Priority Health IVIG/SCIG Coverage Prior Auth

Coverage Criteria and Indication-specific Requirements

General medical necessity criteria

Covered when ALL of the following are met

General approval prerequisites: Diagnosis reasonably certain based on history, examination, and appropriate testing (e.g., EMG, spinal fluid, serum tests, biopsy); documentation of previous treatment failures; objective baseline assessment documented and used for monitoring; prescriber agrees to attempt dose reduction and discontinue IVIG if improvement is sustained (except for primary immunodeficiency when Ig levels are maintained).

Objective assessments include MRC scale, INCAT, ADL measures; subjective improvement alone generally insufficient.

Primary immunodeficiency initial coverage

Primary immunodeficiency — Covered when ANY of the following are met

Primary immunodeficiency diagnosis: Patient has one of the listed primary immunodeficiencies (e.g., hypogammaglobulinemia unspecified; selective IgM or other selective immunoglobulin deficiencies; X-linked agammaglobulinemia; X-linked immunodeficiency with hyper-IgM; SCID; common variable hypogammaglobulinemia; Wiskott-Aldrich syndrome).

See Section 1 list for covered diagnoses.

Laboratory or clinical criteria: Patient's IgG level < 200 mg/dL OR history of multiple hard-to-treat infections OR demonstrated deficiency in producing antibodies in response to vaccination with baseline titers drawn before challenge and repeat titers 4–8 weeks after showing <70% of antigens in protective range.IgG < 200 mg/dL; titers <70% protective; 4–8 week post-vaccination draw

'Multiple hard-to-treat infections' defined as four or more ear infections in 1 year; two or more serious sinus infections in 1 year; two or more months of antibiotics with little effect; two or more pneumonias in 1 year; recurrent/deep skin abscesses; need for IV antibiotics; or two or more deep-seated infections including septicemia.

CLL-related hypogammaglobulinemia

Chronic lymphoid leukemia (CLL) — Covered when ALL of the following are met

CLL criteria: 1) History of multiple hard-to-treat infections; and 2) Deficiency in producing antibodies in response to vaccination with baseline titers drawn before challenge and repeat titers 4–8 weeks after showing <70% protective antigens.titers <70% protective; 4–8 week draw

'Multiple hard-to-treat infections' defined as in primary immunodeficiency section.

ITP (acute and chronic)

Primary immune thrombocytopenia (ITP) — Criteria differ by acute vs chronic

Acute ITP: IVIG is medically necessary for rapid platelet rise when used before surgery with platelets <100,000/mm3; OR for acute bleeding with platelets <30,000/mm3; OR when patient is at risk for intracerebral hemorrhage (platelets <20,000/mm3).<100,000/mm3 before surgery; <30,000/mm3 with bleeding; <20,000/mm3 intracerebral hemorrhage risk

Chronic ITP: Patient age ≥10; platelet count <30,000/mm3 for children or <20,000/mm3 for adults; illness duration >6 months; and failed, contraindication to, or intolerance of corticosteroid therapy.children <30,000/mm3; adults <20,000/mm3; illness >6 months

For renewals, maintenance of platelet count ≥50 x10^9/L documented indicates response.

Pregnancy and neonatal thrombocytopenia

Pregnancy and neonatal conditions

ITP in pregnancy: One of: refractory to steroids with platelet <10,000/mm3 in third trimester; platelet <30,000/mm3 with bleeding prior to delivery; prior delivery of infant(s) with autoimmune thrombocytopenia; cordocentesis at ≥20 weeks showing fetal platelets <20,000/mm3; or screening revealing platelet alloantibodies.<10,000/mm3 third trimester; <30,000/mm3 with bleeding; fetal <20,000/mm3

Neonatal alloimmune thrombocytopenia: Immune globulin is not covered for routine use; covered when BOTH: neonate is severely thrombocytopenic (platelets <30,000/mm3) and/or symptomatic; AND neonate failed, has a contraindication to, or is intolerant of platelet transfusions.<30,000/mm3

ITP in pregnancy / fetal alloimmune thrombocytopenia

Covered when ONE of the following is met:

ITP pregnancy/fetal AIT: 1) Refractory to steroids with platelet count <10,000/mm3 during third trimester; 2) Platelet count <30,000/mm3 with bleeding prior to delivery; 3) Prior infant(s) with autoimmune thrombocytopenia; 4) ≥20 weeks gestation cordocentesis with fetal platelets <20,000/mm3; 5) Screening reveals platelet alloantibodies.see items

Neonatal alloimmune thrombocytopenia

Covered only when BOTH criteria are met:

Neonatal alloimmune thrombocytopenia: 1) Neonate severely thrombocytopenic (platelet count <30,000/mm3) and/or symptomatic; and 2) Neonate failed, has a contraindication to, or is intolerant of platelet transfusions.see items

IVIG not covered for routine use.

