By Counterforce Health Team in Exondys 51 (eteplirsen) —

How to Get Exondys 51 (Eteplirsen) Covered by Cigna in North Carolina: Appeals Guide, Forms & Timelines

Answer Box: Getting Exondys 51 Covered by Cigna in North Carolina

Exondys 51 (eteplirsen) requires prior authorization from Cigna with genetic testing proving exon 51 skipping amenability. Submit PA request via fax to (855) 840-1678 with genetic test results, specialist prescription, and clinical documentation. If denied, you have 180 days for internal appeals, then 120 days for North Carolina's binding external review through Smart NC. Start today: Contact your neurologist or MDA Care Center to confirm genetic eligibility and gather required documentation.

Table of Contents

  1. Understanding Cigna's Coverage Requirements
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Playbook for North Carolina
  5. Medical Necessity Letter Template
  6. North Carolina External Review Process
  7. Costs & Patient Assistance Options
  8. FAQ: Exondys 51 Coverage Questions

Understanding Cigna's Coverage Requirements

Exondys 51 (eteplirsen) is a specialty medication that treats Duchenne muscular dystrophy (DMD) in patients with confirmed genetic mutations amenable to exon 51 skipping. Cigna requires prior authorization with specific clinical criteria.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization PA required before dispensing Cigna formulary Cigna PA Form
Genetic Testing Confirmed exon 51 skipping mutation Genetic lab report FDA Label
Specialist Prescriber Neurologist, neuromuscular specialist, or MDA Care Center Provider credentials Cigna Policy
Age Restriction Under 14 years for new starts Medical records Cigna Policy
Ambulatory Status Patient must be able to walk Clinical assessment Cigna Policy
Specialty Pharmacy Usually through Accredo Call 1-866-759-1557 Cigna PA Form

Step-by-Step: Fastest Path to Approval

1. Confirm Genetic Eligibility

Who: Your neurologist or genetic counselor
What: Order genetic testing to confirm DMD mutation amenable to exon 51 skipping
Timeline: 2-4 weeks for results
Source: FDA prescribing information

2. Gather Required Documentation

Who: Patient/caregiver and clinical team
What: Collect genetic test results, diagnosis confirmation (ICD-10), baseline function tests, current weight
Timeline: 1-2 weeks

3. Submit Prior Authorization

Who: Prescribing physician or designee
What: Complete Cigna PA form and fax to (855) 840-1678
Timeline: Standard review within 15 days
Source: Cigna PA requirements

4. If Urgent, Request Expedited Review

Who: Prescriber
What: Call (800) 882-4462 for urgent cases
Timeline: 72 hours for expedited decisions
Source: Cigna PA Form

5. Coordinate with Accredo Specialty Pharmacy

Who: Patient/caregiver
What: Contact Cigna's preferred specialty pharmacy at 1-866-759-1557
Timeline: 1-3 days after approval

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
No genetic testing Submit genetic lab report confirming exon 51 amenability Genetic test results with specific mutation details
Non-specialist prescriber Transfer prescription to neurologist or MDA Care Center Specialist consultation notes
Age over 14 (new starts) Provide clinical justification for older patient Detailed medical necessity letter
Patient not ambulatory Document walking ability with or without assistance Physical therapy assessment, 6-minute walk test
Missing baseline assessments Submit cardiac and renal function tests Echocardiogram, creatinine, urinalysis
Site of care issues Confirm infusion center meets requirements Facility accreditation documentation

Appeals Playbook for North Carolina

Internal Appeals with Cigna

First Level Appeal:

  • Deadline: 180 days from denial date
  • How to Submit: Written request to address on denial letter
  • Timeline: 60 days for standard, 72 hours for expedited
  • Required: Denial letter, medical records, prescriber letter

Second Level Appeal:

  • Deadline: 60 days from first-level denial
  • Process: Independent medical review
  • Timeline: 30 days for decision

North Carolina External Review

If Cigna denies your final internal appeal, North Carolina's Smart NC program provides binding external review.

Eligibility:

  • State-regulated Cigna plan (not self-funded employer plans)
  • Exhausted Cigna's internal appeals
  • Denial based on medical necessity or experimental treatment

How to File:

  • Deadline: 120 days from Cigna's final denial
  • Contact: Smart NC at 855-408-1212
  • Address: Health Insurance Smart NC, 1201 Mail Service Center, Raleigh, NC 27699-1201
  • Timeline: 45 days for standard review, 72 hours for expedited

Success Rates: Historical data suggests approximately 40-55% of external reviews result in overturning insurer denials, though specific rates for specialty drugs aren't publicly available.

