Neighborhood Health Plan SCIG Coverage Update

Coverage Criteria for SCIG

Primary Immunodeficiency (PID) — Initial Therapy

Covered when ALL of the following are met

PID initial coverage: Baseline BUN and serum creatinine obtained within 30 days of request; AND patient is at least 2 years of age; AND (IgG level <200 mg/dL OR (history of multiple hard-to-treat infections as specified AND documented deficiency in producing antibodies in response to vaccination with titers drawn before and between 4-8 weeks after vaccination)); AND for requests for non-preferred SCIG formulations, documented failure or intolerance to preferred formulations (Gammaked/Gamunex-C or Gammagard liquid) unless already established on the requested product.

Infection history examples include: ≥4 ear infections/year, ≥2 serious sinus infections/year, ≥2 pneumonias/year, recurrent deep skin/organ abscesses, persistent thrush, need for IV antibiotics, two or more deep-seated infections (including septicemia), or family history of PID.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) — Initial Therapy (Hizentra and HyQvia ONLY)

Covered when ALL of the following are met

CIDP initial coverage: Patient is at least 18 years of age; AND physician-documented baseline disease severity using an objective measure/tool (e.g., INCAT, MRC, 6-MWT, Rankin); AND use is for maintenance therapy after treatment and stabilization with IVIG OR for re-initiation of maintenance after a relapse requiring IVIG re-induction; AND the patient meets the referenced IVIG initiation criteria (progressive/relapsing course ≥2 months, abnormal/absent deep tendon reflexes, electrodiagnostic evidence of demyelination, refractory/intolerant to corticosteroids after ≥3 months, and documented baseline strength).

CIDP coverage under this policy is limited to Hizentra and HyQvia only; follow product-specific dosing guidance (see Dosage/Administration).

Renewal Criteria — PID and CIDP

Renewal authorized when ALL of the following are met

Renewal general: Patient continues to meet initial criteria (section III); AND absence of unacceptable toxicity from the drug (examples include severe hypersensitivity/anaphylaxis, thrombosis, aseptic meningitis, hemolytic anemia, hyperproteinemia, acute lung injury); AND BUN and serum creatinine obtained within the last 6 months with infusion concentration and rate adjusted accordingly.

PID response: Disease response evidenced by a decrease in frequency OR severity of infections.

CIDP response: Demonstrated beneficial clinical response to maintenance therapy without relapses based on an objective clinical measuring tool (e.g., INCAT, MRC, 6-MWT, Rankin) OR patient is re-initiating maintenance after a relapse and demonstrated improvement/stabilization on IVIG and was not at maximum Hizentra/HyQvia dosing prior to relapse.

Initial dosing when converting products

Dosing when switching from IVIG or prior SCIG

Switching from IVIG to SCIG: Initiate SCIG approximately 1 week after the last IVIG infusion; calculate the weekly SCIG dose using the product-specific conversion factor (examples: Xembify and many 10% products: weekly dose = 1.37 * (previous IVIG dose in grams / number of weeks between IVIG doses); Cutaquig/Cuvitru and some products: weekly dose = 1.30 * (previous IVIG or HyQvia dose in grams / number of weeks between IVIG/HyQvia doses)). To convert grams to mL where specified, follow product labeling (e.g., Xembify: grams × 5 = mL).start ~1 week after last IVIG

Different products specify conversion factors of ~1.30–1.37; choose product-specific factor per prescribing information; dosing intervals may range from daily up to biweekly.

Switching from prior SCIG: When converting from a prior SCIG product, maintain the same weekly dose in grams as the prior regimen; biweekly dosing equals twice the weekly dose; for frequent dosing (2–7 times/week) divide the weekly dose by the number of weekly administrations.weekly grams preserved

Applies across products (Cuvitru, Xembify, Cutaquig) per product instructions.

