Neighborhood Health Plan RI SCIG Coverage & Prior Auth

Coverage Criteria for SCIG Therapies

Initial Therapy — Covered when ALL of the following are met for the listed condition

Covered when ALL of the following are met for the listed condition

General initial requirements: Baseline BUN and serum creatinine are obtained within 30 days of request; if requesting a non-preferred SCIG formulation, patient has documented failure or intolerance to preferred formulations (Gammaked/Gamunex-C or Gammagard Liquid).

Patients already receiving non-preferred agents (Cuvitru, Cutaquig, Xembify, Hizentra, HyQvia) may remain on treatment.

Primary Immunodeficiency (PID): Patient is at least 2 years of age AND (IgG level < 200 mg/dL OR [history of recurrent/hard-to-treat infections AND demonstrated antibody deficiency with vaccine titers drawn before and 4–8 weeks after vaccination]).

Examples of PID listed in policy (e.g., Wiskott-Aldrich, X-linked agammaglobulinemia, common variable immunodeficiency) are illustrative, not exhaustive.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [Hizentra and HyQvia ONLY]: Patient is at least 18 years of age AND physician-documented baseline disease severity using an objective tool (e.g., INCAT, MRC muscle strength, 6‑minute walk test, Rankin) AND SCIG is used as initial maintenance after stabilization with IVIG OR for re-initiation of maintenance after relapse requiring IVIG re‑induction.

Initial IVIG diagnostic/electrodiagnostic criteria and steroid-refractory/intolerance guidance are referenced for determination of eligibility (policy Section III/IV).

Continuation / Renewal Therapy — Renewal authorized when ALL of the following are met

Renewal authorized when ALL of the following are met

General renewal requirements: Patient continues to meet the initial approval criteria; absence of unacceptable toxicity to immunoglobulin therapy; and BUN and serum creatinine obtained within the last 6 months with infusion concentration and rate adjusted as clinically indicated.

Examples of unacceptable toxicity include severe hypersensitivity/anaphylaxis, thrombosis, aseptic meningitis syndrome, hemolytic anemia, hyperproteinemia, acute lung injury.

PID response evidence: Demonstration of disease response by one or more of: decrease in frequency of infections OR decrease in severity of infections.

Used to support renewal for primary immunodeficiency indications.

CIDP renewal criteria (Hizentra/HyQvia): Either (a) demonstrated beneficial clinical response to maintenance therapy without relapses based on an objective clinical measurement tool (e.g., INCAT, MRC, 6‑MWT, Rankin) OR (b) patient is re‑initiating maintenance after a relapse, improved and stabilized with IVIG, and was not receiving maximum dosing of Hizentra or HyQvia prior to relapse.

Initial and switch dosing criteria — Covered when dosing and switching/calculation follow product-specific conversion and ramp-up guidance

Covered when dosing and switching/calculation follow product-specific conversion and ramp-up guidance

HyQvia initial ramp-up: For IgG‑naïve patients or those switching from SCIG: target total dose 300–600 mg/kg at 3–4 week intervals after the initial ramp‑up. When switching from IVIG, use the same dose and frequency as prior IVIG after completion of the ramp‑up. Initial ramp‑up infusions use percentage multipliers per infusion: 3‑week interval — infusion 1 = 0.33 of dose, infusion 2 = 0.67, infusion 3 = total dose; 4‑week interval — infusion 1 = 0.25, infusion 2 = 0.50, infusion 3 = 0.75, infusion 4 = total dose.see text

Exact ramp percentages and infusion numbering provided in policy HyQvia dosing table.

Xembify switching from IVIG or SCIG: When switching from IVIG: initiate one week after last IVIG; weekly dose = 1.37 × (previous monthly or every‑3‑week IVIG dose in grams) / number of weeks between IVIG doses. To convert grams to mL multiply grams by 5. Provided total weekly grams are maintained, administration interval may range from daily up to weekly. When switching from SCIG, use the same weekly gram dose as prior SCIG.1.37 multiplier

Maintain total weekly dose; conversion to mL specified in policy.

