By Counterforce Health Team in Kalydeco (ivacaftor) —

How to Get Kalydeco (ivacaftor) Covered by Aetna (CVS Health) in Georgia: Complete Guide to Prior Authorization and Appeals

Answer Box: Getting Kalydeco Covered in Georgia

Kalydeco (ivacaftor) requires prior authorization from Aetna (CVS Health) in Georgia. The fastest path to approval: 1) Verify your plan covers specialty drugs through CVS Caremark, 2) Have your CF specialist submit a complete prior authorization with CFTR genetic testing results showing responsive mutations (like G551D or R117H), and 3) If denied, file an internal appeal within 60-65 days, then pursue Georgia's external review within 60 days of final denial. Start by calling Aetna Member Services at 1-888-632-3862 to confirm your specialty pharmacy benefits.

Table of Contents

  1. Start Here: Verify Your Plan Coverage
  2. Prior Authorization Forms and Requirements
  3. Submission Portals and Methods
  4. Common Denial Reasons and Solutions
  5. Appeals Process for Georgia Residents
  6. CVS Specialty Pharmacy Requirements
  7. Support Resources and Contact Information
  8. Costs and Financial Assistance
  9. FAQ: Your Most Common Questions

Start Here: Verify Your Plan Coverage

Before diving into paperwork, confirm that your Aetna plan in Georgia includes specialty drug coverage through CVS Caremark. Most Aetna plans do, but verification saves time later.

What to check:

  • Log into your Aetna member portal or call 1-888-632-3862
  • Confirm CVS Caremark manages your prescription benefits
  • Verify Kalydeco is on your formulary (it typically requires prior authorization regardless of tier)
  • Check if you need to use CVS Specialty Pharmacy specifically
Tip: Have your member ID card ready when calling. Ask specifically about "specialty drug coverage" and "prior authorization requirements for Kalydeco."

Prior Authorization Forms and Requirements

Coverage Requirements at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all plans Aetna precertification list
CFTR Genetic Testing Must show responsive mutations FDA-cleared test results
CF Specialist Pulmonologist required Provider directory
Age Requirements Per FDA label (varies by mutation) FDA Access Data
Formulary Status Specialty tier (verify with plan) Member portal

Required Documentation

Your CF specialist must submit these documents for prior authorization:

  1. Completed Aetna prior authorization form - Available through the Aetna provider portal (Availity)
  2. CFTR genetic test results showing responsive mutations such as:
    • G551D (most common gating mutation)
    • R117H with residual function
    • Other FDA-approved responsive mutations
  3. Clinical documentation including:
    • CF diagnosis with ICD-10 codes
    • Current pulmonary function tests
    • Treatment history and previous therapies tried
    • Medical necessity justification
Note: Submit requests at least 2 weeks before your desired start date. Most prior authorizations are approved within 24 hours according to Aetna's streamlining initiatives.

Submission Portals and Methods

Aetna Provider Portal (Availity):

  • Fastest processing method
  • Real-time status updates
  • Secure document upload for lab results and clinical notes
  • Access at Aetna's Availity portal

Alternative Submission Methods

CVS Caremark Fax: 1-800-378-0323

  • Include clear cover sheet with member information
  • Ensure all pages are legible
  • Follow up with phone confirmation

Phone Support:

  • Aetna Provider Services: 1-888-632-3862
  • CVS Specialty Pharmacy: 1-800-237-2767

Common Denial Reasons and Solutions

Denial Reason How to Fix It Required Documentation
Missing genetic testing Submit FDA-cleared CFTR test results Lab report showing specific responsive mutation
Insufficient clinical documentation Provide comprehensive CF specialist notes Pulmonary function tests, treatment history
Age requirements not met Verify FDA label requirements for your mutation Birth certificate, updated clinical assessment
Step therapy required Document failures/intolerances of preferred agents Treatment records, adverse event documentation
"Not medically necessary" Submit detailed medical necessity letter Clinical rationale, guideline references

Clinician Corner: Medical Necessity Letter Checklist

If you're a healthcare provider preparing documentation, include:

  • Problem statement: Current CF status and limitations with standard care
  • Prior treatments: Specific therapies tried, duration, and outcomes
  • Clinical rationale: Why Kalydeco is appropriate for this patient's genotype
  • Guideline support: Reference CF Foundation guidelines and FDA labeling
  • Monitoring plan: How you'll assess treatment response

Appeals Process for Georgia Residents

Step 1: Internal Appeal with Aetna

Timeline: File within 60-65 days of denial notice Methods:

Decision timeframe:

  • Standard appeals: 7 calendar days
  • Expedited appeals: 72 hours (if delay could jeopardize health)

Step 2: Georgia External Review

If Aetna denies your internal appeal, Georgia residents have powerful additional rights.

