Mass General Brigham IVIG/SCIG Coverage Update

Coverage Criteria and Indications

CIDP / MMN / Prevention of recurrent infection in CLL

Authorization may be granted when ALL of the following are met:

Primary conditions: 1. ONE of the following: a) Chronic inflammatory demyelinating polyneuropathy (CIDP) with prescriber a specialist (e.g., neurologist or immunologist) or consult notes from a specialist; b) Multifocal Motor Neuropathy (MMN) with prescriber a specialist (e.g., neurologist) or consult notes from a specialist; c) Prevention of recurrent infection in B‑cell chronic lymphocytic leukemia (CLL) with prescriber a specialist (e.g., hematologist or oncologist) or consult notes from a specialist.

Specialist examples: neurologist, immunologist, hematologist/oncologist.

Dosing: 2. Appropriate dosing for the member and treatment course.

Immune Thrombocytopenia (ITP)

Authorization may be granted when ALL of the following are met:

Diagnosis and prescriber: 1. Diagnosis of immune thrombocytopenia (ITP). 2. Prescriber is a specialist (e.g., hematologist) or consult notes from a specialist are provided.

Specialist example: hematologist.

Platelet/bleeding criteria: 3. ONE of the following: a) Platelets < 30,000/µL; b) Clinically significant bleeding; c) History of significant bleeding; d) Risk of significant bleeding; e) Medical necessity to raise platelet count within 12 to 24 hours.

Dosing: 4. Appropriate dosing for the member and treatment course.

Kawasaki Disease

Authorization may be granted when ALL of the following are met:

Diagnosis: 1. Diagnosis of Kawasaki disease (mucocutaneous lymph node syndrome).

Timing/clinical findings: 2. ONE of the following: a) Onset of illness occurred within the previous 10 days; b) Unexplained persistent fever; c) Evidence of aneurysm; d) Signs of persistent inflammation.

Dosing: 3. Appropriate dosing for the member and treatment course.

Primary Immunodeficiency Disorders (PID)

Authorization may be granted when ALL of the following are met:

Diagnosis and labs: 1. Diagnosis of primary immunodeficiency disorder (PID). 2. Laboratory documentation supporting diagnosis (e.g., deficient serum IgG or subclasses [IgG1–4], IgM, and/or IgA; assessment of functional antibody production; B‑cell immunophenotype by flow cytometry; or genetic testing). 3. Serum IgG (or subclasses), IgM, and/or IgA levels provided with dates drawn and reference ranges (pre‑ or post‑treatment acceptable).

Labs may be pre‑ or post‑treatment.

Dosing: 4. Appropriate dosing for the member and treatment course.

Dermatomyositis (adult)

Authorization may be granted when ALL of the following are met:

Diagnosis and age: 1. Diagnosis of dermatomyositis in adults (DM). 2. Member is ≥ 18 years of age.

Steroid failure/intolerance: 3. Inadequate response or adverse reaction to ONE systemic corticosteroid OR contraindication to ALL systemic corticosteroids.

Severity or prior agent failure: 4. ONE of the following: a) Member has severe disease; b) Inadequate response or adverse reaction to ONE or contraindication to ALL of: azathioprine, chloroquine, hydroxychloroquine, methotrexate, mycophenolate mofetil, rituximab.

Dosing: 5. Appropriate dosing for the member and treatment course.

Antibody-mediated Rejection (AMR) - Off-label

Authorization may be granted when ALL of the following are met:

Diagnosis: 1. Diagnosis of antibody‑mediated rejection (AMR).

Steroid failure/intolerance: 2. Inadequate response or adverse reaction to ONE systemic corticosteroid OR contraindication to ALL systemic corticosteroids.

Autoimmune Encephalitis (including anti-NMDA receptor encephalitis) - Off-label

Authorization may be granted when ALL of the following are met:

Diagnosis: 1. Diagnosis of autoimmune encephalitis, including anti‑NMDA receptor encephalitis.

Requested dosing: 2. Requested dose is 2 g/kg divided over 2–5 days, followed by 1 g/kg once monthly.

