By Counterforce Health Team in Galafold (migalastat) — 11 Dec 2025

How to Get Galafold (Migalastat) Approved by Aetna CVS Health in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Galafold Approved by Aetna CVS Health in Michigan

Aetna CVS Health requires prior authorization for Galafold (migalastat) in Michigan with 15-day standard or 72-hour expedited decisions. You'll need: confirmed Fabry disease diagnosis, documented amenable GLA variant, specialist prescription (nephrology/genetics/cardiology), and either ERT failure documentation or contraindication. Michigan's "deemed approved" rule applies if Aetna doesn't respond within statutory timeframes.

First step today: Call the number on your Aetna ID card to confirm Galafold's formulary status and obtain the specific PA form. Then schedule with a Fabry specialist if you haven't already.

What This Guide Covers
Before You Start: Verify Your Coverage
Gather What You Need
Submit the Prior Authorization Request
Follow-Up and Timelines
If You're Asked for More Information
If Your Request is Denied
Renewal and Re-Authorization
Common Denial Reasons and Solutions
Frequently Asked Questions
Quick Reference Checklist

What This Guide Covers

This comprehensive guide helps Michigan patients and their healthcare providers navigate Aetna CVS Health's prior authorization process for Galafold (migalastat), an oral treatment for adults with Fabry disease. Whether you're starting fresh or appealing a denial, we'll walk you through each step with specific forms, timelines, and appeal strategies tailored to Michigan's insurance laws.

Who this helps:

Patients with Fabry disease considering Galafold
Healthcare providers submitting PA requests
Families navigating insurance denials
Anyone preparing for renewal or reauthorization

At Counterforce Health, we specialize in turning insurance denials into successful approvals by crafting evidence-backed appeals that speak directly to payer policies. Our platform analyzes denial letters and plan policies to create targeted rebuttals that significantly improve approval rates.

Before You Start: Verify Your Coverage

Step 1: Confirm Your Plan Type

Call the member services number on your Aetna ID card and ask:

"Is this a commercial plan, Medicare Advantage, or Medicaid (Aetna Better Health)?"
"Is Galafold covered under pharmacy or medical benefits?"
"What's Galafold's formulary tier and copay?"

Different plan types have varying requirements and timelines in Michigan.

Step 2: Check Specialty Pharmacy Requirements

Aetna typically requires Galafold to be dispensed through CVS Specialty pharmacy. Confirm:

Which specialty pharmacy you must use
Whether your current pharmacy can handle the prescription
Any special shipping or storage requirements

Coverage at a Glance

Requirement	What It Means	Where to Find It
Prior Authorization	Required for all Galafold prescriptions	Aetna formulary or member portal
Formulary Tier	Usually specialty tier 4-5	Drug list on Aetna website
Step Therapy	May require ERT trial or contraindication	PA form and clinical criteria
Specialist Prescription	Nephrology, genetics, or cardiology	PA form requirements
Age Restriction	FDA-approved for adults ≥18 years	FDA label

Gather What You Need

Essential Documentation Checklist

Diagnostic Requirements:

✅ Confirmed Fabry disease diagnosis (enzyme assay or genetic testing)
✅ Amenable GLA variant documentation - genetic report explicitly stating the variant is "amenable to migalastat based on in-vitro assay data"
✅ Recent kidney function tests (eGFR ≥30 mL/min/1.73 m²)
✅ ICD-10 diagnosis code (E75.21 - Fabry disease)

Clinical Documentation:

✅ Specialist evaluation from nephrology, genetics, cardiology, or metabolic disease
✅ Current symptom assessment and organ involvement
✅ Baseline labs (GL-3 levels if available)
✅ Treatment goals and monitoring plan

Step Therapy Documentation (if required):

✅ Prior ERT history (Fabrazyme, Elfabrio) with dates, doses, and outcomes
✅ Documentation of ERT failure, intolerance, or contraindication
✅ Objective evidence of inadequate response (lab trends, symptom progression)

Tip: The most common reason for Galafold denials is incomplete documentation of amenable variant status. Ensure your genetic report specifically states the variant is amenable, not just pathogenic.

