CurrentAvMedPolicy Pub. 100-2

Actimmune (interferon gamma-1b) prior authorization

This document governs prior authorization and step-edit requests for Actimmune (interferon gamma-1b) for AvMed members, specifying required prescriber signatures, clinical criteria for Chronic Granulomatous Disease and severe malignant osteopetrosis, and documentation needed for approval.

Policy Summary

PayerAvMed

PolicyActimmune (interferon gamma-1b) prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a signed medical prior authorization/step-edit request form with required clinical documentation faxed to 1-877-535-1391.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2covered diagnoses listed

1 yearlength of therapy

J9216HCPCS code

SC thrice weeklyadministration frequency

Coverage Criteria for Actimmune (interferon gamma-1b)

Initial Therapy d

Covered when ALL of the following are met for the selected diagnosis

Prescriber must be appropriately specialized: Infectious Disease specialist or Hematologist for Chronic Granulomatous Disease (CGD); Endocrinologist or other specified physician for severe malignant osteopetrosis.

checkbox on form

Diagnostic confirmation for CGD: One of: Nitroblue tetrazolium test (Negative) OR Dihydrorhodamine test (DHR+ neutrophils < 95%) OR Genetic analysis/immunoblot positive for p22phox, p40phox, p47phox, p67phox, or gp91phox.

checkboxes on form

Prior prophylactic therapy for CGD: Documented trial and failure of prophylactic antimicrobials: trimethoprim/sulfamethoxazole (5 mg/kg daily, divided) AND itraconazole (200 mg/day for patients > 50 kg).

documented trial and failure required

Policy Summary

PayerAvMed

PolicyActimmune (interferon gamma-1b) prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a signed medical prior authorization/step-edit request form with required clinical documentation faxed to 1-877-535-1391.

SourceLink

On This Page

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Diagnostic confirmation for severe malignant osteopetrosis: Documentation of all of the following: X-ray or increased liver function tests; decreased RBC and WBC counts; growth retardation; and deafness/sensorineural hearing loss. PLUS baseline labs: CBC with differential, platelets, LFTs, electrolytes, BUN, creatinine, and urinalysis.

Administration and dosing: Injections administered subcutaneously three times weekly. Pediatric dosing: 50 mcg/m2 for patients with body surface area > 0.5 m2, and 1.5 mcg/kg/dose for patients with body surface area ≤ 0.5 m2. Length of therapy: ONE year.

dosing and duration language on form

Use of samples to initiate therapy does not meet step edit/preauthorization criteria. Providers should not rely on manufacturer or office samples as the start of therapy when submitting a prior authorization or step-edit request for Actimmune, because sample use will not satisfy the document requirements for prior authorization.

Coding and Dosing Information

Covered HCPCS CodesHCPCSCovered

J9216

Actimmune (interferon gamma-1b)

Length of therapy

Length of therapyONE year

Administration frequencyInjections administered subcutaneously three times weekly

Single-use vial noteA vial of ACTIMMUNE is suitable for a single use only

Body surface area dosing threshold

BSA > 0.5 m2 dosing50 mcg/m2 per dose

BSA ≤ 0.5 m2 dosing1.5 mcg/kg per dose

Dosing scheduleInjections administered subcutaneously three times weekly

Provider Requirements and Prior Authorization Steps

Prior Authorization

Prior authorization required

Prescribers must submit a signed medical prior authorization/step-edit request form faxed to 1-877-535-1391 with required clinical documentation to obtain authorization for Actimmune (J9216).

Step Therapy

Step therapy required for CGD

For Chronic Granulomatous Disease (CGD), the form requires documented trial and failure of prophylactic antimicrobials — trimethoprim/sulfamethoxazole (5 mg/kg daily, divided) AND itraconazole (200 mg/day for patients > 50 kg) — before approval.

Documentation Required

Required documentation and prescriber signature

Provide a hand-signed prescriber signature and supporting documentation for every clinical criterion checked on the form, including lab results, diagnostic test results, chart notes, and baseline testing where applicable (CBC with differential, platelets, LFTs, electrolytes, BUN, creatinine, urinalysis).

Denial Risk

Incomplete documentation may delay or deny authorization

Incomplete, incorrect, or illegible information on the request form or missing documentation supporting checked clinical criteria (labs, diagnostics, chart notes) can delay authorization or result in denial.

Background

Actimmune (interferon gamma-1b) is indicated for Chronic Granulomatous Disease (CGD) and severe malignant osteopetrosis per the prior authorization form. The form specifies that prescribers should be appropriately specialized (e.g., Infectious Disease or Hematology for CGD) and documents diagnostic confirmation and baseline testing before approval.

Diagnostic Criteria and Definitions

CGD diagnostic criteria

Nitroblue tetrazolium testNegative

Dihydrorhodamine (DHR) testDHR+ neutrophils < 95%

Genetic/immunoblot evidencePositive for p22phox, p40phox, p47phox, p67phox, or gp91phox

Severe malignant osteopetrosis diagnostic criteria

Required diagnostic findingsDocumentation of all: X-ray or increased liver function tests; decreased RBC and WBC counts; growth retardation; deafness/sensorineural hearing loss

Required baseline testingCBC with differential, platelets, LFTs, electrolytes, BUN, creatinine, and urinalysis

Prescribing specialistEndocrinologist or other specified physician (to be documented)