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.

Flebogamma 10% (immune globulin [Human])

• For diagnosis of Primary Immunodeficiency Disorders
  Indicated as replacement therapy in primary immunodeficiency (PI) including the humoral immune defects in common variable immunodeficiency, xlinked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich syndrome.

• For diagnosis of Chronic Primary Immune Thrombocytopenia (ITP)
  Indicated for the treatment of patients 2 years of age and older with chronic primary ITP to raise platelet count.

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 adults with 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 the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include, but are not limited to: congenital agammaglobulinemia, X-linked agammaglobulinemia, common variable immunodeficiency, 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).

Criteria

Intravenous or subcutaneous immune globulins (IVIG or SCIG)

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
• One of the following:
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
OR
• Trial and failure, contraindication, or intolerance to two of the following (applies to Cutaquig only):
• Cuvitru
• Hizentra
• Xembify
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

Non Formulary

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
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv, Gammagard, Gammagard S/D, Gamunex-C, and Panzyga only):
• Gammaplex
• Privigen
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to two of the following (applies to Cutaquig only):
• Cuvitru
• Hizentra
• Xembify
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

Prior Authorization

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

• For patients with a primary immunodeficiency syndrome
AND
• Patient is 2 years of age or older
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)

Intravenous immune globulins (IVIG)

Prior Authorization

Length of Approval: 6 Month(s)
For diagnosis of Idiopathic Thrombocytopenic Purpura (ITP)

• Diagnosis of idiopathic thrombocytopenic purpura (ITP) [3, 5, 45, 51-53, 69]
AND
• Documented platelet count of less than 50 x 10^9 / L [66]
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Idiopathic Thrombocytopenic Purpura (ITP)

• Diagnosis of idiopathic thrombocytopenic purpura (ITP) [3, 5, 45, 51-53, 69]
AND
• Documented platelet count of less than 50 x 10^9 / L [66]
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulins (IVIG)

Prior Authorization

Length of Approval: 1 Month(s)
For diagnosis of Kawasaki Disease (KD) [5, 7-9]

• Diagnosis of Kawasaki Disease [5]
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

Length of Approval: 1 Month(s)
For diagnosis of Kawasaki Disease (KD) [5, 7-9]

• Diagnosis of Kawasaki Disease [5]
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulins (IVIG)

Prior Authorization

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

• Diagnosis of B-cell chronic lymphocytic leukemia (CLL) [5]
AND
• 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, B]
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

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

• Diagnosis of B-cell chronic lymphocytic leukemia (CLL) [5]
AND
• 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
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG), Hizentra, HyQvia

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 three of the following four 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 or the absence of F waves
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG), Hizentra, HyQvia

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
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

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 three of the following four 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 or the absence of F waves
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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]

Intravenous immune globulin (IVIG)

Prior Authorization

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

• Confirmed allogeneic bone marrow transplant within the last 100 days [19-21, D]
AND
• Documented severe hypogammaglobulinemia (IgG less than 400 mg/dL) [19, D]
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

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

• Confirmed allogeneic bone marrow transplant within the last 100 days [19-21, D]
AND
• Documented severe hypogammaglobulinemia (IgG less than 400 mg/dL) [19, D]
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization

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

• Diagnosis of HIV disease [60, 61, K]
AND
• 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
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

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

• Diagnosis of HIV disease [60, 61, K]
AND
• 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
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Initial Authorization)

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

• 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
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Reauthorization)

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

• Patient demonstrates positive clinical response to therapy as measured by an objective scale [e.g., Rankin, Modified Rankin, Medical Research Council (MRC) scale] [57, 68]
AND
• Documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

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

• 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
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

*This agent may require prior authorization.

