By Counterforce Health Team in Kalydeco (ivacaftor) —

How to Get Kalydeco (ivacaftor) Covered by Humana in Texas: Appeals Guide with Forms and Timelines

Answer Box: Getting Kalydeco (ivacaftor) Covered by Humana in Texas

Kalydeco requires prior authorization from Humana and is classified as a Tier 5 specialty drug dispensed through CenterWell Specialty Pharmacy. Your CF specialist must submit genetic testing confirming a responsive CFTR mutation (like G551D or R117H) plus medical necessity documentation. Standard approval takes 7 days for Part D or 30 days for Medicare Advantage. If denied, you have 65 days to file an internal appeal, followed by external review through Texas's Independent Review Organization if needed. Start today: Contact your CF center to request prior authorization submission to Humana at 800-523-0023.

Table of Contents

  1. Coverage at a Glance
  2. What Drives Kalydeco Costs with Humana
  3. Step-by-Step: Fastest Path to Approval
  4. Benefit Investigation: What to Ask
  5. Assistance Options and Cost-Sharing Help
  6. Appeals Process in Texas
  7. Common Denial Reasons and Fixes
  8. Pharmacy Choice and Coordination
  9. Frequently Asked Questions

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Approval needed before coverage CF specialist submits to Humana Humana PA Process
Formulary Tier Tier 4-5 specialty (25-33% coinsurance) Plan's Prescription Drug Guide Humana Drug Lists
CFTR Genotype Genetic test proving responsive mutation CF center genetic counselor FDA Kalydeco Label
Specialty Pharmacy CenterWell Specialty required Automatic coordination after approval Humana Specialty Network
Appeals Deadline 65 days from denial notice Denial letter date Humana Appeals

What Drives Kalydeco Costs with Humana

Understanding your benefit design helps predict out-of-pocket costs. Kalydeco's annual list price approaches $369,000, making it one of the most expensive oral medications. Humana typically places it in Tier 4 or 5 specialty tiers with coinsurance ranging from 25-33% depending on your coverage phase.

Tier Placement Impact

Most Humana Medicare Advantage and Part D plans structure specialty drug costs as:

  • Deductible phase: You pay full cost until deductible is met (varies by plan, $0-$545 typical)
  • Initial coverage: 25% coinsurance for Tier 4-5 drugs
  • Coverage gap: 25-33% coinsurance (post-Inflation Reduction Act changes)
  • Catastrophic: $0 after reaching $2,100 out-of-pocket in 2025
Tip: Check your specific plan's Evidence of Coverage (EOC) Chapter 6 for exact tier placement and cost-sharing amounts, as employer group plans may differ from standard offerings.

Step-by-Step: Fastest Path to Approval

Follow this sequence to minimize delays and maximize approval chances:

  1. Schedule CF Center Visit (Patient)
    • Request genetic testing results and current pulmonary function tests
    • Ask for specialist prescription and medical necessity letter
    • Timeline: Same-day if records available
  2. Gather Required Documentation (CF Center Staff)
    • CFTR mutation genetic testing confirming responsive variant
    • Specialist prescription from pulmonologist
    • Medical necessity letter detailing diagnosis and rationale
    • Timeline: 1-2 business days
  3. Submit Prior Authorization (CF Center)
    • Fax to Humana: 866-856-8974 (Medicare) or 813-321-7220 (Medicaid)
    • Call 800-523-0023 for submission confirmation
    • Timeline: Submit within 24 hours of gathering documents
  4. Track Decision (Patient/CF Center)
    • Standard review: 7 days (Part D) or 30 days (Medicare Advantage)
    • Expedited review: 72 hours if urgent medical need documented
    • Timeline: Call Humana if no response by deadline
  5. Coordinate Specialty Pharmacy (Upon Approval)
    • CenterWell Specialty will contact patient directly
    • Verify shipping address and delivery preferences
    • Timeline: 2-3 business days for first fill
  6. Appeal if Denied (Within 65 days)
    • File internal appeal with additional clinical evidence
    • Request expedited if delay jeopardizes health
    • Timeline: 7 days standard, 72 hours expedited
  7. External Review if Needed (Texas IRO)
    • File within 4 months of final internal denial
    • Texas Department of Insurance coordinates review
    • Timeline: 20 days standard, 5 days urgent

