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

Getting Xembify (Immune Globulin) Covered by Aetna in Washington: Complete Guide to Prior Authorization and Appeals

Quick Answer: Aetna requires prior authorization for Xembify in Washington. Start by having your doctor submit a Statement of Medical Necessity with your primary immunodeficiency diagnosis, infection history, and lab results. If denied, you can appeal internally and then request an external review through Washington's Office of Insurance Commissioner. The fastest path: complete PA submission with all required documentation upfront. First step today: Call Aetna at (866) 752-7021 to confirm your plan's specific requirements.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timeline and Urgency
  4. Medical Necessity Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals
  7. Renewals and Ongoing Coverage
  8. Specialty Pharmacy Process
  9. Troubleshooting Common Issues
  10. Key Terms Glossary

Coverage Basics

Is Xembify covered by Aetna? Yes, but prior authorization is required for all Aetna commercial and most Medicare plans. Xembify (subcutaneous immune globulin) is typically covered for FDA-approved indications, primarily primary immunodeficiency disorders.

Which Aetna plans cover Xembify? Most Aetna commercial plans, Medicare Advantage, and some Medicaid plans include coverage. However, your specific formulary tier and copay will vary by plan. Check your plan documents or call member services to confirm your coverage details.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Doctor must get approval before prescribing Aetna Precertification List Aetna
Step Therapy May need to try other treatments first Your plan formulary Plan documents
Quantity Limits Dosing restrictions based on weight/indication Aetna Clinical Policy Aetna Policy
Site of Care Specific administration requirements Prior auth determination Varies by plan

Prior Authorization Process

Who submits the prior authorization? Your prescribing physician or their office staff submits the request to Aetna. CVS Specialty Pharmacy can also assist with the submission process if they're your designated specialty pharmacy.

Step-by-Step: Fastest Path to Approval

  1. Doctor gathers documentation (1-2 days)
    • Primary immunodeficiency diagnosis with ICD-10 codes
    • Infection history and frequency
    • Laboratory results (IgG levels, vaccine responses)
    • Prior treatment failures (if applicable)
  2. Submit complete prior authorization (Same day)
    • Use Aetna's online portal or fax to (888) 267-3277
    • Include Statement of Medical Necessity
    • Attach all supporting clinical documentation
  3. Aetna reviews submission (5-15 business days)
    • Standard review: 15 calendar days maximum
    • Expedited review: 72 hours for urgent cases
  4. Receive determination (1-2 days after decision)
    • Approval: Begin treatment coordination
    • Denial: Review reason and prepare appeal
  5. Coordinate with specialty pharmacy (2-3 days)
    • Benefits verification and cost calculation
    • Schedule delivery and nursing support if needed

Timeline and Urgency

How long does Aetna prior authorization take? Standard approvals take 5-10 business days for complete submissions. Incomplete requests may take longer as Aetna requests additional information.

What if it's urgent? For urgent medical needs, request an expedited review. Expedited reviews are processed within 72 hours. Your doctor must document the urgency and potential health risks of delay.

Tip: Start the prior authorization process 60-90 days before your current treatment expires to avoid gaps in therapy.

Medical Necessity Criteria

Aetna's clinical policy for immune globulin therapy requires specific documentation for approval:

Primary Immunodeficiency Requirements

  • Confirmed diagnosis of primary immunodeficiency (PID)
  • Recurrent infections - documented history of serious bacterial infections
  • Low immunoglobulin levels - typically IgG <500 mg/dL or ≥2 standard deviations below normal for age
  • Impaired antibody response - poor response to vaccines (pneumococcal, Hib, etc.)
  • Exclusion of secondary causes - rule out medication-induced or acquired immunodeficiency

Dosing and Administration

Xembify dosing is weight-based at 150 mg/kg/week for treatment-naïve patients. Aetna may require justification for:

  • Doses above FDA-recommended ranges
  • Use of actual body weight in obese patients (>120% ideal body weight)
  • Dose increases without documented clinical need
Clinician Corner: Your medical necessity letter should include the patient's infection frequency before and after other treatments, specific IgG levels with dates, vaccine response titers, and clear rationale for subcutaneous versus intravenous therapy.

Costs and Financial Assistance

Xembify retail costs range from $196 for a 5mL vial to $1,889 for a 50mL vial. Your out-of-pocket costs depend on your plan's specialty tier copay or coinsurance.

Financial Support Options

  • Grifols Patient Assistance Program - Income-based assistance for eligible patients
  • Copay assistance cards - May reduce monthly out-of-pocket costs
  • Washington state assistance programs - Contact Washington Healthplanfinder for additional resources

Denials and Appeals

Common denial reasons include:

  • Missing or incomplete primary immunodeficiency documentation
  • Insufficient infection history
  • Lack of prior treatment failures (when step therapy applies)
  • Dosing above plan limits without justification

Appeals Process in Washington

Washington state provides strong consumer protections for insurance appeals:

  1. Internal Appeal (60-90 days from denial)
    • Submit written appeal to Aetna with additional documentation
    • Include physician statement supporting medical necessity
    • Timeline: Aetna has 30 days to respond
  2. External Review (180 days from final internal denial)

The external review decision is binding on Aetna and provides an independent medical expert's assessment of your case.

From our advocates: We've seen many Xembify denials overturned when families included detailed infection logs showing frequency and severity before and after treatment attempts. Keep a simple calendar noting each infection, antibiotic course, and missed work/school days - this concrete evidence often makes the difference in appeals.

Renewals and Ongoing Coverage

Xembify authorizations typically require renewal every 6-12 months. Start renewal requests 60-90 days before expiration to prevent treatment interruptions.

Renewal Documentation

  • Updated IgG levels and clinical response
  • Infection frequency since starting therapy
  • Any dose adjustments and rationale
  • Physician attestation of continued medical necessity

Specialty Pharmacy Process

Most Aetna plans require Xembify to be dispensed through CVS Specialty Pharmacy. The specialty pharmacy team:

  • Coordinates prior authorization with your doctor
  • Verifies benefits and calculates your costs
  • Arranges delivery and nursing support
  • Manages refills and renewals

Why specialty pharmacy? Immune globulin therapies require special handling, storage, and patient support services that traditional pharmacies typically can't provide.

Troubleshooting Common Issues

Portal or system down? If Aetna's online portal is unavailable, submit requests by fax to (888) 267-3277 or call provider services at (866) 752-7021.

Missing forms? All current prior authorization forms are available on Aetna's provider website.

Delayed response? If you haven't received a decision within the standard timeframe, call Aetna to check status and request expedited review if medically necessary.

Key Terms Glossary

  • Prior Authorization (PA): Approval required before insurance covers a medication
  • Step Therapy (ST): Requirement to try less expensive treatments first
  • Quantity Limit (QL): Restrictions on amount or frequency of medication covered
  • Peer-to-Peer (P2P): Phone call between your doctor and insurance medical director
  • Letter of Medical Necessity (LMN): Detailed explanation of why treatment is required
  • External Review: Independent assessment by medical experts outside your insurance company

This guide provides general information about insurance coverage and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and contact Aetna directly for your specific plan requirements.

For personalized assistance with prior authorizations and appeals, Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer requirements.

Sources & Further Reading

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