CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Scig 2043 A Sgm P2022

Defines coverage, prior authorization documentation, initial and reauthorization clinical criteria, and limitations for subcutaneous immune globulin products (Hizentra, HyQvia, Cutaquig, Cuvitru, Xembify) across FDA-approved and compendial indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyScig 2043 A Sgm P2022

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit required diagnostic and laboratory documentation (IgG/IgA/IgM/IgG subclasses, pneumococcal vaccine response, genetic testing, lymphocyte subset enumeration, and indication-specific tests) as part of prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria in this update.

45Listed covered indications (FDA + compendial)

1–6Common initial authorization (months)

6Frequent re-authorization (months)

Coverage Summary

Defines coverage for subcutaneous immune globulin (SCIG) products — Hizentra, HyQvia, Cutaquig, Cuvitru, Xembify — for FDA‑approved and compendial indications when all specified criteria are met. Prior authorization is required and documentation/testing requirements apply for review.

Key thresholds and quick facts

scope_summaryDefines coverage, prior authorization documentation, initial and reauthorization clinical criteria, and limitations for subcutaneous immune globulin products (Hizentra, HyQvia, Cutaquig, Cuvitru, Xembify).

subjectSubcutaneous Immune Globulin (SCIG) coverage for multiple indications

Pretreatment IgG for SCID threshold< 200 mg/dL

CD3 T cell threshold (SCID)< 300/microliter

Pretreatment IgG for CVID/hypogammaglobulinemia< 500 mg/dL or ≥ 2 SD below mean for age

Pretreatment IgG for CLL prophylaxis< 500 mg/dL

Pretreatment IgG for pediatric HIV and CAR-T / BMT criteria< 400 mg/dL

HLH/MAS IgG threshold< 400 mg/dL or 2 SD below mean for age

Selective IgA deficiencyIgA < 7 mg/dL

Selective IgM deficiencyIgM < 30 mg/dL

ITP platelet thresholds - adults< 30,000/mcL; or < 50,000/mcL with significant bleeding, high bleeding risk, or need for rapid platelet increase

Medical-Necessity Criteria (by indication)

General Indications and Limitations

SCIG products listed are covered for FDA-approved indications and compendial uses when all approval criteria are met and the member has no exclusions.

General Indications and Limitations - requirements: Therapy is for an FDA-approved indication or listed compendial use; all specific indication-specific criteria (diagnostic, laboratory, prior treatments) are met as detailed in section III and Documentation section

See product-specific FDA approvals and compendial list

Primary Immunodeficiency - Re-authorization

Re-authorization of 6 months may be granted when ALL of the following are met:

Re-authorization criteria: A reduction in the frequency of bacterial infections has been demonstrated since initiation of IG therapy; IgG trough levels are monitored at least yearly and maintained at or above the lower range of normal for age (when applicable); and prescriber will re-evaluate dose and consider dose adjustment when appropriate.IgG troughs ≥ lower range of normal for age (when applicable)

Documentation: IgG trough level reports and infection history; prescriber plan for dose re-evaluation

Myasthenia Gravis

Myasthenia Gravis indications

1-month authorization: Authorization of 1 month for worsening weakness, acute exacerbation, or pre-operative management
Worsening weakness examples include increased diplopia, ptosis, blurred vision, dysarthria, dysphagia, difficulty chewing, impaired respiratory status, fatigue, limb weakness; acute exacerbations include severe swallowing difficulties and/or respiratory failure; pre-operative example = prior to thymectomy
6-month authorization: Authorization of 6 months for refractory myasthenia gravis
Requires trial and failure of ≥2 standard therapies (eg corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, rituximab) documented

Documentation requirement: Clinical records describing standard treatments tried and failed must be provided for refractory indications

See Documentation section

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

CIDP initial and reauthorization: Initial authorization of 3 months when disease is progressive or relapsing/remitting ≥2 months, with moderate to severe functional disability, and diagnosis confirmed by electrodiagnostic studies; re-authorization of 6 months when significant improvement in disability and maintenance of improvement since initiation of IG therapy and IG is used at the lowest effective dose and frequency.

