Health Net Immune Globulins Coverage Update | OpenPayer
ModifiedHealth NetPolicy CP PHAR.103
Immune Globulins
Defines medical necessity, prior authorization, product-specific preferences, dosing limits, and approval durations for immune globulin products for Health Net lines of business (Commercial, HIM, Medicaid). Applies to providers requesting IG therapies for listed indications.
Added HCPCS/J‑codes (including J1577 and J1552) and references to new products (e.g., Panzyga, Alyglo, Yimmugo) and dosage forms.
Revised CIDP diagnostic criteria to align with 2021 EAN/PNS CIDP guidelines and adjusted corticosteroid trial requirement to apply only to CIDP (not to GBS/AIDP) and not to pure motor CIDP.
Clarified requirements for dose calculation documentation (use of IBW or adjusted BW) apply to adults with diagnoses other than primary immunodeficiency or cancer-related infection prophylaxis.
Added product- and indication-specific exceptions and bypass language (e.g., oncology bypass for MM infection prophylaxis after BCMA-targeted CAR T-cell therapy).
Added Yimmugo to policy coding.
Added HCPCS code J1552 to allow bypass of PANDAS exclusion in California per state regulations.
Aligned CIDP diagnostic language to 2021 EAN/PNS CIDP guidelines and revised 'atypical CIDP' to 'CIDP variants'.
Added Gamunex and Gammagard liquid ERC as alternative/preferred formulations and allowed bypasses per various state/SDC changes.
Added oncology-related bypasses and criteria for CAR T-cell related toxicities and MM infection prophylaxis per NCCN.
For continued therapy, allowed continuation of current Gammagard or Gamunex unless medical justification supports a product switch.
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CLL/SLL infection prophylaxis criteria: 1) Prescribed by or in consultation with a hematologist, oncologist, or immunologist; 2) Current (within the last 6 months) hypogammaglobulinemia documented by two separate IgG measurements <500 mg/dL; 3) Recurrent serious bacterial infections within the past 12 months requiring IV antibiotics, hospitalization, or infectious disease consultation; 4) Product/step-therapy requirement met: request is for Gammagard or Gamunex-C (or a health plan–preferred product), or there is failure of Gammagard and Gamunex-C, or intolerance/contraindication to preferred products, or documented shortage exceptions (use Gammaked when required); 5) Dose does not exceed 400 mg/kg IV every 3–4 weeks OR dose is supported by practice guidelines or peer‑reviewed literature with prescriber-submitted evidence; 6) For adults calculate dose using TBW or IBW whichever is less; for obese adults use adjBW unless documentation justifies otherwise.
See Appendix F for weight-based dosing calculations
B. CAR T-Cell-Related Toxicities (off-label)
Covered when ALL of the following are met
CAR T-cell related toxicities: 1) Prescribed by or in consultation with a hematologist, oncologist, or immunologist; 2) For management of grade 4 cytokine release syndrome (CRS): failure of both high‑dose systemic corticosteroids and anti‑IL‑6 therapy unless contraindicated or clinically adverse effects (per Appendix B); 3) For secondary hypogammaglobulinemia as infection prophylaxis: prior anti‑CD19 CAR T‑cell therapy OR other CAR T/bispecific therapy per criteria, recurrent serious bacterial infections in past 12 months, and two IgG measurements within last 6 months meeting the specified hypogammaglobulinemia threshold (e.g., <600 mg/dL per CAR T criteria); 4) Product/step‑therapy rules apply (request for Gammagard or Gamunex‑C unless plan‑preferred product; failure/intolerance/shortage exceptions permitted); 5) Dose is within FDA maximum for approved indications or supported by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence).IgG <600 mg/dL for secondary hypogammaglobulinemia per CAR T criteria
Prior authorization may be required for anti‑IL‑6 therapy; oncology-state step therapy exceptions may apply
C. Dermatomyositis / Polymyositis (off-label)
Covered when ALL of the following are met
Dermatomyositis/Polymyositis criteria: 1) Diagnosis of dermatomyositis (DM) or polymyositis (PM); 2) Prescribed by or in consultation with a dermatologist, rheumatologist, neurologist, or neuromuscular specialist; 3) Failure of a 4‑month trial of systemic corticosteroid combined with one immunosuppressive agent at up to maximally indicated doses unless contraindicated or adverse effects; 4) For dermatomyositis requests only: failure of rituximab trial unless contraindicated or juvenile DM with calcinosis; 5) Product/step‑therapy requirements met (request for Gammagard or Gamunex‑C unless plan‑preferred product; failure of preferred agents, intolerance/contraindication, or shortage exceptions including Octagam-specific condition for DM); 6) Dose does not exceed 2 g/kg IV per month OR dose is supported by practice guidelines or peer‑reviewed literature with prescriber evidence; 7) Adult dosing calculated per TBW/IBW/adjBW rules as applicable.<=2 g/kg IV per month (typical limit)
Octagam may be indicated specifically for DM; prescriber must submit supporting evidence for off‑label dosing
General product-preference and interchangeability rules
Covered when ONE of the following product-preference or exception conditions is met
preferred_request: Request is for Gammagard or Gamunex‑C unless there is a specific health plan–preferred immune globulin product.
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failure_of_preferred: Failure of Gammagard and Gamunex‑C (or health plan‑preferred product).
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intolerance_or_shortage: Member has intolerance or contraindication to Gammagard and Gamunex‑C (or plan‑preferred product), or both preferred products are unavailable due to shortage (member must use Gammaked unless contraindicated); if all preferred options including Gammaked are unavailable, request for another product may be allowed per shortage exception.
FNAIT_diagnosis: Diagnosis of fetal/neonatal alloimmune thrombocytopenia (FNAIT).
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prescriber: Prescribed by or in consultation with a hematologist, immunologist, perinatologist, or neonatologist.
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risk_markers: Meets at least one risk marker: previous pregnancy affected by FNAIT; serological confirmation of maternal–fetal HPA incompatibility; fetal intracranial hemorrhage; or nadir platelet count ≤100 x 10^9/L at birth or within 7 days.nadir platelet ≤100 x10^9/L
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dose_limit:
Inflammatory Demyelinating Polyneuropathy (AIDP/GBS or CIDP)
Covered when ALL of the following are met
diagnosis: Diagnosis of acute inflammatory demyelinating polyneuropathy (AIDP/Guillain‑Barré syndrome) OR chronic inflammatory demyelinating polyneuropathy (CIDP).
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prescriber: Prescribed by or in consultation with a neurologist or neuromuscular specialist.
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AIDP_severity: For AIDP/GBS: presence of at least one severe feature (e.g., inability to stand/walk ≥30 feet without assistance; ICU admission for aspiration or mechanical ventilation; inability to raise head against gravity; Miller‑Fisher syndrome; severe bulbar palsy; autonomic dysfunction; bilateral facial weakness).
