By Counterforce Health Team in Voxzogo (vosoritide) —

How to Get Voxzogo (Vosoritide) Covered by Humana in Pennsylvania: 2025 Prior Authorization Guide

Answer Box: Getting Voxzogo (Vosoritide) Covered by Humana in Pennsylvania

Eligibility: Humana requires prior authorization for Voxzogo (vosoritide) with confirmed achondroplasia, open growth plates, and pediatric specialist care. Fastest path: Submit complete PA packet including FGFR3 genetic test, growth plate imaging, and pediatric endocrinologist letter through Humana's provider portal. First step today: Contact BioMarin RareConnections (1-833-869-9646) for PA templates and case manager support. If denied, Pennsylvania's external review program overturns ~50% of appeals within 45 days.

Table of Contents

  1. Humana's Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Quantity Limits and Renewal Rules
  5. Required Diagnostic Documentation
  6. Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Letter
  9. Special Considerations
  10. Pennsylvania Appeals Process
  11. Quick Reference Checklist

Humana's Coverage Policy Overview

Humana Medicare Advantage requires prior authorization for specialty medications like Voxzogo due to high cost and specialized use. As of 2024, Humana processes most PA requests within one business day for complete electronic submissions, with a relatively low denial rate of ~3.5% among major Medicare Advantage plans.

Plan Types Covered:

  • Humana Medicare Advantage (Part C)
  • Humana Medicare Part D (prescription drug plans)
  • Some Humana commercial plans (verify coverage)

Where to Find Official Documentation:

Medical Necessity Requirements

Voxzogo (vosoritide) is FDA-approved for achondroplasia in pediatric patients ≥2 years old (expanded from ≥5 years in 2023) with open epiphyses. Humana's medical necessity criteria align with FDA labeling but require comprehensive documentation.

Core Requirements:

  • Confirmed diagnosis of achondroplasia with pathogenic FGFR3 variant
  • Patient age ≥2 years (verify with current Humana policy)
  • Open growth plates documented by imaging
  • Prescribing by qualified pediatric specialist
  • Absence of contraindications
Note: The FDA label expansion to age ≥2 years may not yet be reflected in all payer policies. Confirm current Humana criteria through their PA search tool.

Step Therapy and Exception Pathways

Voxzogo typically doesn't require step therapy since it's the only FDA-approved pharmacologic treatment for achondroplasia. However, Humana may require documentation of:

Previous Interventions (if applicable):

  • Growth hormone therapy trials (with outcomes)
  • Supportive care measures
  • Physical therapy or orthopedic interventions

Medical Exception Pathways:

  • Contraindications to alternative treatments
  • Previous treatment failures with documented reasons
  • Clinical urgency based on growth velocity decline

Quantity Limits and Renewal Rules

Standard Dosing: 0.24 mg/kg subcutaneously once daily

Quantity Considerations:

  • Weight-based dosing requires regular adjustments
  • Monthly supplies typically align with pediatric weight ranges
  • Renewal requires ongoing growth plate monitoring

Renewal Requirements:

  • Annual reassessment of growth plate status
  • Growth velocity documentation
  • Specialist follow-up notes
  • Safety monitoring results

Required Diagnostic Documentation

Genetic Testing

FGFR3 genetic testing confirming achondroplasia is mandatory. Over 98% of cases involve the G380R variant.

Required Elements:

  • Laboratory report confirming pathogenic FGFR3 mutation
  • Testing performed by certified laboratory
  • Dated within reasonable timeframe (typically ≤2 years)

Growth Plate Imaging

Open epiphyses must be documented through appropriate imaging.

Imaging Options:

  • X-ray (first-line): Hand/wrist for bone age, knee/pelvis as clinically indicated
  • MRI: For equivocal cases or detailed physeal assessment
  • Reports must clearly state "open growth plates" or "unfused epiphyses"

Additional Diagnostics

  • Baseline height and weight measurements
  • Growth velocity calculations
  • Relevant comorbidity assessments

Specialty Pharmacy Requirements

Voxzogo requires specialty pharmacy dispensing due to:

  • Cold chain storage requirements
  • Patient education needs
  • Injection training requirements
  • Ongoing monitoring coordination

Humana-Preferred Specialty Pharmacies:

  • Verify current preferred network through Humana member services
  • BioMarin RareConnections can coordinate specialty pharmacy selection
  • Home delivery is typically standard

Evidence to Support Medical Necessity

Primary Evidence Sources:

  • FDA prescribing information for Voxzogo
  • Clinical trial data showing improved growth velocity
  • Pediatric endocrinology society guidelines (when available)

Key Clinical Studies:

  • Phase 3 trial demonstrating annualized growth velocity improvement
  • Long-term extension study safety data
  • Real-world evidence from post-marketing surveillance

Citation Strategy:

  • Reference FDA label sections directly
  • Include peer-reviewed publications when strengthening the case
  • Cite recognized drug compendia for off-label considerations (if applicable)

Sample Medical Necessity Letter

Template Structure for Medical Necessity:

"Patient [Name] is a [age]-year-old with genetically confirmed achondroplasia (FGFR3 [specific variant]) presenting with [clinical findings]. Current height is [measurement] ([percentile] for achondroplasia growth charts), with recent growth velocity of [rate]. Imaging dated [date] confirms open epiphyses at [anatomical sites].

