ModifiedCentenePolicy CP.PHAR.103

Immune Globulins Prior Authorization Policy

Defines prior authorization requirements, clinical criteria, dosing limits, product preferences, and approval durations for immune globulin products for Centene commercial and Medicaid members.

Policy Summary

PayerCentene

PolicyImmune Globulins Prior Authorization Policy

Policy CodePolicy CP.PHAR.103

Change TypeCriteria revisions and added off‑label indications

Effective DateAug 12, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, specialist documentation, product name, weight‑basis dosing, and supporting labs to demonstrate criteria are met.

SourceLink

POLICY UPDATE CHANGES

Revised requirement for corticosteroid trial to apply only to CIDP (no longer to GBS/AIDP) and limited when CIDP has pure motor symptoms.

Added off‑label measles post‑exposure prophylaxis criteria for IVIG.

Added multiple new HCPCS/J‑codes (examples: J1551, J1577, J1553) and removed others (example: J1572, C9270).

Diagnostic terminology for CIDP updated to 'CIDP variants' aligning with 2021 EAN/PNS guidelines.

~24products requiring PA

6 monthstypical approval

~40excluded diagnoses (approx)

2 g/kgcommon monthly IV cap

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.

preferred product rule

Coverage Criteria and Indication-Specific Rules

A. Chronic Lymphocytic Leukemia / SLL (infection prophylaxis) — Covered when ALL of the following are met

A. Chronic Lymphocytic Leukemia / SLL (infection prophylaxis) — Covered when ALL of the following are met:

ALL of the following

Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Prescribed by or in consultation with a hematologist, oncologist, or immunologist.
Current (within the last 6 months) hypogammaglobulinemia documented by two separate measurements of immunoglobulin G (IgG) level < 500 mg/dL.
Member has had recurrent serious bacterial infections (e.g., requiring IV antibiotics, hospitalization, or infectious disease consultation) within the past 12 months.
Product/step criteria
- Request is for the treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix G).
- Request is for Gammagard or Gamunex-C unless there is a specific health plan-preferred immune globulin product.
- Failure of Gammagard and Gamunex-C (or health plan-preferred immune globulin product).
- Member has intolerance or contraindication to Gammagard and Gamunex-C (or health plan-preferred immune globulin product), or both are unavailable due to shortage; member must use Gammaked unless contraindicated or clinically significant adverse effects occur.
- Gammagard (or health plan-preferred immune globulin product), Gamunex-C, and Gammaked are all unavailable due to shortage and request is for another immune globulin product.
Dose does not exceed 400 mg/kg IV every 3 to 4 weeks, OR dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
For adults, calculate dosing based on total body weight (TBW) or ideal body weight (IBW), whichever is less. For obese members use adjusted body weight (adjBW). See Appendix F for weight-based dosing.

paragraphs[]? omitted? (not allowed)

B. CAR T-Cell-Related Toxicities — Covered when ALL of the following are met

B. CAR T-Cell-Related Toxicities — Covered when ALL of the following are met:

ALL of the following

Indication
- Management of grade 4 cytokine release syndrome (CRS).
- Secondary hypogammaglobulinemia for infection prophylaxis following anti-CD19 CAR T-cell therapy (see dosing and lab criteria below).
- Acute inflammatory demyelinating polyneuropathy (AIDP)-type presentation or bilateral facial palsy related to CAR T-cell therapy.
Prescribed by or in consultation with a hematologist, oncologist, or immunologist.
CRS-specific requirement

C. Dermatomyositis / Polymyositis — Covered when ALL of the following are met

C. Dermatomyositis / Polymyositis — Covered when ALL of the following are met:

ALL of the following

Diagnosis of dermatomyositis (DM) or polymyositis (PM).
Prescribed by or in consultation with a dermatologist, rheumatologist, neurologist, or neuromuscular specialist.
Failure of a 4-month trial of a systemic corticosteroid in combination with one of the following immunosuppressive agents at up to maximally indicated doses unless contraindicated or clinically significant adverse effects occur: methotrexate, azathioprine, cyclophosphamide, mycophenolate mofetil, tacrolimus, or cyclosporine (see Appendix D).
For dermatomyositis requests only: failure of a trial of rituximab unless contraindicated, clinically significant adverse effects are experienced, or the member has juvenile dermatomyositis (JDM).
Prior authorization may be required for rituximab.