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CIDP_criteria:
Dosing limits for AIDP and CIDP
Dosing rules that must be met
AIDP_dose: AIDP/GBS dosing: IVIG dose does not exceed 0.4 g/kg/day IV for 5 days (typical regimen).0.4 g/kg/day x5 days
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CIDP_schedules: CIDP dosing options: loading IV 2 g/kg given over 2–5 days followed by maintenance 1 g/kg IV every 3 weeks; or Hizentra SC 0.2 g/kg/week (increase to 0.4 g/kg/week if worsening); HyQvia dosing not to exceed prior IV dose; product‑specific dosing referenced in Appendix/dosing tables.loading 2 g/kg then maintenance 1 g/kg q3 weeks
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Idiopathic Thrombocytopenic Purpura (ITP) acute or chronic
Covered when ALL of the following are met
diagnosis: Diagnosis of acute or chronic idiopathic thrombocytopenic purpura (ITP).
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prescriber: Prescribed by or in consultation with a hematologist.
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prior_therapy: Failure of one of: systemic corticosteroids (e.g., prednisone) OR Rho(D) immune globulin (RhIG) at up to maximally indicated doses unless contraindicated or adverse effects (prior authorization required for RhIG).
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clinical_triggers: Clinical triggers for IVIG: current platelet count ≤30,000/µL, active bleeding, scheduled splenectomy, high risk of life‑threatening hemorrhage, or pregnancy.
Kawasaki disease (aneurysm prevention)
Covered when ALL of the following are met
kawasaki_diagnosis: Diagnosis of Kawasaki syndrome or incomplete (atypical) Kawasaki disease.
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prescriber: Prescribed by or in consultation with a cardiologist, allergist/immunologist, infectious disease specialist, or rheumatologist.
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aspirin_concurrent: Prescribed concurrently with aspirin unless contraindicated.
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product_preference: Request is for Gammagard or Gamunex‑C unless a specific health plan–preferred product exists; failure/intolerance/shortage exceptions apply.
Kidney transplant (off-label) — desensitization or antibody-mediated rejection
Covered when ALL of the following are met
indication_subtypes: Member is highly sensitized prior to kidney transplant (high antibody levels) OR is receiving treatment following kidney transplant for antibody‑mediated rejection.
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prescriber: Prescribed by or in consultation with a nephrologist, transplant specialist, or hematologist.
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product_preference_transplant: Request is for Gammagard or Gamunex‑C unless plan‑preferred product exists; failure/intolerance/shortage exceptions apply and products are generally interchangeable at plan discretion.
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transplant_dose: Dose does not exceed 140 g IV per infusion OR dose is supported by practice guidelines/peer‑reviewed literature with prescriber evidence.
Multifocal Motor Neuropathy (MMN)
Covered when ALL of the following are met
mmn_diagnosis: Diagnosis of multifocal motor neuropathy (MMN).
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prescriber: Prescribed by or in consultation with a neurologist or neuromuscular specialist.
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product_preference_mmn: Request is for Gammagard or Gamunex‑C unless plan‑preferred product exists; failure/intolerance/shortage exceptions apply.
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mmn_dose: Dose does not exceed 2.4 g/kg IV per month OR dose is supported by practice guidelines/peer‑reviewed literature with prescriber evidence.<=2.4 g/kg/month
MM_infection_prophylaxis: 1) Diagnosis of multiple myeloma; 2) Prescribed by or in consultation with a hematologist, oncologist, or immunologist; 3) Either: (a) current hypogammaglobulinemia (two IgG <400 mg/dL within last 6 months) in patients treated with BCMA‑targeted CAR T‑cell or bispecific antibody therapy, OR (b) recurrent serious bacterial infections requiring IV antibiotics, hospitalization, or ID consult within past 12 months; 4) Product/step‑therapy conditions met (prefer Gammagard/Gamunex‑C or plan‑preferred product; failure/intolerance/shortage exceptions apply); 5) Dose does not exceed 400 mg/kg IV every 3 weeks OR dose is supported by practice guidelines/peer‑reviewed literature with prescriber evidence.IgG <400 mg/dL (two measurements) when applicable
Oncology‑related bypass allowed for members who received BCMA‑targeted CAR T‑cell or bispecific antibody therapy per NCCN guidance
Multifocal Motor Neuropathy (MMN) — Initial or continuing therapy
Covered when ALL of the following are met:
MMN_initial_continuing: 1) Diagnosis of MMN; 2) Prescribed by or in consultation with a neurologist or neuromuscular specialist; 3) Member meets product/step‑therapy conditions (request for Gammagard or Gamunex‑C unless plan‑preferred product; failure of preferred products; intolerance/contraindication; or shortage exceptions including use of Gammaked when required); 4) Dose is supported by guidelines or does not exceed 2.4 g/kg IV per month; 5) For Illinois HIM requests, step‑therapy requirements may be bypassed per IL HB 5395 where applicable.dose <= 2.4 g/kg IV per month
Prescriber must submit supporting evidence for off‑label dosing when applicable
MM_infection_prophylaxis_detailed: 1) Diagnosis of multiple myeloma; 2) Prescribed by or in consultation with a hematologist, oncologist, or immunologist; 3) Member meets one of: (a) has received BCMA‑targeted CAR T‑cell or bispecific antibody therapy AND current hypogammaglobulinemia (two IgG <400 mg/dL within 6 months) AND recurrent serious bacterial infections in past 12 months, OR (b) other qualifying criteria per policy; 4) Product/step‑therapy conditions apply (prefer Gammagard/Gamunex‑C or plan‑preferred product; failure/intolerance/shortage exceptions); 5) Dose does not exceed 400 mg/kg IV every 3 weeks OR is supported by guidelines/peer‑reviewed literature with prescriber evidence.IgG <400 mg/dL (two measurements) when applicable
Oncology bypass language added to permit exceptions after BCMA‑targeted therapies per NCCN
Multiple Sclerosis (off-label)
Covered when ALL of the following are met:
MS_offlabel_criteria: 1) Diagnosis of relapsing‑remitting multiple sclerosis (RRMS); 2) Prescribed by or in consultation with a neurologist; 3) Failure of three FDA‑approved disease‑modifying MS therapies at up to maximally indicated doses unless contraindicated or intolerable; 4) Product/step‑therapy conditions met (request for Gammagard or Gamunex‑C unless plan‑preferred product; failure/intolerance/shortage exceptions); 5) Dose supported by guidelines or does not exceed an initial loading 400 mg/kg IV daily x5 days followed by maintenance 1 g/kg IV monthly (typical regimen) or other guideline‑supported regimen with prescriber evidence.loading 400 mg/kg IV x5 days then maintenance 1 g/kg IV monthly
Prior authorization required for MS therapies; shortages/plan preferences applied as described
