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.
- 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.
- For 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 B-Cell Chronic Lymphocytic Leukemia

AND

Peripheral white cell count >10,000 cells/microliter (mcl)(mm3)

AND

Absolute lymphocytosis in the peripheral blood with a minimal level of more than 5,000/muL, but more usually in the range of 40,000 to 150,000/muL

AND

If the lymphocyte count is 5,000 to 15,000/muL, flow cytometry must express monoclonal surface markers of either kappa or lambda light chains consistent with arrested B-cell lineage

AND

Bone marrow biopsy showing >30% lymphocytes

AND

Patient has associated hypogammaglobulinemia with immunoglobulin G (IgG) level of <600 mg/dl

AND

Patient has one documented, very serious, laboratory-proven bacterial infection within the preceding 6 months

OR

Patient has two or more bacterial infections in the preceding year requiring IV antibiotic infusion therapy in the home or in the hospital

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 intravenous immunoglobulin (IVIG) therapy to be appropriate in any of following indications:
- The 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.

General Information:

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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 body weight IV given every 3 - 4 weeks (with a range of 100 to 500 mg/kg IV every month) Dosing will vary with the product and the degree of hypogammaglobulinemia	6 months or to member's renewal period, whichever is sooner.
(IGSC) Gammaked, Gamunex-C, Gammagard	100 to 200 mg/kg body weight SC per week OR Initial weekly SC dose can be calculated by multiplying the previous IVIG dose by 1.37, and then dividing this dose into weekly doses based on the patient's previous IVIG treatment interval.	6 months or to member's renewal period, whichever is sooner.
(IGSC) Hizentra	Administer SC at regular intervals from daily up to every two weeks (biweekly). To calculate the initial weekly dose of Hizentra, multiply the previous IVIG dose in grams by the dose adjustment factor of 1.37; then divide this by the number of weeks between doses during the patient`s IVIG treatment (i.e., 3 or 4). Weekly Dosing: Administer calculated weekly dose starting 1 week after the last IVIG infusion Biweekly Dosing: Administer twice the calculated weekly dose starting 1 or 2 weeks after the last IVIG infusion or 1 week after the last IGSC infusion. Frequent Dosing (2 to 7 times per week): Divide the calculated weekly dose by the desired number of times per week. Start Hizentra 1 week after the last IVIG or IGSC infusion. To convert the Hizentra dose (in grams) to milliliters (mL), multiply the calculated dose (in grams) by 5.	6 months or to member's renewal period, whichever is sooner.
(IGSC) HyQvia	Infuse the two components of HyQvia sequentially, beginning with the recombinant human hyaluronidase. Initiate the IGSC within 10 minutes of the recombinant human hyaluronidase infusion. Initiation of treatment: Increase dose and frequency from a 1-week dose to a 3- or 4-week dose (see ramp-up schedule below) For patients previously on another IG treatment, administer the first dose of HyQvia approximately one week after the last infusion of their previous treatment Initial dosage ramp-up schedule (e.g., every 4-week dosing): Week 1: [1-week dose interval] 1/4 of target dose Week 2: [2-week dose interval] 1/2 of target dose Week 3: no infusion Week 4: [3-week dose interval] 3/4 of target dose Week 5: no infusion Week 6: no infusion Week 7: [4-week dose interval] target dose, repeat every 4 weeks Switching from IGIV: Administer at the same dose and frequency as the previous intravenous treatment, after the initial dose ramp-up Naive to IG treatment or switching from IGSC: 300 to 600 mg/kg at 3 to 4 week intervals, after initial ramp-up Dose adjustments: See details in prescribing information	6 months or to member's renewal period, whichever is sooner

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: 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; September 2013.
Gammaked [Prescribing Information] Research Triangle Park, NC: Grifols Therapeutic Inc.; September 2013.
Gammaplex [Prescribing Information] Hertfordshire, United Kingdom: Bio Products Laboratory Limited; June 2014.
Gamunex-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.
Hizentra [Prescribing Information] Bern, Switzerland: CSL Behring AG; February 2015.
HyQvia [Prescribing Information] Westlake Village, CA: Baxter Healthcare Corporation; September 2014.
Privigen [Prescribing Information] Bern, Switzerland: CSL Behring AG; December 2013.
Bonilla FA. Primary humoral immune deficiencies: An overview. UpToDate. October 14, 2011.
Chin TW. IgA and IgG Subclass Deficiencies Clinical Presentation. eMedicine. September 28, 2012. Available at: http://emedicine.medscape.com/article/885348-clinical
Lin RY. Hypogammaglobulinemia, eMedicine. April 21, 2014. Available at: http://emedicine.medscape.com/article/136471-overview#showall
Silvergleid AJ. Intravenous immune globulin in hematologic disorders. November 10, 2010.
Micromedex. 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.