Immune Globulin. Prior Authorization

Transcription

1 MB9423 Covered Service: Yes when meets criteria below Prior Authorization Required: Additional Information: Yes as shown below Requires prior authorization through Navitus and is considered medically appropriate for the treatment of the following indications when the listed criteria have been met. Prevea360 Health Plan Medical Policy: Immune globulin is considered medically appropriate for the treatment of the following indications when the listed criteria have been met: 1.0 Primary immunodeficiencies (PI) if prescribed by, or consulted with, an immunologist or hematologist Hypogammaglobulinemia Congenital agammaglobulinemia Common variable immunodeficiency X-linked immunodeficiency with hyperimmunoglobulin M Severe combined immunodeficiency Wiskott-Aldrich syndrome Initial IVIG dose is 300 to 600 mg/kg every 3 to 4 weeks and is titrated based upon patient response Initial and Renewal authorizations for PI are 12 months in duration. 2.0 Idiopathic (Immune)Thrombocytopenic Purpura (ITP). Approved initial prior authorization requests will be for one month. 2.1 For Acute ITP, when a rapid rise in platelets is necessary: Diagnosis of acute ITP; and Documented platelet count < 50 x 10 9 /L (obtained within the past 30 days); and IVIG dose does not exceed 1,000 mg/kg/day for 1 to 2 days 2.2 Chronic ITP, when platelet count is low (<30,000/uL in children and <20,000/uL in adults, and all of the following are present: 1 of 11

2 2.2.1 Age of 10 years or older; and Duration of illness greater than six months; and No concurrent illness or disease causing thrombocytopenia; and Treatment with corticosteroids and splenectomy has failed, or member is at high risk for post-splenectomy sepsis; and ITP in pregnancy, when patient is refractory to steroids with platelets <10,000/uL in 3 rd trimester; or platelet count <30,000/uL associated with bleeding prior to vaginal delivery or c-section; or pregnant women who have previously delivered infants with autoimmune thrombocytopenia; or pregnant women who have platelet count <75,000/uL during the current pregnancy; or pregnant women with a past history of splenectomy; and IVIG dose does not exceed 2,000 mg/kg per month given over 2 to 5 consecutive days. IVIG administration may be repeated monthly as needed to prevent exacerbation. Dosing interval should be adjusted depending upon response and titrated to the minimum effective dose that can be given at maximum intervals to maintain safe platelet levels. 3.0 Kawasaki Disease. To be used within the first ten days of illness. Approved initial prior authorization requests will be for one dose. 3.1 IVIG dose does not exceed 400 mg/kg for five consecutive days or a single dose of 2,000 mg/kg 4.0 Chronic B-cell Lymphocytic Leukemia 4.1 Diagnosis of B-cell chronic lymphocytic leukemia (CLL) and one of the following: Documented hypogammaglobulinemia (IgG < 500 mg/dl); or History of bacterial infection(s) associated with B-cell CLL 4.2 IVIG dose does not exceed 400 mg/kg every 3 to 4 weeks 5.0 Chronic inflammatory demyelinating polyneuropathy (CIDP) 5.1 Initial treatment: Diagnosis of chronic inflammatory demyelinating polyneuropathy as confirmed by all of the following: Progressive symptoms present for at least 2 months; and Symptomatic polyradiculoneuropathy as indicated by progressive or relapsing motor or sensory impairment of more than one limb; and 2 of 11

3 Electrophysiologic findings when at least three of the following four criteria are present: Partial conduction block of 1 motor nerve Reduced conduction velocity of 2 motor nerves Prolonged distal latency of 2 motor nerves Prolonged F-wave latencies of 2 motor nerves or the absence of F waves IVIG dose does not exceed 2,000 mg/kg per month given over 2 to 5 consecutive days administered in up to six monthly infusions. Dosing interval may need to be adjusted in patients with severe comorbidities. 5.2 Continuation of treatment: Documentation of positive clinical response to therapy as measured by an objective scale [e.g., Rankin, Modified Rankin, Medical Research Council (MRC) scale]; and For long-term treatment, documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect; and IVIG dose does not exceed 2,000 mg/kg per month given over 2 to 5 consecutive days. IVIG administration may be repeated monthly as needed to prevent exacerbation. Dosing interval may need to be adjusted in patients with severe comorbidities 6.0 Multifocal Motor Neuropathy Approved initial prior authorization requests will be for three months. 6.1 Initial treatment: Diagnosis of multifocal motor neuropathy as confirmed by all of the following: Weakness with slowly progressive or stepwise progressive course over at least one month; and Asymmetric involvement of two or more nerves; and Absence of motor neuron signs and bulbar signs IVIG dose does not exceed 2,400 mg/kg per month given over 2 to 5 consecutive days. IVIG administration may be repeated monthly as needed to prevent exacerbation. Dosing interval may need to be adjusted in patients with severe comorbidities 6.2 Continuation of treatment: 3 of 11

