CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Prior authorization and coverage criteria for IVIG products (listed brands) across FDA-approved and other supported indications, with dosing, prescriber specialty requirements, approval durations, and continuation criteria. This is part 1 of 2 and contains overview, indications, and recommended authorization criteria through item 16 (partial).

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeClarified / Added / Revised / Administrative

Effective DateNov 6, 2024

Next Review DateN/A

Key ActionAll IVIG requests require prior authorization and will be approved only when criteria and dosing for the specific indication are met; approvals provided for the duration noted.

SourceLink

POLICY UPDATE CHANGES

Cytomegalovirus Pneumonitis wording changed to include 'pneumonitis' replacing prior 'pneumonia' wording.

Multiple Myeloma: added option for approval when patient will be starting, has taken, or is currently receiving CAR-T cell therapy or bispecific antibody therapy.

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

Immune Thrombocytopenia (ITP) duration for initial therapy changed from 1 year to 3 months; continuation/retreatment criteria updated.

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

Multiple editorial/formatting updates and annual revisions with review date 10/25/2023 and 11/06/2024 noted.

15+Indications (FDA-approved and supportive evidence) listed

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 Summary

This policy covers prior authorization and utilization management for intravenous immune globulin (IVIG) products — pooled, concentrated human IgG preparations (brands listed in the policy) — for replacement therapy in primary humoral immunodeficiencies and for multiple immune-mediated and transplant- or cancer-related conditions. Requests require prior authorization and will be approved only when the patient meets the indication-specific criteria, dosing, prescriber specialty/consultation requirements, and duration limits outlined in the policy. Continued or extended approvals are allowed when the patient continues to meet the criteria and dosing and when the prescriber documents clinical benefit.

This submission represents part 1 of 2 (partial): it contains the overview, indications, and recommended authorization criteria through item 16. Effective/last review date: 2024-11-06 (review date noted in policy).

IVIG quick thresholds & facts

IgG threshold (general / CLL / HCT criteria)<= 600 mg/dL (6.0 g/L)

Severe hypogammaglobulinemia threshold (HIV / pediatric / HCT guidance)<= 400 mg/dL (4.0 g/L)

Target IgG trough to maintain (HCT / first 100 days guidance)> 400–500 mg/dL (maintain trough >400 mg/dL; target 400–500 mg/dL)

Alternate trough/CLL dosing target> 500 mg/dL (CLL preventive dosing option to maintain trough >500 mg/dL)

Creatine kinase (CK) threshold for IMNM> 1,000 IU/L

Number of indications summarized~15+ listed FDA-approved/supportive indications

Approximate conditions addressed in policy~30+ conditions referenced across FDA and supportive evidence

Specialist/prescriber requirement noteMany indications require prescription by or consultation with a relevant specialist (eg neurologist, hematologist, oncologist, transplant physician, immunologist, infectious disease, pediatric cardiologist)

Medical-Necessity Criteria (by indication)

General Policy Statement

Covered when ALL of the following general policy statements are met:

ALL of the following

Request is for an FDA‑labeled intravenous immune globulin (IVIG) product or an indicated off‑label use described in this policy.
Clinical documentation is provided that supports the diagnosis and indication, including relevant laboratory, imaging, and specialist consult notes when required by indication.
Dose, frequency, and duration requested are consistent with the dosing and duration parameters specified for the indication in this policy.
Prior authorization has been obtained when required by the payer; medical necessity documentation is available for review upon request.

Products and Codes Referenced

Products referenced (policy applies to listed IVIG 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 intravenous solution - Baxalta (Takeda)
Flebogamma DIF	immune globulin intravenous solution - Grifols
Gammagard SID	immune globulin intravenous solution - Baxalta (Takeda)
Gammaked	immune globulin solution - Kedrion
Gammaplex	immune globulin intravenous solution - Bio Products Laboratory/Kedrion
Octagam	immune globulin intravenous solution - Octapharma/Pfizer
Gamunex-C	immune globulin solution - Grifols

1–10 of 13

1/2

No procedure/cpt/hcpcs codes listed in this partmixed

No codes listed

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for IVIG product initiation and for continuation beyond the initial approval period. Providers must obtain prior authorization through CareSource's utilization management process before administering or dispensing IVIG.

