By Counterforce Health Team in Crysvita (burosumab) —

How to Get Crysvita (burosumab) Covered by Aetna (CVS Health) in North Carolina: Complete PA Guide with Appeals Timeline

Answer Box: Getting Crysvita (burosumab) Covered by Aetna (CVS Health) in North Carolina

Crysvita requires prior authorization from Aetna (CVS Health) for all members. To get approved, you need: genetic testing showing PHEX mutation or elevated FGF23 levels, radiographic evidence of bone disease, and a specialist prescriber experienced in metabolic bone disorders. Submit through CVS Caremark at (866) 752-7021 or fax (888) 267-3277. Standard approval takes 30-45 days; expedited review available for urgent cases (72 hours). If denied, North Carolina residents can appeal internally (180 days) then request external review through Smart NC (120 days after final denial).

First step today: Contact your endocrinologist to order genetic testing (PHEX mutation) or FGF23 lab work if not already completed.

Table of Contents

  1. Verify Your Aetna Plan Coverage
  2. Required Forms and Documentation
  3. Submission Portals and Contact Information
  4. CVS Specialty Pharmacy Enrollment
  5. Common Denial Reasons and Solutions
  6. Appeals Process in North Carolina
  7. Smart NC External Review
  8. Patient Support and Financial Assistance
  9. FAQ: Crysvita Coverage with Aetna

Verify Your Aetna Plan Coverage

Before starting the prior authorization process, confirm your specific Aetna plan details. Crysvita (burosumab) is classified as a specialty tier, non-formulary medication on most Aetna plans, meaning it requires prior authorization regardless of whether you see an in-network provider.

What to check on your member portal:

  • Formulary tier status for Crysvita
  • Specialty pharmacy requirements
  • Your specific prior authorization pathway
Note: Self-funded employer plans may have different coverage rules. Contact Member Services at the number on your ID card to verify your plan type.

Required Forms and Documentation

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Mandatory for all plans Aetna Precertification Form Aetna Policy
Genetic Testing PHEX mutation or elevated FGF23 Your endocrinologist FDA Label
Age Requirement 6+ months for XLH Medical records FDA Approval
Specialist Prescriber Metabolic bone disease experience Provider attestation Aetna Criteria
Bone Imaging X-rays or DEXA scans Radiology department Clinical Requirements

Medical Necessity Documentation

Your prescriber must submit comprehensive documentation establishing medical necessity:

Required lab work:

  • Genetic testing showing PHEX gene mutation, OR
  • Serum FGF23 level above upper limit of normal
  • Baseline serum phosphorus levels
  • Serum alkaline phosphatase activity
  • 25-hydroxyvitamin D levels

Imaging requirements:

  • Radiographic evidence of rickets or bone disease attributed to XLH
  • X-rays showing bone deformities or pseudofractures
  • DEXA scan results (when applicable)

Clinical documentation:

  • Diagnosis confirmation of X-linked hypophosphatemia
  • Documentation of bone disease impact on daily functioning
  • Previous treatment history with oral phosphate and calcitriol
  • Prescriber attestation of metabolic bone disease experience

Submission Portals and Contact Information

Primary Submission Methods

Phone: (866) 752-7021 (fastest for urgent cases)
Fax: (888) 267-3277
Email: [email protected]

Tip: Request a confirmation number when submitting by phone and keep all fax transmission reports as proof of submission.

Timeline Expectations

  • Standard Review: 30-45 days from complete submission
  • Expedited Review: 72 hours for urgent medical situations
  • Incomplete Submissions: Additional 15-30 days if more information is requested

CVS Specialty Pharmacy Enrollment

Once your prior authorization is approved, CVS Specialty will contact you within 24-48 hours to coordinate medication delivery and administration.

Enrollment Process

  1. Complete specialty pharmacy enrollment form with your prescriber
  2. Choose administration site: Home with nurse visit or physician office
  3. Verify insurance benefits and copay responsibilities
  4. Schedule delivery and administration appointments

Key requirement: Your prescriber must provide original signature on enrollment forms (stamped signatures not accepted).

