Health Net Immune Globulins Coverage Update | OpenPayer
ModifiedHealth NetPolicy CP.PHAR.103
Immune Globulins
This policy governs prior authorization, medical necessity criteria, dosing limits, and coverage duration for multiple immune globulin products for commercial and Medicaid members of Health Net/Centene-affiliated plans in North Carolina.
Policy Summary
PayerHealth Net
PolicyImmune Globulins
Policy CodePolicy CP.PHAR.103
Change TypeMaterial coverage and criteria updates
Effective DateAug 12, 2022
Next Review DateN/A
Key ActionPrior authorization is required for the listed immune globulin products; providers must submit supporting clinical documentation with requests.
Revised requirement for trial of corticosteroid before immune globulin to apply only to CIDP (no longer to GBS/AIDP) and only when the member does not have CIDP with pure motor symptoms.
Added HCPCS codes including J1551, J1553, J1554, J1558, J1560, J1577 and others at various reviews.
Added off-label measles post-exposure prophylaxis criteria for IVIG.
For continued therapy, added language to allow member to continue use of Gammagard or Gamunex (or health plan-preferred immune globulin product) unless medical justification supports a product switch.
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.
Dermatomyositis dose limit
~40+explicitly listed non-covered diagnoses
Gammagard, Gamunex-Cpreferred products referenced
Coverage Criteria and Indication-Specific Rules
Initial Therapy — CLL/SLL infection prophylaxis
Covered when ALL of the following are met:
CLL/SLL infection prophylaxis: 1. Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); 2. Prescribed by or in consultation with a hematologist, oncologist, or immunologist; 3. Current (within the last 6 months) hypogammaglobulinemia documented by two separate IgG measurements <500 mg/dL; 4. Recurrent serious bacterial infections within the past 12 months (e.g., requiring IV antibiotics, hospitalization, or infectious disease consultation); 5. Member meets one of the product-preference/step options: a) request is for treatment associated with cancer in a State with oncology step-therapy restrictions (Appendix G), b) request is for Gammagard or Gamunex-C unless there is a specific health plan–preferred product, c) failure of Gammagard and Gamunex-C (or plan-preferred product), d) intolerance/contraindication to Gammagard and Gamunex-C (or plan-preferred) or those products unavailable due to shortage then use Gammaked unless contraindicated, e) Gammagard/Gamunex-C/Gammaked all unavailable due to shortage and request is for another IG product; 6. Dosing meets one of: a) does not exceed 400 mg/kg IV every 3–4 weeks, or b) dosing is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).IgG <500 mg/dL
Weight-based dosing: use TBW or IBW, whichever is less; use adjusted body weight for obese members per Appendix F.
Approval duration: Medicaid 6 months; Commercial 6 months or to the member's renewal date, whichever is longer.
Initial Therapy — CAR T-cell related toxicities
Covered when ALL of the following are met (select per scenario):
Indication selection: One of the following: a) management of Grade 4 cytokine release syndrome (CRS); b) secondary hypogammaglobulinemia for infection prophylaxis after anti-CD19 CAR T‑cell therapy; c) acute inflammatory demyelinating polyneuropathy (AIDP)-type presentation or bilateral facial palsy following CAR T‑cell therapy.
General prescriber requirement: Prescribed by or in consultation with a hematologist, oncologist, or immunologist.
CRS specifics: For management of CRS: failure of both high‑dose systemic corticosteroids and anti‑IL‑6 therapy is required unless clinically adverse effects or contraindications exist (see Appendix B).
If approved for CRS, duration typically one month.
Secondary hypogammaglobulinemia specifics: For infection prophylaxis following anti‑CD19 CAR T‑cell therapy: a) member received anti‑CD19 CAR T‑cell therapy; b) two separate IgG measurements <600 mg/dL within the last 6 months; c) recurrent serious bacterial infections within the past 12 months.
Initial Therapy — Dermatomyositis/Polymyositis
Covered when ALL of the following are met:
Diagnosis and prescriber: 1. Diagnosis of dermatomyositis (DM) or polymyositis (PM); 2. Prescribed by or in consultation with a dermatologist, rheumatologist, neurologist, or neuromuscular specialist.
Prior therapy requirements: Failure of a 4‑month trial of systemic corticosteroid (e.g., prednisone) in combination with one immunosuppressive agent at maximally indicated doses unless contraindicated or intolerant; for dermatomyositis only, failure of rituximab trial unless contraindicated or juvenile dermatomyositis (prior authorization for rituximab may be required).
IVIG may be considered earlier for profound, rapidly progressive, or life‑threatening weakness per CARRA guidance (see Appendix D).
Product preference/step: Member meets one of: a) Octagam request for DM per product‑specific allowance; b) request for Gammagard or Gamunex‑C unless plan‑preferred product; c) failure of Gammagard and Gamunex‑C; d) intolerance/contraindication or shortage pathway to Gammaked; e) all three unavailable due to shortage and request is for another IG product.
General dosing limit
Requests must meet one of the following dosing conditions:
General dosing: a. Dose does not exceed 2 g per kg IV per month; b. Dose is supported by practice guidelines or peer‑reviewed literature for the relevant indication (prescriber must submit supporting evidence).2 g/kg/month
Weight calculation per Appendix F (TBW or IBW whichever is less; adjBW for obesity).
Fetal/Neonatal Alloimmune Thrombocytopenia (FNAIT) — must meet all
Covered when ALL of the following are met:
FNAIT criteria: 1. Diagnosis of fetal/neonatal alloimmune thrombocytopenia (FNAIT); 2. Prescribed by or in consultation with a hematologist, immunologist, perinatologist, or neonatologist; 3. One of: a) previous pregnancy affected by FNAIT; b) serologic confirmation of maternal‑fetal HPA incompatibility; c) nadir platelet <100 x10^9/L at birth or within 7 days; d) fetal intracranial hemorrhage.
Prescriber must provide supporting evidence for off‑label use.
Inflammatory Demyelinating Polyneuropathy (AIDP/GBS or CIDP) — must meet all
Covered when ALL of the following are met:
Diagnosis & prescriber: 1. Diagnosis of acute inflammatory demyelinating polyneuropathy (AIDP/Guillain‑Barré syndrome) or chronic inflammatory demyelinating polyneuropathy (CIDP); 2. Prescribed by or in consultation with a neurologist or neuromuscular specialist; 3. Meets clinical criteria per subtype: for AIDP/GBS one of severe functional/respiratory/autonomic features (e.g., inability to stand/walk 30 feet unaided, ICU admission for aspiration/ventilation, Miller‑Fisher syndrome, inability to raise head against gravity, severe bulbar palsy, bilateral facial weakness, autonomic dysfunction); for CIDP progressive/relapsing ≥2 months and either typical CIDP signs (symmetric proximal/distal weakness and sensory involvement in ≥2 limbs with reduced/absent reflexes) or a CIDP variant with electrodiagnostic confirmation and exclusion of alternative causes; for non‑pure motor CIDP, failure of at least one corticosteroid at maximally indicated doses unless contraindicated.
