Drug Class Prior Authorization Criteria Immune Globulins

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1 Drug Class Prior Authorization Criteria Immune Globulins Line of Business: Medicaid P & T Approval Date: August 16, 2017 Effective Date: August 16, 2017 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Drugs Requiring Prior Authorization Review: Bivigam, Carimune, Flebogamma, Gammagard, Gammaked, Gammaplex, Gamunex C, Octagam, Privigen (immune globulin), Cubitru, Hizentra (immune globulin, subcutaneous) FDA Approved Indications for IVIG products (CBER): Brand PID CLL ITP Kawasaki Syndrome CIDP Multifocal Motor Neuropathy Bivigam Carimune NF Flebogamma DIF Gammagard Liquid Gammagard S/D Gammaked Gammaplex Gamunex C Hizentra (SCIG) Hyqvia (SCIG) Octagam Privigen PID = primary immune deficiency, CLL = chronic lymphocytic leukemia, ITP = idiopathic thrombocytopenic purpura, CIDP = chronic inflammatory demyelinating polyneuropathy 1. Due to the various dosage forms and adverse events profile IVIG products will be covered based on approved indications after failure of first line treatment options (For detailed criteria please see section: Criteria) a. Approvable non FDA approved indications or off label indications where anecdotal evidence has shown efficacy and where clinical trials may not be appropriate due to rarity of the disease or ethics: Guillain Barre syndrome, dermatomyositis, bone marrow transplantation, and Lambert Eaton Syndrome. b. Other non FDA approved indications ( off label condition) will be reviewed and considered based on evidence for efficacy. Use for the non FDA approved indication must be found in at least one pharmaceutical compendium: United States Pharmacopeia Drug 1 P age

2 Information (USPDI), Drug Information for Healthcare Professional, American Hospital Formulary Service (AHFS) Drug Information, or Micromedex DrugDex. The Clinical Review process will also consider information submitted by the prescriber supporting the intended off label use in the form of two supporting journal articles from nationally recognized peer reviewed journals (e.g. New England Journal of Medicine) or if the use is endorsed by the Local Coverage Determination per CMS. 2. Lab Tests/Monitoring Parameters: a. Baseline renal (BUN & Creatinine Clearance) b. Platelets and Hgb levels c. Immunoglobulin levels (Ig) d. IgA deficiency or IgA antibodies Criteria: 1. Primary Immunodeficiency Syndrome (PID) a. For patients with a primary immunodeficiency syndrome, including the following: i. Hereditary hypogammaglobulinemia ii. Immunodeficiency with increased immunoglobulin M (IgM) iii. Severe combined immunodeficiency (SCID) iv. Major histocompatibility complex deficiency v. Combined immunodeficiency, unspecified vi. Wiskott Aldrich syndrome vii. Common variable immunodeficiency with predominant abnormalities of B cell numbers and function b. Individuals with agammaglobulinemia or hypogammaglobulin i. IgG levels are less than 200mg/dl c. Duration of Prior Authorization: Re evaluate every 6 months d. Confirmed CCS eligibility for age< Idiopathic Thrombocytopenic Purpura (ITP) a. For patients with idiopathic thrombocytopenic purpura (ITP) who meet one of the following: i. To increase platelet count prior to surgery ii. To control excessive bleeding or symptomatic thrombocytopenia iii. To defer or avoid splenectomy iv. Platelet count at or below 30,000/mm3 b. Duration of Prior Authorization: Re evaluation every 6 months c. Confirmed CCS eligibility for age< Idiopathic Thrombocytopenic Purpura (ITP) in Pregnancy a. IVIG will be approved in any one of the following: i. Pregnant women who have previously delivered infants with autoimmune thrombocytopenia ii. Pregnant women who have platelet counts less than 75,000/mm3 during the current pregnancy iii. Pregnant women with a past history of splenectomy 2 P age