Specialist Requirements in Michigan

Aetna requires prescribing by or consultation with appropriate specialists. In Michigan, consider referral to:

University of Michigan Inherited Kidney Diseases Clinic - Adult nephrologists with Fabry expertise
Medical genetics programs at major academic centers
Cardiologists with metabolic disease experience for cardiac-predominant Fabry

The specialist must provide a detailed letter supporting medical necessity and confirming the Fabry diagnosis.

Submit the Prior Authorization Request

Michigan-Specific Timeline Rules

Michigan law sets binding PA timelines that apply to all Aetna plans:

Standard PA: 15 calendar days or automatically approved
Expedited PA: 72 hours for urgent cases or automatically approved
Additional information requests: Same timelines restart from when you provide the info

Step-by-Step Submission Process

1. Obtain the Correct Form

Access Aetna's provider portal or call for the specific Galafold PA form
Michigan accepts the state uniform PA form (FIS 2288) as an alternative

2. Complete Documentation Package

Fill out PA form completely (incomplete forms cause delays)
Attach all clinical documentation in organized order
Include specialist letter of medical necessity

3. Submit via Preferred Channel

Electronic PA: CoverMyMeds or Surescripts (fastest)
Fax: Use number provided on PA form
Portal: Aetna provider portal with document upload

4. Request Expedited Review (if applicable)

Check "expedited" box on form
Include physician letter stating delay would seriously jeopardize health
Common for declining kidney function or severe symptoms

Note: Keep copies of everything and document submission dates. Michigan's "deemed approved" rule means automatic approval if Aetna doesn't respond within statutory timeframes.

Follow-Up and Timelines

When to Call for Updates

Day 3: Confirm receipt of submission
Day 10: Status check for standard PA
Day 14: Final follow-up before 15-day deadline
48 hours: For expedited requests

Sample Call Script

"Hi, I'm calling to check the status of a Galafold prior authorization for [patient name], member ID [number], submitted on [date]. The reference number is [if available]. Can you tell me the current status and expected decision date?"

Key questions to ask:

Is any additional information needed?
What's the expected decision timeline?
Can I speak with a pharmacist or medical director?
Is there a peer-to-peer review option?

If You're Asked for More Information

Common Information Requests

Medical Necessity Clarification:

More detailed symptom documentation
Objective measures of disease progression
Treatment goals and success metrics

Step Therapy Documentation:

Complete ERT trial history with specific outcomes
Formal contraindication letter from specialist
Evidence of inadequate response or intolerance

Responding Effectively

When Aetna requests additional information:

Respond quickly - you typically have 21 days for standard or 5 days for expedited
Be comprehensive - address each specific question raised
Include supporting literature - FDA labeling, clinical guidelines, peer-reviewed studies
Restart the clock - Aetna has another 15 days (or 72 hours) from receipt

At Counterforce Health, we've seen that thorough responses to information requests often lead to approval, especially when they directly address the payer's specific clinical criteria.

If Your Request is Denied

Understanding Your Appeal Rights in Michigan

Internal Appeal Timeline:

File within: 180 days of denial (check your specific plan)
Decision timeframe: 30 days standard, 72 hours expedited
Required: Use Aetna's appeal form and include new supporting evidence

External Review Options:

Michigan DIFS External Review: Available 127 days after final internal denial
Independent medical review: Binding decision on medical necessity
Expedited external review: 72 hours for urgent cases

Step-by-Step Appeal Process

1. Analyze the Denial Letter

Identify specific denial reasons
Note appeal deadlines and procedures
Gather additional evidence to address each concern

2. Request Peer-to-Peer Review

Ask your specialist to speak directly with Aetna's medical director
Schedule within appeal timeframe
Prepare talking points addressing denial reasons

3. Submit Comprehensive Appeal

Use Aetna's appeal form
Include updated medical necessity letter
Address each denial reason specifically
Attach supporting clinical literature

4. Consider External Review

File with Michigan DIFS if internal appeal fails
No cost to patient
Independent medical experts review case
Decision is binding on Aetna

From our advocates: We've found that appeals addressing specific clinical criteria in the denial letter have significantly higher success rates than generic medical necessity arguments. Focus on the exact reasons cited.

