CurrentCareSourcePolicy Immune Globulin Intravenous UM Medical Policy

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization criteria, approved indications, dosing regimens, prescriber specialty requirements, approval durations, and continuation criteria for a list of IVIG products. Covers FDA-approved indications and other uses with supportive evidence for adults and pediatrics; specifies dosing ranges and conditions for approval.

Policy Summary

PayerCareSource

PolicyImmune Globulin Intravenous Utilization Management Medical Policy

Policy CodePolicy Immune Globulin Intravenous UM Medical Policy

Change TypeNo material change

Effective DateNov 6, 2024

Next Review Date

Key ActionPrior authorization required; approvals provided for specified durations per indication and may be extended if patient continues to meet criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

15+Indications listed (FDA-approved or supported)

MultipleSpecialist prescriber/consultation requirements

1 mo–1 yrApproval durations (range)

Coverage Summary

Policy Title: Immune Globulin Intravenous UM Medical Policy (Policy Number: Immune Globulin Intravenous UM Medical Policy), Effective Date: 2024-11-06. Scope: Defines prior authorization criteria, approved indications, dosing regimens, prescriber specialty/consultation requirements, approval durations, and continuation criteria for a listed group of IVIG products. Background overview: IVIG products are concentrated human IgG preparations used both for replacement therapy in primary immunodeficiencies and for a broad range of immune-mediated and transplant-related conditions; coverage is provided as covered_with_criteria when the patient meets the indication-specific criteria, dosing regimens, and prescriber/specialist requirements outlined in the policy, with approvals issued for the durations specified and eligible for extension if continued criteria are met.

Policy thresholds and dates

IgG level for CLL prevention<= 600 mg/dL (6.0 g/L)

IgG level for Hematologic neoplasm/SIDI< 600 mg/dL (6.0 g/L) excluding paraprotein

IgG trough target post-HCT> 400 mg/dL (maintain trough >400 mg/dL)

Pretreatment IgG level for PIDBelow normal range (age-adjusted per lab reference)

Effective date2024-11-06

Last review2024-11-06

Next review

Medical Necessity Criteria and Authorization Framework

Overall Authorization Framework

Top-level authorization requirements that apply to all IVIG requests.

ALL of the following

Indication-specific criteria: Request meets one of the listed indication-specific criteria (see individual indication nodes)
Dosing and intervals correspond to one of the approved dosing regimens for the indication
Specialist involvement: If required for the indication, medication is prescribed by or in consultation with the specified specialist (examples provided per indication)

FDA-Approved Indications - Primary Immunodeficiencies (PID)

Approve for 1 year if patient meets either Initial Therapy (A) or is Currently Receiving IVIG (B).

Top-level PID

A) Initial Therapy
- A - diagnostic categories (a,b,c)
  - a) Congenital/Severe PID: Diagnosis of congenital agammaglobulinemia, X-linked agammaglobulinemia, other agammaglobulinemia due to absence of B-cells, Wiskott-Aldrich syndrome, ataxia telangiectasia, DiGeorge syndrome, severe combined immunodeficiency, Hyper-IgM syndromes, an IgG level lower than normal, or a primary immune deficiency confirmed by genetic or molecular testing
  - b) CVID or significant hypogammaglobulinemia: Diagnosis of common variable immunodeficiency or other with significant hypogammaglobulinemia AND meets BOTH: (1) pretreatment IgG below normal range (age-adjusted per lab) AND (2) one of: impaired antibody response OR recurrent infections; OR impaired antibody response plus recurrent infections as specified
  - c) IgG subclass/SAD/other PID: IgG subclass deficiency, selective antibody deficiency (SAD), or another confirmed PID with impaired antibody response and recurrent infections

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

Approve for initial therapy or continued therapy for prevention of infections in CLL per specialist involvement and IgG threshold.

CLL prevention

A) Initial Therapy (Approve for 4 months): Patient has IgG level <= 600 mg/dL (6.0 g/L) OR history of recurrent infections; medication prescribed by or in consultation with an oncologist, hematologist, or infectious diseases physician<= 600 mg/dL
B) Continued Therapy (Approve for 1 year): Patient has a positive response to therapy according to the prescriber (examples: maintaining increased IgG trough level or decrease in number of infections)

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

Approve when electrodiagnostic studies support CIDP diagnosis AND either initial (3 months) or continued therapy criteria met with neurologist involvement.

