ModifiedUnitedHealthcarePolicy IEXD0035.17

Immune Globulin (IVIG and SCIG)

Defines coverage, preferred products, and medical necessity criteria for intravenous and subcutaneous immune globulin for Individual Exchange plans (excludes MA, NV, NY). Applies to prescribing providers and utilization reviewers.

Policy Summary

PayerUnitedHealthcare

PolicyImmune Globulin (IVIG and SCIG)

Policy CodePolicy IEXD0035.17

Change TypeMaterial revision — measles PEP criteriapreferred/non-preferred product updates

Effective DateJanuary 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document trials of all preferred immune globulin products or provide clinician attestation of intolerance/contraindication when requesting a non-preferred product.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria for measles (rubeola) post-exposure prophylaxis was revised to expand HSCT-related eligibility to include patients currently receiving immunosuppressive treatment or those who finished treatment within the past 12 months.

Qivigy (immune globulin intravenous, human-kthm) was added to the Review at Launch program; some members may not be eligible for coverage at this time.

Clarified that coverage for a list of named preferred immune globulin products is contingent on meeting the General Requirements and Diagnosis-Specific Requirements sections.

Non-preferred immune globulin products (and any IG not listed by name) will be considered non-preferred until review; members already on non-preferred products will be required to change to a preferred product for continued coverage unless they meet Preferred Product exceptions.

Removed reference link to the Medical Benefit Drug Policy titled Review at Launch for New to Market Medications for Yimmugo (immune globulin intravenous, human - dira).

~20+diagnoses with criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

measles PEP dose limit

IgG <500 mg/dLIgG threshold

~14preferred products listed

Coverage Criteria and Indications

Rheumatology - Kawasaki disease

Additional information to support medical necessity review where applicable:

ALL of the following

Diagnosis of Kawasaki disease; and
IVIG treatment does not exceed five consecutive days
IVIG is intended to reduce the rate of coronary artery aneurysms and the duration of fever and other symptoms in Kawasaki disease, consistent with established guidelines; and
Prescribed by or in consultation with a pediatrician or cardiologist experienced in the management of Kawasaki disease (recommended).

Billing and Diagnosis Codes

Applicable procedure codes (IVIG/SCIG)mixed

90283	Immune globulin (IgIV), human, for intravenous use.
90284	Immune globulin (SCIg), human, for use in subcutaneous infusions, 100 mg, each.
J1459	Injection, immune globulin (Privigen), intravenous, non-lyophilized (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 (e.g., liquid), 500 mg.
J1558	Injection, immune globulin (Xembify), 100 mg.

1–10 of 19

1/2

Applicable diagnosis codes (selected examples listed)ICD-10

G36.0	Neuromyelitis optica [Devic]
G61.0	Guillain-Barre syndrome
G25.82	Stiff-man syndrome
M30.3	Mucocutaneous lymph node syndrome [Kawasaki]
D80.0	Hereditary hypogammaglobulinemia
D83.0	Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function
G35.A	Relapsing-remitting multiple sclerosis
G61.81	Chronic inflammatory demyelinating polyneuritis
G70.00	Myasthenia gravis without (acute) exacerbation
L10.0	Pemphigus vulgaris

Neurologic and peripheral neuropathy ICD-10 codesICD-10

G11.3	Cerebellar ataxia with defective DNA repair.
G25.82	Stiff-man syndrome.
G35.A	Relapsing-remitting multiple sclerosis.
G35.B0	Primary progressive multiple sclerosis, unspecified.
G35.B1	Active primary progressive multiple sclerosis.
G35.B2	Non-active primary progressive multiple sclerosis.
G35.C0	Secondary progressive multiple sclerosis, unspecified.
G35.C1	Active secondary progressive multiple sclerosis.
G35.C2	Non-active secondary progressive multiple sclerosis.
G35.D	Multiple sclerosis, unspecified.

