CurrentUnitedHealthcarePolicy 2025D0035AQ

Immune Globulin (IVIG and SCIG)

Defines medical necessity criteria, covered indications, unproven/not medically necessary indications, general requirements for initial and continuation authorization, diagnosis-specific requirements, and applicable billing codes for IVIG and SCIG products effective for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyImmune Globulin (IVIG and SCIG)

Policy CodePolicy 2025D0035AQ

Change TypeAdded measles PEP criteria; ICD-10 codes added; references updated

Effective DateAug 1, 2025

Next Review Date

Key ActionInclude diagnosis, history/physical and lab/diagnostic evidence and obtain prior authorization documenting that general and diagnosis-specific medical necessity criteria are met.

POLICY UPDATE CHANGES

Added language to indicate immune globulin is proven for measles (rubeola) post-exposure prophylaxis and specified medical necessity criteria.

Added ICD-10 diagnosis codes B05.0, B05.1, B05.2, B05.3, B05.4, O98.511, O98.512, O98.513, and O98.519 to applicable codes.

Updated Clinical Evidence and References sections to reflect the most current information.

Corrected formatting error in References section.

~40Listed addressed diagnoses (covered + unproven)

1New coverage indication (measles PEP)

9ICD-10 codes added

manyConditions not recommended/insufficient evidence

Coverage Summary

This policy addresses coverage for intravenous and subcutaneous pooled human immunoglobulin G (IVIG/SCIG) preparations used to treat primary immunodeficiency states and a range of FDA-approved, guideline-supported, and selected off-label autoimmune, neurologic, rheumatologic, dermatologic, infectious, hematologic and transplant-related indications. The background and scope summarize FDA-approved uses (including primary immunodeficiencies, prevention of infections in select hematologic conditions, Kawasaki disease, CIDP and multifocal motor neuropathy) and recognize IVIG/SCIG as a mainstay for immunodeficiency and certain immune-mediated disorders.

The policy was updated to add a new covered indication: measles (rubeola) post-exposure prophylaxis. The revision specifies medical necessity criteria for measles post-exposure prophylaxis (timing since exposure, route/weight considerations, qualifying high-risk groups, and dosing limits) and adds applicable ICD-10 diagnosis codes to support billing and claims.

Quick thresholds & limits

Initial authorization durationNo more than 12 months

Continuation authorization durationNo more than 12 months

ITP platelet thresholdDocumented platelet count < 50 x 10^9 / L (obtained within the past 30 days)

IgG threshold — pediatric HIVIgG < 400 mg/dL

IgG threshold — CLL / Multiple myeloma / post B-cell therapyIgG < 500 mg/dL (or history of bacterial infections); consider IVIG when IgG < 400 mg/dL or 400–600 mg/dL with serious/persistent/unusual/recurrent infections

Measles (rubeola) PEP timing/dose/weightExposure < 6 days; one-time dose not to exceed 400 mg/kg; IVIG for patients > 30 kg (≤ 30 kg → use IMIG)

HSCT / CAR-T / ALL windows (measles PEP qualifying risk groups)HSCT: finished immunosuppressive treatment within 12 months or HSCT recipient with chronic GVHD; CAR T therapy within 12 months; ALL: completing/completed chemotherapy within last 6 months

HIV severe immunosuppression (measles PEP)CD4% < 15% (all ages) or CD4 < 200 cells/mm3 (age > 5 years)

IVIG duration limits for specific indicationsPosttransfusion purpura: IVIG dose ≤ 2 days; Kawasaki disease: IVIG treatment ≤ 5 consecutive days

CIDP electrodiagnostic thresholds (definite)Motor distal latency ≥50% above ULN in 2 nerves; motor conduction velocity reduction ≥30% below LLN in 2 nerves; F-wave latency prolongation ≥30% above ULN in 2 nerves (≥50% if distal CMAP <80% LLN); distal CMAP duration increases (median ≥6.6 ms, ulnar ≥6.7 ms, peroneal ≥7.6 ms, tibial ≥8.8 ms)

General Medical Necessity Requirements

General Requirements (Applicable to all Medical Necessity Requests)

The following information pertains to medical necessity review general requirements (applicable to all medical necessity requests).

