By Counterforce Health Team in Crysvita (burosumab) —

Get Crysvita (Burosumab) Covered by UnitedHealthcare in North Carolina: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Crysvita Covered by UnitedHealthcare in North Carolina

Yes, UnitedHealthcare covers Crysvita (burosumab) for X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO), but requires prior authorization through specialty providers. Your endocrinologist submits the PA via UnitedHealthcare's provider portal with genetic testing results, lab values, and treatment history. If denied, you can appeal internally within 180 days, then request external review through North Carolina's Smart NC program within 120 days. Start today: Contact your specialist to verify your diagnosis meets UnitedHealthcare's criteria and gather required documentation.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Deadlines
  4. Medical Necessity Criteria
  5. Costs and Coverage Tiers
  6. Denials and Appeals in North Carolina
  7. Renewal Requirements
  8. Specialty Pharmacy Network
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Crysvita Covered by UnitedHealthcare?

UnitedHealthcare covers Crysvita (burosumab-twza) for two FDA-approved conditions:

  • X-linked hypophosphatemia (XLH) in patients 6 months and older
  • Tumor-induced osteomalacia (TIO) with unresectable or unknown tumor location

Coverage applies across UnitedHealthcare's commercial plans, Medicare Advantage, and Medicaid Community Plans in North Carolina. The medication is classified as a specialty drug requiring prior authorization and dispensing through designated specialty pharmacies.

Which Plans Cover Crysvita?

All UnitedHealthcare plans in North Carolina that include prescription drug benefits cover Crysvita when medically necessary, including:

  • Commercial employer-sponsored plans
  • Individual marketplace (ACA) plans
  • Medicare Advantage plans with Part D coverage
  • Medicaid Community Plans
Note: Self-funded employer plans may have different coverage criteria. Check your specific plan documents or contact member services.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm Diagnosis (Patient/Provider): Obtain genetic testing for PHEX mutation (XLH) or imaging/biopsy confirming TIO with unresectable tumor
  2. Gather Lab Results (Provider): Document low serum phosphorus, elevated FGF23, normal/low 1,25(OH)2D, adequate vitamin D status
  3. Document Prior Treatments (Provider): Record trials and outcomes of phosphate supplements plus vitamin D analogs (especially for adults)
  4. Submit PA Request (Provider): Use UnitedHealthcare Provider Portal with complete clinical documentation
  5. Monitor Status (Patient/Provider): Check portal or call 888-397-8129 for commercial plans
  6. Coordinate Specialty Pharmacy (Provider): Upon approval, send prescription to network specialty pharmacy
  7. Schedule Monitoring (Provider): Establish serum phosphorus monitoring plan per FDA labeling

Who Submits the Prior Authorization?

Your endocrinologist or metabolic bone disease specialist must submit the prior authorization. UnitedHealthcare requires specialist oversight for Crysvita coverage. Primary care providers cannot typically obtain approval without specialist consultation.

Timing and Deadlines

Process Standard Timeline Expedited Timeline
Initial PA Decision 72 hours to 15 business days 24-72 hours (urgent cases)
Internal Appeal 60 days 72 hours
External Review (NC) 45 days 72 hours
Annual Reauthorization Submit 30-60 days before expiration N/A
Tip: For urgent cases where treatment delay could seriously jeopardize health, request expedited review at the time of submission.

Medical Necessity Criteria

Coverage Requirements Table

Requirement XLH Patients TIO Patients Documentation Needed
Age ≥6 months ≥6 months Birth certificate/medical records
Diagnosis Confirmation PHEX mutation OR elevated FGF23 Unresectable tumor + elevated FGF23 Genetic testing, lab reports, imaging
Biochemical Evidence Low serum phosphorus Low serum phosphorus Recent lab values
Vitamin D Status 25(OH)D ≥16 ng/mL 25(OH)D ≥16 ng/mL Lab results
Kidney Function Normal creatinine for age Normal creatinine for age Serum creatinine, eGFR
Prior Therapy Failure/intolerance of phosphate + vitamin D (adults) Standard therapy failure Treatment records, outcomes
Prescriber Endocrinologist/specialist Endocrinologist/specialist Provider credentials

