PHARMACY PRIOR AUTHORIZATION. Parenteral Immune Globulins Clinical Guideline

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1 PHARMACY PRIOR AUTHORIZATION Parenteral Immune Globulins Clinical Guideline Bivigam Inj 10% Carimune NF Inj 12gm Carimune NF Inj 3gm Carimune NF Inj 6gm Cuvitru 1g/5mL Cuvitru 2g/10mL Cuvitru 4g/20mL Cuvitru 8g/40mL Flebogamma Inj 10% Flebogamma Inj 5% Flebogamma Inj Dif 10% Flebogamma Inj Dif 5% Gammagard Inj 10gm/100 Gammagard Inj 1gm/10ml Gammagard Inj 2.5gm/25 Gammagard Inj 20gm/200 Gammagard Inj 30gm/300 Gammagard Inj 5gm/50ml Gammagard SD Inj 10gm PRODUCTS Gammagard SD Inj 5gm Gammaked Inj 10gm/100 Gammaked Inj 1gm/10ml Gammaked Inj 20gm/200 Gammaked Inj 5gm/50ml Gammaplex Inj 10% Gammaplex Inj 10/100ml Gammaplex Inj 10gm Gammaplex Inj 20gm Gammaplex Inj 5gm Gammaplex 5 % Gamunex Inj 10% Gamunex-C Inj 10gm/100 Gamunex-C Inj 1gm/10ml Gamunex-C Inj 2.5gm/25 Gamunex-C Inj 20gm/200 Gamunex-C Inj 40/400ml Gamunex-C Inj 5gm/50ml Hizentra Inj 10/50ml Hizentra Inj 1gm/5ml Hizentra Inj 2gm/10ml Hizentra Inj 4gm/20ml Hyqvia 10g/100mL Hyqvia 2.5g/25mL Hyqvia 30g/300mL Hyqvia 5g/50mL Octagam Inj 10/100ml Octagam Inj 10gm Octagam Inj 20/200ml Octagam Inj 5gm Octagam Inj 5gm/50ml Privigen Inj 10gm Privigen Inj 20gm Privigen Inj 40gm Authorization Guidelines: Documentation of ALL of the following: I. The dose prescribed is within the FDA-approved range for the indication or is supported by compendia/peer-reviewed literature II. III. Request is not for experimental/investigational use or for a clinical trial The use of parenteral immunoglobulin therapy is approved for members with any of the following conditions: 1. Acquired red cell aplasia 2. Acute disseminated encephalomyelitis: documentation of an inadequate response to intravenous corticosteroid treatment. Page 1 of 9

2 3. Autoimmune mucocutaneous blistering diseases: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid (a.k.a., cicatrical pemphigoid), gestational pemphigoid, linear IgA disease, and epidermolysis bullosa acquisita. a) The diagnosis has been proven by biopsy and confirmed by pathology report; and b) The condition is rapidly progressing, extensive or debilitating; and c) Corticosteroids or immuno-suppressive agents have failed or the member has experienced significant complications from standard treatment, such as diabetes or steroid-induced osteoporosis. 4. Autoimmune hemolytic anemia, refractory: documentation of an inadequate response or contraindication to corticosteroids or splenectomy 5. Autoimmune neutropenia, refractory: documentation that treatment with Granulocyte-Colony Stimulating Factors (G-CSF) is not appropriate. 6. B-cell chronic lymphocytic leukemia (CLL): For persons with hypogammaglobulinemia associated with CLL and recurrent infections or specific antibody deficiency a) IgG level less than 600 mg/dl; and b) One (1) severe bacterial infection within preceding 6 months or 2 or more bacterial infections in 1 year OR evidence of specific antibody deficiency 7. Birdshot (vitiligenous) retinochoroidopathy: documentation of an inadequate response to immunosuppressive agents (e.g., corticosteroids, cyclosporine) 8. Chronic inflammatory demyelinating polyneuropathy [also known as Chronic Relapsing Polyneuropathy, including diabetes mellitus-cidp and multifocal acquired demyelinating sensory and motor neuropathy (MADSAM) variant] a) Documentation of symmetric or focal neurologic deficits with slowly progressive or relapsing course over 2 months or longer (with neurophysiological abnormalities). 9. Churg-Strauss Syndrome (CSS) (allergic granulomatosis) a) Documentation that IVIG will be used as adjunctive therapy for persons with severe active illness for whom other interventions have been unsuccessful, have become intolerable, or are contraindicated 10. Dermatomyositis: Member is intolerant or refractory to 1st (corticosteroids) and 2nd line (immunosuppressants) therapies 11. Enteroviral meningoencephalitis Page 2 of 9

