By Counterforce Health Team in Fabrazyme (agalsidase beta) —

How to Get Fabrazyme (agalsidase beta) Covered by Aetna in Washington: Complete Prior Authorization and Appeals Guide

Answer Box: Fabrazyme (agalsidase beta) requires prior authorization from Aetna in Washington. Your fastest path: 1) Have your specialist complete Aetna's PA form with genetic testing results and organ involvement documentation, 2) Submit via provider portal or fax, and 3) If denied, file internal appeal within 60-180 days, then request external review through Washington's IRO system within 120 days. Start today by calling Aetna member services to confirm your plan's exact PA requirements and forms.

Table of Contents

Coverage Basics

Is Fabrazyme covered by Aetna?

Fabrazyme (agalsidase beta) is typically covered by Aetna under the medical benefit as a specialty infusion medication, but prior authorization is required for most commercial and ACA plans. The medication is manufactured by Sanofi and approved by the FDA for treating Fabry disease in adults and children 2 years and older.

Which Aetna plans cover Fabrazyme?

Most Aetna commercial plans, including those purchased through Washington Healthplanfinder, cover Fabrazyme with prior authorization. Medicare Advantage plans through Aetna also typically provide coverage. Medicaid managed care plans (Apple Health) in Washington may have different criteria - verify with your specific plan.

Note: Self-funded employer plans administered by Aetna may have different coverage rules. Check your Summary Plan Description or contact HR for specific coverage details.

The Prior Authorization Process

Who submits the prior authorization?

Your prescribing physician or their office staff submits the PA request. For Fabrazyme, this is typically a specialist in genetics, nephrology, cardiology, or metabolic diseases who has experience treating Fabry disease.

Step-by-Step: Fastest Path to Approval

  1. Confirm coverage (Patient): Call the number on your Aetna ID card to verify Fabrazyme is covered under your specific plan and obtain the correct PA form.
  2. Gather documentation (Clinic): Collect genetic testing results, enzyme activity levels, clinical notes showing organ involvement, and prior treatment history.
  3. Complete PA form (Prescriber): Submit via Aetna provider portal or fax the completed specialty drug PA form with all supporting documentation.
  4. Track submission (Both): Follow up within 3-5 business days to ensure receipt and check decision timeline.
  5. Receive decision (Patient): Standard decisions typically come within 3-5 calendar days for electronic submissions, 14 days for paper submissions.
  6. If approved: Coordinate with CVS Specialty or your preferred specialty pharmacy for infusion scheduling and delivery.
  7. If denied: Review denial letter carefully and prepare appeal with additional documentation addressing specific denial reasons.

Timing and Deadlines

How long does prior authorization take?

  • Standard PA: 3-5 calendar days for electronic submissions, up to 14 days for paper submissions
  • Expedited PA: 24-72 hours when medical urgency is documented
  • Appeal decisions: 14 days for standard internal appeals, 72 hours for expedited appeals

What if it's urgent?

If delay could seriously harm your health, your doctor can request an expedited review. Include a letter from your specialist explaining why immediate treatment is medically necessary to prevent organ damage or serious complications.

Washington State Advantage: Washington requires faster appeal timelines than federal minimums - standard external reviews must be decided within 15 calendar days, with expedited reviews completed within 72 hours.

Clinical Criteria and Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
PA Required Prior authorization mandatory Member ID card, benefits summary Aetna Precert List
Genetic Testing Pathogenic GLA mutation required Lab report from CLIA-certified facility Clinical documentation
Specialist Prescriber Genetics, nephrology, cardiology, or metabolic specialist Provider credentials in PA form PA submission requirements
Organ Involvement Evidence of renal, cardiac, or neurologic manifestations Clinical notes, imaging, lab results Medical records
Dosing Limits 1 mg/kg every 2 weeks, weight-based maximum FDA labeling, clinical guidelines FDA Label

What counts as medical necessity for Fabrazyme?

Aetna typically requires confirmed Fabry disease diagnosis plus evidence of organ involvement or high-risk status that would benefit from enzyme replacement therapy, as supported by clinical guidelines and FDA labeling.

Clinician Corner: Medical Necessity Letter Checklist

Your specialist's letter should include:

  • Confirmed diagnosis: Pathogenic or likely pathogenic GLA gene mutation with lab report
  • Clinical manifestations: Specific organ involvement (renal, cardiac, neurologic) with supporting test results
  • Disease progression: Evidence of worsening symptoms or organ function without treatment
  • Treatment rationale: Why Fabrazyme is medically necessary and appropriate for this patient's specific mutation and phenotype
  • Monitoring plan: How treatment response will be assessed and safety monitored
  • Guideline support: Reference to FDA labeling and relevant clinical practice guidelines

Understanding Costs

Fabrazyme is expensive - approximately $1,100 per 5-mg vial and $7,600 per 35-mg vial at cash-pay prices. Your out-of-pocket costs depend on your specific Aetna plan's cost-sharing structure.

