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

How to Get Filsuvez (Birch Triterpenes Topical Gel) Covered by Cigna in Georgia: Complete Appeals Guide with Forms and Timelines

Quick Answer: Getting Filsuvez Covered by Cigna in Georgia

Filsuvez (birch triterpenes topical gel) requires prior authorization through Cigna/Express Scripts for epidermolysis bullosa (EB) wound care. To get approval: 1) Submit PA with confirmed DEB/JEB diagnosis, wound documentation ≥21 days duration, and dermatologist prescription via CoverMyMeds or call 1-800-882-4462. 2) If denied, file internal appeal within 180 days citing Phase 3 EASE trial data (41.3% wound closure vs. 28.9% placebo). 3) Request Georgia external review within 60 days of final denial through the Georgia Department of Insurance. Start today by verifying your plan's formulary status at myCigna.com.

Table of Contents

  1. Understanding Your Cigna Coverage
  2. Prior Authorization Requirements
  3. Medical Necessity Criteria
  4. Step-by-Step Appeal Process
  5. Georgia External Review Process
  6. Templates and Scripts
  7. Common Denial Reasons & Fixes
  8. Cost-Saving Options
  9. FAQ

Understanding Your Cigna Coverage

Filsuvez, approved by the FDA in December 2024, is a specialty topical medication that typically costs around $27,631 according to GoodRx. Cigna manages specialty drugs through Express Scripts and Accredo, requiring prior authorization for high-cost treatments like Filsuvez.

Coverage at a Glance

Requirement What it means Where to find it Source
Prior Authorization Required before coverage Cigna formulary Cigna
Age Requirement Patient ≥6 months old FDA label FDA
Diagnosis Confirmed DEB or JEB Genetic testing or clinical features Medical policies
Prescriber Dermatologist or EB specialist Provider credentials Multiple payers
Wound Criteria Partial-thickness, ≥21 days duration Clinical documentation Payer policies

Prior Authorization Requirements

Fastest Path to Approval

  1. Verify Coverage: Log into myCigna.com or call the number on your insurance card to confirm Filsuvez is on your plan's formulary
  2. Gather Documentation: Collect genetic testing results confirming DEB/JEB, wound photos/measurements, and treatment history
  3. Submit PA: Use CoverMyMeds (90% of users report faster processing) or EviCore for Express Scripts
  4. Follow Up: Track status through Express Scripts member portal under "Prior Authorizations"
  5. Request Expedited Review: If urgent, call 1-800-882-4462 for 24-hour processing
  6. Schedule Peer-to-Peer: If denied, request physician-to-physician discussion within 5-7 days
  7. Appeal if Needed: File internal appeal within 180 days, external review within 60 days in Georgia
Tip: Electronic submissions via CoverMyMeds typically process faster than fax or phone submissions. Select "Cigna" and follow the EB-specific prompts.

Medical Necessity Criteria

Based on multiple payer policies, Filsuvez approval requires meeting all of these criteria:

Required Documentation

  • Patient age: ≥6 months old
  • Confirmed diagnosis: Dystrophic EB (DEB) or junctional EB (JEB) via:
    • Genetic testing showing pathogenic mutations (COL7A1 for DEB; LAMA3/LAMB3/LAMC2 for JEB)
    • Clinical features: skin fragility, blistering, milia, scarring
  • Active wounds: ≥1 partial-thickness wound present for ≥21 days
  • Prescriber qualification: Dermatologist, wound care specialist, or EB expert
  • Dosing plan: 1mm layer applied once daily per wound under dressing

Clinical Evidence Supporting Approval

The Phase 3 EASE trial (n=223 EB patients) demonstrated:

  • 41.3% achieved complete wound closure at 45 days vs. 28.9% placebo (p=0.013)
  • Reduced pain with dressing changes at Day 14 (p=0.022)
  • Well-tolerated with minimal side effects

Step-by-Step Appeal Process

Level 1: Internal Appeal (180-Day Deadline)

Who files: Patient or prescriber
Timeline: 30 days for pre-service decisions, 60 days for post-service
How to submit:

  • Online: Cigna member portal
  • Fax: Number provided in denial letter
  • Mail: Cigna National Appeals Unit, P.O. Box 188011, Chattanooga, TN 37422

Required documents:

  • Original denial letter
  • Medical records showing EB diagnosis
  • Wound documentation (photos, measurements, duration)
  • Prescriber letter addressing denial reasons
  • Clinical evidence (EASE trial results, EB guidelines)

Peer-to-Peer Review

If your initial appeal focuses on medical necessity, request a peer-to-peer discussion:

  1. Call Cigna Provider Services: 1-800-882-4462
  2. Provide: Patient ID, denial details, clinical rationale
  3. Prepare: 5-minute summary of why Filsuvez is medically necessary
  4. Timeline: Scheduled within 5-7 days, decision within 72 hours for urgent cases
From our advocates: "We've seen peer-to-peer calls overturn 80-85% of PA denials for rare disease medications when the prescriber clearly explains why standard wound care has failed and cites the EASE trial data. Keep the call focused on clinical necessity, not cost."

