UnitedHealthcare IVIG/SCIG Coverage Update

Coverage Criteria and Indications

SCIG Preferred Product Criteria (Cutaquig)

Cutaquig (non-preferred SCIG) is medically necessary when ONE of the following groups is met

Cutaquig approval paths

Trial failure path: History of a trial of adequate dose and duration of at least one preferred SCIG (Cuvitru, Hizentra, HyQvia, Xembify) with minimal clinical responseprovider must submit drug, dose, duration
Physician attestation for superiority: Physician attests that, in their clinical opinion, the clinical response with Cutaquig would be expected to be superior to experience with the preferred SCIG products
Contraindication/intolerance path: History of contraindication, intolerance, or severe adverse event to all preferred SCIG products not previously tried (Cuvitru, Hizentra, HyQvia, Xembify) and physician attests the same adverse event would not be expected to occur with Cutaquigprovider must submit drug, dose, duration

IVIG Preferred Product Criteria (Alyglo, Asceniv, Panzyga, Yimmugo)

Alyglo, Asceniv, Panzyga, or Yimmugo (non-preferred IVIG) are medically necessary when ONE of the following groups is met

Non-preferred IVIG approval paths

Trial failure path: History of a trial of adequate dose and duration of at least two other IVIG products resulting in minimal clinical response (alternative IVIG options include Bivigam, Gammagard, Gamunex, Privigen, etc.); provider must submit drug, dose, and duration; and physician attests requested non-preferred IVIG would be expected to be superiorat least two other IVIG products tried
Contraindication/intolerance path: History of contraindication, intolerance, or severe adverse events to all other IVIG products not previously tried (e.g., Bivigam, Gammagard, Gamunex, Privigen, etc.); provider must submit drug, dose, and duration; and physician attests the same adverse event would not be expected to occur with the requested non-preferred IVIG

Initial Therapy General Requirements

Initial therapy is medically necessary when ALL of the following are met

Initial therapy general requirements: Diagnosis; medical records documenting history and physical with severity (including infection frequency/severity where applicable); laboratory results or diagnostic evidence supporting the indication; and prescriber attestation that dosing follows FDA labeling or published clinical evidence for non‑FDA dosing

Continuation Therapy General Requirements

Continuation of therapy is medically necessary when ALL of the following are met

Continuation therapy general requirements: Documentation of positive clinical response to immune globulin therapy; prescriber attestation that dosing follows FDA labeling or published clinical evidence for non‑FDA dosing; authorization will be for no more than 12 months

Diagnosis-Specific Proven Indications (selected)

Diagnosis-specific proven indications and their medical necessity conditions (selected examples from document)

Autoimmune bullous diseases (dermatology): Diagnosis of an autoimmune bullous disease; extensive and debilitating disease; history of failure, contraindication, or intolerance to systemic corticosteroids with concurrent immunosuppressive treatment (e.g., azathioprine, cyclophosphamide, mycophenolate mofetil)

Feto-neonatal alloimmune thrombocytopenia (hematology) — pregnant women: Diagnosis of feto-neonatal alloimmune thrombocytopenia (AIT); and one or more of: previously affected pregnancy, family history of the disease, or platelet alloantibodies on screening

Feto-neonatal alloimmune thrombocytopenia (newborns): Diagnosis of AIT in a newborn and thrombocytopenia that persists after transfusion of antigen‑negative compatible platelets

Idiopathic thrombocytopenic purpura (ITP): Either: (1) acute ITP with documented platelet count < 50 x 10^9/L within the past 30 days; OR (2) chronic ITP with history of failure, contraindication, or intolerance to at least one of corticosteroids or splenectomy

CLL — Infection prevention

Prevention of infection in B-cell chronic lymphocytic leukemia (CLL) — covered when BOTH are met

CLL infection prophylaxis: Diagnosis of B-cell chronic lymphocytic leukemia (CLL); AND one of: documented hypogammaglobulinemia (IgG < 500 mg/dL) OR history of bacterial infection(s) associated with B-cell CLL OR CMV‑induced pneumonitis in solid organ transplants.IgG < 500 mg/dL

Pediatric HIV — Infection prevention

Prevention of bacterial infection in pediatric HIV — covered when ALL are met

Pediatric HIV prophylaxis: Diagnosis of HIV disease; AND patient age ≤ 13 years; AND one of: documented hypogammaglobulinemia (IgG < 400 mg/dL) OR functional antibody deficiency demonstrated by poor specific antibody titers OR recurrent bacterial infections.IgG < 400 mg/dL

