Clinical Policy: Immune Globulins Reference Number: ERX.SPMN.129

Transcription

1 Clinical Policy: Immune Globulins Reference Number: ERX.SPMN.129 Effective Date: 03/14 Last Review Date: 09/16 Revision Log Coding_Implications See Important Reminder at the end of this policy for important regulatory and legal information. Policy/Criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions that the following immune globulin therapies: Bivigam (IVIG) GamaSTAN S/D (IMIG) Carimune NF (IVIG) Gamunex -C (IVIG and SCIG) Flebogamma DIF (IVIG) Hizentra (SCIG) Gammagard S/D (IVIG) Octagam (IVIG) Gammagard Liquid (IVIG and SCIG) Privigen (IVIG) Gammaked (IVIG and SCIG) Hyqvia (SCIG) Gammaplex (IVIG) Cytogam (IVIG) are medically necessary for members when one of the following criteria are met: I. Initial Approval Criteria A. IVIG Formulations (must meet all): 1. Patient meets one of the following diagnosis and drug criteria as applicable: a. PID, CIDP, or ITP; b. Kawasaki syndrome: i. Gammagard S/D is requested; ii. Treatment plan includes high dose aspirin; c. MMN and Gammagard Liquid is requested; d. B-cell CLL: i. Gammagard S/D is requested; ii. Prescribed for prophylaxis of bacterial infection; iii. Prior to starting IVIG, the patient will/did have hypogammaglobulinemia with a pretreatment serum IgG < 500 mg/dl, or a) The patient has a history of recurrent bacterial infections; e. CMV disease: i. Cytogam is requested; ii. Prescribed for prophylaxis of CMV disease associated with transplantation of kidney, lung, liver, pancreas, or heart; iii. If transplant of any of the above organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir; f. For any other indications, refer to section D below. B. SCIG Formulations (must meet all): Approval duration: 6 months Page 1 of 12

2 1. The requested drug is Gamunex-C, Hizentra, Gammagard Liquid, Gammaked, or Hyqvia; 2. Therapy will be administered in a controlled healthcare setting, or a. If it won t be administered in a healthcare setting, the treatment plan includes appropriate treatment for managing an acute hypersensitivity reaction; 3. Diagnosis of PID; 4. For any other indications, refer to section D below. Approval duration: 6 months C. IMIG Formulations (must meet all): 1. Requested drug is GamaSTAN S/D; 2. Patient is ineligible to receive vaccine for post-exposure prophylaxis per appendix B; 3. Prophylaxis is indicated for one of the following indications: a. Hepatitis A: i. Patient has been exposed to hepatitis A (e.g., household contact, sexual contact, child care center or classroom contact with an infected person) in the past 2 weeks, or ii. Patient is at a high risk for hepatitis A exposure (e.g., travelers to and workers in countries of high endemicity of infection and illicit drug users); b. Measles (rubeola): i. Patient has been exposed to measles within the past 6 days; c. Varicella: i. Patient has been recently exposed to Varicella; ii. Patient is immunocompromised; iii. Varicella zoster immune globulin is currently unavailable; d. Rubella: i. Patient is pregnant; ii. Patient had recent exposure to rubella; 4. For any other indications, refer to section D below. Approval duration: 1 injection D. Compendial Indications 1. Use is for a confirmed diagnosis of one of the medically accepted compendial indications listed*: a. Fetal/neonatal thrombocytopenia; b. Refractory dermatomyositis and polymyositis; c. Myasthenia gravis; d. Relapsing-remitting multiple sclerosis (RRMS); e. Guillain-Barre syndrome (GBS); f. Fetal/neonatal alloimmune thrombocytopenia; g. Parvovirus B19-induced PRCA with impaired immune system and/or severe anemia associated with bone marrow suppression (pediatric); h. Prophylaxis of bacterial infection in HIV infection (pediatric); Page 2 of 12

