Currentharvard pilgrim health carePolicy N/A

Actimmune (interferon gamma-1b) prior authorization

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Defines prior authorization criteria for coverage of Actimmune for members of Harvard Pilgrim Health Care and affiliated Tufts commercial products, covering indications of Chronic Granulomatous Disease and severe malignant osteopetrosis and who may prescribe it.

Policy Summary

Payerharvard pilgrim health care

PolicyActimmune (interferon gamma-1b) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 12, 2026

Last ReviewMay 12, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis and required specialist involvement; for reauthorization, provide evidence of therapeutic response or absence of disease progression.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications covered

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Currentharvard pilgrim health carePolicy N/A

Actimmune (interferon gamma-1b) prior authorization

Customize your policy alerts

Sign up for all harvard pilgrim health care policy alerts

Know when harvard pilgrim health care releases new policies or updates existing guidance.

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Policy Summary

Payerharvard pilgrim health care

PolicyActimmune (interferon gamma-1b) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 12, 2026

Last ReviewMay 12, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis and required specialist involvement; for reauthorization, provide evidence of therapeutic response or absence of disease progression.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications covered

Coverage Criteria for Actimmune (interferon gamma-1b)

Initial Therapy - Chronic Granulomatous Disease

Covered when ALL of the following are met:

CGD Initial: 1. Documented diagnosis of Chronic Granulomatous Disease

Initial authorization criteria for CGD

CGD Initial: 2. Prescribed by or in consultation with an immunologist

Prescriber specialty requirement

Reauthorization - Chronic Granulomatous Disease

Covered when ALL of the following are met:

CGD Reauthorization: 1. Documented diagnosis of Chronic Granulomatous Disease

Reauthorization requires continued diagnosis

CGD Reauthorization: 2. Documentation the patient has experienced a therapeutic response defined by a reduction in the frequency and severity of serious infections associated with Chronic Granulomatous Disease

Evidence of clinical benefit is required for reauthorization

Initial Therapy - Severe, Malignant Osteopetrosis

Covered when ALL of the following are met:

SMO Initial: 1. Documented diagnosis of Severe, Malignant Osteoporosis

Initial authorization criteria for SMO

SMO Initial: 2. Prescribed by or in consultation with an endocrinologist

Prescriber specialty requirement

Reauthorization - Severe, Malignant Osteopetrosis

Covered when ALL of the following are met:

SMO Reauthorization: 1. Documented diagnosis of Severe, Malignant Osteoporosis

Reauthorization requires continued diagnosis

SMO Reauthorization: 2. Prescribed by or in consultation with an endocrinologist

Prescriber specialty requirement

SMO Reauthorization: 3. Documentation the patient has experienced a therapeutic response defined by an absence of disease progression (e.g., significant reduction in hemoglobin or platelet counts, serious bacterial infection requiring antibiotics, 50 decibel decrease in hearing, progressive optic atrophy)

Evidence of absence of disease progression required for reauthorization

Coverage decisions for Actimmune are made on a case-by-case basis and are subject to member-specific benefits and plan documents. The Pharmacy Medical Necessity Guideline provides the clinical criteria used to evaluate requests, but individual determinations depend on the member’s medical needs and the plan’s benefit provisions.

The guideline is intended to clarify the clinical basis for coverage decisions but does not guarantee payment. Claims adjudication remains subject to member eligibility and benefits on the date of service, coordination of benefits, referral/authorization and utilization management rules, and any applicable claims editing logic. For self‑insured plans, the member’s benefit document governs when it differs from this guideline.

Codes and Billing

Codes listed in policymixed

No codes listed

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for Actimmune for applicable Harvard Pilgrim and Tufts commercial products. Fax prior authorization requests to 617-673-0988.

Applies to: Harvard Pilgrim Health Care Commercial products
Applies to: Tufts Health Plan Commercial products

Note

Reserved for additional provider action highlights.

Documentation Required

Required Documentation

Document and retain: • A confirmed diagnosis of Chronic Granulomatous Disease or Severe, Malignant Osteoporosis; • Prescriber specialty or documented consultation (immunologist for CGD; endocrinologist for severe malignant osteoporosis); • For reauthorization, documentation of therapeutic response or absence of disease progression as described in policy; • Length of authorization: 12 months; • Review members new to the plan who are stable on Actimmune against reauthorization criteria.

Background on Actimmune

Actimmune (interferon gamma‑1b) is an interferon gamma product with FDA‑approved indications that include reducing the frequency and severity of serious infections in Chronic Granulomatous Disease (CGD) and delaying disease progression in Severe, Malignant Osteopetrosis (SMO). Coverage criteria in this policy align with those FDA‑approved indications and require specialist involvement and documentation of therapeutic response on reauthorization.

Therapeutic Response and Clinical Definitions

Therapeutic response / absence of disease progression

CGD — definition of therapeutic responseReduction in the frequency and severity of serious infections associated with Chronic Granulomatous Disease

SMO — definition of absence of disease progressionAbsence of disease progression as evidenced by examples such as no significant reduction in hemoglobin or platelet counts

SMO — additional examples of disease progression to monitorNo serious bacterial infection requiring antibiotics; no 50-decibel decrease in hearing; no progressive optic atrophy