BlueCross BlueShield of Tennessee Medical Policy Manual

Intravenous Immune Globulin (IVIG)

Alyglo™ Asceniv™; Bivigam®; Flebogamma® DIF; Gammagard® Liquid; Gammagard® S/D; Gammaked™; Gammaplex®; Gamunex®-C; Octagam®; Panzyga®; Privigen®; Yimmugo^®

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

Primary immunodeficiency
Idiopathic thrombocytopenic purpura (ITP)
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Multifocal motor neuropathy
Kawasaki syndrome
B-cell chronic lymphocytic leukemia (CLL)
Dermatomyositis

Compendial Uses

Prophylaxis of bacterial infections in pediatric human immunodeficiency virus (HIV) infection
Bone marrow transplant (BMT)/hematopoietic stem cell transplant (HSCT)
Polymyositis
Myasthenia gravis
Guillain-Barré syndrome
Lambert-Eaton myasthenic syndrome
Fetal/neonatal alloimmune thrombocytopenia
Parvovirus B19-induced pure red cell aplasia
Stiff-person syndrome
Management of immune checkpoint inhibitor-related toxicites
Acquired red cell aplasia
Acute disseminated encephalomyelitis
Autoimmune mucocutaneous blistering diseases
Autoimmune hemolytic anemia
Autoimmune neutropenia
Birdshot retinochoroidopathy
BK virus associated nephropathy
Churg-Strauss Syndrome
Enteroviral meningoencephalitis
Hematophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
Hemolytic disease of newborn
HIV-associated thrombocytopenia
Hyperimmunoglobulinemia E Syndrome
Hypogammaglobulinemia from chimeric antigen receptor T (CAR-T) therapy
Multiple myeloma
Neonatal hemochromatosis, prophylaxis
Opsoclonus-myoclonus
Paraneoplastic opsonus-myoclonus ataxia associated with neuroblastoma
Post-transfusion purpura
Rasmussen encephalitis
Renal transplantation from a live donor with ABO incompatibility or positive cross match
Secondary immunosuppression associated with major surgery, hematological malignancy, major burns, and collagen-vascular diseases
Solid organ transplantation, for allosensitized members
Toxic epidermal necrolysis and Stevens-Johnson syndrome
Toxic shock syndrome
Systemic lupus erythematosus (SLE)
Toxic necrotizing fasciitis due to group A streptococcus
Measles (Rubeola) prophylaxis
Tetanus treatment and prophylaxis
Varicella prophylaxis

All other indications are considered experimental/investigational and not medically necessary.

DOCUMENTATION

The following information is necessary to initiate the prior authorization review:

Primary immunodeficiency

Diagnostic test results

Copy of laboratory report with serum immunoglobulin levels: IgG, IgA, IgM, and IgG subclasses
Vaccine response to pneumococcal polysaccharide vaccine (post-vaccination Streptococcus pneumoniae antibody titers)
Pertinent genetic or molecular testing in members with a known genetic disorder
Copy of laboratory report with lymphocyte subset enumeration by flow cytometry

IgG trough level for those continuing with IG therapy

Myasthenia gravis

Clinical records describing standard treatments tried and failed

Secondary hypogammaglobulinemia (e.g., CLL, BMT/HSCT recipients)

Copy of laboratory report with pre-treatment serum IgG level

Chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN)

Pre-treatment electrodiagnostic studies (electromyography [EMG] or nerve conduction studies [NCS])

Dermatomyositis and polymyositis

Clinical records describing standard treatments tried and failed

Lambert-Eaton Myasthenic Syndrome (LEMS)

Neurophysiology studies (e.g., electromyography)
A positive anti- P/Q type voltage-gated calcium channel antibody test

Idiopathic thrombocytopenic purpura

Laboratory report with pre-treatment/current platelet count
Chronic/persistent ITP: copy of medical records supporting trial and failure with corticosteroid or anti-D therapy (unless contraindicated)

Parvovirus B19-indicated Pure Red Cell Aplasia (PRCA)

Copy of test result confirming presence of parvovirus B19

Stiff-person syndrome

Anti-glutamic acid decarboxylase (GAD) antibody testing results
Clinical records describing standard treatments tried and failed