Billing Codes, Dosing Limits, and Coding Notes

ICD-10 codes cited in exclusionsICD-10Not Covered

G7281	Critical illness myopathy (ICD10: G7281)
G603	Idiopathic progressive neuropathy (ICD10: G603)
H209	Iridocyclitis, unspecified (ICD10: H209)
H05123	Orbital myositis, bilateral (ICD10: H05123)
I788	Other diseases of capillaries [Clarkson disease] (ICD10: I788)

No explicit CPT/HCPCS/ICD codes in this extractmixed

No codes listed

No explicit codes in this sectionmixed

No codes listed

Covered HCPCS/J Codes (sample group 1)HCPCSCovered

J1459	Injection, immune globulin (Privigen), intravenous, non-lyophilized (e.g., liquid), 500 mg.
J1460	Injection, gamma globulin, intramuscular, 1 cc.
J1551	Injection, immune globulin (Cutaquig), 100 mg.
J1552	Injection, immune globulin (alyglo), 500 mg.
J1553	Injection, immune globulin (yimmugo), 100 mg.
J1554	Injection, immune globulin (Asceniv), 500.
J1555	Injection, immune globulin (Cuvitru), 100 mg.
J1556	Injection, immune globulin (Bivigam), 500 mg.

Covered HCPCS/J Codes (sample group 2)HCPCSCovered

J1557	Injection, immune globulin (Gammaplex), intravenous, non-lyophilized (e.g., liquid), 500 mg.
J1558	Injection, immune globulin (Xembify), 100 mg.
J1559	Injection, immune globulin (Hizentra), 100 mg.
J1560	Injection, gamma globulin, intramuscular, over 10 cc.
J1561	Injection, immune globulin (Gamunex-C/Gammaked), intravenous, non-lyophilized (e.g., liquid), 500 mg.
J1566	Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg.
J1568	Injection, immune globulin (Octagam), intravenous, non-lyophilized (e.g., liquid), 500 mg.
J1569	Injection, immune globulin (Gammagard liquid), intravenous, non-lyophilized (e.g., liquid), 500 mg.
J1575	Injection, immune globulin/hyaluronidase (Hyqvia), 100 mg immuneglobulin.
J1577	Injection, immune globulin (panzyga), intravenous, non-lyophilized (e.g., liquid), 500 mg.

1–10 of 13

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Dosing caps and thresholds — multiple indication-specific limits

General monthly capDose does not exceed 2 g/kg IV per month (adult dosing based on TBW or IBW, whichever is less; use adjBW for obese).

AIDP/GBS regimen0.4 g/kg IV per day for 5 days (typical course for AIDP/GBS).

CIDP loading/maintenanceLoading dose up to 2 g/kg IV divided over 2–5 days, then maintenance 1 g/kg IV every 3 weeks (or SC alternatives per product).

MMN monthly ceilingDose does not exceed 2.4 g/kg IV per month for multifocal motor neuropathy unless guideline-supported evidence provided.

Dermatomyositis ceilingDoes not exceed 2 g/kg IV per month for dermatomyositis unless supported by guidelines/literature with prescriber evidence.

Prior Authorization, Documentation, Step Therapy and Denial Risks

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization (PA) is required for requests for the immune globulin products listed in this policy. Requests must include the specific product, indication, dosing regimen, and the weight-basis used to calculate the dose (TBW, IBW, or adjBW as applicable).

PA required for listed products (see policy Product list)
Prescriber must specify product name, formulation, indication, dose, and weight basis (TBW/IBW/adjBW)

Prior Authorization

Prior Authorization Considerations

Prior Authorization Considerations: All PA requests will be reviewed for appropriate diagnosis, prescriber specialty, product-preference/step therapy adherence, dosing limits, and prior therapy requirements. Requests that exceed stated dosing caps or are for off-label uses must be supported by practice guidelines or peer-reviewed literature; prescribers must submit supporting evidence. Requests for oncology-associated treatments may be subject to state-specific redirection/step-therapy exceptions (see Appendix G).