MG_LEMS_criteria: 1) Diagnosis of myasthenia gravis (MG) or Lambert‑Eaton myasthenic syndrome (LEMS); 2) Prescribed by or in consultation with a neurologist or neuromuscular specialist; 3) Acute severity or prior therapy failure criteria met (e.g., scheduled thymectomy, acute crisis with low vital capacity, inability to perform activities of daily living, or failure of amifampridine/cholinesterase inhibitors, systemic corticosteroid, and immunosuppressant unless contraindicated); 4) Product/step‑therapy conditions met (prefer Gammagard/Gamunex‑C or plan‑preferred product; failure/intolerance/shortage exceptions); 5) Dose does not exceed 2 g/kg IV divided over 2–5 consecutive days per treatment course OR dose supported by guidelines/literature.<=2 g/kg IV per treatment course
Revised requirement: both steroid and alternative immunosuppressant requirements applied per updates
Paraneoplastic Neurologic Syndromes (off-label)
Covered when ALL of the following are met:
Paraneoplastic_neuro_criteria: 1) Diagnosis of a specified paraneoplastic neurologic syndrome subtype (e.g., opsoclonus‑myoclonus syndrome, anti‑NMDA encephalitis); 2) Prescribed by or in consultation with a neurologist, neuromuscular specialist, or oncologist; 3) For OMS, failure of at least one systemic corticosteroid at maximally indicated doses unless contraindicated; 4) Product/step‑therapy conditions apply; 5) Dose options/limits include ≤0.4 g/kg IV per day, ≤2 g/kg IV per month, or ≤200 mg/kg SC per week, or other guideline‑supported regimens with prescriber evidence.varies up to 2 g/kg/month
Concurrent IVIG with methylprednisolone preferred for anti‑NMDA encephalitis per available reviews
Parvovirus B19 Infection with Anemia (off-label)
Covered when ALL of the following are met:
Parvovirus_B19_anemia: 1) Diagnosis of anemia secondary to chronic parvovirus B19 infection; 2) Prescribed by or in consultation with a hematologist, infectious disease specialist, or immunologist; 3) Current (within 30 days) severe anemia (Hgb <10 g/dL or Hct <30%) due to bone marrow suppression; 4) Product/step‑therapy conditions apply (prefer Gammagard/Gamunex‑C unless plan‑preferred product; failure/intolerance/shortage exceptions); 5) Dose limited to an initial 2 g/kg IV given over up to 5 days followed by maintenance 400 mg/kg IV every 4 weeks OR dose supported by guidelines/peer‑reviewed literature with prescriber evidence.initial 2 g/kg IV (up to 5 days) then 400 mg/kg q4w
IVIG is standard of care in prolonged aplastic crisis though RCTs are lacking; prescriber must submit evidence when using alternative regimens
Pediatric HIV — Prophylaxis of Serious Bacterial Infection (off-label)
Covered when ALL of the following are met:
Pediatric_HIV_prophylaxis: 1) Prescribed by or in consultation with an HIV or infectious disease specialist for prophylaxis of serious bacterial infection in a child with HIV; 2) Current (within 6 months) hypogammaglobulinemia documented by two IgG measurements <400 mg/dL; 3) Recurrent serious bacterial infections OR inadequate antibody response to vaccines OR exposure/high‑prevalence scenario OR chronic bronchiectasis refractory to therapy; 4) Product/step‑therapy conditions met (prefer Gammagard/Gamunex‑C unless plan‑preferred product; failure/intolerance/shortage exceptions); 5) Dose does not exceed 400 mg/kg IV every 2–4 weeks OR dose is supported by guidelines/peer‑reviewed literature with prescriber evidence.IgG <400 mg/dL (two measurements); dose 400 mg/kg q2–4w
Prescriber must submit supporting evidence for off‑label pediatric dosing
Pemphigus vulgaris and other autoimmune blistering diseases (off-label)
Covered when ALL of the following are met:
Pemphigus_bullous_criteria: 1) Diagnosis of an autoimmune blistering disorder (pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, or epidermolysis bullosa acquisita); 2) Prescribed by or in consultation with a dermatologist; 3) Failure of at least one corticosteroid at up to maximally indicated doses unless contraindicated; 4) Failure of at least one immunosuppressive agent at up to maximally indicated doses unless contraindicated; 5) Failure of rituximab unless contraindicated; 6) Product/step‑therapy conditions met (request for Gammagard or Gamunex‑C unless plan‑preferred product; failure/intolerance/shortage exceptions); 7) Prescriber submits supporting evidence for off‑label use and dosing when required.prior failure of steroids, immunosuppressant, and rituximab unless contraindicated
IVIG for pemphigus used for short‑term therapy; not for maintenance
Off-label autoimmune blistering diseases (pemphigus, bullous pemphigoid, mucous membrane pemphigoid, epidermolysis bullosa acquisita) — covered when ALL of the following are met
Autoimmune blistering diseases criteria: 1. Diagnosis of pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, or epidermolysis bullosa acquisita; 2. Prescribed by or in consultation with a dermatologist; 3. Failure of at least one corticosteroid at up to maximally indicated doses unless contraindicated; 4. Failure of at least one immunosuppressive agent at up to maximally indicated doses unless contraindicated; 5. Failure of rituximab unless contraindicated; 6. Request is for Gammagard or Gamunex‑C unless a plan‑preferred product is specified; 7. Member meets step‑therapy exceptions or alternatives for product selection;see dosing limits
Prescriber must submit supporting evidence for off‑label use
Primary immunodeficiency — must meet ALL of the following (examples extracted)
Primary immunodeficiency (PI) — must meet ALL of the following (examples extracted)
PI_diagnostic_and_treatment: 1) Diagnosis of primary immunodeficiency (examples include agammaglobulinemia, CVID, congenital hypogammaglobulinemia, hyper‑IgM syndromes, SCID, selective immunodeficiencies, subclass deficiency, or functional/specific antibody deficiency); 2) Prescribed by or in consultation with an immunologist or hematologist; 3) For functional/specific antibody deficiency: inadequate antibody response to polysaccharide antigens per testing criteria; 4) For total or subclass deficiency: two separate low immunoglobulin measurements within 6 months plus at least one clinical criterion (e.g., recurrent serious bacterial infections within 12 months requiring IV antibiotics, hospitalization, or ID consult); 5) Product selection and dosing per plan and Appendix F (dose examples per product: IV up to 800 mg/kg every 3–4 weeks; SC up to 600 mg/kg every 3–4 weeks; conversion factors for SC dosing documented).diagnostic labs and infection history per policy
Trough IgG monitoring every 3 months for lifelong treatment; specific ADA‑SCID/Revcovi rules apply
Stiff person syndrome (off-label) — must meet ALL of the following
Stiff person syndrome (off-label) — must meet ALL of the following
Stiff_person_criteria: 1) Diagnosis of stiff person syndrome; 2) Prescribed by or in consultation with a neurologist or neuromuscular specialist; 3) Failure of a benzodiazepine (e.g., diazepam) or baclofen at up to maximally indicated doses unless contraindicated; 4) Request is for Gammagard or Gamunex‑C unless plan‑preferred product specified; 5) Member meets step‑therapy exceptions or alternatives for product selection (failure of preferred products, intolerance, or shortage exceptions); 6) Dose does not exceed 2 g/kg IV divided over 2–5 consecutive days per treatment course OR dose is supported by guidelines/peer‑reviewed literature with prescriber evidence.dose limits as specified
IL HIM step‑therapy exceptions may apply per IL HB 5395
Viral post-exposure prophylaxis (Hep A, Measles, Varicella, Rubella)
Viral post-exposure prophylaxis (IM formulation) — must meet ALL of the following