3 i. Pemphigus vulgaris; j. Infectious disease prophylaxis (neonates); k. Stiff-man syndrome; l. Toxic shock syndrome; m. Transplant of kidney, pretransplant desensitization of highly sensitized patients n. Autoimmune hemolytic anemia (pediatric); 2. Use is in compliance with ERX.SPMN.16 - Global Biopharm Policy. *It is the policy of health plans affiliated with Envolve Pharmacy Solutions that the use of immune globulins for any other indication not listed in this policy is considered not medically necessary as safety and effectiveness have not been proven. II. Continued Approval A. IVIG and SCIG Formulations (must meet all): 1. Currently receiving medication via health plan benefit and documentation supports positive response to therapy. Approval duration: 6 months Background As a result of differences in the production process, IG products differ with respect to formulation and composition. Product characteristics such as content (e.g., IgA concentration, stabilizer), volume, and osmolarity may be important considerations for some patients. 13 Immune globulin is the standard treatment for primary immunodeficiency disease (PID). 14,15 IG was shown to improve neuromuscular disability in patients with CIDP and received FDA approval for this indication in IG increases platelet counts in patients with ITP and is an important treatment for this condition. 14 IG in conjunction with high-dose aspirin prevents the development of coronary aneurysms and is the standard of care for Kawasaki syndrome, an acute vasculitis, the cause of which remains unknown, but there is strong support for an infectious or postinfectious origin. The numerous autoimmune and neurological clinical uses of IG have resulted from its anti-inflammatory and immunomodulatory activity. 14 In a clinical study evaluating muscle strength and functional ability in patients with MMN, Gammagard liquid demonstrated a lower decline, from baseline, in mean grip strength over the placebo (22.3% differential). 5 IG has been shown to reduce the number of infections in patients with secondary immune deficiency related to B-cell CLL. 14 In these groups of patients, current guidelines recommend IG therapy for prevention of bacterial infections only when hypogammaglobulinemia and/or recurrent infection is present. 14,16-18 IMIG may be used for post-exposure prophylaxis of hepatitis A or rarely, in certain circumstances, for prevention of other viral illnesses such as measles, rubella, or varicella zoster. 12, 18,19 Patients receiving Gammagard had fewer infections with Streptococcus pneumonia and haemophilus influenza. 6 Page 3 of 12

4 Some of the common or proposed uses for IG lack good quality evidence of clinical benefit. 14 Given the increasing demand and limited supply of IG, along with the potential risks and relatively high cost of therapy, the indications for use of IG require careful consideration. 14 It is critical that IG therapy be used appropriately for only those indications that are supported by clinical evidence. 14 Appendices Appendix A: Abbreviation Key BMT: bone marrow transplant CIDP: chronic inflammatory demyelinating polyneuropathy CLL: chronic lymphocytic leukemia CMV: cytomegalovirus DIF: dual inactivation plus nanofiltration GBS: Guillain-Barre syndrome HIV: human immunodeficiency virus HSCT: hematopoietic stem cell transplant IgA: immune globulin A IVIG: intravenous immune globulin SCIG: subcutaneous immune globulin IMIG: intramuscular immune globulin ITP: idiopathic thrombocytopenic purpura MMN: multifocal motor neuropathy NF: nanofiltered PID: primary immunodeficiency disease PRCA: pure red cell aplasia SubQ: subcutaneously S/D: solvent/detergent treated VZIG: varicella zoster immune globulin Appendix B: Conditions in which a patient is not eligible to receive vaccines for postexposure prophylaxis Hepatitis A vaccine: Severe allergic reaction (anaphylaxis) after a previous dose or to a vaccine component Patient age < 1 year or > 40 years, immunocompromised, or has chronic liver disease Patients traveling to countries with high hepatitis A endemicity departing in < 2 weeks Vaccine is unavailable in the area 2. Measles and Rubella vaccine and Varicella vaccines: Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, or long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised) Pregnancy Patients who have been exposed to measles for > 72 hours Vaccine is unavailable in the area Page 4 of 12