Savings Options:

  • Manufacturer support: Sanofi offers copay assistance and patient assistance programs for eligible patients
  • Foundation grants: Several rare disease foundations provide financial assistance
  • CVS Specialty support: May help coordinate manufacturer programs and identify additional resources
Important: Copay cards typically cannot be used with Medicare, Medicaid, or other government insurance programs.

Denials and Appeals

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"No genetic confirmation" Submit complete GLA gene sequencing report from CLIA-certified lab
"Insufficient organ involvement" Provide detailed specialist notes documenting renal, cardiac, or neurologic manifestations
"Not medically necessary" Include literature showing ERT benefits for patient's specific phenotype and mutation
"Step therapy required" Request exception with documentation of contraindications to preferred alternatives
"Experimental/investigational" Cite FDA approval and established clinical guidelines supporting use

Appeals Playbook for Aetna in Washington

Level 1 - Internal Appeal

  • Deadline: 60-180 days from denial (check your specific plan)
  • How to file: Submit via Aetna member portal or mail written appeal
  • Timeline: 14 days for standard, 72 hours for expedited
  • Required: Denial letter, additional clinical documentation, specialist letter

Level 2 - External Review (IRO)

  • Deadline: 120 days from final internal denial
  • How to file: Request through Washington Office of Insurance Commissioner or notify Aetna
  • Timeline: 15 calendar days for standard, 72 hours for expedited
  • Binding: IRO decision is final and binding on Aetna
From our advocates: We've seen many Fabrazyme appeals succeed at the external review level when the specialist provides detailed documentation linking the patient's specific GLA mutation to their clinical manifestations and explains why enzyme replacement therapy is necessary to prevent irreversible organ damage. The key is addressing each denial reason point-by-point with objective evidence.

Renewal Requirements

When do I need to renew authorization?

Most Aetna plans require annual reauthorization for Fabrazyme. Some plans may approve for longer periods based on clinical stability.

What's needed for renewal?

  • Evidence of treatment adherence (infusion records)
  • Clinical notes showing stable or improved organ function
  • Continued specialist oversight
  • Documentation of no unacceptable side effects

What if my situation changes?

Notify your prescriber if you experience significant side effects, have changes in kidney or heart function, or need to modify dosing. These changes may require a new PA submission.

CVS Specialty Pharmacy Process

Why was my prescription transferred to CVS Specialty?

Aetna often requires specialty medications like Fabrazyme to be filled through CVS Specialty Pharmacy for cost management and clinical coordination.

Enrollment Process:

  1. Your prescriber completes a CVS Specialty enrollment form
  2. CVS Specialty conducts benefits verification and PA submission
  3. A care team is assigned to coordinate infusion scheduling and nursing support
  4. Temperature-controlled delivery is arranged to your infusion site

What to expect: CVS Specialty will contact you to verify insurance, schedule deliveries, and provide ongoing support throughout treatment.

Troubleshooting Common Issues

Provider portal down or not working? Contact Aetna provider services at the number on your member ID card for alternative submission methods.

Missing required forms? All current PA forms are available through the Aetna provider portal or by calling provider services.

Delayed response from Aetna? Washington state law requires timely PA decisions. If deadlines are missed, contact the Washington Office of Insurance Commissioner consumer hotline at 1-800-562-6900.

Peer-to-peer review needed? Your specialist can request to speak directly with an Aetna medical director. This often helps resolve complex cases where written documentation alone isn't sufficient.

FAQ

How long does Aetna PA take in Washington? Standard electronic PA submissions typically receive decisions within 3-5 calendar days. Paper submissions may take up to 14 days. Expedited reviews are completed within 24-72 hours when medical urgency is documented.

What if Fabrazyme is non-formulary on my plan? You can request a formulary exception with clinical justification from your specialist. The process is similar to PA but requires additional documentation explaining why formulary alternatives are not appropriate.

Can I request an expedited appeal? Yes, if delay could seriously jeopardize your health. Your doctor must provide written certification that expedited review is medically necessary to prevent serious harm.

Does step therapy apply if I've tried treatments outside Washington? Prior treatment history from other states typically counts toward step therapy requirements. Provide complete documentation of previous therapies tried and outcomes.

What happens if my appeal is denied? After exhausting Aetna's internal appeals, you can request external review through Washington's IRO system. The IRO decision is binding on Aetna and often provides a fresh perspective from independent medical experts.

How do I know if my plan is subject to Washington state appeals rules? Most individual and small group plans purchased in Washington are subject to state rules. Large employer self-funded plans may use federal ERISA appeal processes instead. Check your Summary Plan Description or contact HR.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed responses that align with each plan's specific requirements. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals with the right clinical evidence and procedural compliance for better outcomes.

When to Escalate

If you're having trouble with Aetna's appeal process or believe your case isn't being handled properly, contact the Washington Office of Insurance Commissioner:

  • Consumer Hotline: 1-800-562-6900
  • Online: File a complaint
  • What to include: Denial letters, appeal submissions, timeline documentation, and correspondence with Aetna

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies and appeal processes can change. Always verify current requirements with your specific Aetna plan and consult with your healthcare provider for medical decisions. For personalized assistance with appeals and prior authorization, consider working with advocacy services like Counterforce Health that specialize in insurance coverage for specialty medications.

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