4 6.2.1 Documentation of positive clinical response to therapy as measured by an objective scale [e.g., Rankin, Modified Rankin, Medical Research Council (MRC) scale]; and IVIG dose does not exceed 2,400 mg/kg per month given over 2 to 5 consecutive days. Dosing interval may need to be adjusted in patients with severe comorbidities; and 6.3 For long term treatment, documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect. Immune globulin for the following off label indications requires prior authorization through Navitus and is considered medically appropriate for the treatment of the following indications when the listed criteria have been met. All initial approved prior authorization requests will be for a maximum of three months. 7.0 Acquired red cell aplasia. Patient must have 1 of the following: 7.1 Immunologic acquired red cell aplasia, with failure of or inability to tolerate first-line therapy with prednisone, cyclophosphamide, or cyclosporine; or 7.2 Immunocompromised patient with aplasia associated with parvovirus B19 infection. 8.0 Autoimmune encephalopathy. Patient must have all of the following: 8.1 Diagnosis of autoimmune encephalitis 8.2 Documentation of one of the following: Prior therapy with corticosteroids has been ineffective or not tolerated; or Disease progression warrants immune globulin as first-line therapy 9.0 Autoimmune mucocutaneous blistering disease (AMBD). Patient must have all of the following: 9.1 For patients with biopsy-proven diagnosis of pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid or epidermolysis bullosa acquisita; and 9.2 Patient is intolerant of, or refractory to, corticosteroid or immunosuppressant therapy Bone Marrow Transplant. Patient must meet all of the following criteria: 10.1 One of the following uses: Prevention of acute graft vs. host disease (GVHD); or 4 of 11

5 Prevention of infection 10.2 Confirmed allogeneic bone marrow transplant within the last 100 days; and 10.3 Documented severe hypogammaglobulinemia (IgG < 400 mg/dl); and 10.4 IVIG dose does not exceed 500 mg/kg once weekly for the first 90 days of therapy, then monthly up to 360 days after transplantation 11.0 Solid Organ Transplant. Patient must have one of the following: 11.1 Prior to a medically necessary solid organ transplantation for suppression of panel reactive anti-hla antibodies in individuals with high panel reactive antibody (PRA) levels to human leukocyte antigens (HLA); or 11.2 Transplant recipient at risk for CMV 12.0 Dermatomyositis or Polymyositis. Patient must have all of the following: 12.1 Diagnosis of dermatomyositis or polymyositis; and 12.2 History of failure, contraindication, or intolerance to immunosuppressive therapy (e.g., azathioprine, corticosteroids, cyclophosphamide, methotrexate); and 12.3 IVIG dose does not exceed 2,000 mg/kg per month given over 2 to 5 consecutive days administered as monthly infusions. Dosing interval may need to be adjusted in patients with severe comorbidities; and 12.4 For long term treatment, documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect Fetomaternal alloimmune thrombocytopenia 13.1 For pregnant women: Diagnosis of fetomaternal alloimmune thrombocytopenia; and IVIG dose does not exceed 1,000 mg/kg once weekly until delivery; and One or more of the following: 13.2 For newborns: Previously affected pregnancy Family history of the disease Platelet alloantibodies found on screening 5 of 11