5 Coding Implications This clinical policy references Current Procedural Terminology (CPT ). CPT is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2015, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. CPT * Description /HCPCS Codes Immune globulin (Ig), human, for intramuscular use Immune globulin (IgIV), human, for intravenous use Immune globulin (SCIg), human, for use in subcutaneous infusions, 100 mg, each Unlisted immune globulin Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular J0850 Injection, cytomegalovirus immune globulin intravenous (human), per vial J1459 Injection, immune globulin (Privigen), intravenous, non-lyophilized (e.g., liquid), 500 mg J1556 Injection, immune globulin (Bivigam), 500 mg J1557 Injection, immune globulin (gammaplex), intravenous, non-lyophilized (e.g., liquid), 500 mg J1559 Injection, immune globulin (hizentra), 100 mg J1561 Injection, immune globulin (Gamunex-C/Gammaked), non-lyophilized (e.g., liquid), 500 mg J1562 Injection, immune globulin (Vivaglobin), 100 mg J1566 Injection, immune globulin, lyophilized (e.g., powder), not otherwise specified, 500 mg J1568 Injection, immune globulin (Octagam), intravenous, non-lyophilized (e.g., liquid), 500 mg Page 5 of 12

6 CPT * /HCPCS Codes J1569 J1572 J1599 Description Injection, immune globulin, (Gammagard Liquid), non-lyophilized (e.g., liquid), 500 mg Injection, immune globulin (flebogamma/flebogamma DIF) intravenous, nonlyophilized (e.g., liquid), 500 mg Injection, immune globulin, intravenous, non-lyophilized (e.g., liquid), not otherwise specified, 500 mg *CPT Copyright 2013 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. ICD-9-CM Diagnosis Codes that Support Medical Necessity ICD-9-CM Description Code Toxic shock syndrome 042 Human immunodeficiency virus [HIV] disease Parvovirus B Chronic lymphoid leukemia, without mention of having achieved remission Chronic lymphoid leukemia, in remission Chronic lymphoid leukemia, in relapse Hypogammaglobulinemia, unspecified Congenital hypogammaglobulinemia Immunodeficiency with increased IgM Common variable immunodeficiency Other deficiency of humoral immunity DiGeorge s syndrome Wiskott-Aldrich syndrome Combined immunity deficiency Autoimmune hemolytic anemias Immune thrombocytopenic purpura Evans syndrome Post-transfusion purpura Other secondary thrombocytopenia Stiff-man syndrome 340 Multiple sclerosis Acute infective polyneuritis Chronic inflammatory demyelinating polyneuritis Other inflammatory and toxic neuropathy Myasthenia gravis with (acute) exacerbation Page 6 of 12

7 ICD-9-CM Code Description Myasthenic syndromes in diseases classified elsewhere Acute febrile mucocutaneous lymph node syndrome (MLNS) Pemphigus Pemphigoid Benign mucous membrane pemphigoid without mention of ocular involvement Benign mucous membrane pemphigoid with ocular involvement Other specified bullous dermatoses Stevens-Johnson syndrome Stevens-Johnson syndrome-toxic epidermal necrolysis overlap syndrome Toxic epidermal necrolysis Dermatomyositis Polymyositis Hemolytic disease of fetus or newborn, due to Rh isoimmunization Hemolytic disease of fetus or newborn, due to ABO isoimmunization Hemolytic disease of fetus or newborn, due to other and unspecified ISO immunization Transient neonatal thrombocytopenia Complications of transplanted organ, bone marrow V07.2* Prophylactic immunotherapy V42.81 Bone marrow replaced by transplant V42.82 Peripheral stem cells replaced by transplant *For prevention of infection for high-risk, preterm, low-weight neonates, the claim should contain 2 diagnosis codes: the prophylaxis code V07.2 plus the applicable low-birth-weight code from within the range. ICD-10-CM Diagnosis Codes that Support Medical Necessity ICD-10-CM Description Code A48.3 Toxic shock syndrome B20 Human immunodeficiency virus (HIV) disease B34.3 Parvovirus infection, unspecified C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission C91.11 Chronic lymphocytic leukemia of B-cell type in remission C91.12 Chronic lymphocytic leukemia of B-cell type in relapse D59.0 Drug-induced autoimmune hemolytic anemia D59.1 Other autoimmune hemolytic anemias D69.3 Immune thrombocytopenic Purpura D69.41 Evans syndrome Page 7 of 12