General coverage criteria — Covered when ALL of the following are met

Covered when ALL of the following are met

Primary Coverage Requirements: 1) Requested medication is one of the listed IG products (Hizentra, Gammagard Liquid, Gamunex‑C/Gammaked, HyQvia, Cuvitru, Cutaquig, Xembify). 2) Indication aligns with FDA‑approved labeling or relevant clinical literature for IG replacement and is supported by clinical documentation. 3) An appropriate ICD‑10 diagnosis code from Appendix 1 is provided. 4) Prior authorization is obtained and cost‑effective product selection is considered (use of alternatives may be required). 5) For Medicare members, applicable NCD/LCD criteria are applied when present.

Neighborhood P&T adopted these criteria to align use with FDA labeling and clinical literature; individual consideration will be given to requests based on submitted clinical information.

The policy limits coverage to defined, evidence‑based indications by requiring that requests meet the plan’s clinical criteria and include an appropriate Appendix 1 diagnosis code. Coverage is therefore impliedly restricted to FDA‑labeled or literature‑supported uses for listed products (Hizentra, Gammagard Liquid, Gamunex‑C, Gammaked, HyQvia, Cuvitru, Cutaquig, Xembify) and to the clinical scenarios specified in the criteria (e.g., primary immunodeficiency, CIDP maintenance/re‑initiation for selected products). Requests that do not document an approved indication or relevant supportive literature may be denied per the plan’s coverage conformity requirement.

The policy also incorporates utilization management elements — prior authorization, preferred product sequencing, documentation of baseline labs, and product‑specific dosing rules — which functionally exclude non‑indicated or unsupported uses by requiring documentation and justification before coverage is granted.

For Cutaquig, initiation after switching from IVIG or SCIG is allowed only when started one week after the last infusion and when the patient has "received IVIG or SCIG treatment at regular intervals for at least 3 months." This requirement means Cutaquig is not authorized as a first‑line SCIG if the member lacks documented prior regular IVIG/SCIG therapy of at least 3 months.

The policy text and appendices indicate that non‑Medicare coverage determinations are handled under the plan’s criteria and that additional indications or precedents may be applied at the plan’s discretion. For Medicare members, National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs) take precedence when present; otherwise Neighborhood applies its clinical criteria and individualized review process.

Coverage of SCIG for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is explicitly limited to Hizentra and HyQvia and only in the circumstances described: as maintenance therapy after stabilization with IVIG or for re‑initiation of maintenance therapy following relapse requiring IVIG re‑induction. Requests for CIDP treatment with other SCIG products are not supported by this policy.

The document does not include a stand‑alone phrase declaring particular uses as "not medically necessary" within the cited sections; rather, it frames coverage through required adherence to FDA labeling, clinical literature, and the plan’s specific authorization criteria (including prior authorization and documentation requirements). Requests inconsistent with these standards may be considered not covered under the plan’s conformity rules.

Neighborhood’s policy states that use inconsistent with FDA‑approved labeling or relevant clinical literature and not supported by clinical documentation may be denied. The rationale notes that the P&T Committee adopted criteria to ensure use aligns with FDA labeling or the clinical literature and that individualized consideration will be given to each request; Medicare requests will follow NCD/LCD when applicable.

Billing, Codes, and Quantity Limits

No codes listed

Covered HCPCS/CPT and miscellaneous billing codes referencedmixed

J1559	Hizentra - Injection, immune globulin (Hizentra), 100 mg
J1555	Cuvitru - Injection, immune globulin, 100 mg
J1558	Xembify - immune globulin (SCIG), human
90284	Immune globulin (SCIg), human, for use in subcutaneous infusions
J3590	Unclassified biologic
C9399	Unclassified drug or biological
90284	(also referenced for Xembify as HCPCS)
(misc)	Hyaluronidase component NDCs and related billing items

