See Important Reminder at the end of this policy for important regulatory and legal information.

Transcription

1 Clinical Policy: Immunoglobulin for Parvovirus B19 Infection Reference Number: CP.CPA.90 Effective Date: Last Review Date: Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are Immunoglobulin agents requiring prior authorization: Human Immunoglobulin G Infusion (Bivigam ), Immune Globulin Intravenous (Carimune NF ), Immune Globulin Intravenous (Flebogamma ), Immune Globulin Infusion (Gammagard Liquid ), Immune Globulin Intravenous (Gammagard S/D ), Immune Globulin Injection (Gammaked ), Immune Globulin Intravenous (Gammaplex ), Immune Globulin Injection (Gamunex -C), Immune Globulin Intravenous (Octagam ), Immune Globulin Intravenous (Privigen ), Immune Globulin Subcutaneous (Hizentra, Cuvitru), Immune Globulin Infusion with Recombinant Human Hyaluronidase (Hyqvia) FDA approved indication Immune globulin intravenous: Bivigam, Carimune NF, Flebogamma, Gammaplex, Octagam, Privigen (including Gamunex -C, Gammaked and Gammagard S/D when used intravenously) are indicated: Replacement therapy for primary immunodeficiency (PI) This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies For the treatment of patients with idiopathic thrombocytopenic purpura (ITP) to raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery. Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN) For prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL) For prevention of coronary artery aneurysms associated with Kawasaki syndrome For treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse Bivigam: For treatment of patients with primary humoral immunodeficiency (PI) o This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies Immune globulin subcutaneous: Hizentra, Hyqvia, Cuvitru (including Gamunex-C, Gammaked, Gammagard Liquid when used subcutaneously) are indicated: For the treatment of/replacement therapy for patients with primary immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies Page 1 of 7

2 Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation Bivigam, Carimune NF, Cuvitru, Flebogamma, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Privigen, Hizentra and Hyqvia are medically necessary when the following criteria are met: I. Initial Approval Criteria A. Parvovirus B19 Infection (must meet all): 1. Diagnosis of parvovirus B19 Infection; 2. Severe, chronic refractory anemia due to bone marrow suppression (i.e., Hgb <10 or Hct < 30) unresponsive to Epogen/Procrit and secondary to documented parvovirus B19 viremia; 3. Dose does not exceed 400 mg/kg every 28. Approval duration: 6 months or to member s renewal period, whichever is longer B. Other diagnoses/indications 1. Refer to CP.CPA.09 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). II. Continued Therapy A. Parvovirus B19 Infection (must meet all): 1. Currently receiving medication via health plan benefit or member has previously met initial approval criteria; 2. Documentation of positive response to therapy; 3. Dose does not exceed 400 mg/kg every 28. Approval duration: 6 months or to member s renewal period, whichever is longer B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via health plan benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to CP.CPA.09 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy CP.CPA.09 or evidence of coverage documents; B. A list of specific indications for which coverage is not authorized may be found in the PA guideline: CP.CPA.191 Immune Globulin Conditions Not Medically Necessary. IV. Appendices/General Information Page 2 of 7

3 Appendix A: Abbreviation/Acronym Key PI: primary humoral immunodeficiency CVID: common variable immunodeficiency ITP: thrombocytopenic purpura MMN: multifocal motor neuropathy CLL: chronic lymphocytic leukemia (CLL) CIDP: chronic inflammatory demyelinating polyneuropathy IVIG: intravenous immunoglobulin HPV: human parvovirus Appendix B: General Information Human parvovirus B19 infection can give rise to the loss of mature red blood cells, severe anemia and the formation of immune complexes. A robust antibody response is necessary for virus clearance and control of the infection. IVIG has been shown to be effective in recurrent infection in augmenting the inadequate humoral immune response. Based on the evidence available, IVIG therapy has become the standard of care if the aplastic crisis becomes prolonged, even though there are no definitive clinical trials demonstrating the efficacy of HPV B19-induced anemia. IVIG dose adjustments: i. Adjustment of the IVIG dose and time interval between doses should be based on trough levels measured every month for the first three months of therapy and again at six months ii. Adjustments to infusion rates and measuring of serum IgG levels may be needed during infections or in persons who have a high catabolism of infused IgG iii. To reduce infection frequency in immunodeficient patients, serum trough levels should be maintained at mg/dl, a value close to the lower limit of normal. All IgG trough levels outside of the low normal range of mg/dl require dosage adjustment. Appendix C: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/Maximum Dose systemic glucocorticoid (Various - prednisone, prednisolone, or methylprednisolone) An equivalent of prednisone 2 mg/kg per day with a prolonged taper over several months and pulsed dexamethasone therapy of 20 mg/m 2 for three, given This field intentionally left blank H.P. Acthar Gel (repository corticotropin) * V. Dosage and Administration monthly Begin with 75 U/m 2 IM/SC BID for one week and subsequent tapers based upon clinical response for a total therapy period of 40 weeks, This field intentionally left blank Page 3 of 7