1–10 of 21

1/3

Dermatology, myositis, and neuromuscular ICD-10 codesICD-10

G65.0	Sequelae of Guillain-Barre syndrome.
G70.00	Myasthenia gravis without (acute) exacerbation.
G70.01	Myasthenia gravis with (acute) exacerbation.
G70.80	Lambert-Eaton syndrome, unspecified.
G70.81	Lambert-Eaton syndrome in disease classified elsewhere.
G73.1	Lambert-Eaton syndrome in neoplastic disease.
L10.0	Pemphigus vulgaris.
L10.2	Pemphigus foliaceous.
L12.0	Bullous pemphigoid.
L12.1	Cicatricial pemphigoid.

1–10 of 18

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Pregnancy, transplant, and additional ICD-10 codesICD-10

M33.01	Juvenile dermatomyositis with respiratory involvement.
M33.02	Juvenile dermatomyositis with myopathy.
M33.03	Juvenile dermatomyositis without myopathy.
M33.09	Juvenile dermatomyositis with other organ involvement.
M33.10	Other dermatomyositis, organ involvement unspecified.
O26.40	Herpes gestationis, unspecified trimester.
O26.41	Herpes gestationis, first trimester.
O98.511	Other viral disease complicating pregnancy, first trimester.
O98.712	Human immunodeficiency virus [HIV] disease complicating pregnancy, second trimester.
Z92.22	Personal history of monoclonal drug therapy.

1–10 of 14

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Codes referencedmixed

NDC/CPT/HCPCS not specified in excerpt

No specific billing codes provided in this document excerpt

No codes listed in this sectionmixed

No codes listed

No explicit codes in this sectionmixed

No codes listed

No specific codes in this sectionmixed

No codes listed

IgG level

IgG threshold (CLL, multiple myeloma, post B-cell therapy)IgG < 500 mg/dL

IgG threshold (pediatric HIV prevention)IgG < 400 mg/dL

Use contextApplied for prevention of infection in CLL, multiple myeloma, and after B-cell targeted therapies when documented hypogammaglobulinemia present

Platelet count for ITP/AILT/newborns

Platelet count threshold (ITP / AIT / newborns)Platelet count < 50 x 10^9 /L (documented within past 30 days)

Timing requirementPlatelet value must be obtained within the past 30 days

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior authorization and benefit verification

Prior authorization is required for immune globulin products per the medical benefit drug policy. Verify member-specific certificate of coverage and any applicable state mandates prior to authorization — benefit coverage may be limited by the member’s plan or superseded by state law.

Prior authorization expected per the medical benefit drug policy.
Check member certificate of coverage and state mandates before approving.
Some Certificates of Coverage allow coverage for experimental/off-label uses when conditions are met.

Documentation Required

Provider submission expectations for initial therapy

Requests for initial therapy must include: diagnosis, medical records (history and physical), documentation of severity (e.g., infection frequency, objective scales where applicable), and prescriber attestation that dosing follows FDA labeling or published evidence for non‑FDA dosing. Initial authorizations are limited to up to 12 months.

Definitions and Preferred Product List

Preferred immune globulin products

Preferred immune globulin products (named)Bivigam; Cutaquig; Cuvitru; Flebogamma DIF; Gammagard Liquid; Gammagard S/D; Gammaked; Gammaplex; Gamunex-C; Hizentra; HyQvia; Octagam; Privigen; Xembify

Coverage conditionCoverage for these preferred products is contingent on meeting General Requirements and Diagnosis-Specific Requirements

New-to-market reviewSome products (e.g., Qivigy) may be subject to the Review at Launch program affecting eligibility

Non-preferred product

Non-preferred product definitionAny FDA‑approved immune globulin product not listed by name in this policy will be considered non-preferred until reviewed

Coverage for non-preferred productsCoverage contingent on meeting Preferred Product exception criteria (trial of all preferred products with minimal response OR intolerance/contraindication to all preferred products plus physician attestation)

Background and Evidence Summary

Immune globulin (intravenous or subcutaneous) is a sterile, purified human immunoglobulin preparation (primarily IgG) derived from pooled plasma that provides passive antibodies and immunomodulatory effects. IVIG/SCIG is used across a broad range of immune, hematologic, neurologic, dermatologic, and infectious indications — most prominently as replacement therapy for primary immunodeficiency, for selected hematology indications (e.g., ITP), for certain neurologic immune‑mediated disorders (e.g., CIDP, GBS, MMN), for Kawasaki disease to reduce coronary artery complications, and in transplant protocols as an adjunct for antibody‑mediated rejection or desensitization. The policy references FDA‑licensed indications and professional guidance to define when immune globulin is considered medically necessary.