Documentation Required

Specialist Prescribing / Consultation Required

IVIG must be prescribed or ordered by a specialist appropriate to the treated condition (for example: hematology/oncology, immunology, neurology, transplant medicine, rheumatology). If a non‑specialist initiates therapy, documentation must include specialist consultation notes or a plan for prompt specialist follow‑up.

Documentation Required

Clinical Response Documentation for Continuation

For requests for continuation of IVIG (beyond initial course or authorization), submit documentation of clinical response and rationale for ongoing therapy. Documentation should include objective measures of benefit (laboratory values such as IgG trough levels where applicable, vaccination titers when used for prophylaxis, platelet counts for ITP, functional scores or strength testing for neurologic indications, infection frequency for immunodeficiency) and the treating specialist's assessment that the member continues to derive clinical benefit.

Background, Evidence, and Definitions

IVIG products are pooled human plasma–derived immunoglobulin G preparations used for replacement therapy in patients with primary humoral immunodeficiencies and for a wide range of immune-mediated, infectious, neurologic, hematologic, and transplant-related indications. The policy notes many uses extend beyond FDA approvals and that evidence for some off-label indications is limited and often derived from case series, cohort studies, or expert guidance.

Dosing regimens, frequency, and duration vary substantially by indication (examples include loading doses, maintenance intervals, and indication-specific trough IgG targets). Because evidence can be limited, many recommendations and criteria rely on professional society guidelines and specialty clinical practice (e.g., NCCN, AAN, ASH, ASBMT, AAP, KDIGO) and on prescriber specialty consultation where noted.

Evidence	Detail
Randomized trial for Alzheimer disease	Phase III trial (n=390) showed no significant benefit for IVIG
Guidelines cited	Multiple society guidelines and prescribing information referenced (NCCN, AAN, ASH, AAP, CDC, KDIGO, etc.)

Definitions

IVIG: Intravenous immune globulin (concentrated human IgG preparations)

HCT: Hematopoietic cell transplantation (allogeneic or autologous)

Revision History

11/06/2024administrative/editLatest

Annual revision with review date 11/06/2024 noted (multiple editorial/formatting updates and annual revisions).

10/25/2023administrative/edit

Annual revision with review date 10/25/2023 noted (multiple editorial/formatting updates).

10/25/2023clarification

FDA‑Approved Indications - Primary Immunodeficiencies (PID)

FDA‑Approved Indications: Primary Immunodeficiencies (PID). Approvals follow the Initial Therapy and Patient Currently Receiving branches below. Dosing is weight‑based unless otherwise specified.

A. Initial Therapy

Diagnosis of primary humoral immunodeficiency (PID) established by immunologist or appropriate specialist (examples: common variable immunodeficiency, X‑linked agammaglobulinemia, Wiskott‑Aldrich syndrome, severe combined immunodeficiency with predominant humoral defect).
Replacement therapy indicated for recurrent or severe infections related to antibody deficiency, or for prophylaxis as per specialty guidance.
- 0.4–0.6 g/kg IV every 3–4 weeks (typical maintenance range).
- 0.8–1.2 g/kg IV given as 0.4 g/kg IV on two consecutive days for some regimens.
- Higher or more frequent dosing individualized to maintain trough IgG levels appropriate for clinical control; document target trough and pre‑dose IgG level.
Initial approval duration: 12 months to allow stabilization and monitoring.

B. Patient Currently Receiving IVIG

Documented clinical benefit from IVIG (reduction in infections, decreased antibiotic courses, fewer hospitalizations, or improved quality of life/function).
Dose and frequency unchanged or adjusted with rationale; continued therapy requested for ongoing replacement.
Approval duration: 12 months (renewal requires documentation of continued benefit and monitoring of trough IgG if used to guide dosing).