See electrodiagnostic confirmation and exclusion criteria including Lyme, diphtheria, hereditary neuropathy, IgM anti‑MAG, POEMS, etc.
Product selection: Request must meet product preference/step options: a) Gammagard or Gamunex‑C preferred unless plan‑preferred product; b) failure of those products; c) intolerance/contraindication or shortage — use Gammaked; d) if all unavailable due to shortage, other IG products permitted.
Idiopathic Thrombocytopenic Purpura (ITP) — Acute or Chronic — must meet all
Covered when ALL of the following are met:
Diagnosis & prescriber: 1. Diagnosis of acute or chronic immune thrombocytopenic purpura (ITP); 2. Prescribed by or in consultation with a hematologist; 3. Either a) failure of systemic corticosteroids or Rho(D) immune globulin (RhIG) at maximally indicated doses unless contraindicated (prior authorization required for RhIG), or b) pregnant.
Clinical severity: Member meets one of: a) platelet count <30,000/µL within last 30 days; b) actively bleeding; c) high risk of life‑threatening hemorrhage; d) splenectomy scheduled; e) pregnant.platelets <30,000/µL
Product selection: Product preference/step rules apply (Gammagard/Gamunex‑C preferred; failure/intolerance/shortage pathways to Gammaked or other products).
Dosing options:
Kawasaki syndrome — aneurysm prevention — must meet all
Covered when ALL of the following are met:
Diagnosis & co-therapy: 1. Diagnosis of Kawasaki syndrome or incomplete (atypical) Kawasaki disease; 2. Prescribed by or in consultation with a cardiologist, allergist/immunologist, infectious disease specialist, or rheumatologist; 3. Prescribed concurrently with aspirin unless contraindicated; 4. Product preference/step options met.
Dosing meets one: a) ≤1 g/kg IV single infusion; b) 400 mg/kg IV daily for 4 consecutive days; c) ≤2 g/kg IV single infusion; d) dosing supported by guidelines or literature (prescriber must submit evidence).1–2 g/kg or 400 mg/kg x4 days
Approval duration: one‑time (1 month).
Kidney transplant (off-label) — must meet all
Covered when ALL of the following are met:
Indication specifics: 1. If prescribed prior to kidney transplant: member is highly sensitized with high anti‑donor antibodies (HLA/ABO incompatibility); or if prescribed after transplant: used for antibody‑mediated rejection; 2. Prescribed by or in consultation with a nephrologist, transplant specialist, or hematologist.
Product selection and dosing: 3. Member meets product‑preference/step options; 4. Dose does not exceed 140 g IV per infusion OR dosing is supported by practice guidelines or peer‑reviewed literature (prescriber must submit evidence).140 g per infusion
Weight calculation guidance applies (Appendix F).
Multifocal Motor Neuropathy (MMN) — must meet all
Covered when ALL of the following are met:
Diagnosis & prescriber: 1. Diagnosis of multifocal motor neuropathy (MMN); 2. Prescribed by or in consultation with a neurologist or neuromuscular specialist; 3. Product preference/step rules met (Gammagard/Gamunex‑C preferred with failure/intolerance/shortage pathways).
Dosing: 4. Dose does not exceed 2.4 g/kg IV per month OR dosing is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).2.4 g/kg/month
Weight calculation per Appendix F (use TBW or IBW whichever is less; adjBW for obesity).
Multifocal Motor Neuropathy (MMN) — Initial/Continuing
Covered when ALL of the following are met
MMN criteria set: 1. Diagnosis of MMN; 2. Prescribed by or in consultation with a neurologist or neuromuscular specialist; 3. Product preference/step rules (a–d) apply; 4. Dose does not exceed 2.4 g/kg IV per month OR dose supported by guidelines/literature (prescriber must submit evidence). Adults: calculate dosing using TBW or IBW whichever is less; use adjusted body weight for obese members.
Product preference/step options (one required): a. Request is for Gammagard or Gamunex‑C unless there is a specific health plan‑preferred product; b. Failure of Gammagard and Gamunex‑C (or plan‑preferred product); c. Intolerance/contraindication to Gammagard and Gamunex‑C (or plan‑preferred) or shortage — use Gammaked unless contraindicated; d. If Gammagard/Gamunex‑C/Gammaked all unavailable due to shortage, request for another IG product permitted.
MM infection prophylaxis core criteria: 1. Diagnosis of multiple myeloma; 2. Prescribed by or in consultation with a hematologist, oncologist, or immunologist; 3. Either a) hypogammaglobulinemia within last 6 months evidenced by two IgG <400 mg/dL after BCMA‑targeted CAR T‑cell or bispecific antibody therapy, or b) IgG <400 mg/dL (two measurements within 6 months) AND recurrent serious bacterial infections within past 12 months; 4. Product preference/step rules met; 5. Dose does not exceed 400 mg/kg IV every 3 weeks OR dosing supported by guidelines/literature (prescriber must submit evidence).IgG <400 mg/dL
Weight calculation per Appendix F.
Multiple Sclerosis (off-label)
Covered when ALL of the following are met
MS criteria: 1. Diagnosis of relapsing‑remitting multiple sclerosis (MS); 2. Prescribed by or in consultation with a neurologist; 3. Failure of three FDA‑approved disease‑modifying MS therapies at maximally indicated doses unless contraindicated or intolerable; 4. Product preference/step rules met; 5. Dose option: initial 400 mg/kg/day IV x5 followed by 1 g/kg IV monthly OR dosing supported by guidelines/peer‑reviewed literature (prescriber must submit evidence).
Prior authorization is required for MS therapies (Appendix B referenced).
MG/LEMS core 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. One of: a) acute crisis (e.g., vital capacity <1 L/min, inability to walk 100 ft unaided, intubation, dysphagia with aspiration, mechanical ventilation), b) scheduled thymectomy, c) failure of amifampridine (for LEMS) or cholinesterase inhibitor (for MG), systemic corticosteroid, and an immunosuppressant at maximally indicated doses unless contraindicated; 4. Product preference/step rules met; 5. Dose does not exceed 2 g/kg IV divided over 2–5 consecutive days per treatment course OR dosing supported by guidelines/literature (prescriber must submit evidence).
Prior authorization may be required for amifampridine.
Paraneoplastic Neurological Syndrome (off-label)
Covered when ALL of the following are met
Paraneoplastic neurologic criteria: 1. Diagnosis of opsoclonus‑myoclonus syndrome (OMS) or 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 preference/step rules met; 5. Dose meets one of: ≤2 g/kg IV per month, ≤0.4 g/kg IV per day, ≤200 mg/kg SC per week, OR dosing supported by guidelines/peer‑reviewed literature (prescriber must submit evidence).
