By Counterforce Health Team in Elelyso (taliglucerase alfa) —

How to Get Elelyso (taliglucerase alfa) Covered by Aetna CVS Health in Virginia: Complete Guide with Forms and Appeal Process

Quick Answer: Getting Elelyso Covered by Aetna CVS Health in Virginia

Elelyso (taliglucerase alfa) requires prior authorization from Aetna CVS Health in Virginia and is typically not on standard formularies. Here's your fastest path to approval:

  1. Confirm diagnosis with enzyme deficiency or genetic testing results
  2. Submit prior authorization through CVS Specialty Pharmacy with complete clinical documentation
  3. If denied, appeal within 180 days using Virginia's external review process

Your first step today: Call Aetna member services (number on your ID card) to verify formulary status and request PA forms. Virginia residents have strong appeal rights through the State Corporation Commission if initial requests are denied.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Alternatives
  3. Prior Authorization Requirements
  4. CVS Specialty Pharmacy Setup
  5. Step-by-Step Approval Process
  6. Appeals Process in Virginia
  7. Cost Considerations
  8. When to Escalate
  9. FAQ

Plan Types & Coverage Implications

Aetna CVS Health operates several plan types in Virginia, each with different coverage rules for specialty medications like Elelyso:

Commercial Plans (Individual/Employer)

  • Require prior authorization for all Gaucher disease treatments
  • Must use CVS Specialty Pharmacy for Elelyso
  • Subject to Virginia insurance regulations for appeals

Medicare Advantage (HMO/PPO)

Medicaid (Aetna Better Health)

  • Coverage varies by state Medicaid formulary
  • Additional state-level approval may be required
Note: Virginia expanded Medicaid in 2019, improving access to specialty drugs. If you qualify for Medicaid, check if Aetna Better Health Virginia covers Elelyso before pursuing commercial coverage.

Formulary Status & Alternatives

Current Coverage Status

Based on 2024 formulary data, Elelyso is not listed as a covered drug on Aetna's standard Virginia formularies. This means you'll likely need to:

  • Request a formulary exception
  • Demonstrate medical necessity
  • Show inadequate response to covered alternatives

Covered Alternatives

Aetna typically covers these Gaucher disease treatments first:

Drug Generic Name Typical Tier PA Required
Cerezyme imiglucerase Specialty Yes
Vpriv velaglucerase alfa Specialty Yes
Cerdelga eliglustat Specialty Yes (adults only)

Medical Necessity Criteria

Aetna considers Gaucher disease treatment medically necessary when:

  • Confirmed diagnosis via enzyme deficiency OR genetic testing
  • Prescribed by specialist familiar with lysosomal storage disorders
  • FDA-approved dosing and administration
  • Clinical documentation of disease manifestations

Prior Authorization Requirements

Required Documentation

To get Elelyso approved, you'll need comprehensive clinical documentation:

Diagnostic Confirmation

  • Beta-glucocerebrosidase enzyme activity results showing deficiency
  • OR genetic testing confirming GBA gene mutations
  • Clinical notes documenting Gaucher disease manifestations

Treatment History

  • Documentation of trials with covered alternatives (if applicable)
  • Reasons for inadequate response or intolerance
  • Previous treatment outcomes and side effects

Prescriber Information

  • Must be prescribed by hematologist, geneticist, or specialist experienced with Gaucher disease
  • Prescriber attestation of medical necessity
  • Treatment plan and monitoring schedule

Submission Process

Submit PA requests through Aetna's provider portal or via:

  • Fax: Check your specific plan's PA fax number
  • Phone: Aetna provider services for urgent requests
  • Online: Availity or Aetna provider portal
Tip: Submit PA requests 2-3 weeks before treatment start date to allow processing time.

CVS Specialty Pharmacy Setup

Since Elelyso requires specialty handling, you must use CVS Specialty Pharmacy. Here's the enrollment process:

Patient Enrollment Requirements

Complete the Lysosomal Storage Disorders enrollment form with:

  • Full patient demographics and contact information
  • Insurance information and member ID
  • Prescriber details including NPI and DEA numbers
  • Clinical information and diagnosis codes
  • Site of care designation (home, clinic, hospital)

Submission Methods

  • Fax: 1-800-323-2445
  • Email: [email protected]
  • Electronic: Through your EMR system if integrated

Setup Timeline

  • Standard enrollment: 3-5 business days
  • Expedited enrollment available for urgent cases
  • CVS Specialty will coordinate PA submission with Aetna

Step-by-Step Approval Process

Step 1: Verify Coverage (Patient/Clinic Staff)