Selected NDCs listedNDC

44206-0451-01	Hizentra 20% - 1 g per SDV? (as listed)
44206-0452-02	Hizentra 20% - 2 g per SDV? (as listed)
00944-2850-03	Cuvitru 20% - NDC as listed
13533-0810-05	Xembify 20% - NDC as listed

Covered ICD-10 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

1–10 of 23

1/3

CMS LCD/LCA references and MAC jurisdictionsmixed

No codes listed

V. Dosage/Administration - Weight-based dosing thresholds

BMI threshold for adjusted body weight30 kg/m2

Actual body weight vs IBW threshold for adjusted body weightActual body weight >= 20% higher than IBW

Initial dosing conversion

Initial dosing conversion — HyQvia ramp-up multipliers3-week interval: infusion1=0.33, infusion2=0.67, infusion3=1.0; 4-week interval: infusion1=0.25, infusion2=0.50, infusion3=0.75

Initial dosing conversion — Xembify switch from IVIGWeekly dose = 1.37*(previous monthly IVIG dose in g)/number of weeks between IVIG doses; convert g to mL by multiplying grams by 5

Initial dosing conversion — General switch from IVIG/SCIGWeekly dose = 1.30*(previous IVIG dose (g)/weeks between IVIG doses); biweekly = 2x weekly; frequent dosing divide weekly accordingly

Authorization, Documentation, and Billing Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all requests. Providers must demonstrate that the member meets Neighborhood's clinical coverage criteria (see Initial Approval Criteria and Renewal Criteria) and include an appropriate diagnosis code from Appendix 1. Requests inconsistent with FDA labeling or the cited clinical literature may be denied.

Include Appendix diagnosis code with the request (see Appendix 1 - Covered Diagnosis Codes).
Prescriber must supply documentation supporting FDA indication or relevant clinical literature when applicable.

Billing Rule

Billing and Coding Requirements

Use the HCPCS/CPT and NDC codes listed below for prior authorization requests, billing, and documentation. Providers must bill using the HCPCS/CPT and NDC codes specific to the product requested.

Background and Clinical Context

Subcutaneous immune globulin (SCIG) products are used primarily for immunoglobulin replacement in primary humoral immunodeficiency disorders (PID) and, for selected products, as maintenance therapy in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The policy lists multiple SCIG formulations — including facilitated SCIG (HyQvia) and high‑concentration 16.5–20% preparations (Cuvitru, Xembify, Cutaquig, Hizentra) — and summarizes product roles: replacement therapy for PID (patients ≥2 years for most products) and CIDP maintenance/re‑initiation specifically with Hizentra or HyQvia in adults. Dosing and conversion differ by product and by whether the patient is switching from IVIG or another SCIG; the policy includes product‑specific conversion multipliers and ramp‑up schedules and requires baseline and periodic renal function monitoring as part of authorization and renewal.

Product and Condition Definitions

inv-34: PID — Primary Immunodeficiency definition / related note

DefinitionPrimary Immunodeficiency (PID): a group of disorders (e.g., Wiskott‑Aldrich, X‑linked agammaglobulinemia, common variable immunodeficiency) characterized by antibody deficiency or combined immunodeficiencies

Age requirementPatient must be at least 2 years of age for PID coverage under policy

Diagnostic criteria examplesIgG level <200 mg/dL OR history of recurrent/hard‑to‑treat infections plus inadequate vaccine response with titers drawn before and 4–8 weeks after vaccination

inv-35: CIDP — Chronic Inflammatory Demyelinating Polyneuropathy (maintenance therapy limited to Hizentra and HyQvia)

CIDP coverage limitationCIDP maintenance therapy is limited to Hizentra and HyQvia under this policy

Age requirement

OpenPayer

Subcutaneous Immune Globulin (SCIG) — Coverage Criteria

Coverage Criteria for SCIG Therapies

Billing, Codes, and Quantity Limits

Authorization, Documentation, and Billing Requirements

Background and Clinical Context

Product and Condition Definitions