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:

Diagnosis of dermatomyocitis (DM) or polymyositis (PM)

AND

Biopsy-proven inflammatory myopathy (polymyositis, dermatomyositis)

AND

Failure or clinically significant adverse effects to at least a 4 month trial of continual high dose corticosteroids in combination with other immunosuppressive agents (e.g., methotrexate, azathioprine, cyclophosphamide, mycophenolate mofetil, tacrolimus, and cyclosporine).

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.
Inclusion-body myositis (IBM)

General Information:

IVIG may be medically necessary after less than 4 months trial of prednisone or prednisone combination therapies if the patient has profound, rapidly progressive and/or potentially life threatening muscular weakness (e.g., life-threatening aggressive disease with involvement of respiratory musculature, possibly requiring hospitalization, elective intubation and mechanical ventilatory support) and is refractory to or intolerant of previous therapy.
Failure or clinically significant adverse effects to continual high dose steroids in combination with other immunosuppressive agents is defined as the patient being unresponsive or poorly responsive to therapy (persistently elevated serum creatine kinase (CK) levels and/or lack of improvement on muscle strength improvement scales) or intolerant of therapy (i.e., steroid myopathy or severe osteoporosis).
IBM is classified as one of the idiopathic inflammatory myopathies. However, despite some histologic similarities, the clinical manifestations, treatment and prognosis are different from DM and PM. IBM is relatively resistant to standard immunosuppressive therapy.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
systemic glucocorticoid (Various - prednisone, prednisolone, or methylprednisolone)	An equivalent dose of prednisone 1 mg/kg per day PO, to a maximum daily dose of 80 mg. Begin slow taper after 4-6 weeks. Pulse methylprednisolone at 1000 mg IV QD for three days may be used for patients who are severely ill.	2 mg/kg/day
azathioprine (Imuran^R)	50 mg PO QD for two weeks, then increase the daily dose by 50 mg each week to 1.5 mg/kg/day. In patients with an inadequate response after three months of therapy, increase the dose as tolerated up to as high as 2.5 mg/kg/day	2.5 mg/kg/day
methotrexate (Rheumatrex^R)	15 mg/week PO/IV, increasing slowly by 2.5 mg increments to 25 mg/week if there is inadequate response to the lower dose after two to three months.	50 mg/week. Leucovorin rescue is required at doses greater than 25 mg/week.
cyclophosphamide (Cytoxan^R)	300 to 800 mg/m² IV every four weeks for at least six courses	This section intentionally left blank
cyclosporine (Various brand names)	3.5 mg/kg PO QD for six months	This section intentionally left blank
tacrolimus (Prograf^R)	0.075 mg/kg/day PO BID	This section intentionally left blank
mycophenolate mofetil (Cellcept^R)	Mean dose 1.6gm/day PO	This section intentionally left blank

