ModifiedCareSourcePolicy N/A

Immune Globulin Intravenous (IVIG) Utilization Management

Defines prior authorization, coverage criteria, dosing guidance, and prescribing requirements for IVIG products for CareSource members; applies to clinicians requesting IVIG for FDA‑approved and selected off‑label indications.

Policy Summary

PayerCareSource

PolicyImmune Globulin Intravenous (IVIG) Utilization Management

Policy CodePolicy N/A

Change TypeMaterial revisions and additions (new approved indicationsrevised durations and dosing windows)

Effective DateNov 6, 2024

Next Review DateNov 6, 2024

Key ActionObtain prior authorization that documents indication-specific criteria, specialist involvement, required prior therapies, dosing regimen, and evidence of response when applicable.

SourceLink

POLICY UPDATE CHANGES

Aquaporin-4 Immunoglobulin Antibody (AQP4-IgG)-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD); Immune-Mediated Necrotizing Myopathy; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) were added as conditions of approval.

Duration of approval for initial therapy for immune thrombocytopenia (ITP) was changed from 1 year to 3 months and continuation/retreatment criteria were updated.

CIDP maintenance and loading dose schedules were revised to allow dosing over 2 to 5 consecutive days and maintenance doses divided over up to 4 consecutive dosing days.

Several specific IVIG products (e.g., Alyglo, Yimmugo, Alyglo 10%/Alyglo) were added to the policy with the same criteria as other immune globulin products.

Primary immunodeficiencies: molecular testing was noted as a type of genetic testing.

~15IVIG products listed

1 yearapproval duration (PID)

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.

3 monthsnew ITP initial duration

2–5 daysCIDP loading window

2–4 daysCIDP maintenance window

>20distinct indications listed

Coverage Criteria and Clinical Indications

Primary Immunodeficiency — Initial and Continued Therapy

Covered when ONE of the FDA‑approved primary immunodeficiency criteria below are met and dosing conforms to listed regimens.

Eligible primary immunodeficiency diagnoses: Patient has one of: congenital agammaglobulinemia, X‑linked agammaglobulinemia, other agammaglobulinemia due to absence of B‑cells, Wiskott‑Aldrich syndrome, ataxia telangiectasia, DiGeorge syndrome, severe combined immunodeficiency (SCID), Hyper‑IgM syndromes, an IgG level lower than normal, OR another primary immunodeficiency confirmed by genetic or molecular testing

(chunk 18)

Other PID presentations (CVID / significant hypogammaglobulinemia): Patient has common variable immunodeficiency (CVID), unspecified hypogammaglobulinemia, or other immunodeficiency with significant hypogammaglobulinemia AND meets BOTH: (1) pretreatment IgG below the laboratory normal range (age‑adjusted) AND (2) impaired antibody response OR recurrent infectionspretreatment IgG below lab normal; impaired antibody response or recurrent infections

(chunk 19)

Specialist prescription and continued benefit for ongoing therapy: Medication is prescribed by or in consultation with an appropriate specialist (allergist, immunologist, ENT, pulmonologist, or infectious diseases physician) AND if currently receiving IVIG, prescriber attests the patient is continuing to receive benefit from therapy (examples: increased IgG levels or prevention/control of infections)

(chunk 19)

Dosing options: Approve one of: (A) an initial loading dose of 1 g/kg IV one time; OR (B) 0.2–0.8 g/kg IV once every 3–4 weeks; OR (C) dose and interval adjusted based on clinical response as determined by the prescriber1 g/kg initial OR 0.2–0.8 g/kg q3–4 weeks

(chunk 19)

Primary Immunodeficiencies (general)

Covered when ONE of the diagnostic categories is met and associated criteria are satisfied

Primary immunodeficiency categories: Patient has congenital agammaglobulinemia, X‑linked agammaglobulinemia, other agammaglobulinemia due to absence of B‑cells, Wiskott‑Aldrich syndrome, ataxia telangiectasia, DiGeorge syndrome, SCID, Hyper‑IgM syndromes, an IgG level lower than normal, OR a primary immunodeficiency confirmed by genetic or molecular testing

