ModifiedCareSourcePolicy N/A

Intravenous Immune Globulin (IVIG) utilization management

Defines prior authorization, coverage criteria, and dosing guidance for FDA-approved and selected off-label uses of intravenous immune globulin products for CareSource members and the providers who treat them.

Policy Summary

PayerCareSource

PolicyIntravenous Immune Globulin (IVIG) utilization management

Policy CodePolicy N/A

Change TypeMaterial updates to indications, dosing, and approval durations

Effective DateNov 6, 2024

Next Review DateNov 6, 2024

Key ActionObtain prior authorization with documentation that the patient meets the indication-specific diagnostic, laboratory, prior-therapy, and prescriber specialty criteria.

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 retreatment/continuation criteria were updated.

CIDP maintenance and loading dose schedules were updated to allow dosing spread over 2 to 5 consecutive days for loading and maintenance dosing divided over up to 4 consecutive days.

Parvovirus B19 infection dosing alternative of 0.2 g/kg to 0.4 g/kg IV daily for 5 to 10 days was added.

Alyglo and Yimmugo IVIG products were added to the policy with the same criteria as other immune globulin products.

Primary immunodeficiencies section clarified that molecular testing is a type of genetic testing.

≥14IVIG products listed by brand name in policy

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.

Coverage Criteria and Clinical Indications

Primary Immunodeficiency (PID) — Initial and Ongoing Therapy

Covered when ONE of the listed FDA‑approved indication groups is met and dosing/authorization requirements are satisfied.

FDA‑Approved Indications: Coverage is recommended for members who meet one of the policy's FDA‑approved indication groups (for example, Primary Immunodeficiencies).

See specific PID initial and continuation criteria below; dosing options include maintenance 0.2–0.8 g/kg every 3–4 weeks or initial loading doses as specified (chunks 18–19).

Primary Immunodeficiency - Initial Therapy: Approve if patient meets BOTH diagnostic criteria and immunologic testing criteria for initial PID therapy.

Diagnostic options include congenital agammaglobulinemia, CVID, significant hypogammaglobulinemia, or confirmatory genetic/molecular testing; impaired antibody response or recurrent infections as specified (chunks 18–19).

Primary Immunodeficiency - Continuation Therapy: Approve if patient has diagnosed primary immunodeficiency and the prescriber documents the patient is deriving continued benefit from IVIG (eg, increased IgG troughs or fewer/controlled infections).

Medication should be prescribed by or in consultation with an allergist, immunologist, ENT, pulmonologist, or infectious disease physician (chunk 19).

Primary Immunodeficiencies (FDA-approved)

Covered when ONE of the following sets of criteria is met (initial therapy OR currently receiving and benefiting):

Primary immunodeficiency approval paths

Initial Therapy - congenital or severe primary deficiencies: Patient has diagnosis of congenital agammaglobulinemia, X‑linked agammaglobulinemia, other agammaglobulinemia due to absence of B‑cells, Wiskott‑Aldrich, ataxia telangiectasia, DiGeorge syndrome, severe combined immunodeficiency, Hyper‑IgM syndromes, or a primary immune deficiency confirmed by genetic or molecular testing.
Molecular testing is considered a type of genetic testing (chunks 18–19)
Initial Therapy - CVID or hypogammaglobulinemia: Patient has common variable immunodeficiency, unspecified hypogammaglobulinemia, or other immunodeficiency with significant hypogammaglobulinemia AND both: (1) pretreatment IgG below the laboratory age‑adjusted normal range; AND (2) impaired antibody response OR recurrent infections consistent with impaired antibody function or documented IgG subclass/selective antibody deficiency with recurrent infections.IgG below lab normal
An exception may be made when delay for post‑vaccination antibody measurement would be deleterious (chunks 18–19)

B-cell Chronic Lymphocytic Leukemia (CLL) – Prevention of Infections

Covered when ONE pathway is met:

CLL prevention: Initial therapy: patient has IgG ≤ 600 mg/dL OR history of recurrent infections AND medication is prescribed by or in consultation with an oncologist, hematologist, or infectious disease physician; approve initial course (4 months) or extend to 1 year if prescriber documents a positive response to therapy.IgG <= 600 mg/dL

Dosing examples include 0.4 g/kg IV every 3–4 weeks or 0.3–0.5 g/kg once monthly; aim for pre‑dose IgG trough >500 mg/dL when indicated (chunk 20).