Benefit Investigation: What to Ask

Before starting the prior authorization process, gather this information from Humana:

Questions for Member Services (800-457-4708)

  • "What tier is Kalydeco (ivacaftor) on my formulary?"
  • "What's my coinsurance percentage for Tier 4-5 specialty drugs?"
  • "Do I need to use CenterWell Specialty Pharmacy?"
  • "What's my current deductible status and out-of-pocket spending?"
  • "Are there quantity limits or step therapy requirements?"

Information to Record

  • Plan ID number and group number
  • Current benefit phase (deductible, initial, gap, catastrophic)
  • Specialty pharmacy network requirements
  • Prior authorization fax numbers and submission methods
  • Appeal deadlines and forms needed
Note: Request this information in writing via your member portal or ask the representative to email a summary for your records.

Assistance Options and Cost-Sharing Help

Multiple programs can reduce your Kalydeco costs, though eligibility varies by insurance type.

Commercial Insurance Patients

Vertex GPS Co-pay Assistance Program

  • Covers up to $20,000 annually in copay reduction
  • Monthly limits: $3,500 (with accumulator plans) or $8,950 (without)
  • Enrollment: Call 1-877-752-5933 or visit vertexgpsportal.com
  • Eligibility: Commercial insurance required; Medicare/Medicaid ineligible

Medicare and Uninsured Patients

The Assistance Fund — Cystic Fibrosis Program

  • Copay assistance for FDA-approved CF treatments
  • Income-based eligibility criteria
  • Contact: 1-855-506-0629

HealthWell Foundation — CF Treatment Fund

  • Cost-share assistance up to 500% Federal Poverty Level
  • Online application with real-time decisions
  • Contact: 1-800-675-8416

CF Foundation Compass

  • Free case management for all CF patients
  • Insurance navigation and financial assistance referrals
  • Available regardless of insurance status or income
From our advocates: "Patients often overlook foundation grants while waiting for insurance approval. We've seen families successfully combine manufacturer copay cards with foundation assistance to reduce monthly costs from $8,000+ to under $100. The key is applying to multiple programs simultaneously since eligibility and funding cycles vary."

Appeals Process in Texas

Texas provides strong patient appeal rights through both internal insurance reviews and external independent review.

Internal Appeal (Redetermination)

Timeline: 65 days from denial notice date Decision: 7 days standard, 72 hours expedited Submission methods:

  • Phone: 800-867-6601
  • Fax: Use plan-specific number from denial letter
  • Mail: Address provided in denial notice
  • Online: Humana member portal

Required documents:

  • Request for Redetermination form
  • Original denial notice
  • Additional medical necessity documentation
  • Prescriber's updated clinical letter

External Review (Texas IRO)

When available: After internal appeal denial based on medical necessity Timeline: 4 months to file, 20 days for decision (5 days urgent) Process: Texas Department of Insurance coordinates Independent Review Organization Cost: Free to patient (insurer pays IRO fees) Decision: Binding on Humana if overturned

Contact for assistance:

  • Texas Department of Insurance: 1-800-252-3439
  • Office of Public Insurance Counsel: 1-877-611-6742

Expedited Appeals

Request expedited review when standard timelines could:

  • Seriously jeopardize life, health, or ability to regain maximum function
  • Cause severe pain that cannot be adequately managed
  • Result in hospitalization or emergency care

