How to Get Voxzogo (Vosoritide) Covered by Humana in North Carolina: Complete PA Guide and Appeal Process
Answer Box: Getting Voxzogo Covered by Humana in North Carolina
Humana requires prior authorization for Voxzogo (vosoritide) with genetic confirmation of achondroplasia, open growth plates, and pediatric specialist prescription. Standard approval takes 72 hours; if denied, North Carolina residents have strong appeal rights through Smart NC external review.
Your first step today: Call Humana (number on your insurance card) to confirm Voxzogo's formulary status and request PA forms. Simultaneously, ensure your child's specialist has FGFR3 genetic testing results and recent growth plate imaging ready.
Table of Contents
- Policy Overview: How Humana Covers Voxzogo
- Indication Requirements: What Qualifies for Coverage
- Required Documentation: The Complete Checklist
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & How to Fix Them
- Appeals Process: From Humana to Smart NC
- North Carolina External Review Rights
- Cost Assistance and Specialty Pharmacy
- FAQ: Your Top Questions Answered
Policy Overview: How Humana Covers Voxzogo
Humana classifies Voxzogo as a specialty medication requiring prior authorization across all plan types—Medicare Advantage, commercial, and employer plans. The drug typically sits on specialty tier with significant cost-sharing, making PA approval crucial for affordability.
Plan Types and Coverage Patterns
- Medicare Advantage Part D: PA required; formulary exceptions available for non-formulary status
- Commercial/Employer Plans: Standard PA with medical necessity review
- Coverage Determination Timeline: 72 hours standard, 24 hours expedited when urgency documented
Note: Humana's PA denial rate for Medicare Advantage is approximately 3.5%—among the lowest of major insurers—but denials often stem from incomplete documentation rather than medical inappropriateness.
Indication Requirements: What Qualifies for Coverage
Voxzogo is FDA-approved for achondroplasia in pediatric patients ≥2 years old with open epiphyses. Humana's coverage criteria align closely with this indication but add specific documentation requirements.
Core Eligibility Criteria
Diagnosis Confirmation:
- Genetic testing showing pathogenic FGFR3 variant
- Clinical documentation of achondroplasia features
- ICD-10 code Q77.4 (achondroplasia)
Age and Growth Requirements:
- Patient ≥2 years old (some older policies may still require ≥5 years—verify with your plan)
- Open growth plates documented by imaging
- Baseline growth velocity measurements
Prescriber Requirements:
- Pediatric endocrinologist, geneticist, or skeletal dysplasia specialist
- REMS program certification (verify with prescriber)
Required Documentation: The Complete Checklist
Based on Humana's PA requirements and successful approval patterns, gather these documents before submitting:
Essential Medical Records
| Document Type | Specific Requirements | Source |
|---|---|---|
| Genetic Testing Report | FGFR3 pathogenic variant confirmation | CLIA-certified lab |
| Growth Plate Imaging | X-ray showing open epiphyses (within 12 months) | Radiology report |
| Growth Data | 6-12 months baseline measurements, AGV calculation | Clinic records |
| Specialist Note | Diagnosis confirmation, treatment rationale | Pediatric specialist |
| Prior Therapy Documentation | Any previous growth treatments tried/failed | Medical records |
Supporting Clinical Information
- Current height, weight, and growth percentile data
- Bone age assessment results
- Treatment goals and monitoring plan
- Dosing calculation (0.24 mg/kg once daily)
- Contraindication screening results
Tip: BioMarin RareConnections provides PA templates and can help coordinate documentation with your prescriber's office.
Step-by-Step: Fastest Path to Approval
1. Verify Coverage and Forms (1-2 days)
Who: Patient/caregiver
Action: Call Humana member services (number on insurance card)
Ask for: Voxzogo formulary status, PA forms, specialty pharmacy requirements
Timeline: Same day confirmation
2. Gather Genetic Testing (if needed)
Who: Prescriber orders, family coordinates
Action: FGFR3 genetic testing if not already completed
Timeline: 2-4 weeks for results
Note: Many achondroplasia patients already have this from diagnosis
3. Obtain Growth Plate Imaging
Who: Prescriber orders
Action: Bone age X-ray with radiologist report noting open epiphyses
Timeline: 1-3 days for imaging and report
4. Compile Growth Data
Who: Clinic staff
Action: Calculate baseline annualized growth velocity from 6-12 months of measurements
Timeline: 1-2 days to organize records
5. Submit PA Request
Who: Prescriber's office
Submit via: Humana provider portal or fax
Include: All documentation from steps 2-4 plus medical necessity letter
Timeline: Same day submission
6. Track Decision
Who: Patient/prescriber
Action: Follow up in 48-72 hours if no response
Options: Call member services or check provider portal for status
7. Coordinate Specialty Pharmacy
Who: Patient with prescriber support
Action: If approved, coordinate with Humana specialty pharmacy network
Timeline: 3-5 days for first delivery
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Evidence |
|---|---|---|
| Missing FGFR3 testing | Submit genetic lab report | Pathogenic variant confirmation |
| Growth plates not documented | Provide recent bone age X-ray | Radiology report stating "open epiphyses" |
| Insufficient growth data | Submit detailed growth chart | 6+ months baseline measurements |
| Non-specialist prescriber | Transfer to qualified provider | Pediatric endocrinologist/geneticist |
| Age outside criteria | Verify current FDA indication | Birth certificate, recent clinic note |
| Non-formulary status | Request formulary exception | Medical necessity letter explaining alternatives inadequate |
From our advocates: "We've seen Humana approvals turn around quickly when families submit complete packets upfront. One family in Charlotte had their PA approved in 24 hours because their endocrinologist included growth velocity calculations and explicitly stated the FGFR3 variant type in the medical necessity letter."