Viral_prophylaxis_criteria: 1) Request is for IM immune globulin formulation; 2) Indication is one of: Hepatitis A post‑exposure/high‑risk prophylaxis, measles post‑exposure prophylaxis, varicella (chickenpox) post‑exposure prophylaxis, or rubella post‑exposure prophylaxis with applicable subcriteria (exposure timing, lack of immunity, pregnancy, immunocompromise, vaccine unavailability, or severe vaccine allergy); 3) Dosing limits by indication and weight apply (e.g., Hep A: 0.1–0.2 mL/kg IM once or repeated per exposure period; Measles: up to 15 mL IM once; Varicella: up to 1.2 mL/kg IM once; Rubella: up to 0.55 mL/kg IM once) OR dose supported by guidelines with prescriber evidence.indication‑specific dosing limits (see policy)
Hepatitis A duration limited to request duration or 6 months; other indications typically one‑time approval (1 month)
Other diagnoses/indications — must meet 1 and 2
Other diagnoses/indications — must meet 1 and 2
Other_indications_criteria: 1) One of the following: request is for treatment associated with cancer in a state with regulations against step therapy in certain oncology settings; request is for Gammagard or Gamunex‑C unless a plan‑preferred product exists; failure of Gammagard and Gamunex‑C; or intolerance/contraindication/shortage exceptions including use of Gammaked when required; 2) If the requested use, diagnosis, age, or dosing regimen is not listed under Section III and the above does not apply, refer to the applicable off‑label or non‑formulary policy per line of business for coverage determination.refer to Appendix and other policies as needed
Products are generally interchangeable; plan may prefer alternatives
Continued therapy / Re-authorization
Continued therapy — coverage conditions for ongoing treatment
Continued_therapy_general: 1) Re‑authorization requires that member currently be receiving medication via the plan benefit or previously met initial approval criteria (note: re‑authorization is not permitted for certain indications such as Kawasaki disease/incomplete and certain CAR T‑cell related toxicities); 2) Member is responding positively to therapy (clinical response documented); 3) For members on plan‑preferred products (e.g., Gammagard or Gamunex‑C), continue the same product unless medical justification supports a switch (e.g., adverse reaction, ineffectiveness); 4) Dose increases require either appropriate dose titration per product labeling OR support by practice guidelines/peer‑reviewed literature with prescriber evidence; 5) Adult dosing calculations for reauthorization use TBW or IBW whichever is less; for obese adults use adjBW unless documentation supports inability to adjust dosing this way.response and documentation required
Approval durations vary by indication (HIM 12 months for PI; typically 6 months for others)
Dose increase and adult dosing
Dose increase requests and adult dose calculations are covered when ALL of the following are met:
Dose_increase_and_calc: For dose increases due to inadequate response, request must meet either: (a) dose titration or conversion appropriate per package insert labeling; OR (b) new dose is supported by practice guidelines or peer‑reviewed literature with prescriber‑submitted supporting evidence. For adults with diagnoses other than primary immunodeficiency or cancer‑related infection prophylaxis, dose must be calculated using TBW or IBW (whichever is less); for obese adults use adjusted body weight (adjBW) unless documentation justifies inability to adjust.
See Appendix F for weight‑based dosing calculations
Product preference and continuation
Product selection and switching covered when ALL of the following are met:
product_interchangeability: Immune globulin products are generally interchangeable and the health plan may prefer a clinically appropriate alternative; members currently receiving plan‑preferred products (e.g., Gammagard or Gamunex‑C or health plan‑preferred IG) should generally continue those products unless medical justification supports a switch (e.g., adverse reactions, ineffectiveness); documentation must support medical justification for switching products.
State‑specific bypass/redirect rules may apply (e.g., IL HB 5395)
Covered Indications with Supporting Evidence
Covered when supported by disease-specific evidence or established standard practice:
ITP_evidence: IVIG use for immune thrombocytopenia (ITP) is supported: acute ITP single‑dose use with defined response criteria per International Working Group/ASH; definitions for early, initial, durable response and CR/NR provided in Appendix D.
Appendix D contains response thresholds such as platelet ≥30,000/µL for response
GBS_AIDP_evidence: Initiation of IVIG within 2 weeks of symptom onset for GBS/AIDP is effective and comparable to plasma exchange; combination IVIG and plasmapheresis not superior; pulmonary function thresholds are provided to assess respiratory risk.treatment within 2 weeks of onset
Appendix D references pulmonary function risk factors
Kawasaki_evidence: IVIG in acute Kawasaki disease reduces coronary artery abnormalities; retreatment with 2 g/kg may be used for persistent fever ≥36 hours after initial infusion per expert practice.
Excluded Indications
Not covered — investigational or insufficient evidence:
Excluded_investigational: Use of immune globulins is excluded for conditions listed as investigational due to lack of conclusive randomized controlled trial evidence (examples include idiopathic progressive neuropathy, critical illness myopathy/necrotizing myopathy, iridocyclitis unspecified, systemic capillary leak syndrome/Clarkson disease, bilateral orbital myositis, and others enumerated in Section III).N/A
Alternative therapies such as corticosteroids or immunosuppressants may be appropriate per the exclusions list
Selected Indication-Based Dosing
Product-specific dosing guidance (selected examples) — use dosing per indication and adjust by body weight method as specified:
PI_dosing_examples: For primary immunodeficiency: typical IV initial dosing 300–800 mg/kg every 3–4 weeks; SC dosing converted from IV dose using product conversion factors (e.g., SC = IV grams / weeks x1.30–1.37); maintain dosing per serum IgG trough and clinical response; use TBW or IBW whichever is less and adjBW for obese members as applicable.300–800 mg/kg IV q3–4w (product dependent)
Refer to specific product prescribing information for exact regimens (Alyglo, Cuvitru, etc.)
CIDP_dosing_examples: For CIDP: common IV loading 2 g/kg given over 2–5 days then maintenance 1 g/kg IV every 3 weeks; SC regimens (e.g., Hizentra 0.2–0.4 g/kg/week) are product‑specific and dosing must not exceed prior IV dosing for HyQvia per product labeling.loading 2 g/kg then maintenance 1 g/kg q3 weeks
See product dosing tables (Gammagard, Privigen) for details
CIDP authorization criteria (revised)
Selected coverage logic and changes reflected in this document portion include:
CIDP_authorization_revised: Authorization for CIDP requires confirmation of CIDP per guideline diagnostic criteria aligned to EFNS/PNS and 2021 EAN/PNS updates; a documented trial of corticosteroid therapy is required for CIDP except for pure motor CIDP variants.
Diagnostic alignment updated; corticosteroid trial requirement applies to CIDP only
Dosing and documentation
Dose calculation and product selection rules:
Dose_calc_doc: For adults (excluding primary immunodeficiency and cancer‑related infection prophylaxis), dose calculations for authorization and reauthorization must use IBW or adjusted body weight (adjBW) where applicable; documentation must be provided if unable to adjust dosing as required. Products are generally interchangeable and health plan may redirect to preferred products per policy; product shortages and state‑specific bypass rules apply.
