By Counterforce Health Team in Fabrazyme (agalsidase beta) —

How to Get Fabrazyme (Agalsidase Beta) Covered by Blue Cross Blue Shield in Washington: Complete PA Guide

Quick Answer: Getting Fabrazyme Covered by Blue Cross Blue Shield in Washington

Fabrazyme (agalsidase beta) requires prior authorization from Blue Cross Blue Shield in Washington and is typically covered as a specialty medication when medical necessity criteria are met. The fastest path to approval: (1) Ensure genetic or biochemical confirmation of Fabry disease, (2) Submit complete prior authorization with specialist documentation, and (3) Use in-network specialty pharmacy (Accredo or CVS Specialty). If denied, Washington's external review process through the Office of Insurance Commissioner provides binding independent review within 30 days.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Network
  5. Cost-Share Dynamics
  6. Submission Process
  7. Appeals Process in Washington
  8. Common Denial Reasons & Solutions
  9. When to Escalate
  10. FAQ

Plan Types & Coverage Implications

Blue Cross Blue Shield operates through 33 independent plans across the country, with Premera Blue Cross and Regence BlueShield serving as the primary Blue plans in Washington state. Your specific coverage for Fabrazyme depends on your plan type:

Commercial Plans (HMO/PPO/EPO): All require prior authorization for Fabrazyme, with specialty pharmacy dispensing mandatory. PPO plans may offer more flexibility in specialist selection, while HMO plans typically require referrals to geneticists or metabolic specialists.

Medicare Advantage: Subject to Medicare Part B coverage rules for infused medications, with additional plan-specific prior authorization requirements and formulary placement.

Medicaid (Apple Health): Washington's expanded Medicaid program covers Fabrazyme through managed care organizations, each with their own prior authorization processes.

Note: Self-funded employer plans may follow different appeals processes under ERISA, though many voluntarily use Washington's external review system.

Formulary Status & Tier Placement

Fabrazyme is typically placed on the specialty tier of Blue Cross Blue Shield formularies due to its high cost and specialized indication. Based on current formulary documents, this means:

  • Specialty Tier Placement: Higher copayment or coinsurance rates compared to generic or preferred brand medications
  • Prior Authorization Always Required: No exceptions for any indication
  • Specialty Pharmacy Dispensing: Must use contracted specialty pharmacy network
  • Annual Renewal: Authorization typically valid for one plan year, requiring renewal with updated clinical documentation

The exact tier placement and cost-sharing can vary between Premera Blue Cross and Regence BlueShield plans. Check your specific plan's formulary through your member portal or by calling member services.

Prior Authorization Requirements

Essential Documentation Needed

For Males with Fabry Disease:

  • Low alpha-galactosidase A enzyme activity (blood or leukocyte testing)
  • GLA gene sequencing showing pathogenic variant
  • Clinical symptoms consistent with Fabry disease
  • Specialist evaluation (geneticist, metabolic specialist, or nephrologist)

For Females with Fabry Disease:

  • GLA gene sequencing is required (enzyme activity unreliable due to X-inactivation)
  • Pathogenic or likely pathogenic GLA variant identification
  • Clinical presentation and family history documentation
  • Specialist confirmation of diagnosis

Additional Supporting Evidence:

  • Lyso-Gb3 biomarker levels (when available)
  • Documentation of organ involvement (kidney, heart, nervous system)
  • Treatment goals and monitoring plan
Tip: Incomplete genetic or biochemical confirmation is the most common reason for initial denial. Ensure all diagnostic testing is complete before submitting.

Specialty Pharmacy Network

Blue Cross Blue Shield contracts with two primary specialty pharmacies for Fabrazyme:

Accredo Specialty Pharmacy

  • Phone: 1-888-608-9010
  • Services: Home infusion coordination, case management, nursing support
  • Enrollment: Provider-initiated with patient consent

CVS Specialty

  • Phone: 1-800-237-2767
  • Website: CVSSpecialty.com for enrollment forms
  • Services: Infusion center network, home health coordination, 24/7 support

Patient Enrollment Process:

  1. Provider submits prescription and enrollment forms
  2. Specialty pharmacy verifies insurance and prior authorization
  3. Coordinates infusion site (home or infusion center)
  4. Manages ongoing shipments and refills

Using out-of-network pharmacies will result in significantly higher out-of-pocket costs or complete denial of coverage.

Cost-Share Dynamics

Typical Cost Structure for Specialty Tier:

  • Preferred Specialty Drugs: Often $75 copay per 30-day supply
  • Non-Preferred Specialty Drugs: Up to 50% coinsurance
  • Deductible: May apply before copay/coinsurance kicks in
  • Out-of-Pocket Maximum: Annual limit provides protection from catastrophic costs

Cost-Saving Options:

  • Sanofi Patient Assistance: Contact Sanofi at 1-800-633-1610 for copay assistance programs
  • State Pharmaceutical Assistance: Washington has limited programs for specialty medications
  • Foundation Grants: National Fabry Disease Foundation may provide guidance on assistance programs
Important: This information is educational only. Consult your specific plan documents for exact cost-sharing details.

