HN Logo
Prior Authorization Protocol
BIVIGAMTM, CARIMUNE NFR, FLEBOGAMMA DIFR, GAMMAGARD LIQUIDR, GAMMAGARD S/DR, GAMMAKEDR, GAMMAPLEXTM, GAMUNEX-CR,OCTAGAMR, PRIVIGEN, HIZENTRATM, HYQVIA

NATL

[Immunoglobulin for Idiopathic Thrombocytopenic Purpura]


These criteria apply to requests for use of immunoglobulins for the indication of Idiopathic Thrombocytopenic Purpura (ITP) only. For the use of immunoglobulins for any other indication, please refer to the appropriate indication specific criteria.
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For immune globulin intravenous (IVIG) (including Gamunex-C, Gammaked and Gammagard when used intravenously)
      • 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.
      • 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).
      • Prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL).
      • Prevention of coronary artery aneurysms associated with Kawasaki syndrome.
      • Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.
    • For immune globulin subcutaneous (including Gamunex-C, Gammaked, Gammagard Liquid, Hizentra, and Hyqvia when used subcutaneously)
      • 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.
  2. Health Net Approved Indications and Usage Guidelines:
    Acute idiopathic thrombocytopenic purpura (ITP)
    • Diagnosis of ITP with duration of illness < 6 months
    AND
    • Diseases known to be associated with "secondary" thrombocytopenia have been ruled out by history, physical examination, complete blood cell count and examination of the peripheral blood smear
    AND
    • Failure or clinically significant adverse effects to corticosteroids or patient is unresponsive to Rho(D) Immune Globulin (RhIG)
    AND
    • When a rapid temporary rise in platelet counts is required for any of the following:
      • Persistent or potentially life-threatening hemorrhage due to severe thrombocytopenia (platelet counts < 30,000/uL)
    OR
      • Patients whose platelet counts remain persistently at or below 20,000/uL despite prior treatment with corticosteroids or splenectomy
    OR
      • To defer or avoid splenectomy
    OR
      • To correct thrombocytopenia prior to splenectomy or other necessary major surgical procedure
    OR
      • To correct thrombocytopenia of <20,000/uL in adults with risk factors for bleeding (i.e., hypertension, peptic ulcer disease, vigorous lifestyle, intracerebral hemorrhage)
    OR
      • For pregnant women who are at risk for delivering thrombocytopenic infants as evidenced by any of the following:
        • A history of delivering an infant with ITP
    OR
        • A platelet count < 75,000/ul during current pregnancy
    OR
        • A past history of splenectomy for ITP
    OR
    Chronic idiopathic thrombocytopenic purpura (ITP)
    • Diagnosis of ITP with duration of illness > 6 months
    AND
    • No concurrent illness/disease explaining thrombocytopenia
    AND
    • Failure or clinically significant adverse effects to corticosteroids or splenectomy
    AND
    • Platelet counts persistently at or below 20,000/uL
    AND
    • Patient is symptomatic, at high risk for bleeding or post-splenectomy sepsis
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
    • A list of specific indications for which coverage is not authorized may be found in the PA guideline: Immunoglobulin Conditions Not Medically Necessary - NATL.
    • Health Net does not consider IVIG therapy to be appropriate if only mild manifestations of bleeding.

  4. General Information:
    • Some diseases, which may cause secondary thrombocytopenia, include:
      • Hypersplenism or Chronic Liver disease
      • Aplastic anemia (Fanconi`s syndrome)
      • Wiskott-Aldrich syndrome
      • Myelophthisic disease
      • Myelosuppressive drugs
      • Neonatal alloimmune thrombocytopenia
      • Neonatal ITP
      • Drug-induced ITP
      • Posttransfusion
      • Autoimmune disease (systemic lupus erythematosus, Evans`s syndrome, Graves`s disease)
      • Aortic valve replacement
      • Heparin-induced thrombocytopenia (HIT)
      • Disseminated intravascular coagulation (DIC)
      • Acute or chronic infections
    • A response would be defined as a platelet count ≥ 30,000/5L and a greater than 2-fold increase in platelet count from baseline measured on 2 occasions > 7 days apart and the absence of bleeding.
    • A failure would be defined as a platelet count < 30,000/5L or a less than 2-fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on 2 occasions more than a day apart.
    • There have been reports of fatal intravascular hemolysis with Rho(D) immune globulin and specific monitoring is required. This therapy is not necessarily recommended over IVIG but can be used instead in patients who are Rh positive, have a negative direct antiglobulin test (DAT), and have not had a splenectomy
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    systemic glucocorticoid (Various -prednisone, prednisolone, or methylprednisolone)

    An equivalent dose of PO prednisone 1 mg/kg per day until platelet count improves, then taper.
    A response should be seen in 4-14 days peaking by 28 days.

    2 mg/kg/day

    WinRho SDFR(RHO(D) Immune Globulin)*

    Rho(D) positive non-splenectomized patients.
    Initial: 250 u/kg (50 mcg/kg) IV over 3-5 minutes.
    A response should be seen in 1-3 days peaking by 7 days.