See Appendix F for IBW/adjBW formulas and documentation requirements
Product substitution and oncology bypass
Product availability and bypass rules:
product_substitution_bypass: If preferred product is unavailable due to shortage, specified alternatives (e.g., Gamunex‑C or Gammaked) should be used; oncology‑related bypass is allowed for multiple myeloma infection prophylaxis after BCMA‑targeted CAR T‑cell or bispecific antibody therapy per NCCN guidance and added operational redirection language applies.
Operational redirection and oncology bypass language added
Policy modifications affecting coverage and continuation
Policy modifications relevant to coverage and continuation
continued_therapy_mods: Member may continue current immune globulin (e.g., Gammagard or Gamunex‑C) for ongoing therapy unless medical justification supports a change; approval durations and continuation rules updated to reflect allowance for continuation of current product and state‑specific bypasses for step therapy where applicable.
Added language to permit continuation of current product and state bypass allowances
state_bypass_allowances: State‑specific bypass allowances apply (e.g., California allowance to bypass PANDAS exclusion via HCPCS J1552; Illinois HB 5395 step therapy bypass for HIM), which override general exclusions when applicable.
State‑specific exceptions override general exclusions for Medicaid when applicable
CIDP_variant_update: CIDP diagnostic language revised to align with 2021 EAN/PNS guidelines replacing 'atypical CIDP' with 'CIDP variants,' affecting eligibility determinations for CIDP‑related IVIG coverage.
Affects CIDP eligibility determinations
Privigen maintenance therapy in CIDP is noted to have not been studied beyond 6 months. In addition, the policy states that the safety and efficacy of chronic use of recombinant human hyaluronidase (Hyqvia) have not been established in conditions other than primary immunodeficiency, and these limitations should be considered when evaluating long‑term maintenance requests.
The policy lists specific alternative causes that must be excluded when diagnosing demyelinating neuropathies. Excluded etiologies include Borrelia burgdorferi (Lyme) infection, diphtheria, drug or toxin exposure, hereditary demyelinating neuropathy, and other named conditions (for example, POEMS syndrome and IgM monoclonal gammopathy with high‑titer anti‑MAG antibodies). These alternative causes are part of the diagnostic exclusion criteria for CIDP.
The excerpt provided does not reproduce the full Section III exclusions; several exclusions and administrative rules are present elsewhere in the complete policy. This section of the document focuses on coverage criteria, product‑preference/step‑therapy options, and prescriber requirements; readers should refer to the full policy for the comprehensive exclusion list and related operational details.
If the requested use, diagnosis, age, or dosing regimen is not specifically addressed in Section III and no recent label change applies, the request should generally be referred to the applicable off‑label or non‑formulary policy for the member’s line of business (for example, CP.CPA.09 for commercial or HIM.PA.154 for marketplace members). This provides the fallback pathway when a use is not listed in the policy excerpt.
The policy identifies an extensive set of diagnoses and clinical scenarios considered not medically necessary or investigational. Examples include idiopathic progressive neuropathy, critical illness myopathy (necrotizing myopathy), iridocyclitis unspecified, Clarkson disease (systemic capillary leak syndrome), bilateral orbital myositis, inclusion body myositis, many neuropsychiatric and rheumatologic conditions, and numerous other listed disorders. Where an indication is designated investigational or not medically necessary, alternative therapies (for example, corticosteroids or immunosuppressants) are suggested in the policy text.
Uses considered investigational and therefore excluded from coverage are summarized where randomized controlled trial evidence is lacking. The policy explicitly lists several conditions for which immune globulin therapy is viewed as investigational (see policy for full list) and directs clinicians to consider alternative evidence‑based therapies for those indications.
The policy’s investigational indication rationale is grounded in current guideline alignment and evidence review. Notable operational and clinical changes include alignment of CIDP diagnostic language with updated guideline recommendations and addition of oncology‑related bypasses (for example, for multiple myeloma infection prophylaxis after BCMA‑targeted CAR T‑cell or bispecific antibody therapy). These modifications reflect incorporation of guideline and specialty society guidance into coverage logic.
Section III exclusions were updated in recent revisions. Changes included the removal of Rasmussen’s syndrome from the exclusion list and clarification that the antiphospholipid syndrome (APS) exclusion does not apply to catastrophic antiphospholipid syndrome (CAPS). The policy also documents state‑level adjustments and cross‑references to state‑specific guidance where applicable.
Injection, gamma globulin, intramuscular, over 10 cc
1–10 of 16
1/2
Added HCPCSHCPCS
J1552
HCPCS code added to allow bypass of PANDAS exclusion in California
Products addedmixed
Yimmugo
Product added to policy coding list
Panzyga
Immune globulin product listed for prior authorization
inv-63: Maximum dosing (initial criteria examples)
Maximum initial IV dosing (common)Dose does not exceed 400 mg/kg IV every 3–4 weeks (commonly used as the initial maximum for many indications)
Dermatomyositis monthly capDose does not exceed 2 g/kg IV per month for dermatomyositis
Alternative supported dosingHigher or alternate dosing allowed if supported by practice guidelines or peer‑reviewed literature (prescriber must submit evidence)
inv-64: IgG level threshold for MM infection prophylaxis
IgG threshold for MM infection prophylaxisTwo separate IgG measurements < 400 mg/dL within the last 6 months
Provider Requirements, Prior Authorization and Documentation
Prior Authorization
Prior Authorization Required
Prior authorization is required for requests for immune globulin products and certain referenced therapies (e.g., rituximab, Revcovi). Providers must submit supporting clinical documentation (office notes, specialty consultation, labs, serum IgG levels, antibody response testing, and prior therapy trials) showing the member meets the applicable criteria. Failure to supply required documentation may result in denial or delay.
Prior authorization required for listed IG products and select referenced therapies (rituximab, Revcovi).
Include office chart notes, relevant labs (e.g., serum IgG troughs per Appendix E), specialty consult notes, and documentation of prior therapy trials.
Requests for off-label doses or regimens must include supporting evidence from practice guidelines or peer-reviewed literature.
Prior Authorization
Prior Authorization and Approval Durations
Typical approval durations vary by line of business and indication. Standard approvals are generally 6 months for Medicaid/HIM and commercial (commercial may be to the member's renewal date if longer). Certain indications have different durations (e.g., HIM: 12 months for primary immunodeficiency; Kawasaki disease: one-time approval of 1 month).
Background and Context
Immune globulins are indicated across a broad set of clinical contexts including primary and secondary immunodeficiency, immune‑mediated neurologic and hematologic disorders, and infection prophylaxis. Products are available in IV and SC formulations and product selection, dosing, and monitoring vary by indication; the policy references dosing tables, weight‑based calculations (TBW/IBW/adjBW), and monitoring requirements such as trough IgG levels for primary immunodeficiency.