CIDP (Chronic Inflammatory Demyelinating Polyneuropathy)

Covered when diagnostic and prescriber requirements are met:

CIDP initial therapy: Electrodiagnostic studies support the diagnosis of CIDP AND the medication is prescribed by or in consultation with a neurologist; initial approval 3 months.

Continuation requires significant clinical improvement as determined by the prescriber; dosing: loading 2 g/kg divided over 2–5 days, maintenance 1 g/kg divided over 1–4 days every 3 weeks, maximum 2 g/kg per treatment course (chunks 20–21).

Dermatomyositis/Polymyositis and Autoimmune Myopathies

Covered when ALL initial-therapy criteria are met:

Dermatomyositis/Polymyositis initial therapy: Patient has elevated CK or compatible findings (skin manifestations, myositis autoantibodies, muscle biopsy or EMG) AND has tried a systemic corticosteroid or corticosteroid is contraindicated AND has tried an immunosuppressive agent or it is contraindicated AND the medication is prescribed by or in consultation with a neurologist or rheumatologist.CK elevation referenced; examples include CK >1000 IU/L in other myopathies context

Initial approval 6 months; continuation 1 year if responded to therapy per prescriber (chunks 21–22, 26).

Immune Thrombocytopenia (ITP)

Covered when ONE of the listed initial therapy scenarios is met:

ITP initial therapy: Adults: tried systemic corticosteroid (or corticosteroid contraindicated) AND there is an urgent need to raise platelet count; OR prescribed by or in consultation with a hematologist (including pregnant patients with specified duration rules). Approve initial therapy for 3 months; continuation/extension to 1 year if responding according to prescriber.

Dosing options include up to 1 g/kg for 1–2 days or 0.4 g/kg daily for 5 days to a total of 2 g/kg per course (chunks 22–23).

Multifocal Motor Neuropathy

Covered when diagnostic support and prescriber requirements are met:

MMN criteria: Diagnosis supported by motor conduction block on nerve conduction studies or by motor nerve biopsy or MRI neurography AND medication is prescribed by or in consultation with a neurologist; continuation approvals require prescriber‑documented improvement.

Maintenance dosing regimens and course dosing options described in policy (chunks 23–24).

Autoimmune Mucocutaneous Blistering Diseases

Covered when initial-therapy criteria are met or continuation after response:

Pemphigus and related blistering diseases: Initial therapy: patient has severe or rapidly progressive disease OR has tried a systemic corticosteroid (or corticosteroid contraindicated) AND has tried an immunosuppressive agent (or is contraindicated); initial approval 6 months; continuation 1 year if responded according to prescriber.

Aggressive ocular disease dosing variants and dose‑tapering schedules noted (chunks 25–26).

AQP4-IgG-Positive NMOSD

Covered when core clinical features and diagnostic confirmation are present:

AQP4‑IgG‑Positive NMOSD initial therapy: Presence of ≥1 core clinical feature of NMOSD AND diagnosis confirmed by positive blood AQP4‑IgG (or CSF) AND either patient is ≥18 years OR has tried/has contraindication to another therapy for attack prevention; medication prescribed by or in consultation with a neurologist.

Initial approval 6 months; continuation 1 year if responding; dosing up to 2 g/kg/month (chunks 26–27).

Transplant-related indications (antibody-mediated rejection, desensitization) and CMV pneumonitis

Covered when prescribed by or in consultation with transplant or appropriate specialists:

Transplant and CMV uses: Approve for transplant‑related indications (eg, antibody‑mediated rejection, desensitization) when prescribed by or in consultation with a transplant‑affiliated physician (typical duration 1 year) OR for CMV pneumonitis/pneumonia in cancer/transplant patients when prescribed/consulted with oncology/hematology/infectious disease (typical duration 2 months).

Dosing may follow transplant center protocol or up to 2 g/kg per month (chunks 25,27,28).

Guillain-Barré Syndrome (GBS)

Covered when initial timing and prescriber requirements are met:

GBS initial therapy: IVIG initiated within 2 weeks and no longer than 4 weeks after onset of neuropathic symptoms OR for treatment‑related fluctuation after an initial response; medication prescribed by or in consultation with a neurologist or specialist experienced in GBS; approve for 1 month to allow one course.

Dosing 2 g/kg IV divided over 2–5 days (chunk 28).

