By Counterforce Health Team in Voxzogo (vosoritide) —

How to Get Voxzogo (vosoritide) Covered by Cigna in North Carolina: Complete PA Guide and Appeal Process

Quick Answer: Getting Voxzogo Covered by Cigna in North Carolina

Cigna requires prior authorization for Voxzogo (vosoritide) with specific criteria: child under 18, genetically confirmed achondroplasia via FGFR3 testing, open growth plates, and prescription by pediatric endocrinologist or geneticist. If denied, North Carolina's Smart NC external review offers free appeals with a 50% overturn rate for specialty medications.

Your first step today: Contact BioMarin RareConnections at 1-866-906-6100 for free PA support and Cigna-specific documentation checklists, then gather FGFR3 genetic test results and recent growth plate X-rays before submission.

Table of Contents

Understanding Cigna's Voxzogo Coverage Requirements

Cigna's prior authorization criteria for Voxzogo requires all of the following conditions to be met:

Coverage at a Glance

Requirement What It Means Documentation Needed Timeline
Age Under 18 years old Medical records showing birthdate Required at submission
Diagnosis Genetically confirmed achondroplasia FGFR3 pathogenic variant test report Must be recent/valid
Growth plates Open epiphyses confirmed X-ray or MRI showing open growth plates Within 6 months
Prescriber Specialist authorization Endocrinologist or geneticist consultation Required for PA
No surgery No concurrent limb-lengthening Orthopedic records confirming no plans At submission

Important update: As of March 2024, Cigna removed the previous age restriction of 5 years, now covering children as young as 2 years old per FDA approval.

Step-by-Step: Fastest Path to Approval

1. Enroll with BioMarin RareConnections (Patient/Family)

Timeline: Same day

  • Call 1-866-906-6100 or visit biomarin-rareconnections.com
  • Complete Patient Enrollment Form and consent
  • Get assigned a dedicated case manager for Cigna-specific support

2. Gather Required Documentation (Medical Team)

Timeline: 1-2 weeks

  • FGFR3 genetic test report confirming achondroplasia
  • Recent growth plate imaging (X-ray or MRI)
  • Specialist consultation notes from pediatric endocrinologist or geneticist
  • Growth charts and baseline measurements
  • Confirmation of no planned limb-lengthening surgery

3. Submit Prior Authorization (Prescriber)

Timeline: 72 hours for standard review

  • Submit via Cigna provider portal or designated pharmacy benefit manager
  • Include medical necessity letter with clinical rationale
  • Attach all supporting documentation
  • Request expedited review if growth plates are closing soon

4. Follow Up and Track Status (Patient/Clinic)

Timeline: 3-5 business days

  • Contact Cigna member services at 1-800-882-4462 if no response within 72 hours
  • Document all communications with reference numbers
  • Prepare appeal documentation in case of denial
Tip: BioMarin RareConnections reports a 97% coverage success rate when working with families through the entire process, including appeals when necessary.

Common Denial Reasons and How to Fix Them

Based on Cigna's policy requirements, here are the most frequent denial reasons and solutions:

Denial Reason How to Overturn Required Documentation
Missing genetic confirmation Submit FGFR3 test results Pathogenic variant report from certified lab
Growth plates not confirmed open Provide recent imaging X-ray or MRI within 6 months showing open epiphyses
Non-specialist prescriber Get specialist consultation Pediatric endocrinologist or geneticist evaluation
Age outside criteria Verify current policy Medical records confirming age 2-17 years
Experimental/investigational claim Cite FDA approval Reference FDA label and clinical trial data

Medical Necessity Letter Key Points

When your specialist drafts the medical necessity letter, ensure it includes:

  • FDA approval status: Voxzogo is the only FDA-approved treatment for achondroplasia
  • Time-sensitive nature: Effective only while growth plates remain open
  • Clinical evidence: Reference pivotal trial data showing 1.57 cm/year growth velocity improvement
  • No alternatives: Emphasize lack of other pharmacologic options
  • Complication prevention: Potential to reduce risks of spinal stenosis and other complications

Appeals Process: Internal and External Review

If Cigna denies your initial prior authorization, you have multiple appeal options in North Carolina.

Internal Appeals with Cigna

Timeline: 180 days from denial notice to file

  1. First-level appeal: Submit within 60 days of denial
    • Include new clinical evidence or documentation
    • Request peer-to-peer review with pediatric specialist
    • Use Cigna member portal or call 1-800-882-4462
  2. Second-level appeal: If first appeal denied
    • Independent medical review within Cigna
    • Include additional specialist opinions
    • Emphasize urgency due to closing growth plates

Expedited Appeals

For urgent cases where delay could harm the child's growth potential:

  • Timeline: 72 hours for decision
  • Criteria: Growth plates closing soon or medical urgency
  • Process: Request expedited review at time of appeal submission

North Carolina Smart NC External Review

North Carolina offers one of the strongest external review programs in the country through Smart NC.