Regarding Privigen and long‑term use, the policy specifically notes that Privigen maintenance therapy in CIDP has not been studied beyond 6 months. Consistent with this limitation, the CIDP criteria require guideline‑based diagnostic confirmation and specify prior corticosteroid trial requirements for non‑pure motor CIDP, emphasizing the importance of documented short‑term efficacy and careful consideration for ongoing maintenance therapy.
Dose does not exceed 2 g/kg IV per week OR dose is supported by practice guidelines/peer‑reviewed literature (prescriber must submit evidence).
2 g/kg IV per week
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For CIDP: disease progressive or relapsing ≥2 months; typical clinical features (symmetric proximal and distal weakness of ≥2 limbs with sensory involvement and absent/reduced reflexes); confirmation by electrodiagnostic testing; exclusion of alternative causes; and for non‑pure motor CIDP failure of at least one corticosteroid at maximally indicated doses unless contraindicated (corticosteroid trial requirement applies to CIDP per guideline alignment).
disease duration ≥2 months
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<=30,000/µL or clinical state
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dosing_limits: Dose does not exceed 1 g/kg IV for 1–2 days OR 400 mg/kg/day IV up to 5 days; for Gammagard S/D limit 1 g/kg up to 3 total doses qod; alternative doses require supporting evidence.1 g/kg single or 400 mg/kg/day up to 5 days
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kawasaki_doses: Dose options: does not exceed 1 g/kg IV as single infusion OR 2 g/kg IV as single infusion OR 400 mg/kg IV daily for 4 consecutive days; alternative doses supported by guidelines require evidence submission.1 g/kg single OR 2 g/kg single OR 400 mg/kg/day x4
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<=140 g per infusion
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fever ≥36 hours after initial infusion indicates retreatment
Appendix D discusses efficacy and retreatment rationale
NAIT_evidence: Maternal IVIG (e.g., weekly 1 g/kg starting 20–24 weeks gestation) increases fetal platelet counts in NAIT and is standard practice; in very high‑risk pregnancies therapy may start at 12–14 weeks per expert recommendations.weekly 1 g/kg maternal dosing starting 20–24 weeks (earlier for very high risk)
Appendix D summarizes NAIT management
PI_evidence: IVIG indicated for primary immunodeficiency with documented antibody defects; dosing individualized with trough IgG monitoring every 3 months to maintain low‑normal levels (~400–600 mg/dL).trough IgG ~400–600 mg/dL
Appendix D and product dosing tables referenced
MG_evidence: High‑dose IVIG can rapidly improve severe myasthenia gravis exacerbations; benefit typically within <1 week and lasts 3–6 weeks; not clearly superior to plasmapheresis for life‑threatening MG.severe exacerbation/crisis
Clinical trial data and EFNS guidance referenced
Anti_NMDA_and_OMS_evidence: Concurrent IVIG (0.4 g/kg/day x5) with methylprednisolone is preferred over plasma exchange in anti‑NMDA encephalitis per available reviews; OMS may require steroid failure before IVIG.early combined therapy
Appendix D and literature summaries support use
Parvovirus_evidence: IVIG is standard of care for prolonged aplastic crisis due to parvovirus B19 in immunocompromised patients (NCCN category 2A), despite lack of RCTs.prolonged aplastic crisis
Appendix and NCCN references cited
ITP_dosing_examples:
For ITP: typical IV dosing options include 1 g/kg IV for 1–2 days or 0.4 g/kg IV daily for 5 days, with product‑specific variations (e.g., Gammagard S/D limits); prescriber may submit evidence for alternative dosing regimens.
Associated clinical requirementRecurrent serious bacterial infections within past 12 months required in conjunction with low IgG for prophylaxis eligibility
Relevant therapies notedApplies to patients post‑BCMA CAR T‑cell or bispecific antibody therapy per NCCN‑referenced updates
inv-65: Dose limits (examples)
MMN monthly limitDose does not exceed 2.4 g/kg IV per month for multifocal motor neuropathy (MMN)
General monthly cap for many indicationsDose does not exceed 2 g/kg IV per month for several indications unless supported by evidence
Single‑infusion ITP/Kawasaki examplesSingle‑infusion limits include 1 g/kg (common for ITP/Kawasaki) or 2 g/kg for retreatment strategies
Daily course examples0.4 g/kg IV per day (e.g., AIDP/GBS for 5 days) used as a per‑day limit in some acute indications
inv-66: Dosing limits — additional examples
IV monthly maximum (policy general)IV dosing generally does not exceed 2 g/kg every 4 weeks for many indications
Short high‑dose coursesExamples include 300–400 mg/kg/day IV for 5 days (used in some acute regimens)
PI maintenance IV ceilingPrimary immunodeficiency IV dosing up to 800 mg/kg every 3–4 weeks (individualized per trough IgG and product)
inv-67: ITP response definitions
Early response (ITP)Platelet count ≥30,000/µL and ≥2× baseline at 1 week
Initial response (ITP)Platelet count ≥30,000/µL and ≥2× baseline at 1 month
Durable response (ITP)Platelet count ≥30,000/µL and ≥2× baseline at 6 months
Authorization for disease-specific IVIG use requires meeting the diagnosis-specific criteria (e.g., CIDP confirmation per EFNS/PNS guidance, AIDP/GBS dosing limits) and documentation for retreatment or maintenance scenarios. Continued-therapy rules require evidence of ongoing response and that members currently on a preferred product generally continue that product unless medical justification for switch is provided.
Disease-specific criteria and limits apply (see sections for CIDP, AIDP/GBS, primary immunodeficiency, oncology-related prophylaxis, etc.).
Continued therapy: member must be responding to therapy; members currently receiving Gammagard or Gamunex-C (or health plan-preferred product) generally continue that product unless medical justification supports a switch.
Re-authorization is not permitted for certain single-use or acute indications (e.g., Kawasaki one-time approval, some CRS scenarios) — subsequent requests must meet initial criteria.
Documentation Required
Prior Authorization Dosing Reference
Dosing references and calculations: use product-specific dosing regimens and weight-based calculations (TBW, IBW, adjBW) per Appendix F and individual product prescribing information. For adults (except primary immunodeficiency or cancer-related infection prophylaxis), calculate dose using the lesser of TBW or IBW; for obese members use adjusted body weight. Document rationale when unable to use IBW/adjBW.
Refer to Appendix F for IBW, adjBW formulas and online calculators.
For adults (non-PI/non-oncology prophylaxis): dose = TBW or IBW, whichever is less; if obese (BMI ≥ 30 or TBW >20–30% over IBW) use adjBW.
Product prescribing information should be used for product-specific loading/maintenance dosing and administration guidance.
Note
Clinical Guideline Sources Referenced
Clinical guideline sources referenced in policy include NCCN guidance (CLL, multiple myeloma, CAR T toxicities, cancer-related infection prevention), EFNS/PNS (CIDP guidance), AAN/other neurology society documents, and systematic reviews cited in Appendix VI. Providers should reference these sources when supporting off-label uses or diagnostic confirmation.
NCCN: CLL, Multiple Myeloma, Management of Immunotherapy-Related Toxicities.