Post-transfusion purpura

Covered when ONE of the following is met:

Post-transfusion purpura: 1) Platelet count <10,000/mm3; OR 2) Patient experienced bleeding complications due to thrombocytopenia.see items

Autoimmune hemolytic anemia (AIHA)

Not covered for routine use; covered when ALL criteria met:

Warm-type AIHA: 1) Warm-type autoimmune hemolytic anemia; 2) Failed, contraindication to, or intolerance of corticosteroid therapy; and 3) Had splenectomy or is at high risk for post-splenectomy sepsis.see items

Immune-mediated neutropenia

Not covered for routine use; covered when ALL criteria met:

Immune-mediated neutropenia: 1) Serious clinical infection related to neutropenia; and 2) Failed to respond to both corticosteroids and filgrastim or pegfilgrastim therapies.see items

Pure red cell aplasia due to parvovirus B19

Covered when ALL criteria met:

PRCA due to parvovirus B19: 1) Severe, refractory anemia; 2) Documented erythrovirus (parvovirus) B19 viremia; and 3) Evaluated for underlying conditions that could lead to aplasia.see items

Pure red cell aplasia, immunologic subtype

Covered when ALL criteria met (document presents multiple lists of qualifying immunologic features and treatment prerequisites):

Immunologic PRCA (first list): 1) Failed, contraindication to, or intolerance of corticosteroid therapy; 2) Failed, contraindication to, or intolerance of cyclosporine; and 3) Failed, contraindication to, or intolerance of cyclophosphamide.see items

Immunologic PRCA (alternate supportive criteria): a) Recurrent serious bacterial infections despite prophylactic antibiotics; b) Demonstrated antibody deficiency to common antigens with poor antibody titers; c) Bronchiectasis suboptimally responsive to therapy; or d) HIV-associated thrombocytopenia despite ART.see items

Documented immunologic features supportive of IVIG use.

Immunologic PRCA (treatment bridging): 1) Unable to use or tolerate glucocorticoid therapy; and 2) Being started on immunosuppressive therapies (e.g., azathioprine, mycophenolate, cyclosporine).

Allogeneic bone marrow or stem cell transplant

Covered when ALL criteria met:

Allogeneic BMT/SCT prophylaxis: 1) IVIG used for prevention of acute graft-versus-host disease or infection (e.g., CMV); and 2) Transplant occurred 0 to 99 days before starting IVIG.see items

Approved for 3 months; continuation approved when IgG ≤400 mg/dL and total treatment duration ≤360 days from transplant.

Transplant complications (solid organ/bone marrow)

Covered when ONE of the following purposes is met:

Transplant complications: 1) Suppress panel reactive anti-HLA antibodies prior to transplantation; 2) Treat antibody-mediated rejection of solid organ transplant; or 3) Prevent CMV-induced pneumonitis.see items

Guillain-Barré syndrome (GBS)

Covered when ALL criteria met:

GBS coverage: 1) Severe Guillain-Barré disease requiring aid to stand and/or walk; and 2) IVIG started within 4 weeks of symptom onset.see items

Initial approval limited to one dose; up to two doses may be covered if inadequate response to first dose, with second dose given within 3 weeks.

Myasthenia gravis (MG)

Not covered for routine use; covered in limited circumstances when ALL criteria met

Myasthenia gravis (acute severe): 1) Severe MG to treat acute, severe decompensation (e.g., myasthenic crisis, impending respiratory or bulbar compromise, difficulty swallowing, acute respiratory failure) when other treatments unsuccessful or contraindicated; and 2) Given concomitantly with glucocorticoids or other immunosuppressive therapy (e.g., azathioprine, cyclosporine).see items

When used to bridge immunosuppressive therapies, IVIG is covered only until the immunosuppressive therapy takes effect; maintenance IVIG for MG is not covered.

