Pharmacy Prior Authorization Criteria

Immune Globulins - PA, NF

Indications for Prior Authorization

Bivigam (immune globulin [Human])

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated for the treatment of adults and pediatric patients 2 years of age and older with primary humoral immunodeficiency (PI). 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.

Flebogamma 5% (immune globulin [Human])

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated in adults and pediatric patients 2 years of age and older for the treatment of primary immunodeficiency (PI), including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich syndrome.

Gamastan (immune globulin [Human])

• For diagnosis of Measles (Rubeola)
  Indicated to prevent or modify measles in a susceptible person exposed fewer than 6 days previously. A susceptible person is one who has not been vaccinated and has not had measles previously. Gamastan may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest. Gamastan is also indicated for pregnant women without evidence of immunity. Gamastan and measles vaccine should not be given at the same time. If a child is older than 12 months and has received Gamastan, he should be given measles vaccine about 5 months later when the measles antibody titer will have disappeared. If a susceptible child exposed to measles is immunocompromised, give Gamastan immediately.

• For diagnosis of Rubella
  Indicated to modify rubella in exposed women who will not consider a therapeutic abortion. Some studies suggest that the use of Gamastan in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, Gamastan may benefit those women who will not consider a therapeutic abortion. Do not give Gamastan for routine prophylaxis of rubella in early pregnancy to an unexposed woman.

• For diagnosis of Hepatitis A
  Indicated for prophylaxis following exposure to hepatitis A. The prophylactic value of Gamastan is greatest when given before or soon after exposure to hepatitis A. Gamastan is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.

• For diagnosis of Varicella
  Indicated to modify varicella. Passive immunization against varicella in immunosuppressed patients is best accomplished by use of Varicella Zoster Immune globulin (Human) [VZIG]. If VZIG is unavailable, Gamastan, promptly given, may also modify varicella.

Privigen (immune globulin [Human])

• For diagnosis of Chronic Immune Thrombocytopenic Purpura (ITP)
  Indicated for the treatment of patients age 15 years and older with chronic ITP to raise platelet counts.

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated as replacement therapy for primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

• For diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  Indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment. Limitation of Use: Privigen maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with Privigen in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy.

Gammagard S/D (immune globulin [Human])

• For diagnosis of Kawasaki Disease
  Indicated for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.

• For diagnosis of B-cell Chronic Lymphocytic Leukemia (CLL)
  Indicated for prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL).

• For diagnosis of Idiopathic Thrombocytopenic Purpura (ITP)
  Indicated for the treatment of adult chronic idiopathic thrombocytopenic purpura to increase platelet count and to prevent and/or to control bleeding.

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated for the treatment of primary immunodeficiency (PI) associated with defects in humoral immunity, in adults and children two years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Gammaked and Gamunex-C (immune globulin [Human])

• For diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  Indicated for the treatment of CIDP in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.

• For diagnosis of Idiopathic Thrombocytopenic Purpura (ITP)
  Indicated for the treatment of adults and children with idiopathic thrombocytopenic purpura to raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Immune globulin products (IVIG)

• For diagnosis of Bone Marrow Transplant (BMT) [6, 19-22]
  Has been used to decrease the incidence of infections and graft versus host disease (GVHD) in patients 20 years of age and older who underwent bone marrow transplantation.

• For diagnosis of Dermatomyositis [6, 23]
  In patients with treatment-resistant dermatomyositis, IVIG therapy resulted in improvements in muscle strength and neuromuscular symptoms.

• For diagnosis of Multifocal Motor Neuropathy (MMN) [6, 24, 25, 26]
  In placebo-controlled trials, IVIG has been shown to improve muscle strength and reduce disability and conduction block in patients with MMN.

• For diagnosis of HIV [6, 27, 28]
  Used to decrease the frequency of serious and minor bacterial infections; the frequency of hospitalization; and to increase the time free of serious bacterial infections in patients with HIV.

• For diagnosis of Guillain-Barre Syndrome [6, 29]
  Considered to be equally effective as plasma exchange for the treatment of Guillain-Barre Syndrome.

