune Deficiency Foundation. Diagnostic and clinical care guidelines for primary immunodeficiency diseases.

Osteopetrosis Working Group consensus guidelines (Diagnosis and management of osteopetrosis).

Background & Definitions

Actimmune is recombinant interferon gamma-1b.

FDA‑approved indications: 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).

Also considered as an off‑label option for certain oncologic uses such as mycosis fungoides and Sezary syndrome under specified criteria and specialist oversight.

Term	Definition
BSA	Body surface area
CGD	Chronic granulomatous disease
SMO	Severe, malignant osteopetrosis

Revision History

1Q 2026 (P&T 02.26; 11.05.25)annual_reviewLatest

1Q 2026 annual review — MATERIAL: for Medicaid and HIM, extended approval durations from 6 to 12 months for this maintenance medication for chronic conditions; references reviewed and updated. (is_material: true)

1Q 2025 (P&T 02.25; 10.31.24)annual_review

1Q 2025 annual review — MATERIAL: for CGD, added immunologist as an additional prescriber specialist option; for mycosis fungoides and Sezary syndrome, added hematologist as an additional prescriber specialist option; references reviewed and updated. (is_material: true)

Template/formatting updates (various years)template_update

Template/formatting updates (non-material). Coding implications list HCPCS code J9216. (is_material: false)

Policy Summary

Payermhn

PolicyACTIMMUNE (PDF)

Policy CodePolicy CP.PHAR.52

Change TypeAnnual review updates (2025-2026)

Effective DateJun 1, 2010

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

OpenPayer

ACTIMMUNE (PDF)

Coverage Summary & Indications

Initial Therapy Criteria (by indication)

Continuation Therapy Criteria

Unapproved Indications / Not Authorized

Provider Actions & Authorization Requirements

Applicable Codes

Clinical Evidence & References

Background & Definitions

Revision History