By Counterforce Health Team in Voxzogo (vosoritide) —

How to Get Voxzogo (vosoritide) Covered by UnitedHealthcare in Pennsylvania: 2025 Requirements, Appeals, and Documentation

Answer Box: Quick Path to Voxzogo Coverage

UnitedHealthcare requires prior authorization for Voxzogo (vosoritide) in Pennsylvania. Your fastest path to approval: (1) Ensure prescription comes from a pediatric endocrinologist or geneticist, (2) Submit complete PA with FGFR3 genetic test results, open growth plate imaging, and baseline growth data via UnitedHealthcare provider portal, (3) If denied, use Pennsylvania's new state external review process—which overturns 50% of denials—within 4 months. Start with BioMarin RareConnections (1-833-869-9646) for PA support and bridge therapy during appeals.

Table of Contents

  1. UnitedHealthcare's Voxzogo Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Required Documentation Checklist
  5. Prescriber Qualification Rules
  6. Coverage at a Glance
  7. Appeals Process in Pennsylvania
  8. Common Denial Reasons and Solutions
  9. BioMarin RareConnections Support
  10. Frequently Asked Questions

UnitedHealthcare's Voxzogo Policy Overview

UnitedHealthcare covers Voxzogo (vosoritide) for pediatric achondroplasia patients under its specialty pharmacy benefit through OptumRx. The medication requires prior authorization across all plan types—commercial, Medicare Advantage, and Medicaid managed care plans in Pennsylvania.

Plan Coverage Details:

  • Formulary Status: Specialty tier requiring PA
  • Site of Care: Specialty pharmacy only (home delivery)
  • Initial Authorization: 12 months
  • Reauthorization: Annual with updated growth data

The policy follows UnitedHealthcare's medical necessity criteria updated through December 2024, which aligns with FDA labeling for achondroplasia treatment in pediatric patients with open epiphyses.

Medical Necessity Requirements

UnitedHealthcare defines medical necessity for Voxzogo based on specific clinical criteria that must all be met:

Initial Authorization Criteria

  • Age: Patient must be under 18 years old
  • Diagnosis: Confirmed achondroplasia via clinical features OR genetic testing
  • Growth Plates: Open epiphyses documented by imaging
  • Surgical History: No limb-lengthening surgery in prior 18 months; no planned procedures during therapy
  • Prescriber: Clinical geneticist, endocrinologist, or achondroplasia specialist

Reauthorization Requirements

  • Clinical Response: Documented positive response (improved annualized growth velocity vs. baseline)
  • Open Epiphyses: Confirmed via recent bone age imaging or assessment
  • Growth Data: Updated height measurements and growth charts
Note: UnitedHealthcare may auto-approve renewals based on claim history and diagnosis codes, but complete documentation should still be submitted.

Step Therapy and Exception Pathways

Good news: Voxzogo has no step therapy requirements with UnitedHealthcare. As the only FDA-approved pharmacologic treatment for achondroplasia, it doesn't require trials of alternative medications.

However, the policy does require documentation that:

  • Conservative management (monitoring, supportive care) has been considered
  • Surgical interventions are not immediately planned or recently completed
  • The patient meets growth velocity thresholds for treatment benefit

Medical Exception Process: If any standard criteria aren't met, providers can request exceptions by submitting:

  • Detailed medical necessity letter
  • Peer-reviewed literature supporting off-label use (if applicable)
  • Clinical rationale for deviation from standard criteria

Required Documentation Checklist

Essential Documents for PA Submission

Patient Information:

  • Demographics and insurance details
  • ICD-10 code Q77.4 (achondroplasia)
  • Complete prescription with dosing (0.24 mg/kg daily subcutaneous)

Clinical Documentation:

  • FGFR3 pathogenic variant genetic test report (if available)
  • Baseline annualized growth velocity measurements
  • Growth charts showing height percentiles
  • X-rays documenting open epiphyses (bilateral lower extremities preferred)
  • Physical exam findings consistent with achondroplasia