CIDP

Electrodiagnostic requirement: Electrodiagnostic studies support the diagnosis of CIDP
Therapy timing
- A) Initial Therapy (Approve for 3 months): Initial course: medication prescribed by or in consultation with a neurologist; monitor neurologic symptoms, strength (e.g., grip strength), and sensation for response
- B) Continued Therapy: Significant improvement in neurologic symptoms as determined by prescriber — if so, approve continuation per prescriber

FDA-Approved Indications - Dermatomyositis or Polymyositis

Initial therapy requires prior evidence and trials of corticosteroid and immunosuppressive agents unless contraindicated; specialist involvement required. Initial approval 6 months; continuation 1 year.

Dermatomyositis/Polymyositis

A) Initial Therapy (Approve for 6 months): Prior evidence: elevated creatine kinase OR evidence from skin manifestations, autoantibody testing, muscle biopsy, or EMG; patient has tried a systemic corticosteroid or corticosteroid is contraindicated; patient has tried an immunosuppressive agent or it is contraindicated (examples: methotrexate, cyclosporine, cyclophosphamide, mycophenolate mofetil); medication prescribed by or in consultation with a neurologist or rheumatologist
B) Patient Currently Receiving Immune Globulin (Approve for 1 year): Patient has responded to therapy according to the prescriber (examples: improved muscle strength, neuromuscular symptoms, functional ability)

FDA-Approved Indications - Immune Thrombocytopenia (ITP)

Approve initial and continuation ITP therapy with hematologist involvement as noted; urgent-need exceptions apply. Initial adult therapy 3 months; pregnant initial therapy 6 months; continuation 1 year.

Immune Thrombocytopenia (ITP)

A) Initial Therapy Adult >18 (Approve for 3 months): Patient has tried a systemic corticosteroid OR corticosteroid contraindicated; AND there is an urgent need to increase platelet count quickly
B) Initial Therapy prescribed by or in consultation with a hematologist (Approve for 3 months): Initial therapy when prescribed by or in consultation with a hematologist
D) Initial Therapy Pregnant Patient (Approve for 6 months): Prescribed by or in consultation with a hematologist
E) Continued Therapy (Approve for 1 year):

FDA-Approved Indications - Kawasaki Disease

Approve for 3 months if prescribed by or in consultation with a pediatric cardiologist or pediatric infectious diseases physician. Dosing: up to 2 g/kg IV as single dose or divided; may be repeated.

Kawasaki Disease: Pediatric patient with Kawasaki disease: medication prescribed by or in consultation with a pediatric cardiologist or pediatric infectious diseases physician; approve for 3 months

Dose: up to 2 g/kg IV as a single dose or over multiple consecutive days; dose may be repeated if needed

FDA-Approved Indications - Multifocal Motor Neuropathy

Approve when diagnostic support and neurologist involvement criteria met. Continuation approvals up to 1 year.

Multifocal Motor Neuropathy

Diagnostic support: Diagnosis supported by weakness without sensory abnormalities, upper motor neuron signs, or marked bulbar involvement AND one of: nerve conduction studies demonstrate motor conduction block or probable motor conduction block OR motor nerve biopsy or MRI neurography supports diagnosis; medication prescribed by or in consultation with a neurologist
B) Patient Currently Receiving (Approve for 1 year): Has improvement in neurologic symptoms as determined by prescriber (examples: improvement in disability, grip strength)

Other Uses with Supportive Evidence (selected examples)

Selected other uses with supportive evidence; each subgroup below preserves dosing, approval durations, diagnostic/support and specialist requirements, and continuation criteria from the policy.

Other uses - grouped subcriteria

Antibody-Mediated Rejection (ABMR) in Transplantation: Approve for 1 year if prescribed by or in consultation with a physician affiliated with a transplant center; dosing up to 2 g/kg IV as single dose or divided (e.g., 400 mg/kg daily x5) OR dosage per transplant center protocol
Autoimmune Mucocutaneous Blistering Diseases - Initial Therapy: Initial Therapy Approve for 6 months if patient has tried systemic corticosteroid or corticosteroid is contraindicated AND tried an immunosuppressive agent or immunosuppressive agent is contraindicated OR disease is so serious that inadequate time for corticosteroid+immunosuppressive therapy; medication prescribed by or in consultation with appropriate specialist
Autoimmune Mucocutaneous Blistering Diseases - Continuation: Patient has responded to therapy per prescriber (e.g., healing of lesions or fewer new lesions); dosing: 2 g/kg IV every 3-4 weeks divided over 2-5 days; aggressive ocular disease may use 2 g/kg every 2 weeks