Hematologic Neoplasm-associated Hypogammaglobulinemia and Post B-cell Therapies (SIDI)

Covered when IgG thresholds, infection risk, and prescriber involvement are met:

SIDI initial therapy: Patient has IgG < 600 mg/dL (excluding paraprotein) AND recurrent or severe infections or high infection risk per prescriber AND medication is prescribed by or in consultation with an oncologist, hematologist, infectious disease physician, or immunologist; approve initial therapy for 6 months; continuation if positive response per prescriber.IgG < 600 mg/dL

Dosing examples include 0.4–0.6 g/kg monthly or 0.2–0.8 g/kg every 3–4 weeks adjusted per clinical response (chunks 30–31).

Hematopoietic Cell Transplantation (HCT) to prevent infection

Covered per timing post-transplant and IgG targets:

HCT prophylaxis: During first 100 days post‑HCT: dosing and frequency per protocol with dose adjusted to maintain trough IgG >400 mg/dL; >100 days post‑HCT: 0.5 g/kg every 3–4 weeks adjusted to keep IgG >400 mg/dL.Maintain IgG >400 mg/dL

Initial approvals vary (eg, 3 months for initial therapy; continuation approvals per prescriber response) (chunk 31).

HIV – prevention of recurrent infections

Covered when combination antiretroviral therapy and immunologic criteria are met:

HIV‑related indications: Patient is receiving combination antiretroviral therapy AND is adult AND has hypogammaglobulinemia (eg, IgG ≈ 400 mg/dL) or functional antibody deficiency with recurrent serious infections despite ART and appropriate prophylaxis; medication prescribed by or in consultation with an infectious diseases specialist or immunologist; approve initial therapy for 6 months; continuation 1 year if infections decrease per prescriber.IgG ~400 mg/dL or functional antibody deficiency

Dosing options include 0.4 g/kg IV every 2–4 weeks or up to 2 g/kg divided over 2–5 days as clinically indicated (chunks 32–33).

Immune-mediated necrotizing myopathy (INM)

Covered when initial diagnostic and treatment-failure criteria are met:

INM initial therapy: Patient has muscle weakness AND CK > 1000 IU/L AND myositis‑associated autoantibodies or supportive imaging/biopsy/EMG AND has tried systemic corticosteroid (or corticosteroid contraindicated) AND has tried or failed other immunosuppressive agents (or contraindication); medication prescribed by or in consultation with a neurologist or rheumatologist.CK >1000 IU/L

Initial approval 6 months; continuation 1 year if responding (chunk 33).

Immunotherapy-related toxicities from checkpoint inhibitors

Covered when corticosteroid trial or contraindication documented:

Checkpoint inhibitor toxicities: Initial therapy: IVIG started with systemic corticosteroid and patient has not adequately responded OR corticosteroid is contraindicated; initial approval 1 month with continuation up to 6 months if responding.

Dosing examples include up to 0.4 g/kg daily x5 days or up to 2 g/kg over 2–5 days, adjusted per clinical response (chunks 34–35).

Lambert-Eaton Myasthenic Syndrome (LEMS)

Covered when symptomatic and prior symptomatic therapy tried:

LEMS criteria: Patient has refractory weakness after symptomatic treatment (eg, amifampridine, guanidine, pyridostigmine) AND has paraneoplastic LEMS or non‑paraneoplastic LEMS with prior corticosteroid/immunosuppressant trial or contraindication; medication prescribed by or in consultation with a neurologist.

Initial approval 1 month; continuation up to 1 year if responding; dosing options include up to 2 g/kg divided over 2–5 days or maintenance every 4 weeks up to 2 g/kg (chunks 35–36).

Multiple Myeloma

Covered for infection risk related to therapy or CAR‑T/bispecific antibody therapy:

Multiple myeloma indications: Approve when patient has or is at risk of severe recurrent infections according to prescriber OR will be starting/has received CAR‑T or bispecific antibody therapy AND medication is prescribed by or in consultation with hematology/oncology/infectious disease; continuation approvals typically 1 year.

Dosing example: 0.4–0.5 g/kg IV every 3–4 weeks (chunk 37).

Multiple Sclerosis (acute severe exacerbation)

Covered for one course when systemic corticosteroids or plasma exchange are not effective or contraindicated:

MS acute relapse: Patient has failed or had significant adverse reaction to systemic corticosteroids OR plasma exchange OR corticosteroid is contraindicated; patient is on or will start maintenance MS therapy; approve for one course (1 month).1 month

Medication is prescribed by or in consultation with a neurologist or MS specialist; dosing options include single 1 g/kg or 0.4 g/kg daily x5 days (chunks 37–39).