Parvovirus B19 Infection and Anemia (off-label)
Covered when ALL of the following are met
Parvovirus B19 anemia criteria: 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 last 30 days) severe anemia (Hgb <10 g/dL or Hct <30%) due to bone marrow suppression; 4. Product preference/step rules met; 5. Dose does not exceed an initial 2 g/kg/day for up to 5 days followed by maintenance 400 mg/kg IV every 4 weeks OR dosing supported by guidelines/peer‑reviewed literature (prescriber must submit evidence).Hgb <10 g/dL or Hct <30%
Prophylaxis of Serious Bacterial Infection in HIV-infected Child
Covered when ALL of the following are met
Pediatric HIV prophylaxis criteria: 1. Prescribed for prophylaxis of serious bacterial infection in a child with HIV; 2. Prescribed by or in consultation with an HIV or infectious disease specialist; 3. Current (within last 6 months) hypogammaglobulinemia documented by two serum IgG <400 mg/dL; 4. One of: recurrent serious bacterial infections (≥2 in 12 months), inadequate antibody response to protein/polysaccharide antigens, lives in measles‑endemic area and failed to develop antibody after two MMR doses, exposure to measles (single dose), or chronic bronchiectasis suboptimally responsive to therapy; 5. Product preference/step rules met; 6. Dose does not exceed 400 mg/kg IV every 2–4 weeks OR dosing supported by guidelines/literature (prescriber must submit evidence).IgG <400 mg/dL
Approval duration: Medicaid 6 months; Commercial 6 months or to member renewal date.
Pemphigus and Pemphigoid Spectrum Disorders (off-label)
Covered when ALL of the following are met
Pemphigus/pemphigoid 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 maximally indicated doses unless contraindicated; 4. Failure of at least one immunosuppressive agent at maximally indicated doses unless contraindicated; 5. Failure of rituximab unless contraindicated; 6. Product preference/step rules met (Gammagard/Gamunex‑C preferred unless plan‑preferred or exceptions apply).
Prior authorization is required for rituximab.
Pemphigus and related disorders
Covered when ALL of the following are met
Pemphigus/bullous disease 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 ≥1 corticosteroid at maximally indicated doses unless contraindicated; 4. Failure of ≥1 immunosuppressive agent at maximally indicated doses unless contraindicated; 5. Failure of rituximab unless contraindicated; 6. Product preference/step criteria met (Gammagard or Gamunex‑C preferred unless plan‑preferred or exceptions apply); 7. Dose limits met (e.g., ≤2 g/kg IV every 4 weeks OR ≤400 mg/kg/day IV x5, etc.) OR dosing supported by guidelines (prescriber must submit evidence).
IVIG for pemphigus should be used short‑term; treatment considered complete when disease free after a 16‑week interval between last two infusion cycles.
Primary immunodeficiencies
Covered when ALL of the following are met
Primary immunodeficiency criteria: 1. Diagnosis of a primary immunodeficiency (PI) such as agammaglobulinemia, CVID, congenital hypogammaglobulinemia, Hyper‑IgM syndromes, selective subclass deficiency, SCID, subclass deficiency, or functional/specific antibody deficiency; 2. Prescribed by or in consultation with an immunologist or hematologist; 3. For functional/specific antibody deficiency: normal immunoglobulin levels with inadequate antibody response to polysaccharide antigens and recurrent serious bacterial infections within past 12 months; for other PIs: two separate low immunoglobulin measurements within 6 months plus qualifying features (e.g., ADA‑SCID with failure of Revcovi or HSCT, SCID, recurrent serious bacterial infections, or inadequate antibody response); 4. Product preference/step criteria met (Gammagard or Gamunex‑C preferred with exceptions); 5. Dosing limits met (examples: IV ≤800 mg/kg every 3–4 weeks; SC ≤600 mg/kg every 3–4 weeks; SC conversion as specified).
For ADA‑SCID, failure of Revcovi or HSCT required prior to IVIG; prior authorization required for Revcovi.
Stiff person syndrome
Covered when ALL of the following are met
Stiff person syndrome criteria: 1. Diagnosis of stiff person syndrome (Moersch‑Woltmann); 2. Prescribed by or in consultation with a neurologist or neuromuscular specialist; 3. Failure of a benzodiazepine (e.g., diazepam) or baclofen at maximally indicated doses unless contraindicated; 4. Product preference/step criteria met; 5. Dose does not exceed 2 g/kg IV divided over 2–5 days per treatment course OR dosing supported by guidelines/literature (prescriber must submit evidence).
Measles post-exposure prophylaxis
Covered when ALL of the following are met
Measles PEP criteria: 1. Exposure to measles within the past 6 days; 2. Pregnancy without evidence of measles immunity OR immunocompromised; 3. Product preference/step rules met (Gammagard or Gamunex‑C preferred unless exceptions); 4. Dose does not exceed single 400 mg/kg IV OR dosing supported by guidelines/peer‑reviewed literature (prescriber must submit evidence).
Approval duration: one‑time (1 month).
GamaSTAN/GamaSTAN S/D viral prophylaxis
Covered when ALL of the following are met
GamaSTAN IM indications: 1. Request is for intramuscular formulation (GamaSTAN or GamaSTAN S/D); 2. Indication is one of: Hepatitis A post‑exposure/high‑risk prophylaxis when vaccine unavailable/contraindicated and meets exposure/travel and risk criteria, measles post‑exposure with exposure within 6 days and meeting additional criteria, varicella post‑exposure with exposure within 10 days and meeting high‑risk conditions and Varizig unavailable, or rubella post‑exposure in pregnant women; 3. Dosing limits by indication met (e.g., Hep A 0.1–0.2 mL/kg IM once or repeated per exposure duration; Measles 15 mL IM once; Varicella 1.2 mL/kg IM once; Rubella 0.55 mL/kg IM once).
Weight calculation per Appendix F.
NCCN compendium indications
Covered when ALL of the following are met
NCCN compendium indications: 1. Diagnosis of an NCCN‑listed condition such as immune checkpoint inhibitor‑related toxicities, LCH‑associated CNS neurodegeneration, refractory/autoimmune HIT or high‑bleeding‑risk HIT, or pediatric ALL with specified prior/ongoing therapies; 2. For LACI/ND, used in combination with cytarabine; 3. For pediatric ALL, member has received specified agents and current hypogammaglobulinemia (two IgG <400 mg/dL within 6 months); 4. Product preference/step rules met; 5. Dose is within FDA maximum for any FDA indication or supported by practice guidelines/NCCN (prescribed regimen must be FDA‑approved or NCCN‑recommended).
Approval duration: 6 months.
