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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 Chronic Inflammatory Demyelinating Polyneuropathy]

These criteria apply to requests for use of immunoglobulins for the indication of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 chronic inflammatory demyelinating polyneuropathy (CIDP)
    AND
    • Classical clinical presentation is that of symmetric proximal and distal weakness, progressive for more than 2 months, with impairment of predominately large-fiber sensory modalities and absent or diminished deep tendon reflexes
    AND
    • Electrodiagnostic features include abnormalities involving the compound muscle action potential (CMAP), distal motor latency (DL), conduction velocity, F-wave or H-reflex minimal latencies in at least 3 nerves, with demyelinating range abnormalities or partial conduction block in at least one nerve.
  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 therapy for maintenance therapy in patients failing to respond to an initial course of IVIG following therapies with other agents.
  4. General Information:
    • The definition of CIDP includes multifocal acquired demyelinating sensory and motor neuropathy (MADSAM) variant or when Sensory CIDP exists with other causes of neuropathy such as diabetes and Charcot-Marie-Tooth (CMT), as evidenced by superimposed features of CIDP.
    • Findings of predominant demyelination on a sural nerve biopsy can be used in conjunction with the other studies and the clinical presentation to suggest a diagnosis of CIDP. Finding of demyelination and inflammation on the nerve biopsy, although rare, definitely confirms the diagnosis, however, the absence of inflammation does not entirely rule it out.
    • As evidence of progression is more significant than the level of disability, mild cases of CIDP may not need to be treated aggressively if they are stable, but any signs of progression warrants effective treatment with IVIG to begin immediately.
    • Plasmapheresis has not been shown to be more effective than IVIG, however, it may be used in patients who are unresponsive to both IVIG and corticosteroid therapy
  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)

    Loading dose:
    2 g/kg IV given in divided doses over two to five consecutive days.
    Maintenance dose:
    1 g/kg IV administered over 1 day or divided into two doses
    of 0.5 g/kg given on two consecutive days, every 3 weeks.

    Medical:
    6 months or 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% (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, 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% (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. Micromedex. Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 4, 2015.
    2. Immune Globulin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 4, 2015.
    3. Gammagard-SD [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
    4. Gammaplex [Prescribing Information]. Temecula, CA; FFF Enterprises: June 2014.
    5. Gamunex-C [Prescribing Information]. Research Triangle Park, NC. Talecris: July 2014.
    6. Hizentra [Prescribing Information], Bern, Switzerland; CSL Behring AG, February 2015.
    7. Carimune [Prescribing Information]. Bern, Switzerland; CSL Behring AG: October 2013.
    8. Privigen [Prescribing Information]. Bern, Switzerland; CSL Behring AG: December 2013.
    9. Gammagard Liquid [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
    10. Sander HW, Latov N. Chronic Inflammatory Demyelinating Polyradiculoneuropathy Neurology. 2003 Apr 1; 60(8 Suppl 3): S8-15. Available at: http://www.cidpusa.org/P/VARIANTA.htm
    11. Patwa HS, Chaudhry V, So YT, etal. Evidence-based guideline: intravenous immunoglobulin in the treatment of neuromuscular disorders. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2012 Mar 27;78(13):1009-15. Available at: http://www.guideline.gov/content.aspx?id=36895&search=inflammatory+demyelinating
    12. Association of British Neurologists (ABN). Guidelines for the Use of Intravenous Immunoglobulin in Neurologic Diseases. London, UK: ABN; March 2002. Available at: http://www.theabn.org/downloads/IVIgGuidelines.pdf
    13. Elovaara I, Apostolski S, van Doorn P, et al. EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases: EFNS task force on the use of intravenous immunoglobulin in treatment of neurological diseases. Eur J Neurol. 2008 Sep;15(9):893-908.
    14. Joint Task Force of the EFNS and the PNS. European Federation of Neurological Societies/Peripheral Nerve Society Guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society--First Revision. J Peripher Nerv Syst. 2010 Mar;15(1):1-9. Available at: http://www.eaneurology.org/fileadmin/user_upload/guidline_papers/EFNS_guideline_2010_inflammatory_demyelinating_polyradiculoneuropathy.pdf
    15. Lewis R. Chronic inflammatory demyelinating polyneuropathy: Treatment and prognosis. UpToDate. April 24, 2015. Available at: http://www.uptodate.com/contents/chronic-inflammatory-demyelinating-polyneuropathy-treatment-and-prognosis?source=search_result&search=CIDP&selectedTitle=2%7E46
    16. Flebogamma DIF [Prescribing Information], Los Angeles, CA; Grifols Biologicals: August 2014.
    17. Gammaked [Prescribing Information], Fort Lee, NJ; Kedrion Biopharma: September 2013.
    18. Octagam 5%[Prescribing Information]. Hoboken, NJ; Octapharma USA: November 2013.
    19. Bivigam [Prescribing Information], Boca Raton, FL; Biotest Pharmaceuticals: May 2015.
    20. Octagam 10%[Prescribing Information]. Hoboken, NJ; Octapharma USA: December 2014.
    21. 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: 29-NOV-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, 14-JUL-14 DT, 23-FEB-15 DM, 05-JUN-15 LS