Prior Auth Protocol

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.

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

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

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.

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

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 SDF^R(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

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

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

References:

Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 11, 2015.
Immune Globulin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 11, 2015.
Gammagard-SD [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
Gammaplex [Prescribing Information]. Temecula, CA; FFF Enterprises: June 2014.
Gamunex-C [Prescribing Information]. Research Triangle Park, NC. Talecris: July 2014.
Hizentra [Prescribing Information], Bern, Switzerland; CSL Behring AG, February 2015.
Carimune [Prescribing Information]. Bern, Switzerland; CSL Behring AG: October 2013.
Privigen [Prescribing Information]. Bern, Switzerland; CSL Behring AG: December 2013.
Gammagard Liquid [Prescribing Information], Westlake Village, CA; Baxter: September 2013.
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.
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
Flebogamma DIF [Prescribing Information], Los Angeles, CA; Grifols Biologicals: August 2014.
Gammaked [Prescribing Information], Fort Lee, NJ; Kedrion Biopharma: September 2013.
Octagam 5% [Prescribing Information]. Hoboken, NJ; Octapharmac USA: November 2013.
Bivigam [Prescribing Information], Boca Raton, FL; Biotest Pharmaceuticals: May 2015.
Octagam 10%[Prescribing Information]. Hoboken, NJ; Octapharma USA: December 2014.
HyQvia [Prescribing Information]. Westlake Village, CA; Baxter: September 2014.
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
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
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.