CurrentHawaii Medical Service Association (HMSA)Policy N/A

Subcutaneous immune globulin (SCIG) and related immune globulin products prior authorization

Prior authorization requirements and clinical criteria for coverage of SCIG products (Cutaquig, Cuvitru, Hizentra, HyQvia, Xembify) and certain immune globulin uses (primary immunodeficiency, CIDP, measles, tetanus, varicella) for members whose prescription benefit is administered by CVS Caremark on behalf of HMSA.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicySubcutaneous immune globulin (SCIG) and related immune globulin products prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed CVS Caremark Specialty Programs prior authorization form and fax to 1-866-237-5512 with required laboratory and diagnostic reports attached.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5products listed

5indications with question flows

2lab thresholds specified

18CIDP duration threshold (months)

Coverage Criteria for SCIG and Immune Globulin

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicySubcutaneous immune globulin (SCIG) and related immune globulin products prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed CVS Caremark Specialty Programs prior authorization form and fax to 1-866-237-5512 with required laboratory and diagnostic reports attached.

SourceLink

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Primary immunodeficiency diagnostic requirements: Member has one of the specified primary immunodeficiency diagnoses and laboratory evidence of immunoglobulin deficiency defined as agammaglobulinemia (total IgG < 200 mg/dL) OR persistent hypogammaglobulinemia (total IgG < 400 mg/dL or ≥2 SD below normal on at least two occasions) OR absence of B lymphocytes.IgG thresholds as specified

Attach laboratory report(s)

Impaired vaccine response: Member demonstrates inability to mount an adequate antibody response to protein or polysaccharide antigens (e.g., <4-fold rise for tetanus or <4-fold rise in ≥50% of pneumococcal serotypes).4-fold rise criteria

Attach vaccine response lab reports

History of infections: Member has persistent and severe infections despite treatment with prophylactic antibiotics.clinical documentation

Attach clinical records

Initial Therapy - CIDP

Covered when ALL of the following are met:

New vs continuation: Form documents whether this is a new start or continuation of SCIG; prior authorization history is requested.prior auth status

Baseline functional disability: For new starts, documentation of significant baseline functional disability is required.documentation of baseline functional disability

Attach baseline functional disability notes

Diagnostic confirmation: Diagnosis of CIDP must be confirmed by slowing of nerve conduction velocity on EMG or NCS.EMG/NCS showing slowed conduction

Attach EMG/NCS report

Continuation Therapy - CIDP

Covered when ALL of the following are met:

Clinical improvement: Member has demonstrated significant clinical improvement since starting SCIG therapy (including improvement in sensory symptoms where applicable).documented improvement

Attach clinical documentation (chart notes, medical records)

Duration-based reassessment: If total duration of treatment ≥ 18 months, periodic attempts at SCIG dose reduction or withdrawal must have been attempted and the effects measured to validate continued use.>= 18 months

Attach documentation of dose reduction/withdrawal attempts

Postexposure Prophylaxis / Alternate immune globulin use

Covered when ALL of the following are met:

Measles postexposure: Request is for postexposure prophylaxis to prevent or modify measles (rubeola) symptoms when patient is susceptible and was exposed within 6 days prior to the request.exposure within 6 days

Tetanus alternative when TIG unavailable: Request is for treatment or postexposure prophylaxis of tetanus as an alternative when tetanus immune globulin (TIG) is unavailable.TIG unavailable

Varicella when VZIG unavailable: Request is for treatment or postexposure prophylaxis of varicella in susceptible patients when varicella-zoster immune globulin (VZIG) is unavailable.VZIG unavailable

Requests that do not include the form’s required diagnostic documentation will not meet the coverage criteria. For primary immunodeficiency this includes missing laboratory evidence such as the specified IgG thresholds (IgG < 200 mg/dL for agammaglobulinemia or IgG < 400 mg/dL or ≥2 SD below normal on at least two occasions for persistent hypogammaglobulinemia), absence of B lymphocytes, or lack of documented inadequate vaccine response (e.g., failure to achieve a 4‑fold rise when expected). For CIDP, requests without an attached EMG/NCS report demonstrating slowed nerve conduction (requested on the form) will not satisfy the diagnostic confirmation requirement.