Initial Therapy

Diagnosis;
- History and physical examination documenting the severity of the condition, including frequency and severity of infections where applicable;
- Laboratory results or diagnostic evidence supporting the indication for which immune globulin is requested;
One of the following:

Diagnosis-Specific Requirements — Dermatology (Selected Proven Indications)

Diagnosis-Specific Requirements - Selected Proven Indications (Dermatology)

Immune globulin is medically necessary for the following dermatology and related hematologic indications when specified criteria are met:

Autoimmune bullous diseases: Diagnosis of an autoimmune bullous disease (pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane (cicatricial) pemphigoid, epidermolysis bullosa acquisita, pemphigoid gestationis, linear IgA bullous dermatosis); extensive and debilitating disease; history of failure, contraindication, or intolerance to systemic corticosteroids with concurrent immunosuppressive treatment (e.g., azathioprine, cyclophosphamide, mycophenolate mofetil)

Toxic epidermal necrolysis or Stevens-Johnson syndrome: Diagnosis of toxic epidermal necrolysis or Stevens-Johnson syndrome

Feto-neonatal alloimmune thrombocytopenia (AIT) - Pregnant women or Newborns

For Pregnant Women:

Diagnosis-Specific Requirements — Infectious Disease

Diagnosis-Specific Requirements - Infectious Disease

Selected infectious disease indications with specific criteria:

CLL - prevention of infection in B-cell CLL: Diagnosis of B-cell chronic lymphocytic leukemia (CLL) AND one of: documented hypogammaglobulinemia (IgG < 500 mg/dL) OR history of bacterial infection(s) associated with B-cell CLLIgG < 500 mg/dL (or history of infections)

Prevention of bacterial infection in pediatric HIV: Diagnosis of HIV disease AND patient age ≤ 13 years AND one of: documented hypogammaglobulinemia (IgG < 400 mg/dL) OR functional antibody deficiency demonstrated by poor specific antibody titers or recurrent bacterial infectionsIgG < 400 mg/dL

Measles (rubeola) post-exposure prophylaxis:

Diagnosis-Specific Requirements — Neurology

Diagnosis-Specific Requirements - Neurology

Selected neurologic proven indications with criteria for initial and/or continuation therapy:

Acute disseminated encephalomyelitis (ADEM): Diagnosis of ADEM AND history of failure, contraindication, or intolerance to intravenous glucocorticoids

Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial therapy: diagnosis of CIDP confirmed by all of: progressive symptoms ≥ 2 months; symptomatic polyradiculoneuropathy affecting >1 limb; electrodiagnostic findings consistent with EFNS/PNS definite CIDP (presence of at least one listed nerve conduction abnormality including motor distal latency prolongation in 2 nerves; reduction of motor conduction velocity in 2 nerves; prolongation of F‑wave latency in 2 nerves; absence of F‑waves in ≥1 nerve; partial motor conduction block in ≥1 motor nerve; abnormal temporal dispersion in ≥2 nerves; distal CMAP duration increase in ≥1 nerve). Continuation: documentation of positive clinical response measured by objective scale (e.g., Rankin, Modified Rankin, MRC)Electrodiagnostic thresholds per EFNS/PNS

Diagnosis-Specific Requirements — Primary Immunodeficiency

Primary Immunodeficiency

Criteria for primary immunodeficiency syndromes:

Primary immunodeficiency: Diagnosis of primary immunodeficiency (refer to disease list linked in policy) AND clinically significant functional deficiency of humoral immunity as evidenced by one of: documented failure to produce antibodies to specific antigens OR history of significant recurrent infections

Refer to IDF disease list

Rheumatology and Transplantation Requirements

Rheumatology - Dermatomyositis/Polymyositis and Kawasaki disease; Transplantation - Bone marrow transplantation (BMT)

Rheumatologic and transplantation indications with specified limits:

