SCIG: (Immune globulin SQ) Hizentra, Vivaglobin, Gammagard Liquid, Gamunex- C, Gammaked, Hyqvia Page 1 of 6

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1 Moda Health Plan, Inc. Medical Necessity Criteria Subject: Origination Date: 04/1 Revision Date(s): 02/16 Developed By: Medical Criteria Committee Effective Date: 0/01/1 SCIG: (Immune globulin SQ) Hizentra, Vivaglobin, Gammagard Liquid, Gamunex- C, Gammaked, Hyqvia Page 1 of 6 Approved: Mary Engrav, MD Date: 02/24/16 Description: Hyqvia, Hizentra, Gammagard, Gammaked, and Gamunex-C are immune globulin products used for subcutaneous administration in certain conditions. Immune globulin has various short-term and long-term immunomodulatory effects. Impacts on immune function include alterations of T cells and macrophages, particularly cytokine synthesis, and B-cell immune function and its regulatory action on the membranedamaging components of the complement system. Criteria: I. Moda Health considers SCIG immune globulin SQ medically necessary for1 or more of the following conditions: a. Primary immunodeficiency (PID)/Wiscott-Aldritch Syndrome such as: (x-linked agammaglobulinemia, common variable immunodeficiency, transient hypogammaglobulinemia of infancy, IgG subclass deficiency with or without IgA deficiency, antibody deficiency with near normal immunoglobulin levels) and combined deficiencies (severe combined immunodeficiencies, ataxia-telangiectasia, x-linked lymphoproliferative syndrome, (list is not all inclusive)) with 1 or more of the following: i. Patient s IgG level is <0 or ii. Patient meets ALL of the following: 1. Patient has a history of multiple hard to treat infections as indicated by at least 1 or more of the following: a. Four of more ear infections within 1 year b. Two or more serious sinus infections within 1 year c. Two or more months of antibiotics with little effect d. Two or more pneumonias within 1 year e. Recurrent or deep skin abscesses f. Need for intravenous antibiotics to clear infections g. Two or more deep seated infection including septicemia

2 2. The patient has a deficiency in producing antibodies in response to vaccination and ALL of the following: a. Baseline titers were drawn before challenging with vaccination b. Titers were drawn within 30 days of vaccination b. Renewal criteria is medically necessary with ALL of the following: i. Patient continues to meet criteria ii. Disease response iii. Absence of unacceptable toxicity from the drug II. III. Warnings and Contraindications a. Due to a potential risk of hematoma formation, do not administer Gammaked or Gamunex- C subcutaneously in patients with ITP b. IgA-deficient patients with anti-iga antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions Dosage/Administration Dosing should be calculated using adjusted body weight if 1 or more of the following criteria are met: 1. Patient s body mass index (BMI) is 30 kg/m2 or more 2. Patient s actual body weight is % higher than his or her ideal body weight (IBW) Use the following dosing formulas to calculate the adjusted body weight (round dose to nearest gram increment in adult patients): Dosing Formulas BMI = 703 x (weight in pounds/height in inches2) IBW (kg) for males = 0 + [2.3 (height in inches 60)] IBW (kg) for females = 4. + [2.3 x (height in inches 60)] Adjusted body weight = IBW + 0. (actual body weight IBW) This information is not meant to replace clinical decision making when initiating or modifying medication therapy and should only be used as a guide. Patient-specific variables should be taken into account Indication Primary immune deficiency including Wiskott-Aldrich Syndrome Dose Hizentra weekly dose: 1.37 *(previous IVIG dose(g)/# of weeks between IVIG doses); or biweekly dose would be weekly dose multiplied by 2 Vivaglobulin: 0-0 mg/kg every week Gamunex-C/Gammaked/Gammagard Liquid weekly dose: 1.37 *(previous IVIG dose(g)/# of weeks between IVIG doses) HyQvia: Naïve to IgG or switching from IGSC: 300 to 600 mg/kg at 3 to 4 week intervals after initial ramp-up*

3 Switching from IGIV: use the same dose and frequency as the previous IV treatment after initial ramp-up* Hyqvia initial treatment interval/dosage ramp up schedule Week Infusion Number 2-week treatment interval 4-week treatment interval 1 1 st infusion Grams X 0.33 Grams X nd infusion Grams X 0.67 Grams X rd infusion Total grams Grams X th infusion N/A Total Grams Information to be Submitted with Pre-Authorization Request: I. Chart notes including prior treatments II. Laboratory reports Billing Code/Availability Information: Jcode & NDC Drug Name Manufacturer J Code 1 Billable unit NDC IgG (grams) Hizentra % CSL Behring AG J19 0 mg Vivaglobin 16% CSL Behring AG J162 0 mg Discontinued Gammaked % Gammunex-C Gammagard Liquid % Kedrion Biopharma, Inc Talecris Biotherapeutics Baxter Healthcare Corporation J mg J mg J mg Volume

