By Counterforce Health Team in Crysvita (burosumab) —

Get Crysvita (Burosumab) Covered by UnitedHealthcare in New Jersey: Prior Authorization, Appeals & Cost Assistance Guide

Answer Box: Fast Track to Coverage

Getting Crysvita (burosumab) covered by UnitedHealthcare in New Jersey requires prior authorization with genetic testing or elevated FGF23 levels, specialist involvement, and documentation of failed conventional therapy (especially for adults). Submit through the UnitedHealthcare provider portal with complete medical records. If denied, you have 180 days for internal appeals, then access to New Jersey's binding external review through IHCAP. First step today: Contact your endocrinologist to gather genetic test results, phosphate levels, and prior treatment history for the PA submission.

Table of Contents

What Drives Crysvita Costs

Crysvita's high cost—with wholesale prices ranging from $4,451 for 10mg to $13,354 for 30mg per vial—stems from its status as a rare disease biologic. Your out-of-pocket costs depend on several factors:

Formulary Tier Placement UnitedHealthcare typically places Crysvita in Tier 4 (specialty preferred) or Tier 5 (specialty non-preferred) when covered. This means:

  • Tier 4: ~20% coinsurance with $50-$100 min/max per 30-day supply
  • Tier 5: ~40% coinsurance with $50 minimum, no maximum

Medical vs. Pharmacy Benefit Crysvita is usually covered as a medical benefit (billed under HCPCS code J0584) rather than pharmacy benefit, which affects your deductible and coinsurance structure.

Note: UnitedHealthcare requires Crysvita to be dispensed through specific specialty pharmacies: Accredo, Amber, CVS Specialty, Orsini, or PANTHERx.

Benefit Investigation Checklist

Before starting treatment, gather this information by calling UnitedHealthcare member services:

Essential Questions to Ask:

  • Is prior authorization required for Crysvita (J0584)?
  • What's my specialty drug deductible and coinsurance?
  • Which specialty pharmacies are in-network?
  • Are there quantity limits or step therapy requirements?
  • What's my annual out-of-pocket maximum?

Information to Record:

  • Member ID and group number
  • Plan effective dates
  • Deductible remaining
  • Specialty pharmacy contact numbers
  • Reference number for your call

Counterforce Health helps patients navigate these benefit investigations by analyzing denial letters and plan policies to identify the most effective appeal strategies.

Manufacturer & Foundation Assistance

Kyowa Kirin Cares Co-Pay Assistance Program

For commercially insured patients, this program can significantly reduce out-of-pocket costs:

Eligibility Requirements:

  • Commercial (private) insurance that covers Crysvita
  • U.S. resident prescribed Crysvita for FDA-approved use
  • Cannot use with government insurance (Medicare, Medicaid, TRICARE)
  • Must sign HIPAA authorization

Coverage Includes:

  • Eligible out-of-pocket costs for the drug
  • Associated administration cost-sharing
  • Annual maximum benefit (contact program for specific amount)

How to Apply:

  1. Have your prescriber complete the Kyowa Kirin Cares enrollment form
  2. Fax completed form for benefits investigation
  3. Case manager will contact you within 5-7 business days
Important: Claims more than 90 days before enrollment are not eligible. Don't seek HSA/FSA reimbursement for copay-assisted amounts.

Patient Assistance Program (PAP) For patients with limited or no coverage, Kyowa Kirin may provide Crysvita at no cost based on income and financial need criteria.

Contact: 1-833-KK-CARES (1-833-552-2737)

Prior Authorization Requirements

UnitedHealthcare's medical drug policy requires comprehensive documentation:

Coverage Criteria Table

Requirement What It Means Documentation Needed
Confirmed XLH Diagnosis Genetic or biochemical proof PHEX mutation OR elevated FGF23 above lab reference
Age ≥6 months FDA-approved age range Date of birth verification
Specialist Prescriber Endocrinologist involvement Prescriber credentials or consultation note
Hypophosphatemia Low baseline phosphate Fasting serum phosphorus below normal range
Step Therapy (Adults) Failed conventional therapy Documentation of oral phosphate + calcitriol trial
Appropriate Dosing FDA-compliant regimen Weight-based calculation within label limits

Step-by-Step: Fastest Path to Approval

  1. Gather Diagnostic Evidence (Patient/Clinic)
    • Obtain genetic testing results showing PHEX mutation
    • OR get FGF23 level with lab reference ranges
    • Timeline: 1-2 weeks if tests needed
  2. Document Prior Treatments (Clinic)
    • For adults: detailed history of oral phosphate and calcitriol use
    • Include dates, doses, outcomes, and any adverse effects
    • Timeline: Same day if records available
  3. Complete PA Submission (Clinic)
  4. Track Decision (Patient/Clinic)
    • Standard review: 5-15 business days
    • Expedited review: 72 hours if urgency documented
    • Check status online or call provider services
  5. Coordinate Specialty Pharmacy (Clinic)
    • Send prescription to approved specialty pharmacy
    • Arrange delivery to clinic for administration
    • Timeline: 3-5 business days for first shipment

Specialty Pharmacy Coordination

Required Specialty Pharmacies for UnitedHealthcare:

  • Accredo Health Group
  • Amber Specialty Pharmacy
  • CVS Specialty (Caremark)
  • Orsini Pharmaceutical Services
  • PANTHERx Rare Pharmacy

Coordination Tips:

  • Provide clinic NPI, shipping address, and administration schedule
  • Confirm cold-chain delivery 1-3 days before appointment
  • Verify insurance coverage before each shipment
  • Track expiration dates for temperature-sensitive vials
Tip: Build scheduling templates around Q2W (pediatric) vs Q4W (adult) dosing cycles, accounting for delivery logistics.

