Neighborhood Health Plan RI SCIG Coverage Policy Update

Covered Indications

Covered when ALL FDA-approved indications or listed compendial uses apply and approval criteria are met

Primary and compendial indications: Product use aligns with an FDA-approved indication (e.g., listed SCIG products for primary humoral immunodeficiency and CIDP maintenance where specified) or a listed compendial use (see compendial uses list for autoimmune, infectious, transplant, hematologic, and neurologic conditions).

Use must meet the specific documentation and prior authorization requirements.

Primary Immunodeficiency - Initial Authorization

Initial authorization of 6 months may be granted for primary immunodeficiency when ALL of the following criteria appropriate to the diagnosis are met:

SCID or congenital agammaglobulinemia: Diagnosis confirmed by genetic or molecular testing OR pretreatment IgG < 200 mg/dL OR absence/very low T cells (CD3 < 300/µL) or presence of maternal T cells (SCID only)IgG < 200 mg/dL; CD3 < 300/µL

Wiskott-Aldrich, DiGeorge, Ataxia-telangiectasia or other non‑SCID combined immunodeficiency: Diagnosis confirmed by genetic or molecular testing (if applicable) AND history of recurrent bacterial infections AND impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A)

See Appendix A for vaccine response documentation

Common Variable Immunodeficiency (CVID): Age ≥ 2 years AND exclusion of other causes of immune deficiency AND pretreatment IgG < 500 mg/dL or ≥2 SD below mean for age AND history of recurrent bacterial infections AND impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A)IgG < 500 mg/dL or ≥2 SD below mean

Other antibody deficiency disorders: History of recurrent bacterial infections AND impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A) AND pretreatment hypogammaglobulinemia (IgG < 500 mg/dL or ≥2 SD below mean for age) or defined subclass/specific antibody deficienciesIgG < 500 mg/dL or ≥2 SD below mean

Appendix A excludes hospital‑initiated therapy; provide diagnostic labs and vaccine response evidence

Primary Immunodeficiency - Reauthorization

Re-authorization criteria for primary immunodeficiency (12 months):

Reauthorization: Reduction in frequency of bacterial infections since initiation of IG therapy AND IgG trough levels monitored at least yearly and maintained at or above the lower range of normal for age OR prescriber will re-evaluate dose and consider adjustmentIgG troughs at least yearly

Reauthorization period: 12 months

Myasthenia Gravis

Myasthenia gravis authorization:

Short-term IG for exacerbation or perioperative use: Authorization of 1 month for worsening weakness, acute exacerbation, or pre-operative management (worsening weakness includes new/worse diplopia, ptosis, dysarthria, dysphagia, respiratory impairment, limb weakness, or increased fatigue)1 month

Provide clinical records documenting the acute indication

Refractory myasthenia gravis: Authorization of 6 months when refractory MG has failed ≥2 standard therapies (examples: corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, rituximab)failed ≥2 therapies

Documentation of prior therapies required

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

CIDP authorization:

Initial CIDP authorization: Initial authorization of 3 months when disease is progressive or relapsing/remitting for ≥2 months AND moderate to severe functional disability AND diagnosis confirmed by electrodiagnostic studies (EMG/NCS)disease ≥2 months

Provide pre‑treatment electrodiagnostic studies

CIDP reauthorization: Re-authorization of 6 months when there is significant improvement in disability with maintenance of improvement since IG initiation AND IG is used at the lowest effective dose and frequency

Dermatomyositis or Polymyositis

Dermatomyositis/Polymyositis initial authorization:

Diagnostic criteria met: Initial authorization of 3 months when member has at least 4 of the listed diagnostic features (e.g., proximal muscle weakness, elevated CK/aldolase, myogenic EMG changes, anti‑synthetase antibodies, compatible pathology, systemic inflammatory signs) AND standard first‑ and second‑line treatments have failed or are contraindicated≥4 features

Provide clinical records showing prior standard therapies tried and failed

Reauthorization: Re-authorization of 6 months when significant improvement in disability and maintenance of improvement since initiation of IG therapy

Idiopathic Thrombocytopenic Purpura (ITP)

Idiopathic Thrombocytopenic Purpura (ITP):

Newly diagnosed pediatric ITP: Authorization of 1 month for children (<18 years) with significant bleeding (mucosal or moderate/severe) OR high risk for bleeding OR need for rapid platelet increase (e.g., surgery/procedure)<18 years

