By Counterforce Health Team in Kalydeco (ivacaftor) —

How to Get Kalydeco (ivacaftor) Covered by Humana in Ohio: Complete Guide with Appeals Process and Forms

Quick Answer: Getting Kalydeco (ivacaftor) Covered by Humana in Ohio

Kalydeco requires prior authorization from Humana in Ohio. You need genetic test results showing a responsive CFTR mutation (like G551D or R117H), a prescription from a CF specialist, and complete clinical documentation. The fastest path: 1) Gather your genetic testing and CF diagnosis records, 2) Have your CF specialist submit the PA request with all required documents, and 3) Use CenterWell Specialty Pharmacy for dispensing. If denied, you have 65 days to file an internal appeal, followed by external review through federal Medicare processes.

Start today: Contact your CF center to request your genetic testing results and ask them to begin the prior authorization process with Humana.

Table of Contents

Is Kalydeco Covered by Humana?

Yes, Kalydeco (ivacaftor) is covered by Humana, but it's classified as a Tier 5 specialty medication requiring strict prior authorization. This means you can't simply fill a prescription at your local pharmacy—you need approval first.

Kalydeco is FDA-approved for cystic fibrosis patients with specific CFTR mutations that respond to ivacaftor therapy. The drug costs approximately $369,255 annually without insurance coverage, making prior authorization essential for most patients.

Coverage at a Glance

Prior Authorization Requirements

To get Kalydeco approved by Humana, you'll need to submit comprehensive documentation proving medical necessity and genetic eligibility.

Required Documentation

1. Genetic Testing Results Your genetic test must show a CFTR mutation that responds to ivacaftor therapy. Approved mutations include:

  • G551D (most common)
  • R117H
  • Other FDA-recognized gating mutations

The test must come from a certified laboratory and clearly identify the specific mutation. Humana will not approve coverage without this genetic confirmation.

2. Specialist Prescription The prescription must come from:

  • A cystic fibrosis center specialist
  • A pulmonologist with CF expertise
  • A physician with documented CF treatment experience

3. Clinical Documentation Your doctor needs to provide:

  • Confirmed CF diagnosis with supporting lab results
  • Patient age (FDA-approved for 1 month and older)
  • Previous treatments tried and outcomes
  • Current clinical status and treatment goals

Clinician Corner: Medical Necessity Letter Checklist

If you're a healthcare provider submitting a Kalydeco PA request, include these elements in your medical necessity letter:

  • Patient identification: Name, DOB, Humana member ID
  • Genetic confirmation: Specific CFTR mutation and lab report
  • Clinical rationale: Why ivacaftor is appropriate for this mutation
  • Previous therapies: Other CF treatments tried and outcomes
  • Treatment goals: Expected clinical benefits
  • Dosing rationale: Age-appropriate dosing per FDA label
  • Monitoring plan: How you'll track treatment response

Reference the FDA label for Kalydeco and current CF Foundation guidelines to support your request.

Step-by-Step: Fastest Path to Approval

1. Gather Your Genetic Testing (Patient/Family)

  • Contact your CF center for copies of genetic test results
  • Ensure the report clearly shows your specific CFTR mutation
  • Timeline: Same day if records are available

2. Schedule CF Specialist Visit (Patient/Family)

  • If you don't have a recent appointment, schedule one
  • Discuss Kalydeco therapy and get clinical assessment
  • Timeline: 1-2 weeks depending on availability

3. Provider Submits PA Request (CF Specialist)

  • Complete Humana's prior authorization form
  • Include genetic testing, clinical notes, and medical necessity letter
  • Submit via Humana provider portal or fax
  • Timeline: Provider should submit within 1-2 business days

4. Humana Reviews Request (Humana)

  • Standard review takes up to 7 calendar days for Part D drugs
  • Expedited review available if delay risks health (72 hours)
  • Timeline: 7 days standard, 72 hours expedited

5. Approval and Specialty Pharmacy Setup (Patient/Provider)

  • If approved, prescription transfers to CenterWell Specialty Pharmacy
  • Complete enrollment and insurance verification
  • Timeline: 2-3 business days for first fill

6. Medication Delivery (CenterWell)

  • Home delivery or provider office delivery available
  • Clinical support and monitoring included
  • Timeline: 1-2 business days after pharmacy processing
Tip: Request expedited review if you're currently hospitalized, have declining lung function, or your doctor determines that waiting poses a health risk.

Understanding Costs and Coverage

Kalydeco's high cost makes understanding your coverage crucial for financial planning.

Humana Coverage Details

  • Tier 5 Specialty: Typically 20-33% coinsurance
  • Annual cost without insurance: ~$369,255
  • 28-day supply cost: ~$28,404
  • Specialty pharmacy required: Cannot fill at retail pharmacy

Patient Assistance Options

Vertex Patient Assistance Program

  • Income-based assistance for eligible patients
  • May cover copays or provide free medication
  • Apply at Vertex Connect (verify current link)

CenterWell Financial Assistance

  • Specialists help identify assistance programs
  • Call 1-800-486-2668 for personalized help
  • Available Monday-Friday 8am-11pm, Saturday 8am-6:30pm ET
Note: Even with insurance, your out-of-pocket costs could be significant. Apply for patient assistance programs before your first fill to avoid unexpected bills.