3 b. Duration of Prior Authorization: Duration of the pregnancy c. Confirmed CCS eligibility for age< Kawasaki Disease (Mucocutaneous Lymph Node Syndrome) a. Confirmed diagnosis of Kawasaki Disease b. Duration of Prior Authorization: Re evaluate every month 5. B cell Chronic Lymphocytic Leukemia (CLL) a. Confirmed diagnosis of Chronic Lymphocytic Leukemia b. One of the following: i. Documented hypogammaglobulinemia (IgG < 600 mg/dl) ii. evidence of specific antibody deficiency and presence of repeated bacterial infections c. Duration of Prior Authorization: Re evaluate every 6 months 6. Acute or Chronic Inflammatory Demyelinating Neuropathy a. Confirmed diagnosis of acute or chronic inflammatory demyelinating neuropathy b. Duration of Prior Authorization: Re evaluate every 3 months 7. Bone Marrow Transplantation a. Confirmed allogeneic bone marrow transplant b. Documented hypogammaglobulinemia (IgG < 400 mg/dl) or Cytomegalovirus (CMV) seropositive c. Duration of Prior Authorization: Re evaluate every month 8. Dermatomyositis and Polymyositis a. Confirmed diagnosis of dermatomyositis or polymyositis. b. One of the following is met: i. Failure or intolerance to one of the following: corticosteroid therapy, methotrexate, azathioprine, or cyclophosphamide ii. Rapidly progressive form of the disease c. Duration of Prior Authorization: Re evaluate every 3 months 9. Multifocal Motor Neuropathy (MMN) a. Confirmed diagnosis of MMN b. Failure of or contraindications to other therapy c. Rapidly progressive form of the disease d. Duration of Prior Authorization: Re evaluate every 3 months 10. Guillain Barre Syndrome a. Confirmed diagnosis of Guillain Barre Syndrome b. One of the following scenarios is present: i. Failure of or contraindications to other therapy ii. Rapidly progressive form of the disease c. Duration of Prior Authorization: Re evaluate every 3 months 11. Lambert Eaton Myasthenic Syndrome a. Failure of or contraindications to other therapy, and rapidly progressive form of the disease b. Clinical record must document medical necessity to initiate IVIG therapy and the ongoing need as long as treatment continues. 3 P age

4 c. Re authorization: Quantitative monitoring and documented improvement with therapy d. Duration of Prior Authorization: Re evaluate every 3 months 12. Acute Myasthenia Gravis Exacerbation a. Confirmed diagnosis of myasthenia gravis b. Documented significant limiting symptoms that affect one of the following: i. Difficulty swallowing ii. Speech iii. Respiration iv. Motor function (limit physical activity) c. And one of the following i. Failed contraindicated or intolerant to an immunomodulator therapy (e.g. azathioprine, mycophenolate, cyclosporine, corticosteroids, etc.) ii. Concurrently receiving an immunomodulator therapy d. Duration of Prior Authorization: Re evaluate every 6 months 13. Solid organ transplant recipients at risk for infections (e.g. cytomegalovirus infection, pneumonia etc.) a. Duration of Prior Authorization: Re evaluate every 6 months 14. Autoimmune retinopathy a. Limited to three months unless there is improvement on therapy 15. Immune neutropenia a. Duration of Prior Authorization: Re evaluate every 6 months 16. Multiple Myeloma a. Confirmed diagnosis of Multiple Myeloma b. Failure of or contraindications to other therapy, and rapidly progressive form of the disease c. Clinical record must document medical necessity to initiate IVIG therapy and the ongoing need as long as treatment continues. d. Duration of Prior Authorization: Re evaluation every 6 months 17. Symptomatic Human Immunodeficiency Virus (HIV) a. CD4+ lymphocyte counts greater than or equal to 200/mm 3 b. Clinically symptomatic or asymptomatic, but immunologically abnormal c. Confirmed CCS eligibility for age < Autoimmune mucocutaneous blistering diseases a. Confirmed diagnosis of autoimmune bullous disease or one of the following: i. Pemphigus vulgaris ii. Pemphigus foliaceus iii. Bullous pemphigoid iv. Mucous membrane pemphigoid or Cicatrical pemphigoid v. Epidermolysis bullosa acquisita b. And one of the following i. Failed, intolerant or contraindicated to systemic corticosteroids and an immunosuppressive agent (e.g. cyclophosphamide, azathioprine, mycophenolate mofetil etc.) 4 P age