Pre-treatment/current platelet count required

Newly diagnosed adult ITP: Authorization of 1 month for adults (≥18 years) with platelet count <30,000/mcL OR platelet count <50,000/mcL with significant bleeding/high bleeding risk or need for rapid platelet increase; corticosteroid therapy contraindicated and IG will be used alone or with corticosteroidplatelets <30,000 or <50,000 with conditions

Provide platelet count and bleeding risk documentation

Chronic/persistent ITP: Authorization of 6 months for ITP ≥3 months from diagnosis or unresponsive to first‑line therapy when platelets <30,000/mcL OR <50,000/mcL with significant bleeding/high risk AND relapse after prior response to IG or inadequate response/intolerance/contraindication to corticosteroid or anti‑D therapy

B-cell Chronic Lymphocytic Leukemia (CLL)

B-cell Chronic Lymphocytic Leukemia (CLL):

CLL prophylaxis: Initial authorization of 6 months when IG is prescribed for prophylaxis of bacterial infections AND member has recurrent sinopulmonary infections requiring IV antibiotics or hospitalization AND pretreatment serum IgG < 500 mg/dLIgG < 500 mg/dL

Reauthorization when infections decrease

Prophylaxis of Bacterial Infections in HIV-Infected Pediatric Patients

Prophylaxis in HIV-infected pediatric patients:

Pediatric HIV prophylaxis indications: Initial 6‑month authorization when IG is prescribed for primary prophylaxis with pretreatment IgG < 400 mg/dL OR for secondary prophylaxis after >2 serious bacterial infections in 1 year OR failure to form antibodies to common antigens OR lack of measles antibody after 2 MMR doses in a high‑prevalence area OR single‑dose post‑exposure OR chronic bronchiectasis suboptimally responsive to therapyIgG < 400 mg/dL for primary prophylaxis

Reauthorization when infections decrease

BMT/HSCT

BMT/HSCT:

BMT/HSCT initial authorization: Initial 6‑month authorization when used to prevent graft‑versus‑host disease, interstitial pneumonia, septicemia, and other infections AND either IG requested within first 100 days post‑transplant OR pretreatment serum IgG < 400 mg/dLwithin 100 days post‑transplant OR IgG < 400 mg/dL

Reauthorization when infections decrease

Multifocal Motor Neuropathy (MMN)

Multifocal Motor Neuropathy (MMN):

MMN initial authorization: Initial 3‑month authorization when progressive, multifocal, asymmetrical weakness without objective sensory loss in ≥2 nerves for ≥1 month AND diagnosis confirmed by electrodiagnostic studies≥1 month; ≥2 nerves

Reauthorization of 6 months when significant improvement maintained; provide pre‑treatment electrodiagnostic studies

Guillain-Barre Syndrome (GBS)

Guillain‑Barre Syndrome (GBS):

GBS authorization: Authorization of 1 month total for severe GBS with significant weakness (e.g., inability to stand/walk without aid, respiratory weakness) when onset of neurologic symptoms occurred <4 weeks from anticipated therapy startonset <4 weeks

Lambert‑Eaton Myasthenic Syndrome (LEMS)

Lambert‑Eaton Myasthenic Syndrome (LEMS):

LEMS initial authorization: Initial 6‑month authorization when diagnosis is confirmed by neurophysiology studies OR positive anti‑P/Q type VGCC antibody AND anticholinesterases and amifampridine have been tried and were unsuccessful or not tolerated AND weakness is severe or venous access for plasmapheresis is difficult

Reauthorization of 6 months may be granted when member is responding to therapy (stability or improvement)

Kawasaki Syndrome

Kawasaki syndrome:

Kawasaki authorization: Pediatric member with Kawasaki syndrome1 month

Authorization of 1 month may be granted

Lambert-Eaton Myasthenic Syndrome (LEMS)

LEMS — Covered when ALL of the following are met:

LEMS initial authorization: Diagnosis confirmed by neurophysiology OR positive anti‑P/Q VGCC antibody; prior trials of anticholinesterases (e.g., pyridostigmine) and amifampridine tried and unsuccessful or not tolerated; weakness is severe or there is difficulty with venous access for plasmapheresis.

Initial authorization 6 months; re‑authorization 6 months if responding (stability or improvement).