Other/unspecified indications
Covered when ALL of the following are met
Other indications criteria: 1. Member meets product‑preference/step criteria or cancer‑treatment state exceptions; 2. If recent label change within 6 months not reflected in policy, refer to formulary/no‑coverage/non‑formulary policies as directed; 3. If requested use not listed in Section III and criterion 2 does not apply, refer to off‑label use policy for line of business (CP.CPA.09 or CP.PMN.53).
Contains product‑preference and shortage rules.
Other diagnoses/indications — product and shortage rules
Other diagnoses/indications (must meet 1 and 2)
Other indications primary requirements: 1. One of: a) request is for treatment associated with cancer in a State with oncology step‑therapy restrictions (Appendix G); b) request is for Gammagard or Gamunex‑C unless plan‑preferred product; c) failure of Gammagard and Gamunex‑C (or plan‑preferred product); d) intolerance/contraindication to Gammagard and Gamunex‑C (or plan‑preferred) or shortage — then use Gammaked unless contraindicated; e) all three (Gammagard, Gamunex‑C, Gammaked) unavailable due to shortage and request is for a different IG product; 2. Note: immune globulin products are generally interchangeable and plan may prefer an alternative.
Contains product preference and shortage rules.
Continued therapy — specific and general rules
Covered when ALL of the following are met
Continued therapy pathways: A. Kawasaki syndrome/viral prophylaxis: re‑authorization not permitted — members must meet initial approval criteria. B. CAR T‑cell related toxicities: for CRS or AIDP‑type presentations or facial palsy re‑authorization not permitted; for secondary hypogammaglobulinemia see All Other Indications. C. All Other Indications: member must meet listed items including current enrollment/previous approval or continuity‑of‑care regulations, positive clinical response to therapy, continued use of Gammagard or Gamunex‑C (or plan‑preferred product) unless medical justification for switch, dose increase provisions, and adult weight‑based dosing rules.
Continued therapy approvals typically 6 months; see state exceptions and Appendix F for dosing calculations.
Dose increase and adult weight-based dosing
Dose increase and dosing calculation rules
Dose increase requirements: If request is for a dose increase due to inadequate response, one of the following must be met: a) dose titration/conversion appropriate per package insert labeling; b) new dose is supported by practice guidelines or peer‑reviewed literature with prescriber‑submitted evidence. For adults (except PI or cancer‑related infection prophylaxis): dosing calculated using the lesser of TBW or IBW; for obese members use adjusted body weight unless the newly calculated dose is lower than the currently administered dose. Refer to Appendix F for calculations.
Prescriber must document weight‑method used and provide justification for increases.
IVIG in dermatomyositis (DM)
IVIG for dermatomyositis and related inflammatory myopathies
Dermatomyositis IVIG criteria: IVIG may be medically necessary after less than a 4‑month trial of prednisone or prednisone combination therapies if the patient has profound, rapidly progressive, and/or potentially life‑threatening muscular weakness and is refractory to or intolerant of previous therapy; failure or significant adverse effects to continual high‑dose steroids plus other immunosuppressive agents is defined as lack of response (persistently elevated CK or no improvement in muscle strength) or intolerance (steroid myopathy, severe osteoporosis).
CARRA and AAD guideline references cited in Appendix D.
ITP (acute and response definitions)
IVIG for immune thrombocytopenia (ITP)
Acute ITP initial therapy: Single dose of IVIG is used as first‑line treatment for acute ITP in adults; a second dose may be given if necessary. Response definitions follow ASH and International Working Group guidance (early, initial, durable responses and platelet thresholds).
Platelet counts should be confirmed on separate occasions per consensus guidance.
AIDP/GBS
IVIG for Guillain-Barré Syndrome (GBS)/AIDP
GBS IVIG timing: Initiation of IVIG within 2 weeks of symptom onset is effective and comparable to plasma exchange; combining IVIG with plasmapheresis or IV methylprednisolone has not shown additional benefit. Monitor pulmonary function risk factors for respiratory compromise.within 2 weeks of symptom onset
CIDP first-line options: IVIG, corticosteroids, and plasma exchange are recommended treatments for disabling CIDP; plasma exchange typically reserved for refractory patients. Diagnostic criteria align with 2021 EAN/PNS CIDP guideline for variants. Loading and maintenance dosing per product labeling (e.g., 2 g/kg loading then 1 g/kg maintenance every 3 weeks for some products).
Corticosteroid trial requirement applies only to CIDP when member does not have pure motor CIDP (policy revision).
Immune checkpoint toxicities and Kawasaki disease
Immune checkpoint inhibitor-related toxicities and Kawasaki disease
Checkpoint inhibitor toxicities: NCCN lists severe immune‑related toxicities (e.g., myocarditis, severe bullous dermatitis, G3‑4 myasthenia gravis, GBS, encephalitis) where IVIG may be used as part of management depending on severity and in combination with high‑dose methylprednisolone where specified. Document severity grade and corticosteroid response.G2‑G4 or life‑threatening per NCCN
Kawasaki disease retreatment: Retreatment with IVIG 2 g/kg is recommended for persistent or recrudescent fever ≥36 hours after completion of the initial IVIG infusion.≥36 hours post‑infusion
Dose rationale referenced in policy.
NAIT and Primary Immunodeficiency
Pregnancy-related and primary immunodeficiency (PI) uses
NAIT maternal IVIG: Administering IVIG to the mother during pregnancy (weekly 1 g/kg starting at 20–24 weeks, earlier in very high‑risk pregnancies) is standard to increase fetal platelet count in alloimmune thrombocytopenia; consider starting at 12–14 weeks if prior intracranial hemorrhage. Optimal protocol after initiation lacks consensus.start 20–24 weeks; consider 12–14 weeks if prior ICH
Primary immunodeficiency replacement therapy: IVIG reserved for patients with serious defects of antibody function such as CVID with impaired vaccine response; diagnosis requires functional antibody testing and ongoing monitoring including trough IgG measurements (monitor troughs approximately every 3 months for lifelong therapy).IgG ≥2 SD below mean or impaired vaccine response
Dose and monitoring per product labeling.
Paraneoplastic syndromes and anti-NMDA encephalitis
Paraneoplastic and autoimmune encephalitis indications
Anti‑NMDA encephalitis: Concurrent IVIG (0.4 g/kg/day for 5 days) and methylprednisolone (1 g/day for 5 days) is preferred over plasma exchange; if no response after 10 days, start second‑line therapy. IVIG given with corticosteroids associated with improved recovery in many cases.0.4 g/kg/day x5 days
Early tumor treatment associated with better outcomes.
Paraneoplastic cerebellar degeneration: Combination of IVIG, cyclophosphamide, and methylprednisolone is not effective for paraneoplastic cerebellar degeneration with antineuronal antibodies; IVIG role is limited.