ALL of the following

Special considerations: Subcutaneous immune globulin (SCIG) formulations may be used for PID when appropriate; this policy addresses IVIG dosing only. Transition documentation (reason for IV vs SC) should be provided.

FDA‑Approved Indications - B‑cell Chronic Lymphocytic Leukemia (CLL) for Prevention of Infections

FDA‑Approved Indication: B‑cell Chronic Lymphocytic Leukemia (CLL) — IVIG for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent infections.

Initial Therapy

Diagnosis of CLL confirmed by hematologist/oncologist.
Documented hypogammaglobulinemia and/or recurrent serious bacterial infections attributable to hypogammaglobulinemia.
Laboratory requirement: Serum IgG <= 600 mg/dL.
- 0.4 g/kg IV every 3–4 weeks.
- 0.4 g/kg IV every 2–3 weeks for patients with frequent infections or as clinically indicated.
Initial approval duration: 12 months; shorter initial authorizations may be issued per payer workflow but clinical aim is ongoing prophylaxis as long as criteria met and benefit observed.

Continuation Therapy

Documented clinical benefit: reduced frequency/severity of bacterial infections or other clinician‑documented prophylactic rationale.
Laboratory: most recent trough (pre‑dose) IgG provided; if IgG > 600 mg/dL, provide clinical justification for continued therapy.
Dose and frequency consistent with initial dosing; approval duration: typically 12 months.

ALL of the following

Specialist requirement: hematologist/oncologist involvement documented.

FDA‑Approved Indications - Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

FDA‑Approved Indication: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Requirements include electrodiagnostic confirmation and neurologist involvement; includes initial and continuation branches.

ALL of the following

Diagnosis of CIDP supported by electrodiagnostic studies (nerve conduction studies showing demyelinating features) or other accepted diagnostic criteria; documentation must be provided.
Prescribing clinician is a neurologist or peripheral nerve specialist.

Initial Therapy

Clinical presentation consistent with CIDP and impairment that warrants immunotherapy.
Dose: Loading regimen 2 g/kg IV given as a single dose or divided over 2–5 days as clinically appropriate.
- 1 g/kg IV every 3 weeks (typical maintenance).
- 0.4 g/kg IV every week (alternative maintenance schedule).
Initial approval duration: 8–12 weeks to assess response.

Continuation Therapy

Documented clinical improvement (e.g., improved strength, function, validated scales) during the initial treatment period.
Maintenance dosing consistent with regimens above; approval duration: typically 12 months with periodic documentation of continued benefit.

ALL of the following

If inadequate response to IVIG after an adequate trial, document alternative therapies tried or reasons IVIG remains appropriate.

FDA‑Approved Indications - Dermatomyositis / Polymyositis

FDA‑Approved Indication: Dermatomyositis / Polymyositis. Requires diagnosis confirmation, prior therapy trial or intolerance, and specialist management. Includes initial and continuation criteria with dosing.

ALL of the following

Diagnosis of dermatomyositis or polymyositis confirmed by rheumatologist or neurologist, with supporting clinical, laboratory, and/or biopsy findings.
Patients should have received or have contraindications/intolerance to first‑line therapy (corticosteroids with or without up to two conventional immunosuppressants) unless IVIG is initiated for an urgent indication documented by the specialist.

Initial Therapy

IVIG indicated for adult dermatomyositis refractory to or intolerant of standard therapy, or when rapid improvement is required as documented by specialist.
Dose: 2 g/kg IV given as a single dose or divided over 2–5 days per cycle (typical regimen).
Initial approval duration: 3 months to assess clinical response.

Continuation Therapy

Documented clinical response during the initial period (improvement in muscle strength, CK normalization or decline, functional gains).
Maintenance dosing individualized; commonly 1–2 g/kg IV every 4 weeks or other specialist‑directed schedule.
Approval duration: typically 12 months with periodic specialty documentation of ongoing benefit.