Autoimmune Small Fiber Neuropathy / AAG - Off-label

Authorization may be granted when ALL of the following are met:

Diagnosis: 1. Diagnosis of autoimmune small fiber neuropathy or autoimmune autonomic ganglionopathy (AAG).

Dose and frequency: 2. Requested IVIG dose is 1 g/kg monthly (administered in weekly divided doses); dose may be increased up to a maximum of 2 g/kg monthly for inadequate response. A corresponding subcutaneous dose may be used.

Guillain-Barré Syndrome

Authorization may be granted when ALL of the following are met:

Diagnosis: 1. Diagnosis of Guillain‑Barré Syndrome.

Dose limit: 2. Requested dose is ≤ 2 g/kg.

Immune-mediated Necrotizing Myopathy (IMNM) - Off-label

Authorization may be granted when ALL of the following are met:

Diagnosis: 1. Diagnosis of immune‑mediated necrotizing myopathy (IMNM).

Steroid failure/intolerance: 2. Inadequate response or adverse reaction to ONE systemic corticosteroid OR contraindication to ALL systemic corticosteroids.

Severity or prior agent failure: 3. ONE of the following: a) Diagnosis of severe disease; b) Inadequate response or adverse reaction to ONE or contraindication to ALL of the following: azathioprine, chloroquine, cyclophosphamide, cyclosporin, hydroxychloroquine, methotrexate, mycophenolate mofetil, plasma exchange, rituximab, tacrolimus.

Immune Neutropenia

Authorization may be granted when ALL of the following are met:

Diagnosis: 1. Diagnosis of immune neutropenia (autoimmune neutropenia or chronic benign neutropenia).

Recurrent infections: 2. Recurrent infections despite prophylactic antibiotics and colony‑stimulating factors.

Interstitial Lung Disease (ILD) - Off-label

Authorization may be granted when ALL of the following are met:

Diagnosis: 1. Diagnosis of interstitial lung disease (ILD).

Steroid failure/intolerance: 2. Inadequate response or adverse reaction to ONE systemic corticosteroid OR contraindication to ALL systemic corticosteroids.

Second-line failure: 3. Inadequate response or adverse reaction to ONE or contraindication to BOTH azathioprine and mycophenolate mofetil.

Immune-mediated necrotizing myopathy (IMNM) - Initial therapy

Covered when ALL of the following are met:

IMNM initial criteria: 1. Diagnosis of IMNM; 2. Inadequate response or adverse reaction to ONE systemic corticosteroid or contraindication to ALL systemic corticosteroids; 3. ONE of the following: (a) diagnosis of severe disease OR (b) inadequate response or adverse reaction to ONE or contraindication to ALL of the listed second‑line agents (azathioprine, chloroquine, cyclophosphamide, cyclosporin, hydroxychloroquine, methotrexate, mycophenolate mofetil, plasma exchange, rituximab, tacrolimus).

Stepwise requirement: steroid trial then either severity or failure of multiple agents.

Interstitial Lung Disease (ILD) - Initial therapy

Covered when ALL of the following are met:

ILD initial criteria: 1. Diagnosis of ILD; 2. Inadequate response or adverse reaction to ONE systemic corticosteroid or contraindication to ALL systemic corticosteroids; 3. Inadequate response or adverse reaction to ONE or contraindication to BOTH azathioprine and mycophenolate mofetil.

Requires failure/intolerance to both steroid and two steroid‑sparing agents.

Multiple Myeloma (MM) - Infection prevention

Covered when ALL of the following are met:

MM infection prophylaxis: 1. Diagnosis of multiple myeloma; 2. Recurrent infections despite prophylactic antibiotics.

Targeted to members with ongoing infection despite prophylaxis.

Myasthenia Gravis (MG) - Initial or rescue therapy

Covered when ALL of the following are met:

MG criteria: 1. Diagnosis of myasthenia gravis; 2. ONE of the following: (a) member has severe or rapidly worsening disease and IVIG will be used as initial therapy followed by longer‑acting immunomodulating agents (e.g., azathioprine, cyclosporine, mycophenolate, corticosteroids) OR (b) inadequate response, adverse reaction, or contraindication to ALL of the following: pyridostigmine, systemic corticosteroids, and one immunomodulating agent (azathioprine, cyclosporine, mycophenolate).