Myasthenia gravis
Myasthenia gravis (MG)
MG IVIG use: IVIG is used to rapidly reverse exacerbations of severe myasthenia gravis; high‑dose IVIG typically shows effect within a week lasting 3–6 weeks; not shown superior to plasmapheresis for life‑threatening MG. Evidence includes EFNS level A recommendation for acute exacerbations.
Covered when ALL of the following are met for PI replacement:
PI replacement criteria: 1. Diagnosis of a primary immunodeficiency (e.g., CVID, IgG subclass deficiency, specific antibody deficiency) supported by laboratory and clinical findings; 2. Serious defects of antibody function warranting immune globulin replacement; 3. Dosing and monitoring per product labeling with trough IgG monitoring approximately every 3 months for lifelong therapy; 4. Dose calculated using the lesser of TBW or IBW (use adjBW for obesity); 5. Product preference/step criteria met and dosing within listed ranges (e.g., IV 300–800 mg/kg every 3–4 weeks) or supported by guidelines (prescriber must submit evidence).
Document functional antibody testing and trough monitoring results.
Covered when ALL of the following are met for listed autoimmune/neurologic indications:
Autoimmune/neurologic indications: 1. Indication is one of the recognized diagnoses (examples include stiff person syndrome, pemphigus vulgaris for short‑term use, ITP, CIDP, Kawasaki syndrome, MMN); 2. Therapy consistent with product‑specific dosing regimens and durations (e.g., pemphigus short‑term only; treatment considered complete when disease‑free after 16‑week interval between last two infusion cycles); 3. Alternatives or prior therapies (corticosteroids, immunosuppressants, plasma exchange) have been considered per clinical context; 4. Product preference/step criteria met; 5. Dosing within product limits or supported by guidelines (prescriber must submit evidence).
See product dosing in sections V and Appendix F for weight calculations and route conversions.
Product-specific dosing and prophylaxis
Coverage and dosing follow product-specific regimens:
Product dosing examples: Branded immune globulin products have indication‑specific dosing (examples: IV or SC dosing ranges for PI 300–800 mg/kg IV every 3–4 weeks; ITP 1 g/kg IV QD x2 or 0.4 g/kg IV QD x5; CIDP loading 2 g/kg then maintenance 1 g/kg q3 weeks; SC conversion uses multiplier (e.g., 1.37) when appropriate).
Follow manufacturer ramp‑up when switching routes; document prior IV dose and conversion method.
Dosing and administration — covered when per product labeling and weight-based rules
Dosing regimens covered when administered per product-specific, indication-based schedules and using appropriate weight basis:
General dosing rules: Use total body weight (TBW) or ideal body weight (IBW), whichever is less; if member is obese, use adjusted body weight (adjBW) per Appendix F for mg/kg dosing calculations.
Document weight‑method used on prior authorization request.
ITP dosing: IVIG 1 g/kg IV once daily for 2 consecutive days OR 0.4 g/kg IV once daily for 5 consecutive days (product‑specific labeling consistent across multiple products).
Use TBW or IBW whichever is less; adjBW for obese members.
Primary immunodeficiency dosing: IV: initial 300–800 mg/kg IV every 3–4 weeks with maintenance adjusted by IgG trough and clinical response; SC: convert prior IV grams divided by number of weeks between IV doses and multiply by 1.37, administer weekly or prorate per product labeling.
Products include Hizentra, HyQvia, Panzyga, Privigen, Qivigy, Xembify, Yimmugo among others.
Evidence-supported indications (references only)
Supportive evidence and guideline citations for indications where IVIG/SCIG may be considered include:
Hematology: ITP: ASH and international consensus guidelines and practice parameters provide evidence for IVIG use in acute and chronic ITP.
See references in Appendix (chunks cited).
Pediatrics/Cardiac: Kawasaki disease: AHA and ACR/VF guideline citations support IVIG to reduce coronary artery abnormalities in acute phase.
Transplant: Kidney transplant desensitization and IVIG use in HLA‑sensitized recipients: transplant literature and KDIGO guidance cited; combination with rituximab considered investigational for desensitization context per policy.
Neurology: Multiple neurologic autoimmune conditions (MMN, MG, LEMS, paraneoplastic syndromes, stiff‑person syndrome): EFNS, consensus guidance, and trials cited supporting IVIG use in selected indications.
Policy criteria updates and notable coverage directions
Notable criteria-level changes and policy coverage directions recorded in these chunks:
Corticosteroid trial requirement for CIDP: Requirement for trial of corticosteroid before immune globulin now applies only to CIDP and no longer to GBS/AIDP; it applies only when the member does not have CIDP with pure motor symptoms.
Policy revision recorded in Coding Implications.
Off-label additions: Off‑label indications added including CAR‑T cell related toxicities (with AIDP‑type picture or bilateral facial palsy), immune checkpoint inhibitor‑related toxicities, LCH‑associated neurodegeneration, HIT, and pediatric ALL per NCCN; measles PEP for IVIG was also added.
Updates reflected in recent annual reviews and P&T notes.
Continued therapy product consistency: For continued therapy, members currently receiving Gammagard or Gamunex (or health plan‑preferred immune globulin product) may continue that product unless medical justification supports a product switch (e.g., adverse reaction, ineffectiveness).
Added in recent updates.
Limitation of use: Privigen maintenance therapy for CIDP has not been studied beyond 6 months. This limitation should be considered when authorizing ongoing maintenance therapy with Privigen for CIDP and when documenting duration of planned treatment.
Exclusion for demyelinating neuropathies with identified alternative causes: immune globulin is not indicated when neuropathy is attributable to identified causes such as Borrelia burgdorferi (Lyme disease), diphtheria, drug or toxin exposure likely to have caused the neuropathy, hereditary demyelinating neuropathy, or when other listed etiologies are present (e.g., IgM monoclonal gammopathy with high‑titre anti‑MAG antibodies, POEMS, osteosclerotic myeloma, diabetic and non‑diabetic lumbosacral radiculoplexus neuropathy). These alternate causes must be excluded before IVIG is considered under the CIDP criteria.
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Uses not listed in Section III and not addressed by this policy should be managed per existing off‑label or non‑formulary management policies: refer to CP.CPA.09 (Commercial), CP.PMN.53 (Medicaid), CP.CPA.190 (Commercial no‑coverage criteria) or CP.PMN.16/255 (Medicaid non‑formulary/no‑coverage) as applicable when a recent label change or an unlisted use applies.
The policy contains an extensive enumerated list of diagnoses for which immune globulin treatment is considered not medically necessary. Examples include (but are not limited to) critical illness myopathy (G7281), idiopathic progressive neuropathy (G603), iridocyclitis, unspecified (H209), orbital myositis, bilateral (H05123), and Clarkson disease (I788). Requests for these listed indications will generally be denied as not medically necessary unless otherwise specified by state‑level exceptions.
