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

How to Get Filsuvez Covered by Cigna in North Carolina: Prior Authorization Forms, Appeal Scripts & External Review Guide

Answer Box: Fast-Track to Filsuvez Coverage

Cigna requires prior authorization for Filsuvez (birch triterpenes topical gel) via Express Scripts/Accredo for epidermolysis bullosa patients ≥6 months with confirmed dystrophic or junctional subtypes. Submit through Cigna provider portal or CoverMyMeds with genetic testing, wound photos (10-50 cm², 21 days-9 months old), and medical necessity letter. If denied, file internal appeal within 180 days, then external review through North Carolina's Smart NC (855-408-1212) within 120 days. Approximately 50% of specialty drug denials are overturned through Smart NC's binding external review process.

First step today: Call Cigna member services (1-800-88-CIGNA) to confirm your plan uses Accredo specialty pharmacy and download form CNF-850.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Tracking
  6. Typical Timelines in North Carolina
  7. If You're Asked for More Information
  8. Appeals Process: Internal and External
  9. Renewal and Re-Authorization
  10. Quick Reference Checklist
  11. FAQ

What This Guide Covers

This comprehensive guide helps patients with epidermolysis bullosa (EB) and their healthcare teams navigate Cigna's prior authorization process for Filsuvez (birch triterpenes topical gel) in North Carolina. We'll walk you through every step from initial submission to appeals, including North Carolina's powerful external review system through Smart NC.

Filsuvez is the first FDA-approved topical treatment for wounds in junctional and dystrophic epidermolysis bullosa, approved in December 2023. In clinical trials, 41.3% of patients achieved complete wound closure by day 45 compared to 28.9% with placebo. However, with costs around $27,631 for common quantities, prior authorization is standard.

From our advocates: We've seen families wait months for EB wound treatments while navigating insurance red tape. The key is submitting a complete packet upfront—genetic confirmation, detailed wound documentation, and a strong medical necessity letter typically cut approval time in half compared to back-and-forth requests for more information.

Before You Start: Verify Your Coverage

Coverage at a Glance

Requirement Details Where to Find It Source
PA Required Yes, via Express Scripts/Accredo Cigna member portal Cigna PA Policy CNF-850
Age Limit ≥6 months FDA label, Cigna policy FDA Drug Trials Snapshot
EB Subtype Dystrophic or junctional (genetic testing required) Cigna policy CNF-850 Cigna Coverage Criteria
Wound Criteria 10-50 cm², 21 days-9 months duration, non-infected Clinical trial protocol Filsuvez Clinical Trial
Prescriber Dermatologist or EB specialist preferred Cigna provider requirements Cigna Specialty Pharmacy Guide
Pharmacy Accredo (Express Scripts network) Cigna member services Accredo Prior Auth

Essential First Steps

  1. Confirm plan type: Call Cigna at 1-800-88-CIGNA to verify you have a North Carolina-regulated plan (not self-funded ERISA) eligible for Smart NC external review
  2. Check specialty pharmacy: Confirm Accredo is your designated specialty pharmacy for Filsuvez
  3. Verify network status: Ensure your dermatologist or EB specialist is in-network
  4. Download forms: Get the current CNF-850 prior authorization form from your provider portal

Gather Required Documentation

Medical Records Checklist

Essential Documents:

  • Genetic testing results confirming dystrophic or junctional EB subtype
  • Recent dermatology/EB specialist consultation notes
  • Wound assessment with measurements and photos
  • Documentation of wound duration (21 days to 9 months)
  • Confirmation of non-infected status
  • ICD-10 diagnosis codes (Q81.2 for dystrophic EB, Q81.1 for junctional EB)

Supporting Evidence:

  • Prior wound treatment history and outcomes
  • Quality of life impact documentation
  • Dressing change frequency logs
  • School/work absence records (if applicable)

Clinician Corner: Medical Necessity Letter

Your dermatologist's letter should address these key points:

  1. Confirmed EB diagnosis: Specify subtype with genetic or biopsy confirmation
  2. Current wound status: Size, location, duration, and infection status
  3. Prior treatments: Document failed standard wound care approaches
  4. Clinical rationale: Why Filsuvez is medically necessary over alternatives
  5. Treatment goals: Expected outcomes and monitoring plan

Include citations to the FDA approval data and relevant EB treatment guidelines.

Submit Your Prior Authorization Request

Step-by-Step Submission Process

  1. Access the portal (Provider): Log into Cigna provider portal or CoverMyMeds
  2. Complete form CNF-850 with all required fields
  3. Upload documentation: Attach genetic results, wound photos, and medical necessity letter
  4. Submit electronically or fax to the number on the form
  5. Get confirmation: Note the reference number and submission date
  6. Coordinate with Accredo: Ensure they're aware of the pending authorization

Alternative Submission Methods

  • Accredo ePA tool: MyAccredoPatients.com for streamlined specialty pharmacy routing
  • Phone: 1-800-88-CIGNA for urgent cases (have all documents ready)
  • Fax: Use the current fax number from the CNF-850 form (verify with source)
Tip: Submit before 2 PM EST on weekdays to ensure same-day processing and avoid weekend delays.

