ACTIMMUNE (interferon gamma-1b injection)

ACTIMMUNE (interferon gamma-1b injection)

Self-Administration – injectable

Diagnosis considered for coverage:

• Chronic Granulomatous Disease (CGD) - Indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD).
• Malignant osteopetrosis (SMO) - Indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO).

Coverage Criteria:

For diagnosis of Chronic Granulomatous Disease:

• Dose does not exceed:
  • Body surface area (BSA) greater than 0.5 m²: 50 mcg/m² (1 million international Units/m²) three times weekly, 
  • BSA equal to or less than 0.5 m²: 1.5 mcg/kg/dose three times weekly, AND
• Patient is at least 1 year of age or older, AND
• Prescribed by or in consultation with a hematologist or infectious disease specialist, AND
• Diagnosis of Chronic Granulomatous Disease confirmed by medical records.

For diagnosis of Malignant osteopetrosis:

• Dose does not exceed:
  • BSA greater than 0.5 m²: 50 mcg/m² (1 million international Units/m²) three times weekly, 
  • BSA equal to or less than 0.5 m²: 1.5 mcg/kg/dose three times weekly, AND
• Patient is at least 1 month of age or older, AND
• Prescribed by or in consultation with an endocrinologist or rheumatologist, AND
• Diagnosis of severe malignant osteopetrosis confirmed by medical records.

Reauthorization Criteria:

For diagnosis of Chronic Granulomatous Disease OR Malignant osteopetrosis:

• Dose does not exceed:
  • BSA greater than 0.5 m²: 50 mcg/m² (1 million international Units/m²) three times weekly, 
  • BSA equal to or less than 0.5 m²: 1.5 mcg/kg/dose three times weekly, AND
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration: 

•    Initial: 1 year
•    Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information: 

• Actimmune is contraindicated in patients who develop or have known hypersensitivity to interferon gamma, E. coli derived products, or any component of the product.
• Prior to the beginning of treatment and at three-month intervals during treatment the following laboratory tests are recommended for all patients on Actimmune (interferon gamma-1b) therapy:
  • Hematologic tests – including complete blood counts, differential and platelet counts
  • Blood chemistries – including renal and liver function tests. In patients less than 1 year of age, liver function tests should be measured monthly
  • Urinalysis

Policy Updates:

• 11/15/22 – New policy approved by P&T.

References:

• Actimmune Prescribing Information. Horizon Therapeutics USA, Inc. Deerfield, IL. May 2021.