ALL of the following

Specialist requirement: rheumatologist or neuromuscular specialist managing care and documenting objective response measures.

FDA‑Approved Indications - Immune Thrombocytopenia (ITP)

FDA‑Approved Indication: Immune Thrombocytopenia (ITP). Covers adults and select pregnancy scenarios; includes specialist consult, initial and continuation criteria, dosing regimens, and duration notes.

ALL of the following

Diagnosis of ITP confirmed by hematologist or other qualified specialist; secondary causes ruled out or addressed.
IVIG is indicated when a rapid increase in platelet count is required to prevent or control bleeding, or to allow urgent surgery/procedure.

Initial Therapy - Adult

Dose regimens (choose one):
1 g/kg IV as a single dose (may repeat once) or 0.4 g/kg IV daily x3 days.
Pregnancy: IVIG may be used to rapidly increase platelets in pregnant patients when indicated; dosing as above in consultation with obstetric and hematology specialists.

Continuation Therapy

Continuation requires documentation of initial platelet response and ongoing clinical need (e.g., upcoming procedures, bleeding risk, or refractory disease).
If used as maintenance for chronic ITP, document alternative therapies attempted or contraindicated and specialist justification for ongoing IVIG; maintenance dosing individualized.
Approval duration: typically short term (e.g., up to 3 months) for episodic use; longer durations for documented chronic maintenance require specialist documentation and periodic reauthorization (commonly 12 months).

ALL of the following

Specialist requirement: hematologist involvement documented for continued/recurrent IVIG use in ITP.

FDA‑Approved Indications - Kawasaki Disease

FDA‑Approved Indication: Kawasaki Disease. Pediatric cardiology or pediatric infectious disease specialist involvement required; dosing up to 2 g/kg single or divided; typical approval is 3 months.

ALL of the following

Diagnosis of Kawasaki disease established by pediatric specialist following accepted clinical criteria.
Prescribing clinician: pediatric cardiologist, pediatric infectious disease specialist, or pediatric rheumatologist involvement documented.

ALL of the following

Dose: Up to 2 g/kg IV as a single infusion or divided over 2 days per specialist direction; may be repeated if clinically indicated.
Approval duration: initial authorization for 3 months to allow acute management and follow‑up for coronary artery outcomes.

ALL of the following

Adjunctive therapy (e.g., aspirin, corticosteroids) should be documented per guideline‑based care when applicable.

FDA‑Approved Indications - Multifocal Motor Neuropathy

FDA‑Approved Indication: Multifocal Motor Neuropathy (MMN). Requires diagnostic support, neurologist involvement, documented improvement, and maintenance dosing options.

ALL of the following

Diagnosis of MMN supported by clinical findings and electrophysiologic studies; documentation required.
Prescribing clinician is a neurologist or neuromuscular specialist.

Initial Therapy

Documented weakness pattern consistent with MMN and functional impairment warranting immunotherapy.
Dose: Typical induction/initial dosing often 2 g/kg IV divided over 2–5 days or 0.4 g/kg IV weekly depending on regimen.
Initial approval duration: 8–12 weeks to assess response.

Continuation Therapy

Documented clinical improvement in strength or function during initial therapy period.
Maintenance dosing options (choose one):
1 g/kg IV every 2–4 weeks.
0.4 g/kg IV weekly.
Approval duration: typically 12 months with periodic documentation of ongoing benefit.

ALL of the following

If inadequate response to IVIG, document alternative treatments tried or reason to continue IVIG; consider specialty peer review for ongoing authorization.

Other Uses with Supportive Evidence (selected examples)

Other Uses with Supportive Evidence (selected examples). These indications have varying levels of evidence; specialist involvement and indication‑specific dosing/duration are required as outlined below.