Measles post-exposure prophylaxis

Measles (rubeola) post-exposure prophylaxis — covered when ALL are met

Measles PEP: Exposure to measles less than 6 days previously; AND patient weight > 30 kg (if ≤ 30 kg give intramuscular immune globulin); AND patient is nonimmune or severely immunocompromised and not already receiving immune globulin (e.g., pregnant woman without immunity OR recent bone marrow transplant recipient under specified immunosuppression timelines or other listed immunosuppressed states).initial one-time dose not to exceed 400 mg/kg; administer within 6 days

Post–B-cell targeted therapy prophylaxis

Prevention of infection secondary to B-cell targeted therapy — covered when ALL are met

Post B-cell therapy infection prevention: Documentation confirming previous B-cell targeted therapy within the last 100 days; AND both: documented hypogammaglobulinemia (IgG < 500 mg/dL) AND history of bacterial infection(s) associated with B-cell depletion.prior therapy within 100 days and IgG < 500 mg/dL

ADEM

Acute disseminated encephalomyelitis (ADEM) — covered when BOTH are met

ADEM treatment: Diagnosis of ADEM; AND history of failure, contraindication, or intolerance to intravenous glucocorticoids.

CIDP

Chronic inflammatory demyelinating polyneuropathy (CIDP) — initial and continuation therapy criteria

CIDP initial therapy: Diagnosis of CIDP with progressive symptoms ≥2 months; symptomatic polyradiculoneuropathy affecting >1 limb; AND electrodiagnostic findings consistent with EFNS/PNS guidelines showing at least one objective criterion (e.g., conduction velocity reduction, F-wave abnormalities, conduction block, temporal dispersion, CMAP duration increase); AND prescribed by or in consultation with a neurologist.

Continuation requires documented objective clinical response measured by an objective scale (Rankin, MRC, etc.)

ICI-induced encephalitis

Encephalitis, ICI-induced — covered when ALL are met

ICI-induced encephalitis: Diagnosis of severe or progressive immune checkpoint inhibitor-induced encephalitis; AND history of failure, contraindication, or intolerance to glucocorticoids; AND the use of the immune checkpoint inhibitor has been interrupted; AND prescribed by or in consultation with a neurologist.

Guillain-Barré syndrome

Guillain-Barré syndrome (GBS) — covered when ALL are met

GBS treatment: Diagnosis of Guillain-Barré Syndrome; AND severe disease requiring aid to walk; AND onset of neuropathic symptoms within the last 4 weeks; AND prescribed by or in consultation with a neurologist.

MMN

Multifocal motor neuropathy (MMN) — covered when BOTH are met (initial) and continuation requires response

MMN initial therapy: Diagnosis of multifocal motor neuropathy with weakness having a slowly progressive or stepwise course ≥1 month; asymmetric involvement of ≥2 nerves; absence of motor neuron and bulbar signs; AND prescribed by or in consultation with a neurologist. Continuation requires documented positive clinical response measured by an objective scale.

Relapsing multiple sclerosis

Relapsing forms of multiple sclerosis — covered when ALL are met

Relapsing MS treatment: Diagnosis of relapsing forms of MS; AND documentation of an MS exacerbation or clinical worsening prompting IVIG; AND history of failure, contraindication, or intolerance to at least two listed disease‑modifying therapies (examples provided).

Prescribed by or in consultation with a neurologist

Myasthenia gravis

Myasthenia gravis — exacerbation and refractory disease covered when specified criteria are met

Myasthenia gravis exacerbation: Generalized myasthenia gravis with evidence of exacerbation (e.g., difficulty swallowing, acute respiratory failure, major functional disability, or recent checkpoint inhibitor immunotherapy) AND either history of failure/contraindication to immunomodulators OR currently receiving immunomodulator therapy for long-term management; AND prescribed by or in consultation with a neurologist.

Refractory myasthenia gravis: Diagnosis of refractory generalized myasthenia gravis by or with an expert center; AND persistent or worsening disease despite failure/contraindication/intolerance to corticosteroids AND two immunomodulator therapies (adequate dose/duration); AND currently receiving immunomodulator therapy for long-term management; AND prescribed by or in consultation with a neurologist.

