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. 

 

Last review date: December 1, 2022

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