By Counterforce Health Team in Galafold (migalastat) —

How to Get Galafold (migalastat) Covered by Cigna in Michigan: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Galafold Covered by Cigna in Michigan

Cigna requires prior authorization for Galafold (migalastat) with strict criteria: you must be 18+ with an amenable GLA variant confirmed by genetic testing, prescribed by a specialist (geneticist, nephrologist, or cardiologist), and have kidney function with eGFR ≥30. Submit through CoverMyMeds electronic PA or call 1-800-882-4462. If denied, you have 180 days for internal appeals and 127 days for Michigan DIFS external review. First step today: Contact your specialist to order genetic amenability testing if not already completed.

Table of Contents

  1. Verify Your Cigna Plan Coverage
  2. Prior Authorization Forms and Requirements
  3. Genetic Testing Documentation
  4. Submission Portals and Methods
  5. Specialty Pharmacy Setup
  6. Appeals Process for Denials
  7. Michigan External Review Rights
  8. Support Contacts and Case Management
  9. Common Denial Reasons and Solutions
  10. FAQ

Verify Your Cigna Plan Coverage

Before starting the prior authorization process, confirm your specific Cigna plan covers specialty medications. Most Cigna plans manage specialty drugs through Express Scripts/Accredo, but coverage varies by plan type.

What to check:

  • Your member ID card for specialty pharmacy information
  • Whether your plan includes prescription drug coverage
  • Your current formulary tier for Galafold (typically specialty tier)
  • Any step therapy requirements
Tip: Call the member services number on your ID card to verify specialty drug coverage before proceeding.

Prior Authorization Forms and Requirements

Coverage Requirements

Cigna covers Galafold when ALL criteria are met:

Requirement Details Documentation Needed
Age 18 years or older Date of birth verification
Diagnosis Confirmed Fabry disease (ICD-10: E75.21) Medical records, genetic testing
Genetic Testing Amenable GLA variant confirmed by in vitro assay CLIA-certified lab report
Prescriber Geneticist, nephrologist, or cardiologist Specialist prescription
Kidney Function eGFR ≥30 mL/min/1.73 m² Recent lab results
No Concurrent ERT Cannot use Fabrazyme or Elfabrio simultaneously Medical records confirmation

Source: Cigna Galafold Coverage Policy

Michigan-Specific PA Timeline

Michigan law requires insurers to process prior authorization requests within specific timeframes using standardized form FIS 2288:

  • Standard requests: 15 days from submission
  • Expedited requests: 72 hours (requires physician certification of urgency)
  • Auto-approval: If Cigna doesn't respond within these timeframes, the request is automatically granted

Genetic Testing Documentation

The most critical requirement for Galafold approval is confirming you have an amenable GLA variant. Only about 35-50% of Fabry patients have variants that respond to migalastat.

Required Genetic Testing Elements

Your genetic test report must include:

  • CLIA-certified laboratory results
  • Specific GLA mutation identified
  • Explicit amenability confirmation for migalastat therapy
  • Clear statement that the variant responds to pharmacological chaperone treatment
Note: A general Fabry disease diagnosis isn't sufficient—the genetic report must specifically confirm amenability to migalastat.

Where to Get Testing

If you haven't had amenability testing:

  1. Ask your genetics specialist to order specific amenability testing
  2. Use the Galafold Healthcare Provider tool to identify testing options
  3. Ensure the lab explicitly tests for migalastat responsiveness

Submission Portals and Methods

Electronic Submission (Preferred)

Cigna prioritizes electronic prior authorization through:

  • CoverMyMeds: Available in most EHR systems
  • SureScripts: Integrated electronic PA platform

Your prescriber can submit directly through their electronic health record system.

Alternative Submission Methods

If electronic submission isn't available:

Required Supporting Documents

Include with your PA submission:

  • Completed prior authorization form
  • Genetic amenability test results
  • Specialist prescription with 123 mg every-other-day dosing
  • Medical necessity letter from prescriber
  • Recent kidney function labs (eGFR ≥30)
  • Fabry disease diagnosis documentation

Specialty Pharmacy Setup

Once approved, Cigna typically requires specialty pharmacy dispensing for Galafold.

Cigna Specialty Pharmacy Contacts

  • Cigna Specialty Pharmacy Services: 1-800-351-3606
  • Accredo (Cigna partner): Specialized rare disease support
  • Express Scripts: Part of Cigna's pharmacy network

Setup Process

  1. Your prescriber faxes the approved prescription to Cigna Specialty Pharmacy
  2. The pharmacy contacts you to coordinate delivery
  3. First shipment typically arrives within 3-5 business days of approval
  4. Ongoing shipments are scheduled every 28 days (14 capsules per bottle)
Important: Galafold requires specific storage and must be taken on an empty stomach (2 hours before and after meals).