3 12. Guillain-Barré syndrome (GBS) and GBS variants [infective polyneuritis (includes GBS variants: Miller-Fisher syndrome [MFS], pan autonomic polyneuropathy, acute pandysautonomia, acute motor axonal neuropathy (AMAN), and acute motor and sensory axonal neuropathy (AMSAN))] a) Severe GBS with significant weakness such as inability to stand or walk without aid, respiratory or bulbar weakness, or Miller-Fisher syndrome (MFS); and b) The disorder has been diagnosed during the first 2 weeks of the illness; and c) IVIG is initiated within one month of symptom onset. 13. Hemolytic disease of newborn, to decrease need for exchange transfusion 14. HIV infected children; bacterial control or prevention. Documentation of any of the following: a) Serum IgG concentration less than 400 mg/dl; b) Recurrent serious bacterial infections, i.e., defined as two or more infections such as bacteremia, meningitis, or pneumonia in a 1-year period c) Failure to form antibodies to common antigens, such as measles, pneumococcal, and/or Haemophilus influenzae type b vaccine; d) Member lives in area where measles is highly prevalent and has not developed an antibody response after two doses of measles, mumps, and rubella virus vaccine live; e) Exposure to measles; f) Chronic bronchiectasis that is suboptimally responsive to antimicrobial and pulmonary therapy. 15. HIV-associated thrombocytopenia: a) Significant bleeding in thrombocytopenic members or platelet count less than 20,000/ul; and b) Failure of RhIG in Rh-positive patients. 16. Hyperimmunoglobulinemia E syndrome: For treatment of severe eczema 17. Immune or idiopathic thrombocytopenic purpura (ITP): ITP (Adults) a) Other causes of thrombocytopenia have been ruled out; and b) Unresponsive to corticosteroid therapy; and c) Documentation of ONE of the following: 1. Management of acute bleeding due to severe thrombocytopenia (platelet counts less than 30,000/ul); or 2. To increase platelet counts prior to invasive major surgical procedures (e.g., splenectomy), or 3. To defer or avoid splenectomy; or Page 3 of 9

4 4. In members with severe thrombocytopenia (platelet counts less than 20,000/ul) considered to be at risk for intra-cerebral hemorrhage. ITP (Chronic Refractory) a) Age of 10 years or older; and b) Duration of illness of greater than 6 months; and c) No concurrent illness/disease explaining thrombocytopenia; and d) Prior treatment with corticosteroids and splenectomy has failed or member is at highrisk for post-splenectomy sepsis. ITP (Pediatrics) a) Acute ITP: 1. IVIG as initial therapy if platelet count less than 20,000/ul, especially when member has emergency bleeding or is at risk for severe life-threatening bleeding; or 2. Persons with severe thrombocytopenia (platelet counts less than 20,000/ul) considered to be at risk for intra-cerebral hemorrhage. b) Chronic ITP: 1. In high-risk persons when platelet count low or person symptomatic; and 2. Failure of other therapies, or 3. Member is a high risk for post-splenectomy sepsis. ITP (Pregnancy) a) Refractory to steroids with platelet counts less than 10,000/ul in the 3rd trimester; or b) Platelet counts less than 30,000/ul associated with bleeding before vaginal delivery or C- section; or c) Pregnant women who have previously delivered infants with autoimmune thrombocytopenia; or d) Pregnant women who have platelet counts less than 50,000/ul during the current pregnancy; or e) Pregnant women with past history of splenectomy. 18. Kawasaki disease (mucocutaneous lymph node syndrome) 19. Lambert-Eaton myasthenic syndrome: documentation of the following a) No response to anticholinesterases (e.g., pyridostigmine)and dalfampridine (Ampyra); and b) Used as an alternative to plasma exchange if weakness is severe or there is difficulty with venous access for plasmapheresis. 20. Moersch-Woltmann (Stiff-man) syndrome: Documentation of trial and failure with benzodiazepines and/or baclofen, phenytoin, clonidine, tizanidine. 21. Multifocal motor neuropathy Page 4 of 9

