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Interferons bind to specific cell surface receptors and initiate a sequence of intracellular events that lead to the transcription of interferon-stimulated genes. The three major groups of interferons (alpha, beta, gamma) have partially overlapping biological activities that include immunoregulation such as increased resistance to microbial pathogens and inhibition of cell proliferation. Type 1 interferons (alpha and beta) bind to the alpha/beta receptor. Interferon-gamma binds to a different cell surface receptor and is classified as Type 2 interferon. Specific effects of interferon –gamma include the enhancement of the oxidative metabolism of macrophages, antibody dependent cellular cytotoxicity, activation of natural killer cells, and the expression of Fc receptors and major histocompatibility antigens.
Interferon gamma-1b (Actimmune®) is a biologic response modifier that is derived by fermentation of a genetically engineered Escherichia coli bacterium containing the DNA which encodes for the human protein.
Chronic Granulomatous Disease is an inherited disorder of leukocyte function caused by defects in the enzyme complex responsible for phagocyte superoxide generation. Interferon gamma-1b (Actimmune®) does not increase phagocyte superoxide production even in treatment responders. In severe, malignant osteopetrosis, a treatment related enhancement of superoxide production by phagocytes was observed. Interferon gamma-1b (Actimmune®) was found to enhance osteoclast function in vivo.
In both disorders, the exact mechanisms by which interferon gamma-1b (Actimmune®) has a treatment effect has not been established. Changes in superoxide levels during therapy do not predict efficacy and should not be used to assess patient response to therapy.
FDA APPROVED INDICATIONS
Interferon gamma-1b (Actimmune®) is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). It is also indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis.
Prior authorization is required.
Interferon gamma-1b (Actimmune®) is considered medically necessary for the treatment of Chronic Granulomatous Disease and for delaying of time to disease progression of severe, malignant osteopetrosis.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
10/21/2003: Approved by Pharmacy & Therapeutics Committee (P & T)
8/15/2005: Code Reference section reviewed, no changes
09/06/2006: FDA approved section added. Accredo information updated.
12/31/2008: Code Reference section updated per the 2009 CPT/HCPCS revisions
01/01/2009: Accredo preferred provider information removed. BCBSMS information added.
04/02/2014: Policy description revised; policy statement unchanged.
08/18/2015: Medical policy revised to add ICD-10 codes.
05/27/2016: Policy number L.5.01.439 added. Policy Guidelines updated to add medically necessary definition.
11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
Clinical Pharmacology Online
Bolinger AM, Taeubel MA. Recombinant gamma interferon for the treatment of chronic granulomatous disease and other disorders. Clin Pharm 1992;11:834-50.
Actimmune® Prescribing Information
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.