State and School Employees' Health Insurance Plan - Actimmune (interferon gamma-1b)

POLICY NUMBER

S.5.01.439

Actimmune (interferon gamma-1b)

Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.

DESCRIPTION

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.

Actimmune (interferon gamma-1b) is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) and delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO). CGD is an inherited disorder of leukocyte function caused by defects in the enzyme complex responsible for phagocyte superoxide generation. SMO is an inherited disorder characterized by osteoclast defect, leading to bone overgrowth, and by deficient phagocyte oxidative metabolism. The exact mechanisms by which Actimmune (interferon gamma-1b) has a treatment effect has not been established for either disorder.

POLICY

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Initial Criteria

Actimmune (interferon gamma-1b) may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. The individual has a documented diagnosis of serious infections associated with Chronic Granulomatous Disease (CGD) AND is ≥1 year old; OR

   2. The individual has a documented diagnosis of severe, malignant osteopetrosis (SMO) AND is ≥1 month old; 

2. The prescriber is a specialist or has consulted with a specialist in an area of the individual's diagnosis (i.e.,

   hematologist, immunologist, or infectious disease specialist for CGD;

   endocrinologist or rheumatologist for SMO);

3. ALL of the following are obtained prior to initiation of treatment and will be obtained at three-month intervals during treatment:

   1. Hematological tests - including complete blood counts, differential and platelet counts;

   2. Blood chemistries - including renal and liver function tests (In patients less than 1 year of age, liver function tests measured monthly); AND

   3. Urinalysis;

4. The individual does not have any FDA labeled contraindication(s) to the requested agent or E.coli-derived products; AND

5. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

Renewal Criteria

Actimmune (interferon gamma-1b) may be approved for continuation when ALL of the following criteria are met:

1. The individual has previously been approved for therapy with the requested agent through BCBSMS review process;

2. The individual has documented clinical improvement (i.e. slowing of disease progression or decrease in symptom severity and/or frequency);

3. The prescriber is a specialist or has consulted with a specialist in an area of the individual's diagnosis (i.e.,

   hematologist, immunologist, or infectious disease specialist for CGD;

   endocrinologist or rheumatologist for SMO);

4. The individual does not have any FDA labeled contraindication(s) to the requested agent or E.coli-derived products; AND

5. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months 

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): Self-administered drugs may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a self-administered drug are not covered under the medical benefit.

POLICY GUIDELINES

Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.

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 Participant’s illness, injury or Mental Health Disorders, 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 Participant’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 Participant, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to the Participant. When applied to the care of an Inpatient, it further means that services for the Participant’s medical symptoms or conditions require that the services cannot be safely provided to the Participant as an Outpatient.

For the definition of medical necessity, “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.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

POLICY HISTORY

07/01/2023: New policy added.

10/01/2024: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Medically necessary policy statement criteria revised to include documentation of hematological tests and blood chemistries. Policy Guidelines updated to define adherence. Sources updated.

09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Actimmune (interferon gamma-1b). Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Initial criteria updated to change "osteoporosis" to "osteopetrosis," revise prescriber requirements, and to revise criteria that must be obtained prior to initiation of treatment. Renewal criteria updated regarding prescriber requirements. Policy Guidelines updated to remove adherence definition. Sources updated.

10/01/2025: Code Reference section updated to add new ICD-10 diagnosis code D71.8.

SOURCE(S)

1. Bolinger AM, Taeubel MA. Recombinant gamma interferon for the treatment of chronic granulomatous disease and other disorders. Clin Pharm 1992;11:834-50.

2. Actimmune Prescribing Information. Horizon Therapeutics USA, Inc. April 2025. Last accessed June 2025.

CODE REFERENCE

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.

Medically Necessary Codes        

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.