6 Diagnosis of fetomaternal alloimmune thrombocytopenia; and Thrombocytopenia that persists after transfusion of antigen-negative compatible platelets Guillain-Barre Syndrome. Patient must have all of the following: 14.1 Diagnosis of Guillain-Barré Syndrome; and 14.2 Severe disease requiring aid to walk; and 14.3 Onset of neuropathic symptoms within the last four weeks; and 14.4 IVIG dose does not exceed 2,000 mg/kg per month given over 2 to 5 consecutive days. IVIG administration may be repeated in up to three monthly infusions. Dosing interval may need to be adjusted in patients with severe comorbidities; and 14.5 For long term treatment, documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect Hemolytic disease of newborn. Patients must have 1 of the following: 15.1 Total serum bilirubin still rising despite intensive phototherapy; or 15.2 Total serum bilirubin level within 2mg/dl of age-adjusted and gestationadjusted threshold for initiation of exchange transfusion Hemolytic transfusion reaction. Patient must have 1 of the following: 16.1 After incompatible blood transfusion for severe life-threatening disease unresponsive to other therapies; or 16.2 Sickle cell disease, for severe life-threatening disease unresponsive to other therapies Hemolytic uremic syndrome or thrombotic thrombocytopenic purpura when the patient is unable to tolerate first-line management (plasma exchange for thrombotic thrombocytopenic purpura and hemodialysis with supportive care for hemolytic uremic syndrome) HIV in pediatric patients Approved initial prior authorization requests will be for three months; if all of the following conditions are present; 18.1 HIV diagnosis; and 18.2 Children < than 13 years old; and 18.3 IgG Level <400 mg/dl 6 of 11

7 19.0 HIV induced thrombocytopenia. Patient must meet all of the following: 19.1 Significant bleeding in thrombocytopenic patients or platelet count less than 10,000/uL; and 19.2 Failure of RhIG in Rh-positive patients 19.3 For initial therapy, IVIG dose does not exceed 1,000 mg/kg/day for 1 to 2 days For continuation of therapy, IVIG dose does not exceed 2,000 mg/kg per month given over 2 to 5 consecutive days. IVIG administration may be repeated monthly as needed to prevent exacerbation. Dosing interval should be adjusted depending upon response and titrated to the minimum effective dose that can be given at maximum intervals to maintain safe platelet levels Lambert Eaton Myasthenic Syndrome, Patient must meet all of the following: 20.1 Diagnosis of Lambert-Eaton myasthenic syndrome (LEMS); and 20.2 History of failure, contraindication, or intolerance to immunomodulator monotherapy (e.g., azathioprine, corticosteroids); and 20.3 Concomitant immunomodulator therapy (e.g., azathioprine, corticosteroids), unless contraindicated, will be used for long-term management of LEMS; and 20.4 IVIG dose does not exceed 2,000 mg/kg per month given over 2 to 5 consecutive days.62 IVIG administration may be repeated monthly as needed to prevent exacerbation. Dosing interval may need to be adjusted in patients with severe comorbidities; and 20.5 For long term treatment, documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect Myasthenic exacerbation. Note: evidence does not support the use of immune globulin maintenance therapy for generalized myasthenia gravis or for ocular myasthenia. Patients must meet all of the following: 21.1 Diagnosis of generalized myasthenia gravis; and 21.2 Evidence of myasthenic exacerbation, defined by at least one of the following symptoms in the last month: Difficulty swallowing Acute respiratory failure 7 of 11

8 Major functional disability responsible for the discontinuation of physical activity 21.3 One of the following: History of failure, contraindication, or intolerance to immunomodulator therapy (e.g., azathioprine, mycophenolate mofetil, cyclosporine) for long-term management of myasthenia gravis Currently receiving immunomodulator therapy (e.g., azathioprine, mycophenolate mofetil, cyclosporine) for long-term management of myasthenia gravis IVIG dose does not exceed 2,000 mg/kg per month given over 2 to 5 days administered in up to three monthly infusions. Dosing interval may need to be adjusted in patients with severe comorbidities Post-transfusion purpura. Patient must meet all of the following: 22.1 Decreased platelets (less than 10,000/uL); and 22.2 Two to 14 days post-transfusion with bleeding Rasmussen Syndrome. Patients must meet all of the following: 23.1 Documentation that short term amelioration of encephalitis is needed prior to definitive surgical therapy; and 23.2 IVIG dose does not exceed 2,000 mg/kg per month given over 2 to 5 days. IVIG is not recommended for long-term therapy for Rasmussen s encephalitis as surgical treatment is the current standard of care Relapse Remitting Multiple Sclerosis (RRMS). Patient must meet all of the following: 24.1 Patient must have documented inadequate response to an appropriate trial with all of the following: A beta-interferon product (Avonex, Rebif, or Extavia) OR Copaxone/glatiramer acetate; and AUBAGIO, GILENYA, or TECFIDERA; and OCREVUS 24.2 For initial therapy, member must have a definitive diagnosis of relapsing, remitting multiple sclerosis, diagnosed by a neurologist, with at least one documented relapse within the prior 12 months; and 8 of 11

