Department of Origin: Pharmacy. Approved by: Pharmacy and Therapeutics Quality Management Subcommittee Effective Date: Date approved: 11/09/16

Transcription

1 Reference #: PC/I002 Page: 1 of 9 PRODUCT APPLICATION: PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Community Health Plan (PCHP) PreferredOne Insurance Company (PIC) Individual PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group PURPOSE: The intent of the Immune Globulin Therapy criteria document is to provide medical necessity criteria for the prior authorization process to ensure appropriate use. This guideline does not address use of immunoglobulins for postexposure prophylaxis, eg, Cytogam, Hepatitis A or B immune globulin, Rabies immune globulin, Rhogam, or RSV immune globulin. Table 1: Medications Affected* Biosimilar Route Brand Name available Bivigam N intravenous infusion Carimune NF N intravenous infusion Cuvitru N subcutaneous infusion Flebogamma N intravenous infusion Gammagard Liquid N intravenous or subcutaneous infusion Gammagard S/D N intravenous infusion Gammaked N intravenous or subcutaneous infusion Gammaplex N intravenous infusion Gamunex N intravenous infusion Gamunex-C N intravenous or subcutaneous infusion Hizentra N subcutaneous infusion HyQvia N subcutaneous infusion Iveegam EN N intravenous infusion Octagam N intravenous infusion Polygam S/D N intravenous infusion Privigen N intravenous infusion * Listing of drugs in table above does not ensure coverage. Please check member s prescription benefit. Revised 09/20/16 GUIDELINES: Medical Necessity Criteria Must satisfy: I or II I. Initial requests: must have both A and B, or C A. Immune globulin is requested for one of the following diagnoses: 1-51 [Note: *indicates FDA approved indication] 1. Adult Still s disease - approve for 12 months

2 Reference #: PC/I002 Page: 2 of 9 2. *Allogeneic bone marrow transplantation or hematopoietic stem cell transplantation (HSCT) within the previous year, in members 20 years of age or older approve for six months 3. Autoimmune hemolytic anemia (AIHA) [warm antibody] - approve for 12 months 4. Autoimmune mucocutaneous blistering diseases (pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid [cicatricial pemphigoid], and epidermolysis bullosa acquisita) - approve for 12 months 5. *B-cell chronic lymphocytic leukemia (CLL) in members with hypogammaglobulinemia and with a previous history of a serious bacterial infection (one that required IVAB) - approve for 12 months 6. *Chronic inflammatory demyelinating polyneuropathy (or polyradiculoneuropathy) (CIDP), including rare variants of CIDP such as multifocal acquired demyelinating sensory and motor neuropathy (MADSAM) or Lewis Sumner syndrome) - approve for 12 months 7. Churg-Strauss syndrome (allergic granulomatosis and angiitis) - approve for 12 months 8. Cytomegalovirus (CMV) interstitial pneumonia in allogeneic bone marrow transplantation or HSCT members approve for 2 months 9. Dermatomyositis approve for 12 months 10. Encephalomyelitis, acute disseminated when there is an insufficient response to intravenous corticosteroid treatment approve for 1 month 11. End stage heart failure awaiting transplantation or post-transplantation (to lower allosensitization and/or for antibody mediated rejection) approve for 12 months 12. End stage lung or liver disease awaiting transplantation or post-transplantation (to lower allosensitization and/or for antibody mediated rejection) approve for 12 months 13. End stage renal disease (ESRD) awaiting transplantation or post-transplantation (to lower allosensitization and/or for antibody mediated rejection) approve for 12 months 14. Epilepsy, pediatric intractable approve for 12 months 15. Evans syndrome approve for 12 months 16. Guillain-Barre syndrome approve for 12 months 17. Hemophilia, autoimmune - approve for 12 months 18. *Human immunodeficiency virus (HIV) infected infants and children less than 13 years of age - for prevention of recurrent bacterial infections approve for 12 months 19. Human immunodeficiency virus (HIV) - associated thrombocytopenia, adults approve for 1 month

