By Counterforce Health Team in Filsuvez (birch triterpenes topical gel) —

How to Get Filsuvez (Birch Triterpenes Gel) Covered by UnitedHealthcare in North Carolina: Complete Prior Authorization Guide

Answer Box: Getting Filsuvez Covered by UnitedHealthcare in North Carolina

Filsuvez requires prior authorization from UnitedHealthcare/OptumRx for epidermolysis bullosa wound care. To get approval in North Carolina: 1) Gather genetic testing confirming dystrophic or junctional EB, wound documentation, and specialist evaluation, 2) Submit PA request via UnitedHealthcare provider portal with all required documentation, 3) If denied, file internal appeal within 180 days, then external review through Smart NC within 120 days. Start today by contacting your dermatologist to begin collecting required documentation.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Filsuvez prescriptions UnitedHealthcare PA Form
Age Requirement Patient must be 6 months or older FDA label, UHC policy
Diagnosis Confirmed dystrophic or junctional EB with genetic testing UHC clinical criteria
Wound Criteria Partial-thickness wound, 10-50 cm², lasting 3+ weeks UHC policy documentation
Prescriber Dermatologist or EB specialist required UHC PA requirements
Step Therapy May require Vyjuvek trial/failure documentation OptumRx formulary
Appeals Deadline 180 days for internal, 120 days for external North Carolina insurance law

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis Documentation

Who does it: Your dermatologist or EB specialist
What's needed: Genetic testing results confirming dystrophic or junctional EB (COL7A1, LAMA3, LAMB3, LAMC2, or other relevant mutations)
Timeline: May take 2-4 weeks if not already completed

2. Document Your Wounds

Who does it: Your healthcare provider
What's needed: Clinical photos, measurements (10-50 cm²), wound age (≥3 weeks), confirmation no active infection
Submit to: Include with PA request

3. Gather Prior Treatment History

Who does it: You and your care team
What's needed: Documentation of previous wound care attempts, Vyjuvek trial/failure if applicable
Timeline: Collect within 1-2 weeks

4. Complete Prior Authorization Request

Who does it: Your prescriber
How to submit: UnitedHealthcare Provider Portal or fax completed forms
Expected timeline: 5-10 business days for standard review, 72 hours for urgent cases

5. Follow Up on Status

Who does it: You or your clinic
When: 3-5 business days after submission
How: Check provider portal or call UnitedHealthcare member services

6. Prepare for Potential Appeal

Who does it: You and your provider
When: Immediately upon any denial
What's needed: Additional clinical documentation, peer-to-peer review request

7. Use Smart NC if Internal Appeals Fail

Who does it: You (with free Smart NC assistance)
When: After exhausting internal appeals
Contact: 1-855-408-1212 for free advocacy support

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"Not medically necessary" Submit specialist letter with clinical rationale, wound photos, treatment history, and FDA indication confirmation
"Missing EB subtype confirmation" Provide genetic testing results or immunofluorescence mapping confirming dystrophic or junctional EB
"Step therapy not completed" Document Vyjuvek contraindication, failure, or intolerance with clinical notes and specialist attestation
"Non-specialist prescriber" Transfer prescription to dermatologist or obtain consultation letter from EB specialist
"Insufficient wound documentation" Submit clinical photos, precise measurements, wound age documentation, and infection status
"Quantity limits exceeded" Provide dosing rationale based on wound size and treatment protocol per FDA labeling

Appeals Playbook for North Carolina

Internal Appeals (UnitedHealthcare)

  • Level 1: 180 days from denial date
  • Level 2: Available if Level 1 denied
  • Timeline: 30 days standard, 72 hours expedited
  • How to file: Provider portal, written appeal, or fax
  • Required: Original denial letter, additional clinical documentation

Peer-to-Peer Review

Request within 5 business days of denial. Your prescriber can speak directly with a UnitedHealthcare medical director to present clinical rationale and unique circumstances.

External Review (Smart NC)

  • When: After exhausting internal appeals
  • Deadline: 120 days from final internal denial
  • Timeline: 45 days standard, 72 hours expedited
  • Cost: Free to consumers
  • Contact: Smart NC at 1-855-408-1212
  • Decision: Binding on UnitedHealthcare if approved
Note: Self-funded employer plans may not be eligible for Smart NC external review unless the employer opted into the state process. Verify eligibility with Smart NC.