5 22. Multiple myeloma: documentation of recurrent, serious infections despite the use of prophylactic antibiotics. 23. Myasthenia gravis: documentation of treatment of acute myasthenic crisis with decompensation (respiratory failure, or disabling weakness requiring hospital admission)). 24. Neonatal alloimmune thrombocytopenia (NAIT) (also known as fetal alloimmune thrombocytopenia or FAIT) 25. Neonatal hemochromatosis, prophylaxis: documentation that member is pregnant with a history of pregnancy that ended in neonatal hemochromatosis 26. Opsoclonus-myoclonus 27. Paraneoplastic opsoclonus-myoclonus-ataxia associated with neuroblastoma 28. Parvovirus B19 infection, chronic, with severe anemia 29. Polymyositis in persons who are resistant to first and second line therapies 30. Post-transfusion purpura: a) Decreased platelets (less than 10,000/ul); and b) 2 to 14 days post-transfusion with bleeding. 31. Preparation for thymoma surgery (to prevent myasthenia exacerbation) 32. Primary humoral immunodeficiency diseases (such as congenital agammaglobulinemia (X-linked agammaglobulinemia), hypogammaglobulinemia, common variable immunodeficiency, X-linked immunodeficiency with hyperimmunoglobulin M, Wiscott-Aldrich syndrome, immunodeficiency with thymoma (Good syndrome), hyper IgM syndromes, and severe combined immunodeficiency) a) Agammaglobulinemia (total IgG less than 200 mg/dl or infants with BTK gene and/or absence of B lymphocytes)); or b) Persistent hypogammaglobulinemia (total IgG less than 400 mg/dl or two standard deviations below the mean for age) with recurrent bacterial infections and for adults and children older than 2 years old: lack of response to protein or polysaccharide antigens (inability to make IgG antibody against diphtheria and tetanus toxoids, pneumococcal polysaccharide vaccine, or both) or c) Selective IgG subclass deficiencies 1. Deficiency of one or more IgG subclasses to levels less than 2 standard deviations below the age-specific mean and Page 5 of 9

6 2. Member has recurrent or persistent severe bacterial infections despite adequate treatment and 3. For adults and children older than 2 years old, documentation of an inability to mount an adequate response to protein and polysaccharide antigens or d) Evidence of recurrent severe difficult-to-treat infections (e.g., recurrent otitis media, bronchiectasis, recurrent infections requiring IV antibiotics, multiple antibiotic hypersensitivities, chronic or recurrent sinusitis) and for adults and children older than 2 years old, documentation of normal total IgG levels with severe polysaccharide nonresponsiveness and 33. Rasmussen encephalitis (Rasmussen's syndrome): documentation of inadequate response or inability to tolerate anti-epileptic drugs and corticosteroids. 34. Relapsing-remitting multiple sclerosis (MS): documentation of the following a) Severe manifestations of relapsing-remitting MS (not primary or secondary progressive MS); and b) Standard approaches (i.e., interferons (Betaseron, Avonex, Rebif), glatiramer (Copaxone)) have failed, become intolerable, or are contraindicated. 35. Renal transplantation from live donor with ABO incompatibility or positive cross-match, where a suitable non-reactive live or cadaveric donor is unavailable (preparative regimen) 36. Secondary immunosuppression associated with major surgery (such as cardiac transplants) and certain diseases (extensive burns, or collagen-vascular diseases) 37. Selective IgG subclass deficiencies with severe infection: a) Deficiency of one or more IgG subclasses to levels less than 2 standard deviations below the age-specific mean and b) Member has recurrent or persistent severe bacterial infections despite adequate treatment and c) For adults and children older than 2 years old, documentation of an inability to mount an adequate response to protein and polysaccharide antigens 38. Solid organ transplantation, for allosensitized members undergoing solid organ transplant 39. Staphylococcal toxic shock syndrome 40. Stem cell or bone marrow transplantation: a) Prophylaxis in allogeneic or syngeneic transplant members within the first 100 days post-transplant; Page 6 of 9