Dermatomyositis or polymyositis: Diagnosis of dermatomyositis or polymyositis AND history of failure, contraindication, or intolerance to immunosuppressive therapy (e.g., azathioprine, corticosteroids, cyclophosphamide, methotrexate)

Kawasaki disease: Diagnosis of Kawasaki disease AND IVIG treatment does not exceed five consecutive daysIVIG ≤ 5 consecutive days

Bone marrow transplantation (BMT): After allogeneic BMT, immune globulin is medically necessary for one of the following uses: prevention of acute graft‑versus‑host disease (GVHD) OR prevention of infection

Applies after allogeneic BMT

Not Medically Necessary / Unproven Indications

Unproven and Not Medically Necessary Indications

Immune globulin is unproven and not medically necessary for the following conditions:

Unproven/Not Medically Necessary Conditions: List of conditions for which IVIG is unproven/not medically necessary (any): acquired hemophilia; adrenoleukodystrophy; Alzheimer's disease; amyotrophic lateral sclerosis (ALS); antiphospholipid antibody syndrome (APS) in pregnancy; asthma; atopic dermatitis; autism spectrum disorders; autoimmune liver disease; autoimmune neutropenia; BMT prevention of acute GVHD after autologous BMT; BMT prevention of chronic GVHD after autologous BMT; BMT prevention of infection after autologous BMT; Campylobacter enteritis; cerebral infarctions with antiphospholipid antibodies; chronic fatigue syndrome; demyelinative brain stem encephalitis; demyelinating neuropathy associated with monoclonal IgM; diabetes mellitus; dilated cardiomyopathy; HIV infection to reduce viral load; HTLV‑1‑associated myelopathy; idiopathic dysautonomia, acute; inclusion body myositis; isolated IgA deficiency; isolated IgE deficiency; isolated IgG4 deficiency; isolated IgM deficiency; lumbosacral or brachial plexitis; monoclonal gammopathy; myocarditis, acute; neonatal isoimmune hemolytic jaundice; neonatal sepsis prevention; ocular myasthenia; opsoclonus myoclonus; paraneoplastic cerebellar degeneration/sensory neuropathy/encephalopathy; PANS; PANDAS; POEMS syndrome; postinfectious cerebellar ataxia; postoperative sepsis; pseudomembranous colitis; rheumatic fever, acute; Sjogren's syndrome; spontaneous recurrent abortions prevention; urticaria chronic; urticaria delayed pressure; vasculitides and antineutrophil antibody syndromes

Operator any

Indications and Evidence Summary

The policy lists evidence-supported indications and links determinations to FDA approvals, randomized trials, and guideline recommendations. Examples include: CIDP (guided by EFNS/PNS recommendations supporting IVIG for induction and objective electrodiagnostic/clinical criteria for diagnosis and continuation), dermatomyositis (a randomized controlled trial showing significant dermatologic improvement with IVIG), and Kawasaki disease (standard-of-care IVIG to reduce coronary artery aneurysms and fever duration per AHA guidance).

Selected infectious indications are supported by regulatory and evidence summaries: prevention of bacterial infections in hypogammaglobulinemia associated with CLL or multiple myeloma when IgG thresholds and infection history are met; treatment or prevention roles after B‑cell targeted therapies depending on IgG level and infection history; and covered measles (rubeola) post-exposure prophylaxis when specified timing (exposure < 6 days), weight/route (> 30 kg for IVIG, IMIG for ≤30 kg), qualifying nonimmune or severely immunocompromised groups, and a one-time dose ≤ 400 mg/kg are documented.

Expert guidance and randomized data inform other neurologic and rheumatologic determinations: IVIG is beneficial for Guillain-Barré syndrome, multifocal motor neuropathy, myasthenia gravis (including use for exacerbations and as short-term therapy prior to surgery or when rapid response is needed), and is an accepted option for refractory cases; IVIG demonstrated benefit in some vasculitides in a randomized trial (transient response in ANCA-associated vasculitis) though longer-term effects may be limited.