Stiff-person Syndrome

Stiff-person Syndrome — Covered when ALL of the following are met:

Stiff-person Syndrome authorization: Diagnosis confirmed by anti‑GAD antibody testing; inadequate response to first‑line treatment (benzodiazepines and/or baclofen)

Authorization 6 months.

Management of Immune Checkpoint Inhibitor-Related Toxicities

Management of immune checkpoint inhibitor‑related toxicities — Covered when ALL of the following are met:

ICI toxicity management: Member experienced a moderate or severe adverse event to a PD‑1 or PD‑L1 inhibitor; offending medication has been held or discontinued; member experienced one or more listed severe immune‑related adverse events (e.g., myocarditis, Stevens‑Johnson syndrome, pneumonitis, myasthenia gravis, GBS, encephalitis, severe inflammatory arthritis)

Authorization 1 month.

HLH or MAS

HLH/MAS‑related hypogammaglobulinemia — Covered when ALL of the following are met:

HLH/MAS hypogammaglobulinemia: Total IgG < 400 mg/dL or two standard deviations below the mean for age; IG prescribed for treatment of hypogammaglobulinemia in HLH or MASIgG < 400 mg/dL or two SD below mean for age

Authorization 6 months.

Hypogammaglobulinemia from CAR-T therapy

CAR‑T therapy‑associated hypogammaglobulinemia — Covered when ALL of the following are met:

CAR‑T hypogammaglobulinemia: Member is receiving CAR‑T therapy and has total IgG < 400 mg/dLIgG < 400 mg/dL

Authorization 6 months; applicable to listed CAR‑T products but not limited to them.

Autoimmune Mucocutaneous Blistering Disease

Autoimmune mucocutaneous blistering disease — Covered when ALL of the following are met:

Autoimmune mucocutaneous blistering disease: Diagnosis proven by biopsy with pathology confirmation; condition is rapidly progressing, extensive, or debilitating; member has failed or experienced significant complications from standard treatments (corticosteroids, immunosuppressives)

Authorization 6 months. Provide biopsy/pathology and prior therapy documentation.

Miscellaneous covered indications

Other covered indications (each with condition-specific criteria):

Other indications list: Includes fetal/neonatal alloimmune thrombocytopenia (F/NAIT) (6 months); parvovirus B19‑induced pure red cell aplasia with viremia (6 months); acquired red cell aplasia (6 months); acute disseminated encephalomyelitis after insufficient response or contraindication to IV corticosteroids (1 month); warm‑type autoimmune hemolytic anemia refractory to corticosteroids or splenectomy (6 months); autoimmune neutropenia where G‑CSF is inappropriate (6 months); birdshot retinochoroidopathy not responsive to immunosuppressives (6 months); BK virus associated nephropathy (6 months); severe Churg‑Strauss (6 months); enteroviral meningoencephalitis (6 months); hemolytic disease of newborn (6 months); HIV‑associated thrombocytopenia (6 months); hyper‑IgE syndrome severe eczema (6 months).

Authorization lengths vary by condition as noted; provide condition‑specific documentation.

Hyperimmunoglobulinemia E Syndrome

Authorization of 6 months may be granted for the following condition:

Hyperimmunoglobulinemia E Syndrome: Authorization of 6 months may be granted to treat severe eczema in hyperimmunoglobulinemia E syndrome

Hypogammaglobulinemia from CAR-T therapy

Authorization of 6 months may be granted when laboratory criteria met:

Hypogammaglobulinemia from CAR‑T therapy: Authorization of 6 months may be granted for members receiving CAR‑T therapy who have total IgG < 400 mg/dL (examples of CAR‑T products listed)IgG < 400 mg/dL

Multiple Myeloma

Authorization of 6 months may be granted when infection criteria met:

Multiple Myeloma: Authorization of 6 months may be granted for multiple myeloma in members who have recurrent, serious infections despite use of prophylactic antibiotics

Neonatal Hemochromatosis

Authorization of 6 months may be granted for prophylaxis in pregnancy when history present:

Neonatal Hemochromatosis Prophylaxis: Authorization of 6 months may be granted for prophylaxis in pregnant members with a prior pregnancy ending in documented neonatal hemochromatosis

Opsoclonus-myoclonus

Authorization of 6 months may be granted for opsoclonus‑myoclonus in either scenario:

Opsoclonus‑myoclonus indications: Paraneoplastic opsoclonus‑myoclonus‑ataxia associated with neuroblastoma OR refractory opsoclonus‑myoclonus as a last‑resort treatment

Authorization 6 months.

