CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Immune Globulins (immunoglobulin) — Non-hematology/Non-oncology coverage criteria

Defines coverage, authorization periods, quantity limits, and medical necessity criteria for intravenous immune globulin products for Medicaid, Commercial, and Medicare members (non-hematology/non-oncology indications). Affects providers requesting IVIG for listed clinical conditions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImmune Globulins (immunoglobulin) — Non-hematology/Non-oncology coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionObtain baseline BUN and serum creatinine within 30 days and document trial of preferred IVIG formulations before approving non-preferred products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial auth (default)

1 yearrenewal length (default)

BUN/Cr within 30dlab requirement

Myasthenia Gravisnon-renewable example

~20+indications listed

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Coverage Criteria for IVIG (non-hematology/non-oncology)

Non-renewable indications

Not eligible for renewal: The following indications are not eligible for authorization renewal. Initial authorization details noted in each indication apply.

ANY of the following

Guillain-Barré Syndrome (Acute inflammatory polyneuropathy) — Authorization is valid for 2 months only; approval granted for a maximum of 2 courses of therapy within 6 weeks of onset and cannot be renewed.
Myasthenia Gravis — Authorization is valid for 1 course (1 month) only and may not be renewed.
Kawasaki Disease (Pediatric) — Authorization is valid for 1 course (1 month) only and cannot be renewed.
Fetal alloimmune thrombocytopenia (FAIT) — Authorization is valid through the delivery date only and cannot be renewed.
Neonatal Alloimmune Thrombocytopenia — Authorization is valid for 1 course (1 month) only and cannot be renewed.
Management of Immune-Checkpoint-Inhibitor Related Toxicity — Initial uses described may not be renewed (see individual clinical criteria).

General coverage criteria

General coverage criteria — IVIG is covered when aligned with FDA-approved labeling and/or relevant clinical literature and when associated with covered ICD-10 diagnoses. Requests must meet the specific indication criteria listed elsewhere in this section and supporting documentation must be provided.

ALL of the following

Use is for non-oncology/non-hematology indications; oncology or hematology indications are excluded from this policy and are covered under a separate NHPRI policy (Immune Globulin (IG) (IVIG, SCIG, IMIG) Policy).
Documentation must include diagnosis, relevant diagnostic testing/results, baseline physical exam findings, and objective measures of disease severity or response where applicable (e.g., IgG level, antibody titers, electrodiagnostic testing, strength measures such as INCAT or MRC, 6-minute walk test, or other disease-specific scales).
For primary immunodeficiency (PID) and other infection-risk indications, supporting laboratory values (e.g., IgG trough levels, vaccine response titers) and infection history must be provided. Specific numeric thresholds noted in indication criteria (e.g., IgG <200 mg/dL or <400 mg/dL) must be met when stated.

Coding, Diagnoses, and Product Listings

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Baseline renal labs and preferred‑product trial required

Obtain baseline BUN and serum creatinine within 30 days of the prior authorization request; when requesting non-preferred IVIG formulations, document prior failure or intolerance to preferred formulations (Gammaked/Gamunex‑C, Gammagard liquid, Flebogamma/Flebogamma DIF, or Octagam).

Baseline BUN and serum creatinine must be obtained within 30 days of the request.
Non-preferred products (e.g., Asceniv, Alyglo, Bivigam, Gammagard S/D, Gammaplex, Privigen, Panzyga) require documented failure/intolerance to preferred formulations: Gammaked/Gamunex‑C, Gammagard liquid, Flebogamma/Flebogamma DIF, or Octagam.

Prior Authorization

Provide indication‑specific documentation with PA

Submit prior authorization with indication‑specific supporting documentation as required by the policy (examples below must be met for approval).

Stiff‑Person Syndrome: anti‑GAD antibody positivity, failure of ≥2 listed therapies, and documented baseline physical exam.

Background and Policy Scope

Intravenous immune globulin (IVIG) is used to replace or modulate immune function across a range of primary immunodeficiencies and immune-mediated conditions. Neighborhood reviewed multiple IVIG preparations and adopted clinical coverage criteria to align use with FDA labeling and relevant literature; baseline renal function (BUN and serum creatinine) and indication-specific documentation are required prior to approval.