Source: NC Department of Insurance External Review

Medical Necessity Letter Template

Clinician Corner: Essential Elements

Patient Information:

  • Name, DOB, Cigna member ID
  • Primary diagnosis: Duchenne muscular dystrophy (ICD-10: G71.01)
  • Genetic testing results confirming exon 51 skipping amenability

Clinical Justification:

  • Current ambulatory status and functional assessment
  • Prior treatments attempted and outcomes
  • Contraindications to alternative therapies
  • Treatment goals and expected outcomes

Evidence Base:

  • FDA approval under accelerated pathway for exon 51 skipping
  • Lack of alternative disease-modifying therapies for this genetic subset
  • Progressive, fatal nature of DMD requiring early intervention

Sample Letter Opening:

"I am requesting coverage for Exondys 51 (eteplirsen) for my patient [Name], who has Duchenne muscular dystrophy with a confirmed genetic mutation amenable to exon 51 skipping. This medication received FDA accelerated approval specifically for patients with this genetic profile, and there are no alternative disease-modifying therapies available for this population."

Key Guidelines to Reference:

North Carolina External Review Process

North Carolina residents have strong consumer protections through the Smart NC program, which provides free advocacy and binding external review for insurance denials.

When to Use External Review

  • Cigna has denied coverage after internal appeals
  • Denial is based on medical necessity or experimental treatment determination
  • You have a state-regulated insurance plan

The Process

  1. Contact Smart NC: Call 855-408-1212 for free guidance
  2. Gather Documents: Final denial letter, medical records, supporting evidence
  3. Submit Request: Complete external review form within 120 days
  4. Independent Review: Medical experts review your case
  5. Binding Decision: If overturned, Cigna must provide coverage within 3 business days
From our advocates: "We've seen families successfully overturn Cigna denials for rare disease medications through Smart NC's external review process. The key is submitting comprehensive medical evidence, including genetic testing results and specialist letters explaining why the treatment is medically necessary. While not every case succeeds, having an independent medical expert review the denial often leads to better outcomes than the initial insurance company decision."

For assistance with Counterforce Health, a platform that helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer requirements.

Costs & Patient Assistance Options

Manufacturer Support

  • Sarepta Therapeutics Patient Services: Financial assistance and copay support programs
  • Contact: Visit Exondys51.com for current programs

Foundation Grants

  • Patient Advocate Foundation
  • National Organization for Rare Disorders (NORD)
  • Muscular Dystrophy Association (MDA)

State Programs

  • North Carolina expanded Medicaid (effective 2024)
  • State pharmaceutical assistance programs for eligible residents

FAQ: Exondys 51 Coverage Questions

Q: How long does Cigna prior authorization take in North Carolina? A: Standard PA review takes up to 15 days. Expedited requests are decided within 72 hours if medical urgency is documented.

Q: What if Exondys 51 is non-formulary on my plan? A: You can request a formulary exception through Cigna's appeals process, providing medical necessity documentation and evidence that formulary alternatives aren't appropriate.

Q: Can I request an expedited appeal? A: Yes, if waiting could seriously jeopardize your health. Both Cigna internal appeals and NC external review offer expedited timelines (72 hours).

Q: Does step therapy apply to Exondys 51? A: Cigna may require documentation of corticosteroid use or contraindications, though step therapy requirements vary by plan.

Q: What happens if my child ages out during treatment? A: Continuation criteria focus on maintaining ambulatory function rather than age limits. Document ongoing clinical benefit for renewals.

Q: How much does Exondys 51 cost without insurance? A: Typical U.S. cash prices are approximately $7,822 for a 10 mL vial, though actual costs vary by pharmacy and patient weight-based dosing.

When Treatment is Approved

Once Cigna approves Exondys 51, coordinate with Accredo Specialty Pharmacy (1-866-759-1557) for delivery and infusion scheduling. The medication requires weekly IV infusions, typically administered at an accredited infusion center.

Ongoing Requirements:

  • Regular monitoring of cardiac and renal function
  • Periodic functional assessments (6-minute walk test)
  • Annual genetic counseling as recommended
  • Coordination with multidisciplinary DMD care team

Platforms like Counterforce Health can help streamline renewal processes by tracking approval requirements and generating targeted documentation for continued coverage.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance plan for specific guidance regarding your situation. For personalized assistance with insurance appeals in North Carolina, contact Smart NC at 855-408-1212.

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