Neurologic and neuroimmunologic indications

Covered when criteria per specific diagnosis and prior therapies are met; duration and dosing specified per indication.

Myasthenia gravis - Initial short‑term (acute) use: Approve for up to 5 days to provide one course if patient has MG exacerbation, needs perioperative stabilization, or is starting steroids to prevent exacerbation; medication prescribed by or in consultation with a neurologist.5 days

Dosing options include 0.4 g/kg daily x5 days or single 1 g/kg dose (chunk 39).

Myasthenia gravis - Maintenance therapy: Approve for up to 1 year for refractory MG if patient has tried pyridostigmine and at least one immunosuppressive agent with inadequate response, prescriber is/consults neurologist, and patient is responding per prescriber.1 year

Maintenance dosing adjusted to minimal effective dose; maximum per month up to 2 g/kg (chunks 39–40).

MOGAD - Initial therapy:

Hematologic, infectious, transplant, obstetric indications

Covered when diagnosis-specific criteria and specialist prescriber requirements are met; durations and dosing depend on indication.

Multiple myeloma - infection risk: Approve if patient is at risk of severe, recurrent infections per prescriber or is starting/receiving CAR‑T or bispecific antibody therapy AND medication is prescribed by or in consultation with hematology/oncology/infectious disease; continuation approvals typically 1 year.1 year if currently receiving

Dosing: 0.4–0.5 g/kg IV every 3–4 weeks (chunk 37).

Parvovirus B19 in immunocompromised: Initial therapy: patient has an immunodeficiency condition AND medication is prescribed by or in consultation with infectious disease, immunology, hematology, or transplant specialist; approve for 2 months.2 months

Dosing options include 0.4–0.5 g/kg daily x5 days, 2 g/kg over 2–5 days, or maintenance 0.4 g/kg every 4 weeks (chunks 42–43).

Passive immunization - measles post‑exposure:

Dosing and maintenance

Dosing regimens permitted per indication and response.

Short‑term (acute) dosing options: Examples include 2 g/kg IV divided over 2–5 consecutive days or a single 1 g/kg IV dose for certain acute indications (eg, GBS, severe MG exacerbation).course‑specific

Maximum per treatment course commonly referenced as up to 2 g/kg (chunks 40–41).

Maintenance dosing options: Maintenance regimens include 0.4 g/kg to 1 g/kg IV every 4 weeks; dose adjusted to minimal effective dose; policy notes maximum monthly dosing up to 2 g/kg and allows dividing doses over multiple consecutive days for administration convenience or tolerance.every 4 weeks

CIDP loading/maintenance may be fractionated over 2–5 days (loading) and up to 4 days (maintenance) per recent updates (chunks 21, 60).

Summarized updated coverage criteria

Policy-level covered indications and criteria updates (summarized from history notes):

Newly added indications: Aquaporin‑4 (AQP4‑IgG) NMOSD, Immune‑Mediated Necrotizing Myopathy (INM), and MOGAD were added as approved indications for IVIG.

These additions are reflected in the condition‑specific criteria (chunks 26–27, 33, 40–41).

ITP initial approval duration changed: Initial approval duration for ITP was changed to 3 months (previously 1 year); continuation and retreatment criteria were updated and require documentation of response for continued therapy.3 months

See ITP criteria for adult and pregnant patient specifics (chunk 22, 60).

Parvovirus B19 dosing alternative: An alternative Parvovirus B19 regimen was added: 0.2–0.4 g/kg IV daily for 5–10 days.0.2–0.4 g/kg x 5–10 days

The provided document does not specify any single, blanket exclusion that applies to all IVIG requests. Instead, coverage determinations are guided by the indication-specific criteria and the conditions listed elsewhere in the policy. The partial content reviewed notes multiple uses for IVIG (both FDA‑approved and off‑label) and emphasizes that many off‑label applications are supported only by anecdotal evidence, rather than an explicit universal exclusion statement.

Coverage for intravenous immune globulin in this policy is governed by indication‑specific criteria. Approvals require documentation that the member meets the diagnostic, laboratory (for example, IgG thresholds), prior‑therapy, prescriber specialty, dosing, and duration requirements described for each listed indication.

