Prior Auth Protocol

FDA Approved Indications:

For immune globulin intravenous (including Bivigam, Carimune NF, Flebogamma DIF, Gamunex-C, Gammaked, Gammagard Liquid, Gammagard S/D, Gammaplex, Octagam, Privigen, when used intravenously)
- Replacement therapy for primary immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
- Treatment of patients with thrombocytopenic purpura (ITP) to raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.
- Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN)
- Prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL).
- Prevention of coronary artery aneurysms associated with Kawasaki syndrome.
- Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.
For immune globulin subcutaneous (including Gamunex-C, Gammaked, Gammagard Liquid, Hizentra, and Hyqvia when used subcutaneously)
- Treatment of/replacement therapy for patients with primary immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Health Net Approved Indications and Usage Guidelines:

Patient is a child diagnosed with human immunodeficiency virus (HIV)

AND

Patient has hypogammaglobulinemia, (i.e., serum IgG concentration less than 250 mg/dL)

OR

Patient has recurrent serious bacterial infections (defined as two or more infections such as bacteremia, meningitis, or pneumonia in a 1-year period)

OR

Patient has failed to form antibodies to common antigens, such as measles, pneumococcal, and/or Haemophilus influenzae type b vaccine

OR

Patient lives in an area where measles is highly prevalent and patient has not developed an antibody response after two doses of measles, mumps, and rubella virus live vaccine

OR

Patient has been exposed to measles (requires a single dose)

OR

Patient has chronic bronchiectasis that is suboptimally responsive to antimicrobial and pulmonary therapy.

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
A list of specific indications for which coverage is not authorized may be found in the PA guideline: Immunoglobulin Conditions Not Medically Necessary - NATL.

General Information:

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Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
IVIG (Various Brand names)	Bacterial infection in children infected with HIV 400 mg/kg IV every 2 - 4 weeks Bronchiectasis 600 mg/kg IV every 28 days	6 months or to member's renewal period, whichever is sooner.

Product Availability:

Intravenous Immunoglobulin

Bivigam: 10% (1 g/10 mL) in 50 mL, 100 mL vials

Carimune NF powder for injection: 3 g, 6 g, 12 g vials

Flebogamma DIF: 5% (50 mg/mL) in 10 mL, 50 mL, 100 mL, 200 mL, 400 mL vials; 10% (5 g/50 mL) in 50 mL, 100 mL, 200 mL vials

Gammagard Liquid: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 300 mL vials

Gammagard S/D powder for injection: 0.5 g, 2.5 g, 5 g, 10 g bottles

Gammaked: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL vials

Gammaplex: 5% (50 mg/mL) in 50 mL, 100 mL, 200 mL, 400 mL vials

Gamunex-C: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 400 mL vials

Octagam: 5% (50 mg/mL) in 20 mL, 50 mL, 100 mL, 200 mL, 500 mL bottles; 10% (1 g/10 mL) in 20 mL, 50 mL, 100 mL, 200 mL bottles

Privigen: 10% (100 mg/mL) in 50 mL, 100 mL, 200 mL, 400 mL vials

Subcutaneous Immunoglobulin

Gammagard Liquid: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 300 mL vials

Gammaked: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL vials

Gamunex-C: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 400 mL vials

Hizentra protein solution for subcutaneous injection: 20% (0.2 g/mL) in 5 mL, 10 mL, 20 mL, 50 mL vials

HyQvia: 10% (1 g/10 mL) in 25 mL, 50 mL, 100 mL, 200 mL, 300 mL vials and 160 U/mL recombinant human hyaluronidase in 1.25 mL, 2.5 mL, 5 mL, 10 mL, 15 mL vials

References:

Bivigam [Prescribing Information] Boca Raton, FL: Biotest Pharmaceuticals Corporation; April 2014.
Carimune Nonfiltered [Prescribing Information] Bern, Switzerland: CSL Behring AG; October 2013.
Flebogamma 5% DIF [Prescribing Information] Barcelona, Spain: Instituto Grifols, S.A.; August 2014.
Flebogamma 10% DIF [Prescribing Information] Barcelona, Spain: Instituto Grifols, S.A.; July 2014.
Gammagard Liquid [Prescribing Information] Westlake Village, CA: Baxter Healthcare Corporation; September 2013.
Gammagard S/D [Prescribing Information] Westlake Village, CA; Baxter Healthcare Corporation; September 2013.
Gammaked [Prescribing Information] Research Triangle Park, NC: Grifols Therapeutic Inc.; September 2013.
Gammaplex [Prescribing Information] Hertfordshire, United Kingdom: Bio Products Laboratory Limited; June 2014.
Gamunex-C [Prescribing Information]; Research Triangle Park, NC: Grifols Therapeutics Inc.; July 2014.
Octagam 5% [Prescribing Information] Hoboken, NJ: Octapharma USA Inc.; November 2013.
Octagam 10% [Prescribing Information] Vienna, Austria: Octapharma Pharmazeutika Produktionsges m.b.H; December 2014.
Privigen [Prescribing Information] Bern, Switzerland: CSL Behring AG; December 2013
Hizentra [Prescribing Information] Bern, Switzerland: CSL Behring AG; February 2015.
Hyqvia [Prescribing Information] Westlake Village, CA: Baxter Healthcare Corporation; September 2014.
Pastori D, Esposito A, Mezzaroma I. Immunomodulatory effects of intravenous immunoglobulins (IVIGs) in HIV-1 disease: a systematic review. Int Rev Immunol. 2011 Feb;30(1):44-66
National Guideline Clearinghouse. New York State Department of Health. Neurologic complications in HIV-infected children and adolescents. New York State Department of Health; 2003 Mar. 19 p.
National Guideline Clearinghouse. New York State Department of Health. HIV-related hematologic manifestations in pediatrics. New York (NY): New York State Department of Health; 2003. 12 p.
Calvelli TA, Rubinstein A. Intravenous gamma-globulin in infant acquired immunodeficiency syndrome. Pediatr Infect Dis. 1986 May-Jun;5(3 Suppl):S207-10.
Falloon J, Eddy J, Wiener L, Pizzo PA. Human immunodeficiency virus infection in children. J Pediatr. 1989 Jan;114(1):1-30.
Micromedex^R Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 2, 2015.
Immune Globulin. American Hospital Formulary Service Drug Information. Avalable at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 2, 2015.
Clinical Pharmacology Web site. Available at http://www.clinicalpharmacology-ip.com/default.aspx. Accessed July 2, 2015.