• For diagnosis of Lambert-Eaton Myasthenic Syndrome [6, 30]
  Considered a first-line treatment option to treat the refractory pattern of weakness seen in patients with LEMS.

• For diagnosis of Myasthenia Gravis [6, 34]
  A clinical study comparing IVIG with plasma exchange did not show a significant difference between the two treatments in patients with myasthenia gravis exacerbation. Several open studies support beneficial effects of IVIG in treating myasthenia gravis.

• For diagnosis of Relapsing Remitting Multiple Sclerosis [6, 35, 36]
  Published studies indicate that IVIG may reduce the frequency of acute exacerbations and provide symptomatic relief in patients with relapsing-remitting forms of multiple sclerosis.

• For diagnosis of Stiff-Person Syndrome [6, 64, 65]
  The efficacy of IVIG for the treatment of stiff-person syndrome was demonstrated in a randomized, double-blind, placebo-controlled, crossover trial.

• For diagnosis of Polymyositis [6, 23]
  Found to be effective in reversing chronic polymyositis previously unresponsive to immunosuppressive therapy.

Gammagard Liquid (immune globulin [Human])

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

• For diagnosis of Multifocal Motor Neuropathy (MMN)
  Indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

• For diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  Indicated as a therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

  Limitation of Use: Gammagard Liquid has not been studied in immunoglobulin-naive patients with CIDP. Gammagard Liquid maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with Gammagard Liquid in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy.

Gammaplex (immune globulin [Human])

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

• For diagnosis of Chronic Immune Thrombocytopenic Purpura (ITP)
  Indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to raise platelet counts

Octagam 10% (immune globulin [Human])

• For diagnosis of Chronic Immune Thrombocytopenic Purpura
  Indicated in chronic immune thrombocytopenic purpura to rapidly raise platelet counts to control or prevent bleeding in adults.

• For diagnosis of Dermatomyositis
  Indicated for the treatment of dermatomyositis in adults.

Octagam 5% (immune globulin [Human])

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.

Cytogam (cytomegalovirus immune globulin [Human])

• For diagnosis of Cytomegalovirus
  Indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.

Varizig (varicella zoster immune globulin [Human] solution)

• For diagnosis of Post-exposure prophylaxis of varicella
  Indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include: immunocompromised children and adults, newborns of mothers with varicella shortly before or after delivery, premature infants, neonates and infants less than one year of age, adults without evidence of immunity, pregnant women.

  Limitations of Use: There is no convincing evidence that Varizig reduces the incidence of chickenpox infection after exposure to VZV. There is no convincing evidence that established infections with VZV can be modified by Varizig administration. There is no indication for the prophylactic use of Varizig in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone marrow transplantation.

Hizentra (immune globulin [Human]) for subcutaneous administration

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

• For diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  Indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.

  Limitations of Use: Hizentra maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Maintenance therapy beyond these periods should be individualized based upon the patient's response and need for continued therapy.

Panzyga (immune globulin intravenous [Human] - ifas)

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated for treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

• For diagnosis of Chronic Immune Thrombocytopenia (ITP)
  Indicated for the treatment of adult patients with ITP to raise platelet counts to control or prevent bleeding.

• For diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  Indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment.

Cuvitru (immune globulin [Human])

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Cutaquig (Immune globulin subcutaneous [Human] - hipp)

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Xembify (immune globulin subcutaneous, human - klhw)

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated for treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Asceniv (immune globulin intravenous, human - slra)

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).

HyQvia (immune globulin with recombinant human hyaluronidase) for subcutaneous administration

• For diagnosis of Primary Immunodeficiency
  Indicated for the treatment of Primary Immunodeficiency (PI) in adults and pediatric patients two years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

• For diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  Indicated for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults.

Alyglo (immune globulin intravenous, human-stwk)

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated for the treatment of primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiency (SCID).

Yimmugo (immune globulin intravenous, human - dira)

• For diagnosis of Primary humoral immunodeficiency (PI)
  Indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.