Toxic shock syndrome or toxic necrotizing fasciitis due to group A streptococcus

Documented presence of fasciitis (toxic necrotizing fasciitis due to group A streptococcus only)
Microbiological data (culture or Gram stain)

COVERAGE CRITERIA

Primary Immunodeficiency

Initial authorization of 6 months may be granted for members with any of the following diagnoses:

Severe combined immunodeficiency (SCID) or congenital agammaglobulinemia (eg, X-linked or autosomal recessive agammaglobulinemia):

Diagnosis confirmed by genetic or molecular testing, or
Pretreatment IgG level < 200 mg/dL, or
Absence or very low number of T cells (CD3 T cells < 300/microliter) or the presence of maternal T cells in the circulation (SCID only)

Wiskott-Aldrich syndrome, DiGeorge syndrome, or ataxia-telangiectasia (or other non-SCID combined immunodeficiency):

Diagnosis confirmed by genetic or molecular testing (if applicable), and
History of recurrent bacterial infections (eg, pneumonia, otitis media, sinusitis, sepsis, gastrointestinal), and
Impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A)

Common variable immunodeficiency (CVID):

Age 2 years or older, and
Other causes of immune deficiency have been excluded (eg, drug induced, genetic disorders, infectious diseases such as HIV, malignancy), and
Pretreatment IgG level < 500 mg/dL or ≥ 2 SD below the mean for age, and
History of recurrent bacterial infections, and
Impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A)

Hypogammaglobulinemia (unspecified), IgG subclass deficiency, selective IgA deficiency, selective IgM deficiency, or specific antibody deficiency:

History of recurrent bacterial infections, and
Impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A), and
Any of the following pre-treatment laboratory findings:

Hypogammaglobulinemia: IgG < 500 mg/dL or ≥ 2 SD below the mean for age
Selective IgA deficiency: IgA level < 7 mg/dL with normal IgG and IgM levels
Selective IgM deficiency: IgM level < 30 mg/dL with normal IgG and IgA levels
IgG subclass deficiency: IgG1, IgG2, or IgG3 ≥ 2 SD below mean for age assessed on at least 2 occasions; normal IgG (total) and IgM levels, normal/low IgA levels
Specific antibody deficiency: normal IgG, IgA and IgM levels

Other predominant antibody deficiency disorders must meet all of the following:

History of recurrent bacterial infections, and
Impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A), and
A pre-treatment laboratory finding of hypogammaglobulinemia: IgG < 500 mg/dL or ≥ 2 SD below the mean for age

Other combined immunodeficiency must meet all of the following:

Diagnosis confirmed by genetic or molecular testing (if applicable), and
History of recurrent bacterial infections (e.g., pneumonia, otitis media, sinusitis, sepsis, gastrointestinal), and
Impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A)

Re-authorization of 12 months may be granted when the following criteria are met:

A reduction in the frequency of bacterial infections has been demonstrated since initiation of IG therapy, AND
IgG trough levels are monitored at least yearly and maintained at or above the lower range of normal for age (when applicable for indication), OR
The prescriber will re-evaluate the dose of IG and consider a dose adjustment (when appropriate).

Myasthenia Gravis

Authorization of 1 month may be granted to members who are prescribed IG for worsening weakness, acute exacerbation, or in preparation for surgery.

Worsening weakness includes an increase in any of the following symptoms: diplopia, ptosis, blurred vision, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), difficulty chewing, impaired respiratory status, fatigue, and limb weakness. Acute exacerbations include more severe swallowing difficulties and/or respiratory failure
Pre-operative management (eg, prior to thymectomy)

Authorization of 6 months may be granted to members with refractory myasthenia gravis who have tried and failed 2 or more standard therapies (eg, corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, rituximab).