Specialist or center expertise required

Neuromyelitis optica (NMOSD)

Neuromyelitis optica spectrum disorder (NMOSD) — covered when ALL are met

NMOSD initial therapy: Diagnosis of NMOSD by a neurologist with serologic testing for AQP4-IgG/NMO-IgG performed; AND past medical history meeting core clinical syndrome criteria (if AQP4-IgG positive then one core syndrome; if negative then two core syndromes); AND alternative diagnoses (e.g., MS) have been ruled out; AND history of failure, contraindication, or intolerance to at least three listed agents (e.g., azathioprine, corticosteroids, mycophenolate, complement inhibitors, anti-IL6, anti-CD19, anti-CD20); AND patient is not receiving immune globulin in combination with listed disease-modifying or targeted therapies; AND prescribed by or in consultation with a neurologist.

Extensive pre-requisite therapy requirements and combination therapy exclusions

Rasmussen and stiff-person syndromes

Rasmussen syndrome and stiff-person syndrome — covered when specified criteria are met

Rasmussen syndrome: Documentation that short-term amelioration of encephalitis is needed prior to definitive surgical therapy, OR disease symptoms persist despite surgical treatment, OR patient is not a surgical candidate.

Stiff-person syndrome initial therapy: Diagnosis of stiff-person syndrome; AND history of failure, contraindication, or intolerance to GABAergic medication (e.g., baclofen, benzodiazepines); AND prescribed by or in consultation with a neurologist.

Primary immunodeficiency

Primary immunodeficiency syndromes — covered when the following criterion is met

Primary immunodeficiency: Diagnosis of a primary immunodeficiency included in the policy's PID disease list (see referenced disease list).

Replacement therapy indication; IVIG/SCIG are FDA-approved for many PIDs

Dermatomyositis, polymyositis, and ANCA-associated vasculitis

Dermatomyositis, polymyositis, and ANCA-associated vasculitis — Rheumatology indications covered when specified criteria are met

Dermatomyositis/polymyositis: Diagnosis of dermatomyositis or polymyositis; AND history of failure, contraindication, or intolerance to immunosuppressive therapy (e.g., azathioprine, corticosteroids, cyclophosphamide, methotrexate)

ANCA-associated vasculitis initial therapy: Diagnosis of ANCA-associated vasculitis confirmed by specialist; continued symptoms or findings after corticosteroid therapy (or corticosteroids contraindicated/not tolerated); continued symptoms or findings after immunosuppressive therapy (or immunosuppressive therapy contraindicated/not tolerated); and discussion with patient/caregiver of risks (thrombosis, renal dysfunction, acute renal failure); and either IG-naive or prior IG stopped for reasons other than anaphylaxis or inadequate response. Continuation requires manageable/no side effects, improvement in clinical condition, and incomplete complete response.

Immune globulin after allogeneic bone marrow transplantation (BMT)

Immune globulin after allogeneic bone marrow transplantation (BMT) — Covered when ALL of the following are met:

Allogeneic BMT IG criteria: One of the following uses: prevention of acute graft-versus-host disease (GVHD) or prevention of infection; confirmed allogeneic bone marrow transplant within the last 100 days; and documented severe hypogammaglobulinemia (IgG < 400 mg/dL).

Continuation of immune globulin for ANCA-associated vasculitis

Continuation of immune globulin for ANCA-associated vasculitis — Covered when ALL of the following are met:

Continuation therapy for ANCA-associated vasculitis: Diagnosis confirmed by specialist; manageable or no side effects; improvement in clinical condition; complete response not yet achieved; and either patient is IG‑naive or prior IG stopped for reasons other than anaphylaxis or inadequate response. Risk discussion documented.

Replacement therapy for primary immune deficiency

Replacement therapy for primary immune deficiency — Covered when ALL of the following are met

Primary immune deficiency replacement: IVIG/SCIG is FDA‑approved and indicated as replacement therapy in primary immune deficiencies (see PID list).