Criteria

Hizentra

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Primary Immunodeficiency Syndrome

• For patients with a primary immunodeficiency syndrome [1, 3, 5, 6, 40, 44, 48-64, I, J]
AND
• Clinically significant functional deficiency of humoral immunity as evidenced by one of the following: [56]
• Documented failure to produce antibodies to specific antigens
OR
• History of significant recurrent infections
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Cutaquig, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen, Cuvitru, Xembify

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Primary Immunodeficiency Syndrome

• Submission of medical records (e.g., chart notes) confirming patients have a primary immunodeficiency syndrome [1, 3, 5, 6, 40, 44, 48-64, I, J]
AND
• Submission of medical records (e.g., chart notes) confirming clinically significant functional deficiency of humoral immunity as evidenced by one of the following: [56]
• Documented failure to produce antibodies to specific antigens
OR
• History of significant recurrent infections
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Hizentra (applies to Cutaquig, Cuvitru, Xembify only)
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

HyQvia

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Primary Immunodeficiency Syndrome

• Submission of medical records (e.g., chart notes) confirming patients have a primary immunodeficiency syndrome
AND
• Patient is 2 years of age or older
AND
• Submission of medical records (e.g., chart notes) confirming clinically significant functional deficiency of humoral immunity as evidenced by one of the following: [56]
• Documented failure to produce antibodies to specific antigens
OR
• History of significant recurrent infections
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Idiopathic Thrombocytopenic Purpura (ITP)

• Submission of medical records (e.g., chart notes) confirming diagnosis of idiopathic thrombocytopenic purpura (ITP) [3, 5, 45, 51-53, 69]
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming one of the following:
• Patient had trial and failure, contraindication or intolerance to a corticosteroid (e.g., prednisone, dexamethasone)
OR
• Documented platelet count of less than 30,000 cells/mm3 [66]
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Kawasaki Disease (KD) [5, 7-9]

• Submission of medical records (e.g., chart notes) confirming diagnosis of Kawasaki Disease [5]
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of B-cell Chronic Lymphocytic Leukemia (CLL) [5, 10-14]

• Submission of medical records (e.g., chart notes) confirming diagnosis of B-cell chronic lymphocytic leukemia (CLL) [5]
AND
• Submission of medical records (e.g., chart notes) confirming one of the following:
• Documented hypogammaglobulinemia (IgG less than 500 mg/dL) [13, 14, 59, B]
OR
• History of bacterial infection(s) associated with B-cell CLL [13,14, 59, A]
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Hizentra

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [15, 17, 18, 41, 45, 55, 78, 79, C, H]

• Diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) as confirmed by all of the following [58, C]:
• Progressive symptoms present for at least 2 months
AND
• Symptomatic polyradiculoneuropathy as indicated by one of the following:
• Progressive or relapsing motor impairment of more than one limb
OR
• Progressive or relapsing sensory impairment of more than one limb
AND
• Electrophysiologic findings when one of the following criteria are present:
• Partial conduction block of 1 or more motor nerve
• Reduced conduction velocity of 2 or more motor nerves
• Prolonged distal latency of 2 or more motor nerves
• Prolonged F-wave latencies of 2 or more motor nerves
• Absence of F waves of 2 or more motor nerves
• Abnormal Temporal Dispersion of 2 or more motor nerves
• Distal compound muscle action potential (CMAP) duration increase of 1 or more motor nerves
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Hizentra

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [15, 17, 18, 41, 45, 55, 78, 79, C, H]

• Patient demonstrates positive clinical response to therapy as measured by an objective scale (e.g., Modified Rankin, Medical Research Council [MRC] scale) [58, H, P]
AND
• Documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect [P]
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, HyQvia, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [15, 17, 18, 41, 45, 55, 78, 79, C, H]

• Submission of medical records (e.g., chart notes) confirming diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) as confirmed by all of the following [58, C]:
• Progressive symptoms present for at least 2 months
AND
• Symptomatic polyradiculoneuropathy as indicated by one of the following:
• Progressive or relapsing motor impairment of more than one limb
OR
• Progressive or relapsing sensory impairment of more than one limb
AND
• Electrophysiologic findings when one of the following criteria are present:
• Partial conduction block of 1 or more motor nerve
• Reduced conduction velocity of 2 or more motor nerves
• Prolonged distal latency of 2 or more motor nerves
• Prolonged F-wave latencies of 2 or more motor nerves
• Absence of F waves of 2 or more motor nerves
• Abnormal Temporal Dispersion of 2 or more motor nerves
• Distal compound muscle action potential (CMAP) duration increase of 1 or more motor nerves
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Gamastan