9 24.3 For continual therapy, member must show a decrease in the number of relapses from the most recent 12 month period prior to treatment; and 24.4 Induction, when indicated, does not exceed a dose of 400 mg/kg daily for up to five days Renal transplantation, prevention of acute humoral rejection 26.0 Stevens-Johnson syndrome or toxic epidural necrolysis for patients with severe cases only Stiff person syndrome (Moersch-Woltmann) Patient must meet all of the following: 27.1 Documented presence of anti-gad antibody; and 27.2 Tried and failed at least three of the following: Benzodiazepines Baclofen Phenytoin Clonidine Tizanidine 27.3 IVIG does not exceed 2,000 mg/kg per month given over 2 to 5 days. IVIG administration may be repeated monthly as needed for patients requiring maintenance therapy. Dosing interval may need to be adjusted in patients with severe comorbidities 28.0 Systemic Lupus Erythematosus (SLE). Patient must meet all of the following: 28.1 Must have tried and failed, or has contraindications to, 1 st line therapies of NSAIDs, steroids, and antimalarials (hydroxychloroquine); and 28.2 Patient has tried and failed, or has contraindications to 2 nd line therapies immunosupressants (azathioprine, cyclosphosphamide, mycophenolate, methotrexate, cyclosporine) Viral-associated hemophagocytic syndrome. For severe, life threatening disease unresponsive to other therapies All other indications not listed above are considered investigational/experimental, and therefore, are not a covered service. Comment(s): 9 of 11

10 1.0 *Coding specifications *Codes and descriptors listed below are provided for informational purposes only and may not be all inclusive or current. Listing of a code in this drug policy does not imply that the service described by the code is a covered or non-covered service. Benefit coverage for any service is determined by the member s policy of health coverage with Prevea360 Health Plan, Inc. Inclusion of a code in the table below does not imply any right to reimbursement or guarantee claim payment. Other drug or medical policies may also apply. 1.1 HCPCS codes HCPCS Code J1459 J1555 J1556 J1557 J1559 J1561 J1566 J1568 J1569 J1572 J1575 J1599 Description Injection, immune globulin (Privigen), intravenous, nonlyophilized (e.g., liquid), 500 mg Injection, immune globulin (Cuvitru), 100 mg Injection, immune globulin (Bivigam), 500 mg Injection, immune globulin, (Gammaplex), intravenous, non-lyophilized (e.g. liquid), 500 mg Injection, immune globulin (Hizentra), 100 mg Injection, immune globulin, (Gamunex-C/Gammaked), intravenous, nonlyophilized (e.g., liquid), 500 mg Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg Injection, immune globulin, (Octagam), intravenous, nonlyophilized (e.g., liquid), 500 mg Injection, immune globulin, (Gammagard liquid), intravenous, nonlyophilized, (e.g., liquid), 500 mg Injection, immune globulin, (Flebogamma/Flebogamma DIF), intravenous, nonlyophilized (e.g., liquid), 500 mg Injection, immune globulin/hyaluronidase, (Hyqvia), 100 mg immuneglobulin Injection, immune globulin, intravenous, nonlyophilized (e.g., liquid), not otherwise specified, 500 mg 2.0 NOTE: The use of physician samples or manufacturer discounts does not guarantee later coverage under the provisions of the medical certificate and/or pharmacy benefit. All criteria must be met in order to obtain coverage of the listed drug product. 10 of 11

11 Committee/Source Date(s) Originated: Medical Director Committee/ Medical Affairs May 26, 2011 Revised: Reviewed: Management Division/Pharmacy Services Management Division/Pharmacy Services Management Division/Pharmacy Services Medical Policy Committee/Health Services Division/Pharmacy Services Medical Director Committee/Quality and Care Management Division Management Management Management Division/Pharmacy Services Medical Policy Committee/Health Services Division/Pharmacy Services January 21, 2015 February 15, 2017 January 10, 2018 July 18, 2018 August 15, 2018 May 16, 2012 August 15, 2012 January 16, 2013 January 15, 2014 January 21, 2015 January 20, 2016 February 15, 2017 January 10, 2018 July 18, 2018 August 15, 2018 Published: 09/01/2018 Effective: 09/01/ of 11