CurrentUnitedHealthcarePolicy CS2026D0035XX

Immune Globulin (IVIG and SCIG)

UnitedHealthcare Medical Benefit Drug Policy governing coverage, preferred product criteria, diagnosis-specific medical necessity criteria, documentation and authorization periods for IV and subcutaneous immune globulin products; excludes states with state-specific policies.

Policy Summary

PayerUnitedHealthcare

PolicyImmune Globulin (IVIG and SCIG)

Policy CodePolicy CS2026D0035XX

Change TypeAdded non-preferred product (Yimmugo); Preferred Product Criteria revised

Effective DateJan 1, 2026

Next Review Date

Key ActionProvider must submit diagnosis, history/physical, laboratory evidence, and drug trial/dosing/duration information (and physician attestation for non-preferred products) to support authorization.

POLICY UPDATE CHANGES

Revised list of applicable IV and SC immune globulin products; added Yimmugo (IV).

Added language that treatment with Yimmugo is medically necessary for specified indications when criteria are met.

Updated References section to reflect the most current information.

MultipleProven Indications Listed

1New product added

ManyApplicable J-codes Listed

6Neuroimmunologic disorders supported

8Unsupported/insufficient evidence conditions

1CDC measles PEP groups included

Coverage Summary

This policy governs coverage of FDA-approved intravenous (IVIG) and subcutaneous (SCIG) immune globulin products. Where applicable, Preferred Product Criteria and state-specific preferred product pathways apply; in states not listed for preferred pathways, coverage is determined by the Diagnosis-Specific Criteria and product labeling. The policy lists multiple proven clinical indications across dermatology, hematology, infectious disease, neurology, primary immunodeficiency, rheumatology, and transplantation. Yimmugo (IV) has been added to the product list as a non-preferred IVIG; coverage of Yimmugo is contingent on meeting the policy's Preferred Product Criteria and the relevant Diagnosis-Specific Criteria, with defined pathways requiring either prior trials of other IVIGs or documented contraindication/intolerance to alternatives. The policy distinguishes indications that are proven and covered from many other indications that are considered unproven or not medically necessary.

Key Numeric Thresholds / Limits

Initial authorization durationno more than 12 months

Continuation authorization durationno more than 12 months

IgG threshold (CLL / Multiple myeloma / Post B-cell therapy)< 500 mg/dL

IgG threshold (Severe hypogammaglobulinemia post-allogeneic BMT)< 400 mg/dL

Platelet count threshold (ITP / secondary thrombocytopenia)< 50 x 10^9 / L

Measles PEP maximum IG doseNot to exceed 400 mg/kg (one-time dose)

CDC definition of severe immunosuppression (for measles PEP)CD4% < 15% (all ages) or CD4 < 200 cells/mm3 (age >5 years); HSCT recipients until ≥12 months after finishing immunosuppressive treatment (longer if chronic GVHD)

Initial Therapy Criteria

General Requirements (Applicable to All Medical Necessity Requests)

For initial therapy, all of the following:

ALL of the following

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

Continuation Therapy Criteria

General Requirements - Continuation of Therapy

For continuation of therapy, all of the following:

ALL of the following

Response documentation: Documentation of positive clinical response to immune globulin therapy
Dosing attestation: One of the following dosing attestations must be provided: Prescriber attests dosing is in accordance with FDA approved labeling; or for indications without FDA approved dosing, prescriber attests there is published clinical evidence to support the dosing

CIDP - Continuation of Therapy (and other continuation notes)

For continuation, all of the following:

Preferred Product Criteria (Non-preferred product pathways)

Unproven / Not Medically Necessary Indications

The policy identifies a set of conditions for which IVIG is considered not recommended or unproven / not medically necessary based on guideline reviews and randomized trials. Examples include adrenoleukodystrophy (ALD), amyotrophic lateral sclerosis (ALS), inclusion body myositis (IBM), POEMS syndrome, autism spectrum disorders, chronic fatigue syndrome, antiphospholipid syndrome (APS) in pregnancy, routine prophylactic IVIG after autologous BMT, isolated IgA or isolated IgG4 deficiency, and dilated cardiomyopathy. The policy explains that evidence for these indications is limited to small case series, uncontrolled reports, or negative/neutral RCTs and guideline recommendations, and therefore IVIG claims for these diagnoses are at risk for denial unless compelling supporting documentation is provided or the patient is enrolled in a clinical trial.

