By Counterforce Health Team in Crysvita (burosumab) —

How to Get Crysvita (Burosumab) Covered by Humana in North Carolina: Prior Authorization, Appeals & Step Therapy Guide

Answer Box: Getting Crysvita Covered by Humana in North Carolina

Crysvita (burosumab) requires prior authorization from Humana and step therapy through oral phosphate plus vitamin D analogs first. To get coverage in North Carolina: (1) Document failed conventional therapy with your endocrinologist, (2) Submit PA request with genetic/biochemical confirmation of XLH or TIO, (3) If denied, file internal appeal within 65 days, then external review through Smart NC if needed. Start by calling Humana member services (number on your ID card) to confirm formulary status and request PA forms.

Table of Contents

Humana Plan Types & Coverage Implications

Medicare Advantage Plans If you have Humana Medicare Advantage in North Carolina, your Crysvita coverage follows Medicare Part D rules with Humana-specific formulary placement. These plans typically have robust prior authorization requirements for high-cost specialty drugs like Crysvita, which can cost $4,000-$40,000+ per vial depending on dosing.

Dual Eligible Special Needs Plans (D-SNPs) Humana's dual eligible plans in North Carolina provide enhanced coverage coordination between Medicare and Medicaid. Crysvita is covered under these plans but still requires prior authorization and step therapy documentation.

Commercial Plans Humana's commercial insurance plans in North Carolina follow similar utilization management protocols, though specific formulary tiers may vary by employer group or individual market plan.

Crysvita Formulary Status & Tier Placement

Crysvita (burosumab-twza) is covered under Humana Medicare Advantage and Dual Medicare-Medicaid plans, but requires prior authorization before coverage approval. The medication is listed on Humana's Medicare and Dual Eligible Special Needs Plans Preauthorization List.

What This Means for You:

Tip: To find your exact formulary tier and copay amount, log into MyHumana and search for "burosumab" or "Crysvita" under your specific plan.

Prior Authorization & Step Therapy Requirements

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must get approval before filling Humana PA List
Step Therapy Try oral phosphate + vitamin D first PA submission form
Diagnosis Confirmation Genetic testing or biochemical proof Medical records
Specialist Prescription Endocrinologist or metabolic specialist Provider credentials
Monitoring Plan Serum phosphorus every 4 weeks Clinical protocol

Step Therapy Alternatives Required

Before Humana will approve Crysvita, you must have documented failure or intolerance to:

  1. Oral phosphate supplements (sodium phosphate or potassium phosphate)
  2. Active vitamin D analogs (calcitriol, doxercalciferol, or paricalcitol)

Important: Crysvita cannot be taken with oral phosphate and active vitamin D - these must be discontinued at least one week before starting treatment.

Step Therapy Bypass Options

You can skip step therapy if you have:

  • Medical contraindications to conventional therapy
  • Documented adverse effects from prior treatment
  • Clinical evidence that oral phosphate/vitamin D will be ineffective
  • History suggesting these medications will cause adverse reactions

Specialty Pharmacy Requirements

Crysvita is typically dispensed through specialty pharmacies due to its high cost and specialized handling requirements. Kyowa Kirin offers patient support through Kyowa Kirin Cares to help locate specialty pharmacies and facilitate prescription processing.

Administration Details:

Cost-Share Basics

Your out-of-pocket costs depend on several factors:

Deductible Phase If you haven't met your annual deductible, you may pay the full negotiated price until reaching the deductible amount.

Coverage Gap In Medicare Part D's "donut hole," you typically pay 25% of the drug cost until reaching catastrophic coverage.

Catastrophic Coverage Once you reach the catastrophic threshold, you pay the greater of 5% coinsurance or small copay amounts.

Note: These are educational basics only. Your actual costs depend on your specific plan design and where you are in your benefit year.

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis and Prior Treatments

Who: Your endocrinologist or metabolic specialist What: Document XLH or TIO diagnosis with genetic testing or biochemical markers Timeline: Allow 2-4 weeks for genetic testing results

2. Gather Step Therapy Documentation

Who: Your medical team What: Records showing failed trials of oral phosphate + vitamin D analogs Include: Specific medications, doses, duration, and reasons for discontinuation

3. Submit Prior Authorization Request

Who: Your prescriber or their staff How: Through Humana provider portal or fax Timeline: Standard determination within 72 hours

4. Request Expedited Review if Urgent

When: If delay could harm your health Timeline: Decision within 24 hours for expedited requests

5. File Appeal if Denied

Deadline: 65 calendar days from denial notice Methods: Online, mail, or fax using official forms