Prior Authorization

Length of Approval: 14 Day(s)
For diagnosis of Hepatitis A

• For prophylaxis of Hepatitis A before or soon after exposure [40, 74]
AND
• Patient does not have clinical manifestations of hepatitis A [40, 74]
AND
• Patient does not have exposure to hepatitis A for more than 2 weeks previously [40, 74]

Gamastan

Prior Authorization

Length of Approval: 14 Day(s)
For diagnosis of Measles (Rubeola)

• For use in susceptible individuals exposed to measles fewer than 6 days previously [40, 74]
AND
• Patient is not receiving measles vaccine at the same time [40, 74]

Gamastan

Prior Authorization

Length of Approval: 14 Day(s)
For diagnosis of Varicella

• For passive immunization against varicella [40, 74]
AND
• Patient is immunosuppressed [40, 74]
AND
• Varicella Zoster Immune Globulin (Human) vaccine is not available

Gamastan

Prior Authorization

Length of Approval: 14 Day(s)
For diagnosis of Rubella

• For pregnant women who are exposed or susceptible to Rubella [40, 74]
AND
• Patient will not consider a therapeutic abortion [40, 74]

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Bone Marrow Transplantation (off-label) [19-22]

• Submission of medical records (e.g., chart notes) confirming confirming allogeneic bone marrow transplant within the last 100 days [19-21, D]
AND
• Submission of medical records (e.g., chart notes) confirming documented severe hypogammaglobulinemia (IgG less than 400 mg/dL) [19, D]
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of HIV (off-label) [60, 61, 86]

• Submission of medical records (e.g., chart notes) confirming diagnosis of HIV disease [60, 61, K]
AND
• Submission of medical records (e.g., chart notes) confirming one of the following:
• Documented hypogammaglobulinemia (IgG less than 400 mg/dL) [75, L]
OR
• Functional antibody deficiency as demonstrated by one of the following: [60]
• Poor specific antibody titers
• Recurrent bacterial infections
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Multifocal Motor Neuropathy (off-label) [25, 26]

• Submission of medical records (e.g., chart notes) confirming diagnosis of multifocal motor neuropathy (MMN) as confirmed by all of the following [57, 67, 68, N]:
• Weakness with slowly progressive or stepwise progressive course over at least one month
AND
• Asymmetric involvement of two or more nerves
AND
• Absence of both of the following:
• Motor neuron signs
AND
• Bulbar signs
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Relapsing-Remitting Multiple Sclerosis (off-label) [35, 36]

• Submission of medical records (e.g., chart notes) confirming diagnosis of relapsing remitting multiple sclerosis (RRMS) ) [6, 35, 36, G]
AND
• Submission of medical records (e.g., chart notes) confirming documentation of an MS exacerbation or progression (worsening) of the patient's clinical status from the visit prior to the one prompting the decision to initiate immune globulin therapy [6, 35, 36, G, M, O]
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to two of the following agents: [36, G, M, O]
• Aubagio (teriflunomide)*
• Avonex (interferon beta-1a)*
• Betaseron (interferon beta-1b)*
• Copaxone/Glatopa (glatiramer acetate)*
• Generic dimethyl fumarate
• Gilenya (Fingolimod)*
• Lemtrada (alemtuzumab)*
• Tysabri (natalizumab)*
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Myasthenia Gravis Exacerbation (off-label) [34]

• Submission of medical records (e.g., chart notes) confirming diagnosis of generalized myasthenia gravis [34, 55, F, R]
AND
• Submission of medical records (e.g., chart notes) confirming evidence of myasthenic exacerbation, defined by one of the following symptoms in the last month: [34, 55, F, R]
• Difficulty swallowing
OR
• Acute respiratory failure
OR
• Major functional disability responsible for the discontinuation of physical activity
AND
• Submission of medical records (e.g., chart notes) confirming concomitant immunomodulator therapy (e.g., azathioprine, mycophenolate mofetil, cyclosporine), unless contraindicated, will be used for long-term management of myasthenia gravis [34, 55, F, R]
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Stiff Person Syndrome (off-label) [64, 65]

