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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 Multiple Myeloma]

These criteria apply to requests for use of immunoglobulins for the indication of Multiple Myeloma 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 Multiple Myeloma (MM) with stable plateau phase disease
    AND
    • It is greater than 3 months since diagnosis
    AND
    • The patient is not undergoing induction chemotherapy or patient is not in relapse phase
    AND
    • The patient is at high risk of recurrent infections as evidenced by:
      • IgG level < 600 mg/dL (normal range IgG=723-1,685 mg/dL)
    AND
      • Patient has one documented, very serious, laboratory-proven bacterial infection within the preceding 6 months
    OR
      • Patient has had two or more bacterial infections in the preceding year requiring IV antibiotic infusion therapy in the home or in the hospital
    OR
    • Patient has the presence of a specific antibody deficiency as evidenced by:
      • Low normal IgG levels during acute sepsis episodes
    OR
      • Failure to mount an appropriate IgG humoral immune response on challenge with pneumococcal vaccine
  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
    • Health Net does not consider IVIG therapy to be appropriate for the following indications:
      • Initiation or continuation of IVIG therapy based solely on a low IgG value, or for patients with mild sinopulmonary disease, or for those that do not demonstrate a lack of ability to produce an antibody to protein or carbohydrate antigens.
      • IVIG therapy for patients with normal humoral immunity but recurrent infections, particularly upper respiratory infections.
  4. General Information:
    • Plateau phase is defined as the time when other causitive organisms that may be present due to dysfunction in other immunologic cells besides the B-cell lines of defense are less likely to be present. IVIG in any other phase is considered not medically necessary.
    • These patients have a pattern of infection caused by encapsulated bacteria (Haemophilus influenzae, pneumococci, streptococci) which tends to be chronic and/or recurrent and does not demonstrate improvement with an adequate course of PO antibiotics and/or prophylactic antibiotics. Recurrent infections may include sinus infections, otitis media, bronchiectasis and pyogenic pneumonias.
  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)

    200 - 400 mg/kg IV every 3 - 6 weeks for 6 months to one year
    6 months or to member's renewal date,
    whichever is longer.

    Consideration for an additional 6 month approval will be made following
    receipt of chart note documentation of the patient's response to IVIG therapy.
  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
  8. References:
    1. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 2, 2015.
    2. Immune Globulin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 1, 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: July 2014.
    6. Hizentra [Prescribing Information], Bern, Switzerland; CSL Behring AG, January 2015.
    7. Carimune [Prescribing Information], Bern, Switzerland;CSL Behring AG, September 2013.
    8. Privigen [Prescribing Information], Bern, Switzerland; CSL Behring AG, November 2013.
    9. Gammagard Liquid [Prescribing Information], Westlake Village, CA; Baxter: April 2014.
    10. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. (NCCN Guidelines) Multiple Myeloma. Version 4.2015. Available at http://www.nccn.org. Accessed June 25, 2015.
    11. Blombery P, Prince HM, Worth LJ, et al. Prophylactic intravenous immunoglobulin during autologous haemopoietic stem cell transplantation for multiple myeloma is not associated with reduced infectious complications. Ann Hematol. 2011 Oct;90(10):1167-72.
    12. Kirch W, Gold R, Hensel M, et al. Assessment of immunoglobulins in a long-term non-interventional study (SIGNS Study). Rationale, design, and methods. Med Klin (Munich). 2010 Sep;105(9):647-51
    13. Chapel HM, Hargreaves R, et al. Randomized trial of intravenous immunoglobulin as prophylaxis against infection in plateau-phase multiple myeloma. Lancet. 1994; 343: 1059-1063.
    14. Musto P, Brugiatelli M, Carotenuto M. Prophylaxis against infections with intravenous immunoglobulins in multiple myeloma. Br J Haematol. 1995 Apr;89(4):945-6
    15. Flebogamma [Prescribing Information], Barcelona, Spain: Institutio Grifols, S.A.; September 2013.
    16. Gammaked [Prescribing Information], Research Triangle Park, NC: Grifolis Therapeutics Inc.;September 2013.
    17. Octagam 5% [Prescribing Information]. Hoboken, NJ; Octapharma USA: October 2013.
    18. Bivigam [Prescribing Information], Boca Raton, FL; Biotest Pharmaceuticals: May 2015.
    19. Octagam 10% [Prescribing Information]. Hoboken, NJ; Octapharma USA: December 2014.
    20. 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 MJM
Approved By Health Net National P&T: 20-FEB-13, 20-NOV-13, 19-NOV-14, 18-NOV-15
Revised: 15-JUN-13 SR, 01-JUL-14 MH, 23-FEB-15 DM, 03-JUN-15 SM