Key facts:

  • Deadline: 60 days from Aetna's final denial letter
  • Cost: Free to consumers
  • Decision: Binding on Aetna
  • Timeline: 30 business days (72 hours for urgent cases)

How to file:

  1. Contact Georgia Department of Insurance Consumer Services: 1-800-656-2298
  2. Complete external review application (available by calling above number)
  3. Submit all medical records and Aetna's denial letters
  4. Clearly indicate if you need expedited review
From our advocates: We've seen many Georgia patients successfully overturn Aetna denials for specialty CF medications through the state's external review process. The key is thorough documentation from your CF specialist explaining why standard treatments aren't sufficient and how Kalydeco addresses your specific CFTR mutation.

CVS Specialty Pharmacy Requirements

Once approved, Kalydeco must be dispensed through CVS Specialty Pharmacy in most Aetna plans.

Enrollment Process

  1. Prescription transfer: Your doctor sends the prescription directly to CVS Specialty
  2. Patient enrollment: CVS Specialty calls you to set up delivery
  3. Coordination: They handle prior authorization renewals and refills

CVS Specialty contact: 1-800-237-2767

Delivery and Refills

  • Free overnight shipping available
  • Automatic refill reminders
  • Clinical support from specialty pharmacists
  • Coordination with your CF care team

Support Resources and Contact Information

Aetna/CVS Health Contacts

Service Phone Number Best For
Member Services 1-888-632-3862 Benefits, eligibility, appeals
CVS Specialty 1-800-237-2767 Prescription questions, delivery
Provider Services 1-888-632-3862 Prior authorization status
Expedited Appeals 1-866-235-5660 Urgent medical situations

Georgia State Resources

Georgia Department of Insurance

  • Consumer Services: 1-800-656-2298
  • External review applications and support
  • Insurance complaint assistance

Additional Support:

Costs and Financial Assistance

Kalydeco's annual list price is approximately $369,255, but actual patient costs vary significantly based on insurance coverage and assistance programs.

Financial Assistance Options

Vertex Patient Assistance:

  • Copay assistance for eligible patients
  • Patient assistance program for uninsured/underinsured
  • Contact: Vertex patient support

CF Foundation Compass:

  • Insurance navigation assistance
  • Financial counseling
  • Phone: 1-844-COMPASS

FAQ: Your Most Common Questions

Q: How long does Aetna prior authorization take for Kalydeco in Georgia? A: Most requests are processed within 24 hours when submitted electronically through the provider portal with complete documentation.

Q: What if Kalydeco isn't on my Aetna formulary? A: You can request a formulary exception with medical necessity documentation. Your CF specialist needs to explain why formulary alternatives aren't appropriate for your specific CFTR mutation.

Q: Can I get an expedited appeal if my health is declining? A: Yes. If waiting for standard processing could jeopardize your health, request expedited review. Both Aetna (72-hour decision) and Georgia external review (72-hour urgent process) offer expedited options.

Q: What CFTR mutations qualify for Kalydeco coverage? A: Aetna covers Kalydeco for FDA-approved responsive mutations, including gating mutations like G551D and R117H with residual function. Your genetic test results must show one of these specific mutations.

Q: Do I have to use CVS Specialty Pharmacy? A: Most Aetna plans require specialty medications like Kalydeco to be dispensed through CVS Specialty or other approved specialty pharmacies in their network.

Q: What happens if I miss the 60-day appeal deadline in Georgia? A: Georgia may accept late appeals if you have "good cause" for the delay. Contact the Department of Insurance Consumer Services immediately to discuss your situation.

About Counterforce Health: We help patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, payer-specific documentation that addresses denial reasons point-by-point. Our platform streamlines the prior authorization and appeals process for complex specialty medications like Kalydeco.

For additional support with your Kalydeco appeal, Counterforce Health provides specialized assistance in crafting medical necessity letters and appeals documentation that align with Aetna's specific coverage criteria and Georgia's regulatory requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes and is not medical advice. Always consult with your healthcare provider about treatment decisions. Insurance coverage policies change frequently—verify current requirements with Aetna and your healthcare team. For specific legal questions about insurance appeals in Georgia, consider consulting with a healthcare attorney or patient advocate.

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