• Submission of medical records (e.g., chart notes) confirming diagnosis of stiff-person syndrome [64, 65]
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication or intolerance to GABAergic medication (e.g., baclofen, benzodiazepines) [64, 65]
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication or intolerance to immunosuppressive therapy (e.g., azathioprine, corticosteroids) [64, 65]
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Dermatomyositis and Polymyositis (off-label) [6, 23, 47]

• Submission of medical records (e.g., chart notes) confirming one of the following diagnoses [23]:
• Dermatomyositis
• Polymyositis
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to immunosuppressive therapy (e.g., azathioprine, corticosteroids, cyclophosphamide, methotrexate) [23, Q]
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Guillain-Barre Syndrome (off-label) [29, 80, 83]

• Submission of medical records (e.g., chart notes) confirming diagnosis of Guillain-Barre Syndrome
AND
• Patients with severe disease requiring aid to walk [80, E]
AND
• Submission of medical records (e.g., chart notes) confirming onset of neuropathic symptoms within the last four weeks [80, E]
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, Panzyga, Yimmugo, Gammaplex, Privigen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Lambert-Eaton Myasthenic Syndrome (off-label) [84]

• Submission of medical records (e.g., chart notes) confirming diagnosis of Lambert-Eaton Myasthenic Syndrome (LEMS)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming history of failure, contraindication, or intolerance to immunomodulator monotherapy (e.g., azathioprine, corticosteroids) [62, 63]
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming concomitant immunomodulator therapy (e.g., azathioprine, corticosteroids), unless contraindicated, will be used for long-term management of LEMS [62, 63]
AND
• Prescribed by or in consultation with a physician who has specialized expertise in managing patients on immune globulin therapy (e.g., immunologist, hematologist, neurologist)

Cytogam

Prior Authorization

Length of Approval: 16 Week(s)
For diagnosis of Prophylaxis for CMV Infection

• One of the following:
• Both of the following:
• Patient requires prophylaxis for CMV infection following kidney transplantation
AND
• Patient is CMV- seronegative and organ donor is CMV-seropositive
OR
• All of the following:
• Patient requires prophylaxis for CMV infection following liver, heart, lung, or pancreas transplantation
AND
• Patient is CMV- seronegative and organ donor is CMV-seropositive
AND
• Used in combination with ganciclovir or valganciclovir unless the patient has a hypersensitivity to, is intolerant of, or therapy is deemed inappropriate

Varizig

Prior Authorization

Length of Approval: 1 Dose
For diagnosis of Varicella

• For passive immunization or post exposure-prophylaxis of varicella
AND
• Patient is considered a high risk individual (e.g., immune compromised, pregnant woman, newborn of mother with varicella, premature infant, and infant less than 1 year old)
AND
• Prescribed immune globulin is being used intramuscularly

P & T Revisions

2026-05-01, 2026-04-02, 2026-04-02, 2026-02-10, 2025-12-18, 2024-11-01, 2024-09-17, 2024-07-03, 2024-05-02, 2024-04-03, 2024-03-05, 2024-01-30, 2024-01-18, 2023-11-29, 2023-10-26, 2023-04-05, 2022-04-06, 2022-02-03, 2022-01-06, 2021-12-02, 2021-09-01, 2021-05-19, 2021-03-31, 2020-04-28, 2020-04-01, 2019-12-04, 2019-10-30, 2019-10-02, 2019-08-01, 2019-07-01

