By Counterforce Health Team in Kalydeco (ivacaftor) —

Getting Kalydeco (Ivacaftor) Covered by Aetna CVS Health in North Carolina: Complete Prior Authorization and Appeals Guide

Answer Box: Fastest Path to Kalydeco Approval in North Carolina

Aetna CVS Health requires prior authorization for Kalydeco (ivacaftor) with CFTR genetic testing confirming FDA-approved mutations (like G551D), CF specialist prescription, and baseline labs. Submit via Availity portal with genetic test results, specialist notes, and pulmonary function tests. If denied, file internal appeal within 180 days, then external review through Smart NC within 120 days. Start today: Call your CF specialist to request genetic testing and gather baseline PFTs.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Kalydeco prescriptions Aetna Precertification List Aetna
CFTR Genetic Testing FDA-cleared test showing responsive mutation CF specialist or genetic counselor FDA Access Data
Specialist Prescription CF specialist or pulmonologist required Provider network directory Aetna Policy 1884-A
Age Requirements 4 months or older per FDA labeling Patient records FDA Label
Baseline Testing PFTs, liver function tests within 3 months CF center records Aetna Policy
CVS Specialty Enrollment Required for dispensing CVS Specialty CVS

Step-by-Step: Fastest Path to Approval

1. Confirm CFTR Mutation Status (Patient/Family)

Who: Patient works with CF specialist
Document needed: FDA-cleared genetic test report
Timeline: 1-2 weeks if not already done
Action: If unknown, request CFTR panel through your CF center

2. Gather Required Documentation (CF Specialist)

Who: CF specialist and clinic staff
Documents needed:

  • Recent pulmonary function tests (within 6 months)
  • Liver function tests (AST/ALT/bilirubin within 3 months)
  • CF diagnosis confirmation with ICD-10 codes
  • Treatment history and prior medication trials

Timeline: 1-2 days to compile
Source: Aetna PA Requirements

3. Complete Prior Authorization Forms (Clinic Staff)

Who: Provider office
Forms needed:

  • Aetna PA form via Availity portal
  • CVS Specialty enrollment form
  • Medical necessity letter (see template below)

Timeline: Submit 2 weeks before needed start date
Tip: Electronic submission through Availity typically processes faster (average 8.5 hours for some commercial plans)

4. Submit Complete Package (Clinic)

How: Availity portal (preferred) or fax per plan-specific numbers
Include: All forms, genetic testing, specialist notes, baseline labs
Timeline: Follow up in 3-5 days
Mark: "URGENT - Specialty PA" if time-sensitive

5. Track Decision (Patient/Clinic)

Timeline: Standard decisions within 30-45 days; expedited within 72 hours
How to check: Aetna member portal or call member services
If approved: CVS Specialty will contact patient for delivery coordination

6. Handle Denials (If Needed)

Common reasons: Missing genetic testing, inadequate documentation
Immediate action: Request peer-to-peer review with CF specialist
Timeline: File internal appeal within 180 days

7. External Review (If Internal Appeal Fails)

Who: Patient or authorized representative
Timeline: Within 120 days of final internal denial
How: Smart NC External Review
Cost: Free in North Carolina

Medical Necessity Documentation

Essential Elements for CF Specialists

Your medical necessity letter should include these components on letterhead with your signature and credentials:

Patient Demographics: Full name, DOB, Aetna member ID
Diagnosis: Cystic fibrosis with specific ICD-10 codes (e.g., E84.0)
Genetic Testing: "Patient has confirmed [specific mutation] via FDA-cleared CFTR analysis performed at [lab name]"
Clinical Rationale: Current symptoms, FEV1 percentage, exacerbation history
Treatment Goals: Expected improvements in lung function and quality of life
Policy Compliance: "Patient meets all criteria per Aetna Clinical Policy Bulletin 1884-A"

Clinician Corner: Reference the CF Foundation Care Guidelines and FDA labeling in your letter. Include specific data points like "FEV1 improved from X% to Y% predicted" or "reduced pulmonary exacerbations from X to Y per year."

Sample Medical Necessity Statement

"This [age]-year-old patient with cystic fibrosis and confirmed G551D mutation (FDA-cleared testing at [lab]) currently has FEV1 of [X]% predicted with [frequency] of pulmonary exacerbations. Kalydeco (ivacaftor) is medically necessary per FDA labeling for this responsive CFTR mutation and meets all criteria in Aetna CPB 1884-A. Expected outcomes include improved lung function and reduced exacerbations based on pivotal clinical trials."

