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


NATL

[Immunoglobulin for Multifocal Motor Neuropathy]

These criteria apply to requests for use of immunoglobulins for the indication of Multifocal Motor Neuropathy 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 multifocal motor neuropathy (MMN)
    AND
    • On exam, clinical weakness without objective sensory loss in the distribution of 2 or more named nerves
    AND
    • Upper motor neuron signs, including spasticity, clonus, extensor plantar response, and pseudobulbar palsy are absent.
    AND
    • Nerve conduction study (NCS) with needle electromyography (EMG) demonstrating the presence of a definite conduction block in 2 or more motor nerves outside of common entrapment sites, (i.e., at sites not prone to nerve compression)
    AND
    • Sensory nerve conduction velocity is normal across the segments with demonstrated motor conduction block.
  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:
      • If the patient fails to respond to the initial treatment regimen (i.e., the induction dose as stipulated below), additional courses of therapy will not be covered.
      • Lack of improved strength after one, or at most two, IVIG treatments (total 2 to 3 g/kg each) should be considered a treatment failure, and no further IVIG should be used
  4. General Information:
    • Although not required for diagnosis, the presence of a high titer (>1:1000) of serum IgM antibody directed against ganglioside-monodialic acid (IgM Anti-GM1 antibodies) provides independent support for MMN (> 80% of patients).
    • Although no reports exist of controlled trials of immunosuppressive drugs in patients with multifocal motor neuropathy, there are a series of anecdotal reports of patients who transiently responded to oral or pulsed doses of cyclophosphamide, however, this treatment was associated with significant side effects, related in part to the cumulative dose of cyclophosphamide.
  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)

    Multifocal Motor Neuropathy
    400 mg/kg IV for 2-5 days or 1 g/kg/day for 2 days
    Maintenance dose:
    1-2 g/kg IV q 4-8wk; dose is titrated to symptoms; some patients may require IV infusions Q 2-4 months or may even go into prolonged remissions.
    1 month
    Consideration of additional approval for 6 months or to member's renewal period, whichever is longer, will be considered upon receipt of chart documentation of improved strength following initial IVIG treatment.

    If the patient fails to respond to the initial treatment regimen, additional courses of therapy will not be covered.

    Gammagard Liquid

    0.5 to 2.4 g/kg/month IV based on clinical response

    1 month
    Consideration of additional approval for 6 months or to member's renewal period, whichever is longer, will be considered upon receipt of chart documentation of improved strength following initial IVIG treatment.

    If the patient fails to respond to the initial treatment regimen, additional courses of therapy will not be covered
  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 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: 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 1, 2015.
    2. Immune Globulin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 1, 2015.
    3. Gammaplex [Prescribing Information], United Kingdom; Bio Products Laboratory Ltd. June 2014.
    4. Gammagard-SD [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
    5. Gamunex-C [Prescribing Information]. Research Triangle Park, NC. Grifolis Therapeutics Inc: 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. Olney RK, Lewis RA, Putnam TD, Campellone JV Jr. Consensus criteria for the diagnosis of multifocal motor neuropathy. Muscle Nerve 2003 Jan;27(1):117-21. Available at: http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=3730&nbr=2956
    11. National Guideline Clearinghouse. European Federation of Neurological Societies/Peripheral Nerve Society Guideline on management of paraproteinemic demyelinating neuropathies. Report of a 11. joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society. J Peripher Nerv Syst 2006 Mar;11(1):9-19.
    12. Harbo T, Andersen H, Jakobsen. Long-term therapy with high doses of subcutaneous immunoglobulin in multifocal motor neuropathy. J. Neurology. 2010 Oct 12;75(15):1377-80.
    13. Lehmann HC, Hurting HP. Plasma exchange and intravenous immunoglobulins: mechanism of action in immune-mediated neuropathies. J Neuroimmunol. 2011 Feb;231(1-2):61-9. Epub 2010 Nov 5.
    14. Azulay JP, Blin O, Pouget J, et al. Intravenous immunoglobulin treatment in patients with motor neuron syndromes associated with anti-GM1 antibodies: a double-blind, placebo-controlled study. Neurology. 1994;44(3 Pt 1):429-32.
    15. Bivigam [Prescribing Information], Boca Raton, FL : Biotest Pharmaceuticals Corp.; May 2015.
    16. Flebogamma [Prescribing Information],Barcelona, Spain: Institutio Grifols, S.A.; September 2013.
    17. Gammaked [Prescribing Information], Research Triangle Park, NC: Grifolis Therapeutics Inc.; September 2013.
    18. Octagam 5% [Prescribing Information], Hoboken, NJ: Octapharma USA; October 2013.
    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: 04-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, 06-OCT-14 NN, 23-FEB-15 DM, 29-MAY-15 SM