Hyaluronidase-facilitated SCIG dosing

Special product: Hyqvia

Hyqvia dosing/administration: Hyqvia is a dual-component product containing immune globulin and recombinant human hyaluronidase that facilitates dispersion and absorption, allowing larger-volume subcutaneous administration on monthly or biweekly schedules; dosing specifics and schedules should follow product labeling and clinical trial evidence supporting monthly or biweekly administration.monthly or biweekly possible

Hyaluronidase enables less-frequent, larger-volume SC administration compared with conventional SCIG.

Coverage criteria for IG products

Covered when use aligns with FDA-approved labeling or relevant clinical literature and meets Neighborhood clinical criteria:

General coverage: Product is FDA-approved for the requested indication or supported by relevant clinical literature; prescriber submits supporting clinical information demonstrating the indication and clinical need; AND the diagnosis corresponds to a covered code listed in Appendix 1.

Neighborhood will give individual consideration to requests and apply National Coverage Determination (NCD)/Local Coverage Determination (LCD) criteria for Medicare members when present.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) coverage under this policy is limited to the subcutaneous immune globulin products Hizentra and HyQvia only. Other SCIG formulations are not indicated for CIDP in this policy; initiation of SCIG maintenance for CIDP requires prior treatment and stabilization with IVIG or re‑initiation after an IVIG re‑induction.

No explicit clinical exclusions beyond the product‑specific limitations for CIDP are stated in the cited sections of the policy. The document does not list additional conditions or diagnoses that are categorically excluded from SCIG coverage in these excerpts.

For Medicare members, Neighborhood’s clinical coverage criteria for SCIG products apply only in the absence of a National Coverage Determination (NCD) or Local Coverage Determination (LCD). When an NCD or LCD exists, those CMS determinations take precedence over the plan’s criteria; Neighborhood will otherwise review requests against its P&T‑adopted criteria and individual prescriber‑submitted information.

Requests for non‑preferred SCIG formulations submitted without documentation of trial and failure or intolerance to preferred products (the policy cites preferred formulations such as Gammaked/Gamunex‑C or Gammagard liquid) may be considered not medically necessary. The policy requires documentation of prior failure/intolerance for non‑preferred product coverage unless the member is already maintained on a non‑preferred agent.

The reviewed portions of the policy do not contain standalone statements explicitly labeling any uses as not medically necessary beyond the non‑preferred product requirement; no additional explicit not‑medically‑necessary declarations are present in these excerpts.

Use of SCIG that is inconsistent with FDA‑approved labeling or not supported by relevant clinical literature and the plan’s clinical criteria may be considered not medically necessary. Neighborhood’s P&T‑adopted criteria are intended to ensure use aligns with regulatory labeling and the medical evidence cited in the policy rationale.

Coding, Dosing Factors, and Related Values

NDC Quantity LimitsNDC

NDC (multiple)

Quantity limits listed per product (Hizentra = 46 g / 184 g; Gamunex-C & Gammaked = 42 g / 168 g; Gammagard liquid = 42 g / 168 g; HyQvia = 40 g / 160 g; Cuvitru & Cutaquig = 40 g / 160 g; Xembify = 42 g / 168 g).

HCPCS Max UnitsHCPCS

HCPCS (multiple)

Billable units per 28 days listed per product (Hizentra = 1680 (PID) / 1840 (CIDP); Gamunex-C & Gammaked = 336; Gammagard liquid = 336; HyQvia = 1200; Cuvitru & Cutaquig = 1600; Xembify = 1680).

Hizentra HCPCSHCPCSCovered

J1559

Injection, immune globulin (Hizentra), 100 mg

Cuvitru / Xembify HCPCSHCPCSCovered

J1555	Injection, immune globulin (Cuvitru), 100 mg
J1558	Injection, immune globulin (Xembify) / 90284 also referenced

Other SCIG HCPCSHCPCSCovered

J1561	Injection, immune globulin (Gamunex-/Gammaked referenced)
J1569	Injection, immune globulin (Gammagard Liquid referenced)

Unclassified / SCIG codesmixed

90284	immune globulin (SCIg), human, for use in subcutaneous infusions
J3590	unclassified biologic
C9399	unclassified drug or biological