Provider Information:

  • Prescriber credentials (board certification in relevant specialty)
  • Medical necessity attestation
  • Treatment plan and monitoring schedule

Supporting Evidence:

  • Prior therapy documentation (if any conservative treatments tried)
  • Contraindications to surgical interventions (if relevant)
  • Patient/family consent for treatment

Documentation Tips from Counterforce Health

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and crafting evidence-backed appeals. Their platform identifies exactly what documentation payers need and helps assemble the strongest possible submission.

For Voxzogo PAs, they recommend front-loading genetic testing results and growth plate imaging, as these are the most common missing pieces in denied submissions.

Prescriber Qualification Rules

UnitedHealthcare requires prescriptions from qualified specialists to ensure appropriate patient selection and monitoring:

Accepted Prescribers:

  • Pediatric endocrinologist (most common)
  • Clinical geneticist
  • Medical geneticist
  • Achondroplasia specialist with documented expertise

Not Typically Accepted:

  • Primary care physicians
  • General pediatricians
  • Non-specialist providers

Consultation Pathway: If your current provider isn't a qualified specialist, they can:

  1. Refer to an appropriate specialist for initial prescription
  2. Arrange consultation with a qualified provider who can co-sign the PA
  3. Transfer care temporarily for Voxzogo management
Tip: BioMarin RareConnections maintains a provider directory and can help locate qualified specialists in Pennsylvania.

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Prior Auth Required for all plans Complete PA form via provider portal UHC PA Policy
Age Limit Under 18 years Birth certificate or medical records FDA Label
Diagnosis Confirmed achondroplasia FGFR3 genetic test or clinical documentation UHC Policy
Open Growth Plates Documented by imaging X-rays showing open epiphyses UHC Policy
Specialist Rx Qualified prescriber Provider credentials verification UHC Policy
Growth Data Baseline measurements Height/velocity charts UHC Policy
Authorization Period 12 months initial/renewal Annual resubmission required UHC Policy

Appeals Process in Pennsylvania

Pennsylvania offers one of the strongest patient protection systems in the country for insurance appeals, with a new state-run external review process launched in 2024.

Internal Appeals with UnitedHealthcare

Timeline: 180 days from denial notice to file Levels: Two internal review levels available Submission: Via member portal, fax, or mail (check denial letter for specific instructions)

Required Documents:

  • Original denial letter
  • Medical necessity letter from prescriber
  • Updated clinical documentation
  • Peer-reviewed literature supporting treatment

Pennsylvania External Review Process

If UnitedHealthcare upholds the denial after internal appeals, Pennsylvania's Independent External Review offers a powerful next step:

Key Statistics: 50% of external reviews overturn insurer denials (259 of 517 cases in 2024)

Eligibility:

  • Commercial insured plans only (not self-funded ERISA plans)
  • Must complete internal appeals first
  • Request within 4 months of final denial

Process:

  1. Submit request at pa.gov/reviewmyclaim
  2. Pennsylvania Insurance Department confirms eligibility within 5 business days
  3. Independent review organization (IRO) assigned within 1 business day
  4. Submit additional evidence within 15 business days
  5. IRO decision within 45 calendar days (72 hours for expedited cases)

Cost: Free to patients Decision: Final and binding on UnitedHealthcare

Important: Verify your plan type with HR or your insurance documents. Self-funded employer plans follow federal ERISA rules, not Pennsylvania's external review process.

