CurrentNeighborhood Health Plan of Rhode IslandPolicy nhpriorg

Immune globulins (non-hematology, non-oncology)

Policy governing medical- and pharmacy-benefit coverage, quantity limits, authorization periods, and clinical criteria for intravenous immune globulin (IVIG) products for non-hematology and non-oncology indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImmune globulins (non-hematology, non-oncology)

Policy CodePolicy nhpriorg

Change TypeNo material change

Effective DateJan 1, 2020

Next Review Date

Key ActionObtain prior authorization and submit indication-specific documentation (diagnosis, baseline measures, and relevant labs) to support coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthstypical initial authorization duration

3 monthsinitial CIDP authorization

≤2 courses/6wGBS course limit

weight-baseddosing guidance

thrombosis/renalboxed risks listed

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

Auto-Immune Mucocutaneous Blistering Diseases

Covered when ALL of the following are met:

ALL of the following

Patient has a diagnosis of an auto-immune mucocutaneous blistering disease, such as: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, epidermolysis bullosa acquisita, mucous membrane pemphigoid (cicatricial pemphigoid), pemphigus gestationis (herpes gestationis), or linear IgA dermatosis.
Patient has severe disease that is extensive and debilitating (documented by clinical findings).
Diagnosis has been confirmed by appropriate diagnostic testing including biopsy (histopathology and/or direct immunofluorescence) consistent with the specified blistering disease.
Disease is progressive or refractory to a trial of conventional therapy, including corticosteroids plus at least one concurrent immunosuppressive agent (for example azathioprine, cyclophosphamide, mycophenolate mofetil, methotrexate), unless contraindicated or not tolerated.
Patient has a documented baseline physical examination and assessment of disease severity prior to initiating IVIG therapy.

Product, Billing, and Diagnosis Codes

Available IVIG J-Codes and CPT ReferencesmixedCovered

J1554	Asceniv
J1556	Bivigam
J1552	Alyglo
J1566	Carimune NF / Gammagard S/D (and others)
J1572	Flebogamma 10% DIF
J1561	Gamunex-C
J1569	Gammagard Liquid
J1568	Octagam (5%/10%)
J1459	Privigen
J1576	Panzyga

1–10 of 11

1/2

IVIG Products and Example Codes (selected)mixed

Asceniv	Manufacturer ADMA Biologics; 1 unit = 500 mg; IgG per SDV = 5 g; J1554 (or CPT 90283)
Bivigam	Manufacturer Biotest; 1 unit = 500 mg; IgG per SDV = 5 or 10 g; J1556 (multiple presentations)
Alyglo	Manufacturer GC Biopharma; IgG per SDV = 5,10,20 g; J1552
Gamunex-C	Manufacturer Grifols; 1 unit = 500 mg; J1561
Gammagard Liquid/S/D	Manufacturer Baxalta; J1569 / J1566 or CPT 90283
Privigen	Manufacturer CSL Behring; 1 unit = 500 mg; J1459
Panzyga	Manufacturer Octapharma; 1 unit = 500 mg; J1576

Referenced Modifiers / NotationsModifier

Unit Definition	1 billable unit = 500 mg (unless otherwise specified by product)
CPT 90283	Sometimes used as alternative CPT for IVIG administration references

Covered ICD-10 Diagnosis Codes (Appendix 1 — selected)ICD-10Covered

T86.23	Heart transplant infection
T86.00	Unspecified complication of bone marrow transplant
D80.0	Hereditary hypogammaglobulinemia
G61.81	Chronic inflammatory demyelinating polyneuritis (CIDP)
M30.3	Mucocutaneous lymph node syndrome [Kawasaki]

Referenced NCD / LCD Documents and MAC Contractorsmixed

A57187	CMS NCD/LCD document reference (see Appendix 2)
454660	CMS NCD/LCD document reference (see Appendix 2)
A54641	CMS NCD/LCD document reference (see Appendix 2)
MAC Contractors	Jurisdictional MAC contractor listings as documented in Appendix 2 (e.g., Noridian, Novitas, Palmetto, NGS, WPS, etc.)

Prior Authorization, Documentation, and Monitoring Requirements

Prior Authorization

Initial authorization default: 6 months

Initial authorization is generally provided for 6 months unless the policy specifies a different initial approval period for the indication (e.g., CIDP initial authorization is 3 months; GBS authorization valid for 2 months and limited to 2 courses within 6 weeks).