Chronic inflammatory demyelinating polyneuropathy (CIDP)

Covered when ALL criteria met:

CIDP: 1) Progressive or relapsing course ≥2 months; 2) Abnormal or absent deep tendon reflexes in upper or lower limbs; 3) Baseline (and for continuation, current) strength documented with an objective tool (e.g., INCAT, MRC, 6-minute walk, Rankin); and 4) Electrodiagnostic testing indicating demyelination meeting specified criteria (partial motor conduction block, distal CMAP duration increase, temporal dispersion, reduced conduction velocity, prolonged distal motor latency, absent/prolonged F waves as detailed).see items

Electrodiagnostic demyelination criteria are specified in policy.

Multifocal motor neuropathy (MMN)

Covered when ALL criteria met:

MMN: 1) Progressive symptomatic multifocal motor neuropathy with motor involvement in at least two nerves; 2) Electrophysiology rules out other conditions unlikely to respond to IVIG; and 3) Baseline and continuation objective strength documentation using a validated tool (e.g., INCAT, MRC).see items

Stiff-person syndrome

Covered when ALL criteria met:

Stiff-person syndrome: 1) Severe active illness with positive anti-GAD antibody; 2) Other treatments unsuccessful or intolerable (failed/contraindication/intolerance to ≥2 benzodiazepines, baclofen, and corticosteroid therapy); and 3) Baseline physical exam documented with requirement to show improvement for continuation.see items

Dermatomyositis & Polymyositis

Covered when ALL criteria met:

Dermatomyositis/Polymyositis: 1) Baseline physical exam documented and continuation must show improvement including CPK improvement; 2) Condition confirmed by biopsy; and 3) Severe active disease with muscle weakness in all upper and/or lower limbs and failed, contraindication to, or intolerance of corticosteroid therapy and immunosuppressive therapies (e.g., azathioprine).see items

Systemic sclerosis dermatomyositis overlap syndrome

Covered when ALL criteria met:

Scleroderma-dermatomyositis overlap: 1) Failed, contraindication to, or intolerance of corticosteroid therapy; 2) Failed, contraindication to, or intolerance of immunosuppressive therapies (e.g., azathioprine, methotrexate, cyclophosphamide, cyclosporine); and 3) Prescriber must indicate objective clinical endpoints in advance to evaluate ongoing efficacy.see items

Kawasaki disease

Covered when ALL criteria met:

Kawasaki disease: 1) Fever present ≥5 days; 2) Treatment initiated within 10 days of fever onset; and 3) Concomitant aspirin given with IVIG.see items

Dosing options include 400 mg/kg for 4 days or a single 1–2 g/kg dose.

Dermatologic conditions (selected severe cases)

Not covered for routine use; covered when ALL criteria met for listed conditions:

Covered dermatologic conditions: Toxic epidermal necrolysis; Stevens-Johnson syndrome (with or without TEN overlap); pyoderma gangrenosum (must have failed corticosteroids, cyclosporine, and two additional therapies such as other immunosuppressives, dapsone, minocycline, or TNF-alpha inhibitors); autoimmune mucocutaneous blistering disease; mucous membrane pemphigoid (with/without ocular involvement); epidermolysis bullosa; linear IgA dermatosis.see items

Dermatologic general criteria: a) Baseline physical exam documented; b) Condition is rapidly progressing, extensive, or debilitating and confirmed by biopsy; c) Failed, contraindication to, or intolerance of corticosteroid therapy and immunosuppressive therapies (e.g., azathioprine).see items

Continuation requires documented improvement.

Myasthenia gravis bridging

Covered only temporarily to bridge immunosuppressive therapy:

MG bridging: IVIG used to bridge immunosuppressive therapies only until the immunosuppressive therapy takes effect; patient must meet criteria for acute severe MG (myasthenic crisis or severe exacerbation) and IVIG must be given concomitantly with immunosuppressive therapy.see items

Maintenance IVIG for MG is not covered.