Allows initial IVIG in severe rapidly worsening cases; otherwise requires stepwise failure.

PANDAS

Covered when ALL of the following are met:

PANDAS criteria: 1. Diagnosis of PANDAS; 2. Inadequate response or adverse reaction to ONE or contraindication to ALL antibiotics; 3. Inadequate response or adverse reaction to ONE or contraindication to ALL systemic corticosteroids.

Requires failure of antibiotic therapy and steroid therapy prior to approval.

Pemphigus Vulgaris (PV)

Covered when ALL of the following are met:

PV criteria: 1. Diagnosis of pemphigus vulgaris (PV); 2. Inadequate response or adverse reaction to ONE or contraindication to ALL systemic corticosteroids; 3. Inadequate response, adverse reaction, or contraindication to rituximab; 4. Requested dose is ≤ 2 g/kg.

Dose cap specified.

Polymyositis (PM)

Covered when ALL of the following are met:

PM criteria: 1. Diagnosis of polymyositis (PM); 2. Inadequate response or adverse reaction to ONE or contraindication to ALL systemic corticosteroids; 3. ONE of the following: (a) diagnosis of severe disease OR (b) inadequate response or adverse reaction to ONE or contraindication to ALL of the following: azathioprine, chloroquine, cyclophosphamide, cyclosporin, hydroxychloroquine, methotrexate, mycophenolate mofetil, plasma exchange, rituximab, tacrolimus; 4. Requested dose is 1 g/kg per day on 2 consecutive days every 4 weeks (total monthly dose: 2 g/kg).

Specifies exact dosing schedule for approval.

Prevention of recurrent infection in pediatric HIV members

Covered when ALL of the following are met:

Pediatric HIV prophylaxis: 1. Indication is prevention of recurrent infection in pediatric HIV members; 2. Member is < 18 years of age; 3. CD4 count is ≥ 200 cells/µL within the last 3 months; 4. Requested dose is 400 mg/kg every 28 days.

Age and immunologic threshold required.

CMV - Solid organ transplant and Specific Antibody Deficiency (SAD)

Covered when ALL of the following are met for each sub-indication:

CMV-SOT criteria: 1. Diagnosis of cytomegalovirus (CMV) — solid organ transplant indication; 2. Member will also receive antiviral therapy with ganciclovir, foscarnet, or cidofovir.

Requires concurrent antiviral therapy.

SAD criteria: 1. Diagnosis of Specific Antibody Deficiency (SAD) with well‑documented moderate or severe polysaccharide nonresponsiveness; 2. Evidence of recurrent infections requiring antibiotic therapy; 3. Requested dose of 400–600 mg/kg IV every 4 weeks or corresponding subcutaneous dose.

Dose range specified.

Stiff Person Syndrome (SPS)

Covered when ALL of the following are met:

SPS criteria: 1. Diagnosis of Stiff Person Syndrome (SPS); 2. Inadequate response or adverse reaction to ONE or contraindication to ALL benzodiazepines; 3. Inadequate response, adverse reaction, or contraindication to baclofen; 4. Requested dose of 2 g/kg divided over two to three infusions.

Defines prior medication failures and dosing.

Use of IVIG that is obtained solely as manufacturer samples or provided through a manufacturer patient assistance program is excluded from authorization eligibility. Requests for coverage must involve products obtained through standard channels for which prior authorization may be submitted; members receiving only sampled product or assistance-supplied IVIG are not eligible for Plan authorization under this policy.

Initial approvals for most indications are limited to 6 months unless the policy specifies a different period. The policy lists specific exceptions: Kawasaki disease initial approval is limited to 1 month, and for PANDAS an initial single dose regimen (1–2 g/kg) is treated as a 1‑month initial approval in the limitations table; off‑label indications generally receive an initial 3‑month approval unless otherwise stated. Where off‑label dosing is not specified, the policy instructs providers to refer to the FDA‑approved label for dosing expectations. The review history also notes that PANDAS initial and reauthorization durations were updated (effective 10/1/25) to 3 months initial and 6 months reauthorization for that indication.