Prior Authorization (Initial Authorization)

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

• Diagnosis of relapsing remitting multiple sclerosis (RRMS) [6, 35, 36, G]
AND
• 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
• 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)*
• Extavia (interferon beta-1b)*
• Gilenya (Fingolimod)*
• Lemtrada (alemtuzumab)*
• Plegridy (peginterferon beta-1a)*
• Rebif (interferon beta-1a)*
• Tecfidera (dimethyl fumarate)*
• Tysabri (natalizumab)*
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Reauthorization)

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

• The prescriber maintains and provides chart documentation of the patient's evaluation, including both of the following [6, 35, 36, O]:
• Findings of interval examination including neurological deficits incurred
AND
• Assessment of disability (e.g., Expanded Disability Status Score [EDSS], Functional Systems Score [FSS], Multiple Sclerosis Functional Composite [MSFC], Disease Steps [DS])
AND
• Stable or improved disability score (e.g., EDSS, FSS, MSFC, DS) [6, 35, 36]
AND
• Documentation of decreased number of relapses since starting immune globulin therapy [6, 35, 36]
AND
• Diagnosis continues to be the relapsing-remitting form of MS (RRMS)
AND
• Documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

*This agent may require prior authorization.

Non Formulary

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

• Diagnosis of relapsing remitting multiple sclerosis (RRMS) ) [6, 35, 36, G]
AND
• 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
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization

Length of Approval: 3 Month(s)
For diagnosis of Myasthenia Gravis Exacerbation (off-label) [34]

• Diagnosis of generalized myasthenia gravis [34, 55, F, R]
AND
• 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
• 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
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

Length of Approval: 3 Month(s)
For diagnosis of Myasthenia Gravis Exacerbation (off-label) [34]

• Diagnosis of generalized myasthenia gravis [34, 55, F, R]
AND
• 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
• 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
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Initial Authorization)

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

• Diagnosis of stiff-person syndrome [64, 65]
AND
• Trial and failure, contraindication or intolerance to GABAergic medication (e.g., baclofen, benzodiazepines) [64, 65]
AND
• Trial and failure, contraindication or intolerance to immunosuppressive therapy (e.g., azathioprine, corticosteroids) [64, 65]
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Reauthorization)

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

• Documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

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

• 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
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Initial Authorization)

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

• One of the following diagnoses [23]:
• Dermatomyositis
• Polymyositis
AND
• Trial and failure, contraindication, or intolerance to immunosuppressive therapy (e.g., azathioprine, corticosteroids, cyclophosphamide, methotrexate) [23, Q]
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Reauthorization)

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

• Documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

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

• 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
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Guillain-Barre Syndrome (off-label) [29, 80, 83]

• Diagnosis of Guillain-Barre Syndrome
AND
• Patients with severe disease requiring aid to walk [80, E]
AND
• Onset of neuropathic symptoms within the last four weeks [80, E]
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Reauthorization)

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

• Documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

Length of Approval: 3 Month(s)
For diagnosis of Guillain-Barre Syndrome (off-label) [29, 80, 83]

• Diagnosis of Guillain-Barre Syndrome
AND
• Patients with severe disease requiring aid to walk [80, E]
AND
• Onset of neuropathic symptoms within the last four weeks [80, E]
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Initial Authorization)

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

• Diagnosis of Lambert-Eaton Myasthenic Syndrome (LEMS)
AND
• History of failure, contraindication, or intolerance to immunomodulator monotherapy (e.g., azathioprine, corticosteroids) [62, 63]
AND
• Concomitant immunomodulator therapy (eg, azathioprine, corticosteroids), unless contraindicated, will be used for long-term management of LEMS [62, 63]
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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)

Intravenous immune globulin (IVIG)

Prior Authorization (Reauthorization)

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

• Documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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

Non Formulary

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

• 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
• Concomitant immunomodulator therapy (e.g., azathioprine, corticosteroids), unless contraindicated, will be used for long-term management of LEMS [62, 63]
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
• Gammaplex
• Privigen
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

Intravenous immune globulin (IVIG)

Prior Authorization

Length of Approval: 6 Month(s) [74]
For diagnosis of Pediatric Acute-Onset Neuropsychiatric Syndrome/Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANS/PANDAS) (off-label)