Post-transfusion Purpura

Authorization of 1 month may be granted for the following acute hematologic condition:

Post‑transfusion Purpura: Authorization of 1 month may be granted for post‑transfusion purpura

Rasmussen Encephalitis

Authorization of 6 months may be granted when seizures and medical therapy criteria met:

Rasmussen Encephalitis: Authorization of 6 months may be granted for Rasmussen encephalitis in members whose symptoms do not improve with anti‑epileptic drugs and corticosteroids

Renal Transplantation

Authorization of 6 months may be granted for transplant‑related incompatibility:

Renal Transplantation ABO/positive crossmatch: Authorization of 6 months may be granted for a member undergoing renal transplantation from a live donor with ABO incompatibility or a positive cross‑match

Secondary Immunosuppression-associated Indications

Authorization of 6 months may be granted for secondary immunosuppression when lab threshold met:

Secondary immunosuppression: Authorization of 6 months may be granted to prevent or modify recurrent bacterial or viral infections in members with secondary immunosuppression associated with major surgery, hematological malignancy, extensive burns, or collagen‑vascular disease when total IgG < 400 mg/dLIgG < 400 mg/dL

Solid Organ Transplantation

Authorization of 6 months may be granted for transplant sensitization:

Solid organ transplantation (allosensitized members): Authorization of 6 months may be granted for solid organ transplantation for allosensitized members

TEN / SJS

Authorization of 1 month may be granted for acute severe dermatologic emergencies:

Toxic Epidermal Necrolysis / Stevens‑Johnson Syndrome: Authorization of 1 month may be granted for severe cases of toxic epidermal necrolysis or Stevens‑Johnson syndrome

Toxic Shock Syndrome

Authorization of 1 month may be granted for refractory toxic shock syndrome when specific clinical conditions present:

Toxic shock syndrome: Authorization of 1 month may be granted for staphylococcal or streptococcal toxic shock syndrome when infection is refractory to several hours of aggressive therapy, an undrainable focus is present, or member has persistent oliguria with pulmonary edema

Systemic Lupus Erythematosus

Authorization of 6 months may be granted for severe autoimmune disease after failure of standard therapies:

Systemic Lupus Erythematosus (SLE): Authorization of 6 months may be granted for severe, active SLE in members who have inadequate response, intolerance, or contraindication to first‑ and second‑line therapies (examples: hydroxychloroquine, glucocorticoids, anifrolumab, rituximab)

Measles (Rubeola) Prophylaxis

Authorization of 1 month may be granted for postexposure prophylaxis:

Measles (Rubeola) postexposure prophylaxis: Authorization of 1 month may be granted for postexposure prophylaxis to prevent or modify symptoms in susceptible members exposed less than 6 days previously< 6 days since exposure

Tetanus

Authorization of 1 month may be granted for tetanus when TIG unavailable:

Tetanus treatment/postexposure prophylaxis: Authorization of 1 month may be granted for treatment or postexposure prophylaxis of tetanus as an alternative when tetanus immune globulin (TIG) is unavailable

Varicella Prophylaxis

Authorization of 1 month may be granted for varicella postexposure prophylaxis when VZIG unavailable:

Varicella Prophylaxis: Authorization of 1 month may be granted for postexposure prophylaxis of varicella in susceptible individuals when varicella‑zoster immune globulin (VZIG) is unavailable

Toxic Necrotizing Fasciitis

Authorization of 1 month may be granted for severe invasive streptococcal soft tissue infection:

Toxic necrotizing fasciitis due to group A streptococcus: Authorization of 1 month may be granted for members with fasciitis due to invasive group A streptococcal infection when documented fasciitis and supporting microbiologic data are present

Therapy for this indication is specified only when documented fasciitis and microbiologic evidence are provided

Continuation/Reauthorization

Continuation/Reauthorization —

Continuation of Therapy: Members currently receiving IG therapy must meet applicable reauthorization criteria for their condition; for all other conditions, including new members, the standard coverage criteria must be met

Requests for use of subcutaneous immune globulin for indications that are not listed among the FDA-approved indications or the compendial uses are considered experimental/investigational and not medically necessary. Coverage is limited to indications that clearly align with the FDA label or the specific compendial conditions enumerated in this policy and only when the applicable documentation and prior authorization criteria are met.

