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Prior Authorization Protocol
BIVIGAMTM, CARIMUNE NFR, FLEBOGAMMAR, GAMMAGARDR, GAMMAGARD S/DR, GAMMAKEDR, GAMMAPLEXTM, GAMUNEXR , OCTAGAMR, PRIVIGENR (immune globulin intravenous, IVIG), GAMUNEX-CR (immune globulin subcutaneous 10%), HIZENTRATM (immune globulin subcutaneous 20%), HYQVIA (immune globulin infusion 10% with recombinant human hyaluronidase)


NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For immune globulin intravenous (including Gamunex-C, Gammaked and Gammagard when used intravenously)
      • For the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include, but are not limited to, congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
      • In idiopathic thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.
      • For prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL).
      • For the prevention of coronary artery aneurysms associated with Kawasaki syndrome.
      • For treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
    • For immune globulin subcutaneous (including Gamunex-C, Gammaked and Gammagard when used subcutaneously)
      • Treatment of patients with primary immunodeficiency (PID).
  2. 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: Immune Globulin Conditions Not Medically Necessary - NATL.
  3. General Information:
    • Common variable immunodeficiency (CVID), the most frequently diagnosed primary immunodeficiency, is characterized by a low serum IgG level antibody deficiency at least 2 SDs below the mean for age, with most patients having concurrent deficiencies of IgA and IgM. Many Patients with CVID have IgG levels below 639 that require IVIG. However, there are rare instances when a patient will have normal IgG levels. The serum immunoglobulin measurement alone does not establish a diagnosis of CVID. A definitive diagnosis of CVID is established when a patient does not demonstrate a prolonged antibody response to immunization with protein antigens (e.g., tetanus) or carbohydrate antigens (e.g., pneumococcal capsular polysaccharides such as pneumovax).
    • The use of intravenous immune globulin should be reserved for patients with serious defects of antibody function. All immune deficiency conditions require ongoing monitoring of the patients clinical condition with measurement of pre-infusion (trough) serum IgG levels.
    • For lifelong treatment serum trough IgG levels should be measured before the infusion, then monitored every 3 months to maintain low normal level (usually 400  600 mg/dl).
  4. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
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    * Requires Prior Authorization
  5. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
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  6. 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 bottles
    Flebogamma: 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: 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: 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 vials
    Octagam: 5% (50 mg/mL) in 20 mL, 50 mL, 100 mL, 200 mL, 500 mL
    Octagam: 10% (50 mg/mL) in 20 mL, 50 mL, 100 mL, 200 mL
    Privigen: 10% (100 mg/mL) in 50 mL, 100 mL, 200 mL, 400 mL vials
    Subcutaneous Immunoglobulin
    Gammagard: 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 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
  7. References:
    1. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 9, 2013.
    2. Immune Globulin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 9, 2013.Gammagard-SD [package insert], Westlake Village, CA; Baxter: December 2009.
    3. Gammaplex [package insert]. Temecula, CA; FFF Enterprises: September 2009.
    4. Gamunex-C [package insert]. Research Triangle Park, NC. Talecris: October 2010.
    5. Hizentra [package insert], Bern, Switzerland; CSL Behring AG, February 2011.
    6. Carimune [package insert], CSL Behring AG, February 2009.
    7. Privigen [package insert], CSL Behring AG, February 2011.
    8. Gammagard Liquid [package insert], Westlake Village, CA; Baxter: July 2011.
    9. U.S. Food and Drug Administration. Immune Globulin Intravenous (Human) (Gamunex)  Talecris. Update 9/08. Available at: http://www.fda.gov/cber/label/gamunexlb.pdf
    10. Newburger JW, Takahashi M, Gerber MA, Gewitz MH, Tani LY, Burns JC, Shulman ST, Bolger AF, Ferrieri P, Baltimore RS, Wilson WR, Baddour LM, Levison ME, Pallasch TJ, Falace DA, Taubert KA. Diagnosis, treatment, and long-term management of Kawasaki disease: a statement for health professionals from the Committee on Rheumatic Fever, Endocarditis and Kawasaki Disease, Council on Cardiovascular Disease in the Young, American Heart Association. Circulation. 2004;110:27472771
    11. Centers for Disease Control and Prevention Kawasaki Syndrome Case Definition: http://www.cdc.gov/kawasaki/
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.