Step Therapy

Trial of preferred IVIG required before non‑preferred products

When requesting non‑preferred IVIG formulations, the patient must have trialed and had failure or intolerance to preferred formulations (examples: Gammaked/Gamunex‑C, Gammagard liquid, Flebogamma/Octagam) unless the member is a Medicare beneficiary who received the medication within the past 365 days.

Prior Authorization

Prior authorization required; indication-specific durations apply

Background and Clinical Context

Intravenous immune globulin (IVIG) is used for replacement therapy in primary humoral immunodeficiencies and for immunomodulation in a range of immune-mediated neurologic, hematologic, and systemic disorders. The plan’s criteria reference FDA labeling and clinical literature to define covered indications, dosing patterns (e.g., replacement vs high‑dose immunomodulatory regimens), monitoring requirements, and safety concerns such as thrombosis and renal dysfunction; prior authorization and renewal decisions should follow these clinical coverage criteria and applicable Medicare NCD/LCD guidance where present.

Definition — Primary immunodeficiency (examples)

DefinitionPrimary immunodeficiency (PID) includes disorders such as Wiskott‑Aldrich syndrome, X‑linked agammaglobulinemia, common variable immunodeficiency, transient hypogammaglobulinemia of infancy, IgG subclass deficiency, antibody deficiency with near‑normal immunoglobulin levels, and combined immunodeficiencies.

List statusProvided examples are not exhaustive

Relevance to coveragePID diagnosis plus IgG ≤ 200 mg/dL and infection history required for coverage

Policy Revision History

2020-01-01policy_effective

Policy governing IVIG (non-hematology, non-oncology) coverage criteria, prior authorization requirements, and authorization durations became effective.

2020-01-01authorization_periods_defined

Initial and renewal authorization periods and indication-specific limits (e.g., typical initial authorization 6 months; CIDP initial authorization 3 months; GBS authorization valid for 2 months and limited to 2 courses within 6 weeks) were defined.

2020-01-01renewal_criteria_established

Renewal criteria were established requiring documentation of disease response or continued infection risk for indications such as PID, CIDP, MMN, transplant complications, and others with specific renewal intervals (e.g., 6 months for dermatomyositis/autimmune blistering diseases; 3 months for allogeneic transplant).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImmune globulins (non-hematology, non-oncology)

Policy CodePolicy nhpriorg

Change TypeNo material change

Effective DateJan 1, 2020

Next Review Date

Key ActionObtain prior authorization and submit indication-specific documentation (diagnosis, baseline measures, and relevant labs) to support coverage.

SourceLink

On This Page

Prior authorization is required for the listed indications. Specific initial authorization durations are defined for certain diagnoses (examples: Stiff‑Person Syndrome — initial 3 months; Kawasaki disease and Neonatal Alloimmune Thrombocytopenia — 1 course/1 month; FAIT — through delivery).

Prior Authorization

Renewals: follow specified renewal intervals by indication

Renewal approvals are provided at indication‑specific intervals and require continued evidence per the policy (examples: dermatomyositis/polymyositis and autoimmune blistering diseases — renewals provided for 6 months; allogeneic bone marrow/stem cell transplant renewals provided for 3 months).

Documentation Required

Include Appendix 1 ICD‑10 code and indication‑specific documentation

Submit a covered ICD‑10 diagnosis code from Appendix 1 that corresponds to the requested indication and include indication‑specific supporting documentation (e.g., infection rates, IgG trough levels, platelet counts, biopsy confirmation, or objective clinical scores as applicable).

Prior Authorization

PA reviews follow plan P&T criteria and Medicare NCD/LCD when applicable

All requests require prior authorization and will be reviewed against the plan’s P&T‑derived clinical coverage criteria; for Medicare members, applicable NCDs/LCDs take precedence where present.

Step Therapy

Preferred IVIG trial and failure/intolerance must be documented

Prescribers must document trial and failure or intolerance of preferred IVIG formulations before approval of non‑preferred IVIG products, except for Medicare members previously treated within the past 365 days who are not subject to step requirements.

Prior Authorization

Document failure of prior therapies for refractory indications (e.g., SPS)

For certain indications (e.g., Stiff‑Person Syndrome), IVIG is reserved for patients refractory to other therapies — Stiff‑Person Syndrome requires failure of at least two listed agents (benzodiazepines, baclofen, gabapentin, valproate, tiagabine, levetiracetam).