For paraneoplastic cerebellar degeneration associated with antineuronal antibodies, combination therapy with IVIG, cyclophosphamide, and methylprednisolone has been shown to be not effective and should not be expected to provide benefit based on available evidence.
The policy identifies a set of indications considered investigational or excluded due to insufficient randomized controlled trial evidence; these include conditions such as critical illness myopathy, idiopathic progressive neuropathy, unspecified iridocyclitis, bilateral orbital myositis, and systemic capillary leak/Clarkson disease. Use of immune globulins for these indications is therefore not covered under standard policy provisions.
The referenced excerpt contains no additional explicit exclusions beyond those enumerated elsewhere in the document.
A randomized trial in multiple myeloma patients undergoing autologous HSCT reported no reduction in infectious complications with prophylactic IVIG; this trial result is noted in the literature summary and may inform coverage determinations for prophylactic IVIG in some multiple myeloma settings.
Section III exclusions were edited in successive updates: several diagnoses were removed from exclusions when moved into covered criteria (for example, dermatomyositis and autoimmune blistering disorders), and state‑specific exceptions (e.g., PANDAS/PANS bypasses) were added as required by state regulations.
IVIG use for demyelinating neuropathies when an alternate cause is identified (e.g., Lyme disease, diphtheria, hereditary demyelinating neuropathy, or other secondary causes listed) is not supported under the CIDP criteria and is excluded unless diagnostic clarification demonstrates an idiopathic CIDP meeting the policy criteria.
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Requests lacking adequate supporting evidence, requests that exceed stated dosing limits without guideline or peer‑reviewed literature support, or requests that do not follow product preference/step therapy rules may be considered not medically necessary and are subject to denial per the policy and referenced off‑label/formulary policies.
The policy provides a full listing of conditions considered not medically necessary (NMN) in Section III; providers should consult that section for the complete enumerated list when evaluating a request and recognize that coverage for those indications is not authorized under the policy.
IVIG combined with rituximab for renal transplant desensitization is considered investigational at this time based on available retrospective analyses; larger randomized controlled trials are needed and the combination is not established as effective for routine desensitization.
The document classifies a group of listed indications as investigational due to lack of conclusive randomized controlled trial evidence; such uses are excluded from coverage and alternative therapies are suggested where applicable.
No explicit not‑medically‑necessary declarations appear in the product availability excerpts; absence of explicit NMN language in that section does not alter the exclusions listed in Section III.
The multiple myeloma literature includes trials reporting lack of prophylactic benefit for IVIG in some contexts (for example, during autologous HSCT), which is cited in the evidence section and may influence NMN determinations for similar clinical scenarios.
Coding listings and change history note that inclusion or exclusion of specific codes does not by itself guarantee coverage; code lists are informational and coverage decisions rely on meeting the policy's clinical criteria.
Codes, Dose Thresholds and Dosing Limits
Prior Authorization, Documentation, and Step Therapy Requirements
Prior Authorization
Prior Authorization Required
Prior authorization is required for all listed immune globulin products. Providers must submit supporting clinical documentation (office notes, labs, weight-based dosing calculations, prior therapy history, specialty consultation notes) demonstrating that the member meets the applicable indication-specific criteria. Approvals are typically issued for 6 months for Medicaid and Commercial (Commercial may be issued to the member’s renewal date if longer). For continued therapy, members currently receiving Gammagard or Gamunex‑C (or a health plan‑preferred product) should generally continue that product unless medical justification supports a switch (e.g., adverse reaction, inefficacy, documented shortage).
Prior authorization required for all listed immune globulin products
Include office chart notes, lab results, and clinical information with PA request
Typical approval duration: Medicaid 6 months; Commercial 6 months or to member renewal date, whichever is longer
Continued therapy: maintain same product unless medical justification for switch
Prior Authorization
RhIG PA Requirement
Definitions, Dosing Calculations and Background
Background: Immune globulins are used for replacement in primary humoral immunodeficiency, for infection prophylaxis in hypogammaglobulinemia, and as immunomodulatory therapy across multiple autoimmune and inflammatory conditions. Dosing and duration depend on indication and weight‑based calculations (TBW/IBW/adjBW), and product‑specific dosing regimens apply. The policy also notes that Privigen maintenance in CIDP has not been studied beyond 6 months.
2Q 2026 annual review: added CAR‑T cell–related uses for AIDP‑type presentations or bilateral facial palsy per NCCN; added off‑label indications for immune checkpoint inhibitor–related toxicities, LCHI/ND, HIT, and pediatric ALL; added HCPCS code J1553; updated references and Appendix G.
2026-01-21addition
Added off‑label measles post‑exposure prophylaxis criteria for IVIG.
2025-05-15addition
Policy Summary
PayerHealth Net
PolicyImmune Globulins
Policy CodePolicy CP.PHAR.103
Change TypeMaterial coverage and criteria updates
Effective DateAug 12, 2022
Next Review DateN/A
Key ActionPrior authorization is required for the listed immune globulin products; providers must submit supporting clinical documentation with requests.
Dose must be within FDA maximum limits or supported by guidelines; prescriber must submit supporting evidence for off‑label dosing.
Product preference/step therapy: Member must meet one of product‑preference/step options (e.g., Gammagard or Gamunex‑C preferred unless plan‑preferred product; failure/intolerance/shortage pathways to Gammaked or other products).
Weight‑based dosing: use TBW or IBW whichever is less; use adjBW for obesity per Appendix F.
Dosing limit: Dose does not exceed 2 g/kg IV per month, OR dosing supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).2 g/kg IV per month
Weight calculation per Appendix F (TBW or IBW whichever is less; adjBW for obesity).
Approval duration: Medicaid 6 months; Commercial 6 months or to the member's renewal date, whichever is longer.
Dosing for AIDP/GBS and CIDP:
a) For AIDP/GBS: dose does not exceed 0.4 g/kg IV per day for 5 days; b) For CIDP: loading dose 2 g/kg IV divided over 2–5 days followed by maintenance 1 g/kg IV every 3 weeks OR product‑specific SC dosing (Hizentra 0.2–0.4 g/kg/week or HyQvia per labeling); c) dosing supported by guidelines or literature (prescriber must submit evidence).
Dosing meets one: a) ≤1 g/kg/day IV for 1–2 days; b) ≤400 mg/kg/day IV for up to 5 days; c) Gammagard S/D: ≤1 g/kg for up to 3 total doses QOD; d) dosing supported by practice guidelines or peer‑reviewed literature (prescriber must submit evidence).
1 g/kg/day; 400 mg/kg/day
Weight calculation per Appendix F.
CIDP dosing: Loading/maintenance per product labeling (e.g., Privigen loading 2 g/kg divided over 2–5 days; maintenance 1 g/kg every 3 weeks; Hizentra SC 0.2–0.4 g/kg weekly); follow manufacturer ramp‑up when switching routes.