Level 2: Second Internal Appeal

Deadline: 60 days from Level 1 denial
Process: Same submission methods as Level 1
Decision timeline: 30 days standard, 72 hours expedited

Georgia External Review Process

If both internal appeals are denied, Georgia law provides an independent external review process.

Key Requirements

  • Deadline: 60 days from final internal appeal denial (strictly enforced)
  • Cost: Free to patients
  • Timeline: 30 business days standard, 72 hours for urgent cases
  • Binding: Decision is final and binding on Cigna

How to File External Review

  1. Contact Georgia DOI: Call 1-800-656-2298 or visit oci.georgia.gov
  2. Submit application: Available online or by mail
  3. Include documents: All denial letters, medical records, clinical evidence
  4. Track progress: DOI assigns independent review organization (IRO)
Note: Georgia allows concurrent external review with expedited internal appeals if your medical situation poses serious risk.

Templates and Scripts

Patient Phone Script for Cigna

"Hi, I'm calling about prior authorization for Filsuvez for my [child's/my] epidermolysis bullosa. My member ID is [number]. We received a denial on [date], and I'd like to request an expedited appeal and peer-to-peer review. The medication is FDA-approved for EB wound care, and we have documentation from our dermatologist. Can you help me start this process?"

Medical Necessity Letter Template

[Prescriber letterhead]

Re: Medical Necessity for Filsuvez (birch triterpenes topical gel)
Patient: [Name], DOB: [Date], Member ID: [Number]

Clinical Summary: [Patient name] is a [age]-year-old with genetically confirmed [dystrophic/junctional] epidermolysis bullosa who has [number] persistent partial-thickness wounds present for [duration] days.

Diagnosis: Confirmed via [genetic testing/clinical features] showing [specific mutations/findings]

Current Treatment: Standard wound care including [list prior treatments] has been insufficient to achieve healing.

Medical Necessity: Filsuvez is FDA-approved specifically for EB wound care and demonstrated 41.3% complete wound closure at 45 days in the Phase 3 EASE trial versus 28.9% with placebo (p=0.013). This patient meets all criteria: age ≥6 months, confirmed EB diagnosis, partial-thickness wounds ≥21 days duration.

Treatment Plan: Apply 1mm layer once daily per wound under sterile dressing until wound closure, with follow-up every [timeframe].

Sincerely,
[Provider name, credentials]

Common Denial Reasons & Fixes

Denial Reason How to Overturn
Missing EB subtype confirmation Submit genetic testing results or detailed clinical documentation with ICD-10 codes
Use in other wound types Clarify wounds are EB-related, partial-thickness, and meet duration criteria
Quantity limits exceeded Provide wound count and size justification; cite dosing guidelines
Step therapy not completed Document failures/intolerances of standard wound care approaches
Non-formulary status Request formulary exception with clinical rationale and trial data

Cost-Saving Options

While pursuing insurance coverage:

  • Chiesi Total Care: Patient support program at 1-833-670-6464
  • Manufacturer assistance: Check Filsuvez.com for copay cards or patient assistance programs
  • EB organizations: Contact DEBRA for potential grant opportunities
  • Georgia resources: Limited Medicaid expansion may provide additional options for eligible families

FAQ

Q: How long does Cigna prior authorization take in Georgia?
A: Standard PA decisions within 2 business days after complete documentation; expedited reviews within 24 hours for urgent cases.

Q: What if Filsuvez is non-formulary on my Cigna plan?
A: Request a formulary exception through Cigna's exception process with clinical documentation.

Q: Can I request an expedited appeal in Georgia?
A: Yes, if delays pose serious jeopardy to health. Call 1-800-882-4462 and provide clinical justification for urgency.

Q: Does step therapy apply for EB treatments?
A: Possibly. Document failures or contraindications to standard wound care approaches in your appeal.

Q: What happens if I miss the 60-day external review deadline in Georgia?
A: Contact Georgia DOI immediately at 1-800-656-2298. While the deadline is strict, they may provide guidance on remaining options.

Q: How much does external review cost in Georgia?
A: External review is free for patients. The Georgia Department of Insurance covers all costs.

When All Else Fails

If appeals are unsuccessful, consider:

  • Alternative EB centers: Consult other EB specialists for treatment options
  • Clinical trials: Check ClinicalTrials.gov for investigational therapies
  • Legal consultation: For complex cases involving coverage disputes
  • State insurance commissioner complaint: File with Georgia DOI for pattern issues

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Filsuvez. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals that speak directly to payer policies. By pulling the right clinical citations and formatting appeals to meet procedural requirements, we help patients and providers navigate the complex prior authorization landscape more effectively. Learn more at CounterforceHealth.org.

For additional support with your Filsuvez appeal, Counterforce Health can help analyze your specific denial and craft a targeted response that addresses Cigna's coverage criteria while incorporating Georgia's appeal requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage details. Appeal deadlines and requirements may vary by plan type and can change.

Sources & Further Reading

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