Postexposure prophylaxis for measles (rubeola)

Postexposure prophylaxis for measles (rubeola) — Covered when ALL of the following are met

Measles PEP: Immune globulins administered within 6 days of measles exposure for infants <12 months, pregnant women without immunity, or severely immunocompromised persons; IM formulation for <30 kg and IV/SC for >30 kg; initial one-time dose not to exceed 400 mg/kg.within 6 days; dose ≤ 400 mg/kg

Neuroimmunologic disorders with evidence or guideline support

Neuroimmunologic disorders with evidence or guideline support — Covered when clinical criteria or guideline recommendations are met

Conditions with supportive evidence: IVIG is beneficial for CIDP, Guillain‑Barré syndrome, multifocal motor neuropathy, Lambert‑Eaton myasthenic syndrome, myasthenia gravis (acute/severe/refractory indications), and other specified neuroimmunologic diseases per guidelines and trials.

CIDP induction: For induction in sensory and motor CIDP with disabling symptoms, IVIG should be considered; electrodiagnostic and clinical criteria for CIDP apply.

Myasthenia gravis acute/severe: IVIG appropriate for life‑threatening MG signs (e.g., respiratory insufficiency), preparation for surgery with bulbar dysfunction, rapid response needed, or when other treatments are insufficient; maintenance IVIG may be considered for refractory MG.

Dermatomyositis, polymyositis, and Kawasaki disease

Dermatomyositis and Kawasaki disease — Covered when guideline or trial support exists

Dermatomyositis: RCT evidence demonstrates IVIG improves dermatologic symptoms in dermatomyositis, including severe cases; use supported by trial data.

Kawasaki disease: IVIG is standard‑of‑care initial therapy to reduce coronary artery aneurysm risk and fever duration; use limits (e.g., ≤ 5 consecutive days) apply.

Infectious and infection‑related uses (select)

Infectious and infection‑related uses (select) — Covered in evidence‑supported scenarios

CMV pneumonitis post transplant: IVIG may be beneficial for CMV‑induced pneumonitis in solid organ transplant recipients.

Prevention of bacterial infections in hypogammaglobulinemia: IVIG can prevent bacterial infections in patients with hypogammaglobulinemia or recurrent infections (including CLL, multiple myeloma, and pediatric HIV); consider when IgG < 400 mg/dL or 400–600 mg/dL with serious/recurrent infections.consider when IgG < 400 mg/dL or 400–600 mg/dL with serious/recurrent infections

Transplantation and antibody‑mediated rejection (AMR)

Transplantation and antibody‑mediated rejection (AMR) — Covered when used as adjunct in desensitization or AMR treatment

Desensitization and AMR: IVIG used in desensitization protocols and as adjunct therapy for antibody‑mediated rejection in solid organ transplant recipients per community standards and expert opinion.

Coverage groups by evidence strength

Coverage stance summarized by groups of indications based on available evidence:

Not recommended/routinely not covered: IVIG is not recommended for antiphospholipid antibody syndrome in pregnancy, routine prevention of GVHD in autologous BMT, prevention of infection after autologous BMT, chronic fatigue syndrome, recent‑onset dilated cardiomyopathy, asthma, inclusion body myositis, and routine neonatal infection prevention due to lack of proven benefit or potential harms.

May be considered in rare/salvage situations: IVIG may be considered in select salvage situations (e.g., autoimmune neutropenia, post‑BMT autoimmune‑like neutropenia, acute myocarditis) when standard therapies have failed or are contraindicated; evidence is sparse.

Unproven / investigational: Use of IVIG for PANS/PANDAS and autism spectrum disorders is considered unproven; AAP does not recommend routine use—limit to clinical trials if used.

Deficiency-specific guidance:

PANS / PANDAS

Evidence summary and coverage stance for IVIG in PANS/PANDAS:

PANS/PANDAS evidence and recommendation: 1) High‑quality randomized, double‑blind, placebo‑controlled evidence did not demonstrate a statistically significant benefit for IVIG; 2) The American Academy of Pediatrics considers IVIG an unproven treatment and does not recommend routine use—if used, limit to controlled clinical trials.

POEMS syndrome

Coverage stance for IVIG in POEMS:

POEMS — recommendation: Expert guidelines (NAC/Canadian Blood Services and AAAAI update) state there is no role for IVIG in POEMS syndrome; IVIG is not recommended.

Rotaviral enterocolitis

Evidence summary for immune globulin in rotavirus diarrhea:

Rotaviral enterocolitis: Only small studies and case reports suggest oral immune globulin may help rotaviral diarrhea in infants/young children; IV/SCIG were not studied and evidence is insufficient for routine use.

Sjogren's syndrome

Evidence summary for IVIG in Sjogren's:

Sjogren's syndrome: Small case reports/series suggest some efficacy for autonomic dysfunction or neuropathy, but evidence is very limited and larger blinded controlled studies are required; consider only in select refractory cases with documentation.