Provider Actions & Authorization Requirements

Prior Authorization

Authorization required

Authorization is required for initial and continuation therapy. Initial authorization will be for no more than 12 months. Continuation authorizations will be for no more than 12 months. Providers must obtain prior authorization before initiating therapy.

Documentation Required

Submit clinical documentation

Submit clinical documentation to support the requested therapy. Required items include: documentation of the diagnosis, history and physical examination detailing disease severity (including frequency/severity of infections when applicable), relevant laboratory or diagnostic test results, and details of prior drug trials (drug name, dose, and duration).

Diagnosis and H&P documenting severity
Labs or diagnostic evidence supporting indication

Applicable Codes

Procedure HCPCSmixed

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, 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.

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1/2

Applicable ICD-10 Diagnosis Codes (selected examples)ICD-10

A48.3	Toxic shock syndrome.
B20	Human immunodeficiency virus [HIV] disease.
C91.10	Chronic lymphocytic leukemia of B-cell type not having achieved remission.
D69.3	Immune thrombocytopenic purpura.
D80.0	Hereditary hypogammaglobulinemia.
G61.0	Guillain-Barré syndrome.
G35.A	Relapsing-remitting multiple sclerosis.
G70.01	Myasthenia gravis with (acute) exacerbation.
M30.3	Mucocutaneous lymph node syndrome [Kawasaki].

Applicable ICD-10 Diagnosis Codes (listed in this part)ICD-10

T45.AX5A	Adverse effect of immune checkpoint inhibitors and immunostimulant drugs, initial encounter
T45.AX5D	Adverse effect of immune checkpoint inhibitors and immunostimulant drugs, subsequent encounter
T45.AX5S	Adverse effect of immune checkpoint inhibitors and immunostimulant drugs, sequela
P61.0	Transient neonatal thrombocytopenia
T86.00	Unspecified complication of bone marrow transplant
T86.01	Bone marrow transplant rejection
T86.02	Bone marrow transplant failure
T86.03	Bone marrow transplant infection
T86.09	Other complications of bone marrow transplant
T86.10	Unspecified complication of kidney transplant

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Referenced IVIG/SCIG products (examples)mixed

Bivigam	IVIG product example (brand referenced; no billing code provided in this part)
Gammagard	IVIG product example (brand referenced)
Gamunex	IVIG product example (brand referenced)
Privigen	IVIG product example (brand referenced)
Yimmugo	Newly added IVIG (non-preferred) referenced by brand; Yimmugo (IV) added to product list

Clinical Evidence Summary

The evidence summary highlights that randomized controlled trials and guideline-supported data demonstrate benefit for several indications: IVIG has RCT or guideline support for dermatomyositis, immune thrombocytopenic purpura (ITP), Kawasaki disease, induction therapy for chronic inflammatory demyelinating polyneuropathy (CIDP), and some ANCA-associated vasculitides. CDC guidance supports use of immune globulin for measles post-exposure prophylaxis (PEP) in high-risk groups with specific route and dosing by weight. The policy also notes conditions where evidence is low-quality or conflicting (for example certain rheumatologic, dermatologic, neurologic, and transplant-related uses) and where IVIG is reserved for rare circumstances, specialist-guided care, or clinical trials.

14/17ANCA-associated vasculitis response (IVIG) vs placebo at 3 months: 14/17 vs 6/17

6Neuroimmunologic disorders supported/accepted (examples listed)

Multiple (many)Proven indications listed (dermatology, hematology, infectious disease, neurology, primary immunodeficiency, rheumatology, transplantation)