• Diagnosis of one of the following:
• Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
• Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS)
AND
• Disease is moderate to severe as defined by distressing symptoms that interfere with daily activities that occupy at least 50 percent (%) of waking hours [75]
AND
• Trial and failure, contraindication, or intolerance to one of the following: [76]
• Corticosteroids (e.g., prednisone, dexamethasone, methylprednisolone)
• NSAIDs (e.g., Ibuprofen, naproxen, celecoxib)
AND
• Trial and failure, contraindication, or intolerance to both of the following (applies to Alyglo, Asceniv and Panzyga only):
• Gammaplex
• Privigen
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)

P & T Revisions

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

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2. Cuvitru Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. March 2023.
3. HyQvia Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. January 2024.
4. Varizig Prescribing Information. Kamada Inc. Hoboken, NJ. September 2022.
5. Gammagard S/D Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. March 2023.
6. Micromedex Healthcare Series [database on the internet]. Greenwood Village (CO): Thomson Reuters (Healthcare) Inc.; Updated periodically. Available by subscription at: http://www.thomsonhc.com/. Accessed February 27, 2024.
7. Newburger JW, Takahashi M, Beiser AS, et al. A single intravenous infusion of gamma globulin as compared with four infusions in the treatment of acute Kawasaki syndrome. N Engl J Med. 1991;324:1633-9.
8. Newburger JW, Takahashi M, Burns JC, et al. The treatment of Kawasaki syndrome with intravenous gamma globulin. N Engl J Med. 1986;315:341-7.
9. Terai M, Shulman ST. Prevalence of coronary artery abnormalities in Kawasaki disease is highly dependent on gamma globulin dose but independent of salicylate dose. J Pediatr 1997;131:888–93.
10. Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia: Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia: a randomized, controlled trial. N Engl J Med. 1988;319:902-907.
11. Oscier D, Fegan C, Hillmen P, et al. Guidelines on the diagnosis and management of chronic lymphocytic leukaemia. Br J Haematol. 2004;125:294-317.
12. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Chronic lymphocytic leukemia/small lymphocytic lymphoma v1.2024. https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Accessed February 27, 2024.
13. Gamm H, Huber C, Chapel H, et al. Intravenous immune globulin in chronic lymphocytic leukaemia. Clin Exp Immunol. 1994;97 Suppl 1:17-20.
14. Molica S, Musto P, Chiurazzi F, et al. Prophylaxis against infections with low-dose intravenous immunoglobulins (IVIG) in chronic lymphocytic leukemia. Results of a cross-over study. Haematologica. 1996;81:121-126.
15. Koller H, Kieseier BC, Jander S, et al. Chronic inflammatory demyelinating polyneuropathy. N Engl J Med. 2005;352(13):1343-56.
16. Hughes R, Bensa S, Willison H, et al. Inflammatory Neuropathy Cause and Treatment (INCAT) Group. Randomized controlled trial of intravenous immunoglobulin versus oral prednisolone in chronic inflammatory demyelinating polyradiculoneuropathy. Ann Neurol. 2001;50:195-201.
17. Mendell JR, Barohn RJ, Freimer ML, et al. Working Group on Peripheral Neuropathy. Randomized controlled trial of IVIg in untreated chronic inflammatory demyelinating polyradiculoneuropathy. Neurology. 2001;56:445-9.
18. Dyck PJ, Litchy WJ, Kratz KM, et al. A plasma exchange versus immune globulin infusion trial in chronic inflammatory demyelinating polyradiculoneuropathy. Ann Neurol. 1994;36:838-45.
19. Centers for Disease Control and Prevention; Infectious Disease Society of America; American Society of Blood and Marrow Transplantation. Guidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients. MMWR Recomm Rep. 2000;49(RR-10):1-125.
