By Counterforce Health Team in Symdeko / Symkevi (tezacaftor/ivacaftor) —

Getting Symdeko/Symkevi Covered by UnitedHealthcare in North Carolina: Complete Prior Authorization Guide

Answer Box: Getting Symdeko/Symkevi Covered by UnitedHealthcare in North Carolina

Symdeko (tezacaftor/ivacaftor) requires prior authorization from UnitedHealthcare in North Carolina. Your CF specialist must submit documentation including genetic testing results confirming eligible CFTR mutations (like F508del), diagnosis codes, and clinical notes. Initial approval lasts 6 months with reauthorization required thereafter. If denied, you have 180 days for internal appeals and can access North Carolina's Smart NC external review program within 120 days of final denial.

First step today: Contact your CF specialist to initiate the prior authorization request through UnitedHealthcare's provider portal or by calling 866-889-8054.

Table of Contents

  1. Is Symdeko/Symkevi Covered by UnitedHealthcare?
  2. Prior Authorization Process
  3. Timeline and Urgency
  4. Medical Necessity Criteria
  5. Out-of-Pocket Costs
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy Requirements
  9. North Carolina-Specific Resources
  10. Frequently Asked Questions

Is Symdeko/Symkevi Covered by UnitedHealthcare?

Yes, Symdeko (tezacaftor/ivacaftor) is covered by most UnitedHealthcare plans in North Carolina, but it requires prior authorization. The medication is typically classified as a Tier 5 specialty drug on UnitedHealthcare formularies, meaning it carries higher cost-sharing but is covered when medically necessary.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all plans UHC PA Requirements
Formulary Tier Tier 5 (Specialty) NC Exchange PDL
Step Therapy May require trial of alternatives Plan-specific
Quantity Limits 168 tablets per 84 days OptumRx guidelines
Age Requirement 6 years and older FDA labeling
Specialist Required CF specialist or pulmonologist UHC PA Form

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Genetic Testing Confirmation (Patient/Clinic)
    • Obtain FDA-cleared CFTR mutation test results
    • Must document F508del or other responsive mutations
    • Timeline: 1-2 weeks if not already completed
  2. Specialist Consultation (Patient)
    • Schedule appointment with CF specialist or pulmonologist
    • Ensure provider specializes in cystic fibrosis treatment
    • Timeline: 1-4 weeks depending on availability
  3. Prior Authorization Submission (Clinic)
  4. UnitedHealthcare Review (Automated)
    • Standard review: 3-5 business days
    • May request additional information
    • Timeline: Up to 14 days total
  5. Approval and Specialty Pharmacy (Patient/Clinic)
    • If approved, prescription transferred to OptumRx or approved specialty pharmacy
    • Patient contacted for delivery coordination
    • Timeline: 2-3 days for first shipment
Tip: Submit PA requests 3-4 weeks before medication is needed to account for potential delays or additional information requests.

Timeline and Urgency

Standard Timeline: UnitedHealthcare has 14 days to make coverage determinations for non-urgent requests. Most Symdeko approvals are processed within 3-5 business days when complete documentation is provided.

Expedited Review: For urgent situations where delays could seriously jeopardize health, request an expedited review. UnitedHealthcare must respond within 72 hours for urgent cases.

When to Request Expedited Review:

  • Current CFTR modulator therapy discontinued due to adverse effects
  • Rapid decline in pulmonary function
  • Hospitalization due to CF exacerbation

Medical Necessity Criteria

Required Documentation

Your CF specialist must provide:

Clinical Requirements:

  • Confirmed cystic fibrosis diagnosis with ICD-10 code E84.x
  • Laboratory results showing qualifying CFTR mutations
  • Age verification (6 years or older)
  • Documentation of specialist consultation

Genetic Testing Requirements:

  • FDA-cleared CF mutation test results
  • Must show at least one F508del mutation OR
  • One mutation responsive to tezacaftor/ivacaftor combination
  • If genotype unknown, bi-directional sequencing required

Step Therapy Considerations

UnitedHealthcare may require documentation of:

  • Previous trials with other CFTR modulators (Orkambi, Kalydeco, Trikafta)
  • Reasons for discontinuation or inadequate response
  • Contraindications to preferred alternatives
Note: Patients already stable on Symdeko may not be subject to step therapy requirements.

Out-of-Pocket Costs

Cost Structure: As a Tier 5 specialty medication, Symdeko typically requires coinsurance (percentage of drug cost) rather than a flat copay.