Requests exceeding dosing limits require clinical justification and literature support

Definitions, Abbreviations and Weight Calculation Guidance

Abbreviations

AIDPAcute inflammatory demyelinating polyneuropathy (AIDP).

CIDPChronic inflammatory demyelinating polyneuropathy (CIDP).

CVIDCommon variable immunodeficiency (CVID).

IVIG/SCIGIVIG = intravenous immune globulin; SCIG = subcutaneous immune globulin.

CRSCytokine release syndrome (CRS).

Weight calculation note

Adult dosing noteCalculate doses using TBW or IBW, whichever is less; for obese members use adjusted body weight (adjBW) per Appendix F.

Background and Usage Context

Immune globulins are used for replacement therapy in primary humoral immunodeficiency and for multiple other FDA‑approved and off‑label indications such as infection prophylaxis in CLL/SLL, CIDP, ITP, dermatomyositis, CAR T‑cell–related hypogammaglobulinemia, and viral post‑exposure prophylaxis. Route of administration varies by product (IV, SC, IM) and dosing and monitoring guidance (including pre‑infusion trough IgG and weight‑based calculations) are provided elsewhere in the policy.

Policy Updates and Material Changes

2026-04-24amendment

2Q 2026 annual review: added CAR‑T cell–related toxicity uses (AIDP‑type picture or bilateral facial palsy), added off‑label indications (immune checkpoint inhibitor toxicities, LCHI/ND, HIT, pediatric ALL), and added HCPCS code J1553; updated Appendix G and clarified exclusions and bypass options.

2026-01-21addition

Added off‑label measles post‑exposure prophylaxis criteria for IVIG (P&T approval 02.26.26).

2026-01-06removal

Policy Summary

PayerCentene

PolicyImmune Globulins Prior Authorization Policy

Policy CodePolicy CP.PHAR.103

Change TypeCriteria revisions and added off‑label indications

Effective DateAug 12, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, specialist documentation, product name, weight‑basis dosing, and supporting labs to demonstrate criteria are met.

SourceLink

On This Page

For CRS, failure of both high-dose systemic corticosteroids and anti-IL-6 therapy (see Appendix B), unless clinically adverse effects are experienced or both are contraindicated.

Secondary hypogammaglobulinemia criteria

Member received anti-CD19 CAR T-cell therapy (e.g., axicabtagene ciloleucel, tisagenlecleucel, etc).
Current (within the last 6 months) hypogammaglobulinemia evidenced by two separate IgG measurements < 600 mg/dL.
Member has had recurrent serious bacterial infections (e.g., requiring IV antibiotics, hospitalization, or infectious disease consultation) within the past 12 months.

Product/step criteria

Request is for the treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix G).
Request is for Gammagard or Gamunex-C unless there is a specific health plan-preferred immune globulin product.
Failure of Gammagard and Gamunex-C (or health plan-preferred immune globulin product).
Member has intolerance or contraindication to Gammagard and Gamunex-C (or health plan-preferred immune globulin product), or both are unavailable due to shortage; member must use Gammaked unless contraindicated or clinically significant adverse effects occur.
Gammagard (or health plan-preferred immune globulin product), Gamunex-C, and Gammaked are all unavailable due to shortage and request is for another immune globulin product.

Dose is within FDA maximum limits for any FDA-approved indication OR is supported by practice guidelines or peer-reviewed literature for the off-label use (prescriber must submit supporting evidence).

For adults, calculate dosing based on TBW or IBW, whichever is less. For obese members use adjBW. See Appendix F for weight-based dosing.

paragraphs[]? omitted? (not allowed)

Product/step criteria

For Octagam requests, member has dermatomyositis (DM).
Request is for Gammagard or Gamunex-C unless there is a specific health plan-preferred immune globulin product.
Failure of Gammagard and Gamunex-C (or health plan-preferred immune globulin product).
Member has intolerance or contraindication to Gammagard and Gamunex-C (or health plan-preferred immune globulin product), or both are unavailable due to shortage; member must use Gammaked unless contraindicated or clinically significant adverse effects occur.
Gammagard (or health plan-preferred immune globulin product), Gamunex-C, and Gammaked are all unavailable due to shortage and request is for another immune globulin product.