Coverage under this policy varies by indication. Preferred immune globulin products listed in the policy are covered when the General Requirements and relevant Diagnosis‑Specific Requirements are met. Use of a non‑preferred product requires prior authorization and documentation that the member has either tried all preferred products with inadequate response or has documented intolerance/contraindication to all preferred products plus a clinician attestation supporting the exception.

The policy lists many conditions for which routine IVIG use is not recommended or where evidence is insufficient. Examples include ALS, asthma, chronic fatigue syndrome, inclusion body myositis, and routine prevention of neonatal infection; guideline panels and randomized trials frequently show no benefit or inadequate evidence for these indications, and requests for IVIG in these contexts risk denial without strong supporting data.

The policy distinguishes indications supported by FDA licensure or recognized primary immunodeficiency guidance from those that are unproven. IVIG/SCIG is supported for FDA‑licensed indications (including primary immunodeficiencies, prevention of infections in hypogammaglobulinemia, Kawasaki disease, certain transplant and hematology uses, CIDP, and MMN) and for a list of primary immunodeficiency diseases referenced from the Immune Deficiency Foundation. Many other indications are explicitly not supported or require additional justification based on available evidence and guideline recommendations.

Policy History and Changes

2026-01-01policy_historyLatest

Removed a reference link to the Medical Benefit Drug Policy 'Review at Launch for New to Market Medications' for Yimmugo (immune globulin intravenous, human - dira).

2026policy_revision

Coverage criteria for measles (rubeola) post-exposure prophylaxis revised to expand HSCT-related eligibility to include patients currently receiving immunosuppressive treatment or those who finished treatment within the past 12 months.

2026

Policy Summary

PayerUnitedHealthcare

PolicyImmune Globulin (IVIG and SCIG)

Policy CodePolicy IEXD0035.17

Change TypeMaterial revision — measles PEP criteriapreferred/non-preferred product updates

Effective DateJanuary 1, 2026

Next Review DateN/A

SourceLink

On This Page

Applies toAcute ITP, newborns with feto‑neonatal alloimmune thrombocytopenia and related indications where IVIG indicated

Measles post-exposure dose limit

Maximum initial one-time dose (measles PEP)Initial one-time dose not to exceed 400 mg/kg

Administration route noteFor patients > 30 kg IV or SC preferred; for ≤ 30 kg intramuscular IG indicated per policy

TimingAdminister within 6 days of exposure (CDC guidance referenced)

IgG threshold

General IgG thresholdIgG < 500 mg/dL

Context of useUsed to document hypogammaglobulinemia for infection-prevention indications (e.g., CLL, multiple myeloma, post B-cell therapy)

DocumentationLaboratory evidence of IgG level required in prior authorization review

Measles exposure max dose

Measles PEP max initial doseInitial one-time dose not to exceed 400 mg/kg

Eligible windowAdminister within 6 days of exposure

Weight-based routingIV/SC preferred for >30 kg; IM recommended for ≤30 kg

GBS symptom onset window

GBS symptom onset windowOnset of neuropathic symptoms within the last 4 weeks

Severity requirementSevere disease requiring aid to walk is required for IVIG per policy

Specialist involvementPrescribed by or in consultation with a neurologist

IgG

IgG threshold (general) IgG < 400 mg/dL

Applied settingReferenced for pediatric HIV prevention and other severe hypogammaglobulinemia contexts

Alternate criteriaOr functional antibody deficiency demonstrated by poor specific antibody titers or recurrent infections