EMG/NCS required per Documentation section

Idiopathic Thrombocytopenic Purpura (ITP)

ITP initial/ chronic/other

Newly diagnosed/initial therapy - Children (<18): Authorization 1 month when child has significant bleeding symptoms OR high risk for bleeding OR rapid increase in platelets required
Provide risk factors per Appendix B or reason for rapid increase
Newly diagnosed/initial therapy - Adults (≥18): Authorization 1 month when adult has platelet count < 30,000/mcL OR platelet count < 50,000/mcL with significant bleeding/high risk/rapid increase required, and corticosteroids are contraindicated or IG used alone/with corticosteroidPlatelets < 30,000/mcL; or < 50,000/mcL with bleeding/high risk
Document platelet count and contraindication to steroids if applicable
Chronic/persistent ITP (≥3 months): Authorization 6 months when platelet count < 30,000/mcL OR platelets < 50,000/mcL with significant bleeding/high risk/rapid increase required, and relapse after previous response to IG or inadequate response/intolerance/contraindication to corticosteroid or anti-D therapy

B-cell Chronic Lymphocytic Leukemia (CLL)

CLL prophylaxis initial: Initial authorization of 6 months when IG is prescribed for prophylaxis of bacterial infections, member has recurrent sinopulmonary infections requiring IV antibiotics or hospitalization, and pretreatment serum IgG < 500 mg/dL; re-authorization of 6 months when reduction in frequency of bacterial infections demonstrated since initiation of IG therapy.IgG < 500 mg/dL

Provide pre-treatment IgG level and infection history

HIV Pediatric Prophylaxis

HIV pediatric prophylaxis initial/reauth: Initial authorization of 6 months for pediatric HIV prophylaxis when any of the listed criteria apply: primary prophylaxis with pretreatment IgG < 400 mg/dL; secondary prophylaxis for history of >2 serious bacterial infections in 1 year; failure to form antibodies to common antigens; lives in high measles prevalence without antibody after two MMR doses; post-exposure single-dose request; chronic bronchiectasis suboptimally responsive to therapy. Re-authorization of 6 months when reduction in frequency of bacterial infections demonstrated.IgG < 400 mg/dL for primary prophylaxis

Documentation: pre-treatment IgG and infection/vaccine response history

BMT/HSCT Recipients

BMT/HSCT initial: Initial authorization of 6 months when therapy is used to prevent acute GVHD, interstitial pneumonia, septicemia, CMV and other infections, and either IG is requested within the first 100 days post-transplant OR member has pretreatment serum IgG < 400 mg/dL. Re-authorization of 6 months when reduction in frequency of bacterial infections demonstrated.IgG < 400 mg/dL; request within 100 days post-transplant

Provide pre-treatment IgG and transplant timing documentation

Multifocal Motor Neuropathy (MMN)

MMN initial and reauth: Initial authorization of 3 months when progressive, multifocal, asymmetrical weakness without objective sensory loss in ≥2 nerves for ≥1 month and diagnosis confirmed by electrodiagnostic studies; re-authorization of 6 months when significant improvement in disability and maintenance of improvement since initiation of IG therapy.

EMG/NCS required per Documentation section

Guillain-Barré Syndrome (GBS)

GBS 1-month authorization: Authorization of 1 month total when member has severe disease with significant weakness (eg, inability to stand or walk without aid, respiratory weakness) and onset of neurologic symptoms occurred less than 4 weeks from anticipated start of therapy.

Lambert-Eaton Myasthenic Syndrome (LEMS)

LEMS initial and reauth: Initial authorization of 6 months when diagnosis confirmed by neurophysiology studies or positive anti-P/Q type VGCC antibody; anticholinesterases and amifampridine have been tried and were unsuccessful or not tolerated; weakness is severe or venous access for plasmapheresis is difficult. Re-authorization of 6 months when member is responding to therapy (stability or improvement).

Provide neurophysiology/antibody results and prior therapy trial documentation

Other Indications (selected examples)

Authorizations and durations vary by indication with specified criteria; examples below summarize the policy entries.

Examples of other indications and durations

Kawasaki syndrome: authorization 1 month for pediatric members
Fetal/neonatal alloimmune thrombocytopenia: authorization 6 months
Parvovirus B19 PRCA: Parvovirus B19-induced pure red cell aplasia: authorization 6 months for severe refractory anemia with parvovirus B19 viremia
Require parvovirus B19 test result
Stiff-person syndrome: authorization 6 months when diagnosis confirmed by anti-GAD antibody and inadequate response to benzodiazepines and/or baclofen
Provide anti-GAD antibody results and treatment history

Continuation of Therapy

Conditions for continuation (reauthorization) of therapy

Continuation of Therapy: For conditions with listed reauthorization criteria: members currently receiving IG must meet the applicable reauthorization criteria for the condition; For all other conditions: members (including new members) must meet initial authorization criteria

See per-indication reauthorization rules (eg 6-month reauthorizations when infection frequency reduced or clinical improvement maintained)

Coding

Products mentioned (clinical/drug references only)NDC|mixed

Hizentra	Immune Globulin Subcutaneous [Human], 20% Liquid
HyQvia	Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase
Cutaquig	Immune Globulin Subcutaneous [Human] - 16.5% Solution
Cuvitru	Immune Globulin Subcutaneous [Human], 20% Solution
Xembify	Immune Globulin Subcutaneous [Human], 20% Solution

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization review requires submission of the documentation items listed; initial and reauthorization durations and criteria must be met per indication.