Dose does not exceed 2 g/kg IV per month OR dose is supported by practice guidelines or peer-reviewed literature for the off-label use (prescriber must submit supporting evidence).

For adults, calculate dosing based on TBW or IBW, whichever is less. For obese members use adjBW. See Appendix F for weight-based dosing.

paragraphs[]? omitted? (not allowed)

IgG or dosing thresholds

IgG threshold for MM prophylaxis and oncologyTwo IgG measurements <400 mg/dL within the last 6 months required for certain oncology/CAR-T and MM infection prophylaxis criteria.

PI monitoring trough targetFor lifelong PI treatment, monitor pre-infusion (trough) serum IgG every 3 months aiming for low-normal levels (usually 400–600 mg/dL).

General dosing caps referencedExamples include ≤2.4 g/kg IV per month (MMN), ≤400 mg/kg IV every 2–4 weeks (various prophylaxis/maintenance), and ≤2 g/kg per month for some indications.

Dose limits per indication

ITP regimens≤1 g/kg/day IV for 1–2 days OR ≤400 mg/kg/day IV for up to 5 days (weight basis TBW or IBW; adjBW if obese).

Kawasaki dosing options≤1 g/kg IV single infusion OR ≤400 mg/kg IV daily for 4 days OR ≤2 g/kg IV single infusion (approval one time, 1 month).

Parvovirus initial/maintenanceInitial up to 2 g/kg per day for up to 5 days followed by maintenance 400 mg/kg IV every 4 weeks for parvovirus B19 anemia.

Primary immunodeficiency ceilingsIV: ≤800 mg/kg every 3–4 weeks; SC: ≤600 mg/kg every 3–4 weeks (or SC conversion rules per product).

Obesity threshold

Obesity definition for dosingObesity defined as BMI ≥ 30 kg/m2 or total body weight >20–30% over ideal body weight; use adjusted body weight (adjBW) for dose calculations in obese members.

Weight-based dosing — TBW/IBW/adjBW guidance

Weight-basis ruleFor adults use the lesser of total body weight (TBW) or ideal body weight (IBW) for dosing; use adjusted body weight (adjBW) for obese members (see Appendix F).

IBW formulasIBW male = 50 kg + 2.3 kg per inch over 5 feet; IBW female = 45.5 kg + 2.3 kg per inch over 5 feet (Appendix F).

AdjBW calculationAdjBW = IBW + 0.4 × (TBW − IBW); recommended online calculators referenced (MDCalc).

State-specific oncology step-therapy bypasses (Appendix G) may apply

Product interchangeability and plan discretion to prefer clinically appropriate alternative products

Documentation Required

Weight-based Dosing and Product-specific PA

Weight-based dosing and Product-specific PA: Dosing calculations must use the appropriate weight basis: for adults calculate using the lesser of total body weight (TBW) or ideal body weight (IBW); for obese members use adjusted body weight (adjBW). When requesting doses that differ from listed caps, prescribers must submit clinical justification and supporting literature. PA decisions will reflect product-specific dosing recommendations and maximums in Section V and Appendices.

Use TBW or IBW (whichever is less) for most adults; use adjBW for obesity (see Appendix F)
Provide documentation if requested dose exceeds policy dose caps (e.g., >2 g/kg/month for many IV indications)

Documentation Required

Prescriber Must Submit Supporting Evidence

Prescriber Submission Requirements: Prescribers must submit supporting clinical documentation with the PA request (office chart notes, relevant labs, imaging, electrodiagnostic testing, specialist consultation notes, serum IgG levels and functional antibody testing where relevant). For requests that involve dosing above policy limits or off-label indications, include practice guideline citations or peer-reviewed literature supporting the regimen.

