By Counterforce Health Team in Crysvita (burosumab) —

How to Get Crysvita (burosumab) Covered by Cigna in North Carolina: Appeals Guide & Templates

Answer Box: Getting Crysvita (burosumab) Covered by Cigna in North Carolina

For Medicare Advantage: Crysvita requires no prior authorization when billed under Medical Oncology (HCPCS J0584). For Commercial plans: Prior authorization is required with specific XLH or TIO diagnosis documentation, phosphate monitoring plan, and specialist oversight. If denied, appeal internally first, then request external review through North Carolina's Smart NC program within 120 days. Start today: Contact your prescriber to verify your Cigna plan type and initiate the appropriate authorization pathway.

Table of Contents

  1. Understanding Your Cigna Plan Coverage
  2. Prior Authorization Requirements
  3. Reading Your Denial Letter
  4. First-Level Internal Appeal
  5. Peer-to-Peer Review Strategy
  6. North Carolina External Review Process
  7. Medical Necessity Letter Template
  8. Common Denial Reasons & Solutions
  9. Cost Assistance Options
  10. When to Escalate
  11. Frequently Asked Questions

Understanding Your Cigna Plan Coverage

Cigna's coverage for Crysvita (burosumab) varies significantly by plan type. Here's what you need to know:

Coverage at a Glance

Plan Type Prior Authorization Specialty Pharmacy Key Requirements
Medicare Advantage Not required for Medical Oncology May be required Must use HCPCS J0584 billing
Commercial/Employer Required Accredo typically required XLH/TIO diagnosis, specialist oversight
Individual Market Required Express Scripts network Phosphate monitoring plan mandatory

According to Cigna's 2024 Medicare Advantage Medical Oncology drug list, Crysvita is listed without prior authorization requirements when properly coded.

For commercial plans, Cigna's coverage policy requires comprehensive clinical documentation before approval.

Prior Authorization Requirements

Step-by-Step: Fastest Path to Approval

  1. Verify Plan Type (Patient/Clinic)
    • Call Cigna member services using the number on your insurance card
    • Confirm if you have Medicare Advantage or commercial coverage
    • Timeline: Same day
  2. Gather Required Documentation (Clinic)
    • XLH genetic testing or biochemical confirmation
    • Serum phosphate levels (baseline and monitoring plan)
    • Prior therapy history (phosphate supplements, vitamin D analogs)
    • Timeline: 1-3 business days
  3. Submit Prior Authorization (Prescriber)
  4. Coordinate Specialty Pharmacy (Patient/Clinic)
    • If approved, medication typically ships through Accredo
    • Verify patient copay assistance enrollment
    • Timeline: 2-5 business days after approval

Medical Necessity Criteria

Cigna typically requires documentation of:

  • Confirmed diagnosis of XLH (genetic testing preferred) or TIO with unresectable tumor
  • Serum phosphate levels below age-adjusted normal ranges
  • Specialist management by endocrinologist or metabolic bone specialist
  • Monitoring plan for serum phosphate, kidney function, and clinical response
  • Contraindication documentation if unable to use conventional phosphate/vitamin D therapy

Reading Your Denial Letter

When Cigna denies Crysvita coverage, the letter will specify the reason. Common denial codes include:

Denial Reason What It Means Next Step
"Not medically necessary" Clinical criteria not met Submit additional clinical evidence
"Non-formulary" Drug not on preferred list Request formulary exception
"Quantity limits exceeded" Dosing frequency/amount questioned Provide weight-based dosing justification
"Experimental/investigational" Off-label use concern Cite FDA approval and clinical guidelines
Important: Note the appeal deadline in your denial letter. For Cigna, you typically have 180 days from the denial date to file an internal appeal.

First-Level Internal Appeal

What to Include in Your Appeal

Your internal appeal should address the specific denial reason with targeted evidence:

For "Not Medically Necessary" Denials:

  • Laboratory confirmation of hypophosphatemia
  • Genetic testing results (if available)
  • Documentation of skeletal manifestations
  • Prior treatment failures or contraindications
  • Specialist consultation notes

For "Non-Formulary" Denials:

  • Request formulary exception based on medical necessity
  • Document why formulary alternatives are inappropriate
  • Include peer-reviewed literature supporting Crysvita's efficacy

Appeal Submission Process

Submit your appeal through:

  • Cigna member portal (fastest option)
  • Fax: Use the appeals fax number on your denial letter
  • Mail: Send to the address specified in your denial letter
Tip: Always request expedited review if treatment delay could worsen your condition or cause irreversible harm.

Peer-to-Peer Review Strategy

If your written appeal is denied, request a peer-to-peer review. This allows your prescribing physician to speak directly with Cigna's medical director.

Preparation Checklist for Prescribers

  • Review patient's complete medical history
  • Prepare 3-5 key talking points about medical necessity
  • Have clinical guidelines and FDA labeling readily available
  • Document the call date, time, and medical director's name
  • Follow up in writing within 24 hours

Key Talking Points

  1. Diagnosis confirmation: "Patient has genetically confirmed XLH with persistent hypophosphatemia despite conventional therapy"
  2. Treatment failure: "Previous phosphate and calcitriol therapy resulted in nephrocalcinosis, requiring discontinuation"
  3. Clinical guidelines: "Current expert consensus recommends burosumab as first-line therapy for adult XLH"
  4. Monitoring plan: "We have established comprehensive phosphate monitoring protocols per FDA labeling"

North Carolina External Review Process

If Cigna upholds their denial after internal appeals, North Carolina residents can request an external review through the state's Smart NC program.