Definitions and Key Terms

Primary immunodeficiency (PID) — examples of disorders included

Examples of PID disordersWiskott-Aldrich syndrome; X-linked agammaglobulinemia; Common variable immunodeficiency; Transient hypogammaglobulinemia of infancy

Other included disordersIgG subclass deficiency; antibody deficiency with near-normal immunoglobulins; combined immunodeficiencies (e.g., SCID)

NoteList is not all-inclusive; family history and antibody response testing are part of PID criteria

CIDP diagnostic electrodiagnostic criteria — electrodiagnostic demyelination criteria summary

Electrodiagnostic demyelination criteria summaryPartial motor conduction block in ≥2 motor nerves OR distal CMAP duration increase plus another demyelination criterion OR abnormal temporal dispersion in ≥2 motor nerves OR reduced conduction velocity/prolonged distal motor latency/absent or prolonged F waves as specified

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImmune Globulins (immunoglobulin) — Non-hematology/Non-oncology coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionObtain baseline BUN and serum creatinine within 30 days and document trial of preferred IVIG formulations before approving non-preferred products.

SourceLink

On This Page

Therapy should follow dosing and monitoring expectations: use the lowest effective dose to maintain clinical benefit; patients stable or at maximum response should attempt dose reduction (e.g., 25–50% reduction every ~3 months) with documentation. Trials of discontinuation are appropriate when sustained remission is documented, except patients with PID are excluded from discontinuation trials; other exceptions (e.g., certain transplant, HIV, hematologic conditions) require criteria-specified status prior to discontinuation attempts.

Product-specific contraindications and warnings must be observed (e.g., preparations contraindicated in hereditary fructose intolerance or in patients with IgA deficiency and anti-IgA antibodies), and the prescribing clinician must justify product selection if alternatives exist.

Initial authorization lengths and renewal rules follow the indication-specific notes (e.g., CIDP initial authorization valid for 3 months; some indications allow renewals with documented clinical improvement or continued infection risk as described; others are non-renewable).

For Medicare members, applicable National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) take precedence; compliance with CMS guidance is required where applicable.

Use that does not conform to FDA labeling or the plan criteria and supporting literature may be considered not medically necessary and may be denied. Individual consideration may be given based on prescriber-submitted information.

Auto‑immune mucocutaneous blistering diseases: biopsy confirmation, severe/extensive refractory disease after corticosteroids + immunosuppressant, progressive disease, and baseline exam.

Immune‑checkpoint‑inhibitor related toxicity: ongoing checkpoint inhibitor therapy and the specified severe or steroid‑refractory toxicities.

Allogeneic BMT: documentation of allogeneic transplant and indication (prevention of aGVHD or infection) with IgG threshold where applicable.

Prior Authorization

Document clinical response and observe time‑limited approvals

Provide documentation of clinical response for initial authorization and for renewals; note some authorizations are time‑limited per indication (examples given).

Renewal requires documented clinical response and absence of unacceptable toxicity.
Initial authorization for Allogeneic BMT is valid for 3 months; renewals for Allogeneic BMT require IgG < 400 mg/dL and are provided for 3 months.
Dermatomyositis/polymyositis renewals require improvement from baseline and are provided for 6 months.

Note

Product summaries do not substitute for PA documentation

Product monographs in the policy do not replace PA requirements; clinicians should submit the indication, individualized dosing plan, and relevant labs/risk factors when requesting authorization.

Include the indication and dosing regimen (e.g., individualized every 21–28 days or weight‑based ITP regimens).
Provide relevant safety information such as risk factors for thrombosis or renal dysfunction and recent renal labs when applicable.

Prior Authorization

IVIG requests reviewed against P&T clinical coverage criteria

All IVIG products reviewed by the P&T Committee are subject to review against these clinical coverage criteria; coverage is contingent on an applicable covered ICD‑10 diagnosis.

Neighborhood adopted clinical coverage criteria to align IVIG use with FDA labeling and relevant literature.
Coverage is tied to the ICD‑10 diagnoses listed in Appendix 1.

Step Therapy

Document prior failure of preferred IVIG formulations for non‑preferred products

When requesting a non‑preferred IVIG formulation, document prior failure or intolerance to the specified preferred formulations before approval will be granted (Medicare exception noted).

Preferred formulations that must be tried and failed/intolerated: Gammaked/Gamunex‑C, Gammagard liquid, Flebogamma/Flebogamma DIF, or Octagam.
Medicare members previously treated within 365 days may be exempt from step therapy.

Step Therapy

Require prior medication failures for Stiff‑Person Syndrome

For Stiff‑Person Syndrome, document failure of at least two specified medication classes before IVIG will be authorized.

Must have failed at least two of: benzodiazepines, baclofen, gabapentin, valproate, tiagabine, or levetiracetam.

Documentation Required

Perform dose‑reduction and discontinuation trials when appropriate

For patients who are stable or at maximum therapeutic response, attempt dose reduction trials (e.g., 25–50% reduction every 3 months) and consider trials of discontinuation except where explicitly excluded.