Required documentation: chart notes, lab results (e.g., two IgG measurements when required), specialist consult notes
For PI: document baseline and trough IgG levels and plan for monitoring

Documentation Required

Required Clinical Documentation and Prescriber Specialty

Required Clinical Documentation & Prescriber Specialty: PA requests must document the diagnosis and meet indication-specific criteria (including diagnostic testing where required). Many indications require the prescription to be written by or in consultation with the specialty listed in the criteria (e.g., immunologist/hematologist for PI; neurologist for CIDP/MG/MMN; rheumatologist/dermatologist for dermatomyositis and pemphigus disorders; cardiologist or infectious disease for Kawasaki). Failure to include required specialist involvement or documentation may lead to denial.

Ensure prescriber is of required specialty or documentation of consultation is attached
Diagnostic confirmation (e.g., electrodiagnostic testing for CIDP) must be provided when listed

Documentation Required

Required Clinical Monitoring and Diagnostic Documentation

Required Clinical Monitoring and Diagnostic Documentation: For primary immunodeficiency and other chronic indications, document baseline and ongoing monitoring plans. Serum trough IgG levels should be measured prior to infusion and then at regular intervals (typically every 3 months for lifelong therapy) to maintain target troughs; include reference ranges and plans to adjust dose per clinical response.

Document plan for pre-infusion (trough) IgG monitoring and frequency
Provide evidence of functional antibody testing where required (e.g., response to vaccine antigens)

Denial Risk

Requests Exceeding Stated Dosing Limits

Dose Limits, Exceptions, and Requests Exceeding Limits: The policy lists dose ceilings for many indications (e.g., IV monthly caps, CIDP loading and maintenance, AIDP/GB dosing, etc.). If the requested dose exceeds policy limits, the prescriber must provide supporting guidelines or peer-reviewed literature justification; unsupported dose-exceeding requests may be denied.

Common caps include: AIDP/GB 0.4 g/kg/day x5 days; CIDP loading 2 g/kg then 1 g/kg q3 weeks; many IV monthly caps ~2 g/kg/month or indication-specific limits
Prescriber must attach literature/guideline support for higher dosing

Denial Risk

Dose and Prescriber Noncompliance Risk

Dose and Prescriber Noncompliance: Requests that do not adhere to policy dosing calculations (weight basis) or lack required prescriber specialty/consultation may be denied. If the member is already receiving therapy and continuity/renewal rules apply, documentation of ongoing response and prior approvals should be provided.

Noncompliance examples: using TBW when IBW should be used without justification; missing required specialist consultation
For continuation requests: include evidence of clinical response and prior approval history

Denial Risk

Contraindication Triggers

Contraindication Triggers and Safety Documentation: Document any history of severe anaphylactic or systemic reactions to human immune globulin and test for anti-IgA antibodies in IgA-deficient patients with suspected hypersensitivity. Requests for patients with documented contraindications may be denied. Be aware of boxed warnings (thrombosis, renal dysfunction, acute renal failure) and include relevant safety monitoring plans.

Contraindications: history of anaphylactic or severe systemic reactions to human immune globulin; IgA-deficient patients with anti-IgA antibodies and prior hypersensitivity
Include safety monitoring plans for renal function and thrombosis risk when appropriate

Denial Risk

Excluded and Investigational Indications — Denial Risk

Excluded/Investigational Indications — Denial Risk: The policy lists conditions for which immune globulins are considered not medically necessary or investigational (see Section III). Requests for these excluded indications are at high risk for denial unless adequate evidence per off-label policies (CP.CPA.09 for commercial; CP.PMN.53 for Medicaid) is supplied demonstrating efficacy and safety.

Providers should reference off-label use policies if requesting coverage for indications not authorized in this policy
Examples of excluded conditions are listed in Section III of the policy

Step Therapy

Preferred Product / Step Therapy Preference

Preferred Product / Step Therapy Preference and Product Sequencing: The plan generally prefers Gammagard or Gamunex-C (or a health plan-preferred product) as first-line IVIG for many indications. Requests for non-preferred products usually require prior trial and failure of preferred products, intolerance/contraindication documentation, or evidence of product shortage. Exceptions include state oncology redirection rules and specific indication-based exceptions in the policy.