EFNS/PNS and 2021 EAN/PNS CIDP guideline for CIDP diagnostic confirmation and variants.
Systematic reviews and specialty society guidance cited in References (Appendix VI).
Prior Authorization
Prior Authorization Distinction: AIDP/GBS vs CIDP
AIDP/GBS and CIDP criteria are distinct. AIDP/GBS dosing and timing (e.g., IVIG within 2 weeks for GBS, AIDP dose limits) differ from CIDP, which requires electrodiagnostic confirmation, CIDP phenotype classification, and — except for pure motor CIDP presentations — a trial of corticosteroid (e.g., prednisone) at maximally indicated doses unless contraindicated.
AIDP/GBS: acute presentation guidance; initiation within 2 weeks; specified IV dosing limits (e.g., 0.4 g/kg/day x5 days for AIDP/GBS).
CIDP: requires diagnostic confirmation via electrodiagnostic testing and phenotypic classification per EFNS/PNS; for non–pure motor CIDP, require failure of at least one corticosteroid trial unless contraindicated.
CIDP-specific product approvals (e.g., Panzyga) and dosing limits referenced in product sections.
Billing Rule
Updated Coding and State Bypasses
Updated coding and state bypasses: providers must use appropriate HCPCS/other codes (policy notes recent HCPCS additions such as J1552 for CA) and be aware of state-specific step-therapy prohibitions and the Illinois HIM HB 5395 bypass allowing redirection/bypass to preferred IVIG agent for HIM as of 1/1/2026. Coding misalignment or incorrect product coding may lead to redirection or denial.
HCPCS code updates included in policy (e.g., J1552 added for California-specific allowances).
Illinois HIM HB 5395: step therapy bypass applies to HIM requests (effective 1/1/2026) — step requirements do not apply for IL HIM in specified sections.
Appendix G lists states with regulations prohibiting step therapy/redirection for certain oncology settings (FL, GA, IA, LA, MS, NV, OH, OK, PA, TN, TX, etc.).
Requests exceeding stated dose limits or not meeting product-preference/step-therapy requirements may be denied. Common denial triggers include doses above the listed per-indication maximums, lack of required diagnostic confirmation, missing specialty prescriber or consultation, failure to document prior trials of preferred products (e.g., Gammagard, Gamunex-C), and insufficient weight-based dosing justification for adults.
Denial triggers: dose > indication-specific maximum (see per-diagnosis sections), missing documentation of IBW/adjBW use when applicable, absence of required trial of preferred products.
Product-preference/step-therapy denials possible if failure of Gammagard and Gamunex-C (or health plan-preferred agent) not documented and no applicable bypass.
Requests with coding/product misalignment may be redirected or denied.
Documentation Required
Required Documentation
Required documentation: providers must submit office notes, specialty consultation notes, lab results (including serum IgG trough levels per Appendix E), electrodiagnostic testing for CIDP when required, documentation of prior therapies/trials (including corticosteroid trial for CIDP when applicable), and references supporting off-label dosing when used.
Office chart notes and clinical progress documentation.
Labs: serum IgG trough measurements (baseline and monitoring), antibody response testing when relevant.
Electrodiagnostic testing for CIDP confirmation and documentation of prior corticosteroid or alternative immunosuppressant trials where required.
Supporting literature or guideline citations for off-label dosing or non-standard regimens.
Documentation Required
Dose Calculation and Switch Justification
Dose calculation and switch justification: when a requested dose increases or a product switch is requested, providers must document the weight-based dose calculation (TBW, IBW, or adjBW as appropriate) and clinical rationale (e.g., inadequate response, adverse event, product shortage). For adults, document when IBW/adjBW could not be used and why.
Document TBW/IBW/adjBW calculation per Appendix F for any dosing changes or increases.
Provide clinical justification for product switches (e.g., adverse reaction, inefficacy, shortage) and supporting evidence for non-standard dosing.
Failure to document proper dose calculation methodology on reauthorization requests may risk denial.
Step Therapy
Step Therapy and Preferred Products
Step therapy and product preference: the policy generally prefers trial of Gammagard and Gamunex-C (or a health plan–preferred immune globulin product) prior to authorization of alternative IG products. Exceptions and bypasses apply per state regulations (Appendix G) and Illinois HIM HB 5395. If preferred agents are unavailable due to shortage or contraindication, alternate permitted products (e.g., Gammaked) may be authorized with documentation.
Typical requirement: failure of Gammagard and Gamunex-C (or health plan-preferred product) documented before approving alternatives.
Requests preferentially for Gammagard or Gamunex-C unless a specific health plan-preferred product is identified.
Illinois HIM HB 5395: IL HIM bypass of step therapy for certain requests effective 1/1/2026. Appendix G oncology bypasses apply per state.
Note
Product Preference / Therapeutic Alternatives
Product preference, therapeutic alternatives and sequencing: immune globulin products are generally interchangeable and the health plan may prefer clinically appropriate alternatives at the time of request. Consideration should be given to alternative therapies (e.g., plasmapheresis) where evidence supports use. Appendix B lists therapeutic alternatives and may guide sequencing choices.
Health plan discretion to prefer a clinically appropriate alternative product; members on preferred product may continue therapy.
Therapy alternatives such as plasmapheresis/PE or immunoabsorption may be appropriate for certain neuromuscular disorders (e.g., GBS).
Appendix B contains listed therapeutic alternatives and dosing regimens.
Note
Prescribing Information and Evidence References
References and evidence: policy citations include prescribing information for multiple IVIG products (see Appendix VI references), systematic reviews, and specialty society guidelines that support step-therapy and indication-specific criteria. Providers should reference these when submitting requests, especially for off-label or non-standard dosing.
Product prescribing information cited for each IVIG product (see References/Appendix VI).
Systematic reviews and guideline documents referenced (NCCN, EFNS/PNS, EAN/PNS, specialty society guidance).
Use cited guideline evidence when supporting off-label dosing or indication requests.
Step Therapy
Illinois Step Therapy Bypass and State Redirections
Illinois step therapy bypass: per IL HB 5395, step therapy requirements do not apply for Illinois HIM requests as of 1/1/2026 in sections that include redirection to preferred IVIG agents. Providers should document state and line-of-business when seeking bypass; other state-specific prohibitions (Appendix G) may also allow redirection bypass for oncology-associated uses.
IL HIM HB 5395 permits bypass of step therapy/redirection for HIM requests in Illinois effective 1/1/2026.
Appendix G lists other states and the scope of step therapy prohibitions (see policy for state-specific notes).
When requesting bypass, include documentation of state, line of business, and applicable clinical rationale.
