By Counterforce Health Team in Galafold (migalastat) —

Galafold (Migalastat) Approval with UnitedHealthcare in Washington: Answers to the Most Common Questions

Answer Box: Getting Galafold Covered by UnitedHealthcare in Washington

UnitedHealthcare requires prior authorization for Galafold (migalastat) with proof of Fabry disease diagnosis and an amenable GLA variant confirmed by in vitro assay. Initial approval lasts 12 months; reauthorization requires documented positive clinical response. If denied, Washington residents can appeal through UnitedHealthcare's internal process, then request external review through an Independent Review Organization (IRO) via the Washington Office of the Insurance Commissioner. First step: Have your specialist submit the PA request through the UHC Provider Portal with genetic test results and clinical documentation.

Table of Contents

Coverage Basics

Is Galafold Covered by UnitedHealthcare?

Yes, UnitedHealthcare covers Galafold (migalastat) for adults with Fabry disease who have an amenable GLA variant, but prior authorization is required for all commercial plans effective January 1, 2025. The medication is covered under the pharmacy benefit (not medical) and requires specific documentation to prove eligibility.

Which UnitedHealthcare Plans Cover Galafold?

Coverage applies to:

  • Commercial plans (employer-sponsored)
  • Individual marketplace plans
  • Medicare Advantage plans
  • Some Medicaid managed care plans
Note: Self-funded employer plans may have different requirements. Check your specific plan documents or call the customer service number on your insurance card.

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescribing physician (typically a geneticist, nephrologist, or metabolic specialist) must submit the prior authorization request. Patients cannot submit PA requests directly.

How to Submit

Primary method: UnitedHealthcare Provider Portal using the Prior Authorization/Notification tool

Alternative methods:

  • Phone: 888-397-8129
  • Fax: (verify current number with provider portal)

Required Documentation

Your doctor must include:

  • Confirmed Fabry disease diagnosis with ICD-10 code E75.21
  • GLA variant documentation showing amenable variant per in vitro assay
  • Clinical notes supporting medical necessity
  • Confirmation patient is NOT receiving concurrent Fabrazyme or Elfabrio

Timing and Deadlines

Timeline Standard Expedited
UnitedHealthcare Decision 15 business days 72 hours
Internal Appeal 30 days 72 hours
External Review (Washington) 45 days 72 hours

When to Request Expedited Review

Request expedited review if:

  • Delay could seriously jeopardize your health
  • You're currently on treatment and facing interruption
  • Your condition is rapidly progressing

Clinical Criteria

Initial Authorization Requirements

Galafold is approved if all criteria are met:

  1. Confirmed Fabry disease diagnosis
  2. Amenable GLA variant confirmed by in vitro assay data
  3. No concurrent enzyme replacement therapy (Fabrazyme or Elfabrio)

What Counts as an Amenable Variant?

Your genetic test must show that your specific GLA mutation responds to migalastat in laboratory testing. The FDA label lists amenable variants, but your doctor should confirm through the assay data.

Step Therapy Requirements

UnitedHealthcare may require you to try and fail enzyme replacement therapy (Fabrazyme or Elfabrio) before approving Galafold, unless:

  • You have contraindications to ERT
  • You've developed antibodies to ERT
  • Your doctor provides compelling clinical rationale for Galafold as first-line therapy

Costs and Financial Assistance

Patient Financial Responsibility

Your out-of-pocket costs depend on:

  • Your plan's formulary tier for Galafold
  • Whether you've met your deductible
  • Your copay or coinsurance percentage
  • Any quantity limits

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

Financial Assistance Options

Amicus Patient Assistance Program

  • Provides Galafold at no cost for eligible uninsured/underinsured patients
  • Contact: 1-833-264-2872 or visit AMICUSASSIST.com
  • Includes dedicated Patient Education Liaison and Case Manager

Prescription Hope

  • $60/month regardless of insurance
  • Income guidelines: ≤$50K individual, ≤$70K household
  • Works alongside UnitedHealthcare coverage

Denials and Appeals

Common Denial Reasons

Denial Reason How to Fix
Missing amenable variant proof Submit genetic test results showing in vitro assay data
Non-amenable variant Request exception with clinical justification
Concurrent ERT use Confirm you're not receiving Fabrazyme or Elfabrio
Insufficient documentation Provide complete medical records and specialist letter

Appeals Process in Washington

Level 1: Internal Appeal

  • Deadline: 180 days from denial notice
  • Timeline: 30 days (standard) or 72 hours (expedited)
  • How to file: UnitedHealthcare member portal, phone 1-877-542-8997, or fax 1-801-994-1082

Level 2: External Review

  • When: After final internal denial
  • Deadline: 180 days from final internal denial
  • Contact: Washington Office of the Insurance Commissioner at 1-800-562-6900
  • Timeline: 45 days (standard) or 72 hours (expedited)
  • Cost: Free to patient
Washington Advantage: The state's external review process uses independent medical experts who often specialize in rare diseases, making it highly effective for overturning inappropriate denials.