Trial/failure of Gammagard and Gamunex-C required unless documented intolerance, contraindication, shortage, or state/regulatory exception
For continued therapy, members on Gammagard or Gamunex-C may continue on that product unless medical justification supports a switch

Step Therapy

Therapy Sequencing and Prior Treatment Requirements

Therapy Sequencing and Prior Treatment Requirements: Many indications require documented failure of specified prior therapies before approval (e.g., corticosteroids and immunosuppressants for dermatomyositis; corticosteroid trial for CIDP except for pure motor CIDP; failure of rituximab for certain dermatomyositis/pemphigus cases unless exceptions apply). Prior authorization may be required for some comparator therapies (e.g., rituximab, MS therapies).

Document trials of required prior agents at maximally indicated doses unless contraindicated or intolerant
State- and condition-specific revisions (e.g., corticosteroid trial requirement limited to CIDP) must be followed

Note

Prophylactic IVIG in Multiple Myeloma

Prophylactic IVIG in Multiple Myeloma: For multiple myeloma infection prophylaxis, PA requires documentation of diagnosis, prescriber specialty, and IgG thresholds and/or recurrent infections as specified (e.g., IgG <400 mg/dL in many CAR-T/bispecific antibody contexts). Evidence for prophylactic IVIG in MM is mixed; reviewers may consider NCCN guidance and available literature when evaluating requests.

Document IgG measurements (two values within specified timeframe) and infection history when applicable
Provide NCCN or peer-reviewed support for prophylactic use when requested

Documentation Required

Document Product Name and Formulation

Document Product Name, Formulation and Presentation: Prescribers must indicate the exact product name, formulation (IV, SC, IM), concentration, and vial/presentation used. Product availability and formulation differences may affect dosing calculations and approval (see Section VI Product Availability).

Specify product trade name and route (e.g., Privigen IV, Hizentra SC) on the PA request
Include vial strengths or presentation if relevant to dosing/administration

Denial Risk

Medical Necessity Documentation and Denial Risk

Medical Necessity Documentation and Denial Risk: Providers should document medical necessity in accordance with standards of practice, guidelines, and the policy criteria. Failure to provide required documentation or evidence of medical necessity, or requests that do not meet diagnostic, prescriber, prior therapy, product preference, or dosing criteria, may be denied.

Incomplete submissions or missing required documentation may result in denial
Attach specialist assessments, labs, diagnostic tests, and therapy history to support medical necessity

Appendix referenceAppendix F contains IBW and adjBW formulas and links to online calculators (MDCalc).

RationaleCost-effective and safety-oriented dosing achieved by using lesser of TBW or IBW; adjBW applied when TBW substantially exceeds IBW.

Weight-based dosing instruction

Primary instructionUse total body weight (TBW) or ideal body weight (IBW), whichever is less, for adult dose calculations; for obese members use adjusted body weight (adjBW).

When to use adjBWAdjBW should be used when BMI ≥30 kg/m2 or TBW exceeds IBW by 20–30% (see Appendix F for formula).

Product switchingWhen switching IV to SC dosing, follow product-specific conversion (e.g., SC = previous IV grams / weeks × 1.37) and apply weight-basis rules.

Primary immunodeficiencies (PI)

Included PI disordersAgammaglobulinemia; common variable immunodeficiency (CVID); congenital hypogammaglobulinemia; Hyper IgM syndromes; selective immunodeficiencies; SCID; subclass deficiency; functional/specific antibody deficiency.

Prescriber requirementPI management must be prescribed by or in consultation with an immunologist or hematologist (per PI criteria).

Diagnostic evidenceCurrent total or subclass immune globulin deficiency requires two separate measurements (within last 6 months) and/or impaired antibody responses to protein/polysaccharide antigens.

NCCN Compendium Indications

NCCN-supported oncology indicationsImmune checkpoint inhibitor-related toxicities; LCH-associated CNS/neurodegeneration (LACI/ND); refractory/autoimmune HIT; pediatric ALL (with specified prior therapies and hypogammaglobulinemia).