(chunk 18)

CVID or significant hypogammaglobulinemia: Patient has common variable immunodeficiency (CVID), unspecified hypogammaglobulinemia, or other immunodeficiencies with significant hypogammaglobulinemia AND meets BOTH: (1) pretreatment IgG below normal (age‑adjusted) AND (2) impaired antibody response OR recurrent infectionsIgG below normal per lab reference

(chunk 19)

Continuation for current recipients: Patient has a primary immunodeficiency AND, per prescriber, is continuing to receive benefit from IVIG; medication is prescribed by or in consultation with an allergist, immunologist, ENT, pulmonologist, or infectious diseases physician

B‑cell CLL – Prevention of Infections

Covered when initial or continuation criteria met

Initial therapy (4 months): Patient has IgG ≤ 600 mg/dL OR a history of recurrent infections; medication prescribed by or in consultation with an oncologist, hematologist, or infectious diseases physicianIgG ≤ 600 mg/dL

(chunk 20)

Continuation: Approve for 1 year if there is a positive response to therapy as determined by the prescriber (examples: maintained increased IgG trough or decreased infections)

(chunk 20)

CIDP (Chronic Inflammatory Demyelinating Polyneuropathy)

Covered when electrodiagnostic support and specialist involvement present

Initial therapy (3 months): Electrodiagnostic studies support the diagnosis of CIDP AND medication is prescribed by or in consultation with a neurologist

(chunk 20)

Continuation: Approve if current recipient has significant improvement in neurologic symptoms as determined by the prescriber

(chunk 21)

Dermatomyositis / Polymyositis and Immune-mediated Myopathies

Covered when prior therapies tried or contraindicated and specialist involved

Initial therapy (6 months): Patient has elevated CK or supportive testing AND has tried a systemic corticosteroid (or corticosteroid is contraindicated) AND has tried an immunosuppressive agent (or immunosuppressive agent is contraindicated) AND medication is prescribed by or in consultation with a neurologist or rheumatologistCK elevation per prescriber; CK >1000 IU/L for necrotizing myopathy

(chunk 21,33)

Continuation: Approve for 1 year if the patient has responded to therapy according to the prescriber (examples: improved muscle strength, improved function, decreased CK)

(chunk 21,33)

Immune Thrombocytopenia (ITP)

Covered when urgent need for platelet increase or prior corticosteroid trial/hematologist involvement

Initial adult therapy (3 months): Patient >18 years has tried a systemic corticosteroid (or corticosteroid is contraindicated) AND there is an urgent need to increase the platelet count quickly; OR therapy is prescribed by or in consultation with a hematologist

(chunk 22)

Continuation: Approve for 1 year if the patient is responding to therapy according to the prescriber (examples: increased platelet counts, absence of significant bleeding, or ensuring adequate platelets for delivery in pregnancy)

(chunk 22)

Selected other supported uses (transplant rejection, autoimmune blistering diseases, NMOSD, CMV pneumonitis, desensitization, Guillain‑Barré, SIDI, HCT prevention)

Covered when indication‑specific criteria and specialist involvement are met

Antibody‑mediated rejection in transplantation: Medication prescribed by or in consultation with a transplant center physician; dosing per transplant center protocol or up to 2 g/kg per month

(chunk 25,28)

Autoimmune mucocutaneous blistering diseases — initial therapy (6 months): Patient has tried systemic corticosteroid and an immunosuppressive agent (or these are contraindicated) OR disease is so severe/rapid that there is inadequate time for those therapies; specialist involvement required; dosing examples include 2 g/kg divided over consecutive days

(chunk 25,26)

NMOSD (AQP4‑IgG positive) — initial therapy (6 months): At least one core clinical feature present and diagnosis confirmed by positive serum AQP4‑IgG (CSF acceptable); patient is ≥18 years OR has tried/has contraindication to other therapy; medication prescribed by or in consultation with a neurologist

