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Prior Authorization Protocol
BIVIGAMTM, CARIMUNE NFR, FLEBOGAMMA DIFR, GAMMAGARD LIQUIDR, GAMMAGARD S/DR, GAMMAKEDR, GAMMAPLEXTM, GAMUNEX-CR,OCTAGAMR, PRIVIGENR, HIZENTRATM, HYQVIA

NATL

[Immunoglobulin for Parvovirus B19 Infection]
These criteria apply to requests for use of immunoglobulins for the indication of Parvovirus B19 Infection only. For the use of immunoglobulins for any other indication, please refer to the appropriate indication specific criteria.
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 (IVIG) (including Gamunex-C, Gammaked and Gammagard 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 idiopathic 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.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of Parvovirus B19 infection
    AND
    • Severe, chronic refractory anemia due to bone marrow suppression (i.e., Hgb <10 or Hct < 30) unresponsive to Epogen/Procrit and secondary to documented parvovirus B19 viremia.
  3. 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.
  4. General Information:
    • Human parvovirus B19 infection can give rise to the loss of mature red blood cells, severe anemia and the formation of immune complexes.
    • A robust antibody response is necessary for virus clearance and control of the infection.
    • IVIG has been shown to be effective in recurrent infection in augmenting the inadequate humoral immune response. Based on the evidence available, IVIG therapy has become the standard of care if the aplastic crisis becomes prolonged, even though there are no definitive clinical trials demonstrating the efficacy of HPV B19induced anemia.
    • IVIG dose adjustments:
      • Adjustment of the IVIG dose and time interval between doses should be based on trough levels measured every month for the first three months of therapy and again at six months
      • Adjustments to infusion rates and measuring of serum IgG levels may be needed during infections or in persons who have a high catabolism of infused IgG
      • To reduce infection frequency in immunodeficient patients, serum trough levels should be maintained at 670-730 mg/dl, a value close to the lower limit of normal. All IgG trough levels outside of the low normal range of 6.7-7.3 mg/dl require dosage adjustment.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    Procrit(preferred) and Epogen
    50-100 units/kg IV or SC TIW
    If the Hgb level exceeds 10 g/dL, reduce or interrupt the dose,
    and use the lowest dose sufficient to reduce the need for RBC transfusions.

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    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    IVIG (Various Brand names)

    400 mg/kg every 28 days

    6 months or to member's renewal period, whichever is longer

  7. 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 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: 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
  8. References:
    1. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 26, 2015.
    2. Immune Globulin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 26, 2015.
    3. Gammagard-SD [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
    4. Gammaplex [Prescribing Information], Hertfordshire, UK. Bio Products Laboratory Ltd: February 2014.
    5. Gamunex-C [Prescribing Information]. Research Triangle Park, NC. Grifols: July 2014.
    6. Hizentra [Prescribing Information], Bern, Switzerland; CSL Behring AG, January 2015.
    7. Carimune [Prescribing Information], CSL Behring AG, September 2013.
    8. Privigen [Prescribing Information], CSL Behring AG, November 2013.
    9. Gammagard Liquid [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
    10. Frickhofen N, Abkowitz JL, Safford M, et al. Persistent B19 parvovirus infection in patients infected with human immunodeficiency virus type 1 (HIV-1): a treatable cause of anemia in AIDS. Ann Intern Med. 1990;113(12):926-33.
    11. Moudgil A, Shidban H, Nast CC, et al. Parvovirus B19 infection-related complications in renal transplant recipients: treatment with intravenous immunoglobulin. Transplantation. 1997;64(12):1847-50.
    12. Szenborn L. The use of immunoglobulins in the treatment of infectious diseases. Pol Merkur Lekarski. 2011 Jun;30(180):441-7.
    13. Jordan JA. Treatment and prevention of parvovirus B19 infection. UpToDate. June 2013.
    14. Flebogamma [Prescribing Information], Los Angeles, CA; Grifols Biologicals: September 2013.
    15. Gammaked [Prescribing Information], Fort Lee, NJ; Kedrion Biopharma: September 2013.
    16. Octagam 5% [Prescribing Information]. Hoboken, NJ; Octapharma USA: October 2013.
    17. Bivigam [Prescribing Information], Boca Raton, FL; Biotest Pharmaceuticals: October 2013.
    18. Octagam 10% [Prescribing Information]. Hoboken, NJ; Octapharma USA: July 2014.
    19. HyQvia [Prescribing Information]. Westlake Village, CA; Baxter: September 2014.
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.
Draft Prepared: 05-DEC-12 JB
Approved By Health Net National P&T: 20-FEB-13, 20-NOV-13, 19-NOV-14, 18-NOV-15
Revised: 15-JUN-13 SR, 10-JUL-14 MH, 23-FEB-15 DM, 26-JUN-15 EA