Oncology bypass noteState-specific protections may allow bypass of step therapy for cancer-associated indications (see Appendix G).

DocumentationPediatric ALL requires two IgG measurements <400 mg/dL within last 6 months and evidence of prior specified therapies (e.g., inotuzumab, blinatumomab, tisagenlecleucel).

adjBW / TBW / IBW

adjBW definitionAdjBW = adjusted body weight; formula: IBW + 0.4 × (TBW − IBW).

TBW definitionTBW = total body weight (actual body weight).

IBW definitionIBW = ideal body weight (male = 50 kg + 2.3 kg per inch over 5 ft; female = 45.5 kg + 2.3 kg per inch over 5 ft).

Common abbreviations (AIDP/CRS/CVID/IVIG/SCIG)

AIDPAIDP = acute inflammatory demyelinating polyneuropathy.

CRSCRS = cytokine release syndrome.

CVIDCVID = common variable immunodeficiency.

IVIG/SCIGIVIG = intravenous immune globulin; SCIG = subcutaneous immune globulin (appendix definitions).

Other acronymsFNAIT = fetal/neonatal alloimmune thrombocytopenia; LCH = Langerhans cell histiocytosis; MG = myasthenia gravis; MMN = multifocal motor neuropathy.

ITP classification

Newly diagnosed ITPNewly diagnosed: diagnosis to 3 months.

Persistent ITPPersistent: 3 to 12 months from diagnosis.

Chronic ITPChronic: lasting more than 12 months.

GBS timing

Typical GBS time courseGBS typically progresses over ~2 weeks with nadir by 4 weeks. Initiation of IVIG within 2 weeks of symptom onset is effective and comparable to plasma exchange.

Diagnostic featuresGBS subtypes include AIDP, AMAN, AMSAN, and Miller Fisher syndrome; elevated CSF protein with normal WBC often present.

Pulmonary risk thresholdsPulmonary risk factors: FVC <20 mL/kg, maximal inspiratory pressure <30–40 cm H2O, or 30% reduction in vital capacity from baseline.

CVID diagnostic criteria

CVID diagnostic elementsLow serum IgG ≥2 SD below mean for age PLUS impaired antibody response to protein and polysaccharide antigens (serum IgG alone insufficient).

Typical IgG valuesMany patients with CVID have IgG levels below ~639 mg/dL; diagnosis depends on impaired prolonged antibody response to immunization.

Monitoring requirementPre-infusion trough IgG measurements and ongoing monitoring every 3 months for lifelong therapy.

Common variable immunodeficiency (CVID)

CVID definition summaryCommon variable immunodeficiency: primary immunodeficiency with low serum IgG (≥2 SD below mean for age), often low IgA/IgM and impaired antibody responses to immunization.

Diagnosis requirementDefinitive diagnosis requires demonstrating impaired prolonged antibody response to protein or polysaccharide antigens.

Clinical implicationIVIG reserved for patients with serious defects of antibody function; ongoing monitoring of trough IgG required.

IgG subclass deficiency (IGGSD)

IGGSD diagnostic thresholdIgG subclass deficiency diagnosed with deficiency in one or more IgG subclasses (less than 5th percentile or ≥2 SD below) with normal total IgG, IgM, and IgA and recurrent infections.

Clinical contextConsider IGGSD in recurrent respiratory infections with appropriate subclass reductions; evaluate functional antibody responses.

Laboratory requirementConfirm subclass levels and correlate with clinical infection history before IVIG consideration.

Stiff person syndrome

SPS definitionStiff person syndrome is a rare progressive neurologic disorder with axial rigidity and painful spasms, often associated with anti‑GAD autoantibodies.

First-line symptomatic therapyInitial treatments include diazepam and baclofen at high dosages; immunologic therapies (steroids, PLEX, IVIG) considered if symptomatic therapy fails.

When to consider IVIGIVIG considered for refractory disease when symptomatic agents are insufficient; dosing limit example: ≤2 g/kg IV divided over 2–5 days per course.