Primary immunodeficiency and select infectious indications

Covered with dosing and frequency specified for certain conditions:

Pediatric HIV and primary immunodeficiency: Pediatric HIV: IVIG covered to reduce significant bacterial infections in patients ≤13 years with evidence of humoral immunologic defect and bacterial infections. Primary immunodeficiency (e.g., X-linked agammaglobulinemia, CVID, IgG subclass deficiency): IV 400 mg/kg initially and for maintenance monthly OR SC 100 mg/kg weekly; target trough 700–800 mg/dL (or average of low and high every 3 months).trough 700-800 mg/dL

Specific antibody testing and infection history required to document humoral defect.

Covered dosing by indication

Covered dosing varies by diagnosis; examples follow for replacement and immunomodulatory indications

Primary immunodeficiency (e.g., X-linked agammaglobulinemia, CVID, IgG subclass deficiency): IV: 400 mg/kg initial and maintenance monthly OR SC: 100 mg/kg weekly; trough target 700–800 mg/dL (or average of low and high every 3 months).trough 700-800 mg/dL

Frequency monthly IV or weekly SC; use adjusted body weight for dosing per dosing guidance.

Chronic ITP: Initial: 1–2 g/kg total over 2–5 days; Maintenance: 800–1,000 mg/kg every 2–6 weeks guided by platelet counts.platelet-guided frequency

See dosing table for ITP variants.

Multifocal motor neuropathy: Initial: 400 mg/kg per day for 5 days; Maintenance: 1–2 g/kg every ~6 weeks (document lists 2 g/kg and 1 g/kg variants); objective evidence of improved EMG or muscle strength required for continuation.

The policy lists specific immune globulin products that are not covered. Examples include Asceniv, Alyglo, Bivigam, Carimune, Gammagard S/D, Panzyga, and Yimmugo. Prior authorization is required for covered products and the form indicates preferred intravenous products and non-preferred subcutaneous products; any product explicitly listed as not covered should not be authorized. Additionally, Priority Health considers conditions not listed in the Immune Globulin Coverage Policy to be not medically necessary, and requests for uses outside the enumerated indications may be denied unless justification meets the policy criteria.

Use of immune globulin in HLA-identical sibling transplants or autologous transplants is explicitly stated as not considered medically necessary and therefore is not covered under this policy.

For myasthenia gravis (MG) the policy states that immune globulin is not covered for routine use. IVIG is limited to treatment of acute, severe decompensation when other therapies are unsuccessful or contraindicated and must be given concomitantly with glucocorticoids or other immunosuppressive therapy. The policy further specifies that maintenance IVIG for myasthenia gravis is not covered.

Immune globulin is not covered for routine use in dermatologic conditions. Coverage is limited to a defined list of severe dermatologic diagnoses (for example, toxic epidermal necrolysis, Stevens-Johnson syndrome, certain autoimmune blistering diseases, epidermolysis bullosa, linear IgA dermatosis, and pyoderma gangrenosum when additional failure criteria are met) and only when the specified documentation and failure-of-therapy requirements are satisfied.

The policy indicates that maintenance IVIG is not covered for chronic management of myasthenia gravis and similarly notes maintenance therapy is not covered for Lambert-Eaton myasthenia. IVIG may be authorized only for defined acute indications or temporal bridging as specified elsewhere in the criteria.

Continuation of IVIG infusions requires evidence of clinical benefit. The policy states that continued IVIG is not medically necessary when clinical improvement is not demonstrated. Requests for ongoing treatment must include objective baseline and follow-up assessments documenting improvement using the same metrics; absence of such improvement places continuation requests at risk for denial.

Beyond the listed severe dermatologic conditions, the policy affirms that immune globulin is not covered for routine use in autoimmune disorders. Authorization for autoimmune indications requires meeting the specific criteria and documentation described in the policy.

For neonatal alloimmune thrombocytopenia the policy clearly states immune globulin is not covered for routine use. IVIG may be considered only when both of the following are met: the neonate is severely thrombocytopenic (platelets <30,000/mm3) and/or symptomatic, and the neonate has failed, has a contraindication to, or is intolerant of platelet transfusions.

Notes regarding maintenance therapy reiterate that long-term IVIG dosing for conditions such as myasthenia gravis and Lambert-Eaton myasthenia is not covered. When IVIG is used as a temporary bridge to immunosuppressive therapy (for example in acute MG), coverage is limited to the period until the immunosuppressive agent is effective and continuation requires documentation of defined clinical improvement.