Follow-Up and Tracking

When and How to Follow Up

24 hours after submission:

  • Call Cigna to confirm receipt and get reference number
  • Verify all documents were received and legible

72 hours for urgent cases:

  • Request expedited review if patient has risk of serious harm
  • Provide physician certification for medical urgency

Sample Follow-Up Script

"Hi, I'm calling to check on prior authorization reference #[NUMBER] for Filsuvez for [PATIENT NAME], DOB [DATE]. Can you confirm what documents you have on file and if any additional information is needed? When can we expect a decision?"

Typical Timelines in North Carolina

Standard Review Process

  • Initial submission to decision: 3-5 business days (standard) or 72 hours (urgent)
  • Additional information requests: Add 2-3 days to timeline
  • Final determination: Up to 30 days maximum per North Carolina regulations

Expedited Review Criteria

Request expedited review when delay would "seriously jeopardize the life or health of the covered person or jeopardize the covered person's ability to regain maximum function" per North Carolina General Statute 58-50-61.

If You're Asked for More Information

Common Requests and Responses

Request Response Strategy Documentation Needed
"Confirm EB subtype" Provide genetic testing report Lab results with pathogenic variants
"Wound measurements" Submit standardized wound assessment Photos with ruler, clinical measurements
"Prior treatment failures" Document standard care attempts Treatment logs, provider notes
"Medical necessity justification" Enhanced clinical rationale Literature review, guidelines

Appeals Process: Internal and External

Internal Appeals with Cigna

First-level appeal:

  • Deadline: 180 days from denial date
  • How to file: Cigna member portal, written request, or phone
  • Decision time: 14 days (standard) or 72 hours (urgent)
  • Required: Copy of denial letter, additional medical evidence

Second-level appeal:

  • Automatic: If first appeal is denied
  • Review by: North Carolina-licensed physician not involved in original decision
  • Timeline: Additional 14 days

External Review Through Smart NC

If Cigna upholds the denial after internal appeals, North Carolina's Smart NC program provides binding external review.

Smart NC Contact Information:

Expedited External Review:

  • Criteria: Delay would seriously jeopardize life, health, or function
  • Required: Physician Certification Form (Attachment A)
  • Timeline: 4 business days (sometimes 72 hours)

Success Rate: Approximately 50% of specialty drug denials are overturned through Smart NC external review, according to North Carolina patient advocacy data.

Renewal and Re-Authorization

Planning for Continuation

  • Submit renewal: 6-8 weeks before current authorization expires
  • Required updates: New wound assessments, progress photos, provider notes
  • Timeline: Allow 10-12 weeks if EB status has changed significantly

Documentation for Renewal

Include evidence of:

  • Treatment response and wound healing progress
  • Continued medical necessity
  • Any changes in EB severity or wound characteristics
  • Updated quality of life measures

Quick Reference Checklist

Before Starting:

  • Confirm Cigna plan is NC-regulated
  • Verify Accredo specialty pharmacy
  • Download current CNF-850 form

Required Documents:

  • Genetic testing for EB subtype
  • Wound photos and measurements
  • Medical necessity letter
  • Prior treatment documentation

Submission:

  • Complete CNF-850 form
  • Submit via provider portal or CoverMyMeds
  • Get confirmation and reference number
  • Follow up within 24 hours

If Denied:

  • File internal appeal within 180 days
  • Contact Smart NC if final denial: 855-408-1212
  • Submit external review within 120 days

FAQ

How long does Cigna prior authorization take for Filsuvez in North Carolina? Standard review is 3-5 business days, with urgent cases decided within 72 hours. Maximum timeline is 30 days per North Carolina regulations.

What if Filsuvez is non-formulary on my plan? Request a formulary exception through the same CNF-850 process, emphasizing lack of therapeutic alternatives for epidermolysis bullosa.

Can I request expedited review for EB wounds? Yes, if delay would jeopardize health or function. Your physician must certify medical urgency per North Carolina law.

Does step therapy apply if I failed treatments outside North Carolina? Generally yes—document out-of-state treatment failures with provider notes and medication records.

What's the difference between internal appeals and Smart NC external review? Internal appeals are reviewed by Cigna. Smart NC uses independent reviewers, and their decisions are binding on Cigna.

How much does Smart NC external review cost? It's completely free to patients. North Carolina provides this service at no charge.

When dealing with epidermolysis bullosa, time matters. Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters, plan policies, and clinical notes, then identifies the denial basis and drafts point-by-point rebuttals aligned to the plan's own rules. For complex cases like EB treatments, having the right clinical evidence and procedural knowledge can make the difference between approval and prolonged suffering.

The key to success with Filsuvez authorization is thorough preparation and persistence. With North Carolina's strong consumer protections through Smart NC, patients have powerful tools to challenge unfair denials. Don't give up if initially denied—many specialty drug denials are overturned on appeal when the right evidence is presented.

Sources & Further Reading

Medical Disclaimer: This guide provides general information about insurance processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions. For personalized insurance guidance, contact Smart NC at 855-408-1212 or visit the North Carolina Department of Insurance website.

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