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
IVIG (Various Brand names)	1 g/kg body weight IV QD for two days every four weeks or 400 mg/kg body weight for five days every four weeks in patients intolerant of high dose therapy.	Medical: 6 months or renewal date, whichever is longer
(IGSC) Gammaked Gamunex-C, Gammagard	100 to 200 mg/kg body weight SC per week OR Initial weekly subcutaneous dose can be calculated by multiplying the previous IVIG dose by 1.37, and then dividing this dose into weekly doses based on the patient's previous IVIG treatment interval.	Medical: 6 months or renewal date, whichever is longer
(IGSC) Hizentra	Administer SC at regular intervals from daily up to every two weeks (biweekly). To calculate the initial weekly dose of Hizentra, multiply the previous IVIG dose in grams by the dose adjustment factor of 1.37; then divide this by the number of weeks between doses during the patient`s IVIG treatment (i.e., 3 or 4). Weekly Dosing: Administer calculated weekly dose starting 1 week after the last IVIG infusion Biweekly Dosing: Administer twice the calculated weekly dose starting 1 or 2 weeks after the last IVIG infusion or 1 week after the last IGSC infusion. Frequent Dosing (2 to 7 times per week): Divide the calculated weekly dose by the desired number of times per week. Start Hizentra 1 week after the last IVIG or IGSC infusion. To convert the Hizentra dose (in grams) to milliliters (mL), multiply the calculated dose (in grams) by 5.	Medical: 6 months or renewal date, whichever is longer
(IGSC) HyQvia	Infuse SC the two components of HyQvia sequentially, beginning with the recombinant human hyaluronidase. Initiate the IGSC within 10 minutes of the recombinant human hyaluronidase infusion. Initiation of treatment: Increase dose and frequency from a 1-week dose to a 3- or 4-week dose (see ramp-up schedule below) For patients previously on another IG treatment, administer the first dose of HyQvia approximately one week after the last infusion of their previous treatment Initial dosage ramp-up schedule (e.g., every 4-week dosing): Week 1: [1-week dose interval] 1/4 of target dose Week 2: [2-week dose interval] 1/2 of target dose Week 3: no infusion Week 4: [3-week dose interval] 3/4 of target dose Week 5: no infusion Week 6: no infusion Week 7: [4-week dose interval] target dose, repeat every 4 weeks Switching from IGIV: Administer at the same dose and frequency as the previous intravenous treatment, after the initial dose ramp-up Naive to IG treatment or switching from IGSC: 300 to 600 mg/kg at 3 to 4 week intervals, after initial ramp-up Dose adjustments: See details in prescribing information	3 months or to member's renewal period, whichever is sooner. Maintenance therapy generally not required beyond 3 months

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. Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 10, 2015.
Immune Globulin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 10, 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.
Elovaara I, Apostolski S, van Doorn P, et al. EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases: EFNS task force on the use of intravenous immunoglobulin in treatment of neurological diseases. Eur J Neurol. 2008 Sep;15(9):893-908.
Koler RC, Montemarano A. Dermatomyositis. Am Fam Physician. 2001 Nov 1;64(9):1565-1573. Available at: http://www.aafp.org/afp/20011101/1565.html
The Myositis Association. Classification Criteria for Polymyositis and Dermatomyositis. Available at: http://www.myositis.org/for-health-professionals/diagnostic-criteria . Updated March 2012.
Lam CG, Manlhiot C, Pullenayegum EM, Feldman BM. Efficacy of intravenous Ig therapy in juvenile dermatomyositis. Ann Rheum Dis. 2011 Dec;70(12):2089-94.
Marie I, Mouthon L. Therapy of polymyositis and dermatomyositis. Autoimmun Rev. 2011 Nov;11(1):6-13
Miyasaka N, Hara M, Koike T, et al. Effects of intravenous immunoglobulin therapy in Japanese patients with polymyositis and dermatomyositis resistant to corticosteroids: a randomized double-blind placebo-controlled trial. Mod Rheumatol. 2011 Oct 5.
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.
Miller M, Rudnicki S. Initial Treatment of Dermatomyositis and Polymyositis in Adults. UpToDate. April 8, 2014. Available at: http://www.uptodate.com/contents/initial-treatment-of-dermatomyositis-and-polymyositis-in-adults?source=search_result&search=dermatomyositis&selectedTitle=2%7E150.
Miller M, Rudnicki S. Treatment of Recurrent and Resistant Dermatomyositis and Polymyositis in Adults. UpToDate. February 18, 2015. Available at: http://www.uptodate.com/contents/treatment-of-recurrent-and-resistant-dermatomyositis-and-polymyositis-in-adults?source=search_result&search=dermatomyositis&selectedTitle=9%7E150.
Miller M. Treatment and Prognosis of Inclusion Body Myositis. UpToDate. June 3, 2015. Available at: http://www.uptodate.com/contents/treatment-and-prognosis-of-inclusion-body-myositis?source=search_result&search=inclusion+body+myositis&selectedTitle=2%7E30.