3 Reference #: PC/I002 Page: 3 of Human immunodeficiency virus (HIV) - associated thrombocytopenia, infants, children, and adolescents less than 18 years of age approve for 1 week 21. Hyperimmunoglobulinemia E (hyper IgE) syndrome (Job s syndrome) approve for 12 months 22. IgM paraproteinemic demyelinating neuropathy (or other paraproteinemic demyelinating neuropathies) approve for 12 months 23. *Idiopathic (immune) thrombocytopenic purpura (ITP), acute and chronic - one of the following: a or b a. Members less than or equal to 17 years of age one of the following: i-iii i. If significant acute (newly diagnosed or requiring therapy for the first time) mucous membrane or other noncutaneous bleeding - approve for 1 month; or ii. If splenectomy, other surgery, dental extractions, or other procedures likely to cause blood loss - approve for 1 month; or iii. If required to prevent bleeding, including if child is at risk for bleeding (due to inaccessibility or noncompliance) - approve for 12 months. b. Members 18 years of age and older one of the following: i-iii i. If there is acute bleeding (newly diagnosed or requiring therapy for the first time) - approve for 1 month; or ii. If splenectomy, other surgery, dental extractions, or other procedures likely to cause blood loss - approve for 1 month; or iii. If required to prevent bleeding - approve for 12 months. 24. *Kawasaki disease for prevention of coronary artery aneurysms approve for 1 month 25. Lambert-Eaton myasthenic syndrome (LEMS) approve for 12 months 26. Leukemia, acute lymphoblastic in children with hypogammaglobulinemia with either a history of severe invasive infection or with recurrent sinopulomonary infections approve for 12 months 27. Marburg disease (a variant of multiple sclerosis) approve for 12 months 28. *Multifocal motor neuropathy (MMN) approve for 12 months 29. Multiple myeloma, in members who have severe recurrent bacterial infections approve for 12 months 30. Multiple sclerosis, acute severe exacerbation approve for 3 months 31. Multiple sclerosis, post-partum to prevent relapses approve for 6 months 32. Myasthenia gravis, crisis and severe exacerbation approve for 1 week 33. Neutropenia, immune-mediated (autoimmune) approve for 1 month 34. Opsoclonus myoclonus (infantile polymyoclonia, acute cerebellar encephalopathy, oculocerebellomyoclonic syndrome, dancing eyes-dancing feet syndrome) approve for 12 months 35. Polymyositis - approve for 12 months

4 Reference #: PC/I002 Page: 4 of *Primary humoral immunodeficiency, (e.g. X-linked agammaglobulinemia [Bruton s agammaglobulinemia], congenital agammaglobulinemia) common variable immunodeficiency [CVID], severe combined immunodeficiency [SCID], Wiskott-Aldrich syndrome - treatment is lifelong - approve for 12 months 37. Pure red cell aplasia (PRCA) secondary to chronic parvovirus B19 infection - approve for 3 months 38. Pure red cell aplasia (PRCA), immunologic subtype approve for 12 months 39. Pyoderma gangrenosum approve for 6 months 40. Scleromyxedema approve for 12 months 41. Small bowel transplantation or post small bowel transplantation (to lower allosensitization and/or for antibody medicated rejection) approve for 12 months 42. Stevens-Johnson syndrome - approve for 12 months 43. Stiff-person syndrome (Moersch-Woltman syndrome) approve for 12 months 44. Systemic lupus erythematosus (SLE) approve for 12 months 45. Thrombocytopenia refractory to platelet transfusions approve for 12 months 46. Thrombocytopenia, neonatal/fetal alloimmune approve maternal antenatal infusion for 6 months 47. Toxic epidermal necrolysis (TEN) [Lyells syndrome] - approve for 12 months 48. Toxic shock syndrome, staphylococcal or streptococcal - approve for 1 month 49. Urticaria, chronic autoimmune approve for 6 months 50. Uveitis, noninfectious (autoimmune) approve for 6 months 51. Vasculitic syndromes, systemic/anti-neutrophil cytoplasmic antibodies (ANCA)- associated vasculitis (Wegener s granulomatosis or microscopic polyangiitis) approve for 12 months B. Both of the following: 1 and 2 1. Previous treatment failures are documented or not indicated; and 2. Objective quantitative assessment to monitor the progress will be employed once treatment is initiated. [Note: Any accepted metric assessment may be used for objective monitoring of progress, such as the Inflammatory Neuropathy Cause and Treatment (INCAT) scale, the Medical Research Council (MRC) scale, and activities of daily living (ADL) measurements. Changes in these measures should be clearly documented. Subjective or experiential improvement alone is generally insufficient to either continue immune globulin or to expect coverage. See Attachment A for information regarding INCAT and MRC.]