Appeals Process for Denials

If Cigna denies your initial prior authorization, you have multiple appeal options.

Internal Appeals with Cigna

Timeline: 180 days from denial date to file internal appeal

Standard Internal Review: 30 days for decision
Expedited Internal Review: 72 hours (requires physician certification of urgency)

How to file:

  • Call Cigna member services (number on your ID card)
  • Submit written appeal with supporting documentation
  • Include additional medical evidence addressing denial reasons

Second-Level Internal Appeal

If your first internal appeal is denied, you can request a second-level review within the same 180-day window.

Michigan External Review Rights

After exhausting Cigna's internal appeals, Michigan residents have strong external review rights through the Department of Insurance and Financial Services (DIFS).

Filing Timeline

127 days from Cigna's final internal denial to request external review with DIFS.

External Review Process

Standard External Review: Maximum 60 days for decision
Expedited External Review: 72 hours (requires physician letter stating delay would harm patient)

How to File

Required for expedited review: Letter from treating physician verifying medical necessity of expedited timeline.

Key Advantage: External review decisions are binding on Cigna—if DIFS approves coverage, Cigna must comply.

Support Contacts and Case Management

Cigna Member Support

Service Phone Number Best For
General Member Services Number on your ID card Coverage questions, claim status
Specialty Pharmacy Services 1-800-351-3606 Galafold-specific support
Prior Authorization 1-800-882-4462 PA status, requirements

Michigan Consumer Assistance

  • Michigan DIFS: 877-999-6442 for insurance complaints and external reviews
  • DIFS Consumer Assistance: Help with appeal process and insurance rights

Case Management for Rare Diseases

For complex cases involving Fabry disease, request assignment to a Cigna case manager who specializes in rare disease support. Case managers can help coordinate:

  • Prior authorization documentation
  • Specialty pharmacy setup
  • Appeal preparation
  • Provider communication

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
No amenable variant documented Submit genetic amenability testing CLIA-certified lab report with explicit amenability confirmation
Non-specialist prescriber Transfer care to qualified specialist New prescription from geneticist, nephrologist, or cardiologist
Insufficient kidney function Update lab work or appeal with clinical justification Recent eGFR results ≥30 mL/min/1.73 m²
Concurrent ERT use Discontinue enzyme replacement therapy Medical records showing ERT cessation
Age under 18 Wait until 18th birthday or seek off-label appeal Birth certificate, off-label medical necessity letter

From Our Advocates

"We've seen Michigan patients successfully overturn Galafold denials by focusing on the genetic amenability documentation. One common issue is submitting general Fabry genetic testing instead of specific migalastat amenability results. When families work with their genetics team to get the right test and clearly document amenability, approval rates improve significantly. The key is making sure the lab report explicitly states the variant responds to pharmacological chaperone therapy."

FAQ

How long does Cigna prior authorization take for Galafold in Michigan?
Standard PA requests are processed within 15 days per Michigan law. Expedited requests (requiring physician urgency certification) are completed within 72 hours. If Cigna doesn't respond within these timeframes, the request is automatically approved.

What if Galafold is non-formulary on my Cigna plan?
You can request a formulary exception through your prescriber. The physician must document that covered alternatives are ineffective or detrimental to your health. Submit through CoverMyMeds or call 1-800-882-4462.

Can I request an expedited appeal if Cigna denies coverage?
Yes, both internal appeals with Cigna (72 hours) and external reviews with Michigan DIFS (72 hours) offer expedited timelines. Your physician must certify in writing that standard review timelines would seriously jeopardize your health.

Does step therapy apply to Galafold in Michigan?
Cigna typically doesn't require step therapy for Galafold since it's indicated only for patients with amenable variants who may not respond to enzyme replacement therapies. However, some plans may require documentation of why ERT isn't appropriate.

What if I've tried Galafold in another state—do I need new prior authorization?
Yes, you'll need new prior authorization when changing insurance plans or states. However, your previous treatment history and response can strengthen your medical necessity case.

How much does Galafold cost if approved by Cigna?
With specialty tier coverage, your copay depends on your specific plan. Galafold has a list price around $360,000-$400,000 annually. Check with Cigna about your exact copay and consider the Galafold co-pay assistance program if eligible.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform identifies denial reasons and drafts point-by-point rebuttals aligned to each plan's specific requirements, pulling the right clinical evidence and procedural details payers expect. For complex cases like Galafold appeals, Counterforce Health streamlines the documentation process and tracks deadlines to improve approval rates.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For questions about Michigan insurance rights, contact Michigan DIFS at 877-999-6442.

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