(chunk 26,27)

Immunotherapy-related toxicities and checkpoint inhibitor toxicities

Covered when corticosteroid therapy has been tried or contraindicated

Initial therapy (1 month): Patient has an immune‑related toxicity from checkpoint inhibitor therapy and has tried systemic corticosteroids and not adequately responded OR corticosteroids are contraindicated OR IVIG is started concurrently with systemic corticosteroid as indicated; dosing examples include 0.4 g/kg daily ×5 days or up to 2 g/kg over 2–5 days

(chunk 34,35)

Continuation: Approve for 6 months if patient has a positive response to therapy as determined by the prescriber and extended therapy is required

(chunk 35)

Lambert‑Eaton Myasthenic Syndrome (LEMS)

Covered for refractory weakness after symptomatic therapy or paraneoplastic disease

Initial therapy (1 month): Patient has refractory weakness after symptomatic treatment with amifampridine, guanidine, or pyridostigmine; OR has paraneoplastic LEMS; OR has non‑paraneoplastic LEMS after trial of or contraindication to systemic corticosteroid or immunosuppressive agent; medication prescribed by or in consultation with a neurologist

(chunk 36)

Continuation: Approve for 1 year if patient has response or continued effectiveness according to the prescriber (examples: improved muscle strength)

(chunk 36)

Multiple myeloma-associated hypogammaglobulinemia or risk

Covered when patient is at risk for severe recurrent infections or is starting/has received CAR‑T or bispecific therapies

Initial therapy (6 months): Patient has or is at risk of severe, recurrent infections according to the prescriber OR will be starting, has taken, or is currently receiving CAR‑T cell therapy or bispecific antibody therapy; medication prescribed by or in consultation with a hematologist, oncologist, or infectious diseases specialist

(chunk 37)

Continuation: Approve for 1 year if the patient is currently receiving IVIG

(chunk 37)

Dosing guidance (selected examples)

Policy provides dosing ranges; final dosing individualized and may be adjusted per clinical response

Common dosing ranges: Examples across indications include 0.2–0.8 g/kg every 3–4 weeks, 0.4 g/kg every 2–4 weeks, 1–2 g/kg loading doses, and up to 2 g/kg per month for some conditions

(chunk 31,33,34)

Dosing adjusted to trough or clinical response: Dose and interval may be adjusted to maintain trough IgG targets (e.g., >400 mg/dL or >500 mg/dL depending on indication) or based on infection control/clinical effectiveness per prescribertrough IgG >400 or >500 mg/dL depending on indication

(chunk 31,33)

Selected Covered Indications and Criteria (partial)

Covered when specified indication-specific criteria are met (examples below are partial, from this portion of the document).

Lambert‑Eaton myasthenic syndrome (paraneoplastic): Patient has paraneoplastic LEMS AND has tried a systemic corticosteroid or another immunosuppressive agent (or has contraindication to these therapies); medication prescribed by or in consultation with a neurologist; if currently receiving IVIG, approve for 1 year if patient has responded to therapyresponse per prescriber

(chunk 36)

Patients at risk of severe/recurrent infections related to CAR‑T or bispecific antibody therapy: Patient is starting, has taken, or is currently receiving CAR‑T cell therapy or bispecific antibody therapy AND medication prescribed by or in consultation with a hematologist, oncologist, or infectious diseases specialist; if currently receiving IVIG, approve for 1 yearper prescriber

(chunk 37)

Multiple Sclerosis (acute severe exacerbation):

Revised and added coverage criteria (summary)

Selected revisions and additions summarized from policy history

New approved neurologic immune conditions: AQP4‑IgG‑positive NMOSD, immune‑mediated necrotizing myopathy, and MOGAD were added as conditions of approval

Added to policy as approved conditions (chunks 61,27,33)

