Prior Auth Protocol

FDA Approved Indications:

For immune globulin intravenous (including Bivigam, Carimune NF, Flebogamma DIF, Gamunex-C, Gammaked, Gammagard Liquid, Gammagard S/D, Gammaplex, Octagam, Privigen, 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:

Due to lack of sufficient evidence in the published peer-review medical literature regarding its safety and efficacy, Health Net does not consider intravenous immunoglobulin (IVIG) therapy medically necessary for any of the conditions listed in Section III below.

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.
Acquired factor VIII inhibitors
Acute lymphoblastic leukemia
Adrenoleukodystrophy
Alzheimers Disease
Amyotrophic lateral sclerosis
Angioedema
Antiphospholipid syndrome
Aplastic anemia
Asthma
Autism
Autoimmune chronic urticaria
Behget's syndrome
Bullous pemphigoid
Cardiomyopathy, acute
Chronic fatigue syndrome
Chronic sinusitis
Cicatricial pemphigoid
Complex pain regional syndrome (CPRS)
Congenital heart block
Cystic fibrosis
Dermatosis, autoimmune blistering
Diabetes mellitus
Diamond-Blackfan anemia
Dysautonomia, acute idiopathic
Eczema
Encephalopathy, acute
Endotoxemia
Epilepsy
Goodpasture's syndrome
Hemolytic transfusion reaction
Hemolytic-uremic syndrome
Hemophagocytic syndrome
Idiopathic lumbosacral flexopathy
Immune-mediated neutropenia
Inclusion body myositis
Infection prevention and control in newborns
Intractable seizures
Leukemia, acute lymphoblastic
Lower motor neuron syndrome
Multiple sclerosis - primary progressive or secondary types
Myalgia, myositis, unspecified
Myelopathy, HTLV-I associated
Nephropathy, membranous
Nephrotic syndrome
Non-immune thrombocytopenia
Ophthalmopathy, euthyroid
Oral use
Otitis media, recurrent
Paraneoplastic cerebellar degeneration
Paraproteinemic neuropathy
Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS)
POEMS syndrome (see General Information - Section IV for definition)
Polyarteritis nodosa
Progressive lumbosacral plexopathy
Radiculoneuritis, Lyme
Rasmussen's syndrome
Recurrent otitis media
Recurrent spontaneous pregnancy loss
Red cell aplasia
Refractoriness to platelet transfusion
Reiter's syndrome
Renal failure, acute
Rheumatoid arthritis (adult and juvenile)
Scleroderma
Sensory neuropathy
Systemic Lupus Erythematosis
Systemic vasculitides
Thrombocytopenia (non-immune)
Vasculitis associated with other connective tissue diseases
Vogt-Koyanagi-Harada syndrome
Wegener's granulomatosis

General Information:

On May 7, 2013, Baxter announced in a press release that Gammagard had failed to produce a significant improve in Alzheimer symptoms in a Phase III trial when compared to placebo.
The term "POEMS" is actually an acronym for the most common symptoms and signs of the syndrome:
- P - peripheral neuropathy (numbness, tingling, and weakness of the feet and hands);
- O - organomegaly (large organs, like the liver, lymph nodes and spleen);
- E - endocrinopathy (abnormal hormone levels including sex hormones, thyroid hormones, etc.);
- M - monoclonal plasma-proliferative disorder (a collection of abnormal bone marrow cells, called plasma cells); most patients will have at least on abnormal bone x-ray associated with these plasma cells;
- S - skin changes (increased skin pigment, increased body hair, thickening of the skin, etc).

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
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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 Liquid: 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: 0.5 g, 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 bottles; 10% (1 g/10 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 Liquid: 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) IgG 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:

Bivigam [Prescribing Information] Boca Raton, FL: Biotest Pharmaceuticals Corporation; April 2014.
Carimune Nonfiltered [Prescribing Information] Bern, Switzerland: CSL Behring AG; October 2013.
Flebogamma 5% DIF [Prescribing Information] Barcelona, Spain: Instituto Grifols, S.A.; August 2014.
Flebogamma 10% DIF [Prescribing Information] Barcelona, Spain: Instituto Grifols, S.A.; July 2014.
Gammagard Liquid [Prescribing Information] Westlake Village, CA: Baxter Healthcare Corporation; September 2013.
Gammagard S/D [Prescribing Information] Westlake Village, CA: Baxter Healthcare Corporation; June 2011.
Gammaked [Prescribing Information] Research Triangle Park, NC: Grifols Therapeutic Inc.; September 2013.
Gammaplex [Prescribing Information] Hertfordshire, United Kingdom: Bio Products Laboratory Limited; June 2014.
Gammunex-C [Prescribing Information] Research Triangle Park, NC: Grifols Therapeutics Inc.; July 2014.
Octagam 5% [Prescribing Information] Hoboken, NJ: Octapharma USA Inc.; November 2013.
Octagam 10% [Prescribing Information] Vienna, Austria: Octapharma Pharmazeutika Produktionsges m.b.H; December 2014.
Privigen [Prescribing Information] Bern, Switzerland: CSL Behring AG; December 2013.
Hizentra [Prescribing Information] Bern, Switzerland: CSL Behring AG; February 2015.
Hyqvia [Prescribing Information] Westlake Village, CA: Baxter Healthcare Corporation; September 2014.
Micromedex^R Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 2, 2015.
Immune Globulin. American Hospital Formulary Service Drug Information. Avalable at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 2, 2015.
Clinical Pharmacology Web site. Available at http://www.clinicalpharmacology-ip.com/default.aspx. Accessed July 2, 2015.