  • Call Aetna member services (number on ID card)
  • Confirm formulary status for your specific plan
  • Request PA forms if not available online
  • Timeline: Same day

Step 2: Gather Documentation (Clinic)

  • Collect diagnostic test results
  • Document treatment history and failures
  • Prepare prescriber attestation letter
  • Timeline: 1-2 days

Step 3: Submit PA Request (Prescriber)

  • Complete Aetna PA forms
  • Submit through provider portal or fax
  • Include all supporting documentation
  • Timeline: 1 day to submit

Step 4: Aetna Review Process

  • Standard review: 15 business days
  • Expedited review: 72 hours (if urgent)
  • May request additional information
  • Timeline: 2-3 weeks typically

Step 5: CVS Specialty Coordination

  • If approved, CVS Specialty processes prescription
  • Coordinates delivery and nursing services
  • Sets up patient support programs
  • Timeline: 3-5 days after approval

Appeals Process in Virginia

If Aetna denies your Elelyso request, Virginia provides strong appeal rights:

Internal Appeals

Standard Appeal Timeline:

  • Pre-service denials: 30 days for Aetna decision
  • Post-service denials: 60 days for Aetna decision
  • Must exhaust internal appeals before external review

Expedited Appeals:

  • Available if delay could jeopardize health
  • Aetna must decide within 72 hours
  • Requires physician certification of urgency

External Review Process

Virginia's Bureau of Insurance External Review provides independent review:

Key Details:

  • Filing deadline: 120 days from final Aetna denial
  • Standard review: 45 days for IRO decision
  • Expedited review: 72 hours for urgent cases
  • Cost: Free to Virginia residents
  • Decision: Binding on Aetna

Required Forms:

From our advocates: We've seen many Virginia patients successfully overturn specialty drug denials through external review. The key is submitting complete clinical documentation that clearly demonstrates medical necessity and any failures with alternative treatments.

Cost Considerations

Insurance Coverage

  • Specialty tier copays typically range $50-$500+ per month
  • Deductible may apply before coverage begins
  • Out-of-pocket maximums provide annual protection

Patient Assistance Options

Pfizer Patient Assistance Program

  • Income-based eligibility
  • May provide free or reduced-cost medication
  • Apply through Pfizer RxPathways

Copay Assistance

  • Available for commercially insured patients
  • May reduce monthly copays significantly
  • Check eligibility restrictions

Foundation Grants

  • National Organization for Rare Disorders (NORD)
  • HealthWell Foundation
  • Patient Advocate Foundation

When to Escalate

Contact Virginia regulators if you experience:

  • Repeated denials without proper review
  • Missed appeal deadlines by Aetna
  • Lack of response to urgent requests
  • Procedural violations

Virginia Bureau of Insurance Consumer Services

  • Phone: 1-877-310-6560
  • Online complaint form available
  • Free assistance with insurance disputes

Counterforce Health specializes in turning insurance denials into successful appeals through evidence-based advocacy. Their platform helps patients and clinicians navigate complex prior authorization requirements and craft compelling appeals that align with payer policies. Learn more about their services for specialty drug coverage challenges.

FAQ

Q: How long does Aetna CVS Health prior authorization take in Virginia? A: Standard PA reviews take 15 business days. Expedited reviews for urgent cases are completed within 72 hours if your doctor certifies that treatment delay could jeopardize your health.

Q: What if Elelyso isn't on my Aetna formulary? A: You can request a formulary exception by demonstrating medical necessity and providing clinical documentation. Your doctor must show why covered alternatives aren't appropriate for your case.

Q: Can I get expedited approval if I'm currently on Elelyso? A: Yes, if you're already receiving treatment and interruption could harm your health, request expedited review with physician certification of medical urgency.

Q: Does Virginia require step therapy for Gaucher disease treatments? A: Step therapy requirements vary by plan type. Commercial plans may require trials of preferred agents first, but exceptions are available with proper documentation of medical necessity.

Q: What happens if my external review is denied? A: External review decisions are final and binding. However, you retain the right to pursue other legal remedies if you believe there were procedural violations or discrimination.

Q: Can I use manufacturer copay assistance with Aetna? A: Copay assistance availability depends on your specific plan design. Commercial plans typically allow manufacturer assistance, while government plans (Medicare, Medicaid) may not.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always verify current requirements with Aetna CVS Health and consult with your healthcare provider about treatment decisions. For personalized assistance with insurance appeals and prior authorization challenges, Counterforce Health provides specialized support to help patients access necessary medications.

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