When to Use External Review

  • After exhausting Cigna's internal appeals
  • For denials based on medical necessity or experimental treatment claims
  • When you have a fully-insured plan (not self-funded employer plan)

How to File with Smart NC

Timeline: 120 days from final internal denial to file

  1. Contact Smart NC: Call 855-408-1212 for free guidance
  2. Submit application: Online form or Request for Assistance
  3. Include documentation:
    • Final denial letter from Cigna
    • All medical records supporting medical necessity
    • Specialist letters emphasizing urgency
    • Clinical studies and FDA approval documentation

Success Rates and Timeline

  • Standard review: 45 days for decision
  • Expedited review: 72 hours for urgent cases
  • Success rate: Approximately 50% overturn rate for specialty drug denials
  • Binding decision: If approved, Cigna must provide coverage within 3 business days
From our advocates: We've seen families successfully overturn Voxzogo denials by emphasizing the time-sensitive nature of treatment and providing comprehensive growth plate documentation. The key is demonstrating that delayed treatment results in permanent, irreversible loss of growth potential.

Working with Your Medical Team

Choosing the Right Specialist

Cigna requires prescription by or consultation with:

  • Pediatric endocrinologist
  • Medical geneticist
  • Physician specializing in achondroplasia care

FGFR3 Genetic Testing

What you need: Confirmed pathogenic variant in FGFR3 gene Common variants: c.1138G>A (p.Gly380Arg) found in 98% of cases Testing labs: ARUP, Invitae, Blueprint Genetics offer comprehensive testing Insurance coverage: Most plans cover diagnostic genetic testing with appropriate clinical justification

Growth Plate Monitoring

Imaging required: X-ray or MRI confirming open epiphyses Frequency: Every 6-12 months during treatment Key sites: Knees, wrists, or spine depending on specialist preference

Cost and Patient Assistance Programs

BioMarin RareConnections Support

  • Co-pay assistance: Available for commercially insured patients
  • Free medication: Patient Assist program for uninsured/underinsured
  • Coverage navigation: Case managers help with insurance processes
  • Contact: 1-866-906-6100 or [email protected]

Financial Considerations

  • List price: Approximately $320,000 annually before rebates
  • Weight-based dosing: 0.24 mg/kg daily subcutaneous injection
  • Insurance coverage: Most plans cover with prior authorization
  • Patient responsibility: Varies by plan; co-pay assistance available

FAQ: Your Most Common Questions

Q: How long does Cigna prior authorization take in North Carolina? A: Standard review takes up to 72 hours. Expedited review for urgent cases can be completed within 24 hours if growth plates are closing soon.

Q: What if Voxzogo is not on Cigna's formulary? A: You can request a formulary exception through Cigna's appeals process. Provide medical necessity documentation showing no therapeutic alternatives exist.

Q: Can I appeal if my child received treatment in another state? A: Yes. Include all out-of-state medical records and specialist consultations in your appeal. North Carolina's Smart NC external review accepts comprehensive medical histories.

Q: Does step therapy apply to Voxzogo? A: Generally no, since Voxzogo is the only FDA-approved pharmacologic treatment for achondroplasia. However, some plans may require documentation of supportive care attempts.

Q: What happens if my child turns 18 during treatment? A: Coverage typically continues until growth plates close, regardless of age. Work with your specialist to document ongoing medical necessity.

Q: Can I request an expedited appeal? A: Yes, if delay would jeopardize your child's growth potential. Both Cigna and Smart NC offer expedited review processes for urgent cases.

Q: What if I have a self-funded employer plan? A: Self-funded ERISA plans may not be subject to North Carolina's external review. Contact your HR department and consider federal appeals processes or legal consultation.

Q: How often do appeals succeed? A: Smart NC reports approximately 50% success rate for specialty drug appeals. Success rates are higher when comprehensive documentation and specialist support are provided.

At Counterforce Health, we help patients and clinicians turn insurance denials into successful appeals by providing evidence-backed strategies tailored to specific payer requirements. Our platform identifies denial reasons and crafts targeted rebuttals using the right clinical evidence and procedural requirements for each case.

For families navigating Voxzogo coverage with Cigna in North Carolina, the combination of thorough documentation, specialist support, and understanding your appeal rights creates the strongest path to approval. Don't hesitate to use both BioMarin's support services and North Carolina's robust external review system—they're designed to help you get the coverage your child needs.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may change. Always verify current requirements with your insurance plan and consult with your healthcare provider for medical decisions. For personalized assistance with insurance appeals, consider consulting with qualified advocates or legal professionals.

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