By Counterforce Health Team in Galafold (migalastat) —

How to Get Galafold (migalastat) Covered by Aetna (CVS Health) in Pennsylvania: Complete Guide with Forms and Appeals Process

Quick Answer: Getting Galafold Covered by Aetna in Pennsylvania

To get Galafold (migalastat) covered by Aetna (CVS Health) in Pennsylvania, you need prior authorization with proof of an amenable GLA gene variant and Fabry disease diagnosis from a specialist. Submit documentation through the Aetna provider portal or fax to 1-888-267-3277. If denied, use Pennsylvania's new external review program—roughly 50% of appeals succeed. Start with genetic testing confirmation and specialist referral today.

Table of Contents

Verify Your Plan and Find the Right Policy

Before starting your Galafold prior authorization, confirm your specific Aetna plan details. Galafold requires prior authorization across all Aetna commercial plans and is handled through CVS Caremark's specialty pharmacy program.

Key Coverage Requirements:

  • Adults (18+) with confirmed Fabry disease
  • Laboratory-confirmed amenable GLA gene variant (FDA-defined)
  • Specialist prescription (genetics, nephrology, cardiology, or metabolic specialist)
  • Cannot be used with enzyme replacement therapy (ERT)
  • Kidney function eGFR ≥30 mL/min/1.73m²
Note: Aetna covers Galafold only for FDA-approved indications with strict documentation requirements.

Required Forms and Documentation

Prior Authorization Submission Checklist

Essential Documents:

  • Completed Aetna prior authorization form
  • Genetic test results showing amenable GLA variant (in vitro assay)
  • Specialist evaluation and prescription
  • Fabry disease diagnosis with ICD-10 code
  • Documentation of step therapy (ERT trial/contraindication)
  • Recent kidney function tests (eGFR)
  • Insurance card and member information

Medical Necessity Letter Requirements

Your specialist should include:

  • Confirmed Fabry disease diagnosis
  • Genetic testing results with amenable variant confirmation
  • Previous treatments tried (ERT history or contraindications)
  • Clinical rationale for Galafold specifically
  • Dosing plan: 123 mg every other day
  • Monitoring plan for treatment response
Clinician Corner: Include reduction in GL-3 levels, renal function stabilization, or pain improvement as treatment goals. Reference FDA labeling and current Fabry disease management guidelines.

Submission Portals and Methods

Electronic Submission (Fastest)

  • Availity Provider Portal: Submit at Availity.com for real-time processing
  • Surescripts: Electronic PA submission through EMR systems
  • Response time: 14 days standard, expedited available for urgent cases

Fax Submission

  • Specialty Drug PA Fax: 1-888-267-3277
  • Alternative Fax: 1-866-249-6155
  • Include complete documentation to avoid delays

Phone Support

  • Specialty Drug Prior Auth: 1-855-240-0535 or 1-866-814-5506
  • Provider Help Line: 1-888-632-3862 (TTY: 711)

Specialty Pharmacy Enrollment

Galafold is dispensed through CVS Caremark specialty pharmacy. Once approved:

Enrollment Steps:

  1. CVS Specialty will contact you to set up services
  2. Provide insurance and prescription information
  3. Coordinate delivery schedule (every other day dosing)
  4. Set up refill reminders and adherence support

Transfer from Another Pharmacy: Most specialty prescriptions transfer automatically to CVS Caremark, but you may need a new prescription from your provider. Contact CVS Caremark at 1-800-237-2767 for transfer assistance.

Support Lines and Contacts

Purpose Phone Best Times to Call
Prior Authorization Status 1-855-240-0535 Business hours
Specialty Pharmacy Support 1-800-237-2767 24/7
Provider Questions 1-888-632-3862 Business hours
Member Services Number on insurance card 24/7

What to Ask When Calling:

  • Prior authorization status and timeline
  • Required documentation still needed
  • Appeal options if denied
  • Expedited review process for urgent cases

Pennsylvania External Review Process

Pennsylvania launched its Independent External Review Program in 2024, with 50% of appeals overturned in the first year. This is your strongest option after Aetna's internal appeals.

Step-by-Step Appeal Process

1. Complete Aetna's Internal Appeal

  • Submit within 180 days of denial
  • Obtain "Final Adverse Benefit Determination Letter"
  • Include all supporting medical documentation

2. File External Review Request

3. Independent Review

  • Pennsylvania assigns Independent Review Organization (IRO)
  • Standard review: 45 days
  • Expedited review: 72 hours (with physician certification)
  • Decision is binding on Aetna

Required External Review Documents

  • External Review Request Form
  • Copy of Aetna's final denial letter
  • Insurance card information
  • Supporting medical records
  • Physician certification (for expedited review)

When navigating complex prior authorization and appeals processes, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, potentially saving months in the approval process.

Common Denial Reasons and Solutions

Denial Reason Solution Documentation Needed
Non-amenable GLA variant Submit genetic testing results In vitro assay confirming amenable variant
Missing step therapy Document ERT trial or contraindication Treatment history, adverse reactions, or medical contraindication letter
Age restriction Confirm 18+ years Birth date verification
Concurrent ERT use Stop ERT or choose one therapy Treatment plan showing single therapy approach
Insufficient renal function Update kidney function tests Recent eGFR ≥30 mL/min/1.73m²
From our advocates: We've seen cases where initial denials for "non-formulary" status were overturned within 30 days when providers submitted complete genetic testing documentation and specialist letters clearly outlining why Galafold was medically necessary over ERT options. The key was demonstrating amenable variant status and previous ERT challenges.

Costs and Financial Assistance

List Price: Approximately $360,000-$400,000 annually

Financial Support Options:

  • Amicus Therapeutics Patient Support: Contact manufacturer for copay assistance programs
  • Foundation Grants: HealthWell Foundation and other rare disease foundations
  • State Programs: Pennsylvania may have additional assistance through Medicaid or state pharmaceutical programs
Tip: Apply for manufacturer assistance before starting the PA process—some programs provide free medication during appeals.

FAQ

How long does Aetna prior authorization take in Pennsylvania? Standard PA decisions take up to 14 days. Expedited reviews for urgent cases are processed within 72 hours.

What if Galafold is non-formulary on my plan? Submit a formulary exception request with medical necessity documentation. Include genetic testing and specialist evaluation showing why Galafold is required over formulary alternatives.

Can I get an expedited appeal if I'm already on Galafold? Yes, if discontinuation would cause serious health consequences. Your physician must provide certification of medical urgency.

Does step therapy apply if I tried ERT outside Pennsylvania? Previous ERT trials from any location count toward step therapy requirements. Provide complete treatment records and outcomes.

What happens if my external review is approved? Aetna must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal.

How do I track my PA status? Use the Availity provider portal or call 1-855-240-0535 for status updates.

Can a family member help with my appeal? Yes, you can authorize anyone to represent you in the appeals process, including family members or patient advocates.

What if I need Galafold urgently while waiting for approval? Contact Amicus Therapeutics patient support for potential bridge therapy programs, and request expedited PA review with physician certification.

For complex cases requiring detailed appeals strategy, Counterforce Health specializes in transforming insurance denials into successful approvals by crafting evidence-backed appeals that address specific payer requirements and denial reasons.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Requirements and processes may change—verify current information with official sources before taking action.

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