Immune globulin for toxic necrotizing fasciitis is specified only for cases due to group A streptococcus and requires documentation of fasciitis plus supporting microbiological data (for example, culture or Gram stain) demonstrating group A streptococcal infection.

Appendix A specifies that use of impaired antibody response to a pneumococcal polysaccharide vaccine as a basis for IG therapy applies to patients age 2 years and older with documented impaired response, and that the appendix excludes therapy initiated in the hospital setting.

Therapy that is initiated while the patient is hospitalized is excluded from coverage when the indication relied upon is impaired antibody response to pneumococcal polysaccharide vaccine; such hospital-initiated courses are not eligible under the impaired antibody response appendix pathway.

Uses of subcutaneous immune globulin that are not included among the FDA indications or the enumerated compendial list are not medically necessary and therefore are not covered.

The use of impaired pneumococcal polysaccharide vaccine response as a justification for IG therapy is not established for children less than 2 years of age; the appendix applies only to patients age 2 years and older with demonstrated impaired antibody response.

Prior Authorization, Documentation, and Actionable Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for IG therapy and requests must include the supporting documentation listed below. Authorization durations vary by indication (examples include 1, 3, 6, or 12 months) and are granted only when the applicable coverage criteria are met.

Prior authorization required for all listed indications and compendial uses; non‑listed uses are considered experimental/investigational and not medically necessary.
Authorization durations: commonly 1 month (e.g., Guillain‑Barre syndrome, Kawasaki syndrome, management of certain acute toxicities, post‑exposure prophylaxis) ; 3 months (e.g., initial CIDP, MMN) ; 6 months (most chronic indications including primary immunodeficiency, many autoimmune and transplant‑related indications) ; 12 months for reauthorization in some primary immunodeficiency scenarios.

Documentation Required

Documentation Required to Initiate Review

Provide disease‑specific documentation to initiate prior authorization review. Absent or incomplete documentation (e.g., missing lab reports, antibody tests, or evidence of prior therapies) may result in denial.

Primary immunodeficiency: diagnostic test results; laboratory report with serum IgG, IgA, IgM and IgG subclasses; pneumococcal polysaccharide vaccine response (post‑vaccination pneumococcal antibody titers); lymphocyte subset enumeration by flow cytometry; pertinent genetic or molecular testing when applicable; IgG trough level for those continuing IG therapy.
Myasthenia gravis: clinical records documenting standard treatments tried and failed.
Secondary hypogammaglobulinemia (CLL, HIV, BMT/HSCT): pre‑treatment serum IgG level.
CIDP/MMN: pre‑treatment electrodiagnostic studies (EMG/NCS).
Dermatomyositis/polymyositis: clinical records showing standard treatments tried and failed.
LEMS: neurophysiology studies (e.g., EMG) and positive anti‑P/Q type voltage‑gated calcium channel antibody test when available.
ITP: laboratory report with pre‑treatment/current platelet count; for chronic/persistent ITP, records documenting trial and failure of corticosteroid or anti‑D therapy unless contraindicated.
Parvovirus B19 PRCA: test result confirming presence of parvovirus B19.
Stiff‑person syndrome: anti‑GAD antibody testing results and records documenting trials and failure of standard therapies.

Prior Authorization

Prior Authorization: Impaired Pneumococcal Vaccine Response

When relying on impaired pneumococcal vaccine response as part of the indication (see Appendix A), documentation must demonstrate an impaired antibody response to pneumococcal polysaccharide vaccine in patients age 2 years and older. Therapy initiated in the hospital setting is excluded from this appendix and may be denied if this appendix is relied upon.

Appendix A requires impaired antibody response to pneumococcal polysaccharide vaccine for age ≥ 2 years.
Do not use Appendix A for hospital‑initiated therapy (excluded).

Denial Risk

Stiff‑person Syndrome — Diagnostic and Prior Therapy Requirements

Stiff‑person syndrome requests must include confirmatory anti‑GAD antibody testing and documentation that first‑line therapies were tried and inadequate or not tolerated. Failure to document anti‑GAD positivity or adequate trials of first‑line therapy may result in denial.

Required: anti‑glutamic acid decarboxylase (GAD) antibody test results.
Required: clinical records describing trials and inadequate response or intolerance to first‑line therapy (benzodiazepines and/or baclofen).