DefinitionHealth plan‑preferred immune globulin product: a clinically appropriate alternative product that the health plan may prefer at the time of request; preferences can change and products are generally considered interchangeable
ImplicationRequests should be for Gammagard or Gamunex‑C unless a specific plan‑preferred product is documented
Exception rulesFailure/intolerance/shortage exceptions permit alternative products (e.g., Gammaked) as specified
inv-114: Hypogammaglobulinemia — documented by two IgG measurements
Laboratory documentationHypogammaglobulinemia documented by two separate IgG measurements within the specified timeframe (commonly within the last 6 months)
Thresholds vary by indicationFor some indications, policy specifies IgG <400 mg/dL; other PI indications use age‑adjusted reference ranges (see Appendix E)
Clinical correlation requiredDocument recurrent serious bacterial infections or inadequate vaccine responses as applicable
inv-115: Primary immunodeficiency (PI) — examples included
Included examplesPrimary immunodeficiency includes agammaglobulinemia, CVID, congenital hypogammaglobulinemia, hyper‑IgM syndromes, SCID, selective immunodeficiencies, and IgG subclass deficiencies
Diagnostic requirementsDiagnosis requires specified laboratory evidence and clinical history; impaired vaccine response required for CVID diagnosis
Prescriber specialtyPrescribed by or in consultation with an immunologist or hematologist per policy requirements
inv-116: adjBW, TBW, IBW definitions — Appendix F reference
IBW formula (male)IBW (male) = 50 kg + 2.3 kg per inch over 5 ft
IBW formula (female)IBW (female) = 45.5 kg + 2.3 kg per inch over 5 ft
AdjBW formulaAdjBW = IBW + 0.4 × (TBW − IBW); see Appendix F for calculations and online calculators
inv-117: Contraindication - IgA deficiency with anti-IgA
Contraindication summaryIgA‑deficient patients with anti‑IgA antibodies and a history of hypersensitivity are contraindicated for human immune globulin
Severe reaction historyHistory of anaphylactic or severe systemic reactions to human immune globulin is a contraindication
Boxed warningsPolicy notes boxed warnings including thrombosis and renal dysfunction for IG products
inv-118: ITP classification
Acute vs chronic ITPAcute ITP: duration ≤6 months; Chronic ITP: duration >12 months; also defines newly diagnosed (≤3 months) and persistent (3–12 months)
Response timingEarly response at 1 week, initial response at 1 month, durable response at 6 months per International Working Group/ASH
Use of IVIGSingle IVIG dose is first‑line for acute ITP; second dose may be given if necessary
inv-119: GBS/AIDP definitions and clinical features
GBS/AIDP definitionGBS and subtypes (AIDP, AMAN, AMSAN, Miller Fisher) are acute polyneuropathies often with elevated CSF protein and normal CSF WBC; IVIG initiation within 2 weeks is effective
Typical courseGBS typically progresses over ~2 weeks with nadir by 4 weeks
Therapy comparisonIVIG is as effective as plasma exchange; combination therapy offers no added benefit
inv-120: CVID — diagnostic criteria summary
CVID diagnostic elementsCVID characterized by low serum IgG (≥2 SDs below mean) and impaired antibody responses to protein and polysaccharide antigens; diagnosis requires poor vaccine response
IgG monitoringFor lifelong treatment, measure trough IgG pre‑infusion and monitor every 3 months to maintain low‑normal levels (~400–600 mg/dL)
Clinical correlationSerum immunoglobulin alone does not establish CVID; impaired vaccine response required
inv-121: IBW calculation formulas (male/female)
IBW male formulaMale IBW = 50 kg + (2.3 × inches over 5 ft)
IBW female formulaFemale IBW = 45.5 kg + (2.3 × inches over 5 ft)
Use contextIBW used as part of dosing calculation guidance; see Appendix F for examples and calculators
inv-122: AdjBW formula (IBW + 0.4 x (TBW - IBW))
AdjBW formulaAdjBW = IBW + 0.4 × (TBW − IBW)
When to useRecommended for obese members (BMI ≥30 kg/m2 or TBW >20–30% above IBW)
Appendix referenceAppendix F provides calculations and links to online calculators
inv-123: CIDP and related neuropathies — guideline sources referenced
Guideline sourcesCIDP and related neuropathies referenced EFNS/PNS, EAN/PNS and other systematic reviews informing diagnosis and treatment
PurposeGuidelines used to align diagnostic criteria and authorization requirements (including CIDP variants)
Policy impactPolicy diagnostic language revised to align with 2021 EAN/PNS CIDP guideline terminology (CIDP variants)
inv-124: HCPCS/J‑code entries
HCPCS/J code seriesPolicy references J1459, J1551–J1599 series for immune globulin billing descriptors
Coding noteInclusion of codes in policy is informational; billing must follow payer coding rules
inv-125: Updated terminology — CIDP variants
Terminology update'CIDP variants' replaces prior 'atypical CIDP' to align with 2021 EAN/PNS guidelines
Policy effectDiagnostic and authorization language updated accordingly
Reference pointSee CIDP guideline citations in policy appendices for variant‑specific criteria
2025-05-15clinical_criteria_revised
Aligned CIDP diagnostic language with 2021 EAN/PNS guidelines (renaming 'atypical CIDP' to 'CIDP variants') and separated CIDP criteria from AIDP/GBS, adding a corticosteroid trial requirement for CIDP where applicable.
2025-05-15oncology_bypass_added
Added oncology-related bypasses allowing MM infection-prophylaxis redirection after BCMA-targeted CAR T-cell or bispecific antibody therapy per NCCN guidance.
2025-07-09product_formulation_added
Added Gammagard liquid ERC formulation and included Gamunex as an alternative preferred agent per SDC.
2025-09-19operational_clarification
Clarified reauthorization and dose-calculation documentation requirements (IBW/adjBW rules for adults) and added continuation language to allow members to remain on current Gammagard or Gamunex unless medical justification supports a switch.
2025-09-19state_step_therapy_bypass_added
Added Illinois step therapy bypass per IL HB 5395 permitting redirection to a preferred IVIG agent and bypass for non-formulary agents for HIM as of 1/1/2026.
2025-09-19product_added
Added Alyglo and Panzyga references in coding and identified Panzyga (J1577) in HCPCS listings; also referenced Panzyga as a newly approved CIDP product.
2025-09-19product_added
Added Panzyga, Alyglo, and other product listings (including Panzyga/Panzyga J1577 and Alyglo J1552 descriptors) to the policy coding and product tables.
2025-09-19product_addedLatest
Added Panzyga, Alyglo, and Yimmugo product references and updated product availability and substitution rules.
CIDP authorization criteria were revised to align with the 2021 EAN/PNS guidance and to clarify the applicability of a corticosteroid trial: a corticosteroid trial is required prior to IVIG for CIDP except when the presentation is pure motor. Operational updates also expanded the coding table to include new HCPCS/J codes and product listings, and added recently approved products to the policy's coding entries.
The policy’s coding section was expanded to include additional HCPCS/J codes and product listings. Newly added entries include codes such as J1552 (Alyglo) and other J‑codes enumerated in the coding implications, and product additions (for example, Yimmugo) are documented in the coding updates.
State‑specific updates and operational changes were incorporated: HCPCS J1552 was added to enable a California PANDAS bypass, and Illinois HIM step‑therapy bypasses (per IL HB 5395) were added to permit redirection or bypass in certain settings. The policy also added alternative preferred formulations (e.g., Gammagard liquid ERC) and clarified continuity/redirect rules for continued therapy.