References

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51. Gamunex-C Prescribing Information. Grifols Therapeutics LLC. Research Triangle Park, NC. January 2020.
52. Gammaked Prescribing Information. Grifols Therapeutics LLC. Research Triangle Park, NC. January 2020.
53. Bivigam Prescribing Information. ADMA Biologics, Inc. Boca Raton, FL. April 2025.
54. Octagam 5% Prescribing Information. Pfizer Laboratories Div Pfizer Inc. New York, NY. January 2024.
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56. Bonilla FA, Bernstein L, Khan DA, et. al. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol. 2005;94(suppl):S1-S63.
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60. Centers for Disease Control and Prevention. Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV-Exposed and HIV-Infected Children. MMWR 2009;58(No. RR-11):11-12.
61. Yap PL. Does intravenous immune globulin have a role in HIV-infected patients? Clin Exp Immunol. 1994 Jul;97 Suppl 1:59-67.
62. Maddison P. Treatment in Lambert-Eaton myasthenic syndrome. Ann N Y Acad Sci. 2012 Dec;1275:78-84. doi: 10.1111/j.1749-6632.2012.06769.x.
63. Sanders DB. Lambert-Eaton myasthenic syndrome: diagnosis and treatment. Ann N Y Acad Sci. 2003 Sep;998:500-8.
64. McKeon A, Robinson MT, McEvoy KM, et al. Stiff-man syndrome and variants: clinical course, treatments, and outcomes. Arch Neurol. 2012 Feb;69(2):230-8. doi: 10.1001/archneurol.2011.991.
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68. Per clinical consult with neurologist, August 15, 2013.
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73. Asceniv Prescribing Information. ADMA Biologics. Boca Raton, FL. April 2015.
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77. Alyglo Prescribing Information. GC Biopharma USA, Inc. Teaneck, NJ 07666, June 2025.
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81. Kumar A, Patwa HS, Nowak RJ. Immunoglobulin therapy in the treatment of multifocal motor neuropathy. J Neurol Sci. 2017;375:190-197. doi:10.1016/j.jns.2017.01.061
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83. van Doorn PA, Van den Bergh PYK, Hadden RDM, et al. European Academy of Neurology/Peripheral Nerve Society Guideline on diagnosis and treatment of Guillain-Barré syndrome. Eur J Neurol. 2023;30(12):3646-3674. doi:10.1111/ene.16073
84. Wiendl H, Abicht A, Chan A, et al. Guideline for the management of myasthenic syndromes [published correction appears in Ther Adv Neurol Disord. 2024 Apr 30;17:17562864241246400. doi: 10.1177/17562864241246400]. Ther Adv Neurol Disord. 2023;16:17562864231213240. Published 2023 Dec 26. doi:10.1177/17562864231213240
85. Patwa HS, Chaudhry V, Katzberg H, et al. Evidence-based guideline: intravenous immunoglobulin in the treatment of neuromuscular disorders: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2012 Mar 27;78(13):1009-15.
86. AHFS Drug Information/Lexi-Comp Online [internet database]. Hudson, OH. Lexi-Comp, Inc. Updated periodically. Available by subscription at: http://online.lexi.com/. Accessed February 27, 2024.
87. Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology 2002;58:169-78.
88. Yimmugo Prescribing Information. Kedrion Biopharma, Inc. Fort Lee, NJ. July 2024