Allogeneic BMT recency

Allogeneic BMT timing windowAllogeneic bone marrow transplant within the last 100 days

IgG requirementDocumented severe hypogammaglobulinemia (IgG < 400 mg/dL) required in transplant context

Use casesIndications include prevention of infection and select uses related to transplantation/desensitization

Kawasaki IVIG duration

Kawasaki IVIG duration limitIVIG treatment does not exceed five consecutive days

IndicationApplies to Kawasaki disease treatment courses

DocumentationDiagnosis of Kawasaki disease required for medical necessity

Serum IgG

Serum IgG thresholdIgG < 400 mg/dL, or 400–600 mg/dL with serious, persistent, unusual, or recurrent infections

Expert guidanceSome experts recommend considering IVIG when serum IgG is below these thresholds in specific clinical contexts

Applicable situationsConsideration for patients with hypogammaglobulinemia secondary to B-cell therapies, CLL, multiple myeloma, or recurrent infections

Measles PEP administration window

Measles PEP administration windowWithin 6 days of exposure

CDC guidance contextUsed for severely immunocompromised, infants <12 months, and pregnant women without immunity per CDC; route differs by weight

Route by weightIM for ≤30 kg; IV or SC for >30 kg

Submit diagnosis and medical records documenting history/physical and severity.
Prescriber attests dosing is per FDA labeling or published evidence for non‑FDA dosing.
Initial authorization will be for no more than 12 months.

Documentation Required

Indication‑specific prior authorization and documentation

Prior authorization requests must include indication‑specific documentation: diagnosis, prior therapy failures, contraindications or intolerances to recommended/required step therapies, treatment intent (replacement vs immunomodulation), objective measures of response for continuation requests, and specialist involvement where specified.

Diagnosis and indication‑specific evidence (e.g., CIDP, NMOSD, MMN criteria).
Documentation of prior therapies tried, reasons for failure, intolerance, or contraindication.
Statement of treatment intent (replacement vs immunomodulatory).
Objective response documentation for continuation (e.g., Rankin, Modified Rankin, MRC scale).
Specialist involvement: neurologist required or consult for many neurologic indications.

Step Therapy

Requests for non‑preferred immune globulin products

Requests for non‑preferred immune globulin products require documentation that all preferred products were tried and resulted in minimal clinical response, or documentation of intolerance/contraindication/adverse event to all preferred products. Physician attestation that the requested non‑preferred product is clinically expected to provide superior response or avoid prior adverse events is required. Members already on non‑preferred products may be required to switch to a preferred product for continued coverage unless they meet these criteria.

Documentation of trial of all preferred immune globulin products with minimal clinical response and residual disease activity, AND physician attestation expected superior response with requested non‑preferred product.
Or documentation of intolerance/contraindication/adverse event to all preferred products AND physician attestation that the requested product would not be expected to cause the same issue.
Members already on non‑preferred products generally required to switch to a preferred product for continued coverage unless criteria are met.

Documentation Required

Measles exposure — weight and dose documentation

For measles (rubeola) post‑exposure prophylaxis, document patient weight >30 kg to justify IV rather than intramuscular immune globulin; requests must be for a one‑time initial dose not to exceed 400 mg/kg. Requests exceeding this one‑time dose may be denied.

Patient weight > 30 kg required to use IVIG for measles exposure (≤30 kg — use IM).
Initial, one‑time dose limit: do not exceed 400 mg/kg.
Requests exceeding the one‑time 400 mg/kg dose for measles exposure may be denied.

Documentation Required

Required laboratory and diagnostic documentation

Supportive laboratory and clinical documentation is required where specified: documented hypogammaglobulinemia (IgG < 500 mg/dL) for multiple myeloma or post B‑cell targeted therapy prophylaxis; documented severe hypogammaglobulinemia (IgG < 400 mg/dL) after allogeneic BMT when within timing window; and serologic testing (e.g., AQP4‑IgG/NMO‑IgG) where required by the indication.

