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

NATL

[Immunoglobulin for Kidney Transplant]


These criteria apply to requests for use of immunoglobulins for the indication of Kidney Transplant 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:
    • IVIG is used prior to kidney transplant for treatment of patients with high levels of "anti-donor" antibodies (i.e., patients highly sensitized to the tissue of the majority of living or cadaveric donors because of "non-self" human leukocyte antigen [HLA] or ABO incompatibility)
    OR
    • IVIG is used following kidney transplant for treatment of antibody-mediated rejection
  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.
    • IVIG used in combination with RituxanR (rituximab) for desensitization prior to renal transplantation
  4. General Information:
    • Health Net, Inc. considers the combination of intravenous immunoglobulin (IVIG) and Rituxan (rituximab) for desensitization prior to renal transplantation, investigational at this time. Larger, prospective, randomized controlled trials are needed to evaluate the long-term efficacy and safety of this treatment and to compare this protocol with the current treatment of IVIG alone.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
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    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    IVIG (Various Brand names)

    Monthly infusions of 2 g/kg (maximum 140 g)

    6 months or to member's renewal date, 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, 400 ml vials
    Octagam: 5% (50 mg/mL) in 20 mL, 50 mL, 100 mL, 200 mL, 500 mL
    Octagam: 10% (100 mg/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: 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% IgG (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 5, 2015.
    2. Immune Globulin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 5, 2015.
    3. Gammagard-SD [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
    4. Gammaplex [Prescribing Information], United Kingdom : Bio Products Laboratory Ltd. June 2014.
    5. Gamunex-C [Prescribing Information]. Research Triangle Park, NC. Grifolis Therapeutics Inc: July 2014.Hizentra [Prescribing Information], Bern, Switzerland; CSL Behring AG, January 2015.
    6. Carimune [Prescribing Information], Bern, Switzerland; CSL Behring AG, September 2013.
    7. Privigen [Prescribing Information], Bern, Switzerland; CSL Behring AG, November 2013.
    8. Gammagard Liquid [Prescribing Information], Westlake Village, CA; Baxter: April 2014.
    9. Habicht A, Broker V, Blume C, et al. Increase of infectious complications in ABO-incompatible kidney transplant recipients--a single centre experience. Nephrol Dial Transplant. 2011 Dec;26(12):4124-31. Epub 2011 May 28.
    10. Jordan SC, Toyoda M, Kahwaji J, et al. Clinical aspects of intravenous immunoglobulin use in solid organ transplant recipients. Am J Transplant. 2011 Feb;11(2):196-202. Epub 2011 Jan 10.
    11. Jordan SC, Reinsmoen, NL, Vo, AA. Intravenous Immunoglobulin and Rituximab for Desensitization. Transplantation: 27 October 2010, Volume 90, Issue 8, pp 932-933.
    12. Taal: Brenner and Rector's The Kidney, 9th ed. 2011 Saunders, An Imprint of Elsevier. Kidney Transplantation.
    13. Vo AA. Use of intravenous immune globulin and rituximab for desensitization of highly HLA-sensitized patients awaiting kidney transplantation. Transplantation. May 15, 2010; 89 (9): 1095-102.
    14. Jordan SC, Vo AA, Peng A, et al. Intravenous Gammaglobulin (IVIG): A Novel Approach to Improve Transplant Rates and Outcomes in Highly HLA-Sensitized Patients. American Journal of Transplantation 2006;6: 459-466. Available at: http://www.blackwell-synergy.com/doi/pdf/10.1111/j.1600-6143.2005.01214.x?cookieSet=1
    15. Clinicaltrials.gov. Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates. ClinicalTrials.gov Identifier: NCT00986947. Accessed June 1, 2015. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00986947?term=Rituximab+and+Intravenous+Immunoglobulin+%28IVIG%29+for+Desensitization+in+Renal+Transplantation&rank=3
    16. Clinicaltrials.gov. Rituximab + Immune Globulin Intravenous (IVIG) for Desensitization. ClinicalTrials.gov Identifier: NCT01178216. Accessed June 19, 2015. Available at: http://www.clinicaltrials.gov/ct2/show/NCT01178216?term=Rituximab+and+Intravenous+Immunoglobulin+%28IVIG%29+for+Desensitization+in+Renal+Transplantation&rank=2
    17. Clinicaltrials.gov. Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant. ClinicalTrials.gov Identifier: NCT01502267. Accessed June 19, 2015. Available at: http://www.clinicaltrials.gov/ct2/show/NCT01502267?term=Rituximab+and+Intravenous+Immunoglobulin+%28IVIG%29+for+Desensitization+in+Renal+Transplantation&rank=4
    18. Flebogamma [Prescribing Information], Barcelona, Spain: Institutio Grifols, S.A.;September 2013.
    19. Gammaked [Prescribing Information], Research Triangle Park, NC; Grifolis Therapeutics Inc.;September 2013.
    20. Octagam 5%[Prescribing Information]. Hoboken, NJ; Octapharma USA: October 2013.
    21. Bivigam [Prescribing Information], Boca Raton, FL; Biotest Pharmaceuticals: May 2015.
    22. Octagam 10%[Prescribing Information]. Hoboken, NJ; Octapharma USA: December 2014.
    23. 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.