ITP initial approval duration: Initial therapy for immune thrombocytopenia (ITP) — approval duration changed to 3 months (was previously 1 year); continuation/retreatment criteria updated3 months

(chunk 60)

CIDP dosing windows revised: CIDP loading doses may be given over 2–5 consecutive days and maintenance 1 g/kg may be divided over up to 4 consecutive dosing days (revised from prior fixed‑day schedules)2–5 days loading; up to 4 days maintenance

This excerpt of the IVIG policy does not include any broad, explicit blanket exclusions that would categorically bar all uses of IVIG; instead, coverage is defined by specific authorization Criteria and Dosing for individual indications. The document emphasizes indication‑specific requirements and references both FDA‑approved and other condition‑specific guidance rather than a single omnibus exclusion list.

Within the provided excerpt there are no stand‑alone statements listing broad exclusions; coverage determinations are framed around meeting the policy’s discrete diagnostic and dosing criteria for each indication and obtaining prior authorization when required.

The policy explicitly identifies specific conditions for which IVIG is not recommended for approval. Examples listed include adrenoleukodystrophy, Alzheimer’s disease, amyotrophic lateral sclerosis, asthma, atopic dermatitis, autism, complex regional pain syndrome, Crohn’s disease, cystic fibrosis, diabetes mellitus (immunotherapy), fibromyalgia syndrome, in vitro fertilization outcomes, POEMS syndrome, recurrent spontaneous pregnancy loss (including antiphospholipid antibody‑positive), and selective IgA deficiency as the sole abnormality, among others.

COVERAGE CRITERIA — Changes to Conditions Not Recommended for Approval

Conditions removed from or not recommended for approval are summarized here.

Conditions not recommended for approval (examples): Policy lists multiple conditions not recommended for approval (examples include: adrenoleukodystrophy; Alzheimer's disease; amyotrophic lateral sclerosis; asthma; atopic dermatitis; autism; Crohn's disease; cystic fibrosis; fibromyalgia; in vitro fertilization outcomes; POEMS syndrome; recurrent spontaneous pregnancy loss including antiphospholipid antibody‑positive; selective IgA deficiency as sole abnormality).

(chunk 44,45,46)

Removed from not recommended list: Chronic Fatigue Syndrome was removed from the Conditions Not Recommended for Approval list

(chunk 61)

Requests that do not meet the policy’s specified Criteria and Dosing for the listed indications — including dosing outside established regimens without case‑by‑case clinical justification — may be denied. Providers should ensure required clinical documentation (diagnosis, indication‑specific test results, prior therapy trials or contraindications, specialist involvement, and evidence of response when applicable) is included with prior authorization requests to reduce risk of denial.

The provided excerpt does not contain explicit standalone statements labeled "not medically necessary" for specific uses; rather, it frames non‑coverage as situations where the request fails to meet the policy’s clinical Criteria and Dosing or where conditions are listed under "CONDITIONS NOT RECOMMENDED FOR APPROVAL."

Use of IVIG for conditions enumerated in the policy section "CONDITIONS NOT RECOMMENDED FOR APPROVAL" is considered unsupported by the available evidence and therefore is not recommended for approval. Requests for IVIG for these conditions are explicitly identified as likely to be denied per the policy rationale.

An editorial change noted in the policy history removed aplastic anemia (Anemias Aplastic) from the list of conditions not recommended for approval, indicating that this specific prior non‑recommended listing was rescinded in the documented revision.