Antibody‑Mediated Rejection (ABMR)

Indication: Treatment of ABMR in solid organ transplantation as part of multi‑modality therapy (e.g., plasmapheresis, IVIG, anti‑CD20, lymphocyte‑depletion).
Prescribing clinician: transplant surgeon, transplant nephrologist, or transplant infectious disease specialist involvement documented.
Dose/duration: High‑dose regimens commonly used (e.g., 0.5–2 g/kg per course); specific protocol and combination therapy must be documented. Approval duration individualized; short‑term authorization for acute ABMR episodes, with reauthorization based on response and transplant team rationale.

Autoimmune Mucocutaneous Blistering Diseases

Indication: Refractory pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, or epidermolysis bullosa acquisita when standard therapy (systemic corticosteroid ± immunosuppressant) failed or contraindicated.
Specialist: dermatologist or dermatologic immunologist involvement required.
Dose/duration: Typical regimens include 2 g/kg IV per treatment cycle (single or divided) with maintenance dosing individualized; initial authorization commonly 3 months; continuation based on clinical response.

AQP4‑IgG Positive NMOSD

Indication: Acute attacks or when IVIG is chosen by specialist (e.g., pediatric patients or when other therapies contraindicated).
Specialist: neurologist with NMOSD expertise involvement documented.
Dose/duration: Common acute dosing 0.4–1 g/kg IV daily x3–5 days or 2 g/kg divided; authorization individualized based on attack severity with short‑term approval (e.g., up to 3 months) for acute management.

CMV Pneumonitis/Pneumonia

Indication: Adjunctive therapy for CMV pneumonitis/pneumonia in transplant or oncology patients when used with appropriate antivirals per NCCN guidance.
Specialist: transplant infectious disease or oncology/infectious disease specialist involvement documented.
Dose/duration: IVIG dosing per specialist protocol; authorization individualized for course duration of acute illness (short term).

Desensitization

Indication: Peri‑transplant desensitization protocols (e.g., low‑dose IVIG with plasmapheresis or high‑dose IVIG ± rituximab) to reduce donor‑specific antibodies prior to transplantation.
Specialist: transplant team documentation required; protocol and dosing must be provided.
Dose/duration: Protocol‑specific; typically short term around transplantation with authorization for the peri‑transplant period.

Guillain‑Barré Syndrome (GBS)

Indication: Patients with GBS who require aid to walk or ventilatory support; offer IVIG as per neurology guidelines within recommended time window (usually within 2–4 weeks of onset).
Specialist: neurologist involvement documented.
Dose: 0.4 g/kg IV daily x5 days or 2 g/kg total (single or divided).
Repeat course: May be considered for treatment‑related fluctuation; documentation required and specialist review advised.

Hematologic Neoplasm‑Associated Hypogammaglobulinemia / Secondary Immunodeficiency (SIDI)

Indication: Hypogammaglobulinemia associated with hematologic malignancy or B‑cell/plasma‑cell targeted therapies with recurrent or severe infections.
Laboratory: consider IVIG when serum IgG <= 400 mg/dL or per guideline thresholds (or IgG 400–600 mg/dL with serious/recurrent infections as per NCCN/CAR‑T guidance).
Specialist: hematologist/oncologist involvement required.
Dose/duration: Replacement dosing 0.4 g/kg IV every 3–4 weeks or as individualized to maintain protective trough IgG; authorization commonly 12 months with periodic reassessment.

Hematopoietic Cell Transplantation (HCT) - see HCT section for full dosing guidance

Indication: Use of IVIG in HCT recipients to prevent or treat infections per transplant guidelines; dosing and duration guidance provided in dedicated HCT criteria.

Hematopoietic Cell Transplantation (HCT) to Prevent Infection

Hematopoietic Cell Transplantation (HCT) to Prevent Infection. Includes initial versus continuation branches and detailed dosing options for first 100 days and beyond.

ALL of the following

Indication: Prevention of infections in HCT recipients (allogeneic or autologous) with severe hypogammaglobulinemia or per transplant program protocol.