Codes Mentioned in Policy

IVIG Products Listed in PolicymixedCovered

Asceniv	immune globulin intravenous solution - ADMA Biologics
Alyglo	immune globulin intravenous solution - GC Biopharma
Bivigam	immune globulin intravenous solution - AMDA Biologics
Gammagard Liquid	immune globulin solution - Baxalta [Takeda]
Flebogamma DIF	immune globulin intravenous solution - Grifols
Gammagard SID	5% solution immune globulin intravenous - Baxalta [Takeda]
Gammaked	immune globulin solution - Kedrion
Gammaplex	immune globulin intravenous solution - Bio Products Laboratory/Kedrion
Octagam	immune globulin intravenous solution - Octapharma/Pfizer (Octagam 10% noted as exception for FDA replacement therapy)
Gamunex-C	immune globulin solution - Grifols

1–10 of 13

1/2

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for IVIG products. Approvals are provided for indication-specific durations (examples below) and may be extended if the patient continues to meet the criteria. Requests for doses outside the established dosing in the policy will be considered case-by-case by a clinician (Medical Director or Pharmacist).

Examples of approval durations: 1 month for a single course of GBS initial therapy; 3 months for CIDP initial trial; 6 months for some initial therapies (e.g., dermatomyositis, NMOSD initial); 1 year for many continuation approvals (PID, ABMR, hematologic neoplasm-associated hypogammaglobulinemia, etc.).
Dosing must follow one of the approved regimens in the policy; deviations may be reviewed case-by-case.

Documentation Required

Specialist Prescriber or Consultation Requirement

Many indications require that IVIG be prescribed by or in consultation with a specialist appropriate to the condition. Examples of specialists noted in the policy include neurologist, immunologist, hematologist, physicians affiliated with a transplant center, pediatric cardiologist, oncologist, and infectious disease physician.

Documentation Required

Evidence of Diagnosis and Prior Therapies

Initial therapy for multiple indications requires documentation supporting the diagnosis and prior therapeutic trials. Examples include electrodiagnostic studies to support CIDP diagnosis and blood serum AQP4-IgG serology to confirm NMOSD. Many indications also require prior trials of systemic corticosteroids and/or an immunosuppressive agent (or documentation that these are contraindicated) before IVIG is started.

CIDP: electrodiagnostic studies supporting the diagnosis required for initial therapy.
NMOSD: diagnosis confirmed by positive blood serum AQP4-IgG (CSF detection acceptable).
Dermatomyositis/polymyositis and other autoimmune conditions: trial of systemic corticosteroid and an immunosuppressive agent required or documentation of contraindication.

Billing Rule

Approval Duration and Dosing Adherence

Approvals are issued for the duration specified for each indication and dosing must match one of the approved regimens; if dosing is outside the established options, justification is required for case-by-case review.

Examples: GBS initial course approved for 1 month; CIDP initial trial approved for 3 months; many continuation approvals are for 1 year.
Dosing examples: 2 g/kg IV in divided doses over 2–5 days for many acute indications; maintenance dosing options vary by condition (policy lists specific regimens per indication).
Requests for doses outside the policy’s established dosing will be considered on a case-by-case basis by a clinician.

Documentation Required

Monitoring and Response Documentation

Continuation approvals require prescriber-documented positive response to therapy. The policy lists indication-specific examples of acceptable evidence of response.

Examples of response: maintaining increased IgG trough level or a decrease in number of infections (CLL, hematologic neoplasm-associated hypogammaglobulinemia).
Increased IgG trough levels or fewer infections after HCT or in secondary immunodeficiency.
Improved neurologic function such as improved disability or grip strength for CIDP, GBS, or other neurologic indications.
Increased platelet counts or absence of significant bleeding for ITP; healing of lesions or fewer new lesions for autoimmune blistering diseases.

