By Counterforce Health Team in Luxturna (voretigene neparvovec-rzyl) —

How to Get Luxturna Covered by Cigna in Pennsylvania: Complete Guide to Prior Authorization and Appeals

Quick Answer: Getting Luxturna Covered by Cigna in Pennsylvania

Yes, Cigna covers Luxturna (voretigene neparvovec-rzyl) for eligible patients with biallelic RPE65 mutations, but requires strict prior authorization. Your fastest path: 1) Confirm genetic testing shows biallelic RPE65 mutations, 2) Get retinal viability assessment at a certified center (UPMC or CHOP in Pennsylvania), 3) Submit Cigna's prior authorization form with all required documentation. If denied, Pennsylvania's new external review process has overturned 53% of denials in 2024. Start today: Contact your retinal specialist to begin genetic confirmation and viability testing.

Table of Contents

Is Luxturna Covered by Cigna?

Cigna covers Luxturna through its specialty pharmacy partner Accredo, but only for patients who meet strict clinical criteria. The gene therapy has a list price of approximately $425,000 per eye, making prior authorization essential.

Coverage Requirements at a Glance:

Requirement Details Documentation Needed
Age 12 months to under 65 years Medical records
Genetic Testing Confirmed biallelic RPE65 mutations CLIA-certified lab results
Retinal Viability OCT showing >100 microns thickness Imaging reports
Visual Function Specific visual field/acuity thresholds Ophthalmology exam
Treatment Center Must use certified facility Center verification

Prior Authorization Requirements

Cigna requires comprehensive documentation through Express Scripts prior authorization. Here's exactly what you need:

Essential Documentation Checklist

  • Genetic test results confirming biallelic RPE65 mutations from a CLIA-certified laboratory
  • OCT imaging showing retinal thickness >100 microns in the posterior pole
  • Visual field testing demonstrating remaining field within 30 degrees of fixation
  • Full-field stimulus testing (FST) with baseline score >-2.00 log10(cd/m2)
  • Chart notes from a retinal specialist confirming viable retinal cells
  • Age verification (must be ≥12 months and <65 years)
Clinician Corner: Your medical necessity letter should specifically address: 1) Genetic confirmation of biallelic RPE65 mutations, 2) Documentation of retinal viability via OCT measurements, 3) Visual function assessments, and 4) confirmation that no prior gene therapy has been administered to the intended eye(s).

Step-by-Step Approval Process

1. Genetic Testing Confirmation (Week 1-2)

Who: Patient's ophthalmologist orders testing
What: CLIA-certified genetic panel for RPE65 mutations
Timeline: 2-4 weeks for results
Submit to: Include with prior authorization packet

2. Retinal Viability Assessment (Week 2-3)

Who: Certified treatment center performs evaluation
What: OCT imaging, visual field testing, FST
Timeline: 1-2 visits
Documentation: Detailed imaging reports and measurements

3. Prior Authorization Submission (Week 4)

Who: Treatment center submits to Cigna
What: Complete PA form with all documentation
How: Fax to 833-910-1625 or online provider portal
Timeline: 14-30 days for determination

4. Coverage Decision (Week 6-8)

Approved: Proceed with treatment scheduling
Denied: Begin appeals process immediately

Common Denial Reasons & Solutions

Denial Reason How to Fix Required Documentation
Insufficient genetic testing Provide complete biallelic RPE65 results CLIA lab report with specific mutations
Retinal viability questions Submit detailed OCT measurements Imaging showing >100 micron thickness
Age restrictions Verify patient meets criteria Birth certificate or medical records
Non-qualified center Transfer to certified facility UPMC or CHOP verification
Incomplete documentation Resubmit with all requirements Complete checklist review

Appeals Process in Pennsylvania

Pennsylvania's new external review process, launched in January 2024, has achieved a 53% overturn rate for denied claims.

Internal Appeals (First Step)

  • Timeline: Submit within 180 days of denial
  • Process: Two levels of internal review available
  • Expedited: Available for urgent cases
  • Documentation: Include all clinical evidence supporting medical necessity

Pennsylvania External Review (After Internal Appeals)

  • Eligibility: Commercial insurance plans (not self-funded)
  • Timeline: 4 months to request after final internal denial
  • Process: Submit online or call 1-877-881-6388
  • Decision: Binding ruling within 45 days (72 hours if expedited)
  • Cost: Free to consumers
From our advocates: We've seen several gene therapy appeals succeed in Pennsylvania's external review when patients provided comprehensive genetic testing documentation and detailed retinal specialist reports. The key is demonstrating that all FDA-approved criteria are met with objective clinical evidence.

Costs and Financial Assistance

Cigna's Embarc Benefit Protection

For eligible Cigna members, the Embarc Benefit Protection program can eliminate out-of-pocket costs for Luxturna:

  • Coverage: $0 copay for most members (HSA deductibles may apply)
  • Exclusions: Does not cover facility or physician administration fees
  • Eligibility: Confirm with Accredo patient support

Additional Financial Support

  • Manufacturer assistance: Contact Spark Therapeutics for patient support programs
  • Pennsylvania resources: State insurance assistance available through Consumer Help Center

Qualified Treatment Centers in Pennsylvania

Luxturna can only be administered at certified facilities:

UPMC Vision Institute (Pittsburgh)

  • Certification: Active since 2021
  • Contact: 412-647-4732 or [email protected]
  • Services: Adult and pediatric administration

Children's Hospital of Philadelphia (CHOP)

  • Specialty: Pediatric gene therapy administration
  • Division: Ophthalmology, Division of Genetics
  • Contact: CHOP Ophthalmology
Note: Always verify current certification status, as additional centers may become qualified. Contact centers directly for eligibility screening and genetic counseling.

FAQ: Most Common Questions

Q: How long does Cigna's prior authorization take for Luxturna?
A: Standard review takes 14-30 days. Expedited review (for urgent cases) is available within 72 hours.

Q: What if my genetic testing is incomplete?
A: You must have confirmed biallelic RPE65 mutations from a CLIA-certified lab. Incomplete testing will result in denial.

Q: Can I appeal if I don't meet standard criteria?
A: Yes, especially if you have compelling clinical evidence. Pennsylvania's external review has overturned 53% of denials.

Q: Does Cigna require step therapy for Luxturna?
A: No traditional step therapy, but you must demonstrate the genetic condition and retinal viability requirements.

Q: What if I'm over 65 years old?
A: Most policies exclude patients ≥65 years. Appeal options may exist based on individual circumstances.

Q: How do I check my prior authorization status?
A: Contact Cigna member services or check the online member portal. Your treatment center can also check status.

Q: What if my treatment center isn't certified?
A: Transfer care to UPMC or CHOP in Pennsylvania. Non-certified centers cannot administer Luxturna.

Q: Can I get emergency approval?
A: Expedited review is available for urgent cases, but Luxturna is typically not considered emergency treatment.

Counterforce Health specializes in turning insurance denials into successful appeals for complex therapies like gene treatments. Our platform analyzes denial letters, identifies specific policy requirements, and creates evidence-backed appeals that address payers' exact criteria—helping patients access life-changing treatments when they need them most.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan directly. For personalized assistance with Pennsylvania insurance appeals, contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388.

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