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Initial authorization of 3 months may be granted when the following criteria are met:

Disease course is progressive or relapsing/remitting for 2 months or longer
Moderate to severe functional disability
The diagnosis was confirmed by electrodiagnostic studies

Re-authorization of 6 months may be granted when the following criteria are met:

Significant improvement in disability and maintenance of improvement since initiation of IG therapy
IG is being used at the lowest effective dose and frequency

Dermatomyositis or Polymyositis

Initial authorization of 3 months may be granted when the following criteria are met:

Member has at least 4 of the following:

Proximal muscle weakness (upper or lower extremity and trunk)
Elevated serum creatine kinase (CK) or aldolase level
Muscle pain on grasping or spontaneous pain
Myogenic changes on EMG (short-duration, polyphasic motor unit potentials with spontaneous fibrillation potentials)
Positive for anti-synthetase antibodies (e.g., anti-Jo-1, also called histadyl tRNA synthetase)
Non-destructive arthritis or arthralgias
Systemic inflammatory signs (fever: more than 37°C at axilla, elevated serum CRP level or accelerated ESR of more than 20 mm/h by the Westergren method)
Pathological findings compatible with inflammatory myositis (inflammatory infiltration of skeletal evidence of active regeneration may be seen), and

Standard first-line treatments (corticosteroids) and second-line treatments (immunosuppressants) have been tried but were unsuccessful or not tolerated, or
Member is unable to receive standard first-line and second-line therapy because of a contraindication or other clinical reason.

Re-authorization of 6 months may be granted when the following criterion is met:

Significant improvement in disability and maintenance of improvement since initiation of IG therapy

Idiopathic Thrombocytopenic Purpura ITP/(Immune Thrombocytopenia)

Newly diagnosed ITP (diagnosed within the past 3 months) or initial therapy: authorization of 1 month may be granted when the following criteria are met:

Children (< 18 years of age)

Significant bleeding symptoms (mucosal bleeding or other moderate/severe bleeding) or
High risk for bleeding (see Appendix B), or
Rapid increase in platelets is required (e.g., surgery or procedure)

Adults (≥ 18 years of age)

Platelet count < 30,000/mcL, or
Platelet count < 50,000/mcL and significant bleeding symptoms, high risk for bleeding or rapid increase in platelets is required, and
Corticosteroid therapy is contraindicated and IG will be used alone or IG will be used in combination with corticosteroid therapy
Chronic/persistent ITP (≥ 3 months from diagnosis) or ITP unresponsive to first-line therapy: authorization of 6 months may be granted when the following criteria are met:

Platelet count < 30,000/mcL, or
Platelet count < 50,000/mcL and significant bleeding symptoms, high risk for bleeding or rapid increase in platelets is required, and
Relapse after previous response to IG or inadequate response/intolerance/contraindication to corticosteroid or anti-D therapy

Adults with refractory ITP after splenectomy: authorization of 6 months may be granted when either of the following criteria is met:

Platelet count < 30,000/mcL, or
Significant bleeding symptoms

ITP in pregnant women: authorization through delivery may be granted to pregnant women with ITP.

The member’s risk factor(s) for bleeding (see Appendix B) or reason requiring a rapid increase in platelets must be provided.

B-cell Chronic Lymphocytic Leukemia (CLL)

Initial authorization of 6 months may be granted when all of the following criteria are met:

IG is prescribed for prophylaxis of bacterial infections.
Member has a history of recurrent sinopulmonary infections requiring intravenous antibiotics or hospitalization.
Member has a pretreatment serum IgG level <500 mg/dL.

Re-authorization of 6 months may be granted when a reduction in the frequency of bacterial infections has been demonstrated since initiation of IG therapy.

Prophylaxis of Bacterial Infections in HIV-Infected Pediatric Patients

Initial authorization of up to 6 months may be granted to pediatric members with HIV infection when any of the following criteria are met:

IG is prescribed for primary prophylaxis of bacterial infections and pretreatment serum IgG < 400 mg/dL, or
IG is prescribed for secondary prophylaxis of bacterial infections for members with a history of recurrent bacterial infections (> 2 serious bacterial infections in a 1-year period), or
Member has failed to form antibodies to common antigens, such as measles, pneumococcal, and/or Haemophilus influenzae type b vaccine, or
Member lives in an area where measles is highly prevalent and who have not developed an antibody response after two doses of measles, mumps, and rubella virus vaccine live, or
Member has been exposed to measles and request is for a single dose, or
Member has chronic bronchiectasis that is suboptimally responsive to antimicrobial and pulmonary therapy

Re-authorization of 6 months may be granted when a reduction in the frequency of bacterial infections has been demonstrated since initiation of IG therapy.