Documentation needed: Prescriber statement explaining urgent medical need

Common Denial Reasons and Fixes

Denial Reason How to Overturn Required Documentation
Missing CFTR genotype Submit genetic testing results Lab report showing responsive mutation (G551D, R117H, etc.)
Not specialist-prescribed Get CF center prescription Pulmonologist or CF specialist prescription
Insufficient medical necessity Provide detailed clinical rationale Updated letter explaining diagnosis, symptoms, treatment goals
Age restrictions Verify FDA-approved age ranges Birth certificate if pediatric indication
Step therapy required Document prior treatment failures Medical records showing intolerance or ineffectiveness
Quantity limits exceeded Request utilization exception Clinical justification for higher quantity

Medical Necessity Letter Checklist

Your CF specialist's letter should include:

  • Diagnosis: Cystic fibrosis with specific CFTR mutation
  • Prior treatments: Other therapies tried and outcomes
  • Clinical rationale: Why Kalydeco is medically necessary
  • Treatment goals: Expected clinical benefits
  • Monitoring plan: How response will be assessed
  • Guideline support: References to CF Foundation or other guidelines

Pharmacy Choice and Coordination

Humana requires specialty drugs like Kalydeco to be dispensed through their preferred network, primarily CenterWell Specialty Pharmacy.

CenterWell Specialty Services

  • Home delivery throughout Texas
  • Clinical support and adherence monitoring
  • Insurance coordination and prior authorization assistance
  • Refill reminders and medication management

Alternative Options

CVS Specialty or Accredo Health may be available with prior approval from Humana member services. Request network exceptions if:

  • Geographic access issues
  • Established relationship with current specialty pharmacy
  • Clinical coordination preferences

Coordination Tips

  • Refill timing: Order 7-10 days before running out
  • Travel planning: Request 90-day supplies when plan allows
  • Emergency fills: Know which local hospitals can provide temporary supplies
  • Insurance changes: Notify pharmacy of any plan updates

At Counterforce Health, we help patients and clinicians navigate complex prior authorization requirements by transforming insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each payer's specific criteria, incorporating the right clinical evidence and procedural requirements to maximize approval chances.

Frequently Asked Questions

How long does Humana prior authorization take for Kalydeco in Texas? Standard review takes 7 days for Part D plans or 30 days for Medicare Advantage plans. Expedited review (72 hours) is available when delays could jeopardize health, requiring prescriber documentation of urgent medical need.

What if Kalydeco is non-formulary on my Humana plan? File a formulary exception request with medical necessity documentation. Include prescriber's letter explaining why formulary alternatives are inappropriate and why Kalydeco is medically necessary for your specific CFTR mutation.

Can I request an expedited appeal in Texas? Yes, both Humana internal appeals and Texas external reviews offer expedited timelines. Internal expedited appeals are decided within 72 hours, while urgent external reviews take 5 days. Prescriber must document that standard timelines could harm your health.

Does step therapy apply if I've tried other CFTR modulators outside Texas? Medical records from any state showing prior treatment failures or intolerances should satisfy step therapy requirements. Ensure your CF center includes this documentation in the prior authorization submission.

What happens if my annual Humana plan changes? Formulary changes occur January 1st annually. If Kalydeco moves to a higher tier or gains new restrictions, you can request a formulary exception or transition fill while exploring plan alternatives during open enrollment.

How do I coordinate Vertex copay assistance with Humana coverage? Enroll in Vertex GPS Co-pay Assistance Program (if commercially insured) before filling your prescription. The program coordinates directly with CenterWell Specialty Pharmacy to apply copay reductions at point of sale.

Can family members help with my Humana appeals? Yes, complete Humana's Appointment of Authorized Representative form to allow family members to discuss your coverage and file appeals on your behalf. This is especially helpful for pediatric patients or when you're too ill to manage the process.

What if I need Kalydeco while traveling in Texas? Contact CenterWell Specialty for travel supplies or emergency fills. Some Texas hospitals can provide temporary supplies while coordinating with your specialty pharmacy for continued delivery.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms, medical circumstances, and current policies. Always consult your healthcare provider for medical decisions and your insurance company for coverage questions. For personalized assistance with complex prior authorization challenges, Counterforce Health provides specialized support in transforming insurance denials into successful appeals through evidence-based advocacy and payer-specific expertise.

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