General requirements applicable to all requests require documentation of diagnosis, history and physical exam, supporting laboratory/diagnostic evidence, and prescriber attestation that dosing follows FDA labeling or published evidence; initial and continuation authorizations are each limited to no more than 12 months and continuation requires documentation of clinical response.

Measles (Rubeola) Post‑Exposure Prophylaxis — Medical Necessity (New Coverage)

Measles (rubeola) post-exposure prophylaxis - Medical necessity

ALL of the following

Patient has a documented exposure to measles (rubeola) < 6 days prior to request
Document exposure date/time in medical records
Patient is either nonimmune or severely immunocompromised
- No evidence of immunity to measles (e.g., no prior vaccination, no lab-confirmed immunity)
- Severely immunocompromised patient as defined below
Qualifying nonimmune or severely immunocompromised groups

Coding

HCPCS / CPT procedure codesmixed

90283	Immune globulin (IgIV), human, for intravenous use.
90284	Immune globulin (SCIg), human, for use in subcutaneous infusions, 100 mg, each

J-codes (drugs)HCPCS

J1459	Injection, immune globulin (Privigen), intravenous, nonlyophilized (e.g., liquid), 500 mg.
J1551	Injection, immune globulin (Cutaquig), 100 mg.
J1552	Injection, immune globulin (Alyglo), 500 mg
J1554	Injection, immune globulin (Asceniv), 500 mg.
J1555	Injection, immune globulin (Cuvitru), 100 mg.
J1556	Injection, immune globulin (Bivigam), 500 mg.
J1557	Injection, immune globulin, (Gammaplex), intravenous, non-lyophilized, 500 mg.
J1558	Injection, immune globulin (Xembify), 100 mg.
J1559	Injection, immune globulin (Hizentra), 100 mg.
J1561	Injection, immune globulin, (Gamunex-C/Gammaked), intravenous, nonlyophilized, 500 mg.

1–10 of 17

1/2

ICD-10 diagnosis codes (selected from list)ICD-10

A48.3	Toxic shock syndrome
A49.9	Bacterial infection, unspecified
B05.0	Measles complicated by encephalitis
B20	Human immunodeficiency virus [HIV] disease
B25.0	Cytomegaloviral pneumonitis
C90.00	Multiple myeloma not having achieved remission
C91.10	Chronic lymphocytic leukemia of B-cell type not having achieved remission
D59.11	Warm autoimmune hemolytic anemia
D69.3	Immune thrombocytopenic purpura
D69.51	Posttransfusion purpura

1–10 of 22

1/3

Referenced Diagnosis Codes (transplant status list excerpt)ICD-10

Z94.0	Kidney transplant status
Z94.1	Heart transplant status
Z94.2	Lung transplant status
Z94.3	Heart and lungs transplant status
Z94.4	Liver transplant status
Z94.81	Bone marrow transplant status
Z94.82	Intestine transplant status
Z94.83	Pancreas transplant status
Z94.84	Stem cells transplant status

Added ICD-10 diagnosis codes for measles and pregnancy-related measles exposureICD-10Covered

B05.0	Measles complicated by encephalitis
B05.1	Measles complicated by meningitis
B05.2	Measles complicated by pneumonia
B05.3	Measles complicated by otitis media
B05.4	Measles with intestinal complications
O98.511	Other viral disease complicating pregnancy, first trimester
O98.512	Other viral disease complicating pregnancy, second trimester
O98.513	Other viral disease complicating pregnancy, third trimester
O98.519	Other viral disease complicating pregnancy, unspecified trimester

Provider Actions & Requirements

Billing Rule

Use IMIG for patients ≤ 30 kg

For patients ≤30 kg, intramuscular immune globulin (IMIG) should be used for measles PEP; ensure billing reflects the IM route and appropriate product.

Use IMIG (intramuscular immune globulin) for patients ≤30 kg for measles post‑exposure prophylaxis
Bill for IMIG product and route accordingly

Definitions

Policy definitions

IVIGIntravenous immune globulin - sterile pooled human IgG product administered intravenously.