Step Therapy

Trial of dose reduction/discontinuation required for stable patients (PID excluded)

Patients who are stable or in sustained remission should have a documented trial of dose reduction and/or treatment discontinuation unless excluded (Primary Immunodeficiency patients are excluded from discontinuation trials; HIV‑infected children have specific control criteria).

Note

No explicit step therapy sequence provided in excerpt

The policy excerpt does not specify an explicit step‑by‑step therapeutic sequence for all indications; no formal step therapy sequence is provided in the document section excerpt.

Step Therapy

Document rationale if selecting specific branded IVIG products

The plan’s intent is to ensure cost‑effective products are used first; if a prescriber selects a specific branded immunoglobulin product they should document the clinical rationale for that selection.

Document clinical justification when requesting a specific branded product

Documentation Required

Document baseline exam and objective strength/functional measures for neuromuscular indications

For neuromuscular indications, document a baseline physical exam and objective measures of strength/function (examples: INCAT, MRC muscle strength, 6‑minute walk test, Rankin/Modified Rankin) prior to authorization.

Documentation Required

Submit diagnosis‑specific baseline and objective measures

Provide diagnosis‑specific baseline and objective documentation as required (examples: baseline physical exam for Stiff‑Person Syndrome; biopsy confirmation for autoimmune mucocutaneous blistering diseases; objective measuring tool scores for CIDP).

Documentation Required

Renewal requires documented improvement from baseline for SPS and blistering diseases

For renewal of Stiff‑Person Syndrome and Auto‑Immune Mucocutaneous Blistering Diseases, include documented improvement from baseline on physical exam to support continuation.

Documentation Required

Provide IgG level (~400 mg/dL) and continued infection‑risk documentation for allogeneic BMT renewals

For allogeneic bone marrow or stem cell transplant patients requesting renewal, document the patient’s IgG level (the policy references ~400 mg/dL) and evidence the patient remains at increased infection risk necessitating continued therapy.

Documentation Required

Document clinical evidence, dosing regimen, and safety monitoring

Include clinical trial evidence or literature support, dosing interval or regimen (e.g., every 3–4 weeks or weight‑based regimens such as 1 g/kg or 2 g/kg), and documentation of monitoring and mitigation for thrombotic, renal, hemolysis, and hypersensitivity risks.

Documentation Required

Submit Appendix 1 diagnosis codes with the request

Submit the supporting ICD‑10 diagnosis codes from Appendix 1 that correspond to the requested indication when requesting coverage for immunoglobulin products.

Billing Rule

Baseline BUN and serum creatinine required within 30 days

Obtain baseline BUN and serum creatinine within 30 days of the prior authorization request; failure to obtain these labs may result in denial.

Denial Risk

Renewal may be denied for lack of response or presence of unacceptable toxicity

Renewal requests may be denied if there is absence of evidence of disease response or if unacceptable toxicity is present (examples of toxicity: acute kidney injury, thrombosis, hemolysis, hypersensitivity, TRALI, volume overload).

Denial Risk

HIV pediatric renewals require documented infection‑response; lack may trigger denial

For HIV‑infected children, lack of documented disease response (no decrease in infection frequency or severity) and failure to meet continued‑use criteria may trigger denial of renewal.

Denial Risk

Transplant complications renewals require documented response; lack may trigger denial

For transplant‑related complications, absence of documented disease response (decrease in infection frequency or severity) and lack of evidence that continued treatment is necessary may lead to denial of renewal.

Denial Risk

Boxed‑warning safety monitoring required (thrombosis, renal dysfunction)

Products carry boxed warnings for thrombosis and renal dysfunction; denials or requests for additional monitoring documentation may occur if monitoring for these safety risks (e.g., renal function) is not documented.

Denial Risk

Denial risk if indication is not medically accepted or conflicts with FDA/clinical literature/NCDs

Requests that do not demonstrate use for a medically accepted indication or that conflict with FDA labeling, relevant clinical literature, or applicable NCD/LCD criteria for Medicare members may be denied.

Definition — CIDP diagnostic criteria

Key diagnostic featuresProgressive or relapsing/remitting course ≥ 2 months; abnormal or absent deep tendon reflexes in affected limbs; electrodiagnostic evidence of demyelination per listed criteria (eg partial motor conduction block in ≥2 motor nerves, prolonged distal motor latency, reduced conduction velocity, prolonged/absent F waves).