Bone marrow transplant/hemopoietic stem cell transplant (BMT/HSCT)

Initial authorization of 6 months may be granted to members who are BMT/HSCT recipients when the following criteria are met:

Therapy will be used to prevent the risk of acute graft-versus-host disease, associated interstitial pneumonia (infectious or idiopathic), septicemia, and other infections (e.g., cytomegalovirus infections [CMV], recurrent bacterial infection).
Either of the following:

IG is requested within the first 100 days post-transplant.
Member has a pretreatment serum IgG < 400 mg/dL.
Re-authorization of 6 months may be granted when a reduction in the frequency of bacterial infections has been demonstrated since initiation of IG therapy.

Multifocal Motor Neuropathy (MMN)

Initial authorization of 3 months may be granted when the following criteria are met:

Member experienced progressive, multifocal, asymmetrical weakness without objective sensory loss in 2 or more nerves for at least 1 month
The diagnosis was confirmed by electrodiagnostic studies

Re-authorization of 6 months may be granted when significant improvement in disability and maintenance of improvement have occurred since initiation of IG therapy

Guillain-Barre Syndrome (GBS)

Authorization of 1 month total may be granted for GBS when the following criteria are met:

Member has severe disease with significant weakness (e.g., inability to stand or walk without aid, respiratory weakness)
Onset of neurologic symptoms occurred less than 4 weeks from the anticipated start of therapy

Lambert-Eaton Myasthenic Syndrome (LEMS)

Initial authorization of 6 months may be granted for LEMS when the following criteria are met:

Diagnosis has been confirmed by either of the following:

Neurophysiology studies (e.g., electromyography)
A positive anti- P/Q type voltage-gated calcium channel antibody test

Anticholinesterases (eg pyridostigmine) and amifampridine (e.g., 3,4-diaminopyridine phosphate, Firdapse) have been tried but were unsuccessful or not tolerated
Weakness is severe or there is difficulty with venous access for plasmapheresis

Re-authorization of 6 months may be granted when member is responding to therapy (i.e., there is stability or improvement in symptoms relative to the natural course of LEMS).

Kawasaki Syndrome

Authorization of 1 month may be granted for pediatric members with Kawasaki syndrome.

Fetal/Neonatal Alloimmune Thrombocytopenia (F/NAIT)

Authorization of 6 months may be granted for treatment of F/NAIT.

Parvovirus B19-induced Pure Red Cell Aplasia (PRCA)

Authorization of 6 months may be granted for severe, refractory anemia associated with bone marrow suppression, with parvovirus B19 viremia.

Stiff-person Syndrome

Authorization of 6 months may be granted for stiff-person syndrome when the following criteria are met:

Diagnosis has been confirmed by anti-glutamic acid decarboxylase (GAD) antibody testing
Member had an inadequate response to first-line treatment (benzodiazepines and/or baclofen)

Management of immune checkpoint inhibitor-related toxicities

Authorization of 1 month may be granted for management of immune checkpoint-inhibitor toxicities when all of the following criteria are met:

Member has experienced a moderate or severe adverse event to a PD-1 or PD-L1 inhibitor (e.g., pembrolizumab, nivolumab, atezolizumab, avelumab, durvalumab)
The offending medication has been held or discontinued
Member experienced one or more of the following adverse events: myocarditis, bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pneumonitis, myasthenia gravis, peripheral neuropathy, encephalitis, transverse myelitis, severe inflammatory arthritis, Guillain-Barre syndrome, or steroid-refractory myalgias or myositis

Acquired Red Cell Aplasia

Authorization of 6 months may be granted for acquired red cell aplasia.

Acute Disseminated Encephalomyelitis

Authorization of 1 month may be granted for acute disseminated encephalomyelitis in members who have had an insufficient response or a contraindication to intravenous corticosteroid treatment.

Autoimmune Mucocutaneous Blistering Disease

Authorization of 6 months may be granted for autoimmune mucocutaneous blistering disease (includes pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, and epidermolysis bullosa acquisita) when the following criteria are met:

Diagnosis has been proven by biopsy and confirmed by pathology report, and
Condition is rapidly progressing, extensive or debilitating, and
Member has failed or experienced significant complications (e.g., diabetes, steroid-induced osteoporosis) from standard treatment (corticosteroids, immunosuppressive agents).