Recurrent spontaneous abortions (prevention)

Evidence summary for IVIG to prevent recurrent miscarriage:

Recurrent spontaneous abortion: Randomized, placebo‑controlled multicenter trials and reviews do not support IVIG for prevention of recurrent spontaneous abortions; cumulative evidence does not support routine use.

Urticaria (chronic and delayed-pressure)

Evidence summary for IVIG in urticaria:

Chronic/Delayed-pressure urticaria: Case reports and open‑label trials show partial or transient benefit in subsets of patients, but randomized placebo‑controlled evidence is lacking; consider only after guideline therapies fail and with documentation of autoimmune mechanism when possible.

ANCA-associated vasculitis and other vasculitides

Evidence summary for IVIG in ANCA-associated systemic vasculitis:

ANCA-associated vasculitis trial evidence: A randomized placebo‑controlled trial (n=34) showed higher therapeutic response at 3 months with IVIG versus placebo but differences were not durable at 3 months for disease activity/CRP; small open‑label trials report transient benefit. May be considered in select patients with documentation.

Primary immunodeficiency diseases and FDA-approved indications

Indications where IVIG/SCIG is established:

Primary immunodeficiencies (PIDs): Multiple PIDs (detailed disease list provided) are proven indications for immune globulin therapy; see the policy's PID list.

FDA-licensed indications: Eight FDA‑licensed IVIG clinical indications are listed (primary immunodeficiencies, prevention in CLL, Kawasaki disease, post‑BMT complications, reduction of serious bacterial infection in pediatric HIV, ITP, CIDP, MMN); SCIG products are FDA‑approved for primary immunodeficiency replacement.

Yimmugo coverage criteria (trial or contraindication-based exceptions)

Yimmugo is non-preferred; treatment is medically necessary for indications in the policy when one of the following criteria groups is met:

Yimmugo exception pathways

Trial‑failure pathway: History of a trial of adequate dose and duration of at least two other IVIG products resulting in minimal clinical response; AND physician attests that clinical response with Yimmugo would be expected to be superior to other IVIG products.at least two other IVIG products tried
Contraindication/intolerance pathway: History of contraindication, intolerance, or severe adverse event to all other IVIG products not previously tried; AND physician attests the same contraindication/intolerance/severe adverse event would not be expected to occur with Yimmugo.

Coverage for some immune globulin products is contingent on product-specific and diagnosis-specific criteria. The policy lists IV and SC products that may be subject to those criteria (examples include Alyglo, Asceniv, Panzyga, Yimmugo, Cuvitru, Hizentra, HyQvia, Xembify, and Cutaquig). Coverage for SCIG products Cuvitru, Hizentra, HyQvia, and Xembify is contingent on the Diagnosis Specific Criteria. For IVIG products, coverage for most IVIG products is contingent on diagnosis-specific criteria, with limited exceptions noted in the policy (for example, Alyglo, Asceniv, and Panzyga are treated differently in the list). Products not explicitly listed in the policy will be evaluated using the product labeling (package insert), recognized compendia, and peer-reviewed literature to determine medical necessity.

Immune globulin is medically necessary for relapsing forms of multiple sclerosis (MS) only when specified criteria are met (diagnosis of a relapsing phenotype, documentation of an exacerbation or clinical worsening, and prior failure/contraindication/intolerance to at least two listed disease‑modifying therapies). Treatment of non‑relapsing forms of MS (any MS type other than relapsing forms) with immune globulin is not supported by clinical evidence and therefore is not covered.

The policy specifies that immune globulin maintenance therapy for ocular myasthenia is not supported by the evidence. IVIG is reserved for generalized myasthenia gravis exacerbations or refractory generalized disease meeting the stated clinical criteria and specialist involvement; maintenance IVIG for isolated ocular myasthenia is not considered medically necessary.

The policy identifies numerous indications for which immune globulin is considered unproven and not medically necessary. Examples include acquired hemophilia, adrenoleukodystrophy, Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), antiphospholipid antibody syndrome (APS) in pregnancy, asthma, atopic dermatitis, autism spectrum disorders, autoimmune liver disease, inclusion body myositis, isolated immunoglobulin subclass deficiencies (e.g., isolated IgA, IgE, IgG4, IgM deficiencies), neonatal sepsis prevention, ocular myasthenia, PANS/PANDAS, POEMS syndrome, Sjogren’s syndrome, chronic or delayed‑pressure urticaria, spontaneous recurrent abortion prevention, and others listed in the policy. The policy notes available evidence for these conditions is limited to case reports, series, or inadequate studies and thus does not support routine coverage.