Route conversion guidance: When switching from IV to SC, follow specified conversion and ramp‑up instructions (example: initial weekly SC dose = previous IGIV grams divided by number of weeks between IV doses × 1.37). Document transition method and dates.
See Appendix F and product labeling.
Infectious disease: Parvovirus B19‑related anemia and viral prophylaxis (Hep A, measles, varicella, rubella): case series, NCCN, and CDC guidance referenced supporting IVIG/IM prophylaxis where vaccine or immune globulin indicated.
Dermatology: Pemphigus and autoimmune blistering diseases: evidence and guideline citations support IVIG as short‑term therapy in refractory cases.
Primary immunodeficiency: Practice parameters and randomized trials for IVIG dosing and infection prevention in primary hypogammaglobulinemia cited (monitoring trough IgG levels and individualized dosing).
Prior authorization is required for Rho(D) immune globulin (RhIG) when used for idiopathic thrombocytopenic purpura and related indications. Document hematology consultation and failure/intolerance of alternatives when applicable.
Prior authorization required for RhIG (Rho[D] immune globulin)
Documentation Required
Dose and Weight‑Method Documentation
Dose calculations must be documented and align with the policy. For adults, use the lesser of total body weight (TBW) or ideal body weight (IBW); for obese members (BMI ≥30 or TBW >20–30% over IBW), use adjusted body weight (adjBW). Provide mg/kg dosing, weight-method used (TBW/IBW/adjBW), and show calculations (Appendix F). Requests that exceed stated dose limits must include supporting evidence from practice guidelines or peer‑reviewed literature.
Document weight-method used (TBW, IBW, or adjBW) and show dose calculations per Appendix F
For adults, dose = lesser of TBW or IBW; use adjBW for obese members
If dose exceeds policy limits, submit guideline- or literature-based justification
Prior Authorization
Investigational / Off‑Label Uses and Evidence
Requests for investigational or excluded indications (see Section III) or for combinations considered investigational (e.g., IVIG plus rituximab for desensitization prior to kidney transplant) may be denied as not medically necessary or investigational. For off‑label uses that are considered, the prescriber must submit practice guidelines or peer‑reviewed literature and document specialty consultation.
Investigational uses (including certain desensitization combinations) are excluded unless adequate evidence provided
For off‑label use, submit practice guideline or peer‑reviewed literature and specialty consultation
Documentation Required
Required Documentation
Providers must supply required documentation with PA requests: indication, relevant diagnostic tests and dates (e.g., IgG troughs, antibody function testing), specialty prescriber or consultation notes, prior treatment history including failures/intolerances, exact mg/kg dosing, vial sizes/products requested, and rationale for product switches or dose increases. Lack of documentation or failure to meet dosing/prescriber requirements is a common reason for delay or denial.
Include IgG measurements (two measurements where required) and antibody response testing when applicable
Document prescriber specialty or documented consultation
Provide prior therapy failure history, dosing regimen (mg/kg), and vial size/product selection
Insufficient documentation may trigger denial or request for additional information
Documentation Required
Support for Dose Changes and Product Switches
When requesting dose increases, product switches, or deviations from standard regimens, provide medical justification (e.g., adverse reactions, inefficacy, documented shortage) and supporting evidence. Dose titration/conversion should follow package insert labeling or be supported by guidelines/literature. Dose exceedance beyond policy limits without evidence-based justification risks denial.
Document medical justification for product switch or dose increase (adverse reactions, ineffectiveness, shortage)
Dose titration/conversion should follow manufacturer labeling or guideline-supported evidence
Requests exceeding policy dose limits may be denied without supporting literature
Billing Rule
Dosing/Product Alignment and Coding Caveat
Dosing and product selection must align with the policy tables and product‑specific dosing guidance (section V). Document vial size and the selected product consistent with policy. Inclusion or exclusion of HCPCS/CPT codes in this policy is informational only and does not guarantee coverage—use current professional coding guidance when submitting claims.
Align requested dosing and product with policy dosing tables (section V) and document vial sizes
Coding listed is informational; inclusion/exclusion of codes does not guarantee coverage
Step Therapy
Product Preference and Step Therapy Rules
Step therapy and product preference rules generally require trial and failure of Gammagard or Gamunex‑C (or a health plan‑preferred product) before coverage of alternative immune globulin products, unless there is intolerance, contraindication, or documented shortage. States with oncology redirection prohibitions (Appendix G) and state-specific step‑therapy bypasses (e.g., Illinois HB 5395 for HIM) may alter these requirements. For dermatomyositis, IVIG is considered after failure/intolerance to systemic corticosteroids and immunosuppressants; some states or indications allow bypass.
Step: Prefer Gammagard or Gamunex‑C (or health plan‑preferred product) before alternatives
Allowances for failure, intolerance, or documented shortage
Appendix G lists states where redirections for cancer are prohibited
Illinois HIM: step therapy bypass per IL HB 5395
Denial Risk
Denial Triggers and Documentation Risks
Denial triggers include: missing or inadequate documentation of diagnosis, prescriber specialty/consultation, weight-method and mg/kg dosing calculations, or prior therapy failures; requests exceeding dose limits without guideline support; failure to provide required labs (e.g., IgG troughs) or infection history where indicated (e.g., multiple myeloma prophylaxis); and requests for indications listed as not medically necessary or investigational in Section III.
Missing specialty prescriber/consultation note may trigger denial
Absent IgG or infection history for MM prophylaxis risks denial
Dose exceedance without supporting literature may be denied
Excluded/Investigational indications in Section III will be considered not medically necessary
Documentation Required
Required Monitoring and Diagnostic Documentation
Monitoring requirements: for primary immunodeficiency and lifelong therapy, pre‑infusion (trough) serum IgG levels should be measured before infusion and monitored every 3 months to maintain target trough levels (often 400–600 mg/dL). Include laboratory reference ranges and cite Appendix E/Appendix references when submitting monitoring data.