Documentation Required

Required diagnostic and laboratory documentation

Submit copies of relevant laboratory and diagnostic reports as part of the prior authorization request.

Serum immunoglobulins: IgG, IgA, IgM
IgG subclasses
Post-vaccination Streptococcus pneumoniae antibody titers (pneumococcal vaccine response)
Pertinent genetic or molecular testing (when applicable)
Lymphocyte subset enumeration by flow cytometry
Electrodiagnostic studies (EMG/NCS) when indicated
Pre-treatment/current platelet counts
Relevant antibody tests (e.g., anti-GAD, anti–P/Q type VGCC)
Parvovirus B19 testing (for PRCA)
Microbiological data (cultures or Gram stain) when applicable

Documentation Required

IgG trough monitoring for continuation

For members continuing on immunoglobulin therapy, IgG trough levels must be monitored at least yearly and maintained at or above the lower range of normal for age when applicable; include IgG trough results with reauthorization requests.

Documentation Required

Provide trial/failure history for refractory indications

For refractory indications that require prior treatment failure (for example myasthenia gravis, dermatomyositis/polymyositis, LEMS, autoimmune mucocutaneous blistering disease), submit clinical records documenting standard therapies tried and failed or reasons they were not tolerated/are contraindicated.

Documentation Required

ITP bleeding risk justification

When ITP approval is sought based on 'high risk for bleeding' or need for a 'rapid increase in platelets', provide the member's bleeding risk factors (see Appendix B) or the reason rapid platelet increase is required (eg, upcoming procedure).

Background & Evidence

Background: SCIG products are covered as replacement therapy for primary humoral immunodeficiency (PI) (FDA‑approved indications) and for numerous compendial and off‑label indications when specific clinical and laboratory criteria are satisfied. The policy specifies required documentation and diagnostic testing (for example, serum immunoglobulin levels, vaccine response testing, genetic/molecular testing, and lymphocyte subset enumeration) that must be submitted for prior authorization.

Primary references: product package inserts for Cutaquig, Cuvitru, Hizentra, HyQvia, and Xembify, and multiple clinical guidelines and reviews (including AANEM, EFNS, IDF, ASH, and NCCN) cited in the policy references.

Impaired antibody response to pneumococcal polysaccharide vaccine (Appendix A)

definitionAge ≥ 2 years: impaired antibody response demonstrated to vaccination with a pneumococcal polysaccharide vaccine; not established for children < 2 years of age; excludes therapy initiated in the hospital setting.

Medicare Determinations

name	number	effective date	type
Intravenous immune globulin for autoimmune mucocutaneous blistering diseases decision	CPG-00109N	2002-01-22	NCD

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyScig 2043 A Sgm P2022

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

Platelets < 30,000/mcL; or < 50,000/mcL with bleeding/high risk

Provide records of prior therapies and responses

Adults refractory after splenectomy: authorization 6 months when platelet count < 30,000/mcL OR significant bleeding symptomsPlatelets < 30,000/mcL

ITP in pregnancy: Authorization through delivery may be granted for pregnant women with ITP

Immune checkpoint inhibitor-related toxicities: Management of immune checkpoint inhibitor-related toxicities: authorization 1 month when moderate/severe adverse event to PD-1/PD-L1 inhibitor, offending medication held/discontinued, and specified serious immune-related toxicities present

Autoimmune mucocutaneous blistering disease: authorization 6 months when biopsy-confirmed, rapidly progressing/extensive/debilitating, and failed or had significant complications from standard treatment

Provide pathology report and treatment failure documentation

Autoimmune hemolytic anemia (warm-type): authorization 6 months when nonresponsive or contraindicated to corticosteroids or splenectomy

Autoimmune neutropenia: authorization 6 months when G-CSF not appropriate

Many other examples: Additional listed indications (eg BK virus nephropathy, Churg-Strauss, enteroviral meningoencephalitis, HLH/MAS with IgG <400 mg/dL, hemolytic disease of newborn, HIV-associated thrombocytopenia, CAR-T hypogammaglobulinemia, multiple myeloma, transplant-related indications, toxic epidermal necrolysis/Stevens-Johnson, measles/tetanus/varicella postexposure prophylaxis, toxic shock syndrome, toxic necrotizing fasciitis) with the authorization durations specified in policy

See policy sections for each indication and required documentation

Documentation requirement for examples: Provide indication-specific diagnostic testing, lab reports, and prior therapy trial/failure documentation as detailed in the Documentation section

OpenPayer

Scig 2043 A Sgm P2022

Coverage Summary

Medical-Necessity Criteria (by indication)

Coding

Provider Actions & Prior Authorization Requirements

Background & Evidence

Medicare Determinations

Revision History