Autoimmune Hemolytic Anemia

Authorization of 6 months may be granted for warm-type autoimmune hemolytic anemia in members who do not respond or have a contraindication to corticosteroids or splenectomy.

Autoimmune Neutropenia

Authorization of 6 months may be granted for autoimmune neutropenia where treatment with G-CSF (granulocyte colony stimulating factor) is not appropriate.

Birdshot Retinochoroidopathy

Authorization of 6 months may be granted for birdshot (vitiliginous) retinochoroidopathy that is not responsive to immunosuppressives (eg corticosteroids, cyclosporine).

BK Virus Associated Nephropathy

Authorization of 6 months may be granted for BK virus associated nephropathy.

Churg-Strauss Syndrome

Authorization of 6 months may be granted for severe, active Churg-Strauss syndrome as adjunctive therapy for members who have experienced failure, intolerance, or are contraindicated to other interventions.

Enteroviral Meningoencephalitis

Authorization of 6 months may be granted for severe cases of enteroviral meningoencephalitis.

Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)

Authorization of 6 months may be granted for treatment of hypogammaglobulinemia in HLH or MAS when total IgG is less than 400 mg/dL or two standard deviations below the mean for age.

Hemolytic Disease of Newborn

Authorization of 6 months may be granted for isoimmune hemolytic disease in neonates.

HIV-associated Thrombocytopenia

Authorization of 6 months may be granted for HIV-associated thrombocytopenia when the following criteria are met:

Pediatric members with IgG < 400 mg/dL and one of the following:

2 or more bacterial infections in a 1-year period despite antibiotic chemoprophylaxis with TMP-SMZ or another active agent, or
Received 2 doses of measles vaccine and lives in a region with a high prevalence or measles, or
HIV-associated thrombocytopenia despite anti-retroviral therapy, or
Chronic bronchiectasis that is suboptimally responsive to antimicrobial and pulmonary therapy, or
T4 cell count ≥ 200/mm3

Adult members with significant bleeding, platelet count < 20,000/mcL, and failure of RhIG in Rh-positive patients

Hyperimmunoglobulinemia E Syndrome

Authorization of 6 months may be granted to treat severe eczema in hyperimmunoglobulinemia E syndrome.

Hypogammaglobulinemia from CAR-T therapy

Authorization of 6 months may be granted for members with IgG < 400 mg/dL receiving treatment with CAR-T therapy (including but not limited to idecabtagene vicleucel [Abecma], tisagenlecleucel [Kymriah], or axicabtagene ciloleucel [Yescarta]).

Multiple Myeloma

Authorization of 6 months may be granted for multiple myeloma in members who have recurrent, serious infections despite the use of prophylactic antibiotics.

Neonatal Hemochromatosis

Authorization of 6 months may be granted for prophylaxis in members who are pregnant with a history of pregnancy ending in documented neonatal hemochromatosis.

Opsoclonus-myoclonus

Authorization of 6 months may be granted for treatment of either of the following:

Paraneoplastic opsoclonus-myoclonus-ataxia associated with neuroblastoma
Refractory opsoclonus-myoclonus, as last-resort treatment

Post-transfusion Purpura

Authorization of 1 month may be granted for post-transfusion purpura.

Rasmussen Encephalitis

Authorization of 6 months may be granted for Rasmussen encephalitis in members whose symptoms do not improve with anti-epileptic drugs and corticosteroids.

Renal Transplantation

Authorization of 6 months may be granted for a member undergoing renal transplantation from a live donor with ABO incompatibility or positive cross match.

Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases

Authorization of 6 months may be granted to prevent or modify recurrent bacterial or viral infections in members with secondary immunosuppression (IgG < 400 mg/dL) associated with major surgery, hematological malignancy, extensive burns, or collagen-vascular disease.

Solid Organ Transplantation

Authorization of 6 months may be granted for solid organ transplantation for allosensitized members.

Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome

Authorization of 1 month may be granted for severe cases of toxic epidermal necrolysis or Stevens-Johnson syndrome.

Toxic Shock Syndrome

Authorization of 1 month may be granted for staphylococcal or streptococcal toxic shock syndrome when the infection is refractory to several hours of aggressive therapy, an undrainable focus is present, or the member has persistent oliguria with pulmonary edema.