SCIGSubcutaneous immune globulin - immune globulin formulations for subcutaneous administration.

IMIGIntramuscular immune globulin; recommended for patients weighing ≤ 30 kg for measles PEP.

Initial authorizationAuthorization for initial therapy up to 12 months when general and diagnosis-specific criteria are met.

Continuation authorizationAuthorization for ongoing therapy up to 12 months contingent on documentation of positive clinical response.

CIDPChronic inflammatory demyelinating polyradiculoneuropathy, an immune-mediated neuropathy with defined clinical and electrodiagnostic criteria.

Revision History

08/01/2025added/Coverage RationaleLatest

ADDED (material): Added language that immune globulin is proven for measles (rubeola) post-exposure prophylaxis with specified medical necessity criteria: exposure <6 days, patient weight >30 kg (use IMIG for ≤30 kg), qualifying high-risk nonimmune or severely immunocompromised groups, and initial one-time dose not to exceed 400 mg/kg.

08/01/2025added/Applicable CodesLatest

ADDED (material): Added ICD-10 diagnosis codes to support measles-related indications: B05.0, B05.1, B05.2, B05.3, B05.4, O98.511, O98.512, O98.513, and O98.519.

Medicare Determinations

Number	Name	Type	Effective date
250.3	Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases	NCD
260.7	Lymphocyte Immune Globulin, Anti-Thymocyte Globulin (Equine)	NCD

Policy Summary

PayerUnitedHealthcare

PolicyImmune Globulin (IVIG and SCIG)

Policy CodePolicy 2025D0035AQ

Change TypeAdded measles PEP criteria; ICD-10 codes added; references updated

Effective DateAug 1, 2025

Next Review Date

Key ActionInclude diagnosis, history/physical and lab/diagnostic evidence and obtain prior authorization documenting that general and diagnosis-specific medical necessity criteria are met.

On This Page

Prescriber attests dosing is in accordance with the United States Food and Drug Administration (FDA) approved labeling;

For indications without FDA approved dosing, prescriber attests there is published clinical evidence to support the dosing.

Continuation Therapy

Documentation of positive clinical response to immune globulin therapy;
One of the following:
- Prescriber attests dosing is in accordance with the United States Food and Drug Administration (FDA) approved labeling;
- For indications without FDA approved dosing, prescriber attests there is published clinical evidence to support the dosing.

Diagnosis of AIT AND one or more of: previously affected pregnancy; family history of disease; platelet alloantibodies found on screening

For Newborns: Diagnosis of AIT AND thrombocytopenia that persists after transfusion of antigen‑negative compatible platelets

Immune thrombocytopenia (ITP)

Acute ITP: Diagnosis of acute thrombocytopenic purpura (ITP) AND documented platelet count < 50 x 10^9 / L (obtained within the past 30 days)Documented platelet count < 50 x 10^9 / L
Chronic ITP: Diagnosis of chronic thrombocytopenic purpura (ITP) AND history of failure, contraindication, or intolerance to at least one of corticosteroids or splenectomy

Posttransfusion purpura: Diagnosis of posttransfusion purpura AND IVIG dose does not exceed 2 daysIVIG dose ≤ 2 days

Thrombocytopenia secondary to HCV, HIV, or pregnancy: Documented platelet count < 50 x 10^9 / L (obtained within the past 30 days) AND one of: thrombocytopenia secondary to HCV with concurrent antiviral therapy unless contraindicated; thrombocytopenia secondary to HIV with concurrent antiviral therapy unless contraindicated; OR thrombocytopenia secondary to pregnancyDocumented platelet count < 50 x 10^9 / L

Warm autoimmune hemolytic anemia: Diagnosis of warm autoimmune hemolytic anemia; other types ruled out; history of failure, contraindication, or intolerance to glucocorticoids; history of failure/contraindication/intolerance to rituximab OR an immunosuppressive agent (e.g., azathioprine, cyclophosphamide, cyclosporin A, danazol, MMF, sirolimus, fostamatinib); patient still transfusion‑dependent at minimum two weeks after initiation of rituximab or a second‑line immunosuppressive agent; IVIG used as adjunct to other therapies