Dose reduction example: reduce dose by 25–50% every 3 months.
Exceptions to discontinuation trials include PID and certain transplant and pediatric HIV scenarios.

Note

No additional universal step therapy steps specified

The policy does not list explicit step‑therapy protocols in all sections; follow the policy language for indication‑specific requirements and preferred‑product trials where specified.

No additional universal step therapy steps are specified beyond the preferred‑product trial and indication‑specific medication failures documented elsewhere in the policy.

Step Therapy

Policy preference for cost‑effective options first

The coverage criteria favor use of more cost‑effective IVIG options first when clinically appropriate; document clinical rationale if using non‑preferred agents.

Neighborhood's criteria are intended to ensure more cost‑effective options are used first when applicable and appropriate.

Documentation Required

Provide PID diagnostic labs or detailed infection history

For Primary Immunodeficiency, include IgG laboratory results or a detailed infection history and vaccine response testing as part of the prior authorization submission.

Either an IgG level < 200 mg/dL OR documentation of infection history (e.g., ≥4 ear infections/year, ≥2 serious sinus infections/year, ≥2 pneumonias/year, recurrent deep infections, persistent thrush, need for IV antibiotics, or family history of PID).
Document antibody response testing with titers drawn before and 4–8 weeks after vaccination.

Documentation Required

Document CIDP diagnostic and prior‑therapy evidence

For CIDP prior authorization, supply documentation of disease course, neurologic exam findings, electrodiagnostic evidence of demyelination, prior corticosteroid trial/failure, and baseline objective strength measure.

Progressive or relapsing course ≥2 months and abnormal/absent deep tendon reflexes.
Electrodiagnostic criteria demonstrating demyelination as specified in the policy.
Refractory or intolerant to therapeutic‑dose corticosteroids for ≥3 months and baseline strength measured with an objective tool (e.g., INCAT, MRC, 6‑MWT).

Documentation Required

Provide documented baseline exam and diagnostic confirmation

Document baseline physical exam findings and diagnostic confirmation where required by the indication (e.g., Stiff‑Person Syndrome, autoimmune blistering diseases).

Stiff‑Person Syndrome requires a documented baseline physical exam.
Auto‑immune mucocutaneous blistering diseases require biopsy confirmation and a documented baseline exam.

Documentation Required

Document authorization duration per indication

Include authorization validity and indication‑specific initial durations in the request (examples: Allogeneic BMT initial authorization valid for 3 months; Kawasaki and neonatal indications valid for one course and non‑renewable).

Allogeneic BMT: initial authorization valid for 3 months.
Kawasaki disease and Neonatal Alloimmune Thrombocytopenia: authorization valid for one course (1 month) and cannot be renewed; FAIT authorization valid through delivery only.

Documentation Required

Document clinical response for renewals

For renewal requests, document disease response or clinical improvement from baseline and/or decreased infection frequency or severity as specified for the indication.

Renewals generally require documentation of improvement from baseline on physical exam or decreased infection frequency/severity depending on the indication.
Specific renewal durations (e.g., 3 or 6 months) apply for certain conditions.

Documentation Required

Include weight and adjusted‑weight calculations for dosing

When documenting dosing, include current weight and any BMI/IBW calculations and adjusted body weight calculations when applicable to support the dosing chosen.

Provide weight and, if applicable, BMI/IBW and adjusted body weight calculations per the policy formula.
Show dosing rationale when dose reduction or individualized intervals (21–28 days) are used.

Documentation Required

Provide core documentation: indication, infection history, IgG goals, dosing

Include general documentation elements with the PA: indication, prior infection or SBI rates or target IgG trough goals where applicable, and the dosing regimen used.

Document indication and prior infection/SBI history or target IgG trough goals.
Report the dosing regimen (individualized 21–28 day intervals or weight‑based regimens) and any contraindications or risk factors.

Documentation Required

Submit prescriber clinical information for individualized review

Prescriber‑submitted clinical information will be considered; Neighborhood will give individual consideration to each request based on the information submitted and other available data.

Submit complete clinical records to allow individualized review by the plan.

Denial Risk

Missing baseline labs or preferred‑product trial may cause denial

Failure to provide baseline BUN and serum creatinine within 30 days of the request or failure to trial preferred IVIG formulations before requesting a non‑preferred product may lead to denial.

Baseline renal labs within 30 days are required for initial approval.
Non‑preferred product requests without documented failure/intolerance to preferred formulations risk denial.

Denial Risk

Renewal denial risk: unacceptable toxicity or missing recent renal labs

Renewal requests may be denied if the patient has unacceptable toxicity from IVIG (examples listed) or if required labs (BUN and serum creatinine within the last 6 months) are not provided and infusion adjusted accordingly.