Initial Therapy (first 100 days post‑HCT)

Adults and adolescents: 0.5 g/kg IV weekly during the first 100 days post‑HCT when severe hypogammaglobulinemia documented (e.g., serum IgG <= 400 mg/dL) or per transplant protocol.
Pediatric allogeneic HCT patients: 0.4 g/kg IV monthly during the first 100 days, adjusted per trough levels and clinical risk; higher or more frequent dosing may be necessary due to shortened IVIG half‑life.
Initial approval duration: up to 100 days post‑HCT; authorization may be issued for the peri‑transplant period with documentation of IgG levels and infection risk.

Continuation Therapy (>100 days post‑HCT)

Use beyond 100 days post‑HCT may be authorized when serum IgG remains <= 400 mg/dL or per clinical guideline thresholds and the patient has recurrent or severe infections.
Dose: 0.5 g/kg IV every 2–4 weeks or individualized dosing to maintain trough IgG > 400–500 mg/dL; approval duration: typically 12 months with periodic reassessment.

ALL of the following

Specialist requirement: transplant physician/heme‑oncologist documentation required; dosing individualized based on trough IgG monitoring and infection history.

Other Uses with Supportive Evidence - Dosing general

Other Uses with Supportive Evidence - Dosing (general). Listed dosing regimens and mapping used across HCT and related transplant/adjunctive protocols. Use these dosing options where referenced by indication.

ANY of the following

A. HCT / peri‑transplant dosing options:
0.5 g/kg IV weekly (adults/adolescents during first 100 days post‑HCT).
0.4 g/kg IV monthly (pediatric allogeneic HCT, adjust per levels).
0.5 g/kg IV every 2–4 weeks for continuation beyond 100 days, individualized to maintain trough IgG > 400–500 mg/dL.

ANY of the following

B. Replacement/maintenance dosing common across indications:
0.4 g/kg IV every 3–4 weeks.
0.4 g/kg IV every week (alternative regimen).
1 g/kg IV every 3–4 weeks or 1 g/kg IV every 2–4 weeks for select neurologic indications.

ANY of the following

C. High‑dose / acute immunomodulatory regimens:
2 g/kg IV as a single dose or divided over 2–5 days (e.g., CIDP induction, dermatomyositis induction, Kawasaki disease single dose up to 2 g/kg).
0.4 g/kg IV daily x3–5 days or 1 g/kg IV x1–2 doses for acute severe indications (e.g., GBS, ITP, NMOSD).

ALL of the following

Note: Dosing must be documented with patient weight and indication; when alternative regimens are used in the literature (e.g., 0.2–0.4 g/kg IV daily x5–10 days for parvovirus B19), document specialist rationale and supporting evidence.

Additional Selected Indications (HIV, IMNM, Immunotherapy‑Related Toxicities, LEMS, Multiple Myeloma, MS, MG, MOGAD, Passive Immunization, PEP, PRCA, FNAIT)

Additional selected indications. Each entry preserves initial/continuation logic, specialist requirements, dosing, and approval durations where applicable.

HIV - Prevention of Recurrent Infections

Indication: Recurrent bacterial infections due to hypogammaglobulinemia in patients with HIV; specialist (infectious disease or HIV clinician) involvement documented.
Dose/duration: IVIG replacement dosing 0.4 g/kg IV every 3–4 weeks; authorization individualized with periodic reassessment (commonly 12 months).

Immune‑Mediated Necrotizing Myopathy (IMNM)

Indication: Severe or refractory IMNM when first‑line immunosuppression inadequate; rheumatologist or neuromuscular specialist must document diagnosis and treatment history.
Dose: Induction commonly 2 g/kg IV (single or divided) with maintenance individualized; initial authorization typically 3 months for response assessment.

Immunotherapy‑Related Toxicities

Indication: Select immune‑related adverse events from checkpoint inhibitors where IVIG is recommended by treating oncologist/immunologist (e.g., severe neurologic toxicities) and standard measures failed or contraindicated.
Dose/duration: Specialist protocol; authorization individualized for acute management.