The policy identifies a list of conditions for which IVIG use is not recommended for approval. Examples explicitly named include Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), asthma, autism, Crohn’s disease, cystic fibrosis, fibromyalgia, in‑vitro fertilization (IVF) outcomes, POEMS syndrome, and several others; use for these indications is considered not supported by the available evidence.

The policy states that coverage recommendations for indications not listed in the authorized criteria may be changed as new published data become available. In other words, the document will be updated when relevant new evidence emerges to alter the Recommended Authorization Criteria.

Historical revision notes indicate that Chronic Fatigue Syndrome was removed from the list of conditions not recommended for approval; this change is recorded in the policy history and reflects updates to the not‑recommended list.

The policy highlights that much of the evidence supporting off‑label IVIG use is anecdotal (case reports, open series, cohort studies). As a result, IVIG is generally considered when standard approaches have failed, are intolerable, or are contraindicated, rather than as a first‑line therapy for off‑label indications.

Requests that do not meet the indication‑specific criteria — including required diagnostic findings, laboratory thresholds (e.g., specified IgG levels), prior therapy trials or contraindications, prescriber specialty, dosing, or duration — are at risk for denial and will be considered not medically necessary under the policy.

Use of IVIG for conditions listed under the policy’s 'CONDITIONS NOT RECOMMENDED FOR APPROVAL' section is considered not supported by evidence and therefore not recommended for approval; these entries function as explicit denial triggers when submitted as indications for IVIG.

The policy history also documents that Aplastic anemia (Anemias Aplastic) was removed from the 'Conditions Not Recommended for Approval' list, indicating that items on the not‑recommended list may be revised over time based on review and evidence updates.

Provider Requirements, Prior Authorization, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for IVIG products. Approvals are recommended only for members who meet the indication‑specific clinical criteria, dosing, and duration specified in this policy. Requests for doses outside the dosing ranges documented in the policy will be considered on a case‑by‑case basis by a clinician (for example, a Medical Director or Pharmacist) and must include justification.

Prior authorization required — approvals granted only when indication, dosing, duration, and documentation criteria are met.
Nonstandard dosing risk — requests for doses or intervals outside policy ranges require case‑by‑case review and clinical justification.

Documentation Required

Required Clinical Documentation

Documentation submitted with the prior authorization request must demonstrate the diagnosis and supporting clinical data relevant to the requested indication. For Primary Immunodeficiency (PID) requests, include diagnostic evidence (e.g., genetic/molecular testing when available), baseline and pretreatment IgG levels (age‑adjusted and laboratory reference range), and evidence of impaired antibody response or recurrent/severe infections as applicable. For neurologic, hematologic, transplant, oncologic, and other specialty conditions, include relevant labs (e.g., CK for myopathies), electrodiagnostic testing, antibody testing (e.g., AQP4, MOG), biopsy/ imaging reports, and clinical measures of response.

Product Codes, Dosing Thresholds, and Key Numeric Criteria

IVIG product HCPCS / brand list (policy lists brands)mixed

Asceniv	immune globulin intravenous solution - ADMA Biologics
Alyglo	immune globulin intravenous solution - GC Biopharma
Bivigam	immune globulin intravenous solution - ADMA Biologics
Gammagard Liquid	immune globulin solution - Baxalta [Takeda]
Flebogamma DIF	immune globulin intravenous solution - Grifols
Gammaked	immune globulin solution - Kedrion
Gammaplex	immune globulin intravenous solution - Bio Products Laboratory/Kedrion
Gamunex-C	immune globulin solution - Grifols
Panzyga	immune globulin intravenous solution - Octapharma/Pfizer
Yimmugo	immune globulin intravenous solution - Biotest/Grifols

1–10 of 12

1/2

No explicit codes in this sectionmixed

No codes listed

IgG level thresholds — ACIP measles post-exposure and HCT example

ACIP measles post-exposure IVIG dose0.4 g/kg IV given one time (single dose)

HCT recipient IgG example cutoffSerum IgG ≤ 400 mg/dL during the first 100 days post-HCT

Measles prophylaxis timing noteAdminister within 6 days of exposure per ACIP guidance

IgG level thresholds — additional numeric thresholds

IgG threshold for SIDI/hematologic indicationsIgG < 600 mg/dL (6.0 g/L) [excluding paraprotein]

CLL trough goalMaintain pre-dose (trough) IgG > 500 mg/dL

Background and Definitions

Intravenous immune globulin (IVIG) products are concentrated, pooled human immunoglobulin G (IgG) preparations derived from plasma donors. They are used for replacement therapy in primary humoral immunodeficiencies and for immunomodulation in a range of immune‑mediated, neurologic, hematologic, and transplant‑related indications, with product‑specific dosing and specialist prescriber considerations.

