By Counterforce Health Team in Kalydeco (ivacaftor) —

Denied for Kalydeco (ivacaftor) by Cigna in Illinois? How to Appeal (Templates & Timelines)

Quick Answer: Cigna requires prior authorization for Kalydeco (ivacaftor) with CFTR genetic testing proof and CF specialist documentation. Submit via CoverMyMeds or fax (855) 840-1678; standard review takes 5 business days. If denied, file internal appeal within 180 days, then Illinois external review within 4 months. Contact Illinois DOI at (877) 527-9431 for help. First step today: Have your CF specialist gather genetic test results and submit PA documentation.

Table of Contents

Understanding Your Denial

Read your Cigna denial letter carefully to identify the specific reason code and policy cited. Common denial reasons for Kalydeco include:

  • Missing CFTR genetic documentation - Lab report not submitted or incomplete
  • Lack of specialist confirmation - Prescriber not recognized as CF specialist
  • Age requirements not met - Patient under 2 years old
  • Non-formulary status - Drug not on your plan's covered list
  • Quantity limits exceeded - Requesting more than approved amount

The denial letter will specify your appeal rights and deadlines. In Illinois, you have 180 days from the denial date to file an internal appeal with Cigna.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
CFTR Genetic Test Lab-confirmed responsive mutation (G551D, R117H, etc.) FDA-cleared CF mutation panel results Cigna Policy IP0431
CF Diagnosis ICD-10 codes E84.0-E84.9 Medical records with sweat test ≥60 mmol/L Cigna Policy IP0431
Specialist Prescriber Board-certified pulmonologist or CF center physician Provider credentials verification Cigna Coverage Policy
Prior Authorization Required for all Kalydeco prescriptions Submit via CoverMyMeds or fax Cigna PA Process
Age Requirement Patient must be ≥2 years old Birth certificate or medical records FDA Label

Step-by-Step: Fastest Path to Approval

  1. Gather Genetic Documentation (Patient/Family)
    • Obtain CFTR mutation test results showing responsive variants
    • Timeline: Same day if already available
    • Find CF testing labs
  2. Confirm CF Specialist Prescriber (Clinic)
    • Verify prescriber is board-certified pulmonologist or from accredited CF center
    • Submit credentials if needed
    • Timeline: 1-2 business days
  3. Complete Prior Authorization (Clinic)
    • Submit via CoverMyMeds portal or fax (855) 840-1678
    • Include all required documentation
    • Timeline: Same day submission
  4. Track Authorization Status (Patient/Clinic)
    • Use confirmation number provided
    • Call Express Scripts at (800) 922-1557 for updates
    • Timeline: 5 business days for standard review
  5. Request Expedited Review if Urgent (Clinic)
    • Call (800) 882-4462 for urgent clinical situations
    • Timeline: 72 hours for expedited decisions
  6. Submit Formulary Exception if Non-Formulary (Clinic)
    • Document why alternatives are inappropriate
    • Timeline: 72 hours for standard, 24 hours for expedited
  7. Initiate Appeal if Denied (Patient/Clinic)
    • File within 180 days of denial
    • Include medical necessity letter and supporting evidence
    • Timeline: 30 days for internal appeal decision

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Genetic testing not provided" Submit FDA-cleared CFTR mutation panel results Lab report showing G551D, R117H, or other responsive mutations
"Not medically necessary" Provide detailed clinical rationale from CF specialist Medical necessity letter with treatment history and outcomes
"Prescriber not qualified" Submit provider credentials Board certification or CF center accreditation proof
"Age requirement not met" Confirm patient is ≥2 years old Birth certificate or medical records
"Non-formulary drug" Request formulary exception Evidence that formulary alternatives are inappropriate
From our advocates: We've seen many Kalydeco denials overturned when families work closely with their CF center to gather comprehensive genetic documentation upfront. The key is ensuring your mutation test clearly identifies FDA-approved responsive variants and that your specialist provides detailed clinical justification for why this specific therapy is essential for your child's care.