IgG lab result: document IgG < 500 mg/dL for multiple myeloma prevention of infection or post B‑cell targeted therapy indications.
BMT: confirmed allogeneic BMT within last 100 days and IgG < 400 mg/dL where applicable.
Serologic testing (e.g., AQP4‑IgG/NMO‑IgG) required for NMOSD initial therapy.

Prior Authorization

Specialist prescriber requirement

Specialist prescriber requirement: many neurologic and complex immune indications must be prescribed by or in consultation with an appropriate specialist (e.g., neurologist for NMOSD, CIDP, GBS, MMN, myasthenia gravis, encephalitis). Requests lacking specialist involvement or consultation where required may be denied.

Neurologist involvement required for NMOSD, CIDP, GBS, MMN, myasthenia gravis, encephalitis, and several other neurologic indications.
Prescriptions without required specialist consultation may be denied.

Documentation Required

Support for FDA‑ and PID‑based indications

Support for FDA‑approved and recognized primary immunodeficiency (PID) indications should be provided by diagnosis documentation and disease‑specific evidence (e.g., IDF disease list). FDA approval supports but does not by itself guarantee coverage — include PID diagnostic criteria, functional humoral deficiency evidence, and documentation of recurrent infections or failure to produce specific antibodies where indicated.

Provide PID diagnosis and evidence of clinically significant functional humoral immunodeficiency (e.g., failure to produce specific antibodies or history of significant recurrent infections).
Reference the IDF list of PIDs and FDA‑approved indications as supporting documentation.
FDA approval alone is informational; include clinical documentation meeting policy criteria.

Note

Benefit limitations and mandates

Benefit limitations and mandates: coverage decisions are contingent on the member‑specific benefit plan document. State mandates for off‑label use may supersede policy language. Some Certificates of Coverage may allow experimental/investigational/unproven treatments for life‑threatening illnesses under specific conditions; consult plan documents and applicable state law.

Consult member certificate of coverage before approving service.
State mandates for off‑label use supersede policy where applicable.
Some plans may allow coverage of otherwise unproven services under defined conditions.

Note

Prior authorization — none specified beyond policy criteria

No separate prior authorization actions beyond the General Requirements and Diagnosis‑Specific Requirements are specified in this section; follow the listed documentation, step‑therapy, and specialist requirements for authorization decisions.

Follow General Requirements and Diagnosis‑Specific Requirements for authorization.
No additional authorization actions specified in this section.

Denial riskRequests for non-preferred products without required documentation may be denied

Preferred product coverage conditions

Preferred products contingent on criteriaNamed IV and SC immune globulin preparations are preferred when General and Diagnosis-Specific Requirements are met

List examplesIncludes products such as Bivigam, Cutaquig, Cuvitru, Flebogamma DIF, Gammagard Liquid, Gamunex-C, Hizentra, Privigen, Xembify

Policy implicationMembers on non-preferred products generally must switch to a preferred product for continued coverage unless exception criteria met

Review at Launch program

Review at Launch programA UnitedHealthcare program that may restrict coverage eligibility for new-to-market medications (e.g., Qivigy) pending review

Policy referenceSee Medical Benefit Drug Policy titled Review at Launch for New to Market Medications for details

Effect on membersSome members may not be eligible for coverage of products under review at launch

Severe immunosuppression (HIV)

Severe immunosuppression (HIV)HIV infection with CD4+ percentage < 15% (all ages) or CD4+ count < 200 cells/mm3 (age > 5 years)

ContextDefines severe immunosuppression for measles PEP and other infectious indications

Source of definitionCDC guidance referenced in policy

Electrodiagnostic findings for CIDP

Electrodiagnostic CIDP criteria (summary)Nerve conduction abnormalities meeting EFNS/PNS guidelines (e.g., motor distal latency prolongation, reduced conduction velocity, prolonged or absent F-waves, conduction block, temporal dispersion, increased distal CMAP duration)

Clinical duration requirementProgressive symptoms present for at least 2 months

Specialist involvementPrescribed by or in consultation with a neurologist

NMOSD diagnostic support

NMOSD diagnostic supportDiagnosis requires neurologist confirmation, AQP4-IgG/NMO-IgG serology, and appropriate clinical history elements (one if seropositive, two if seronegative)