IVIG definition

IVIG (definition)Concentrated human immunoglobulin G (IgG) products prepared from pooled plasma used for replacement therapy and immunomodulation.

Product composition notePrepared from pooled plasma donors with a broad range of antibodies; IgG subclasses similar to normal human serum.

Typical indications (summary)Used for replacement in primary humoral immunodeficiencies and for multiple immune-mediated and transplant-related indications.

HCT recipient criterion

HCT recipient criterion (example)

Policy Updates and Material Changes

2024-11-06additionLatest

Aquaporin-4 IgG-positive NMOSD, Immune-Mediated Necrotizing Myopathy (IMNM), and Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) were added to the list of approved indications for IVIG.

2024-07-24product_addition

Yimmugo was added to the policy as an IVIG product covered under the same criteria as other immune globulin products.

2024-02-07

Policy Summary

PayerCareSource

PolicyIntravenous Immune Globulin (IVIG) utilization management

Policy CodePolicy N/A

Change TypeMaterial updates to indications, dosing, and approval durations

Effective DateNov 6, 2024

Next Review DateNov 6, 2024

Key ActionObtain prior authorization with documentation that the patient meets the indication-specific diagnostic, laboratory, prior-therapy, and prescriber specialty criteria.

SourceLink

On This Page

Documentation Required

Prescriber Specialty and Product Switching

Certain indications require that the prescriber be a specialist or that the therapy be prescribed in consultation with a specialist. If the prescriber is switching between IVIG products and the case has already been clinically approved, a new approval may be entered for the remaining doses and duration only when the indication and dosing remain the same.

Required prescriber specialty examples: allergist/immunologist, neurologist, hematologist/oncologist, infectious disease physician, rheumatologist, transplant center physician.
Product switching / preferred product handling: approved cases may be switched to another product without a full clinical re‑review only for the remaining approved duration and doses if indication and dosing are unchanged; preferred‑product substitutions under a separate IVIG medical management (MM) or step therapy program may be entered without another clinical review per that program.

Step Therapy

Prior Therapy and Step‑Therapy Requirements

Prior therapy requirements and step‑therapy rules apply for many autoimmune and neurologic indications. Requests must document prior trials of systemic corticosteroids and/or immunosuppressive or immunomodulatory agents when required, or document contraindications to these therapies. Continuation or retreatment approvals often require documentation of prior response to therapy and may have different approved durations than initial therapy.

Prior therapy requirements: document trials of systemic corticosteroids and immunosuppressive agents (examples: prednisone, methylprednisolone, methotrexate, azathioprine, mycophenolate) or prescriber‑stated contraindication.
Step therapy / prior treatment requirements: for some indications (e.g., dermatomyositis/polymyositis, immune‑mediated necrotizing myopathy, CIDP, MS relapses, MOGAD), initial approval requires failure of or contraindication to corticosteroids and/or immunosuppressants.
Initial versus continuation/retreatment: some indications specify shorter initial approval durations (e.g., 1–6 months) and separate continuation/retreatment pathways requiring evidence of response to prior IVIG.

Denial Risk

Denial Risks and Diagnosis Wording

Requests that do not meet the documented diagnostic, laboratory, prior‑therapy, prescriber specialty, dosing, or duration criteria in this policy are at risk of denial. In addition, IVIG is not recommended for a number of specific conditions listed below.

Denial triggers — not recommended conditions (non‑exhaustive examples): Alzheimer's disease, amyotrophic lateral sclerosis (ALS), asthma, atopic dermatitis, autism, Crohn's disease, complex regional pain syndrome, cystic fibrosis, diabetes immunotherapy, fibromyalgia, in vitro fertilization, POEMS syndrome, and other conditions listed in the 'Conditions Not Recommended for Approval' section.
Changes in diagnosis wording and specified indications: when diagnosis wording in the request differs from policy language (for example, pneumonitis vs pneumonia in CMV disease), ensure the clinical documentation aligns with policy intent; wording changes captured in policy history may affect how a diagnosis is evaluated.