Examples of unacceptable toxicity include acute kidney injury, thrombosis, hemolysis, hypersensitivity, TRALI, and volume overload.
BUN and serum creatinine must have been obtained within the last 6 months for renewal consideration.

Denial Risk

Certain indications are non‑renewable

Some indications are explicitly non‑renewable; therapy should be planned accordingly and renewals will not be granted for these indications.

Myasthenia Gravis and Management of Immune Checkpoint Inhibitor related Toxicity are noted as may not be renewed.

Denial Risk

Allogeneic transplant renewals require IgG < 400 mg/dL

For Allogeneic Bone Marrow or Stem Cell Transplant, renewal of continued therapy requires documentation of an IgG level < 400 mg/dL; absence of this documentation may lead to denial of renewal.

Renewal authorizations are provided for 3 months and require IgG < 400 mg/dL to support continued therapy.

Note

Watch for product‑specific contraindications when requesting PA

Product sections do not provide explicit authorization steps; be aware of product‑specific contraindications (e.g., hereditary fructose intolerance, anti‑IgA antibodies) when requesting authorization.

Flebogamma is contraindicated in hereditary fructose intolerance.
Gammaplex is contraindicated in patients with IgA deficiency and antibodies to IgA.

Denial Risk

Denial triggers: unmet criteria or insufficient documentation

Requests that do not meet the clinical coverage criteria or lack required documentation may be denied; Medicare requests may also be subject to NCD/LCD criteria where applicable.

Neighborhood will deny requests inconsistent with FDA labeling, relevant literature, or the plan's coverage criteria.
Medicare coverage determinations take precedence when applicable.

Electrodiagnostic evidence required for CIDP coverage alongside clinical features and treatment history

Authorization noteInitial authorization valid for 3 months

Immune-checkpoint-inhibitor related toxicity — definition and examples

DefinitionSevere or steroid‑refractory immune‑mediated adverse events from immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab, ipilimumab) where IVIG may be used as adjunctive therapy

ExamplesSevere bullous dermatitis, SJS/TEN, severe myasthenia gravis, myocarditis not improving after 24–48 h of high‑dose steroids, severe demyelinating disease, steroid‑refractory myositis

RequirementPatient must be receiving immune checkpoint inhibitor therapy for consideration

Allogeneic BMT indication — definition and context

DefinitionIVIG used after allogeneic bone marrow or stem cell transplant for prevention of acute graft‑versus‑host disease (aGVHD) or infection

Coverage conditionPatient's transplant must be allogeneic and IgG < 400 mg/dL

Initial authorizationInitial authorization valid for 3 months

IgG trough level — serum IgG concentration and its role; <400 mg/dL cited

IgG trough level definitionSerum immunoglobulin G concentration used to assess adequacy of replacement; an IgG level < 400 mg/dL cited as evidence of continued need post‑transplant

RoleUsed to determine renewal eligibility for allogeneic BMT supportive therapy

Measurement timingDocument IgG level as part of renewal request evidence

Adjusted body weight — dosing weight calculation when BMI >=30 or actual weight >=20% above IBW

Adjusted body weight purposeDosing weight calculation when BMI ≥30 kg/m2 or actual weight ≥20% above IBW

FormulaAdjusted body weight = IBW + 0.5 × (actual body weight − IBW)

UseRound dose to nearest 5 g increment in adults after calculation

Serious bacterial infection (SBI) — clinical endpoint and FDA benchmark

SBI clinical endpointSerious bacterial infection (SBI) rate per patient‑year used as primary efficacy endpoint in PI trials

FDA benchmarkProducts demonstrate efficacy when SBI rate < 1 per patient‑year

Trial reportingMultiple IVIG products report SBI rates below the FDA benchmark in clinical studies

ITP dosing — immunomodulatory dosing patterns (1 g/kg or 2 g/kg regimens)

ITP dosing regimensCommon immunomodulatory regimens: 1 g/kg (single or repeated doses) or total 2 g/kg given over 2–5 days

PurposeUsed to rapidly increase platelet counts in ITP

Product evidenceSeveral products demonstrated platelet increases with these regimens in trials

IVIG products — examples of products reviewed

Examples of IVIG products reviewedAsceniv; Alyglo; Bivigam; Flebogamma; Gamunex‑C; Gammagard Liquid; Gammagard S/D; Gammaked; Gammaplex; Octagam; Privigen; Panzyga

P&T reviewThese products were reviewed by the NHPRI P&T Committee and coverage criteria applied accordingly

Product-specific notesIndividual product sections list indications, common adverse events (≥5%), and contraindications where applicable