7 b) After 100 days post-transplant, member has IgG level less than 400 mg/dl and one of the following: 1. Member has primary immunodeficiency or 2. Member has CMV, EBV, or RSV infection c) Steroid-resistant graft-versus-host disease in bone marrow transplant members 20 years of age or older, in the first 100 days post-transplant, and with IgG level less than 400 mg/dl. 41. Systemic lupus erythematosus (SLE), for members with severe active SLE for whom other interventions have been unsuccessful, have become intolerable, or are contraindicated 42. Toxic epidermal necrolysis and Steven-Johnson syndrome 43. Toxic shock syndrome or toxic necrotizing fasciitis due to group A streptococcus. Criteria for Renewal Supporting documentation showing clinical improvement or stabilization of the disease state. Duration Initial approval: 6 months Renewal: 6 months References: 1. Anderson D, Ali K, Blanchette V, et al. Guidelines on the use of intravenous immune globulin for hematologic conditions. Transfusion Medicine Reviews. 2007;21(2):Suppl 1:S9-S Provan D, Nokes TJC, Agrawal S, et al; IVIg Guideline Development Group of the IVIg Expert Working Group. Clinical guidelines for the use of intravenous immunoglobulins. London, UK: Department of Health (DoH); March Available at: Accessed January 23, Suzuki Y, Hayakawa H, Miwa S, et al. Intravenous immunoglobulin therapy for refractory interstitial lung disease associated with polymyositis/dermatomyositis. Lung. 2009;187(3): Jurisdictional Blood Committee, for and on behalf of the Australian Health Ministers Conference. Criteria for the clinical use of intravenous immunoglobulin in Australia. Canberra, ACT: Commonwealth of Australia; Available at: Accessed January 23, Kubota T. Orbital myositis. In: Idiopathic Inflammatory Myopathies - Recent Developments. JT Gran, ed. Rijeka, Croatia; InTech Europe; September Available at: Accessed January 23, Li SC, Torok KS, Pope E, et al; the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Localized Scleroderma Workgroup. Development of consensus treatment plans for juvenile localized Page 7 of 9

8 scleroderma. A roadmap toward comparative effectiveness studies in juvenile localized scleroderma. Arthritis Care Res (Hoboken). 2012;64(8): Shinder R, Nasser QJ, Brejt S, et al. Idiopathic inflammation of the orbit and contiguous structures. Ophthal Plast Reconstr Surg. 2012;28(4): Deka D, Sharma KA, Dadhwal V, et al. Direct fetal intravenous immunoglobulin infusion as an adjunct to intrauterine fetal blood transfusion in rhesus-allommunized pregnancies: A pilot study. Fetal Diagn Ther. 2013;34(3): Mathew P. Evans syndrome treatment & management. Medscape. New York, NY: Medscape; January 8, Available at: Accessed January 23, Themistocleous AC, Ramirez JD, Serra J, Bennett DL. The clinical approach to small fibre neuropathy and painful channelopathy. Pract Neurol. 2014;14(6): Jaime-Perez JC, Guerra-Leal LN, Lopez-Razo LN, et al. Experience with Evans syndrome in an academic referral center. Revista Brasileira de Hematologia e Hemoterapia. 2015;37(4): Ware RE. Autoimmune hemolytic anemia in children and adolescents. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Bird SJ. Treatment of myasthenia gravis. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December 2015a. 14. Bird SJ. Thymectomy for myasthenia gravis. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December 2015b. 15. Stoller JK. Treatment of alpha-1 antitrypsin deficiency. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Moise KJ. Overview of Rhesus (Rh) alloimmunization in pregnancy. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Chon WJ, Brennan DC. Acute renal allograft rejection: Treatment. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Cruse RP. Hereditary sensory and autonomic neuropathies. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December 2015a. 19. Cruse RP. Hereditary primary motor sensory neuropathies, including Charcot-Marie-Tooth disease. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December 2015b. 20. Flaherty KR. Nonspecific interstitial pneumonia. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Lake FR. Interstitial lung disease in rheumatoid arthritis. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Dellaripa PF, Miller ML. Interstitial lung disease in dermatomyositis and polymyositis: Treatment. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Varga J. Prognosis and treatment of interstitial lung disease in systemic sclerosis (scleroderma). UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Zulian F. Localized scleroderma in childhood. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Goldstein BG, Goldstein AO. Oral lesions. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Page 8 of 9