ExclusionMultiple sclerosis or other diagnoses must be ruled out

Specialist involvementPrescribed by or in consultation with a neurologist

Allogeneic BMT window

Allogeneic BMT window for IG useTransplant within the last 100 days

IgG requirementDocumented severe hypogammaglobulinemia (IgG < 400 mg/dL) required

Denial riskRequests may be denied if transplant occurred >100 days prior or if IgG ≥ 400 mg/dL

IVIG / SCIG definition

IVIG / SCIG definitionSterile, purified human immunoglobulin (primarily IgG) derived from pooled plasma

CompositionProvides immunomodulating peptides and antibodies; contains high concentrations of IgG with subclass distribution similar to normal serum

FormulationsAvailable as intravenous (IV) and subcutaneous (SC) products

Severely immunocompromised (CDC)

Severely immunocompromised (CDC)Includes severe primary immunodeficiency, recent bone marrow transplant recipients (until at least 12 months after finishing immunosuppression or longer with GVHD), recent ALL treatment until at least 6 months after chemo, and advanced HIV/AIDS (CD4% <15% or CD4 <200/mm3)

RelevanceUsed to determine eligibility for measles PEP and other infection-related IG indications

SourceCDC guidance as cited in policy

Antibody-mediated rejection (AMR)

Antibody-mediated rejection (AMR)Organ transplant rejection driven by donor-specific antibodies causing complement activation and tissue injury; IVIG used as an adjunct to glucocorticoids in treatment protocols

Role of IVIGIVIG is standard adjunct therapy in AMR despite limited RCT data, recommended by expert opinion

ApplicationUsed in desensitization protocols and treatment of AMR in solid organ transplant recipients

Primary immunodeficiency (PID)

Primary immunodeficiency (PID)Heterogeneous group of >300 recognized disorders; many are established indications for immune globulin replacement therapy

ReferenceSee Immune Deficiency Foundation and WHO lists for specific PID diagnoses

Coverage implicationIVIG/SCIG is FDA-approved and indicated as replacement therapy for many PIDs

FDA-licensed IVIG indications

FDA-licensed IVIG indications (summary)Eight clinical indications including treatment of PIDs; prevention of bacterial infections in hypogammaglobulinemia/CLL; Kawasaki disease; prevention of infections after BMT; reduction of serious bacterial infection in children with HIV; increase platelet counts in ITP; CIDP maintenance; MMN maintenance

Regulatory noteFDA approval is informational and not sole basis for coverage decisions per policy

Subcutaneous approvalsSeveral SCIG products are FDA-approved for primary immunodeficiency replacement

Qivigy (immune globulin intravenous, human-kthm) was added to the Review at Launch program; some members may not be eligible for coverage at this time.

2026policy_update

Clarified that coverage for a list of named preferred immune globulin products is contingent on meeting the General Requirements and Diagnosis-Specific Requirements sections; non-preferred products will be considered non-preferred until review and their coverage is contingent on Preferred Product criteria.

This revision cycle added and clarified rules about preferred versus non‑preferred immune globulin products and updated measles post‑exposure prophylaxis criteria. The policy now lists named preferred products whose coverage is contingent on meeting General and Diagnosis‑Specific Requirements, specifies criteria and documentation needed for approval of non‑preferred products, and revised the measles PEP eligibility timeframe for certain HSCT‑related patients.

Policy history notes indicate removal of a reference link to the Medical Benefit Drug Policy 'Review at Launch for New to Market Medications' for a specific product (Yimmugo) and elimination of prior lists that included certain products. The document removes the earlier cross‑reference link while preserving the Review at Launch program language elsewhere in the policy history.

A new product, Qivigy, was added to the Review at Launch program and may be subject to coverage restrictions for some members. The policy also clarifies the named list of preferred immune globulin products and details the Preferred Product exception process that governs coverage for non‑preferred agents.