Common Denial Reasons and How to Fix Them

Understanding why Kalydeco requests get denied helps you submit stronger appeals.

Denial Reason How to Fix Required Documentation
Missing genetic testing Submit certified lab report CFTR mutation analysis from certified lab
Non-responsive mutation Confirm mutation is FDA-approved Cross-reference FDA label mutation list
Prescriber not qualified Get prescription from CF specialist Provider credentials showing CF expertise
Incomplete clinical notes Submit comprehensive medical records CF diagnosis, previous treatments, current status
Step therapy not completed Document previous CFTR modulator trials Treatment history with outcomes/failures

Most Common Fix: Complete Documentation

About 80% of initial denials stem from incomplete documentation. Before submitting your appeal, ensure you have:

  • Complete genetic testing report (not just a summary)
  • Detailed medical necessity letter from your CF specialist
  • Recent clinic notes showing current clinical status
  • Documentation of any previous CF treatments and outcomes

Appeals Process in Ohio

If Humana denies your Kalydeco request, Ohio residents have specific appeal rights and timelines.

Level 1: Internal Appeal (Redetermination)

  • Deadline: File within 65 days of denial notice
  • Timeline: Humana has 7 days to respond (72 hours if expedited)
  • How to file: Humana member portal or written request
  • Required: Copy of denial letter, additional medical documentation, provider statement

Level 2: External Review (Independent Review Entity)

  • When: If Level 1 appeal is denied
  • Timeline: 7 days for standard review, 72 hours for expedited
  • Process: Automatic referral to independent medical experts
  • Cost: No charge to patient

Level 3: Administrative Law Judge Review

  • When: If Level 2 is denied and amount exceeds $190 (2025 threshold)
  • Deadline: 60 days after Level 2 decision
  • Process: Federal Medicare hearing process

Ohio-Specific Resources

Ohio Department of Insurance

OSHIIP (Ohio Senior Health Insurance Information Program)

  • Free Medicare counseling for Ohio residents
  • Can help with Medicare Advantage appeals
  • Find local office at Medicare.gov
From our advocates: "We've seen many Kalydeco appeals succeed at Level 2 when patients include updated genetic testing and a detailed letter from their CF center explaining why this specific mutation requires ivacaftor therapy. The key is showing that your genetic profile matches exactly what the FDA approved Kalydeco to treat."

Specialty Pharmacy Requirements

Kalydeco must be dispensed through Humana's specialty pharmacy network, primarily CenterWell Specialty Pharmacy.

Why Specialty Pharmacy is Required

  • Complex storage and handling requirements
  • Clinical monitoring and support services
  • Insurance coordination for high-cost medications
  • Patient education and adherence support

CenterWell Specialty Pharmacy Services

  • Phone: 1-800-486-2668
  • Fax for prescriptions: 1-877-405-7940
  • Services: Home delivery, clinical support, insurance coordination
  • Hours: Monday-Friday 8am-11pm, Saturday 8am-6:30pm ET

Setting Up Specialty Pharmacy

  1. Your doctor faxes the prescription to CenterWell
  2. CenterWell contacts you to verify insurance and address
  3. Clinical pharmacist reviews your case and contacts your doctor if needed
  4. Medication ships to your home with tracking
  5. Ongoing refill reminders and clinical check-ins

Frequently Asked Questions

How long does Humana prior authorization take for Kalydeco? Standard prior authorization takes up to 7 calendar days. You can request expedited review (72 hours) if your doctor determines that waiting would risk your health.

What if my CFTR mutation isn't on Humana's approved list? If you have a rare mutation, your CF specialist may need to provide additional evidence from medical literature showing that your specific mutation responds to ivacaftor therapy.

Can I get Kalydeco at my regular pharmacy? No. Kalydeco is classified as a specialty medication and must be dispensed through CenterWell Specialty Pharmacy or another approved specialty pharmacy in Humana's network.

What happens if I move to another state? Your Humana coverage should continue, but you'll need to update your address with CenterWell for medication delivery. Appeal processes may vary by state.

Does Humana require step therapy for Kalydeco? Humana may require documentation that you've tried other appropriate CFTR modulators first, depending on your specific mutation and clinical history.

How often do I need to renew prior authorization? Most prior authorizations are valid for one year, but Humana may require periodic clinical updates to confirm ongoing medical necessity.

When to Get Help

Contact Humana Customer Service

  • Member services: 1-800-281-6918
  • Questions about: Coverage, appeals status, pharmacy network
  • Best times to call: Early morning or late afternoon

Get Professional Advocacy Support

If you're struggling with denials or complex appeals, consider getting professional help. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, identifying the specific coverage criteria, and crafting evidence-backed responses that address each payer's requirements. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes for specialty medications like Kalydeco.

Ohio State Resources

  • Ohio Department of Insurance: 1-800-686-1526
  • OSHIIP Medicare counseling: Find local office at Medicare.gov
  • Legal aid: Ohio State Legal Services Association for low-income residents

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage policies and requirements can change. Always verify current requirements with Humana and consult with your healthcare provider about treatment decisions. For personalized help with coverage issues, contact Humana customer service or consult with a patient advocate who specializes in insurance appeals.

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