The policy was updated to remove products that are no longer manufactured; specifically, Gamastan S/D was removed from the policy after the product was discontinued and therefore is excluded from coverage. This change is reflected in the review history entries noting product removal and associated effective dates.

The excerpted policy text does not include an explicit standalone "not medically necessary" statement; however, the policy makes coverage contingent on meeting the listed clinical criteria and documentation requirements. Consequently, requests that do not meet the stated criteria or that lack required documentation would not be supported for authorization under this policy.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for IVIG and SCIG products under the medical benefit. Authorization may be granted for members who are new to the Plan currently receiving treatment with IVIG (excludes products obtained as samples or via manufacturer patient assistance programs). Requests for discontinued products (e.g., Gamastan S/D) are not approvable.

Prior authorization required for IVIG/SCIG under the medical benefit
New-to-plan members may be authorized if already receiving IVIG (excluding samples or manufacturer assistance)
Discontinued products (e.g., Gamastan S/D) are not approvable

Documentation Required

Product List — Provide Specific Product/Formulation

Named IVIG and SCIG products included in the formulary roster should be identified on the PA request. Examples of products covered (route and indications vary by product): Alyglo, Asceniv, Bivigam, Cutaquig, Cuvitru, Flebogamma (5% and 10%), Gammagard (including ERC formulation), Gammaked, Gammaplex, Gamunex-C, Hizentra, Hyqvia, Octagam (5% and 10%), Panzyga, Privigen, Xembify, and others. Do not request discontinued products.

Dosing, Limits, and Coding Notes

Dosing thresholds and limits — examples

Pediatric HIV prophylaxis dosingRequested dose is 400 mg/kg every 28 days for members <18 years with CD4 ≥200 cells/µL (within last 3 months)

Specific Antibody Deficiency (SAD) dosing rangeRequested dose of 400–600 mg/kg IV every 4 weeks or corresponding subcutaneous dose for members with well‑documented moderate or severe polysaccharide nonresponsiveness and recurrent infections requiring antibiotics

Pemphigus Vulgaris dose capRequested dose must be ≤ 2 g/kg (after failure/intolerance to corticosteroids and rituximab per criteria)

Polymyositis dosing scheduleRequested dose is 1 g/kg per day on 2 consecutive days every 4 weeks (total monthly dose: 2 g/kg)

Stiff Person Syndrome dosingRequested dose of 2 g/kg, divided over two to three infusions after failure/intolerance to benzodiazepines and baclofen

Definitions and Condition Descriptions

IVIG/SCIG — definition

DefinitionIntravenous and subcutaneous human immune globulin preparations providing IgG antibodies for replacement therapy and immunomodulation

Primary usesReplacement therapy for primary and secondary immunodeficiencies and immunomodulation for autoimmune cytopenias and other immune‑mediated diseases

Mechanism summaryProvides passive immunity by increasing antibody titers and may modulate immune response via Fc receptor interference

Specific Antibody Deficiency (SAD) — definition and criteria

Definition of SADSpecific Antibody Deficiency (SAD): well‑documented moderate or severe polysaccharide nonresponsiveness with recurrent infections requiring antibiotic therapy

Required documentation

Background and Clinical Rationale

Intravenous immune globulin (IVIG) and subcutaneous immune globulin (SCIG) provide passive immunity by replacing IgG in patients with primary or secondary immunoglobulin deficiencies and act as immunomodulatory therapies in a variety of autoimmune and immune‑mediated conditions. Their mechanisms include replacement of deficient antibodies to prevent or reduce infections and immunomodulatory effects (for example, Fc receptor interference) that can alter pathogenic immune responses; dosing and route vary by product and indication.

Policy Changes and Revision History

Consistent with the review history, Gamastan S/D was removed from the policy when the product was discontinued (effective 1/1/26), and a new formulation of Gammagard ERC was added to the policy (effective 3/9/26). These product list updates should be applied when determining eligible products for authorization.

OpenPayer

Intravenous and Subcutaneous Immune Globulin (IVIG/SCIG) - Medical Benefit

Coverage Criteria and Indications

Provider Requirements, Prior Authorization, and Documentation

Dosing, Limits, and Coding Notes

Definitions and Condition Descriptions

Background and Clinical Rationale

Policy Changes and Revision History