Background & Definitions

At the policy level, IVIG/SCIG are described as pooled human IgG preparations used for replacement or immunomodulation; coverage applies to FDA-approved IV and SC products with preferred product pathways specified for certain states and explicit Preferred Product Criteria for non-preferred agents. The product list was revised to add Yimmugo (IV) as a non-preferred IVIG; coverage for Yimmugo requires meeting the Preferred Product Criteria (either documented trials of at least two other IVIGs with inadequate response or documented contraindication/intolerance to alternatives plus physician attestation) in addition to the Diagnosis-Specific Criteria. The policy enumerates proven clinical areas for IG use, including dermatology (autoimmune bullous disease, dermatomyositis), hematology (ITP, feto‑neonatal AIT), infectious disease (CMV pneumonitis, measles PEP, infection prevention in hypogammaglobulinemia/CLL), neurology (CIDP, GBS, MG, MMN, LEMS, NMO), primary immunodeficiency (FDA‑approved replacement), rheumatology (dermatomyositis, Kawasaki disease), and transplantation (desensitization and adjunctive therapy for antibody-mediated rejection). General documentation, attestation, and authorization period requirements (initial and continuation authorizations up to 12 months) apply.

Term	Definition
IVIG / SCIG
Intravenous or subcutaneous preparations of pooled human immunoglobulin G used for replacement or immunomodulation.
AMR
Antibody-mediated rejection in solid organ transplantation.
Non-preferred product
A product designated by the payer as non-preferred; coverage requires meeting Preferred Product Criteria and Diagnosis-Specific Criteria as specified in the policy.

Revision History

2026-01-01effective_dateLatest

Policy effective date set to 2026-01-01. (is_material: true)

2026-01-01coverage_changeLatest

Revised list of applicable IV and SC immune globulin products; added Yimmugo (IV) as a non-preferred IVIG product and specified coverage is contingent on Preferred Product Criteria and Diagnosis-Specific Criteria. (is_material: true)

2026-01-01coverage_criteria_specification

Policy Summary

PayerUnitedHealthcare

PolicyImmune Globulin (IVIG and SCIG)

Policy CodePolicy CS2026D0035XX

Change TypeAdded non-preferred product (Yimmugo); Preferred Product Criteria revised

Effective DateJan 1, 2026

Next Review Date

On This Page

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

Initial authorization will be for no more than 12 months<= 12 months

Initial Indication-Specific Criteria (selected proven indications and general evidence-based statements)

ALL of the following

Diagnosis of neuromyelitis optica spectrum disorder (NMOSD) with aquaporin-4 (AQP4) antibody positive status or clinical features consistent with NMOSD;
Presentation consistent with an acute relapse or clinical scenario for which initial immune globulin is being requested;
History and physical examination and supporting diagnostic testing (e.g., MRI, serologic testing for AQP4-IgG) documenting disease activity;
AND one of the following treatment conditions:
- Patient has contraindication, intolerance, or inadequate response to standard first-line NMOSD therapies and clinician documents rationale for IVIG use;
- IVIG is being requested as initial therapy for acute severe relapse when clinician documents that rapid immunomodulation with IVIG is clinically appropriate and alternative indicated therapies (e.g., high-dose corticosteroids, plasmapheresis) are contraindicated or unavailable
Prescriber attests dosing is in accordance with FDA labeling or, for indications without FDA dosing, attests there is published clinical evidence to support the dosing.

ALL of the following

Diagnosis of one of the proven/general indications for immune globulin (see policy list of proven indications including but not limited to primary immunodeficiency syndromes, chronic inflammatory demyelinating polyneuropathy, Guillain-Barré syndrome, myasthenia gravis exacerbation/refractory disease, pediatric HIV prevention of bacterial infection, Kawasaki disease, dermatomyositis/polymyositis, autoimmune bullous diseases, ITP, warm autoimmune hemolytic anemia, CLL-related hypogammaglobulinemia, etc.);
Clinical documentation supporting the specific indication (history, exam, relevant labs/imaging) consistent with the disease-specific criteria in this policy;
Where the disease-specific criteria specify thresholds or prior therapies (e.g., platelet counts for ITP, prior failure/intolerance of corticosteroids/immunosuppressants for autoimmune bullous disease or warm AIHA, documentation of infection history or IgG levels for CLL or primary immunodeficiency), such documentation is provided;
Prescriber attests dosing is in accordance with FDA labeling or, for indications without FDA dosing, attests there is published clinical evidence to support the dosing;

CIDP - Continuation of Therapy:

Documentation of positive clinical response to therapy as measured by an objective scale (e.g., Rankin, Modified Rankin, MRC scale)

Applies to continuation therapy

Prior drug trial details: drug, dose, duration

Documentation Required

Attestation of dosing

Prescriber must attest that dosing is consistent with FDA-approved labeling. For indications without FDA-approved dosing, the prescriber must attest that published clinical evidence supports the requested dosing.