20. Sullivan KM, Kopecky KJ, Jocom J, et al. Immunomodulatory and antimicrobial efficacy of intravenous immunoglobulin in bone marrow transplantation. N Engl J Med. 1990;323:705-12.
21. Sullivan KM, Storek J, Kopecky K, et al. A controlled trial of long-term administration of intravenous immunoglobulin to prevent late infection and chronic graft-vs.-host disease after marrow transplantation: clinical outcome and effect on subsequent immune recovery. Biol Blood Marrow Transplant. 1996;2:44-53.
22. Sokos DR, Berger M, Lazarus HM. Intravenous immunoglobulin: appropriate indications and uses in hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2002;8:117-30.
23. Dalakas MC, Illa I, Dambrosia JM, et al. A controlled trial of high-dose intravenous immune globulin infusions as treatment for dermatomyositis. N Engl J Med. 1993;329:1993-2000.
24. Keddie S, Eftimov F, van den Berg LH, Brassington R, de Haan RJ, van Schaik IN. Immunoglobulin for multifocal motor neuropathy. Cochrane Database Syst Rev. 2022;1(1):CD004429. Published 2022 Jan 11. doi:10.1002/14651858.CD004429.pub3
25. Federico P, Zochodne DW, Hahn AF, et al. Multifocal motor neuropathy improved by IVIg: randomized, double-blind, placebo-controlled study. Neurology. 2000;55:1256-62.
26. Leger JM, Chassande B, Musset L, et al. Intravenous immunoglobulin therapy in multifocal motor neuropathy: a double-blind, placebo-controlled study. Brain. 2001;124:145-53.
27. Mofenson LM, Moye J Jr, Bethel J, et al. Prophylactic intravenous immunoglobulin in HIV-infected children with CD4+ counts of 0.20 x 10(9)/L or more. Effect on viral, opportunistic, and bacterial infections. The National Institute of Child Health and Human Development Intravenous Immunoglobulin Clinical Trial Study Group. JAMA. 1992;268:483-8.
28. Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf. Accessed February 27, 2024.
29. Plasma Exchange/Sandoglobulin Guillain-Barre Syndrome Trial Group. Randomised trial of plasma exchange, intravenous immunoglobulin, and combined treatments in Guillain-Barre syndrome. Lancet. 1997;349:225-30.
30. Anwar A, Saleem S, Ahmed MF, Ashraf S, Ashraf S. Recent Advances and Therapeutic Options in Lambert-Eaton Myasthenic Syndrome. Cureus. 2019;11(8):e5450. Published 2019 Aug 21. doi:10.7759/cureus.5450
31. Winston DJ, Antin JH, Wolff SN, et al. A multicenter, randomized, double-blind comparison of different doses of intravenous immunoglobulin for prevention of graft-versus-host disease and infection after allogeneic bone marrow transplantation. Bone Marrow Transplant. 2001;28:187-96.
32. Cordonnier C, Chevret S, Legrand M, et al. GREFIG Study Group. Should immunoglobulin therapy be used in allogeneic stem-cell transplantation? A randomized, double-blind, dose effect, placebo-controlled, multicenter trial. Ann Intern Med. 2003 1;139:8-18.
33. Immune Globulin. In: McEvoy GK, ed. AHFS 2004 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2004:3154-3164.
34. Gajdos P, Chevret S, Toyka K. Intravenous immunoglobulin for myasthenia gravis. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD002277.
35. Fazekas F, Deisenhammer F, Strasser-Fuchs S, et al. Randomised placebo-controlled trial of monthly intravenous immunoglobulin therapy in relapsing-remitting multiple sclerosis. Austrian Immunoglobulin in Multiple Sclerosis Study Group. Lancet. 1997;349:589-93.
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37. Newburger JW, Takahashi M, Gerber MA, et al. Diagnosis, treatment, and long-term management of Kawasaki disease: a statement for health professionals from the Committee on Rheumatic Fever, Endocarditis and Kawasaki Disease, Council on Cardiovascular Disease in the Young, American Heart Association. Circulation. 2004;110:2747-71.
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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

• 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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