Medical Necessity Documentation

Required Clinical Documentation

Your healthcare provider should include:

Patient Information:

  • Confirmed diagnosis of dystrophic or junctional epidermolysis bullosa
  • Genetic testing results (specific mutation identified)
  • Patient age (must be ≥6 months)

Wound Characteristics:

  • Clinical photographs showing wound appearance
  • Precise measurements (must be 10-50 cm²)
  • Wound duration (≥3 weeks but <9 months)
  • Confirmation of no active infection

Treatment History:

  • Previous wound care interventions and outcomes
  • Vyjuvek trial history if applicable (duration, response, reasons for discontinuation)
  • Current wound care regimen

Clinical Rationale:

  • Why Filsuvez is medically necessary for this patient
  • Expected treatment outcomes
  • Monitoring plan

Clinician Corner: Medical Necessity Letter Checklist

✓ Problem Statement: Clear description of EB subtype and wound characteristics
✓ Prior Treatments: Detailed history of previous therapies and outcomes
✓ Clinical Rationale: Why Filsuvez is appropriate based on FDA indication and clinical guidelines
✓ Guideline Citations: Reference to FDA labeling and relevant dermatology guidelines
✓ Dosing Plan: Application schedule aligned with wound size and dressing changes
✓ Monitoring: Plan for assessing treatment response and wound healing progress

When to Contact Smart NC

Contact Smart NC's free consumer assistance program at 1-855-408-1212 if:

  • Your internal appeals with UnitedHealthcare have been exhausted
  • You need help understanding your appeal rights in North Carolina
  • You require assistance completing external review forms
  • You want guidance on gathering additional medical evidence
  • You're unsure whether your plan qualifies for state external review

Smart NC provides free advocacy and can help you navigate the entire external review process, including form completion and communication with your insurer.

Cost-Saving Resources

Manufacturer Support:

  • Chiesi Total Care provides patient assistance and copay support programs
  • Prior authorization assistance available through manufacturer

Patient Assistance:

  • Verify eligibility for copay cards and foundation grants
  • Contact Chiesi Total Care for income-based assistance programs

Estimated Costs:

  • Retail price: Approximately $27,631 per month (varies by quantity)
  • With coverage: Cost depends on your specific UnitedHealthcare plan's specialty drug tier and copay structure

Counterforce Health helps patients navigate the complex prior authorization and appeals process by turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with each insurer's specific requirements, potentially saving weeks of back-and-forth with insurance companies.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in North Carolina? Standard prior authorization decisions are typically made within 5-10 business days. Urgent cases can be expedited to 72 hours if medical urgency is documented.

What if Filsuvez is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and lack of suitable alternatives. Include comprehensive clinical documentation and specialist support.

Can I request an expedited appeal in North Carolina? Yes, if delay would seriously jeopardize your health or ability to regain function. Both UnitedHealthcare internal appeals and Smart NC external reviews offer expedited timelines (72 hours).

Does step therapy apply if I failed treatments outside North Carolina? Yes, prior treatment history from other states is valid. Provide documentation of previous therapies, including Vyjuvek trials, regardless of where treatment occurred.

What happens if Smart NC approves my external review? The decision is binding on UnitedHealthcare. They must provide coverage within 3 business days of the external review approval.

Can my dermatologist request a peer-to-peer review? Yes, peer-to-peer reviews should be requested within 5 business days of denial. This allows your prescriber to speak directly with a UnitedHealthcare medical director about your case.

What if I have an employer-sponsored plan? Self-funded employer plans may not be eligible for Smart NC external review unless the employer opted into the state process. Contact Smart NC to verify your plan's eligibility.

How can I check my prior authorization status? Use the UnitedHealthcare provider portal, call member services, or have your prescriber check the status through their provider portal.

From Our Advocates: We've seen cases where initial Filsuvez denials were overturned simply by providing more detailed wound documentation and genetic testing results. The key is ensuring your dermatologist includes comprehensive clinical photos, precise measurements, and clear documentation of your specific EB subtype. Don't give up after the first denial—many patients receive approval on appeal with stronger documentation.

When navigating insurance coverage for rare disease treatments like Filsuvez, having expert support can make the difference between approval and denial. Counterforce Health specializes in analyzing insurance denials and crafting targeted appeals that address each payer's specific requirements, helping patients and providers build stronger cases for coverage approval.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for the most current coverage requirements and appeal procedures. Coverage policies may vary by specific plan and are subject to change.

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