8 ICD-10-CM Description Code D69.51 Posttransfusion Purpura D69.59 Other secondary thrombocytopenia D80.0 Hereditary hypogammaglobulinemia D80.1 Nonfamilial hypogammaglobulinemia D80.5 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 (SID) 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 D82.0 Wiskott-Aldrich syndrome D82.1 Di George s 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 G25.82 Stiff-man syndrome G35 Multiple sclerosis G61.0 Guillain-Barre syndrome G61.81 Critical illness polyneuropathy G61.89 Other specified polyneuropathies G61.9 Inflammatory polyneuropathy, unspecified G70.01 Myasthenia gravis with (acute) exacerbation G73.3 Myasthenic syndromes in other diseases classified elsewhere L10.0 Pemphigus vulgaris L10.1 Pemphigus vegetans L10.2 Pemphigus follaceous L10.4 Pemphigus erythematosus L10.9 Pemphigus, unspecified L12.0 Bullous pemphigoid L12.1 Cicatricial pemphigoid L12.30 Acquired epidermolysis bullosa, unspecified L12.31 Epidermolysis bullosa due to drug L12.35 Other acquired epidermolysis bullosa L12.8 Other pemphigoid L13.8 Other specified bullous disorders Page 8 of 12

9 ICD-10-CM Description Code L51.1 Stevens-Johnson syndrome L51.2 Toxic epidermal necrolysis L51.3 Stevens-Johnson syndrome-toxic epidermal necrolysis overlap syndrome M30.3 Mucocutaneous lymph node syndrome (Kawasaki) M33.00 Juvenile dermatopolymyositis, organ involvement unspecified M33.01 Juvenile dermatopolymyositis with respiratory involvement M33.02 Juvenile dermatopolymyositis with myopathy M33.09 Juvenile dermatopolymyositis with other organ involvement M33.10 Other dermatopolymyositis, organ involvement unspecified M33.11 Other dermatopolymyositis with respiratory involvement M33.12 Other dermatopolymyositis with myopathy M33.19 Other dermatopolymyositis with other organ involvement M33.20 Polymyositis, organ involvement unspecified M33.21 Polymyositis with respiratory involvement M33.22 Polymyositis with myopathy M33.29 Polymyositis with other organ involvement M33.90 Dermatopolymyositis, unspecified, organ involvement unspecified M33.91 Dermatopolymyositis, unspecified with respiratory involvement M33.92 Dermatopolymyositis, unspecified with myopathy M33.99 Dermatopolymyositis, unspecified with other organ involvement P55.0 Rh isoimmunization of newborn P55.1 ABO isoimmunization of newborn P61.0 Transient neonatal thrombocytopenia T86.00 Unspecified complication of bone marrow transplant T86.01 Bone marrow transplant rejection T86.02 Bone marrow transplant failure T86.09 Other complications of bone marrow transplant Z79.899* Other long term (current) drug therapy [use for prophylactic immunotherapy for high-risk, preterm, low-weight neonates] Z94.81 Bone marrow transplant status Z94.84 Stem cells transplant status *For prevention of infection for high-risk, preterm, low-weight neonates, the claim should contain 2 diagnosis codes: the prophylaxis code Z plus the applicable low-birthweight code from within the P07.00-P07.18 range. Reviews, Revisions, and Approvals Date Approval Date Policy created. 02/14 03/14 Policy converted to new template. Added Hyqvia and Cytogam. Removed requirement for failure of IVIG before SCIG. Removed all safety criteria. Removed preferencing for 07/16 09/16 Page 9 of 12