Prior Authorization

Reauthorization Requirements

Reauthorization requests must meet the specific reauthorization criteria listed for the member’s condition. For primary immunodeficiency, reauthorization of 12 months may be granted when reduced infection frequency is demonstrated and IgG troughs are monitored at least yearly and maintained at or above the lower range of normal (or prescriber will re‑evaluate dose). For other conditions follow the reauthorization durations and response criteria in the coverage criteria; otherwise continuation may be denied.

Primary immunodeficiency reauthorization: reduction in frequency of bacterial infections AND IgG trough monitoring at least yearly with levels maintained at/above lower range of normal, or prescriber will re‑evaluate dose.
Continuation: members currently receiving IG must meet applicable reauthorization criteria for their condition; new members must meet initial coverage criteria.

Documentation Required

Parvovirus B19 Documentation

Provide specific supporting laboratory confirmation for parvovirus B19 when PRCA is the indication. Lack of a documented positive test for parvovirus B19 may result in denial.

Required: copy of test result confirming presence of parvovirus B19 (viremia) for parvovirus B19‑induced PRCA.

Documentation Required

Pneumococcal Vaccine Antibody Response Documentation

Vaccine response documentation: when impaired antibody response to pneumococcal polysaccharide vaccine is cited to support IG coverage, include post‑vaccination Streptococcus pneumoniae antibody titers demonstrating impaired response. This requirement applies to patients age 2 years and older.

Include post‑vaccination pneumococcal polysaccharide antibody titers showing impaired response for age ≥ 2 years.
Document that vaccine testing was performed outside the hospital setting (Appendix A exclusion).

Documentation Required

Bleeding Risk Assessment

Assess and document bleeding risk factors when IG is requested for ITP or when a rapid platelet increase is required (e.g., pre‑operative). Examples include anticipated blood loss for procedures, comorbidities (peptic ulcer disease, hypertension), mandated anticoagulation, and occupations or activities with high trauma risk.

Provide reason requiring rapid platelet increase (e.g., upcoming surgery/procedure) or documentation of significant bleeding symptoms.
Include member’s bleeding risk factors per Appendix B when applicable.

Key Numeric Thresholds, Product Definitions, and Coding-Adjacent Guidance

IgG pretreatment levels — examples

SCID / congenital agammaglobulinemiaPretreatment IgG < 200 mg/dL in the SCID context (or diagnosis confirmed by genetic/molecular testing)

BMT/HSCT or HIV pediatric prophylaxisPretreatment serum IgG < 400 mg/dL

CVID, CLL and other antibody deficiencyPretreatment IgG < 500 mg/dL (or ≥2 standard deviations below mean for age)

Platelet counts for ITP

Adults - acute indicationPlatelet count < 30,000/mcL

Adults - with bleeding or high riskPlatelet count < 50,000/mcL with significant bleeding symptoms, high bleeding risk, or need for rapid platelet increase

Pediatric newly diagnosed ITPChildren (<18 years): significant bleeding or high bleeding risk or need for rapid platelet increase (authorization 1 month)

Total IgG

HLH / MAS and CAR-T hypogammaglobulinemiaTotal IgG < 400 mg/dL or two standard deviations below the mean for age

Secondary immunosuppression and related indicationsIgG < 400 mg/dL used as threshold for authorization in select secondary immunodeficiency contexts

Monitoring requirementProvide IgG level documentation for authorization and reauthorization decisions

Serum IgG level

CAR-T associated hypogammaglobulinemiaSerum IgG level < 400 mg/dL for authorization in members receiving CAR-T therapy

Secondary immunosuppression examplesSerum IgG < 400 mg/dL is used for secondary immunosuppression associated with major surgery, hematologic malignancy, burns, or collagen-vascular disease

DocumentationPretreatment or current serum IgG must be provided with the prior authorization request

Age threshold for pneumococcal vaccine response criterion

Lower age bound for vaccine-response criterionCriterion applies to patients age 2 years and older

Not established for younger childrenUse of this impaired vaccine response criterion is not established for children less than 2 years of age

Setting exclusionTherapy initiated in the hospital setting is excluded from the pneumococcal vaccine response appendix

Cutaquig — Product definition and indication summary

ProductCutaquig (Immune Globulin Subcutaneous [Human] - hipp, 16.5% Solution)

