By Counterforce Health Team in Xembify (immune globulin, SC) —

Getting Xembify (Immune Globulin, SC) Covered by Cigna in Texas: Prior Authorization, Appeals, and Medical Necessity Guide

Answer Box: Quick Path to Xembify Coverage

Getting Xembify approved by Cigna in Texas requires prior authorization through Express Scripts/Accredo. Your doctor must document primary immunodeficiency with IgG levels below normal ranges and recurrent infections. If denied, you have 180 days to appeal internally, followed by binding external review through Texas Department of Insurance within 4 months. Start today: Have your doctor submit PA documentation including diagnosis codes (D80-D84), lab values, and infection history to Cigna via CoverMyMeds or provider portal.

Table of Contents

Policy Overview: How Cigna Manages Xembify in Texas

Cigna covers Xembify (immune globulin subcutaneous, human-klhw) as a Tier 4 or Tier 5 specialty medication for primary humoral immunodeficiency in patients 2 years and older. All Xembify prescriptions route through Express Scripts/Accredo specialty pharmacy network, regardless of your specific Cigna plan type.

Plan Types That Apply:

  • Commercial HMO/PPO plans
  • Medicare Advantage plans
  • Some employer-sponsored plans (verify with member services)
Note: ERISA self-funded employer plans may have different appeal rights and don't use Texas external review processes.

Where to Find Official Policies:

Medical Necessity Requirements

Primary Immunodeficiency Diagnosis

Cigna requires documented primary immunodeficiency with ICD-10 codes D80-D84 and specific clinical evidence:

Laboratory Requirements:

  • Serum IgG below age-adjusted normal ranges (typically <400-600 mg/dL for adults) documented on at least two separate occasions
  • Complete immunoglobulin panel (IgG, IgA, IgM levels)
  • Functional antibody testing showing inadequate vaccine responses when available

Clinical Documentation:

  • Recurrent bacterial infections: At least 4 ear infections per year OR 2+ serious sinus/pneumonia episodes
  • Pattern of infections requiring multiple or prolonged antibiotic courses
  • Documentation that underlying conditions (asthma, allergies) have been managed or excluded

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Xembify prescriptions Submit via CoverMyMeds or provider portal Cigna PA requirements
Formulary Tier Tier 4-5 specialty Check your plan's formulary Cigna member portal
Step Therapy May require trial of preferred alternatives Document failures/contraindications Coverage policy
Age Limit 2 years and older FDA labeling requirement Xembify prescribing information
Diagnosis Codes D80-D84 (primary immunodeficiency) Medical records documentation Cigna coverage policy

Step Therapy & Formulary Exceptions

Required Trials Before Xembify

Cigna may require documented trials of lower-tier immune globulin products before approving Xembify:

Preferred Alternatives:

  • Hizentra (subcutaneous)
  • Cuvitru (subcutaneous)
  • Various IVIG formulations

Medical Exception Pathways

If step therapy alternatives are inappropriate, document:

  • Previous therapy failures with specific start/stop dates
  • Intolerance or contraindications to preferred products
  • Clinical rationale for subcutaneous versus intravenous route
  • Expected outcomes specific to Xembify
Tip: Include detailed notes about why subcutaneous administration is medically necessary for your patient's specific situation.

Quantity Limits & Dosing Requirements

Authorization Limits

  • Initial authorization: Up to 6 months for primary immunodeficiency
  • Reauthorization: Up to 12 months with documented clinical response
  • Dose limits: Based on weight and FDA labeling calculations (typically 100-600 mg/kg/week)

Dosing Documentation Requirements

For New Patients:

  • Weight-based dose calculation
  • If switching from IVIG: monthly dose × 1.37 conversion factor for weekly dosing

For Reauthorization:

  • Clinical response documentation
  • Serum IgG trough levels
  • Infection frequency improvements
  • Dose titration records

Required Diagnostics & Documentation

Laboratory Evidence Checklist

  • Serum IgG levels below normal (documented twice)
  • IgA and IgM levels where relevant
  • Vaccine response testing showing inadequate responses
  • Complete blood count with differential
  • Recent trough IgG levels (for ongoing therapy)

Clinical Documentation

  • Infection history with dates, treatments, and outcomes
  • Previous antibiotic courses and effectiveness
  • Quality of life impact assessment
  • Prior immune globulin therapies with reasons for changes
Clinician Corner: Use structured documentation that directly addresses Cigna's criteria. Include specific infection counts, antibiotic courses, and measurable outcomes like missed work/school days.