Systemic Lupus Erythematosus

Authorization of 6 months may be granted for severe, active SLE in members who have experienced inadequate response, intolerance or have a contraindication to first and second line therapies (e.g., hydroyxychloroquine, glucocorticoids, anifrolumab, rituximab).

Measles (Rubeola) prophylaxis

Authorization of 1 month may be granted for postexposure prophylaxis to prevent or modify symptoms of measles (rubeola) in susceptible members exposed to the disease less than 6 days previously.

Tetanus treatment and prophylaxis

Authorization of 1 month may be granted for treatment or postexposure prophylaxis of tetanus as an alternative when tetanus immune globulin (TIG) is unavailable.

Varicella prophylaxis

Authorization of 1 month may be granted for postexposure prophylaxis of varicella in susceptible individuals when varicella-zoster immune globulin (VZIG) is unavailable.

Toxic Necrotizing Fasciitis Due To Group A Streptococcus

Authorization of 1 month may be granted for members with fasciitis due to invasive streptococcal infection.

CONTINUATION OF THERAPY

Authorization may be granted for continuation of therapy when either the following criteria is met:

For conditions with reauthorization criteria listed under the coverage criteria section: Members who are currently receiving IG therapy must meet the applicable reauthorization criteria for the member’s condition.
For all other conditions, all members (including new members) must meet the requirements in the coverage criteria.

APPENDICES

Appendix A: Impaired Antibody Response to Pneumococcal Polysaccharide Vaccine

Age 2 years and older: impaired antibody response demonstrated to vaccination with a pneumococcal polysaccharide vaccine
Not established for children less than 2 years of age
Excludes the therapy initiated in the hospital setting

Appendix B: Examples of Risk Factors for Bleeding (not all inclusive)

Undergoing a medical or dental procedure where blood loss is anticipated
Comorbidity (eg, peptic ulcer disease, hypertension)
Mandated anticoagulation therapy
Profession or lifestyle predisposes patient to trauma (eg, construction worker, fireman, professional athlete)

MEDICATION QUANTITY LIMITS

Drug Name	Diagnosis	Maximum Dosing Regimen
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Acquired Red Cell Aplasia, Acute Disseminated Encephalomyelitis, Autoimmune Hemolytic Anemia, Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Autoimmune Mucocutaneous Blistering Diseases, Birdshot Retinochoroidopathy, Opsoclonus-Myoclonus, Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous ≥18 Years 400mg/kg every 3 weeks ≤18 Years 400mg/kg every 2 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	BK Virus Associated Nephropathy, Enteroviral Meningoencephalitis, Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS), Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Guillain-Barré Syndrome, Toxic Necrotizing Fasciitis due to Group A Streptococcus, Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Gammagard S/D Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once; may repeat on alternating days for a maximum of 3 doses 400mg/kg every day for 5 days
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous ≤18 Years 2g/kg as a single dose; repeat if needed
Gammagard S/D Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous ≤18 Years 400mg/kg every day for 4 days ≤18 Years 1g/kg as a single dose
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Multiple Myeloma, Primary Immunodeficiency, Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg per dose
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Polymyositis	Route of Administration: Intravenous ≥18 Years 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous ≤18 Years 400mg/kg every 2 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg per dose
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Alyglo, Asceniv Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen Immune Globulin Intravenous (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION

REFERENCES

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Flebogamma 10% DIF [package insert]. Los Angeles, CA: Grifols Biologicals, Inc.; September 2019.
Flebogamma 5% DIF [package insert]. Los Angeles, CA: Grifols Biologicals, Inc.; September 2019.
Gammagard Liquid [package insert]. Westlake Village, CA: Baxalta US Inc.; January 2024.
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Alyglo [package insert]. Teaneck, NJ: GC Biopharma USA, Inc.; December 2023.
Illinois Statutes Chapter 215. Insurance § 5/356z.24. Immune gamma globulin therapy: https://www.ilga.gov/legislation/ilcs/documents/021500050K356z.24.htm
Yimmugo [package insert]. Dreieich, Germany: Biotest AG; June 2024.

ORIGINAL EFFECTIVE DATE: 12/4/97

MOST RECENT REVIEW DATE: 1/14/2025

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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