5 ii. Rapidly progressive disease in which a clinical response could not be affected quickly enough using conventional agents. IVIG must be given concomitantly with conventional immunosuppressive agents until conventional therapy take effect. c. Duration of Prior Authorization: Re evaluate every 6 months Common Dosing Range (dosing will vary between products, please refer to FDA approved label, the following recommendations is not all inclusive): 1) Primary Immunodeficiency Syndrome a) Carimune NF: mg/kg IV every 3 to 4 weeks b) Flebogamma, Gammagard Liquid, Gammagard S/D, Gamunex C, or Gammaked: mg/kg IV every 3 to 4 weeks c) Privigen: mg/kg IV every 3 to 4 weeks d) Gammaplex or Bivigam: mg/kg IV every 3 to 4 weeks e) Please refer to FDA labeled dosing for specific subcutaneous immune globulin products 2) Idiopathic Thrombocytopenic Purpura a) Carimune NF: 0.4 g/kg IV daily for 2 5 consecutive days i) In acute ITP of childhood, if an initial platelet count reaches 30 50,000/μL after the first two doses, therapy may be discontinued after the second day of the 5 day course ii) In adults and children, if after induction therapy the platelet count falls to less than 30,000/μL and/or the patient manifests clinically significant bleeding, 0.4 g/kg may be given as a single infusion. If an adequate response does not result, the dose can be increased to g/kg given as a single infusion. b) Gammagard S/D: 1 g/kg IV; up to three separate doses may be given on alternate days if required c) Gamunex C or Gammaked: 1 g/kg/day IV for two consecutive days, or 0.4 g/kg/day IV for five consecutive days i) If after administration of the first 1 g/kg dose, an adequate increase in the platelet count is observed at 24 hours, the second dose may be withheld d) Privigen, Gammaplex, or Octagam: 1g/kg IV daily for 2 consecutive days 3) Chronic Inflammatory Demyelinating Polyneuropathy a) Gamunex C or Gammaked: i) Initial dose: 2 g/kg IV in divided doses over two to four consecutive days ii) Maintenance: 1 g/kg IV over 1 day or 0.5 g/kg/day IV given on two consecutive days, every 3 weeks 4) Kawasaki Disease a) Gammagard S/D: One dose of 1 g/kg IV, or 400 mg/kg/day for four days beginning within 7 days of fever onset, administered concomitantly with appropriate aspirin therapy (80 100mg/kg/day in four divided doses) is recommended 5) Chronic Lymphocytic Leukemia a) Gammagard S/D: 400 mg/kg IV every 3 to 4 weeks 6) Multifocal Motor Neuropathy 5 P age

6 a) Gammagard Liquid: g/kg/month based on clinical response b) Initial dose*: 400 mg/kg IV for 2 5 days or 1 g/kg/day for 2 days c) Maintenance dose*: 1 2 g/kg IV every 4 8 weeks, titrated based on clinical response and symptoms 7) Bone Marrow Transplant* a) Prevention of bacterial infections during the first 100 days after HCT with severe hypogammaglobulinemia (IgG < 400mg/dL): 500 mg/kg/week b) Prevention of bacterial infections beyond 100 days post HCT with severe hypogammaglobulinemia (IgG < 400mg/dL) i) 500mg/kg every 3 4 weeks 8) Dermatomyositis* a) 2 g/kg IV divided over two to five days, every month for three months 9) Guillain Barre Syndrome* a) 400 mg/kg/day IV for 5 days or 1 g/kg daily for 2 days 10) Lambert Eaton Myasthenic Syndrome* a) 2 g/kg IV divided over two consecutive days 11) Myasthenia Gravis Exacerbation* a) 400 mg/kg/day IV for 5 days 12) Bacterial infection in children infected with HIV* a) 400mg/kg given every 28 days 13) Autoimmune bullous diseases* a) 400mg/kg/day for 5 days per month or mg/kg per month divided into 3 equal doses over 3 days * Suggested dosing for off label indications is based on clinical trial data. Change Control Date Change RPH 06/29/2018 Changed Format IK 08/16/2017 Renewed with no updates/changes 6 P age

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