Products, Dosing Thresholds, and Key Clinical Values

Listed IVIG productsmixed

brand_list

Asceniv; Alyglo; Bivigam; Gammagard Liquid; Flebogamma DIF; Gammagard SID; Gammaked; Gammaplex; Octagam; Gamunex-C; Panzyga; Yimmugo; Privigen

No explicit CPT/HCPCS/ICD codes listed in this excerptmixed

No codes listed

No explicit codes in this sectionmixed

No codes listed

IgG serum level thresholds — HCT context

HCT severe hypogammaglobulinemia thresholdSerum IgG ≤ 400 mg/dL used as criterion for IVIG in hematopoietic cell transplant (HCT) recipients

HCT dosing frequency during first 100 days (adult/adolescent)0.5 g/kg per week; dose individualized to maintain trough IgG >400–500 mg/dL

Pediatric allogeneic HCT dosing0.4 g/kg per month, adjusted to maintain trough IgG >400 mg/dL

Measles post-exposure IVIG dose

Measles post-exposure IVIG dose400 mg/kg IV administered within 6 days of exposure

Indications for IVIG post-exposure to measles

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for IVIG products. Approvals are granted only when the request meets the policy Criteria and Dosing for the indicated condition and are provided for the duration specified. Requests for dosing outside established regimens or for indications listed in CONDITIONS NOT RECOMMENDED FOR APPROVAL risk denial and will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist). If a previously authorized case is switching between IVIG products, a new approval may be entered without another clinical review only for the remaining doses and duration of the original approval, provided the indication and dosing remain the same. Some approvals require the medication to be prescribed by or in consultation with a specialist (e.g., allergist/immunologist, neurologist, hematologist/oncologist, infectious disease physician, rheumatologist, transplant physician) or per a transplant center protocol.

Prior authorization required for IVIG products
Case-by-case review for non-standard dosing or indications
Specialist prescribing/consultation may be required

Documentation Required

Policy Background and Scope

Intravenous immune globulin (IVIG) products are pooled human immunoglobulin G (IgG) preparations used both for replacement therapy in primary humoral immunodeficiencies and for immunomodulatory treatment in a range of immune‑mediated and transplant‑related conditions. Products differ by manufacturer and formulation; many indications rely on specialist evaluation and the evidence base ranges from randomized trials for some approved uses to case series or guideline‑based recommendations for other uses.

Definitions and Clinical Terms

IVIG (Intravenous Immune Globulin) — definition and product variance

Definition of IVIGPooled human immunoglobulin G (IgG) preparations administered intravenously for replacement or immunomodulatory therapy; products differ by manufacturer and formulation

Product variabilityManufacturers and formulations differ; donor plasma pools provide a wide range of antibodies across IVIG products

Clinical usesUsed for replacement therapy in primary humoral immunodeficiencies and as immunomodulatory therapy for various immune-mediated and transplant-related indications

Severe hypogammaglobulinemia (HCT context)

Severe hypogammaglobulinemia (HCT) thresholdSerum IgG ≤ 400 mg/dL used as criterion for IVIG to prevent infections in HCT recipients

Timeframe in HCT recipients

Policy Summary

PayerCareSource

PolicyImmune Globulin Intravenous (IVIG) Utilization Management

Policy CodePolicy N/A

Change TypeMaterial revisions and additions (new approved indicationsrevised durations and dosing windows)

Effective DateNov 6, 2024

Next Review DateNov 6, 2024

Key ActionObtain prior authorization that documents indication-specific criteria, specialist involvement, required prior therapies, dosing regimen, and evidence of response when applicable.

SourceLink

On This Page

Guillain‑Barré syndrome — initial therapy (1 month): IVIG initiated within 2 weeks (no longer than 4 weeks) after onset of neuropathic symptoms AND medication prescribed by or in consultation with a neurologist or specialist experienced in GBS

(chunk 28)

HCT infection prevention: Patient had hematopoietic cell transplant (HCT) within the relevant timeframe AND dosing/IgG thresholds per transplant protocol or policy (adjust dose to maintain trough IgG >400 mg/dL) AND medication prescribed by or in consultation with hematology/oncology or infectious diseasestrough IgG >400 mg/dL referenced; IgG 600 mg/dL referenced in some contexts

(chunk 31)

Approve for 1 month (one course) if patient has not responded to or had significant adverse reaction to systemic corticosteroids or plasma exchange OR corticosteroids are contraindicated; medication prescribed by or in consultation with a neurologist