Patient exposed to measles less than 6 days previously; patient weight > 30 kg (for patients ≤ 30 kg, administer intramuscular immune globulin); patient is a non‑immune or severely immunocompromised individual not already receiving immune globulin AND meets one of listed risk groups; request is for an initial, one-time dose not to exceed 400 mg/kg

Exposure < 6 days; weight > 30 kg; dose ≤ 400 mg/kg

One-time initial dose only

Multiple myeloma - prevention of infection: Diagnosis of multiple myeloma AND one of: documented hypogammaglobulinemia (IgG < 500 mg/dL) OR history of bacterial infection(s) associated with multiple myelomaIgG < 500 mg/dL

Post B-cell targeted therapies: Documentation confirming previous B-cell targeted therapy within the last 100 days (e.g., CAR-T, rituximab, inotuzumab ozogamicin) AND documented hypogammaglobulinemia (IgG < 500 mg/dL) AND history of bacterial infection(s) associated with B-cell depletionIgG < 500 mg/dL; prior B-cell therapy within 100 days

Parvovirus B19 infection, treatment, immunocompromised host: Diagnosis of parvovirus B19 infection in an immunocompromised host (solid organ transplant recipient or HIV‑related)

Encephalitis, immune checkpoint inhibitor-induced, severe or progressive:

Diagnosis of immune checkpoint inhibitor-induced encephalitis, severe or progressive; history of failure, contraindication, or intolerance to glucocorticoids; use of the immune checkpoint inhibitor has been interrupted; prescribed by or in consultation with a neurologist

Specialist involvement required

Multifocal motor neuropathy (MMN): Initial therapy: diagnosis of MMN confirmed by weakness with slowly progressive or stepwise progressive course ≥ 1 month; asymmetric involvement of ≥2 nerves; absence of motor neuron signs and bulbar signs

Multiple sclerosis, relapsing forms: Diagnosis of relapsing forms of MS AND documentation of an MS exacerbation or progression from prior visit AND history of failure, contraindication, or intolerance to at least two listed disease‑modifying therapies AND prescribed by or in consultation with a neurologist

Specialist involvement required

Myasthenia Gravis - exacerbation or refractory

Myasthenia Gravis exacerbation: Diagnosis of generalized MG; evidence of myasthenic exacerbation (difficulty swallowing, acute respiratory failure, major functional disability causing discontinuation of activity, or recent checkpoint inhibitor immunotherapy) AND history of failure/contraindication/intolerance to immunomodulator therapy for long‑term management OR currently receiving such therapy; AND prescribed by or in consultation with a neurologist
Myasthenia Gravis, refractory: Diagnosis of refractory generalized MG by or in consultation with MG expert; disease unchanged or worsening despite failure/contraindication/intolerance to corticosteroids AND two immunomodulator therapies used in adequate doses/duration; currently receiving immunomodulator therapy for long‑term management; prescribed by or in consultation with a neurologist

Neuromyelitis optica (NMOSD): Initial therapy: diagnosis of NMOSD by a neurologist with serologic testing for AQP4‑IgG/NMO‑IgG performed and history consistent with NMOSD (if AQP4 positive one listed syndrome; if negative two listed syndromes); multiple sclerosis or other diagnoses ruled out; history of failure/contraindication/intolerance to at least three listed agents (e.g., azathioprine, corticosteroids, mycophenolate mofetil, complement inhibitors, anti‑IL6, anti‑CD19, anti‑CD20); patient not receiving immune globulin in combination with listed DMTs/complement inhibitors/anti‑IL6/anti‑CD19/anti‑CD20 therapies; prescribed by or in consultation with a neurologist

Specialist involvement required

Rasmussen syndrome: Documentation that short term amelioration of encephalitis is needed prior to definitive surgical therapy; OR symptoms persist despite surgical treatment; OR patient is not a candidate for surgical treatment

