Prior Auth Protocol

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.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of Guillain Barre Syndrome (GBS) (also referred to as acute inflammatory demyelinating polyneuropathy (AIDP).

The disorder has been diagnosed during the first 2 weeks of the illness

Patient has significant muscle weakness as evidenced by any of the following:
- Weakness is at least sufficient to preclude walking 30 feet without assistance

Inability to stand or walk without aid

Respiratory or bulbar weakness (i.e., deteriorating pulmonary function tests)

Miller-Fisher syndrome

Patient has an acutely worsening (<7 days) form of GBS as evidenced by any of the following:
- Inability to raise head against gravity

Severe bulbar palsy (impaired gag reflex, dysarthria and/or dysphagia)

Patient has the need for intensive care unit (ICU) monitoring and/or elective intubation with mechanical ventilation

Bilateral facial weakness

Significant autonomic dysfunction (unexplained dysrhythmia, blood pressure fluctuations, significant bowel involvement or bladder involvement)

Obvious aspiration

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 indication:
- The use of cerebral spinal fluid (CSF) filtration followed by IVIG
- The use of immunoabsorption followed by IVIG
- Sequential treatment of plasma exchange followed by IVIG
- The combined use of IV methylprednisolone and IVIG

General Information:

GBS subtypes: Acute inflammatory demyelinating polyneuropathy (AIDP), Acute motor axonal neuropathy (AMAN), Acute motor-sensory axonal neuropathy (AMSAN), and Miller Fisher Syndrome (MFS).
Miller Fisher syndrome is a rare, acute polyneuropathy characterized by ataxia (abnormal muscle coordination), ophthalmoplegia (paralysis of the eye muscles), and areflexia (absence of the reflexes). Serum IgG antibodies to GQ1b (a ganglioside component of nerve) is useful for diagnosis of MFS.
Elevated CSF protein, with a normal CSF white blood cell count, is often present; fifty to 66 percent the first week of symptoms and ≥75 percent the third week.
Initiation of IVIG within 2 weeks of symptom onset appears to be as effective as Plasma Exchange.
The combination of IVIG and plasmaphoresis used together is not better than either treatment used alone.
Pulmonary function risk factors include one or more of the following:
- Forced vital capacity < 20 mL/kg
- Maximal inspiratory pressure < 30 cm H2O
- Maximal inspiratory pressure < 40 cm H2O
- 30% reduction in vital capacity from baseline

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
IVIG (Various Brand names)	400 mg/kg IV per day for 5 days or 1 g/kg body weight IV daily for two days	Medical: 6 months or renewal date, whichever is longer

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 mLPrivigen: 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

References:

Micromedex. Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 8, 2015.
Immune Globulin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 8, 2015.
Gammagard-SD [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
Gammaplex [Prescribing Information]. Temecula, CA; FFF Enterprises: June 2014.
Gamunex-C [Prescribing Information]. Research Triangle Park, NC. Talecris: July 2014.
Hizentra [Prescribing Information], Bern, Switzerland; CSL Behring AG, February 2015.
Carimune [Prescribing Information]. Bern, Switzerland; CSL Behring AG: October 2013.
Privigen [Prescribing Information]. Bern, Switzerland; CSL Behring AG, December 2013.
Gammagard Liquid [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
El-Bayoumi MA, El-Refaey AM, Abdelkader AM, et al. Comparison of intravenous immunoglobulin and plasma exchange in treatment of mechanically ventilated children with Guillain Barri syndrome: a randomized study. Crit Care. 2011 Jul 11;15(4):R164.
Hughes R, Swan A, Hartung H, etal. Randomised trial of plasma exchange, intravenous immunoglobulin, and combined treatments in Guillain-Barri syndrome. Lancet 1997; 349:225-230.
Flebogamma DIF [Prescribing Information], Los Angeles, CA; Grifols Biologicals: August 2014.
Gammaked [Prescribing Information], Fort Lee, NJ; Kedrion Biopharma: September 2013.
Octagam 5%[Prescribing Information]. Hoboken, NJ; Octapharmac USA: November 2013.
Bivigam [Prescribing Information], Boca Raton, FL; Biotest Pharmaceuticals: May 2015.
Octagam 10%[Prescribing Information]. Hoboken, NJ; Octapharma USA: December 2014.
HyQvia [Prescribing Information]. Westlake Village, CA; Baxter: September 2014.
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
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.
Vriesendorp FJ. Clinical Features and Diagnosis of Guillain Barre Syndrome in Adults. UpToDate. November 18, 2014. Available at: http://www.uptodate.com/contents/clinical-features-and-diagnosis-of-guillain-barre-syndrome-in-adults?source=search_result&search=guillain+barre&selectedTitle=1%7E150.
Vriesendorp FJ. Treatment and Prognosis of Guillain Barre Syndrome in Adults. UpToDate. June 3, 2015. Available at: http://www.uptodate.com/contents/treatment-and-prognosis-of-guillain-barre-syndrome-in-adults?source=search_result&search=guillain+barre&selectedTitle=3%7E150.
Sederholm, BH. Treatment of Acute Immune-mediated Neuropathies: Guillain-Barre Syndrome and Clinical Variants. Semin Neurol. 2010;30(4):365-372. Available at: www.medscape.com/viewarticle/730670_9.