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Missing genetic testing Submit PHEX mutation results or elevated FGF23 Lab reports from certified genetic testing facility
Insufficient bone disease evidence Provide comprehensive imaging X-rays, DEXA scans, radiologist interpretation
Prescriber not qualified Specialist attestation Board certification, experience statement
Concurrent phosphate use Document medication discontinuation Pharmacy records, prescriber note
Age criteria not met Verify patient age ≥6 months Birth certificate, medical records

Appeals Process in North Carolina

Step-by-Step Appeals Timeline

Level 1: Internal Appeal (First Level)

  • Deadline: 180 days from denial date
  • Timeline: 30 days for standard, 72 hours for expedited
  • How to submit: Call Member Services or submit written appeal
  • Required: Copy of denial letter, additional medical records

Level 2: Internal Appeal (Second Level)

  • Deadline: 60 days from first-level denial
  • Timeline: 30 days for standard, 72 hours for expedited
  • Process: Independent medical review within Aetna
  • Outcome: Final internal decision letter
Clinician Corner: For medical necessity letters, include specific details about failed oral phosphate therapy, documented intolerance to calcitriol, and how bone disease impacts the patient's mobility and quality of life. Reference FDA labeling and relevant endocrine society guidelines.

When to Request Expedited Appeals

Request expedited processing if:

  • Delays could seriously jeopardize your health
  • You're experiencing progressive bone pain or fractures
  • Your doctor certifies urgent medical need
  • Current bone disease is affecting your ability to function

Smart NC External Review

If Aetna denies your internal appeals, North Carolina residents have robust external review rights through Smart NC.

External Review Process

Contact Smart NC: 1-855-408-1212 (free consumer assistance)
Deadline: 120 days after final internal denial
Timeline: 45 days for standard review, 72 hours for expedited
Success Rate: 37-43% overturn rate for specialty drug denials

Required for external review:

  • Completed both internal appeal levels with Aetna
  • State-regulated plan (most employer and individual plans qualify)
  • Denial based on medical necessity or experimental treatment claims
From our advocates: We've seen cases where patients initially denied for "insufficient genetic evidence" were approved on external review after submitting comprehensive FGF23 testing and detailed bone imaging reports. The key is ensuring all clinical documentation clearly establishes the connection between genetic findings and bone disease manifestations.

Smart NC Support Services

Smart NC provides free advocacy beyond just processing external reviews:

  • Help completing external review request forms
  • Assistance gathering medical records
  • Communication facilitation with insurers
  • Clinical guideline research support

Important: Once Smart NC makes a decision, it's binding on Aetna. If approved, coverage must begin within 3 business days.

Patient Support and Financial Assistance

Manufacturer Support Programs

Kyowa Kirin Cares Program

  • Copay assistance for eligible patients
  • Free drug program for uninsured patients meeting income requirements
  • Patient access coordinators for insurance navigation

Enrollment: Visit kyowakirincares.com or call the number provided by your prescriber

Foundation Grants

Several patient assistance foundations provide grants for specialty medications:

  • The HealthWell Foundation
  • Patient Access Network Foundation
  • National Organization for Rare Disorders (NORD)
Note: Foundation funding availability changes frequently. Apply early in the calendar year when funds are typically most available.

FAQ: Crysvita Coverage with Aetna

Q: How long does Aetna prior authorization take for Crysvita in North Carolina?
A: Standard review takes 30-45 days from complete submission. Expedited review is available for urgent cases and must be completed within 72 hours.

Q: What if Crysvita is non-formulary on my Aetna plan?
A: You can request a formulary exception with supporting medical documentation. Your doctor must provide a clinical statement explaining why the non-formulary drug is medically necessary.

Q: Can I request an expedited appeal if my initial PA is denied?
A: Yes, if your doctor certifies that delays could seriously jeopardize your health or ability to regain function. Expedited appeals must be decided within 72 hours.

Q: Does step therapy apply to Crysvita?
A: Aetna typically requires documentation of failed or inappropriate oral phosphate and calcitriol therapy before approving Crysvita, though this isn't always formally structured as step therapy.

Q: What happens if Smart NC denies my external review?
A: Smart NC's decision is binding, meaning you've exhausted the standard administrative appeals process. You may still have other legal rights to pursue.

Q: How much does Crysvita cost without insurance?
A: Wholesale acquisition cost ranges from $4,451 (10mg) to $13,354 (30mg) per vial, with total monthly costs depending on weight-based dosing requirements.

Counterforce Health helps patients navigate complex prior authorization and appeals processes for specialty medications like Crysvita. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with payer-specific requirements. Learn more about our services at www.counterforcehealth.org.

When dealing with insurance coverage challenges, having the right documentation and understanding your appeal rights can make the difference between approval and continued denials. North Carolina's robust external review system through Smart NC provides an important safety net when internal appeals fail.

For additional support navigating Aetna coverage decisions, Counterforce Health's platform can help identify specific denial reasons and generate targeted appeals that address your plan's exact coverage criteria.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For official appeals assistance in North Carolina, contact Smart NC at 1-855-408-1212.

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