Measure trough IgG before infusion and monitor every 3 months for lifelong therapy
Provide antibody function testing where relevant (e.g., CVID diagnosis)
Cite Appendix E reference ranges and laboratory sources
Weight calculation guidance
Primary weight ruleFor adults, calculate dosing based on TBW or IBW, whichever is less
Obesity adjustmentFor obese members use adjusted body weight (adjBW) per Appendix F unless the adjBW‑based dose is lower than current administered dose
Documentation requirementPrescriber must submit weight-based dosing calculations and indicate method used (TBW, IBW, or adjBW)
Hypogammaglobulinemia definition
Hypogammaglobulinemia definitionDocumented by two separate serum IgG measurements less than 400 mg/dL within specified time windows for certain indications
Alternate threshold for CAR TPost‑anti‑CD19 CAR T‑cell therapy criteria use IgG <600 mg/dL (two measurements) for infection prophylaxis
Clinical requirementWhere required, documentation of recurrent serious bacterial infections within past 12 months may also be necessary
Prescriber specialty requirement defined
Specialist requirement (general)Many indications require prescription by or consultation with a relevant specialist (e.g., neurologist, hematologist, oncologist, immunologist, dermatologist)
Examples by indicationCIDP/MMN: neurologist; PI: immunologist/hematologist; Kawasaki: cardiologist/allergist/immunology/infectious disease/rheumatology
Prior authorization notePrior authorization requires documentation of specialist involvement when specified in criteria
Diagnostic supportDiagnosis should be supported by two separate low immunoglobulin measurements within 6 months and clinical features per Appendix E
PrescriberPrescribed by or in consultation with an immunologist or hematologist
Stiff person syndrome — definition and treatment context
Stiff person syndrome definitionStiff person syndrome (Moersch-Woltmann) — neurological disorder requiring neurology consult and failure of benzodiazepine or baclofen at maximally indicated doses unless contraindicated
Treatment contextIVIG considered after failure of first‑line symptomatic therapies; dosing not to exceed 2 g/kg IV divided over 2–5 days per course unless guideline‑supported
PrescriberPrescribed by or in consultation with a neurologist or neuromuscular specialist
adjBW, TBW, IBW definitions
adjBW definitionadjBW = adjusted body weight
TBW definitionTBW = total body weight (actual body weight)
IBW definitionIBW = ideal body weight (male: 50 kg + 2.3 kg per inch over 5 ft; female: 45.5 kg + 2.3 kg per inch over 5 ft)
CVID diagnostic criterion (summary)Characterized by low serum IgG ≥2 SD below mean for age with impaired prolonged antibody response to immunization; IgG alone insufficient for diagnosis
Monitoring for PIPre‑infusion (trough) serum IgG levels should be monitored approximately every 3 months for lifelong therapy
Associated immunoglobulinsCVID often presents with low IgA and IgM in addition to low IgG
CVID duplicate noteCVID diagnosis requires impaired prolonged antibody response to protein or carbohydrate antigens; serum IgG measurement alone does not establish diagnosis
Clinical contextMany patients with CVID have IgG below 639 mg/dL and require IVIG
SpecialistDiagnosis and management by immunologist/hematologist recommended
IgG subclass deficiency definition
IgG subclass deficiency definitionRecurrent infections with deficiency in one or more IgG subclass levels (<5th percentile or ≥2 SD below) with normal total IgG, IgM, IgA
Clinical implicationConsidered among primary immunodeficiencies and may warrant IG replacement depending on clinical context
Diagnostic supportSee Appendix D for subclass testing and criteria
Specific antibody deficiency definition
Specific antibody deficiency definitionPatients ≥2 years with recurrent respiratory infections, normal immunoglobulin and subclass levels, but impaired IgG response to pneumococcal capsular polysaccharide
Testing requirementRequires functional antibody testing to pneumococcal and protein antigens
Clinical thresholdRecurrent serious bacterial infections may be part of qualification for IG therapy
TBW/IBW/adjBW dosing guidance
TBW/IBW/adjBW dosing guidanceUse TBW or IBW whichever is less for mg/kg dosing; if member is obese use adjusted body weight per Appendix F
IBW formulasIBW male = 50 kg + 2.3 kg per inch over 5 ft; IBW female = 45.5 kg + 2.3 kg per inch over 5 ft
AdjBW formula reminderAdjBW = IBW + [0.4 × (TBW − IBW)] and online calculators referenced in Appendix F
SC dose conversion (1.37 factor) guidance
SC conversion factorWhen converting prior IV dosing to weekly SC dosing, initial weekly SC dose = previous IV grams divided by number of weeks between IV doses × 1.37 (product-specific guidance)
Prorating guidanceProrate weekly SC dose to QD–every 2 weeks as indicated beginning 1–2 weeks after last IV dose per product labeling
Manufacturer ramp-upFollow manufacturer-recommended ramp-up schedules (e.g., HyQvia) when switching routes
ITP referenced guideline citations
ITP guideline citationsASH practice guidelines and international consensus reports cited for ITP management and IVIG use
Evidence basisMultiple guideline and consensus references included (George JN; Neunert et al.; Provan et al.)
Response/definition supportDefinitions of acute/persistent/chronic ITP and response criteria referenced from ASH/International Working Group
Kawasaki disease references
Kawasaki guideline citationsAHA and ACR/VF guideline citations provided for Kawasaki disease diagnosis and management
Retreatment guidanceRetreatment with IVIG 2 g/kg recommended for persistent or recrudescent fever ≥36 hours after initial infusion
Approval durationInitial Kawasaki and measles PEP approvals are one-time (1 month)
CIDP variants terminology update
CIDP variants terminology updateDiagnostic terminology revised from 'atypical CIDP' to 'CIDP variants' to align with 2021 EAN/PNS guidelines
Guideline alignmentPolicy diagnostic language aligned with 2021 EAN/PNS CIDP guidelines
ImplicationRefer to updated diagnostic criteria for variant presentations
CAPS note
CAPS noteCatastrophic antiphospholipid syndrome (CAPS) — APS exclusion does not apply to CAPS per policy note
Exclusion contextPolicy exclusions for antiphospholipid syndrome were clarified to permit CAPS-related considerations
Reference updateSection III exclusions edited to reflect this exception in recent updates
2Q 2025 annual review: added off‑label SLL (SLL/CLL) infection prophylaxis per NCCN and added criterion for CAR T‑cell related toxicities; Gamunex added as alternative preferred agent; MM infection prophylaxis bypass updated.
2024-06-18addition
Added Yimmugo to the policy (RT4 update).
2024-01-17addition
RT4 updates: for HyQvia and Gammagard Liquid, added CIDP indication per updated product PI; references reviewed and updated.
2023-12-27addition
RT4: added Alyglo to policy.
2022-06-30addition
Added HCPCS code J1551 for Cutaquig.
2021-09-17revision
Revised requirement: trial of corticosteroid before immune globulin now applies only to CIDP (not to GBS/AIDP) and only when member does not have CIDP with pure motor symptoms.
2026-04-24administrativeLatest
Removed HCPCS code J1572 and made Appendix G updates including Tennessee exception and product additions (Qivigy); updated cross‑references and state-specific language.
Evidence and guideline references cited in the policy support many covered indications: ASH and international consensus guidelines for ITP, AHA and ACR/VF guidance for Kawasaki disease, KDIGO and transplant literature for kidney transplant contexts, NCCN guidance for oncology‑related uses and immune‑related toxicities, and practice parameters for primary immunodeficiency. These citations are provided as supporting rationale for the covered criteria and dosing recommendations.