By Counterforce Health Team in Galafold (migalastat) —

How to Get Galafold (migalastat) Covered by Aetna CVS Health in Washington: Step-by-Step Prior Authorization Guide with Appeals Process

Quick Answer: Getting Galafold Approved by Aetna CVS Health in Washington

Eligibility: Adults with Fabry disease and a confirmed amenable GLA gene variant (eGFR ≥30 mL/min/1.73m²). Fastest path: Submit prior authorization with genetic test results, specialist prescription, and evidence of enzyme replacement therapy failure/contraindication. First step today: Contact your specialist to order genetic testing if not already done, then gather all required documentation. Timeline: 30-45 days for standard review; 72 hours for expedited appeals in Washington.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timeline Expectations
  6. Common Denial Reasons and Solutions
  7. Appeals Process in Washington
  8. Renewal and Reauthorization
  9. Patient Assistance and Cost Support
  10. FAQ: Galafold Coverage by Aetna CVS Health
  11. Quick Reference Checklist

What This Guide Covers

This comprehensive guide helps patients with Fabry disease and their healthcare providers navigate Aetna CVS Health's prior authorization process for Galafold (migalastat) in Washington state. You'll learn exactly what documentation is required, how to avoid common pitfalls, and what to do if your initial request is denied.

Who this helps: Patients diagnosed with Fabry disease who have an amenable GLA gene variant and their care teams seeking Aetna CVS Health coverage for Galafold in Washington.

Before You Start: Verify Your Coverage

Check Your Plan Details

First, confirm these essential details about your Aetna CVS Health coverage:

  • Plan type: Commercial, Medicare Advantage, or employer-sponsored
  • Pharmacy benefit: Managed by CVS Caremark
  • Formulary status: Verify Galafold's tier placement (typically specialty tier)
  • Network status: Ensure your prescribing specialist is in-network
Note: Galafold requires CVS Specialty Pharmacy for dispensing due to its specialty tier classification.

Gather Required Documentation

Essential Medical Documentation

Genetic Testing Results

  • Laboratory report confirming amenable GLA gene variant
  • Must be from CLIA-certified laboratory
  • Report must explicitly state variant is "amenable" per FDA criteria

Diagnosis Documentation

  • Fabry disease diagnosis with ICD-10 code E75.21
  • Clinical evaluation by genetics, nephrology, or metabolic specialist
  • Documentation of organ involvement (cardiac, renal, neurologic)

Laboratory Requirements

  • Recent kidney function tests showing eGFR ≥30 mL/min/1.73m²
  • Complete metabolic panel within last 6 months
  • Additional labs supporting Fabry disease diagnosis

Prior Treatment History

  • Documentation of enzyme replacement therapy (ERT) trial and failure/intolerance
  • OR medical contraindication to ERT (Fabrazyme, Elfabrio)
  • Detailed treatment timeline and outcomes

Administrative Forms

  • Aetna Prior Authorization Form (verify current link)
  • Specialist prescription for Galafold 123 mg every other day
  • Medical necessity letter from prescribing specialist

Submit Your Prior Authorization Request

Step-by-Step Submission Process

1. Complete Prior Authorization Form

  • Use Aetna's current PA form for specialty medications
  • Include all required clinical information
  • Specialist must sign and date the form

2. Compile Documentation Packet

  • Genetic test results showing amenable variant
  • Specialist evaluation and prescription
  • Laboratory results (kidney function, metabolic panel)
  • Prior ERT treatment records
  • Medical necessity letter

3. Submit via Proper Channels

  • Provider portal: Log into Aetna provider system
  • Fax: 1-888-267-3277 (verify current number)
  • CVS Specialty: May require separate submission for specialty drugs

4. Request Confirmation

  • Obtain submission confirmation number
  • Document submission date and method
  • Keep copies of all submitted materials
Tip: Submit complete packets to avoid delays. Incomplete submissions are the most common cause of processing delays.

Clinician Corner: Medical Necessity Letter Checklist

Healthcare providers should include these elements in the medical necessity letter:

  • Patient demographics and diagnosis: Age, Fabry disease with ICD-10 E75.21
  • Genetic confirmation: Specific amenable GLA variant identified
  • Clinical rationale: Why Galafold is medically necessary for this patient
  • Prior treatments: ERT trials, outcomes, reasons for discontinuation
  • Contraindications: Any medical reasons ERT cannot be used
  • Treatment goals: Expected clinical benefits and monitoring plan
  • Supporting evidence: Reference to FDA labeling and clinical guidelines

Follow-Up and Timeline Expectations

Standard Processing Times

Review Type Timeline When to Follow Up
Standard PA 30-45 days After 2 weeks
Expedited Review 72 hours Next business day
Appeal (Internal) 30 days After 2 weeks
External Review 20-45 days Weekly

Follow-Up Best Practices

Week 1-2: Allow processing time, no action needed unless urgent

Week 3: Call Aetna member services to check status

  • Reference your confirmation number
  • Ask for specific timeline
  • Document representative name and case notes

Sample Follow-Up Script: "I'm calling to check the status of a prior authorization request for Galafold submitted on [date]. My confirmation number is [number]. Can you provide an update on the review timeline?"