Myasthenia gravis — acute/initial maintenance: Initial short‑term therapy: approve for 5 days for exacerbation or pre‑surgical stabilization; initial maintenance: approve for 1 year if patient has refractory MG after trial of pyridostigmine and at least one immunosuppressant with inadequate response; medication prescribed by or in consultation with a neurologist; continuation requires demonstrated responseclinical response per prescriber

(chunk 31,33)

MOG antibody‑associated disease (MOGAD): Initial therapy: approve for 6 months if patient has clinical demyelinating event AND diagnosis confirmed by positive serum MOG‑IgG (CSF acceptable) AND patient has tried systemic corticosteroid or immunosuppressant or has contraindication; medication prescribed by or in consultation with a neurologist; continuation for 1 year if respondeddiagnostic confirmation/response per prescriber

(chunk 61,27)

Post‑exposure prophylaxis (measles): Approve single‑dose post‑exposure prophylaxis when patient has been exposed to measles AND cannot readily show evidence of immunity, is pregnant, or is immunocompromised; dosing example: single 0.4 g/kg dosesingle 0.4 g/kg dose

(chunk 12,19)

Pregnant patients without evidence of immunity and severely immunocompromised persons per ACIP guidance

Purpose of dosingTo prevent or modify measles in nonimmune exposed individuals when indicated

IgG level thresholds (examples)

IgG threshold for some non‑PID indications / HCT contextsIgG < 600 mg/dL (6.0 g/L) referenced for certain indications

Trough target — generalAdjust dose/interval to maintain trough (pre-dose) IgG >400 mg/dL for many transplant/HCT contexts

Trough target — hematologic/CLL contextsDose/interval may be adjusted to maintain trough IgG >500 mg/dL for some hematologic indications

CK thresholds for myopathies

CK threshold for immune‑mediated necrotizing myopathyCreatine kinase (CK) > 1,000 IU/L used as part of diagnostic criteria

Supporting evidence for myopathy diagnosisElevated CK plus myositis-associated autoantibodies, EMG/MRI/biopsy, and prior trials of corticosteroid or immunosuppressant

Response monitoringExamples of response include improved muscle strength, function, and decreased CK according to prescriber

IVIG dosing thresholds — typical regimens

Common IVIG loading regimensUp to 2 g/kg given over 2 to 5 consecutive days (e.g., 2 g/kg total divided over 2–5 days)

Alternate loading/course regimens0.4 g/kg given daily for 5 days is an approved course option

Typical maintenance regimens0.4–0.5 g/kg every 3–4 weeks or 0.4–1 g/kg every 4 weeks (maintenance dosing individualized)

Monthly maximum commonly referencedUp to 2 g/kg per month for some indications (single dose or divided)

Required Clinical Documentation

The prescriber must supply documentation that supports the specific diagnosis and the clinical criteria for the indication requested. Required documentation commonly includes lab values (e.g., age‑adjusted IgG level, IgG troughs), diagnostic testing (e.g., molecular/genetic testing for primary immunodeficiencies, electrophysiologic studies for CIDP, antibody testing for MOGAD/AQP4/NMOSD), and evidence of recurrent or severe infections when applicable. When continuation therapy is requested, documentation should demonstrate ongoing clinical benefit (examples: increased/maintained IgG trough levels, reduction in infection frequency, improvement in functional or neurologic status).

Age‑adjusted IgG levels and IgG troughs where applicable
Impaired antibody response testing or post-vaccination antibody titers when required
Molecular/genetic testing results for primary immunodeficiency when available
Electrodiagnostic/EMG, MRI, or biopsy results when cited in criteria
Documentation of clinical benefit for continuation requests

Step Therapy

Required Prior Therapies and Step Therapy Requirements

For many indications, the prescriber must document prior trials of indicated therapies or that such therapies are contraindicated. Common requirements include trials of systemic corticosteroids and/or immunosuppressive agents (e.g., azathioprine, methotrexate, mycophenolate, cyclophosphamide, cyclosporine, tacrolimus) prior to approval for autoimmune or inflammatory conditions. For some neurologic and hematologic indications, failure or contraindication to plasma exchange, corticosteroids, or specific disease‑modifying therapies must be documented.