Stiff-person syndrome: Diagnosis of stiff‑person syndrome; history of failure, contraindication, or intolerance to GABAergic medication (e.g., baclofen, benzodiazepines); prescribed by or in consultation with a neurologist

Dermatomyositis RCTIVIG significantly improved dermatologic symptoms vs placebo

CIDP guideline recommendation (EFNS/PNS)IVIG should be considered for induction in sensory and motor CIDP with disabling symptoms (level A)

ANCA-associated vasculitis RCTSingle course 400 mg/kg/day for 5 days: therapeutic response 14/17 IVIG vs 6/17 placebo (OR=8.56, p=0.015) at 3 months

PANS/PANDAS RCTNo statistically significant difference in CY-BOCS or CGI-I between IVIG and placebo in double-blind phase

Kawasaki disease guideline (AHA) / standard of careIVIG is standard initial therapy to reduce coronary artery aneurysms and fever duration

Measles PEP (CDC/ACIP referenced)Policy adds measles PEP indication with criteria consistent with CDC/ACIP guidance (exposure interval, risk groups, dosing limit)

IVIG for prevention of infection in hypogammaglobulinemiaEvidence supports IVIG to prevent bacterial infections in CLL, multiple myeloma, and HIV-infected children when IgG thresholds and infection history met

Pregnant women without evidence of measles immunity (do not administer MMR vaccine)

Hematopoietic stem cell transplant (HSCT) recipients within 2 years post-transplant or any time if ongoing graft-versus-host disease

Recipients of chimeric antigen receptor T-cell (CAR-T) therapy

Patients receiving chemotherapy for acute lymphoblastic leukemia (ALL) within the past 3 months

Persons with severe HIV-related immunosuppression (e.g., CD4 count <200 cells/mm3 or per treating infectious disease specialist assessment)

Primary immunodeficiency with significant impairment of humoral immunity (as documented by immunology specialist)

Product and dosing thresholds

For patients > 30 kg: Intravenous immune globulin (IVIG) is indicated
Dose must be a one-time administration and not to exceed 400 mg/kg total
For patients ≤ 30 kg: Intramuscular immune globulin (IMIG) is indicated
Use pediatric-appropriate IMIG dosing per product labeling; one-time dose

Request is for initial post-exposure prophylaxis only (initial authorization).

Initial authorization will be for no more than 12 months where applicable; continuation requires documentation of clinical response and separate prior authorization

Prior Authorization

Prior authorization required for measles PEP

Obtain prior authorization before administering IVIG/IMIG for measles PEP. Document exposure date/time, patient weight, measles immunity status, and qualifying immunocompromised condition.

Prior authorization required for initial IVIG/IMIG for measles PEP; prior authorization likely required for ongoing IVIG/SCIG requests.
Required documentation: diagnosis, exposure date/time, clinical history and physical, laboratory/diagnostic evidence supporting non‑immunity or immunocompromised status, and prescriber attestation of dosing rationale.
Dosing attestation: prescriber must attest dose is per FDA labeling or supported by published clinical evidence; one-time IVIG dose must not exceed 400 mg/kg.
Continuation therapy: prior authorization required; must submit evidence of clinical response to initial IVIG for consideration of ongoing therapy.
Specialist involvement: immunology or infectious disease specialist consultation recommended and required for documentation in primary immunodeficiency or complex neurologic indications where applicable.
IVIG dosing limits: adhere to indication-specific duration limits (e.g., single-dose PEP only; other indications per respective criteria).
Document diagnosis and supporting evidence for IVIG use in the medical record; include lab results (e.g., IgG, CD4), treatment dates (HSCT, CAR-T, chemotherapy), and specialist notes.
For measles PEP specifically, document weight to determine IVIG (>30 kg) versus IMIG (≤30 kg) and ensure administration within 6 days of exposure.

09/01/2025revised/References formatting

REVISED (non-material): Corrected formatting error in References section.

revised/Clinical Evidence and References

REVISED (non-material): Updated Clinical Evidence and References sections to reflect the most current information.