TBW/IBW/adjBW

Weight-basis options acknowledgedPolicy references three weight-basis options for dosing: total body weight (TBW), ideal body weight (IBW), and adjusted body weight (adjBW) for obese members.

Appendix F locationAppendix F provides formulas and calculators for IBW and adjBW and guidance to use lesser of TBW or IBW except when adjBW indicated.

Practical noteWhen switching between IV and SC, apply same weight-basis rules and product-specific conversion factors.

Immune Thrombocytopenic Purpura (ITP)

ASH guideline references for ITPASH and international consensus guidelines cited supporting IVIG use for ITP diagnosis and management (references provided).

Response definitionsASh guidelines define early, initial, and durable responses and platelet thresholds used to assess efficacy (Appendix guidance).

Clinical implicationIVIG is used as first-line for acute ITP with defined response criteria and monitoring.

Kawasaki Disease

Kawasaki guideline citationsMultiple guideline sources cited (AHA 2017; ACR/VF 2021/2022 updates) supporting IVIG as standard therapy for Kawasaki disease.

Retreatment guidanceRetreatment (2 g/kg) may be used for persistent/recurrent fever ≥36 hours after initial infusion.

Approval durationAcute Kawasaki IVIG approval is one time (1 month) per policy dosing and continuation rules.

CIDP variants

CIDP terminology updatePolicy uses updated terminology 'CIDP variants' aligning with 2021 EAN/PNS guidelines (replaces prior 'atypical CIDP').

Implication for diagnosisDiagnostic criteria for CIDP reflect updated variant classifications and electrodiagnostic confirmation requirements.

DocumentationPrescribers must provide electrodiagnostic testing and exclude alternative causes as required by CIDP criteria.

Oncology bypass

Oncology bypass exceptionExceptions permit bypass of usual step therapy/redirection in certain oncology settings (e.g., CAR-T cell therapies, bispecific antibodies, or state-regulated cancer protections per Appendix G).

NCCN alignmentOncology and CAR-T exceptions align with NCCN Compendium indications and state-specific protections where applicable.

Provider documentationRequests for oncology bypass should document cancer-associated indication and applicable state regulation or NCCN recommendation.

Removed HCPCS code J1572 from the policy.

2025-09-19amendment

For continued therapy, added language allowing continuation of health plan–preferred immune globulin products unless medical justification supports a switch.

2025-07-09addition

Added new formulation of Gammagard and implemented step therapy bypass for IL HIM per IL HB 5395 and allowed bypasses for non‑formulary agents.

2024-06-18addition

RT4: added Yimmugo to the policy.

2024-01-17amendment

RT4: for HyQvia and Gammagard Liquid, added CIDP indication per updated product information.

2023-12-27addition

RT4: added Alyglo to the policy.

2022-06-30addition

Added HCPCS code J1551 for Cutaquig.

2022-04-20amendment

Removed acute lymphoblastic leukemia from Section III exclusions and revised continued therapy approval duration for HIM to allow 12 months for PI per Illinois law.

2021-09-17revisionLatest

Revised requirement for trial of corticosteroid before IVIG to apply only to CIDP (no longer to GBS/AIDP) and only when CIDP is not pure motor.

Section III exclusions were edited across policy updates with examples of removals and clarifications: the policy records removal of acute lymphoblastic leukemia and Rasmussen’s syndrome from the exclusions list and documents state‑specific exceptions for PANDAS/PANS in multiple jurisdictions.

A prior‑treatment requirement change was made: the corticosteroid trial requirement now applies only to CIDP (not to GBS/AIDP), and only when the CIDP patient does not have pure motor symptoms; this revision may affect prior authorization outcomes for CIDP requests.

An off‑label criterion for measles post‑exposure prophylaxis (PEP) using IVIG was added to the policy in 01.21.26, with an associated P&T approval on 02.26. This provides a formalized pathway for measles PEP in eligible exposed individuals.

HCPCS/J‑code changes have been made over time and are documented in the policy updates (examples include additions such as J1551, J1553 and removals such as J1572); providers should use current billing code lists in the policy when submitting prior authorization requests.