Clinician Corner: Medical Necessity Letter Checklist

When preparing your letter of medical necessity, include:

  • Patient demographics and diagnosis: ICD-10 codes (E83.31 for familial hypophosphatemia, M83.8 for other osteomalacia)
  • Clinical presentation: Growth retardation, bone deformities, dental problems, bone pain, fractures
  • Laboratory evidence: Serial phosphorus levels, FGF23, 25(OH)D, 1,25(OH)2D, alkaline phosphatase
  • Genetic confirmation: PHEX mutation analysis results (for XLH)
  • Prior treatment history: Specific phosphate and vitamin D analog trials, doses, duration, outcomes, reasons for discontinuation
  • Current functional status: Growth velocity, pain scores, mobility limitations
  • Treatment goals: Expected improvements in phosphorus levels, growth, bone healing
  • Monitoring plan: Laboratory schedule per FDA labeling (serum phosphorus before each dose)

Reference the FDA prescribing information and UnitedHealthcare's medical policy in your documentation.

Costs and Coverage Tiers

Understanding Your Financial Responsibility

Crysvita is typically placed on Tier 4 or 5 (specialty tier) across UnitedHealthcare plans. Your out-of-pocket costs depend on your specific plan design:

  • Commercial plans: 20-50% coinsurance after deductible
  • Medicare Advantage: 27-28% coinsurance (varies by plan)
  • Marketplace plans: Varies widely; check your Summary of Benefits

Cost Assistance Options

Manufacturer Support Programs:

  • Kyowa Kirin Cares: Copay assistance reducing costs to $0 for eligible commercial patients; patient assistance program for uninsured
  • UltraCare by Ultragenyx: Prior authorization support and nurse case management
Important: Government insurance beneficiaries (Medicare, Medicaid) cannot use manufacturer copay assistance programs.

Additional Resources:

  • Patient advocacy organizations for rare diseases
  • State pharmaceutical assistance programs
  • Hospital charity care programs

Denials and Appeals in North Carolina

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Insufficient diagnosis confirmation Provide genetic testing or elevated FGF23 PHEX mutation analysis, FGF23 lab results
Missing prior therapy documentation Submit detailed treatment history Pharmacy records, physician notes, outcomes
Prescriber not specialist Transfer care or obtain specialist consultation Endocrinologist referral, consultation notes
Concurrent phosphate/vitamin D use Confirm discontinuation of prohibited medications Current medication list, prescriber attestation
Missing monitoring plan Provide detailed laboratory schedule Monitoring protocol per FDA labeling

North Carolina Appeals Process

Internal Appeals (UnitedHealthcare):

  • Deadline: 180 days from denial date
  • Process: Submit via provider portal, mail, or fax with additional clinical evidence
  • Timeline: 60 days for standard review, 72 hours for expedited

External Review (Smart NC):

  • Deadline: 120 days after final internal denial
  • Contact: Smart NC at 1-855-408-1212
  • Process: Independent medical review of denial
  • Timeline: 45 days standard, 72 hours expedited
  • Cost: Free to consumers
  • Binding: Yes, insurers must comply with favorable decisions
North Carolina Advantage: Smart NC provides free advocacy to help you navigate the external review process and gather supporting documentation.

When to Escalate

Contact the North Carolina Department of Insurance if you experience:

  • Repeated inappropriate denials
  • Failure to meet appeal deadlines
  • Procedural violations
  • Discrimination based on rare disease status

Renewal Requirements

Annual Reauthorization Process

UnitedHealthcare requires annual reauthorization for Crysvita. Submit renewal requests 30-60 days before your current authorization expires to avoid treatment interruptions.