Requested Products and Codes

Requested product list (drug names)mixed

Cutaquig	Cutaquig
Cuvitru	Cuvitru
Hizentra	Hizentra
HyQvia	HyQvia
Xembify	Xembify
Other	Other

ICD-10 code (requested on form)ICD-10

(blank entry)

What is the ICD-10 code? (requested on the form)

Agammaglobulinemia threshold — inv-10

ThresholdTotal IgG < 200 mg/dL

ContextDefined on the form as diagnostic evidence for agammaglobulinemia

Required actionAttach laboratory report showing IgG level

Persistent hypogammaglobulinemia threshold — inv-11

ThresholdTotal IgG < 400 mg/dL OR ≥2 standard deviations below normal on at least two occasions

ContextForm requires these criteria as evidence of persistent hypogammaglobulinemia

Required actionAttach laboratory reports from at least two occasions documenting IgG levels or standard deviations

Provider Actions, Documentation & Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for the listed subcutaneous immune globulin (SCIG) products and related immune globulin uses. Submit the completed CVS Caremark Specialty Programs prior authorization form and fax to 1-866-237-5512. Contact CVS Caremark Specialty Programs with questions at 1-808-254-4414 or CaremarkConnect 1-800-237-2767. Approvals may be subject to dosing limits per FDA labeling, compendia, and evidence-based guidelines.

Products: Cutaquig, Cuvitru, Hizentra, HyQvia, Xembify
Send completed form/fax: CVS Caremark Specialty Programs — Fax: 1-866-237-5512
CVS Caremark phone: 1-808-254-4414; Specialty Customer Care: CaremarkConnect 1-800-237-2767

Documentation Required

Dose-reduction / withdrawal assessment for CIDP continuation

For continuation of SCIG in chronic inflammatory demyelinating polyneuropathy (CIDP) after ≥18 months of treatment, periodic attempts at dose reduction or withdrawal should have been made and documented, with the effects measured, to validate continued need for therapy. Attach documentation describing the attempt(s) to reduce dose or withdraw therapy and the clinical outcomes of those attempts.

CIDP continuation: If total duration ≥ 18 months, attach documentation of attempts at dose reduction or withdrawal and measured effects
If duration < 18 months, dose-reduction/withdrawal assessment not required for continuation determination

Denial Risk

Missing required documentation — risk of denial

Requests must include required supporting documentation. Missing or incomplete documentation may result in denial. Attach the specific reports and records requested on the CVS Caremark form and any additional records that substantiate the diagnosis and clinical response.

Attach laboratory reports demonstrating immunoglobulin deficiency or antibody response testing (e.g., total IgG values, vaccine response titers)
For CIDP, attach EMG/NCS reports documenting slowed nerve conduction and clinical notes documenting baseline functional disability and subsequent clinical improvement
Attach documentation of clinical response to therapy (e.g., reduction in bacterial infections, improvement in symptoms) for continuation requests
If requested, attach records documenting attempts at dose reduction or withdrawal (for CIDP continuation ≥18 months)

Background and Scope

This prior authorization form covers use of subcutaneous immune globulin (SCIG) products for primary immunodeficiency disorders and for chronic inflammatory demyelinating polyneuropathy (CIDP), and it also captures requests for immune globulin use related to measles, tetanus, and varicella postexposure or treatment scenarios. The form requires submission of supporting documentation specific to each pathway: laboratory reports for immunoglobulin levels and vaccine responses, EMG/NCS reports for CIDP diagnostic confirmation, and clinical notes documenting baseline disability or response to therapy as applicable.

For primary immunodeficiency, the form defines laboratory thresholds that trigger eligibility evaluation: agammaglobulinemia (total IgG < 200 mg/dL), persistent hypogammaglobulinemia (total IgG < 400 mg/dL or ≥2 SD below normal on at least two occasions), or absence of B lymphocytes. It also asks for evidence of impaired vaccine response (for example, failure to achieve a 4‑fold rise in titers when expected) and documentation of recurrent or severe infections despite prophylactic antibiotics.

For CIDP, the form distinguishes new starts from continuation therapy, requests documentation of significant baseline functional disability for new starts, and requires an EMG/NCS report showing slowed nerve conduction to confirm diagnosis. Continuation requests must document clinical improvement and, when total treatment duration is ≥ 18 months, must include documentation that periodic SCIG dose reduction or withdrawal attempts were made and their effects measured to validate ongoing therapy.

Key Definitions

Agammaglobulinemia — inv-17

DefinitionTotal IgG less than 200 mg/dL as defined on the form

Use in criteriaAccepted laboratory evidence for primary immunodeficiency initial therapy

DocumentationAttach a copy of the laboratory report to the form

Persistent hypogammaglobulinemia — inv-18

DefinitionTotal IgG less than 400 mg/dL, or at least two standard deviations below normal, on at least two occasions

Use in criteriaAccepted laboratory evidence for primary immunodeficiency initial therapy

DocumentationAttach copies of laboratory reports from the occasions demonstrating the low IgG or ≥2 SD decline