Renewal and Re-Authorization

Typical Approval Duration

Most Aetna approvals for Galafold are:

Initial: 6 months
Renewal: 12 months with documented clinical benefit

Renewal Documentation Requirements

Clinical Response Evidence:

Updated kidney function tests
Symptom assessment and quality of life measures
GL-3 levels (if monitored)
Cardiac status updates
Any adverse events or tolerability issues

Continued Medical Necessity:

Ongoing Fabry disease management needs
Stability or improvement on current therapy
Absence of contraindications (eGFR still ≥30)
No concurrent ERT use

Timeline for Renewal Submission

Submit renewal requests 30-45 days before expiration to avoid treatment gaps. Set calendar reminders and coordinate with your specialty pharmacy.

Common Denial Reasons and Solutions

Denial Reason	Solution Strategy
"Variant not proven amenable"	Submit genetic report with explicit amenability statement and FDA Table 2 reference
"No documentation of ERT failure"	Provide detailed ERT trial history with objective outcomes or formal contraindication letter
"Severe renal impairment"	Confirm eGFR ≥30 with recent labs; address if borderline with nephrologist input
"Not prescribed by specialist"	Obtain prescription or co-signature from nephrology, genetics, or cardiology
"Experimental/investigational"	Reference FDA approval and labeling for amenable variants

Frequently Asked Questions

Q: How long does Aetna CVS Health PA take in Michigan? A: Standard requests must be decided within 15 days under Michigan law, or they're automatically approved. Expedited requests get 72-hour decisions for urgent cases.

Q: What if Galafold is non-formulary on my plan? A: Request a formulary exception with medical necessity documentation. Aetna must have a process for covering non-formulary drugs when medically necessary.

Q: Can I request an expedited appeal if denied? A: Yes, if delay would seriously jeopardize your health. Your doctor must provide a supporting letter explaining the urgency.

Q: Does step therapy apply if I've never tried ERT? A: Possibly. You may need to document why ERT is contraindicated or inappropriate before Galafold approval.

Q: What's the cost difference between Galafold and ERT? A: Both are expensive (~$300-400k annually), but costs vary by plan. Check with your specialty pharmacy for specific copays.

Q: Can my doctor request a peer-to-peer review? A: Yes, most Aetna denials include information for requesting a clinical review with their medical director.

Q: What happens if I move out of Michigan during treatment? A: Contact Aetna to update your address and confirm continued coverage. You may need to switch specialty pharmacies.

Q: Are there patient assistance programs for Galafold? A: Yes, Amicus Therapeutics offers support programs. Check the Galafold patient resources page for current offerings.

Quick Reference Checklist

Before Submitting PA:

Confirmed Fabry disease diagnosis
Documented amenable GLA variant
Specialist evaluation (nephrology/genetics/cardiology)
Recent eGFR ≥30 mL/min/1.73 m²
ERT history or contraindication documentation
Complete Aetna PA form
Medical necessity letter

After Submission:

Document submission date and method
Set follow-up reminders (days 3, 10, 14)
Prepare for potential information requests
Know appeal deadlines (180 days typically)
Identify specialist for peer-to-peer if needed

If Denied:

Analyze specific denial reasons
Request peer-to-peer review
Submit internal appeal within deadline
Consider Michigan DIFS external review
Maintain treatment if possible during appeals

Medical Disclaimer: This guide provides general information about insurance processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance company directly for coverage determinations.

For additional help with Michigan health insurance appeals, contact the Michigan Department of Insurance and Financial Services at 877-999-6442.

Sources & Further Reading

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