Previous interventions include [list treatments and outcomes]. Voxzogo (vosoritide) is FDA-approved for this exact indication and represents the only pharmacologic therapy available to address the underlying pathophysiology of achondroplasia through FGFR3 pathway modulation.

Treatment goals include improved linear growth velocity and optimization of final adult height while growth plates remain open. The requested dosing of 0.24 mg/kg daily aligns with FDA labeling. Regular monitoring will include [specify plan]."

Special Considerations

Pediatric Considerations:

  • Age verification with birth certificate may be required
  • Growth charts specific to achondroplasia should be referenced
  • Transition planning as patient approaches growth plate closure

Comorbidity Management:

  • Documentation of achondroplasia-related complications
  • Coordination with other specialists (orthopedics, ENT, neurosurgery)
  • Safety monitoring protocols

Escalation Pathways:

  • Peer-to-peer review requests with pediatric endocrinologist
  • Expedited review for urgent clinical situations
  • External review through Pennsylvania's system

Pennsylvania Appeals Process

If Humana denies coverage, Pennsylvania residents have robust appeal options through the state's Independent External Review Program.

Internal Appeals (First Step):

  • Submit through Humana member portal within 65 days
  • Include additional clinical documentation
  • Request peer-to-peer review if available

External Review (Pennsylvania):

  • File within 4 months of Final Adverse Benefit Determination
  • Submit online or by mail/fax
  • Include Physician Certification Form and supporting documents
  • Standard review: 45 days; Expedited: 72 hours
  • Success rate: ~50% of appeals overturned in 2024
From our advocates: We've seen families succeed by submitting comprehensive genetic testing reports alongside detailed growth velocity data and clear imaging confirmation of open growth plates. The key is ensuring every piece of required documentation is included upfront – incomplete submissions often lead to unnecessary delays that can be avoided with thorough preparation.

Quick Reference Checklist

Requirement What to Include Common Errors Source Link
Genetic Testing FGFR3 mutation report from certified lab Using clinical diagnosis alone Genetic Testing Info
Growth Plates X-ray or MRI showing open epiphyses Outdated imaging (>6 months) Imaging Guidelines
Specialist Care Pediatric endocrinologist consultation Primary care provider prescription Humana PA Requirements
Age Verification Birth certificate or medical record Assuming age eligibility FDA Label
Dosing Calculation Weight-based dosing justification Incorrect mg/kg calculations BioMarin Resources

Coverage at a Glance

Element Requirement Where to Find Status
Prior Authorization Yes, required Humana PA Lists ✓ Required
Formulary Status Specialty tier Member benefit summary Verify with plan
Step Therapy None (first-line for indication) Policy documents ✓ Not required
Quantity Limits Weight-based monthly supply PA approval letter Per dosing
Site of Care Specialty pharmacy only Network directory ✓ Required
Age Limits ≥2 years with open epiphyses FDA label ✓ Age + imaging

When to Contact Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, payer policies, and clinical documentation to create targeted, evidence-backed rebuttals. Their platform is particularly valuable for complex specialty drug cases like Voxzogo, where payer-specific workflows and detailed clinical evidence requirements can make the difference between approval and denial.

If you're facing a Humana denial for Voxzogo in Pennsylvania, Counterforce Health can help identify the specific denial basis—whether it's PA criteria, documentation gaps, or "not medically necessary" determinations—and draft point-by-point rebuttals aligned to Humana's own policies while incorporating the right clinical evidence and procedural requirements for Pennsylvania's appeal process.

FAQ

How long does Humana prior authorization take for Voxzogo in Pennsylvania? Most complete electronic submissions receive decisions within one business day. Complex cases may take up to 30 days for Medicare Advantage plans.

What if Voxzogo is non-formulary on my Humana plan? Request a formulary exception with medical necessity documentation. BioMarin RareConnections provides templates for this process.

Can I request expedited review for urgent situations? Yes, both Humana internal appeals and Pennsylvania external reviews offer expedited timelines for urgent medical situations.

Does step therapy apply if previous treatments were tried outside Pennsylvania? Documentation of prior treatments from any location should be accepted. Include detailed records of previous interventions and outcomes.

What happens if my child's growth plates close during treatment? Treatment typically continues until growth plate closure. Regular monitoring ensures appropriate treatment duration.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies change frequently. Always verify current requirements with Humana directly and consult your healthcare provider for medical decisions. For personalized assistance with Pennsylvania insurance appeals, contact the Pennsylvania Insurance Department consumer services.

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