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Non-amenable variant Submit genetic counselor interpretation Updated genetic report with amenability confirmation
Missing step therapy Document ERT failure/contraindication Treatment records, adverse event documentation
Insufficient kidney function Provide recent lab results eGFR ≥30 mL/min/1.73m² within 3 months
Non-specialist prescriber Transfer prescription to specialist Genetics, nephrology, or metabolic medicine provider
Incomplete documentation Submit missing information All items from documentation checklist
From our advocates: "We've seen many Galafold denials overturned when patients provide comprehensive genetic testing documentation. The key is ensuring your genetic report explicitly states the variant is amenable—not just listing the mutation. Work with a genetic counselor if needed to clarify this critical requirement."

Appeals Process in Washington

Internal Appeals (First Level)

Timeline: Must file within 180 days of denial Process:

  1. Submit written appeal with additional documentation
  2. Include peer-reviewed literature supporting medical necessity
  3. Request peer-to-peer review with specialist

Required Elements:

  • Copy of original denial letter
  • Additional medical evidence
  • Updated medical necessity letter
  • Supporting clinical literature

External Review (Independent Review Organization)

Washington state provides robust external review rights through certified Independent Review Organizations (IROs).

Eligibility: After completing internal appeals Timeline: File within 180 days of final internal denial Process:

  1. Submit request through Washington Office of Insurance Commissioner
  2. IRO assigns board-certified specialist reviewers
  3. Decision is binding on Aetna CVS Health

Standard Review: 20-45 days maximum Expedited Review: 72 hours for urgent cases

Note: Washington's external review process is particularly effective for specialty medications like Galafold, with independent medical experts making coverage decisions.

To initiate external review:

  • Contact Washington Office of Insurance Commissioner: 1-800-562-6900
  • Submit all medical records and denial documentation
  • IRO reviewers include specialists familiar with rare diseases

Renewal and Reauthorization

Annual Renewal Requirements

Aetna CVS Health typically authorizes Galafold for 12-month periods. Plan for renewal 60-90 days before expiration.

Required for Renewal:

  • Updated specialist evaluation
  • Current laboratory results (kidney function, clinical markers)
  • Documentation of treatment response and tolerability
  • Continued medical necessity justification

Evidence of Clinical Benefit:

  • Symptom improvement documentation
  • Stable or improved organ function
  • Quality of life measures
  • Adherence to treatment regimen

Patient Assistance and Cost Support

Amicus Therapeutics Support Programs

AMICUS ASSIST Program:

  • Patient education and case management
  • Benefits verification and prior authorization support
  • Note: Co-pay assistance not available for Medicaid/Medicare patients

Commercial Insurance Patients:

Washington State Resources

Apple Health (Medicaid): Galafold typically requires exception request as it's not on standard formulary Washington Healthplanfinder: Coverage varies by individual plan formulary

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Galafold. Their platform analyzes denial letters and creates evidence-backed appeals tailored to each payer's specific requirements, helping patients navigate the prior authorization process more effectively.

FAQ: Galafold Coverage by Aetna CVS Health

Q: How long does Aetna CVS Health prior authorization take for Galafold? A: Standard review takes 30-45 days. Expedited review (when medically urgent) takes up to 72 hours in Washington.

Q: What if my genetic test shows a non-amenable variant? A: Galafold is only FDA-approved for amenable variants. Non-amenable variants require enzyme replacement therapy (ERT) instead.

Q: Can I request an expedited appeal if denied? A: Yes, if your doctor certifies that delay would seriously jeopardize your health. Washington allows 72-hour expedited external review.

Q: Does step therapy apply if I tried ERT in another state? A: Yes, prior ERT trials from any location count toward step therapy requirements if properly documented.

Q: What happens if Aetna CVS Health doesn't respond within the timeline? A: Contact Washington Office of Insurance Commissioner at 1-800-562-6900 for assistance with delayed reviews.

Q: Is genetic counseling required for Galafold approval? A: Not required, but genetic counselor interpretation of amenability can strengthen your prior authorization request.

Q: Can I appeal to an independent reviewer if denied twice internally? A: Yes, Washington provides external review through certified IROs with binding decisions on insurers.

Q: What if I'm switching from ERT to Galafold? A: Document medical reasons for the switch (antibody development, access issues, patient preference) and ensure no concurrent use.

Quick Reference Checklist

Before Submitting PA Request

  • Genetic test confirming amenable GLA variant
  • Specialist prescription (genetics/nephrology/metabolic)
  • Recent kidney function tests (eGFR ≥30)
  • ERT trial documentation or contraindication
  • Fabry disease diagnosis with ICD-10 E75.21
  • Completed Aetna prior authorization form
  • Medical necessity letter from specialist

After Submission

  • Confirmation number documented
  • Follow-up scheduled for 2-3 weeks
  • Appeal timeline noted (180 days from denial)
  • External review option researched
  • Patient assistance programs contacted

If Denied

  • Denial reason identified
  • Additional documentation gathered
  • Internal appeal filed within 180 days
  • Peer-to-peer review requested
  • External review prepared if needed

For personalized assistance with your Galafold prior authorization or appeal, Counterforce Health provides specialized support for complex medication approvals, helping patients and providers create compelling, evidence-based requests that address each insurer's specific requirements.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on individual circumstances, plan details, and medical necessity. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with insurance appeals or coverage questions, contact the Washington Office of Insurance Commissioner at 1-800-562-6900.

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