5 Reference #: PC/I002 Page: 5 of 9 C. Member is hospitalized and receiving immune globulin for any diagnosis - approve for the duration of the hospital stay II. Continued use requests: A and B A. There is documentation of improvement; and B. An attempt has been made to decrease/wean the dosage, if appropriate approve for the lesser of: the requested timeframe or the timeframe corresponding to the diagnosis reflected in I. If diagnosis is not reflected in I., refer case to physician review. [Note: There should be, when clinically appropriate for the diagnosis, an attempt to stop the immune globulin infusion if improvement is sustained with dosage reduction. If improvement does not occur with immune globulin, continued infusion may not be considered medically necessary.] EXCLUSIONS: Immune globulin for any of the following is considered investigative (see Investigative List): I XLIV I. Adrenoleukodystrophy II. Alzheimer s disease III. Amyotrophic lateral sclerosis IV. Anemia, aplastic V. Anemia, Diamond-Blackfan VI. Antiphospholipid syndrome in pregnancy VII. Asthma VIII. Atopic dermatitis IX. Autism X. Behcet s syndrome, ocular manifestations XI. BK virus associated nephropathy (BKVAN) in kidney transplantation patient XII. Bone marrow transplantation/hsct, autologous XIII. Bone marrow transplantation/hsct in allogeneic recipients from human leukocyte antigen (HLA)- identical sibling donors XIV. Chronic fatigue syndrome XV. Crohn s disease XVI. Cystic fibrosis XVII. CMV disease prophylaxis or treatment of CMV disease, in allogeneic bone marrow transplantation or HSCT patients (except when manifested as interstitial pneumonia see I.A.8.) XVIII. CMV disease prophylaxis or treatment of CMV disease in solid organ transplantation patients XIX. Diabetes mellitus XX. Graft Versus Host Disease (GVHD), acute (within first 100 days after transplantation) without presence of hypogammaglobulinemia XXI. Graft Versus Host Disease (GVHD), chronic, prevention without presence of hypogammaglobulinemia XXII. Heart block, congenital XXIII. Heart failure, chronic XXIV. HIV, adults, for prophylaxis of infections and/or immunodeficiency XXV. Inclusion body myositis XXVI. In vitro fertilization (IVF) XXVII. Neonates, for suspected or proven infection

6 Reference #: PC/I002 Page: 6 of 9 XXVIII. Neonates, high risk, preterm, low birth weight, infections in (prophylaxis and treatment adjunct) XXIX. Nephropathy, membranous XXX. Neuropathy, paraproteinemic XXXI. Ophthalmopathy, euthyroid XXXII. Otitis media, recurrent XXXIII. Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS) XXXIV. Plexopathy, progressive lumbosacral XXXV. Post-polio syndrome XXXVI. Pure red cell aphasia due to myelodysplastic syndrome (MDS) XXXVII. Recurrent spontaneous pregnancy loss (RSPL), including antiphospholipid antibody-positive women XXXVIII. Sickle cell disease XXXIX. Surgery or trauma, for prophylaxis of infections usually are inpatient XL. Systemic sclerosis (systemic scleroderma) XLI. Thrombocytopenia, heparin-induced (HIT) XLII. Thrombocytopenia, nonimmune XLIII. Thrombotic thrombocytopenic purpura (TTP)/hemolytic uremic syndrome (HUS) XLIV. West syndrome (infantile spasms) BACKGROUND: This criteria document is based on U.S. Food and Drug Administration (FDA) approved indications, expert consensus opinion and/or available reliable evidence. Immunoglobulins (Ig) are large Y-shaped proteins produced by B-cells and plasma cells that are used by the immune system to identify and neutralize foreign objects such as bacteria and viruses. There are 5 Ig isotopes IgA, IgD, IgE, IgG, and IgM. The majority of antibody-based immunity to pathogens involves IgG. As a result, people with low IgG levels are at greater risk of infections.