The policy lists several conditions for which IVIG is considered unproven or not medically necessary and provides these as examples rather than an exhaustive list. These include, but are not limited to: acquired hemophilia, Alzheimer’s disease, ALS, asthma, atopic dermatitis, autism spectrum disorders, inclusion body myositis, isolated immunoglobulin deficiencies, neonatal sepsis prevention, PANS/PANDAS, POEMS syndrome, Sjogren’s syndrome, and chronic urticaria. Requests for IVIG for these indications are reviewed case‑by‑case but generally lack adequate evidence to support coverage.

Routine use exclusions related to bone marrow transplantation and GVHD are specified. Per CDC guidance and cited reviews, the policy does not support routine IVIG administration to prevent graft‑versus‑host disease (GVHD) or to prevent infection after autologous bone marrow transplantation. Similarly, routine administration of IVIG to prevent neonatal infection or to reduce mortality in infants with suspected neonatal infection is not supported by the available evidence.

Expert guideline updates and national advisory panels state there is no role for IVIG in POEMS syndrome. The policy therefore excludes IVIG for POEMS per those guideline recommendations and the limited anecdotal evidence that does exist.

Randomized, placebo‑controlled multicenter trial reviews and expert committee assessments conclude that cumulative evidence does not support the use of IVIG to prevent recurrent spontaneous abortions. As a result, IVIG is not supported for this preventive indication.

This policy is intended to assist interpretation of UnitedHealthcare standard benefit plans but is subject to applicable federal, state, or contractual benefit plan terms. When there is a conflict between this policy and federal, state, or contractual requirements, those external requirements govern coverage. Providers should verify plan‑specific benefit language prior to relying solely on the policy.

Procedure and Diagnosis Codes

Procedure/HCPCS and CPT codes — selectedmixed

90283	Immune globulin (IgIV), human, for intravenous use.
90284	Immune globulin (SCIg), human, for use in subcutaneous infusions, 100 mg, each
J1459	Injection, immune globulin (Privigen), intravenous, nonlyophilized (e.g., liquid), 500 mg.
J1551	Injection, immune globulin (Cutaquig), 100 mg.
J1552	Injection, immune globulin (Alyglo), 500 mg.
J1553	Injection, immune globulin (yimmugo), 100 mg.
J1554	Injection, immune globulin (Asceniv), 500 mg.
J1555	Injection, immune globulin (Cuvitru), 100mg.
J1556	Injection, immune globulin (Bivigam), 500 mg.
J1557	Injection, immune globulin, (Gammaplex), intravenous, non-lyophilized (e.g., liquid), 500 mg

HCPCS J-codes for immune globulin productsHCPCS

J1558	Injection, immune globulin (Xembify), 100 mg.
J1559	Injection, immune globulin (Hizentra), 100 mg.
J1561	Injection, immune globulin, (Gamunex-C/Gammaked), intravenous, nonlyophilized (e.g., liquid), 500 mg.
J1566	Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg.
J1568	Injection, immune globulin, (Octagam), intravenous, nonlyophilized (e.g., liquid), 500 mg.
J1569	Injection, immune globulin, (Gammagard liquid), intravenous, nonlyophilized, (e.g., liquid), 500 mg.
J1572	Injection, immune globulin, (Flebogamma/Flebogamma DIF), intravenous, nonlyophilized (e.g., liquid), 500 mg.
J1575	Injection, immune globulin/hyaluronidase, (Hyqvia), 100 mg immuneglobulin.
J1576	Injection, immune globulin (Panzyga), intravenous, non-lyophilized (e.g., liquid), 500 mg.
J1599	Injection, immune globulin, intravenous, nonlyophilized (e.g., liquid), not otherwise specified, 500 mg

Applicable ICD-10 Codes (selected list across chunks)ICD-10

A48.3	Toxic shock syndrome.
A49.9	Bacterial infection, unspecified.
A87.8	Other viral meningitis.
A87.9	Viral meningitis, unspecified.
A88.8	Other specified viral infections of central nervous system.
B05.0	Measles complicated by encephalitis.
B05.1	Measles complicated by meningitis.
B05.2	Measles complicated by pneumonia.
B05.3	Measles complicated by otitis media.
B05.4	Measles with intestinal complications.