Lambert‑Eaton Myasthenic Syndrome (LEMS)

Indication: Severe LEMS with documented neuromuscular weakness and specialist neurology involvement.
Dose: Typical regimens include 2 g/kg total (divided) or 0.4 g/kg IV daily x3–5 days for induction; maintenance dosing individualized; authorization duration commonly 3–12 months based on response.

Multiple Myeloma

Indication: Prevention of infections in patients with multiple myeloma and hypogammaglobulinemia with recurrent infections per oncology guidance.
Dose/duration: 0.4 g/kg IV every 3–4 weeks or individualized; authorization commonly 12 months with reassessment.

Multiple Sclerosis - Acute Severe Exacerbation

Indication: Severe acute relapse refractory to corticosteroids or when steroids contraindicated; neurologist documents rationale.
Dose: 0.4–1 g/kg IV daily x3–5 days or 2 g/kg divided; approval individualized for acute management.

Myasthenia Gravis (MG) - Acute and Maintenance

Indication: MG exacerbation or myasthenic crisis requiring rapid improvement in neuromuscular transmission; neurologist or neuromuscular specialist involvement required.
Acute dosing: 0.4 g/kg IV daily x3–5 days or 2 g/kg IV divided over 2–5 days for crisis/exacerbation.
Maintenance dosing: For patients maintained on IVIG, common regimens include 1 g/kg IV every 3–4 weeks or 0.4 g/kg IV weekly; continuation requires documented clinical benefit (reduced exacerbations, improved strength/function) and specialist justification.
Approval durations: Acute courses authorized short term (e.g., up to 1 month); maintenance typically authorized up to 12 months with periodic reassessment.

MOG Antibody Disease (MOGAD)

Indication: Acute attacks or when IVIG selected by neuroimmunology specialist; specialist documentation required.
Dose: Acute regimens 0.4–1 g/kg IV daily x3–5 days or 2 g/kg divided; maintenance dosing individualized; authorization typically short term for acute attacks and up to 12 months for maintenance with evidence of benefit.

Passive Immunization for Measles

Indication: Post‑exposure prophylaxis or passive immunization in high‑risk individuals (e.g., immunocompromised) per public health guidance.
Dose/duration: IVIG dosing per public health protocols; authorization short term and requires documentation of exposure and risk status.

Post‑Exposure Prophylaxis for Varicella or Tetanus

Indication: IVIG for varicella or tetanus post‑exposure prophylaxis in high‑risk individuals per guidelines (e.g., immunocompromised patients).
Dose/duration: Per public health/ID guidance; authorization short term around exposure period.

Pure Red Cell Aplasia (PRCA) - Immunologic Subtype

Indication: PRCA of immunologic etiology (e.g., parvovirus B19‑associated PRCA in immunocompromised, or autoimmune PRCA) with hematology documentation.
Specialist: hematologist involvement required.
Dosing options:
Standard regimens include 0.4 g/kg IV daily x5–10 days or 0.2–0.4 g/kg IV daily x5–10 days (alternative regimen added); some protocols use 1 g/kg IV on two consecutive days.
Approval duration: initial short course authorization for acute therapy (e.g., up to 2 weeks); continuation or repeat courses require documentation of response (hematologic improvement, reticulocyte count recovery) and specialist justification.

Feto‑neonatal Alloimmune Thrombocytopenia (FNAIT)

Indication: Prevention or treatment of fetal/neonatal alloimmune thrombocytopenia per maternal‑fetal medicine and hematology guidance.
Specialist: maternal‑fetal medicine and hematology involvement required.
Dose/duration: Maternal antenatal regimens commonly 1 g/kg IV every 1–4 weeks or per specialist protocol; neonatal dosing per neonatology/hematology guidance; authorization individualized for pregnancy course and neonatal period.