Clinician Corner: Medical Necessity Letter

Your specialist should include:

  • Problem statement: Fabry disease diagnosis with specific symptoms
  • Prior treatments: Any previous ERT trials and outcomes
  • Clinical rationale: Why Galafold is medically necessary
  • Guideline citations: FDA labeling, genetic test results
  • Dosing plan: 123 mg every other day with fasting requirements
  • Monitoring plan: Regular kidney function and clinical assessments

Renewals and Reauthorization

When to Reauthorize

Submit reauthorization requests 30-60 days before your current approval expires. Each approval is valid for 12 months.

Reauthorization Requirements

UnitedHealthcare requires documentation of:

  1. Positive clinical response to Galafold therapy
  2. No concurrent ERT use (Fabrazyme or Elfabrio)

Clinical Response Documentation

Your specialist should provide:

  • Current eGFR lab results (within 3 months)
  • Clinical assessment showing improvement or stabilization
  • Rationale for continuing oral therapy vs. switching to ERT

Specialty Pharmacy

Why Was My Prescription Transferred?

High-cost medications like Galafold are often transferred to specialty pharmacies that:

  • Provide enhanced patient support services
  • Ensure proper storage and handling
  • Coordinate with insurance for authorization
  • Offer financial assistance program enrollment

OptumRx Specialty Pharmacy

If your prescription is transferred to OptumRx (UnitedHealthcare's specialty pharmacy):

  • You'll receive direct contact from a specialty pharmacist
  • Delivery is typically within 2-3 business days
  • Patient support services are included at no extra cost

Troubleshooting

Provider Portal Issues

If your doctor can't access the UnitedHealthcare Provider Portal:

  • Call provider services at 888-397-8129
  • Verify portal registration and credentials
  • Use alternative fax submission if urgent

Missing Forms or Documentation

Common missing items:

  • Genetic test results showing amenable variant
  • Specialist consultation notes
  • Prior therapy documentation
  • Current lab values (eGFR, cardiac function)

When to Contact Washington Regulators

Contact the Washington Office of the Insurance Commissioner at 1-800-562-6900 if:

  • UnitedHealthcare misses appeal deadlines
  • You need help with the external review process
  • You believe your denial was inappropriate

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in Washington? Standard PA decisions take 15 business days. Expedited requests are decided within 72 hours if your health could be seriously jeopardized by delays.

What if Galafold is non-formulary on my plan? You can request a formulary exception with clinical justification. Your doctor must demonstrate medical necessity and that covered alternatives are inappropriate.

Can I request an expedited appeal? Yes, if delays could seriously jeopardize your health or you're facing treatment interruption. Both internal appeals and external reviews can be expedited to 72 hours.

Does step therapy apply if I've tried ERT outside Washington? Yes, prior therapy documentation from any location counts toward step therapy requirements. Provide complete records of previous treatments and outcomes.

What happens if my external review is denied? External review decisions are binding on UnitedHealthcare. If denied, you may seek legal counsel or contact the Washington OIC for guidance on additional options.

How much will I pay out-of-pocket? Costs vary by plan. Contact UnitedHealthcare customer service (number on your insurance card) for your specific copay or coinsurance amount.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform streamlines the prior authorization and appeals process by analyzing denial letters, plan policies, and clinical notes to create compelling rebuttal letters that address payers' specific criteria and requirements.

For Galafold appeals, having the right documentation and understanding UnitedHealthcare's specific requirements can make the difference between approval and denial. If you're facing a complex denial, consider working with experienced healthcare advocates who understand both the clinical evidence and payer requirements for rare disease medications like Galafold.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies and requirements may change. Verify current information with UnitedHealthcare and the Washington Office of the Insurance Commissioner before making healthcare decisions.

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