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FDA indications (informational — no codes provided)mixed

No codes listed

Updated HCPCS/administration codesHCPCS

J1553

Added HCPCS code (document indicates J1553 was added)

Updated ICD-10 diagnosis codes (added)ICD-10

G35.A	Added ICD-10 diagnosis subcode
G35.B0	Added ICD-10 diagnosis subcode
G35.B1	Added ICD-10 diagnosis subcode
G35.B2	Added ICD-10 diagnosis subcode
G35.C0	Added ICD-10 diagnosis subcode
G35.C1	Added ICD-10 diagnosis subcode
G35.C2	Added ICD-10 diagnosis subcode
G35.D	Added ICD-10 diagnosis subcode

Updated ICD-10 diagnosis codes (removed)ICD-10

G35	Removed general G35 code from the policy's ICD-10 list

inv-60: IgG threshold for infection prevention in CLL — IgG < 500 mg/dL

IgG thresholdIgG < 500 mg/dL

ContextUsed to define documented hypogammaglobulinemia for infection prevention in B-cell chronic lymphocytic leukemia (CLL)

Authorization implicationMeets one criterion for IVIG consideration for infection prevention in CLL

inv-61: Pediatric HIV hypogammaglobulinemia threshold — IgG < 400 mg/dL

IgG threshold (pediatric)IgG < 400 mg/dL

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required for Non-Preferred IG Products

Prior authorization is required for requests of non-preferred subcutaneous (e.g., Cutaquig) and intravenous (e.g., Yimmugo, Alyglo, Asceniv, Panzyga) immune globulin (IG) products. When requesting a non-preferred product, submit prior therapy history (drug, dose, duration) showing an adequate trial and documented minimal clinical response or documentation of contraindication/intolerance to preferred products. For non-preferred SCIG (Cutaquig), a trial of at least one preferred SCIG (Cuvitru, Hizentra, HyQvia, Xembify) is required unless contraindicated/intolerant. For non-preferred IVIG (including Yimmugo), a trial of at least two other IVIG products is required unless contraindicated/intolerant. Provider attestation that the requested non-preferred product is expected to provide superior clinical response (or that prior adverse events would not recur with the requested product) is required.

Non-preferred SCIG (Cutaquig): trial of ≥1 preferred SCIG (Cuvitru, Hizentra, HyQvia, Xembify) OR documented contraindication/intolerance
Non-preferred IVIG (Yimmugo, Alyglo, Asceniv, Panzyga): trial of ≥2 other IVIG products OR documented contraindication/intolerance
Provider must submit prior product name(s), dose(s), and duration(s) when documenting trials

Prior Authorization

Background and Scope

This medical benefit policy addresses the use of FDA‑approved intravenous (IVIG) and subcutaneous (SCIG) immune globulin products across multiple specialties including immunology, hematology, neurology, dermatology, infectious disease, rheumatology, and transplantation. It defines medical necessity criteria for initial and continuation therapy, documents product‑specific and diagnosis‑specific coverage rules (including replacement therapy for primary immunodeficiency), and references thresholds used in decision making (for example, serum IgG cutoffs). The policy also outlines required documentation, prior authorization and step‑therapy expectations, and groups indications by the strength of available evidence to guide coverage determinations.

Definitions and Key Terms

inv-101: Immune globulin products — SCIG and IVIG products listed

SCIG examplesCutaquig, Cuvitru, Hizentra, HyQvia, Xembify

IVIG examplesAlyglo, Asceniv, Bivigam, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen, Yimmugo

Coverage noteCoverage for some products is contingent on diagnosis‑specific criteria; Yimmugo is designated non-preferred with exception pathways

inv-102: Authorization duration — Initial and continuation authorization limits

Authorization duration (initial)Initial authorization will be for no more than 12 months

Authorization duration (continuation)Continuation authorization will be for no more than 12 months with documentation of positive clinical response

OpenPayer

Immune Globulin (IVIG and SCIG) (for Pennsylvania Only)

Coverage Criteria and Indications

Procedure and Diagnosis Codes

Prior Authorization, Documentation, and Step Therapy

Background and Scope

Definitions and Key Terms