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End Notes

1. Guidelines from the British Committee for Standards in Haematology [11] and the National Comprehensive Cancer Network [16] state that IVIG therapy may be beneficial in patients with recurrent infections. Clinical studies show that IVIG reduces the number of bacterial infections, but not viral or fungal infections. [22]
2. Based on inclusion criteria from Molica et al. [14]
3. According to published data, there appears to be no difference in efficacy among IVIG, plasma exchange, and corticosteroids. [15, 16]
4. A controlled trial indicated that treatment with IVIG beyond three months was associated with a delayed recovery of humoral immunity, and the rate of infections after two years of treatment was increased significantly in IVIG recipients. [23] Centers for Disease Control and Prevention, Infectious Disease Society of America, and American Society of Blood and Marrow Transplantation guidelines recommended routine IVIG use to prevent bacterial infections among BMT recipients with unrelated marrow grafts who experience severe hypogammaglobulinemia (e.g., IgG < 400 mg/dl) within the first 100 days after transplant. [19]
5. The American Academy of Neurology recommends that IVIG is for patients with GBS who require aid to walk within 2 weeks from the onset of neuropathic symptoms. [80]
6. The effectiveness of IVIG for moderate-to-severe but stable myasthenia gravis, or for moderate exacerbations of myasthenia gravis have not been demonstrated in adequately controlled trials. [34] IVIG may be as effective as plasma exchange for patients with acute exacerbations of myasthenia gravis. The indications for the use of IVIG are the same as those for plasma exchange: to produce rapid improvement to help the patient through a difficult period of myasthenic weakness. It has the advantages of not requiring special equipment or large-bore vascular access. [42] The usual dose of immune globulin is 400 mg per kilogram per day for five successive days. The improvement rate after immune globulin treatment, calculated from eight published reports, was 73 percent, but this figure is likely to be biased by selective reporting of positive uncontrolled trials. In patients who respond, improvement begins within four to five days. The effect is temporary but may be sustained for weeks to months, allowing intermittent long-term therapy in patients with otherwise refractory disease.
7. Guidelines from the American Academy of Neurology [87] state that interferon Beta or glatirimer are appropriate treatments for patients who have relapsing-remitting multiple sclerosis. The guidelines state that it is only possible that IVIG reduces the attack rate in RRMS, and that current evidence suggests IVIG is of little benefit with regard to slowing disease progression.
8. Treatment for CIDP includes corticosteroids such as prednisone, which may be prescribed alone or in combination with immunosuppressant drugs. [41] Plasmapheresis and intravenous immunoglobulin (IVIG) therapy are effective. IVIG may be used even as a first-line therapy. Physiotherapy may improve muscle strength, function and mobility, and minimize the shrinkage of muscles and tendons and distortions of the joints.
9. Subcutaneous formulations of immune globulin are available for the treatment of patients with primary immune deficiency. Subcutaneous infusions may be an alternative for patients with adverse effects to intravenous infusions of immune globulin or with poor venous access. Other advantages include decreased cost of administration, independence from scheduled home nursing visits, better maintenance of intravenous immune globulin trough levels, and a serum IgG profile (smaller variation in the peak and trough IgG concentrations compared to intravenous administration) that is similar to that in a normal population. Disadvantages include more frequent infusions and local reactions. [6]
10. There are good data to show that all immune globulins (IVIG/SCIG) are effective for primary immunodeficiency. There are no data for SCIG for indications other than PI. Efficacy is a class effect for all immune globulins products. It is appropriate to combine all IVIG/SCIG products as they are used interchangeably for PI; can combine all IVIG for other indications. Gamastan S/D (IMIG) has unique indications and should be available on the formulary. [85]
11. IVIG has been used in children with symptomatic human immunodeficiency virus (HIV) infection who are immunosuppressed in association with acquired immunodeficiency syndrome (AIDS) or AIDS-related complex (ARC) in an attempt to control or prevent infections and improve immunologic parameters. Results of studies in adults and children with symptomatic HIV infection indicate that IVIG, used in dosages similar to those used for replacement therapy in patients with primary immunodeficiencies, reduces the incidence of recurrent bacterial infections and sepsis, including upper respiratory tract infections. [86]
12. The ACIP, American Academy of Pediatrics (AAP), Centers for Disease Control (CDC), National Institutes of Health (NIH), HIV Medicine Association of the Infectious Diseases Society of America (IDSA), Pediatric Infectious Diseases Society, and other experts state that HIV-infected infants and children who have hypogammaglobulinemia (IgG less than 400 mg/dL) should receive IVIG (400 mg/kg once every 2-4 weeks) to prevent serious bacterial infections. [86]
13. Per expert consultant regarding MS: IVIG is only used in acute, severe MS. IVIG is used for bad relapses of MS with significant neurological dysfunction when a patient is breaking through their regular maintenance medications. It takes about 3 months to see if there is improvement in MS and one cannot say a patient has failed a medication if they have a breakthrough episode of MS within this 3 month period [67].
14. Per expert consultant regarding multifocal motor neuropathy: the European Federation of Neurological Societies (EFNS) guidelines [69] as outlined on page 344 and in the table are fairly reasonable: 1. Weakness with slowly progressive or stepwise progressive course 2. Asymmetric involvement of two or more nerves 3. Absence of upper motor neuron signs and bulbar signs [68].
15. Per expert consultant regarding MS: there are no data to support the initial length of IVIG treatment in MS. I would suggest 3 months and then reevaluate. An appropriate length of time for reauthorization of IVIG is 12 months. Patients who receive IVIG for RRMS should be in acute exacerbation, should have tried steroids, have documentation of inability to tolerate other disease modifying drugs, as well as show progression of disease. IVIG should be used 2nd or 3rd line if other injectable disease modifying drugs are not tolerated. Guidelines do not support IVIG as first line treatment for MS [68].
16. Per expert consultant regarding CIDP: It is important to reevaluate a patient after initial treatment. Some patients may need changes in dosing intervals due to wearing off of a dose within 2-3 weeks. Treatment can be lifelong for some patient [68].
17. Per expert consultant regarding dermatomyositis: It is reasonable to ask a patient to try steroids prior to treatment with IVIG. [68]
18. Per expert consultant regarding MG: IVIG should be used in patients with moderate to severe myasthenia gravis with acute exacerbation. Most MDs favor plasma exchange for maintenance therapy in MG patients. Myasthenic exacerbation = myasthenic crisis. [68]