10 Reviews, Revisions, and Approvals Date Approval Date Gamunex-C. Added compendial indications. Added coding information. References 1. Bivigam [package insert]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; April Accessed 6 August Carimune NF [package insert]. Kankakee, IL: CSL Behring LLC; October Revised June Accessed 6 August Flebogamma 5% DIF [package insert]. Los Angeles, CA: Grifols Biologicals, Inc.; December Revised September Accessed 6 August Flebogamma 10% DIF [package insert]. Los Angeles, CA: Grifols Biologicals, Inc.; December Revised September Accessed 6 August Gammagard Liquid [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; July Revised September Accessed 6 August Gammagard S/D [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; December Revised September Accessed 6 August Gammaked [package insert]. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; June Revised September Accessed 6 August Gammaplex [package insert]. Hertfordshire, United Kingdom: Bio Products Laboratory; October Revised September Acccessed 6 August Gamunex-C [package insert]. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; June Revised September Accessed 6 August Octagam [package insert]. Hoboken, NJ: Octapharma USA, Inc.; September Revised July Accessed 6 August Privigen [package insert]. Kankakee, IL: CSL Behring LLC; May Revised September Accessed 6 August Hizentra [package insert]. Kankakee, IL: CSL Behring LLC; October Revised September Accessed 6 August GamaSTAN S/D [package insert]. Research Triangle Park, NC: Grifolis Therapeutics, Inc.; June Revised September Accessed 6 August Orange JS, Hossny EM, Weiler CR, et al. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma, and Immunology. J Allergy Clin Immunol. 2006;417(4 Suppl):S Shehata N, Palda V, Bowen T, et al. The use of immunoglobulin therapy for patients with primary immune deficiency: an evidence-based practice guideline. Transfus Med Rev. 2010;24(Suppl 1):S28-S Centers for Disease Control and Prevention. Guidelines for the Prevention and Treatment of Opportunistic Infections among HIV-Exposed and HIV-Infected Children. MMWR. 2009;58 (No. RR-11): Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications among hematopoietic cell transplant recipients: a global perspective. Biol Blood Marrow Transplant. 2009;15(10): Page 10 of 12

11 18. The NCCN Clinical Practice Guidelines in Oncology Non-Hodgkin s Lymphomas (Version ) National Comprehensive Cancer Network, Inc. Accessed August 16, Centers for Disease Control and Prevention. Measles, Mumps, and Rubella Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1998;47(No. RR-8): "Chart of Contraindications and Precautions to Commonly Used Vaccines." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 06 Mar Web. 19 Aug "Update: Prevention of Hepatitis A After Exposure to Hepatitis A Virus and in International Travelers. Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP)." Centers for Disease Control and Prevention. Web. 21 Aug Fiebelkorn, Amy P. "Measles (Rubeola)." Centers for Disease Control and Prevention. Web. 21 Aug Marin, Mona. "Varicella (Chickenpox)." Centers for Disease Control and Prevention. Web. 21 Aug Truven Health Analytics Micromedex Solutions. (2015). Retrieved June 17, 2015, from Hyqvia [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; January Revised September Accessed 22 January Cytogam [package insert]. Kankakee, IL: CSL Behring, LLC, August Accessed 27 January Jolles S. Subcutaneous and intramuscular immune globulin therapy. Stiehm RE, Feldweg AM (Eds.). Waltham, MA: Walters Kluwer Health; Available at UpToDate.com Accessed April 7, Page 11 of 12

12 Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions Envolve Pharmacy Solutions. All rights reserved. All materials are exclusively owned by US Script and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Envolve Pharmacy Solutions. You may not alter or remove any trademark, copyright or other notice contained herein. Page 12 of 12