Attestation that dosing follows FDA labeling or published clinical evidence

Documentation Required

Preferred product trial requirements (including Yimmugo)

For non-preferred products (including Yimmugo), document prior trials of preferred IVIG/SCIG products or document contraindications/intolerances to those products. Provider must submit the drug name, dose, and duration for each prior trial and a physician attestation that the preferred products were ineffective or not tolerated, or that the requested product is expected to be superior.

Document prior trials of preferred products (drug, dose, duration) or contraindications/intolerances
Physician attestation that preferred products were ineffective/intolerable or that non-preferred product is expected to be superior
Yimmugo-specific: submit prior trial details and physician attestation

Documentation Required

Specialist involvement

Certain diagnoses (for example, some neurologic or NMOSD-related indications) require involvement of a specialist. Ensure the treating prescriber is a neurologist or that the neurologist has been consulted and documentation of specialist involvement is included in the request.

Neurologist prescribing or consult required for specified neurologic/NMOSD diagnoses
Include specialist notes or consult documentation

Billing Rule

IVIG dose duration limit for posttransfusion purpura

For posttransfusion purpura, IVIG dosing should not exceed two days.

IVIG dose duration limit: ≤ 2 days for posttransfusion purpura

Documentation Required

Measles post-exposure timing and dosing / Measles PEP selection by weight and immunocompromise

For measles post-exposure prophylaxis (PEP), treatment should be given within 6 days of exposure. Maximum IVIG dose is 400 mg/kg. For patients ≤ 30 kg, IM administration is preferred when appropriate; for larger patients or certain high-risk/immunocompromised groups, IV administration and dosing adjustments per guidance are required. Document weight, immunocompromise status, selected product, dose, route, and timing relative to exposure.

Time window: administer measles PEP ≤ 6 days after exposure
Maximum dose: ≤ 400 mg/kg
Route and selection: IM preferred for patients ≤ 30 kg when appropriate; IV dosing per guidance for larger patients or immunocompromised/high-risk groups
Document weight, immunocompromise status, product, dose, route, and timing

Denial Risk

Use in unsupported indications may be denied

Use of immune globulin for unsupported or not medically necessary indications may be denied. Examples of conditions without sufficient evidence include (but are not limited to) certain off-label cosmetic, non-immune neurologic syndromes without guideline support, and disorders explicitly listed elsewhere in the policy as not proven. Providers should ensure the indication is a documented guideline-supported indication.

Unsupported indications may be denied (examples: cosmetic uses, non-guideline neurologic syndromes without evidence)
Ensure submitted indication is guideline-supported and corresponds to the policy's proven indications

Prior Authorization

Coverage contingent on Preferred Product and Diagnosis-Specific Criteria; prior trial and attestation submission

Coverage for non-preferred IVIG/SCIG products is contingent on meeting Preferred Product Criteria and Diagnosis-Specific Criteria. When required, submit prior trial details and a physician attestation via the prior authorization (Yimmugo or other non-preferred product submissions) confirming prior therapy failures or contraindications and that the requested product is expected to provide benefit.

Coverage contingent on meeting Preferred Product and Diagnosis-Specific Criteria
Submit prior trial details and physician attestation with prior authorization request

Specified two alternative sets of criteria for coverage of non-preferred IVIG products including Yimmugo: (1) history of trial of adequate dose/duration of at least two other IVIG products with minimal clinical response plus physician attestation that Yimmugo would be expected to be superior; or (2) history of contraindication/intolerance/severe adverse event to all other IVIG products plus physician attestation that the same adverse event would not be expected with Yimmugo. (is_material: true)

2026-01-01regional_policy_updateLatest

Removed language indicating the IVIG and SCIG Preferred Product Criteria applied to Minnesota (MN) and Mississippi (MS). (is_material: true)

references_updateLatest

Updated References section to reflect the most current information. (is_material: false)

This criteria group consolidates the policy's General Indications and Evidence-based Statements: clinicians must supply indication-specific supporting documentation and meet the listed disease-specific thresholds and prior-therapy requirements as detailed in the Diagnosis-Specific Criteria section.