Treatment contextPatient must be refractory or intolerant to corticosteroids given in therapeutic doses for ≥3 months

DocumentationBaseline strength/weakness must be documented using an objective tool (eg INCAT, MRC, 6‑MWT)

Definition — Management of immune‑checkpoint‑inhibitor related toxicity

Role of IVIGIVIG may be used as adjunctive therapy for severe or steroid‑refractory immune checkpoint inhibitor–related toxicities (eg severe bullous dermatitis, SJS/TEN, severe myasthenia gravis, myocarditis unresponsive to high‑dose steroids, severe pneumonitis, encephalitis, life‑threatening myositis).

Use conditionsTypically used when toxicity is severe (G3–G4) or steroid‑refractory and often in combination with high‑dose methylprednisolone or rituximab as indicated

NotationListed as adjunct or second‑line in rapidly progressive or life‑threatening scenarios

Definition — Serious Bacterial Infection (SBI) as trial endpoint

SBI as trial endpointSerious Bacterial Infection (SBI) rate was the primary efficacy endpoint in PI trials; efficacy demonstrated when mean SBI rate was <1 per subject per year.

MeasurementTrials measured SBI rates alongside maintenance of IgG trough levels to establish efficacy

Regulatory relevanceFDA criteria for PI efficacy referenced in product clinical trials and labeling

Definition — Supportive care after thymic (rethymic) transplant summary

Supportive care scopeIVIG used as immunoglobulin replacement therapy in pediatric congenital athymia after Rethymic implantation; renewals authorized until immunosuppression is stopped (≥10% naive CD3+ T cells), patient ≥9 months post‑treatment, and PHA response within normal limits.

Re‑initiation guidanceIf re‑initiated after stopping for low IgG trough, continue therapy for 1 year before retesting per above criteria

Patient populationApplies to pediatric patients with congenital athymia post‑Rethymic implant

Definition — SBI efficacy threshold for PI (<1 per patient-year)

SBI efficacy threshold for PIEfficacy threshold: mean SBI rate <1 per patient‑year (used to demonstrate IVIG efficacy in primary immunodeficiency trials)

Clinical evidenceMultiple PI product trials reported SBI rates below this threshold alongside maintained IgG troughs

Implication for coverageSBI <1/year is the benchmark for demonstrating clinical effectiveness in PI indications

Definition — ITP dosing response examples

ITP dosing response examplesPlatelet count increases observed after IVIG total doses such as 1 g/kg daily for two days or 2 g/kg total given over 2–5 days (product‑dependent)

Product contextExamples cited in product trials (eg Flebogamma, Gamunex‑C, Gammaplex, Octagam) demonstrating platelet responses in ITP studies

Dosing noteRegimens vary by product and indication; document platelet response to support continued therapy for ITP

Definition — Immunoglobulin products listed (product examples)

Examples of IVIG products listedAsceniv, Alyglo, Bivigam, Flebogamma, Gamunex‑C, Gammagard (Liquid/S/D), Gammaked, Gammaplex, Octagam, Privigen, Panzyga

Indication noteProducts are reviewed by P&T and used according to FDA labeling and relevant clinical literature; indications and age cutoffs vary by product

Safety considerationsProducts carry boxed warnings (eg thrombosis, renal dysfunction, hemolysis) and some have specific contraindications (eg Flebogamma in hereditary fructose intolerance; certain products contraindicated in IgA deficiency with anti‑IgA antibodies)

2020-01-01P&T_review_and_rationale

Neighborhood Health Plan P&T Committee reviewed listed IVIG products and adopted clinical coverage criteria to align use with FDA labeling, clinical literature, and cost-effective product sequencing.

2020-01-01step_requirement_defined

Step requirement established: trial and failure or intolerance of preferred IVIG formulations required before approval of non-preferred formulations (with Medicare exceptions for prior treatment within 365 days).

2020-01-01safety_monitoring_requirements

Safety-related monitoring and denial triggers were specified, including baseline BUN/creatinine within 30 days, and consideration of boxed warnings for thrombosis and renal dysfunction when reviewing requests.

2020-01-01product_listed

Specific IVIG products (e.g., Asceniv, Alyglo, Bivigam, Flebogamma, Gamunex-C, Gammagard, Gammaked, Gammaplex, Octagam, Privigen, Panzyga) were listed and referenced in billing/coding and policy rationale following P&T review.

2020-01-01policy_rationale_documentedLatest

Policy rationale documented that criteria were drafted with network prescribers and pharmacists to ensure medically accepted indications and minimize adverse effects and costs.