Covered ICD-10 Diagnosis CodesICD-10Covered

B20	Human immunodeficiency virus [HIV] disease.
D80.0	Hereditary hypogammaglobulinemia.
D80.1	Nonfamilial hypogammaglobulinemia.
D80.2	Selective deficiency of immunoglobulin A [IgA].
D80.3	Selective deficiency of immunoglobulin G [IgG] subclasses.
D80.4	Selective deficiency of immunoglobulin M [IgM].
D80.5	Immunodeficiency with increased immunoglobulin M [IgM].
D80.7	Transient hypogammaglobulinemia of infancy.
D81.0	Severe combined immunodeficiency [SCID] with reticular dysgenesis.
D81.1	Severe combined immunodeficiency [SCID] with low T- and B-cell numbers.

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CIDP Hizentra dose escalation

Starting dose (Hizentra, CIDP)Initiate at 0.2 g/kg (1 mL/kg) body weight per week, administered in 1–2 sessions over 1–2 consecutive days.

Escalation if symptoms worsenConsider increasing to 0.4 g/kg (2 mL/kg) body weight per week, administered in 2 sessions over 1–2 consecutive days.

If worsening on 0.4 g/kgIf symptoms worsen despite 0.4 g/kg/week, consider re-initiating IVIG and discontinuing Hizentra.

Conversion factor from IVIG to weekly SCIG dose

Common weekly conversion formulaWeekly SCIG dose commonly calculated as 1.37 × (previous IVIG dose in grams / number of weeks between IVIG doses).

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Neighborhood will review requests against Pharmacy & Therapeutics–adopted clinical coverage criteria and give individual consideration to each request based on the information submitted by the prescriber and other information available to the plan. Requests that do not meet Neighborhood's clinical coverage criteria (including use inconsistent with FDA labeling or relevant literature) may be denied.

Initial authorization for covered indications is granted for 6 months with the possibility of annual renewal thereafter.
Coverage criteria are intended to ensure cost-effective sequencing of therapies and use of preferred products first, when applicable and appropriate.

Step Therapy

Preferred Product Trial and Cost-effective Sequencing

Requests for non-preferred subcutaneous immune globulin formulations (for example: Cuvitru, Cutaquig, Xembify, Hizentra, Hyqvia) require documentation of failure or intolerance to preferred formulations (Gammaked/Gamunex-C or Gammagard liquid). Members currently maintained on a non-preferred product may remain on that treatment.

Background and Rationale

Subcutaneous immune globulin (SCIG) is used for replacement therapy in primary immunodeficiency (PID) and, for selected products, as maintenance therapy in chronic inflammatory demyelinating polyneuropathy (CIDP). The policy rationale notes that multiple SCIG products were reviewed by the plan’s P&T committee and that coverage criteria were adopted to align use with FDA‑approved labeling and relevant clinical literature.

Definitions and Product Notes

Primary Immunodeficiency (PID) — definition and examples

DefinitionPrimary Immunodeficiency (PID) is a group of disorders (examples: Wiskott–Aldrich syndrome, X-linked agammaglobulinemia, common variable immunodeficiency, transient hypogammaglobulinemia, IgG subclass deficiency, severe combined immunodeficiencies).

Age requirement for coveragePatient must be at least 2 years of age for PID coverage with SCIG products.

Diagnostic criteria examplesCoverage criteria include IgG <200 mg/dL OR specified history of recurrent/hard-to-treat infections plus deficient antibody response to vaccination with titers drawn before and 4–8 weeks after vaccination.

CIDP — definition and policy-specific notes

DefinitionChronic Inflammatory Demyelinating Polyneuropathy (CIDP) is an immune‑mediated demyelinating neuropathy requiring objective baseline assessment and prior stabilization with IVIG for SCIG maintenance initiation.

OpenPayer

Subcutaneous Immune Globulin (SCIG) — Coverage Criteria

Coverage Criteria for SCIG

Coding, Dosing Factors, and Related Values

Provider Actions, Prior Authorization, and Documentation

Background and Rationale

Definitions and Product Notes