External Review Timeline

Review Type Deadline to Request Decision Timeline
Standard Review 120 days after final denial 45 calendar days
Expedited Review No specific deadline 4 business days

How to Request External Review

  1. Contact Smart NC: Call 1-855-408-1212 for assistance
  2. Complete forms: Download the external review request form
  3. Submit documentation: Include all medical records and appeal correspondence
  4. Follow up: You can submit additional evidence within 7 days of acceptance

The external review process in North Carolina has helped many patients access expensive rare disease treatments. According to available data, 61.1% of Smart NC external review requests are accepted for review, providing an important avenue when internal appeals fail.

From our advocates: "We've seen several North Carolina patients successfully obtain Crysvita coverage through external review after initial Cigna denials. The key was providing comprehensive genetic testing results and documenting failed conventional therapy attempts. While we can't guarantee outcomes, thorough documentation significantly improves your chances."

Medical Necessity Letter Template

When appealing a Crysvita denial, your medical necessity letter should follow this structure:

Template Framework

Patient Information & Diagnosis

  • Full name, date of birth, Cigna ID number
  • Primary diagnosis: X-linked hypophosphatemia (ICD-10: E83.31) or Tumor-induced osteomalacia
  • Supporting genetic testing or biochemical confirmation

Clinical Rationale

  • Baseline serum phosphate levels and age-adjusted normal ranges
  • Documentation of skeletal manifestations (rickets, osteomalacia, fractures)
  • Growth impairment or functional limitations (if applicable)

Prior Treatment History

  • Previous therapies tried (phosphate supplements, calcitriol, alfacalcidol)
  • Reasons for discontinuation (side effects, inadequate response, contraindications)
  • Specific adverse events (nephrocalcinosis, hyperparathyroidism, GI intolerance)

Burosumab Justification

  • FDA approval for XLH in pediatric and adult patients
  • Mechanism of action (FGF23 inhibition)
  • Expected clinical benefits (improved phosphate levels, bone healing, reduced pain)
  • Monitoring plan per FDA labeling

Supporting Literature

  • Reference current clinical guidelines recommending burosumab
  • Cite peer-reviewed studies demonstrating efficacy
  • Include FDA prescribing information

A customizable template is available from Kyowa Kirin Cares to help structure your appeal letter.

Common Denial Reasons & Solutions

Denial Reason Documentation Needed Where to Find It
Lack of genetic confirmation PHEX gene mutation testing Genetic counselor or metabolic specialist
Insufficient phosphate monitoring Detailed monitoring protocol Prescriber's treatment plan
Concurrent phosphate/vitamin D use Documentation of discontinuation Pharmacy records, prescriber notes
Non-specialist prescriber Referral to endocrinologist Hospital or clinic referral system
Missing prior authorization Complete PA submission Cigna provider portal

Cost Assistance Options

Crysvita's high cost (potentially $4,000-$40,000+ annually depending on dosing) makes financial assistance crucial:

Manufacturer Support

  • Kyowa Kirin Cares: Provides copay assistance and free drug programs
  • Eligibility: Commercial insurance required; income limits apply
  • Website: KyowaKirinCares.com

Foundation Grants

  • Patient Advocate Foundation
  • National Organization for Rare Disorders (NORD)
  • HealthWell Foundation (when funds available)

State Programs

  • North Carolina's Medicaid expansion (effective 2024) may provide additional coverage options
  • State pharmaceutical assistance programs for qualifying residents

When to Escalate

If all appeals are exhausted, consider these escalation options:

File a Complaint with North Carolina Regulators

North Carolina Department of Insurance

  • Phone: 1-855-408-1212 (Smart NC)
  • Online complaint system available
  • Include all denial letters and appeal correspondence

Contact Cigna's Executive Offices

  • Document your case thoroughly
  • Request review by senior medical directors
  • Consider involving your employer's benefits administrator (if applicable)

Healthcare coverage specialists like Counterforce Health can help patients navigate complex appeals by analyzing denial letters, identifying specific coverage criteria, and drafting evidence-backed appeals that align with payer policies. Their platform specializes in turning insurance denials into targeted rebuttals for specialty medications like Crysvita.

Frequently Asked Questions

How long does Cigna prior authorization take in North Carolina? Standard requests: 72 hours. Urgent requests: 24 hours. Medicare Advantage plans may not require PA for Crysvita when billed under Medical Oncology.

What if Crysvita is non-formulary on my plan? Request a formulary exception by documenting medical necessity and why formulary alternatives are inappropriate for your condition.

Can I request an expedited appeal? Yes, if treatment delay would seriously jeopardize your health or ability to regain function. Both Cigna and North Carolina's external review offer expedited pathways.

Does step therapy apply to Crysvita? Many plans require documentation of failed conventional therapy (phosphate supplements, vitamin D analogs) before approving Crysvita.

What happens if my external review is denied? The external review decision is binding on your insurer. If approved, Cigna must provide coverage within 3 business days.

How do I find a metabolic bone specialist in North Carolina? Contact major medical centers like Duke University Medical Center or UNC Health for referrals to endocrinologists specializing in rare bone diseases.

Can I appeal if I move from another state to North Carolina? Yes, but you'll need to follow North Carolina's appeal procedures and timelines for any new denials after establishing residency.

What documentation do I need for tumor-induced osteomalacia? Imaging studies showing unresectable tumor, elevated FGF23 levels, biochemical evidence of phosphate wasting, and documentation that tumor resection is not feasible.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always verify current requirements with your insurance company and consult with your healthcare provider regarding treatment decisions. For personalized assistance with insurance appeals, consider consulting with healthcare coverage specialists or patient advocacy organizations.

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