7 Reference #: PC/I002 Page: 7 of 9 FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes CODING: HCPCs J1459 Injection, immune globulin, (Privigen), intravenous, nonlyophylized (e.g. liquid), 500mg J1556 Injection, immune globulin, (Bivigam), 500mg J1557 Injection, immune globulin, (Gammaplex), intravenous, nonlyophylized (e.g., liquid), 500mg J1559 Injection, immune globulin, (Hizentra), 100mg J1561 Injection, immune globulin, (Gamunex/Gamunex-C/Gammaked), nonlyophylized (e.g. liquid), 500mg J1562 Injection, immune globulin, (Vivaglobin), 100mg J1566 Injection, immune globulin, intravenous, lyophylized (e.g. powder), not otherwise specified, 500mg - use this code for Carimune J1568 Injection, immune globulin, (Octagam), intravenous, nonlyophylized (e.g. liquid), 500mg J1569 Injection, immune globulin, (Gammagard liquid), intravenous, nonlyophylized (e.g. liquid), 500mg J1572 Injection, immune globulin, (Flebogamma/Flebogamma Dif), intravenous, nonlyophylized (e.g. liquid), 500mg J1599 Injection, immune globulin, intravenous, nonlyophylized (e.g. liquid), not otherwise specified, 500mg Coverage is subject to the terms of a member s pharmacy benefit plan and formulary. To the extent there is any inconsistency between this criteria document/policy and the terms of a member s pharmacy benefit plan and /or formulary, the member s pharmacy benefit plan and formulary govern. RELATED CRITERIA/POLICIES/FORMS: Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria Medical Policy: MP/I001 Investigative Services Policy: PP/O001 Off-label Drug Use REFERENCES: 1. Express Scripts. Prior authorization and continuation policy for exclusive clients: Immune globulin intravenous. Revised 01/25/2012, select revision 02/08/ Express Scripts. Prior authorization policy: immune globulin subcutaneous injections. Revised 01/25/ Navarro RP, Ballow M, Fenrick B, Pezalla EJ. Considerations for the Optimal use of Immunoglobulin. Am J Manag Care. 2012;18:S67-S78 4. Silvergleid AJ, Berger M. General principles in the use of immune globulin. In: UpToDate, Tirnauer JS, Feldweg AM (Eds), UpToDate, Waltham, MA. (Accessed on September 16, 2014.) 5. Chu VH. Staphylococcal toxic shock syndrome. In: UpToDate, Baron EL (Ed), UpToDate, Waltham, MA. (Accessed on September 16, 2014.) 6. Lotze TE, Chadwick DJ. Acute disseminated encephalomyelitis in children: Treatment and prognosis. In: UpToDate, Dashe JF (Ed), UpToDate, Waltham, MA. (Accessed on September 16, 2014.) 7. Stevens DL. Treatment of streptococcal toxic shock syndrome. In: UpToDate, Baron EL (Ed), UpToDate, Waltham, MA. (Accessed on September 16, 2014.) 8. Waldman AT, Jacobs D. Acute disseminated encephalomyelitis in adults. In: UpToDate, Dashe JF (Ed), UpToDate, Waltham, MA. (Accessed on September 16, 2014.)

8 Reference #: PC/I002 Page: 8 of 9 9. U.S. Food and Drug Administration. Immune Globulin Intravenous (IGIV) Indications Retrieved from FractionatedPlasmaProducts/ucm htm 10. U.S. Food and Drug Administration. Hizentra. Package Insert Retrieved from uctsblas/fractionatedplasmaproducts/ucm pdf 11. U.S. Food and Drug Administration. Octagam. Package Insert Retrieved from uctsblas/fractionatedplasmaproducts/ucm pdf 12. OPTUMRx. National and Therapeutics Committee (NP&TC) Interval Meeting Agenda Summary. December Cuvitru [package insert] Westlake Village, CA; Baxalta US Inc; 2016 DOCUMENT HISTORY: Created Date: 11/14/07 Reviewed Date: 08/29/12, 08/29/13, 08/28/14, 08/28/15, 08/26/16 Revised Date: 11/19/08, 10/09/09, 09/10/10, 07/27/1, 08/29/11, 05/16/12, 06/29/12, 08/29/12, 04/04/13, 08/28/14, 09/10/15, 09/20/16

9 Reference #: PC/I002 Page: 9 of 9 Attachment A The Inflammatory Neuropathy Cause and Treatment (INCAT) scale is used to access functional disability of both upper and lower extremity components in CIDP. The INCAT scale has upper and lower extremity components, with a maximum of 5 points for the upper extremity (arm disability) and a maximum of 5 points for the lower extremity (leg disability), which add up to a maximum of 10 points (where 0 is normal and 10 is severely incapacitated). The INCAT scores may be used to evaluate the effectiveness and need for immune globulin. Immune globulin may be discontinued when there is a lack of clear clinical improvement (i.e., a decline in INCAT disability score or failure to improve by 1 point at six weeks following the initial infusion or return to baseline at anytime following initial improvement of 1 point). The Medical Research Council (MRC) scale is used to grade muscle strength. Scale: 0 = no muscle movement; 1 = flicker of muscle movement; 2 = trace movement but not able to fully overcome gravity; 3 = just able to overcome gravity, but not against resistance; 4 = moves against resistance, but weak; 5 = full strength against resistance.

10 PreferredOne Community Health Plan Nondiscrimination Notice PreferredOne Community Health Plan ( PCHP ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PCHP does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PCHP: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PCHP has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Community Health Plan PO Box Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at Language Assistance Services NDR PCHP LV (10/16)

11 PreferredOne Insurance Company Nondiscrimination Notice PreferredOne Insurance Company ( PIC ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PIC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PIC: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Insurance Company PO Box Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at Language Assistance Services NDR PIC LV (10/16)