Billing Codes, Products, and Dosing Notes

Prior Authorization

Prior Authorization, Documentation, and Denial Conditions

Prior authorization is required for all listed J‑codes. Documentation must include the indication for therapy, start date (or date of next dose), route of administration, patient weight and height, dosing (g/kg or mg/kg) and frequency, date of last dose (if applicable), trough IgG level and date of trough, place of administration, and number of nursing visits (if applicable). If documentation is insufficient, the request may be delayed or denied — provide complete medical records, lab results, and dosing calculations. Therapy is considered not medically necessary for HLA‑identical sibling transplants and for autologous transplants; do not approve for these indications.

Affected codes: all J‑codes listed in the Immunoglobulin code groups below

Documentation Required

Documentation Insufficiency

Provider documentation insufficiency: insufficient or missing documentation (including absence of indication, dosing calculation, weight/height, trough IgG level/date, or place of administration) is an actionable reason for denial or request for additional information.

Prior Authorization, Documentation, and Submission Requirements

Prior Authorization

Prior authorization requires indication‑specific documentation and dosing

Prior authorization must include indication‑specific documentation and the dosing information requested on the form; dosing tables in the policy list initial and maintenance doses, frequency, and trough targets for many diagnoses.

Provide documentation meeting the indication criteria listed in the policy sections referenced on the form
Dosing tables include initial/maintenance doses, frequency, and trough targets (see Tables 1–3)

Prior Authorization

Prior authorization for IG dosing — document planned dose and frequency

Ongoing IVIG/SCIG therapy requests must include documentation of the indication and the planned dosing and frequency consistent with the policy dosing tables (e.g., IV 400 mg/kg monthly or SC 100 mg/kg weekly for primary immunodeficiencies).

Document planned route, dose (mg/kg), and dosing frequency on the prior authorization form
Use dosing tables in the policy to align requested maintenance dosing and frequency

Background and Scope

Background: Immune globulin (IVIG/SCIG) is used for replacement in primary and secondary immunodeficiencies and as immunomodulatory therapy for select hematologic, neurologic, autoimmune, infectious, and dermatologic conditions. Priority Health requires prior authorization for listed products, prefers specific IVIG formulations, and designates subcutaneous products as non-preferred unless a trial and failure of a preferred IVIG is documented. Documentation requirements include indication, dosing (mg/kg), route, frequency, and objective baseline and follow-up assessments to support ongoing therapy.

Definitions and Dosage Calculation Notes

Adjusted body weight formula and use

Adjusted body weight formulaAdjusted body weight = IBW + 0.5(actual body weight − IBW).

When to applyUse adjusted body weight for dosing when BMI ≥ 30 kg/m2 or actual weight is ≥ 20% higher than IBW.

IBW calculationIBW (kg) for males = 50 + 2.3 × (height in inches − 60); for females = 45.5 + 2.3 × (height in inches − 60).

Medical Research Council (MRC) scale — muscle strength grading

MRC scale rangeGrades 0–5 where 0 = no muscle movement and 5 = full strength against resistance.

Key grade definitions1 = flicker of movement; 2 = movement but not full against gravity; 3 = able to overcome gravity; 4 = movement against resistance but weak.

J1572	Flebogamma/Flebogamma DIF
J1569	Gammagard Liquid/Gammagard ERC
J1557	Gammaplex
J1561	Gamunex‑C/Gammaked
J1568	Octagam
J1459	Privigen

J1555	Cuvitru
J1551	Cxutqaig / cutaquig
J1559	Hizentra
J1575	HyQvia
J1558	Xembify

OpenPayer

Immune globulin (IVIG/SCIG) coverage criteria

Coverage Criteria and Indication-specific Requirements

Billing Codes, Products, and Dosing Notes

Prior Authorization, Documentation, and Submission Requirements

Background and Scope

Definitions and Dosage Calculation Notes

Asceniv	Not covered
Alyglo	Not covered
Bivigam	Not covered
Carimune	Not covered
Gammagard S/D	Not covered
Panzyga	Not covered
Yimmugo	Not covered