Specialty Pharmacy Routing

All Xembify prescriptions must go through Accredo Specialty Pharmacy:

  • Phone: 1-800-803-2523
  • Accredo patient portal for prescription tracking
  • Home delivery or clinic administration coordination

Site of Care Requirements:

  • Home self-administration (with training)
  • Outpatient infusion centers
  • Physician offices
  • Not covered: Inpatient hospital administration for maintenance therapy

Evidence to Support Medical Necessity

Key Guidelines to Reference

  • FDA labeling: Xembify prescribing information for approved indications
  • Primary Immunodeficiency Foundation guidelines for SCIG therapy
  • Clinical Immunology Society recommendations for immunoglobulin replacement

Sample Medical Necessity Paragraph

"Patient has confirmed Common Variable Immunodeficiency (CVID, ICD-10 D83.9) with serum IgG of 285 mg/dL (normal 700-1600 mg/dL) documented on [date] and [date]. Despite prophylactic antibiotics, patient experienced 6 bacterial sinopulmonary infections in the past 12 months requiring hospitalization twice. Previous IVIG therapy was discontinued due to severe infusion reactions. Subcutaneous Xembify is medically necessary to provide stable IgG replacement while avoiding IV access complications."

Appeals Process for Texas Residents

Step-by-Step Appeals Timeline

1. Internal Appeal (First Level)

  • Deadline: 180 days from denial notice
  • Cigna decision time: 30 days (standard) or 72 hours (expedited)
  • Submit via: Cigna member portal or appeals address on denial letter
  • Required: Medical necessity letter, clinical notes, lab results

2. Second-Level Internal Review

  • Automatic if first appeal denied
  • Timeline: Additional 30 days for Cigna decision

3. External Review (Texas IRO)

  • Deadline: 4 months from final internal denial
  • Decision time: 20 days (standard) or 72 hours (expedited)
  • Cost: Free to member (Cigna pays IRO fees)
  • Binding: Yes, IRO decision is final and enforceable

Texas-Specific Rights

Under Texas Insurance Code, you have the right to:

  • Expedited external review for urgent health situations
  • Independent medical review by board-certified physicians
  • Assistance from Texas Department of Insurance: 1-800-252-3439
From Our Advocates: We've seen many Xembify denials overturned at the external review level when prescribers provide comprehensive infection histories and document why subcutaneous administration is specifically needed. The key is showing that IV alternatives have failed or are contraindicated, not just that the patient prefers subcutaneous therapy.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Provide detailed infection history and IgG levels Lab values, infection log, antibiotic records
"Step therapy not met" Document failures/contraindications to preferred products Prior therapy records, adverse event notes
"Exceeds quantity limits" Justify dose based on clinical response Trough IgG levels, dose titration records
"Non-formulary product" Request formulary exception Medical necessity letter, clinical rationale

Costs & Patient Support Programs

Financial Assistance Options

  • Xembify Connexions™: 1-844-MYXEMBIFY for copay assistance
  • Grifols Patient Assistance Program: For uninsured/underinsured patients
  • HealthWell Foundation: Grants for immune deficiency treatments
  • Texas Medicaid: May cover if you qualify for disability benefits

Retail Cash Pricing (Reference)

  • 5 mL vial (1g): ~$196
  • 50 mL vial (10g): ~$1,889
  • Monthly costs: $1,500-$15,000+ depending on dose

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Xembify. Their platform helps patients, clinicians, and pharmacies navigate complex prior authorization requirements by identifying specific denial reasons and crafting point-by-point rebuttals aligned with each payer's policies.

FAQ

Q: How long does Cigna prior authorization take for Xembify in Texas? A: Cigna typically processes complete PA submissions within 5 business days. Incomplete submissions may take longer.

Q: Can I get expedited approval if I'm currently on IVIG? A: Yes, if continuing therapy is urgent for your health. Request expedited review and provide documentation of current treatment schedule.

Q: What if Xembify isn't on my Cigna formulary? A: Request a formulary exception with medical necessity documentation. Your doctor must show why preferred alternatives won't work.

Q: Does step therapy apply if I failed similar products outside Texas? A: Yes, document all previous therapies regardless of where they were tried. Include records from other states or providers.

Q: Can I appeal directly to external review? A: No, you must complete Cigna's internal appeal process first, except in cases where Cigna fails to respond within required timeframes.

Q: What happens if the external review approves my Xembify? A: Cigna must comply with the IRO decision and provide coverage. The decision is binding and enforceable under Texas law.

When to Escalate

Contact the Texas Department of Insurance if:

  • Cigna fails to respond within required timeframes
  • You need help understanding your appeal rights
  • You want to file a complaint about claim handling

TDI Consumer Hotline: 1-800-252-3439
Online complaint form: Available at TDI website

For specialized help with complex appeals, Counterforce Health provides expert assistance in crafting evidence-based appeals that address specific payer criteria and improve approval rates for denied specialty medications.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for specific coverage decisions. Appeal rights and processes may differ for ERISA self-funded employer plans.

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