Background and Definitions

IVIG products are concentrated human immunoglobulin G (IgG) preparations produced from pooled plasma and listed in the policy (examples: Asceniv, Alyglo, Bivigam, Gammagard Liquid, Flebogamma DIF, Gammaked, Gammaplex, Octagam, Gamunex-C, Panzyga, Yimmugo, Privigen). They are FDA-approved for replacement therapy in primary humoral immunodeficiency and for multiple specific conditions (e.g., CLL to prevent infections, ITP when rapid platelet increase is needed, dermatomyositis, Kawasaki disease, CIDP, multifocal motor neuropathy, and others) and are also used for a range of other immune-mediated and transplant-related indications supported by guidelines or evidence (e.g., antibody-mediated rejection in transplantation, desensitization around transplantation, CMV pneumonitis adjunctive therapy, Guillain-Barré syndrome, HCT-associated hypogammaglobulinemia, NMOSD in selected patients). Many indications are FDA-approved while other uses are guideline-recommended or supported by variable-quality evidence; the policy notes that IVIG is usually considered when standard therapies have failed, are contraindicated, or a rapid clinical effect is required (examples: urgent platelet rise in ITP, rapid stabilization in GBS or myasthenia gravis, or when corticosteroids/immunosuppressants are ineffective or contraindicated).

Positive response to therapy: Examples include maintaining increased IgG trough level, decrease in number of infections, improved neurologic function, increased platelet counts, or healing/fewer lesions depending on indication, as determined by the prescriber.

Revision History

2024-11-06Effective/Last reviewLatest

Policy effective and last reviewed

Policy Summary

PayerCareSource

PolicyImmune Globulin Intravenous Utilization Management Medical Policy

Policy CodePolicy Immune Globulin Intravenous UM Medical Policy

Change TypeNo material change

Effective DateNov 6, 2024

Next Review Date

Key ActionPrior authorization required; approvals provided for specified durations per indication and may be extended if patient continues to meet criteria.

SourceLink

On This Page

B) Patient Currently Receiving Immune Globulin: Patient has a diagnosis of primary immunodeficiency and, per prescriber, is continuing to receive benefit from the product; medication prescribed by or in consultation with an allergist, immunologist, otolaryngologist (ENT), pulmonologist, or infectious diseases physician who treats PID

Patient is responding to therapy or previously responded to therapy according to the prescriber (examples: increased platelet counts, absence of significant bleeding, adequate platelet count for delivery)

Aquaporin-4 IgG-Positive NMOSD: Initial Therapy Approve for 6 months if presence of at least one core clinical feature of NMOSD AND diagnosis confirmed by positive serum AQP4-IgG (CSF acceptable) AND patient is adult OR has tried/has contraindication to another therapy; medication prescribed by or in consultation with a neurologist; dosing up to 2 g/kg per month IV; continuation Approve for 1 year if responded

Cytomegalovirus (CMV) Pneumonitis in Cancer/Transplant Patients: Approve for 2 months if prescribed by or in consultation with an oncologist, hematologist, or infectious diseases physician; dosing: for 3 to 5 doses

Desensitization Prior to/After Transplantation: Approve for 1 year if prescribed by or in consultation with a physician affiliated with a transplant center; dosing up to 2 g/kg per month IV or per transplant center protocol

Guillain-Barré Syndrome (GBS): Initial Therapy Approve for 1 month if medication initiated within 2 weeks and no longer than 4 weeks after onset OR treatment-related fluctuation with prior response; medication prescribed by or in consultation with a neurologist or experienced specialist; dosing 2 g/kg IV divided over 2-5 days; continuation Approve for 1 month if currently receiving

Hematologic Neoplasm-Associated Hypogammaglobulinemia or Post-B-cell Therapies (SIDI): Initial Therapy Approve for 6 months if ALL met: IgG < 600 mg/dL (6.0 g/L) excluding paraprotein; recurrent or severe infections or high risk of infection per prescriber; medication prescribed by or in consultation with oncologist, hematologist, infectious disease physician, or immunologist. Continuation if currently receiving and having positive response per prescriber; dosing options 0.4–0.6 g/kg monthly or 0.2–0.8 g/kg every 3–4 weeks< 600 mg/dL

Hematopoietic Cell Transplantation (HCT) to Prevent Infection: If HCT within previous year: Initial Therapy Approve for 3 months if adult/adolescent dosing 0.5 g/kg per week adjusted to maintain trough IgG > 400 mg/dL OR pediatric allogeneic 0.4 g/kg per month adjusted to maintain IgG >400 mg/dL; medication prescribed by or in consultation with hematologist, oncologist, or infectious diseases physician. Continuation Approve for 6 months if respondingmaintain trough > 400 mg/dL