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documents
Missing genetic testing Submit FDA-cleared CFTR report immediately Complete genetic panel results
"Not medically necessary" Provide specialist letter with clinical rationale CF specialist assessment, PFTs, treatment history
Step therapy requirement Document prior CFTR modulator failures/contraindications Previous medication trials and outcomes
Non-formulary status Request formulary exception Medical necessity letter, alternative failures
Age restrictions Verify against FDA labeling Birth certificate, FDA label citation
Inadequate specialist Confirm CF specialist credentials Board certification, DEA number

Appeals Process in North Carolina

Internal Appeals with Aetna CVS Health

Level 1 Internal Appeal

  • Timeline: File within 180 days of denial
  • How: Aetna member portal, mail, or fax
  • Decision time: 30 days standard, 72 hours expedited
  • Include: Denial notice, medical records, specialist letter, genetic testing

Peer-to-Peer Review

  • Who: CF specialist calls Aetna medical director
  • Phone: Use number on denial letter or member services
  • Script: "Requesting peer-to-peer for Kalydeco denial. Patient has [FDA-approved CFTR mutation]. Please provide clinical discussion with medical director."

External Review Through Smart NC

If Aetna's internal appeals fail, North Carolina offers robust external review rights:

Eligibility: State-regulated plan (most individual and small group plans)
Timeline: File within 120 days of final internal denial
Process: Complete External Review Request Form
Decision time: 45 days standard, 72 hours expedited
Cost: Free
Binding: Yes, insurer must comply within 3 business days if approved

Mail to: Insurance Benefit Administrators, Attn: Claim Reviews, PO Box 2917, Shawnee Mission, KS 66201-1317

Note: Smart NC staff at 855-408-1212 provide free assistance with external review applications and can help gather supporting documentation.

For many patients navigating complex insurance denials, Counterforce Health offers AI-powered tools that help draft targeted, evidence-backed appeals by analyzing denial letters and payer policies to create point-by-point rebuttals aligned with the plan's own rules.

Cost Assistance Programs

Vertex Patient Support Programs

Vertex GPS Copay Card

  • Benefit: Up to $20,000 per year in out-of-pocket cost reduction
  • Eligibility: Commercial insurance only (not Medicare/Medicaid)
  • Apply: Vertex GPS Program

Vertex GPS Patient Assistance Program

  • Benefit: Free drug for eligible uninsured/underinsured patients
  • Income limits: Varies by household size
  • Apply: Through CF specialist or directly with Vertex

Additional Support

CF Foundation Compass Program

  • Services: Insurance navigation, financial assistance
  • Contact: CF Foundation

State Programs: North Carolina expanded Medicaid in 2024, potentially covering Kalydeco for newly eligible patients

When to Escalate to State Regulators

Contact the North Carolina Department of Insurance if you experience:

  • Unreasonable delays in prior authorization decisions
  • Repeated denials despite meeting policy criteria
  • Failure to process external review decisions
  • Bad faith claim handling

File a complaint: Online at ncdoi.gov or call 855-408-1212

FAQ

How long does Aetna CVS Health prior authorization take in North Carolina? Standard PA decisions take 30-45 days, but electronic submissions through Availity can be processed in hours. Request expedited review if urgent (72-hour decision).

What if Kalydeco is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Many non-formulary denials are overturned when FDA indication and specialist support are provided.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. Both internal appeals and external reviews offer expedited options with 72-hour decisions.

Does step therapy apply if I've tried other CFTR modulators? Document all prior CFTR modulator trials, outcomes, and reasons for discontinuation. Step therapy can often be waived with proper documentation of failures or contraindications.

What happens if my external review is approved? Aetna must provide coverage within 3 business days of the external review decision. The decision is binding on the insurer.

Can I work while appealing a denial? Yes, continue all appeal processes while exploring other options like manufacturer patient assistance programs or temporary supplies through your CF center.

From our advocates: We've seen many Kalydeco denials overturned when families work closely with their CF specialist to document the genetic testing and clinical rationale clearly. The key is often providing the complete genetic panel results and explaining why this specific mutation responds to ivacaftor per FDA labeling. Don't give up after the first denial—the appeals process exists for exactly these situations.

For complex cases requiring detailed appeal documentation, Counterforce Health helps patients and clinicians turn insurance denials into targeted appeals by identifying the specific denial basis and drafting evidence-backed rebuttals that address each payer concern systematically.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Appeal rights and processes may vary by plan type and can change over time.

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