CurrentHawaii Medical Service Association (HMSA)Policy N/A

Subcutaneous Immune Globulin (SCIG) prior authorization

Prior authorization form and medical necessity criteria for subcutaneous immune globulin products (Cutaquig, Cuvitru, Hizentra, HyQvia, Xembify) administered/dispensed under the CVS Caremark specialty pharmacy benefit for HMSA members.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicySubcutaneous Immune Globulin (SCIG) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form and attach lab reports, EMG/NCS (for CIDP), and clinical notes to CVS Caremark Specialty Programs via fax 1-866-237-5512.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5listed SCIG products

4diagnostic/indication groups

2lab criteria thresholds

1-866-237-5512fax to send form

Coverage Criteria for SCIG

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Initial therapy preconditions: Request is for a new start or continuation of SCIG for a listed primary immunodeficiency diagnosisN/A

Refer to diagnosis list on the form

Laboratory evidence (one of): Agammaglobulinemia (total IgG < 200 mg/dL) OR Persistent hypogammaglobulinemia (total IgG < 400 mg/dL or ≥2 standard deviations below normal on at least two occasions) OR absence of B lymphocytesIgG thresholds as specified

Please attach a copy of the laboratory report

Functional antibody response (one of): Lack of appropriate rise in antibody titer following provocation with a polysaccharide antigen (e.g., inadequate pneumococcal response) OR lack of appropriate rise in antibody titer following provocation with a protein antigen (e.g., inadequate tetanus/diphtheria response)Example: pneumococcal: <4-fold increase in titers for ≥50% of serotypes; protein antigen: <4-fold rise 3-4 weeks after vaccine

Please attach vaccine response laboratory report

Infection history: Persistent and severe infections despite treatment with prophylactic antibioticsN/A

Attach clinical documentation of infections

Continuation: Previous authorization by HMSA/CVS OR demonstrated clinical response to SCIG (e.g., reduction in bacterial infections)N/A

Attach documentation of prior authorization or clinical response

CIDP (Initial and Continuation)

Covered when criteria below are met for new start or continuation

Initial: Request is for a new start or continuation of SCIG for CIDP with documentation of significant baseline functional disabilityN/A

Attach notes documenting baseline functional disability

Objective confirmation: Diagnosis of CIDP confirmed by slowing of nerve conduction velocity on electromyography (EMG) or nerve conduction studies (NCS)N/A

Attach a copy of the EMG/NCS report

Continuation: Demonstrated significant clinical improvement since starting SCIG; if total treatment duration ≥18 months, periodic attempts at dose reduction or withdrawal have been made and effects measuredDuration threshold: 18 months

Attach documentation of clinical improvement and attempts at dose reduction/withdrawal when applicable

Postexposure Prophylaxis Indications

Covered for specific postexposure indications when conditions below are met

Measles postexposure: Patient is susceptible and exposed to measles within 6 days prior to this request and the request is for postexposure prevention or modification of symptomsExposure within 6 days

Attach documentation of exposure

Tetanus: Request is for treatment or postexposure prophylaxis of tetanus when tetanus immune globulin (TIG) is unavailableTIG unavailable

Attach documentation if available

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

Attach documentation if available

When the provider selects Other as the diagnosis on the prior authorization form, the workflow proceeds to No Further Questions. This indicates that no additional SCIG clinical criteria are provided for unspecified or unlisted indications and the form will not prompt for the condition-specific laboratory, diagnostic, or treatment-response documentation required for covered indications.

Requests for subcutaneous immune globulin will not meet medical necessity unless the required supporting documentation is attached. For primary immunodeficiency this includes laboratory reports demonstrating immunoglobulin deficiency (for example, agammaglobulinemia: total IgG < 200 mg/dL or persistent hypogammaglobulinemia: total IgG < 400 mg/dL or ≥2 SD below normal on at least two occasions) and vaccine-response testing when applicable. For CIDP attach EMG/NCS reports confirming slowed nerve conduction velocity and documentation of baseline functional disability. Absence of these specified laboratory, EMG/NCS, or clinical records may result in the request not meeting medical necessity.

Coding and Laboratory Thresholds

Requested diagnosis code fieldICD-10

ICD-10

Form requests the ICD-10 code for the diagnosis (exact code not specified on form).

inv-07: IgG levels — numeric thresholds for agammaglobulinemia and persistent hypogammaglobulinemia

Agammaglobulinemia thresholdTotal IgG less than 200 mg/dL

Persistent hypogammaglobulinemia thresholdTotal IgG less than 400 mg/dL or at least two standard deviations below normal on at least two occasions

Alternate laboratory criterionAbsence of B lymphocytes

inv-08: Vaccine response — definitions for adequate pneumococcal and protein antigen responses

Adequate pneumococcal (polysaccharide) responseDefined example: at least a 4-fold increase in titers for at least 50% of serotypes tested

Protein antigen response (e.g., tetanus/diphtheria)Adequate response defined by a 4-fold rise in titers 3–4 weeks after vaccination (lack of this rise indicates inadequate response)

Evidence requirementAttach laboratory report documenting antibody titers following provocation testing

Provider Submission and Documentation Requirements

Prior Authorization

Prior Authorization and Submission

Prior authorization and supporting documentation must be submitted to CVS Caremark Specialty Pharmacy for review. Send the completed specialty prior authorization form and required attachments to CVS Caremark Specialty Programs via fax: 1-866-237-5512. For questions about the authorization process, call CVS Caremark at 1-808-254-4414 or Specialty Customer Care (CaremarkConnect) at 1-800-237-2767 or CaremarkConnect@cvscaremark.com.