Common Denial Reasons and Solutions

Denial Reason Solution Documents to Include
Missing genetic testing Submit FGFR3 pathogenic variant report Certified lab report with interpretation
Closed growth plates Provide recent imaging showing open epiphyses Bilateral lower extremity X-rays with radiologist report
Non-specialist prescriber Transfer to qualified provider or arrange consultation Board certification documentation
Insufficient growth data Submit comprehensive growth records Height charts, velocity calculations, percentile tracking
"Not medically necessary" Strengthen clinical justification Medical necessity letter with literature citations
Recent surgery Document timing and medical rationale Surgical records, healing timeline, specialist recommendation

Medical Necessity Letter Template

When crafting appeals, successful medical necessity letters typically include:

  1. Patient Summary: Age, confirmed achondroplasia diagnosis, current height percentile
  2. Clinical Rationale: Growth velocity data, impact on quality of life, treatment goals
  3. Evidence Base: FDA approval, clinical trial data, expert guidelines
  4. Monitoring Plan: Growth tracking schedule, safety monitoring, duration of therapy
  5. Alternative Considerations: Why other approaches are insufficient or inappropriate

BioMarin RareConnections Support

BioMarin's patient support program provides comprehensive assistance throughout the coverage process:

Services Available:

  • Prior authorization form completion
  • Appeals letter drafting and submission
  • Bridge therapy during coverage gaps
  • Specialty pharmacy coordination
  • Copay assistance program enrollment

Enrollment Process:

  1. Provider submits enrollment form authorizing BioMarin to handle PA
  2. Patient/caregiver signs consent for PHI release
  3. Case manager assigned within 2 business days
  4. Support continues throughout treatment

Bridge Program: Temporary Voxzogo supply available for patients with:

  • Active appeals in progress
  • Coverage gaps between approvals
  • Specialty pharmacy delays

Contact: 1-833-869-9646 (Monday-Friday, 8 AM - 8 PM ET)

Counterforce Health often works alongside manufacturer support programs to create comprehensive appeal strategies that address both clinical and procedural requirements, increasing the likelihood of successful outcomes.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Voxzogo in Pennsylvania? Standard PA decisions are issued within 72 hours for urgent requests, 15 days for non-urgent. Auto-approvals based on diagnosis codes may be faster.

What if Voxzogo isn't on my UnitedHealthcare formulary? Voxzogo is typically covered on specialty tiers requiring PA. If truly non-formulary, request a formulary exception with medical necessity documentation.

Can I get expedited review if my child needs to start treatment urgently? Yes. Both UnitedHealthcare and Pennsylvania's external review process offer expedited pathways for urgent medical situations (72-hour decisions).

Does step therapy apply if we've tried other treatments outside Pennsylvania? No step therapy is required for Voxzogo since no alternative FDA-approved medications exist for achondroplasia.

What happens if UnitedHealthcare requires genetic testing we haven't done? FGFR3 genetic testing may require separate prior authorization. BioMarin RareConnections can help coordinate testing approval and provide bridge therapy if needed.

How much will Voxzogo cost with UnitedHealthcare coverage? Costs vary by plan. Specialty tier copays typically range from $50-$500+ monthly. BioMarin's copay assistance program may reduce out-of-pocket costs significantly.

What if our pediatrician wants to prescribe but isn't a specialist? UnitedHealthcare requires specialist prescribers. Your pediatrician can refer to a pediatric endocrinologist or geneticist, or arrange a consultation for co-management.

Can we appeal if denied for "experimental" reasons? Yes. Voxzogo has full FDA approval for achondroplasia. Appeals should emphasize FDA approval status and include the official prescribing information.

When Coverage Gets Complex

For families facing repeated denials or complex medical situations, specialized support can make the difference between coverage and costly out-of-pocket payments. Counterforce Health transforms insurance denials into targeted appeals by analyzing payer policies and crafting evidence-backed responses that address specific denial reasons.

Their platform helps identify exactly what UnitedHealthcare needs to see for approval and ensures all documentation meets Pennsylvania's regulatory requirements for appeals.

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 UnitedHealthcare and consult healthcare providers for medical decisions.

Need Help? Contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388 or visit pa.gov for assistance with insurance appeals and complaints.

Sources & Further Reading

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