4 Bivigam, Carimune NF, Flebogamma, Gammagard S/D, Gammaplex, Octagam, Privigen Indication Dosing Regimen Maximum Dose Parvovirus B19 Infection 400 mg/kg IV every mg/kg every 28 Gammagard Liquid, Gammaked, Gamunex-C Indication Dosing Regimen Maximum Dose Parvovirus B19 Infection 400 mg/kg IV/SC every mg/kg every 28 Hizentra, Hyqvia Indication Dosing Regimen Maximum Dose Parvovirus B19 Infection 400 mg/kg SC every mg/kg every 28 VI. Product Availability Drug Availability Bivigam Vial, liquid solution, 10% (1 g/10 ml)): 50 ml, 100 ml Carimune NF Vial, lyophilized powder: 3 g, 6 g, 12 g Cuvitru Vial, 20% (200 mg/ml) in 5 ml, 10 ml, 20 ml, 40 ml Flebogamma 5% Vial, liquid preparation, 5% (50 mg/ml): 10mL, 50mL, 100mL, 200mL, 400mL Flebogamma 10% Vial, liquid preparation, 10% (100 mg/ml): 50 ml, 100 ml, 200 ml Gammagard Liquid, Vial, liquid solution, 10% (1 g/10 ml): 10 ml, 25 ml, 50 ml, 100 ml, 200 ml, 300 ml Gammagard S/D, Bottle, solution, 5 g, 10 g Gammaked Vial, liquid solution, 10% (1 g/10 ml): 10 ml, 25 ml, 50mL, 100mL, 200mL Gammaplex Vial, liquid, 5% (50 mg/ml): 50 ml, 100 ml, 200 ml, 400 ml Gamunex -C, Vial, solution, 10% (1 g/10 ml): 10 ml, 25 ml, 50 ml, 100 ml, 200 ml, 400 ml Octagam 5% Bottle, liquid preparation, 5% (50 mg/ml): 20 ml, 50 ml, 100 ml, 200 ml, 500 ml Octagam 10% Bottle, liquid preparation, 5% (100 mg/ml): 20 ml, 50 ml, 100 ml, 200 ml Privigen Vial, liquid solution, 10% (100 mg/ml): 50 ml, 100 ml, 200 ml, 400 ml Hizentra Vial, liquid solution, 20% (0.2 g/ml): 5 ml, 10 ml, 20 ml, 50 ml Hyqvia Dual vial unit, solution: Page 4 of 7

5 Drug Availability -10% IgG (1 g/10 ml): 25 ml, 50 ml, 100 ml, 200 ml, 300 ml -160 U/mL recombinant human hyaluronidase: 1.25 ml, 2.5 ml, 5 ml, 15 ml VII. References 1. Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed January 13, Immune Globulin. American Hospital Formulary Service Drug Information. Available at: Accessed January 13, Gammagard S/D [Prescribing Information] Westlake Village, CA: Baxalta US Inc.; October Gammaplex [Prescribing Information], Hertfordshire, United Kingdom: Bio Products Laboratory Limited; July Gamunex-C [Prescribing Information] Research Triangle Park, NC: Grifols Therapeutics Inc.: September Hizentra [Prescribing Information] Bern, Switzerland: CSL Behring AG October Carimune NF [Prescribing Information] Bern, Switzerland: CSL Behring AG; November Privigen [Prescribing Information] Bern, Switzerland: CSL Behring AG; October Gammagard Liquid [Prescribing Information] Westlake Village, CA; Baxalta US Inc.; October Frickhofen N, Abkowitz JL, Safford M, et al. Persistent B19 parvovirus infection in patients infected with human immunodeficiency virus type 1 (HIV-1): a treatable cause of anemia in AIDS. Ann Intern Med. 1990;113(12): Moudgil A, Shidban H, Nast CC, et al. Parvovirus B19 infection-related complications in renal transplant recipients: treatment with intravenous immunoglobulin. Transplantation. 1997;64(12): Szenborn L. The use of immunoglobulins in the treatment of infectious diseases. Pol Merkur Lekarski Jun;30(180): Flebogamma 5% DIF [Prescribing Information] Barcelona, Spain; Institutio Grifols, S.A.; April Flebogamma 10% DIF [Prescribing Information] Barcelona, Spain; Institutio Grifols, S.A.; September Gammaked [Prescribing Information] Research Triangle Park, NC: Grifolis Therapeutics Inc.; September Octagam 5% [Prescribing Information] Hoboken, NJ: Octapharma USA Inc.; October Bivigam [Prescribing Information] Boca Raton, FL: Biotest Pharmaceuticals Corporation: April Page 5 of 7

6 18. Octagam 10% [Prescribing Information] Hoboken, NJ: Octapharma USA Inc.; April Hyqvia [Prescribing Information] Westlake Village, CA: Baxalta US Inc.; April Clinical Pharmacology Web Site. Available at: Accessed January 13, Cuvitru [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.; September Reviews, Revisions, and Approvals Date P&T Approval Date Converted to new template; minor changes to verbiage and grammar. References updated 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. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise Page 6 of 7

7 professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation 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 Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 7 of 7