Appeals Process in New Jersey

Internal Appeals (UnitedHealthcare)

Stage 1 Internal Appeal

  • Deadline: 180 days from denial
  • Timeline: 10-30 days (72 hours if expedited)
  • Reviewer: Different clinical reviewer than original decision

Stage 2 Internal Appeal (Group Plans)

  • Deadline: 180 days from Stage 1 denial
  • Timeline: 30 days standard, expedited available
  • Requirement: Must complete before external review

New Jersey External Review (IHCAP)

After exhausting UnitedHealthcare's internal appeals, New Jersey residents can access the Independent Health Care Appeals Program (IHCAP) through Maximus Federal Services.

Eligibility:

  • Fully insured New Jersey plan (not self-funded ERISA)
  • Medical necessity denial
  • Completed internal appeals

Process:

  • Deadline: 4 months from final internal denial
  • Timeline: 45 days standard, 48 hours expedited
  • Cost: Free to patients
  • Decision: Binding on UnitedHealthcare

Required Documents:

  • IHCAP external appeal application
  • All UnitedHealthcare denial letters
  • Complete medical records
  • Physician letter of medical necessity
  • Clinical practice guidelines supporting treatment
From our advocates: We've seen New Jersey patients succeed with IHCAP appeals for specialty biologics when they include detailed medical necessity letters addressing each specific denial reason from UnitedHealthcare. One composite case involved overturning a step-therapy denial after documenting multiple conventional therapy failures with objective lab results and functional assessments.

Contact: 1-888-393-1062 (IHCAP hotline)

Cost Management Strategies

Annual Planning:

  • Review formulary changes each January 1st
  • Track toward out-of-pocket maximum early in year
  • Plan for potential tier changes or new step therapy requirements

Documentation for Cost Appeals:

  • Comparative cost analysis of alternatives
  • Clinical superiority evidence
  • Economic impact of treatment delays

Pharmacy Choice Optimization:

  • Use preferred specialty pharmacy for lowest coinsurance
  • Coordinate 90-day supplies when possible
  • Leverage specialty pharmacy support services

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing plan policies and crafting evidence-backed responses that address specific denial reasons.

Conversation Scripts

Calling UnitedHealthcare Member Services: "I need to verify coverage for Crysvita, HCPCS code J0584, for X-linked hypophosphatemia. Can you tell me if prior authorization is required, what my specialty drug benefits are, and which specialty pharmacies are in-network for this medication?"

Requesting Expedited Review: "This is an urgent request for Crysvita prior authorization. My patient has progressive skeletal deformities and fractures that will worsen without immediate treatment. Please process as expedited under your 72-hour timeline."

Peer-to-Peer Request: "I'm requesting a peer-to-peer review for a Crysvita denial. My patient meets all clinical criteria with confirmed XLH diagnosis and failed conventional therapy. I have additional clinical data that wasn't considered in the initial review."

FAQ

How long does UnitedHealthcare prior authorization take in New Jersey? Standard review takes 5-15 business days. Expedited review for urgent cases is completed within 72 hours when clinical urgency is documented.

What if Crysvita is non-formulary on my plan? Non-formulary drugs may still be covered with prior authorization and medical necessity documentation. You may need to request a formulary exception with clinical justification.

Can I request an expedited appeal? Yes, if delay would jeopardize health or function. Document progressive fractures, severe pain, or rapid skeletal deformity for expedited processing.

Does step therapy apply if I failed treatments outside New Jersey? Yes, documented treatment failures from any location count toward step therapy requirements if properly documented in medical records.

What happens if my appeal is denied? After completing UnitedHealthcare's internal appeals, you can file an external review with New Jersey's IHCAP program, which provides binding independent review.

Are there income limits for manufacturer assistance? The copay card has no income limits for commercially insured patients. The Patient Assistance Program (PAP) has income criteria reviewed case-by-case.

How do I find my exact specialty pharmacy requirements? Check your member ID card or call UnitedHealthcare member services. Crysvita requires use of specific contracted specialty pharmacies listed in their administrative drug chart.

What documentation strengthens a medical necessity appeal? Include genetic testing, FGF23 levels, detailed prior treatment history with outcomes, current phosphate levels, radiographic evidence, and functional assessments showing disease impact.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change over time. Always verify current requirements with your insurance provider and consult your healthcare team for medical decisions. For additional support with insurance appeals and coverage challenges, Counterforce Health provides specialized assistance in navigating complex prior authorization and appeal processes.

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