IndicationIndicated as replacement therapy for primary humoral immunodeficiency in adults and pediatric patients ≥2 years

SettingSubcutaneous immune globulin product for outpatient replacement therapy for PI

Cuvitru — Product definition and indication summary

ProductCuvitru (Immune Globulin Subcutaneous 20% Solution)

IndicationIndicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients ≥2 years

Formulation20% subcutaneous IG solution for home or outpatient use

Hizentra — Product definition and indication summary

ProductHizentra (Immune Globulin Subcutaneous [Human], 20% Liquid)

IndicationsIndicated as replacement therapy for primary humoral immunodeficiency in patients ≥2 years; indicated for maintenance therapy in adult CIDP to prevent relapse

Use caseSubcutaneous replacement therapy and CIDP maintenance in adults

HyQvia — Product definition and indication summary

ProductHyQvia (Immune Globulin Infusion 10% with recombinant human hyaluronidase)

IndicationsIndicated for primary immunodeficiency in patients ≥2 years; indicated for CIDP maintenance therapy in adults

Unique feature10% IG with recombinant hyaluronidase to facilitate larger-volume subcutaneous administration

Xembify — Product definition and indication summary

ProductXembify (Immune Globulin Subcutaneous [Human] - klhw, 20% Solution)

IndicationIndicated for primary humoral immunodeficiency in patients ≥2 years

Formulation20% subcutaneous IG solution for outpatient replacement therapy

Primary immunodeficiency diagnostic thresholds

SCID diagnostic thresholdPretreatment IgG < 200 mg/dL (or genetic/molecular confirmation) used as a diagnostic threshold in the SCID context

CVID and other antibody deficienciesPretreatment IgG < 500 mg/dL or ≥2 standard deviations below the mean for age

Additional lab criteriaSelective IgA < 7 mg/dL; selective IgM < 30 mg/dL; IgG subclass deficits ≥2 SD below mean on ≥2 occasions

LEMS — definition

DefinitionLambert-Eaton Myasthenic Syndrome (LEMS) is a presynaptic neuromuscular junction disorder diagnosed by neurophysiology studies or a positive anti‑P/Q type voltage-gated calcium channel antibody test

Diagnostic basisDiagnosis confirmed by electromyography or positive anti‑P/Q VGCC antibody

Therapy contextAuthorization requires prior trials of anticholinesterases and amifampridine unless not tolerated

Hypogammaglobulinemia threshold

Authorization thresholdHypogammaglobulinemia defined as total IgG < 400 mg/dL or two standard deviations below the mean for age for HLH/MAS and CAR-T associated hypogammaglobulinemia

Use caseApplied as authorization criterion for HLH, MAS and CAR-T therapy-associated hypogammaglobulinemia

DocumentationProvide IgG level documentation with prior authorization requests for these indications

Impaired antibody response to pneumococcal polysaccharide vaccine

Criterion for impaired vaccine responseFor patients age 2 years and older: documented impaired antibody response to pneumococcal polysaccharide vaccine

Age limitationUse of this criterion is not established for children less than 2 years of age

Setting exclusionTherapy initiated in the hospital setting is excluded from this appendix

Risk factors for bleeding — examples

Procedures with anticipated blood lossUndergoing a medical or dental procedure where blood loss is anticipated

Relevant comorbiditiesComorbid conditions such as peptic ulcer disease or hypertension increase bleeding risk

Anticoagulation requirementMandated anticoagulation therapy is an example of a bleeding risk factor to consider

Vaccine response definition

Vaccine response definitionDemonstrated impaired antibody response to pneumococcal polysaccharide vaccine in patients age 2 years and older

Not established in young childrenCriterion not established for children less than 2 years of age

Exclusion noteTherapy initiated in the hospital setting is excluded when relying on this appendix

Examples of risk factors for bleeding

Procedural bleeding riskUndergoing a medical or dental procedure where blood loss is anticipated

Comorbidity examplesPeptic ulcer disease and hypertension are listed comorbidities that increase bleeding risk

Mandated anticoagulationPatients on mandated anticoagulation therapy are at increased risk of bleeding

OpenPayer

Subcutaneous Immune Globulin (SCIG) therapies

Coverage Criteria and Indications

Prior Authorization, Documentation, and Actionable Requirements

Key Numeric Thresholds, Product Definitions, and Coding-Adjacent Guidance

Background and Therapeutic Context

Policy Revision History