6. Pursue External Review in North Carolina

Who: Smart NC through NC Department of Insurance Timeline: 120 days after final internal denial Decision: Within 45 days (72 hours for expedited)

7. Enroll in Specialty Pharmacy

Who: You and your prescriber Support: Kyowa Kirin Cares enrollment assistance

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Lack of genetic confirmation Submit PHEX gene testing or elevated FGF23 levels
Insufficient step therapy Provide detailed records of oral phosphate/vitamin D trials
Missing specialist prescription Transfer care to endocrinologist or metabolic specialist
Concurrent contraindicated meds Document discontinuation of oral phosphate/vitamin D
Inadequate monitoring plan Submit protocol for serum phosphorus checks every 4 weeks

Appeals Process for Humana in North Carolina

Internal Appeals with Humana

First Level (Redetermination)

Who Can Appeal:

  • You (the member)
  • Someone you designate
  • Your prescribing doctor

External Review through North Carolina

If Humana upholds the denial, North Carolina residents have strong appeal rights through Smart NC.

Key Benefits:

  • Free advocacy: Call 1-855-408-1212 for help with your appeal
  • Fast decisions: 45 days standard, 72 hours expedited
  • Binding results: If approved, Humana must cover within 3 business days

Eligibility Requirements:

  • State-regulated plan (most individual and small group plans qualify)
  • Exhausted internal appeals (or qualify for expedited review)
  • Denial based on medical necessity or experimental treatment
From our advocates: We've seen many North Carolina patients successfully overturn Crysvita denials through external review, especially when genetic testing clearly confirms XLH and conventional therapy has failed. The key is submitting comprehensive medical records that directly address the original denial reasons.

Clinician Corner: Medical Necessity Letter Checklist

Healthcare providers should include these elements in prior authorization submissions:

Required Clinical Information

  • Diagnosis: ICD-10 codes for XLH (E83.31) or TIO (M83.89)
  • Genetic confirmation: PHEX gene mutation or biochemical markers (low phosphate, elevated FGF23)
  • Prior treatments: Specific oral phosphate and vitamin D analog trials with outcomes
  • Contraindications: Why conventional therapy failed or is inappropriate
  • Treatment goals: Normalize phosphate levels, improve bone health, reduce pain

Supporting Documentation

  • FDA prescribing information for dosing rationale
  • Relevant clinical guidelines (Endocrine Society, pediatric endocrine societies)
  • Laboratory values showing hypophosphatemia
  • Imaging studies demonstrating bone disease if applicable

Monitoring Protocol

  • Serum phosphorus levels every 4 weeks during dose adjustment
  • Plan for dose modifications based on response
  • Long-term follow-up schedule

Cost Assistance & Patient Support

Manufacturer Programs Kyowa Kirin Cares provides:

  • Patient support specialists
  • Insurance navigation assistance
  • Specialty pharmacy coordination

Additional Resources

  • Patient advocacy organizations for rare diseases
  • State pharmaceutical assistance programs
  • Foundation grants for high-cost medications

Getting Coverage Help Counterforce Health specializes in turning insurance denials into evidence-backed appeals. Their platform analyzes denial letters, identifies specific coverage criteria, and drafts targeted rebuttals using the right clinical evidence and payer-specific requirements. For complex cases like Crysvita appeals, having expert support can significantly improve approval chances.

Frequently Asked Questions

How long does Humana prior authorization take for Crysvita in North Carolina? Standard requests receive decisions within 72 hours, while expedited requests are decided within 24 hours when you and your provider believe waiting could harm your health.

What if Crysvita is non-formulary on my plan? You can request a formulary exception with prescriber support. Humana must respond within 72 hours for standard requests.

Can I get expedited appeal in North Carolina? Yes, both Humana and Smart NC offer expedited reviews when delays could seriously harm your health. Expedited external reviews receive decisions within 72 hours.

Does step therapy apply if I tried conventional therapy in another state? Yes, documented trials from any location should satisfy step therapy requirements. Ensure your new provider has complete medical records.

What happens if my appeal is denied? After exhausting Humana's internal appeals, you have 120 days to file external review with Smart NC. Their decision is binding on Humana.

Can I get transition coverage while appealing? Beginning January 1, 2025, Humana provides 30-day transition coverage for covered drugs during your first 90 days of enrollment while pursuing exceptions or appeals.

Sources & Further Reading

This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual circumstances, plan details, and medical necessity as determined by your healthcare provider and insurance company. For personalized guidance, consult your healthcare team and contact Humana member services directly. North Carolina residents can access free insurance help through Smart NC at 1-855-408-1212.

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