Typical Cost-Sharing:

  • Commercial plans: 20-50% coinsurance
  • Medicare Advantage: Varies by plan
  • Exchange plans: Subject to specialty tier limits

Annual Cost Considerations:

  • Wholesale cost: ~$25,000 per month
  • Your monthly cost: Could be $5,000-12,500 before reaching out-of-pocket maximum
  • 2025 out-of-pocket maximum: $2,000 for specialty drugs on many UnitedHealthcare plans

Financial Assistance Options

Vertex Patient Services: The manufacturer offers copay assistance and patient support programs. Contact 1-877-752-5933 or visit Vertex Patient Services.

Foundation Grants: Organizations like the Cystic Fibrosis Foundation may provide financial assistance for eligible patients.

Denials and Appeals

Common Denial Reasons & Solutions

Denial Reason How to Overturn
Missing genetic testing Submit FDA-cleared CFTR mutation test results
No specialist consultation Provide documentation from CF specialist or pulmonologist
Step therapy not met Document failure/intolerance to required alternatives
Age requirement Verify patient is 6 years or older
Incomplete clinical notes Submit comprehensive CF treatment history

UnitedHealthcare Appeals Process

Internal Appeals:

  • Deadline: 180 days from denial date
  • Method: Submit via UnitedHealthcare member portal, mail, or fax
  • Required: Original denial letter, supporting medical records, physician statement
  • Timeline: 30 days for standard appeals, 72 hours for expedited

Peer-to-Peer Review: Your doctor can request a direct consultation with UnitedHealthcare's medical director to discuss the case.

North Carolina External Review

If UnitedHealthcare upholds the denial after internal appeals, you can request external review through Smart NC.

Smart NC External Review Process:

  • Deadline: 120 days after final internal denial
  • Contact: 1-855-408-1212 or NC Department of Insurance
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Success Rate: External reviews overturn 40-60% of denials with strong clinical documentation
  • Binding: If Smart NC rules in your favor, UnitedHealthcare must provide coverage within 3 business days
From our advocates: We've seen cases where patients initially denied for Symdeko were approved after their CF specialist provided detailed documentation of genetic testing and previous treatment failures. The key was comprehensive medical records showing why alternatives weren't suitable. While outcomes vary, thorough preparation significantly improves approval chances.

Renewal Requirements

Initial Authorization: 6 months from approval date

Reauthorization Process:

  • Must be renewed before expiration
  • Requires updated specialist consultation
  • May need current pulmonary function tests
  • Same genetic testing requirements apply

Timeline for Renewal: Submit reauthorization requests 30 days before expiration to avoid treatment gaps.

Specialty Pharmacy Requirements

Why Specialty Pharmacy: Symdeko cannot be filled at retail pharmacies due to its specialty designation, storage requirements, and need for patient counseling.

UnitedHealthcare Preferred: OptumRx is the primary specialty pharmacy for UnitedHealthcare members. Your prescription will typically be transferred automatically after approval.

What to Expect:

  • Home delivery (usually within 2-3 days)
  • Clinical pharmacist consultation
  • Refill reminders and coordination
  • Temperature-controlled shipping

North Carolina-Specific Resources

Smart NC Consumer Assistance:

North Carolina Medicaid: If you're eligible for Medicaid expansion (effective 2024), coverage rules may differ from commercial UnitedHealthcare plans.

State Health Insurance Assistance Program (SHIIP): For Medicare beneficiaries, SHIIP provides free counseling on coverage options and appeals.

Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, payer-specific documentation. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and craft targeted appeals that address each insurer's specific criteria and procedural requirements.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in North Carolina? Standard reviews take 3-5 business days with complete documentation, up to 14 days maximum. Expedited reviews for urgent cases are completed within 72 hours.

What if Symdeko is non-formulary on my plan? Non-formulary drugs may still be covered with prior authorization and medical necessity documentation. You may also request a formulary exception with your doctor's support.

Can I request an expedited appeal in North Carolina? Yes, both UnitedHealthcare and Smart NC offer expedited reviews for urgent medical situations. Contact your insurer immediately if delays could jeopardize your health.

Does step therapy apply if I've tried alternatives outside North Carolina? Medical records from other states showing previous treatment failures should satisfy step therapy requirements. Ensure your CF specialist includes this documentation in the PA request.

What happens if Smart NC denies my external review? Smart NC decisions are binding on insurers. If denied, you've exhausted administrative appeals, though you may have other legal rights to pursue.

How do I find a CF specialist in North Carolina? Contact the Cystic Fibrosis Foundation for a list of accredited CF care centers in North Carolina, or ask your current pulmonologist for a referral.

For complex cases or repeated denials, Counterforce Health can help create targeted appeals that address UnitedHealthcare's specific requirements and improve your chances of approval.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always consult with your healthcare provider and insurance company for the most current information specific to your situation. For additional help with appeals and prior authorizations, contact Smart NC at 1-855-408-1212 or visit the North Carolina Department of Insurance website.

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