    May repeat: 125-300 u/kg (25-60 mcg/kg) IV over 3-5 minutes prn based on response

    375 u/kg (75 mcg/kg)

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    IVIG (Various Brand names)

    400 mg/kg IV x 5 days or 800 to 1000 mg/kg IV for one to two days.
    Dosing may vary with the product
    Medical:
    6 months or renewal date, whichever is longer
  7. Product Availability:
    Intravenous Immunoglobulin
    Bivigam: 10% (1 g/10 mL) in 50 mL, 100 mL vials
    Carimune NF powder for injection: 3 g, 6 g, 12 g bottles
    Flebogamma DIF: 5% (50 mg/mL) in 10 mL, 50 mL, 100 mL, 200 mL, 400 mL vials; 10% (5 g/50 mL) in 50 mL, 100 mL, 200 mL vials
    Gammagard: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 300 mL vials
    Gammagard S/D powder for injection: 2.5 g, 5 g, 10 g bottles
    Gammaked: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL vials
    Gammaplex: 5% (50 mg/mL) in 50 mL, 100 mL, 200 mL, 400 mL vials
    Gamunex-C: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 400 mL vials
    Octagam: 5% (50 mg/mL) in 20 mL, 50 mL, 100 mL, 200 mL, 500 mL
    Octagam: 10% (50 mg/mL) in 20 mL, 50 mL, 100 mL, 200 mL
    Privigen: 10% (100 mg/mL) in 50 mL, 100 mL, 200 mL, 400 mL vials
    Subcutaneous Immunoglobulin
    Gammagard: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 300 mL vials
    Gammaked: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL vials
    Gamunex-C: 10% (1 g/10 mL) in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 400 mL vials
    Hizentra protein solution for subcutaneous injection: 20% (0.2 g/mL) in 5 mL, 10 mL, 20 mL, 50 mL vials
    HyQvia: 10% (1 g/10 mL) in 25 mL, 50 mL, 100 mL, 200 mL, 300 mL vials
    and 160 U/mL recombinant human hyaluronidase in 1.25 mL, 2.5 mL, 5 mL, 10 mL, 15 mL vials
  8. References:
    1. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 11, 2015.
    2. Immune Globulin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 11, 2015.
    3. Gammagard-SD [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
    4. Gammaplex [Prescribing Information]. Temecula, CA; FFF Enterprises: June 2014.
    5. Gamunex-C [Prescribing Information]. Research Triangle Park, NC. Talecris: July 2014.
    6. Hizentra [Prescribing Information], Bern, Switzerland; CSL Behring AG, February 2015.
    7. Carimune [Prescribing Information]. Bern, Switzerland; CSL Behring AG: October 2013.
    8. Privigen [Prescribing Information]. Bern, Switzerland; CSL Behring AG: December 2013.
    9. Gammagard Liquid [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
    10. Neunert C, Lim W, Crowther M, etal. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood:117(16) Apr 21, 2011. Available at: www.bloodjournal.org/content/117/16/4190?ss.
    11. Portielje JEA, et al. Clinical Observations, Interventions, And Therapeutic Trials. Morbidity and mortality in adults with idiopathic thrombocytopenic purpura. Blood, 1 May 2001, Vol. 97, No. 9, pp. 2549-2554. Available at: http://www.bloodjournal.org/content/97/9/2549
    12. Flebogamma DIF [Prescribing Information], Los Angeles, CA; Grifols Biologicals: August 2014.
    13. Gammaked [Prescribing Information], Fort Lee, NJ; Kedrion Biopharma: September 2013.
    14. Octagam 5% [Prescribing Information]. Hoboken, NJ; Octapharmac USA: November 2013.
    15. Bivigam [Prescribing Information], Boca Raton, FL; Biotest Pharmaceuticals: May 2015.
    16. Octagam 10%[Prescribing Information]. Hoboken, NJ; Octapharma USA: December 2014.
    17. HyQvia [Prescribing Information]. Westlake Village, CA; Baxter: September 2014.
    18. George J, Arnold D. Immune Thrombocytopenia (ITP) in adults: Initial Treatment and Prognosis. UpToDate. March 04, 2015. Available at: http://www.uptodate.com/contents/immune-thrombocytopenia-itp-in-adults-initial-treatment-and-prognosis?source=search_result&search=ITP&selectedTitle=2%7E150
    19. Bussel J. Immune Thrombocytopenia (ITP) in Children: Initial Management. UpToDate. April 8, 2015. Available at: http://www.uptodate.com/contents/immune-thrombocytopenia-itp-in-children-initial-management?source=search_result&search=ITP&selectedTitle=4%7E150
    20. Bussel J. Immune Thrombocytopenia (ITP) in Children: Management of Chronic Disease. UpToDate. December 12, 2014. Available at: http://www.uptodate.com/contents/immune-thrombocytopenia-itp-in-children-management-of-chronic-disease?source=search_result&search=ITP&selectedTitle=3%7E150.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.