Fax: 1-866-237-5512
CVS Caremark Specialty Programs, 2969 Mapunapuna Place, Honolulu, HI 96819
Phone: 1-808-254-4414
Specialty Customer Care: 1-800-237-2767; CaremarkConnect@cvscaremark.com

Denial Risk

Required Documentation — Risk of Denial if Missing

Requests that lack required laboratory documentation or diagnostic reports may be denied. Attach copies of all relevant laboratory reports and diagnostic testing to support the request.

Attach laboratory reports such as total IgG levels, specific antibody titers, vaccine response testing, and B lymphocyte testing where applicable.
Attach EMG/NCS reports when CIDP is the diagnosis.
Attach clinical notes documenting infection history, baseline functional disability, and response to therapy.

Documentation Required

Attach Laboratory Reports

For primary immunodeficiency and other antibody-deficiency indications, attach laboratory reports demonstrating immunoglobulin levels and functional antibody responses. Examples include total IgG, documented hypogammaglobulinemia (e.g., IgG <200 mg/dL for agammaglobulinemia or persistent IgG <400 mg/dL), vaccine titers showing inadequate response (polysaccharide and/or protein antigens), and B-cell enumeration when relevant.

Total IgG values and dates of testing
Specific antibody titers and documentation of provoked vaccine responses (e.g., pneumococcal, tetanus/diphtheria)
B lymphocyte counts if applicable

Documentation Required

CIDP — EMG/NCS and Baseline Functional Documentation Required

For CIDP-specific requests: attach baseline documentation of functional disability and an EMG/NCS report confirming demyelinating features (slowing of nerve conduction velocity). Requests without EMG/NCS confirmation or without notes documenting baseline functional impairment may be denied.

EMG/NCS report confirming diagnosis of CIDP (slowing of nerve conduction velocity).
Baseline functional disability documentation (e.g., gait impairment, strength testing, validated disability scales or clinical exam notes).
If continuation, documentation of clinical improvement since starting SCIG (chart notes, infection reduction, sensory/symptom improvement).

Step Therapy

CIDP Continuation and Step Considerations

Continuation requests for CIDP must include evidence of clinical improvement on SCIG and documentation of attempts to reduce dose or withdraw therapy when treatment duration is ≥ 18 months. Attach chart notes or medical records demonstrating improvement and records describing any dose-reduction or withdrawal trials and measured effects.

Documentation of significant clinical improvement since initiation of SCIG.
Total duration of SCIG therapy for CIDP (specify if ≥ 18 months).
If ≥ 18 months, attach documentation that dose reduction or withdrawal has been periodically attempted and the measured effects to validate continued use.

Background

Subcutaneous immune globulin (SCIG) products are used as replacement therapy for patients with primary immunodeficiency syndromes and as an immune-modulating therapy in certain autoimmune neurologic conditions such as chronic inflammatory demyelinating polyneuropathy (CIDP). SCIG is also an option for postexposure prophylaxis—for example, measles within 6 days of exposure or when TIG/VZIG are unavailable for tetanus/varicella—per the indications specified on the form. The prior authorization form requests laboratory evidence of immunoglobulin deficiency (IgG thresholds or absence of B lymphocytes), documentation of inadequate vaccine responses, EMG/NCS confirmation for CIDP, and clinical notes documenting infection history or functional disability to establish the medical necessity of SCIG.

Definitions

inv-15: Primary immunodeficiency — list of included disorders

Included disorder: congenital agammaglobulinemiaListed as a primary immunodeficiency included for SCIG consideration

Included disorder: X-linked agammaglobulinemiaListed as a primary immunodeficiency included for SCIG consideration

Included disorder: hypogammaglobulinemiaListed as a primary immunodeficiency included for SCIG consideration

Included disorder: common variable immunodeficiencyListed as a primary immunodeficiency included for SCIG consideration

Included disorder: X-linked immunodeficiency with hyper IgM syndromeListed as a primary immunodeficiency included for SCIG consideration

Included disorder: severe combined immunodeficiencyListed as a primary immunodeficiency included for SCIG consideration

Included disorder: Wiskott-Aldrich syndromeListed as a primary immunodeficiency included for SCIG consideration

inv-16: Laboratory evidence of immunoglobulin deficiency — specific numeric thresholds

AgammaglobulinemiaTotal IgG less than 200 mg/dL

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

Absence of B lymphocytesDocumented absence of B lymphocytes qualifies as laboratory evidence of immunoglobulin deficiency