9 26. Dana R. Treatment of scleritis. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed December Poelman CL, Hummers LK, Wigley FM, et al. Intravenous immunoglobulin may be an effective therapy for refractory, active diffuse cutaneous systemic sclerosis. J Rheumatol. 2015;42(2): Baxalta U.S. Inc. Cuvitru, immune globulin subcutaneous (human), 20% solution. Prescribing Information. 16D028-CUV-US. Westlake Village, CA: Baxalta; revised September Kreuter A, Gambichler T, Breuckmann F, et al. Pulsed intravenous immunoglobulin therapy in livedoid vasculitis: An open trial evaluating 9 consecutive patients. J Am Acad Dermatol. 2004;51(4): Mittal MK, Barohn RJ, Pasnoor M, et al. Ocular myasthenia gravis in an academic neuro-ophthalmology clinic: Clinical features and therapeutic response. J Clin Neuromuscul Dis. 2011;13(1): Haines SR, Thurtell MJ. Treatment of ocular myasthenia gravis. Curr Treat Options Neurol. 2012;14(1): Bounfour T, Bouaziz JD, Bezier M, et al. Intravenous immunoglobulins in difficult-to-treat ulcerated livedoid vasculopathy: Five cases and a literature review. Int J Dermatol. 2013;52(9): Petiot P, Choumert A, Hamelin L, et al. Necrotizing autoimmune myopathies. Rev Neurol (Paris). 2013;169(8-9): Monshi B, Posch C, Vujic I, et al. Efficacy of intravenous immunoglobulins in livedoid vasculopathy: Longterm follow-up of 11 patients. J Am Acad Dermatol. 2014;71(4): Kim EJ, Yoon SY, Park HS, et al. Pulsed intravenous immunoglobulin therapy in refractory ulcerated livedoid vasculopathy: Seven cases and a literature review. Dermatol Ther. 2015;28(5): Patil AK, Prabhakar AT, Sivadasan A, et al. An unusual case of inflammatory necrotizing myopathy and neuropathy with pipestem capillaries. Neurol India. 2015;63(1): Ramanathan S, Langguth D, Hardy TA, et al. Clinical course and treatment of anti-hmgcr antibodyassociated necrotizing autoimmune myopathy. Neurol Neuroimmunol Neuroinflamm. 2015;2(3):e Egerup P, Lindschou J, Gluud C, Christiansen OB; ImmuReM IPD Study Group. The effects of intravenous immunoglobulins in women with recurrent miscarriages: A systematic review of randomised trials with meta-analyses and trial sequential analyses including individual patient data. PLoS One. 2015;10(10):e Robinson J, Hartling L, Vandermeer B, Klassen TP. Intravenous immunoglobulin for presumed viral myocarditis in children and adults. Cochrane Database Syst Rev. 2015;(5):CD Davis MDP. Livedoid vasculopathy. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed September Rosenson RS, Baker SK. Statin myopathy. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed November Pelak VS, Quan D. Ocular myasthenia gravis. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed November Merola JF. Sweet syndrome (acute febrile neutrophilic dermatosis): Management and prognosis. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed November Brewer JD, Davis MDP. Urticarial vasculitis. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed November Page 9 of 9