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Revision History

• 2026-05-01: 2026 Annual Review: Removed trial requirement for IVIG products for all indications since products are excluded. Removed trial requirement for SCIG for Immunodeficiency PA. Updated criteria for ITP to add TF/C/I to corticosteroids and update platelet counts to 30,000 to align with current ITP guidelines. Updated CIDP diagnostic criteria by reducing requirement of electrophysiologic findings to 1 and added more finding options per CIDP guidelines. Updated to standard non-formulary verbiage. Removed IVIG PA criteria buckets for all indications. Background updates and updated references
• 2026-04-02: Addition of Gammagard Liquid ERC formulation.
• 2026-04-02: Addition of Yimmugo to NF criteria buckets. Background updates.
• 2026-02-10: Updated approval duration for Non-Formulary criteria
• 2025-12-18: no criteria changes, added IL statute operational note
• 2024-11-01: Created EHB-specific guideline. Removed Gammagard and Gamunex-C as preferred alternatives and added Gammagard and Gamunex-C as targets to non formulary criteria.
• 2024-09-17: Removed age requirement for HIV off label criteria. Updated references.
• 2024-07-03: Added Alyglo as target to non-formulary criteria.
• 2024-05-02: Added Alyglo as target to guideline. Background updates.
• 2024-04-03: Annual review: Updated criteria, added Hyqvia to guideline, GPI clean-up (Cytogam), and background updates.
• 2024-03-05: Updated background information due to new indication for Gammagard liquid.
• 2024-01-30: Background and references updated
• 2024-01-18: Addition of PANS/PANDA off-label indication and GPI update
• 2023-11-29: Addition of PANS/PANDA off-label indication and GPI update
• 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-04-05: Annual review: Removed obsolete/unavailable product GPI. Updated Gamastan's authorization duration and background.
• 2022-04-06: Annual review: Background updates.
• 2022-02-03: Updated criteria.
• 2022-01-06: Updated background with Cutaquig's expanded indication.
• 2021-12-02: Updated to add NF criteria sections for Asceniv, Cutaquig, and Panzyga where applicable.
• 2021-09-01: Updated background.
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-31: Annual review: Cutaquig step updated to include Xembify and background updates.
• 2020-04-28: Added new Hizentra product GPIs.
• 2020-04-01: Annual review: formulary strategy update (Asceniv) with formatting, cosmetic, and background updates.
• 2019-12-04: Added new products, Asceniv and Xembify, GPI updates, and updated background.
• 2019-10-30: Added formulary strategy for subcutaneous products.
• 2019-10-02: Added new Octogam product and updated background.
• 2019-08-01: Copied from TSK-50640 (going to August P&T): Added new Cuvitru 10gm/50mL strength (GPI: 19100020202065) to guideline and updated background. EAH 8/1/19
• 2019-07-01: Added Cutaquig to guideline and embedded step for Panzyga through two of the following: Gammagard, Gammaplex, Gamunex-C, Privigen – with an allowance for continuation of prior therapy. Includes background updates. EAH 7/1/19

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