Submission Process

Step-by-Step Prior Authorization

Step 1: Gather Documentation (Patient/Provider)

  • Insurance card and member ID
  • Complete diagnostic workup results
  • Specialist consultation notes
  • Prior treatment history (if applicable)

Step 2: Complete PA Form (Provider)

  • Submit through Blue Cross Blue Shield provider portal
  • Include all required clinical documentation
  • Specify dosing: 1 mg/kg every 2 weeks by IV infusion

Step 3: Submit and Track (Provider/Patient)

  • Standard review: 14 business days
  • Expedited review available for urgent cases
  • Track status through provider portal or member services

Step 4: Coordinate Specialty Pharmacy (Upon Approval)

  • Provider sends prescription to Accredo or CVS Specialty
  • Patient enrollment and infusion scheduling
  • Insurance verification and benefits coordination

Appeals Process in Washington

Washington state provides robust appeal rights for insurance denials, including specialty medications like Fabrazyme.

Internal Appeals (Required First Step)

  • Timeline: Must file within 180 days of denial
  • Process: Submit through Blue Cross Blue Shield appeals department
  • Documentation: Include additional clinical evidence, specialist letters, published guidelines

External Review (Independent Review Organization)

Washington's external review process is particularly strong for rare disease medications:

  • When to Use: After exhausting internal appeals or for urgent denials
  • Timeline: Request within 4 months of final internal denial
  • Process: Office of Insurance Commissioner assigns certified IRO within 3 business days
  • Decision: Binding on insurer, typically within 30 days (72 hours for expedited)
  • Cost: No cost to patient

Key Advantage: IRO medical reviewers can override insurer medical necessity standards if deemed unreasonable or inconsistent with evidence-based practice.

Contact Information

  • Blue Cross Blue Shield Appeals: Check your EOB or member services for specific appeals address
  • Washington OIC Consumer Advocacy: 1-800-562-6900
  • External Review Requests: Submit to OIC or directly to your insurer

Common Denial Reasons & Solutions

Denial Reason How to Address Required Documentation
Insufficient diagnostic confirmation Submit complete genetic testing GLA gene sequencing with pathogenic variant
Not prescribed by specialist Obtain specialist consultation Geneticist, metabolic specialist, or nephrologist evaluation
Missing clinical documentation Provide comprehensive medical records Symptom documentation, organ involvement, treatment history
Step therapy requirements Document contraindications to alternatives Medical necessity letter explaining why alternatives inappropriate
Quantity/frequency limits Justify standard dosing protocol FDA labeling, clinical guidelines supporting 1mg/kg q2w

When to Escalate

Contact Washington Office of Insurance Commissioner if:

  • Internal appeals process exceeds timeframes
  • Insurer fails to provide required appeal information
  • External review request is improperly denied
  • Procedural violations in appeals process

Office of Insurance Commissioner:

  • Phone: 1-800-562-6900
  • Website: insurance.wa.gov
  • Services: Consumer advocacy, complaint investigation, external review coordination

The OIC maintains a rotational registry of certified IROs and can provide guidance on the appeals process specific to specialty medications.

FAQ

How long does Blue Cross Blue Shield prior authorization take in Washington? Standard prior authorization decisions are made within 14 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if Fabrazyme is non-formulary on my plan? Submit a formulary exception request with medical necessity documentation. If denied, the appeals process and external review options remain available.

Can I request an expedited appeal? Yes, if the delay in treatment would seriously jeopardize your health or ability to regain maximum function. Both internal and external expedited appeals are available.

Does step therapy apply to Fabrazyme? Step therapy is rarely imposed for enzyme replacement therapy in Fabry disease, but some plans may require documentation of why oral alternatives (like Galafold) are inappropriate.

What happens if my appeal is denied? After exhausting internal appeals, you can request external review through Washington's IRO system. The IRO decision is binding on the insurer.

How much does Fabrazyme cost without insurance? Cash prices are approximately $1,100 per 5-mg vial and $7,600 per 35-mg vial, with typical treatment requiring multiple vials per infusion.

From our advocates: "We've seen Fabrazyme appeals succeed when families work closely with their specialist to document not just the genetic diagnosis, but also the clinical progression and specific symptoms. The key is painting a complete picture of medical necessity that goes beyond just having the right gene variant. Washington's external review process has been particularly effective for rare disease cases where the initial denial seemed to misunderstand the condition."

At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Our platform identifies the specific denial basis and drafts point-by-point appeals aligned with each plan's own rules, incorporating the right citations from FDA labeling, peer-reviewed studies, and specialty guidelines.

For complex cases like Fabrazyme denials, Counterforce Health can help ensure your appeal includes all required clinical facts, appropriate diagnostic codes, and operational details that payers expect, while meeting Washington's specific procedural requirements for coverage determinations and external review.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies vary by plan and change frequently. Always verify current requirements with your specific Blue Cross Blue Shield plan and consult with your healthcare provider regarding treatment decisions. For assistance with insurance appeals and coverage issues, contact the Washington Office of Insurance Commissioner at 1-800-562-6900.

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