Document trials of systemic corticosteroids unless contraindicated
Document trial of at least one appropriate immunosuppressive agent or contraindication
Where applicable, document trial/failure of plasma exchange or other required prior therapies

Denial Risk

Denial Triggers

Prescriptions that lack required clinical documentation, specialist involvement when mandated, or evidence meeting indication‑specific thresholds (e.g., IgG cutoffs, timing of therapy initiation such as GBS within 2 weeks of onset) may be denied. Requests that exceed duration limits, request dosing outside policy‑specified regimens, or seek IVIG for conditions listed under CONDITIONS NOT RECOMMENDED FOR APPROVAL are considered not supported and may be denied. Missing or incomplete records (labs, test results, specialist consult notes) increase the likelihood of denial.

Denial possible for missing required diagnostic criteria (e.g., IgG levels, antibody response)
Denial possible for dosing outside established regimens or exceeding duration limits
Denial for indications listed as not recommended in the policy
Denial possible when required specialist prescribing/consultation is not documented

Documentation Required

Specialist Prescribing and Product Management

When a specialist prescriber or consultation is required by the indication, the record should include the specialist’s identity and documentation of their assessment or co-management. Use the Immune Globulin management resources referenced by the plan when product selection or step edits apply. If therapy is authorized under a specific management program (e.g., preferred product), follow that program’s requirements for product substitution and authorization.

Include specialist name and specialty in the documentation when required by the indication
Document specialist assessment or consult note supporting IVIG use
Follow plan-specific Immune Globulin product management and preferred‑product rules

Applied during the first 100 days post-HCT and beyond in recipients who continue to have severe hypogammaglobulinemia

Dosing goal contextDosing individualized to maintain trough IgG >400–500 mg/dL in HCT recipients

Impaired antibody response — definition

Impaired antibody response — definitionFailure to produce antibodies to specific antigens demonstrated by poor specific antibody titers after vaccination or antigen exposure

Role in eligibilityRequired as part of primary immunodeficiency criteria when pretreatment IgG below normal is present

DocumentationPrescriber must document impaired antibody response or recurrent infections to support IVIG for PID

Trough IgG level target

Trough IgG targets — transplant/HCTMaintain trough (pre-dose) serum IgG >400 mg/dL (often targeted >400–500 mg/dL) depending on indication

Trough IgG target — hematologic contextsSome hematologic indications (e.g., CLL) may use a trough goal >500 mg/dL with dose/interval adjusted accordingly

Use of trough targetsDose and interval are individualized and adjusted based on trough IgG and clinical response (infection control)

Maintenance therapy — definition/notes

Maintenance therapy — definitionOngoing immunomodulatory therapy intended to prevent relapses or maintain disease control; explicitly noted that maintenance therapy does NOT include IVIG in some disease maintenance examples

Prescriber specialty for maintenance decisionsMaintenance use decisions should involve the prescriber and appropriate specialist (e.g., neurologist for CIDP/MS)

Continuation documentationContinuation approvals require demonstration of ongoing benefit or response per prescriber for maintenance approval

Molecular testing (definition note)

Molecular testing — noteMolecular testing is recognized as a type of genetic testing for primary immunodeficiency evaluation

Policy history contextThis clarification was added to the primary immunodeficiencies section during policy revision

Use in diagnosisMolecular/genetic testing may be requested/documented when confirming certain primary immunodeficiencies

Response to therapy — clarification

Response to therapy — clarified phrasingContinuation criteria use 'patient is responding to OR the patient has previously responded to' therapy to document benefit

Examples of responseExamples include increased IgG trough, fewer infections, improved strength or function depending on indication

Documentation requirementPrescriber must attest to continued benefit when requesting continuation/maintenance approvals