Appeals Process: From Humana to Smart NC
If your initial PA is denied, North Carolina residents have robust appeal rights with specific timelines and protections.
Internal Appeals with Humana
Level 1: Standard Appeal
- Deadline: 60 days from denial notice
- Submit: Written appeal with new medical evidence
- Timeline: 30 days for decision (72 hours if expedited)
- How: Member portal, phone, or mail to address on denial letter
Level 2: Reconsideration
- Deadline: 60 days from Level 1 denial
- Process: Independent medical review within Humana
- Options: Peer-to-peer review with prescriber
Expedited Appeals
Available when delay would seriously jeopardize health or ability to regain function:
- Timeline: 72 hours for decision
- Trigger: Prescriber attestation of urgency
- Benefit: Can bypass some internal steps
North Carolina External Review Rights
North Carolina offers one of the strongest external review systems in the country through Smart NC.
Smart NC External Review Process
Eligibility Requirements:
- Exhausted Humana's internal appeals (or qualify for expedited bypass)
- State-regulated plan (most individual/small group; verify if employer self-funded)
- Denial based on medical necessity or experimental treatment determination
How to File:
- Deadline: 120 days from final internal denial
- Contact: Smart NC helpline at 1-855-408-1212
- Forms: Available on NCDOI website or by calling Smart NC
- Cost: Free to consumers
Timeline and Process:
- Standard Review: 45 days for decision
- Expedited Review: 72 hours (24-72 hours for urgent drug denials)
- Reviewer: Independent Review Organization (IRO) assigned by Smart NC
- Decision: Binding on Humana—if overturned, coverage required within 3 business days
Smart NC Advantages
Free Advocacy Support:
- Smart NC staff help complete forms and gather records
- Guidance on medical literature and clinical guidelines
- Communication facilitation with insurers
Additional Evidence Window:
- 7 days after case acceptance to submit additional medical information
- Can include new studies, specialist letters, or clinical data
Note: Smart NC has successfully overturned many expensive specialty drug denials, including treatments for rare diseases like achondroplasia.
Cost Assistance and Specialty Pharmacy
Even with insurance approval, Voxzogo's high cost (approximately $320,000 annually before rebates) makes financial assistance crucial.
Manufacturer Support Programs
BioMarin RareConnections:
- Copay assistance for commercial insurance (not available for government plans)
- PA support and appeals assistance
- Specialty pharmacy coordination
- Patient education resources
North Carolina State Resources
Medicaid Expansion: North Carolina expanded Medicaid in 2024, potentially covering more families State Health Plan: If employed by NC state government, separate appeals process through plan administrators
Specialty Pharmacy Requirements
Humana typically requires Voxzogo dispensing through their specialty pharmacy network:
- CenterWell Specialty Pharmacy (Humana-owned)
- Select contracted specialty pharmacies
- 30-day supply limits initially
- Refrigeration and injection training provided
FAQ: Your Top Questions Answered
Q: How long does Humana PA take for Voxzogo in North Carolina? A: Standard review is 72 hours; expedited review is 24 hours with documented urgency. Complete documentation packages typically process faster.
Q: What if Voxzogo is non-formulary on my Humana plan? A: Request a formulary exception with prescriber support showing why formulary alternatives are inappropriate for achondroplasia.
Q: Can I request an expedited appeal in North Carolina? A: Yes, both Humana and Smart NC offer expedited reviews when delays would jeopardize health. Your prescriber must document medical urgency.
Q: Does step therapy apply to Voxzogo? A: Rarely, since no FDA-approved alternatives exist for achondroplasia. If required, document that supportive care and growth hormone (if tried) were insufficient.
Q: What if my prescriber isn't a pediatric specialist? A: Humana typically requires prescription by pediatric endocrinologists or geneticists. Consider referral or consultation to meet coverage criteria.
Q: How often do I need to renew PA for Voxzogo? A: Most Humana plans require annual reauthorization with updated growth data and confirmation of open growth plates.
Q: Can Smart NC help with Medicare Advantage appeals? A: For Medicare Advantage Part D appeals, the process goes through CMS Independent Review Entities (IRE), not Smart NC. However, some NC external review rights may apply—verify with Smart NC at 1-855-408-1212.
Q: What documents should I keep organized for appeals? A: Maintain a file with genetic testing results, growth charts, bone age reports, denial letters, prescriber notes, and all correspondence with Humana.
About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies transform insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with each insurer's specific requirements, helping families access critical medications like Voxzogo more efficiently.
Disclaimer: This guide provides educational information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and work with qualified professionals for insurance appeals. For official North Carolina external review information, visit ncdoi.gov or call Smart NC at 1-855-408-1212.
Sources & Further Reading
- Humana Prior Authorization Process
- Humana Drug Exceptions and Appeals
- North Carolina Department of Insurance - Smart NC
- FDA Voxzogo Prescribing Information
- BioMarin RareConnections Patient Support
- Voxzogo Official Patient Website
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