Continuation Criteria:

  • Evidence of positive clinical response (improved growth velocity, reduced bone pain, fewer fractures)
  • Laboratory improvement (increased serum phosphorus levels)
  • Continued specialist oversight
  • Absence of significant adverse effects
  • Ongoing medical necessity

Documentation for Renewal:

  • Updated growth charts (pediatric patients)
  • Recent laboratory values showing treatment response
  • Specialist assessment of clinical improvement
  • Updated medication list confirming no prohibited concurrent therapies

Specialty Pharmacy Network

Required Dispensing Partners

UnitedHealthcare requires Crysvita to be dispensed through designated specialty pharmacies:

  • OptumRx Specialty (UnitedHealthcare's preferred network)
  • Accredo Health Group
  • Amber Specialty Pharmacy
  • CVS Specialty (Caremark)

Pharmacy Coordination Process

  1. Enrollment: Your specialty pharmacy will contact you to complete enrollment and verify benefits
  2. Delivery: Medication ships refrigerated; refrigerate immediately upon arrival
  3. Injection Training: Many pharmacies provide injection technique education
  4. Refill Coordination: Pharmacy manages refill timing with your provider
  5. Insurance Issues: Pharmacy benefit specialists help resolve coverage problems
Storage Reminder: Crysvita must be refrigerated (36°F to 46°F) and protected from light. Do not freeze or shake.

Troubleshooting Common Issues

Portal and System Problems

Provider Portal Down:

  • Call UnitedHealthcare Provider Services: 888-397-8129 (commercial) or 866-889-8054 (Medicare)
  • Submit via fax as backup (confirm current fax number with customer service)

Missing Prior Authorization Forms:

  • Download current forms from UHCProvider.com
  • Contact provider services for assistance

Delayed Responses:

  • Standard PA decisions: Follow up after 15 business days
  • Expedited requests: Follow up after 72 hours
  • Document all communications for appeal purposes

Coverage Verification Issues

Benefits Not Showing:

  • Verify member ID and group number
  • Confirm effective dates of coverage
  • Check if plan includes prescription drug benefits

Formulary Questions:

  • Access current formulary via member portal
  • Confirm tier placement and any restrictions
  • Verify specialty pharmacy requirements

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Crysvita in North Carolina? Standard decisions typically take 72 hours to 15 business days. Expedited reviews for urgent cases are completed within 24-72 hours.

What if Crysvita is non-formulary on my plan? Non-formulary medications may still be covered through the medical exception process. Your provider must demonstrate medical necessity and failure of formulary alternatives.

Can I request an expedited appeal if my Crysvita is denied? Yes, if treatment delay would seriously jeopardize your health or ability to regain function. Both UnitedHealthcare and North Carolina's external review process offer expedited timelines.

Does step therapy apply if I've tried treatments outside North Carolina? Yes, UnitedHealthcare accepts prior therapy documentation from other states. Ensure your provider submits complete treatment records from previous physicians.

What happens if I miss my reauthorization deadline? Treatment may be interrupted. Contact your specialty pharmacy and provider immediately to expedite the renewal process. You may need to pay out-of-pocket temporarily.

Can my primary care doctor prescribe Crysvita? UnitedHealthcare typically requires specialist (endocrinologist) oversight for Crysvita coverage. Your PCP may need to refer you to a specialist for initial authorization.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex insurance denials by turning rejections into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned with the insurer's own rules. For medications like Crysvita, we pull the right clinical evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—and weave them into appeals with the required clinical facts and operational details that payers expect.

Getting Crysvita covered by UnitedHealthcare in North Carolina requires careful attention to their specific medical necessity criteria and North Carolina's robust external review protections. While the prior authorization process can seem daunting, understanding the requirements and having proper specialist support significantly improves your chances of approval. Don't hesitate to leverage North Carolina's Smart NC program if you encounter denials—their free advocacy services have helped many patients access lifesaving rare disease treatments.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always verify current requirements with UnitedHealthcare and consult with your healthcare provider regarding treatment decisions. For personalized assistance with insurance appeals and prior authorizations, consider consulting with Counterforce Health or other qualified advocacy services.

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