4 HyQvia % with Reombinant Human Hyaluronidase 160 U/mL Baxter Healthcare Corporation J390- unclassified biologic N/A Dosing Limit Quantity Limit (max daily dose) [Pharmacy Benefit] Drug Name Dose/Week Dose/28 days # Vials/28 days Hizentra Male: 27 g or 13 ml Female: 23 g or 11 ml Male: 8 g or 40 ml Female: 92 g or 460 ml Male: 11 x 0 ml Female: x 0 ml Gamunex & Gammaked Male: 24 g or 240 ml Female: 21 g or 2 ml Male: 96 g or 960 ml Female: 84 g or 840 ml Male: x 0 ml Female: 9 x 0 ml Gammagard liquid Male: 24 g or 240 ml Female: 21 g or 2 ml Male: 96 g or 960 ml Female: 84 g or 840 ml Male: x 0 ml Female: 3 x 300 ml HyQvi Male: 17.2 g or 173 ml Female: 1 g or 10 ml Male: 69 g or 690 ml Female: 60 g or 600 ml Male: 7 x 0 ml Female: 2 x 300 ml Vivaglobin Discontinued Discontinued Discontinued Max Units (per dose and over time) [Medical Benefit] Hizentra Must be older than 2 years of age: Male: 80 billable units/28 days Female: 9 billable units/28 days Vivaglobin: Discontinued Gamunex & Gammaked Male: 192 billable units/28 days Female: 168 billable units/28 days Gammagard liquid Must be older than 2 years of age: Male: 192 billable units/28 days Female: 168 billable units/28 days HyQvia Male: Female: 690 billable units/28 days 600 billable units/28 days

5 Covered ICD- Codes: ICD- Codes Diagnosis B Human immunodeficiency virus [HIV] disease D80.0 Hereditary hypogammaglobulinemia D80.1 Nonfamilial hypogammaglobulinemia D80.2 Selective deficiency of immunoglobulin A [IgA] D80.3 Selective deficiency of immunoglobulin G [IgG] subclasses D80.4 Selective deficiency of immunoglobulin M [IgM] D80. Immunodeficiency with increased immunoglobulin M [IgM] D80.7 Transient hypogammaglobulinemia of infancy D81.0 Severe combined immunodeficiency [SCID] with reticular dysgenesis D81.1 Severe combined immunodeficiency [SCID] with low T- and B-cell numbers D81.2 Severe combined immunodeficiency [SCID] with low or normal B-cell numbers D81.6 Major histocompatibility complex class I deficiency D81.7 Major histocompatibility complex class II deficiency D81.89 Other combined immunodeficiencies D81.9 Combined immunodeficiency, unspecified D82.0 Wiskott-Aldrich syndrome D83.0 Common variable immunodeficiency with predominant abnormalities of B- cell numbers and function D83.2 Common variable immunodeficiency with autoantibodies to B- or T-cells D83.8 Other common variable immunodeficiencies D83.9 Common variable immunodeficiency, unspecified Review Date Revisions Effective Date 04/1 New Criteria with ICORE separated from the IVIG /1/1 infusion criteria 02/16 Updated with Magellan criteria- updated references, dosing, added ICD- codes, deleted ICD-9 codes 02/24/16 References: Hizentra [package insert]. Bern, Switzerland; CSL Behring AG; January 1. Accessed November 1. Vivaglobin [package insert]. Marburg, Germancy; CSL Behring AG; April. Accessed November 1. HyQvia [package insert]. Westlake Village, CA; Baxter Healthcare Corporation; September 14. Accessed November 1. Gammagard Liquid [package insert]. Westlake Village, CA; Baxter Healthcare Corporation; September 13. Accessed November 1. Gamunex -C [package insert]. Research Triangle, NC; Talecris Biotherapeutics, Inc.; July

6 14. Accessed November 1. Gammaked [package insert]. Fort Lee, NJ; Kedrion Biopharma, Inc; September 13. Accessed November 1. Emerson GG, Herndon CN, Sreih AG. Thrombotic complications after intravenous immunoglobulin therapy in two patients. Pharmacotherapy. 02;22: Department of Health (London). Clinical Guidelines for Immunoglobulin Use: Update to Second Edition. August, 11. Provan, Drew, et al. "Clinical guidelines for immunoglobulin use." Department of Health Publication, London (08). Jeffrey Modell Foundation Medical Advisory Board, 13. Warning Signs of Primary Immunodeficiency. Jeffrey Modell Foundation, New York, NY Moda Health Pharmacy Specialty Criteria for Immune Globulin (Hizentra, Gammagard, Gammaked, Gamunex-C, Hyqvia) ; 03/1