First-Level Appeal Process

When filing your internal appeal with Cigna, include:

Required Elements:

  • Copy of original denial letter
  • Medical necessity letter from CF specialist
  • Complete CFTR genetic test results
  • Recent pulmonary function tests (if age-appropriate)
  • Clinical notes documenting CF progression
  • Evidence of prior therapy failures (if applicable)

Submission Methods:

  • Online: Cigna member portal (verify current link)
  • Fax: Appeal-specific fax number from denial letter
  • Mail: Address provided in denial notice

Timeline: Cigna has 30 days to respond to standard appeals, 72 hours for expedited appeals involving urgent clinical situations.

Medical Necessity Letter Essentials

Your CF specialist's letter should address these key points:

Patient History Section:

  • Date of CF diagnosis and confirming tests
  • Specific CFTR mutations identified
  • Current clinical status and symptoms
  • Previous treatments attempted and outcomes

Clinical Rationale:

  • Why Kalydeco is specifically indicated for this patient's mutations
  • Expected clinical benefits based on FDA labeling
  • Risks of delaying or denying treatment
  • Monitoring plan for therapy

Supporting Evidence:

  • Reference FDA approval for patient's specific mutations
  • Cite relevant clinical studies if applicable
  • Include recent CF Foundation care guidelines
  • Document baseline pulmonary function if available

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing the specific denial basis and crafting point-by-point rebuttals aligned to each plan's own coverage rules.

Peer-to-Peer Review Strategy

If your initial appeal is denied, request a peer-to-peer review:

Preparation Checklist:

  • Schedule call through Cigna provider services
  • Prepare 5-minute clinical summary
  • Have patient chart and genetic results available
  • Review Cigna's specific coverage criteria beforehand

Key Talking Points:

  • Patient's specific CFTR mutations and FDA-approved indications
  • Clinical progression without treatment
  • Evidence base supporting therapy
  • Lack of suitable alternatives for this genotype

Follow-Up:

  • Request written confirmation of any verbal approvals
  • Ask for specific timeline if additional documentation needed
  • Document conversation details and follow-up commitments

Illinois External Review Process

If Cigna denies your internal appeal, Illinois law provides an independent external review option:

Eligibility Requirements:

  • Must exhaust Cigna's internal appeal process first
  • File within 4 months of final adverse determination
  • Denial must involve medical necessity, experimental status, or coverage disputes

Filing Process:

  1. Complete external review form at Illinois DOI website
  2. Include final denial letter and all supporting medical records
  3. Submit online, by mail, or fax to Illinois Department of Insurance

Timeline:

  • Filing deadline: 4 months from final Cigna denial
  • IRO assignment: 5 business days
  • Decision: 45 days for standard review, expedited for urgent cases
  • Cost: Free to consumers (insurers pay IRO fees)

Contact for Help:

  • Illinois DOI Consumer Hotline: (877) 527-9431
  • Illinois Attorney General Health Care Helpline: (877) 305-5145

The external review decision is binding on Cigna. If the Independent Review Organization overturns the denial, Cigna must provide coverage.

Appeal Templates & Scripts

Patient Phone Script for Cigna: "I'm calling about prior authorization case #[number] for Kalydeco. My CF specialist submitted genetic testing showing I have a G551D mutation, which is FDA-approved for this medication. Can you tell me what specific documentation is still needed?"

Medical Necessity Letter Opening: "I am writing to document the medical necessity of Kalydeco (ivacaftor) for my patient [Name], who has cystic fibrosis with a documented [specific mutation] CFTR gene variant. This medication is FDA-approved for patients with this exact genetic profile and is essential for managing their progressive pulmonary disease."

Appeal Letter Structure:

  1. Reference denial letter and case number
  2. State specific coverage criteria that patient meets
  3. Provide point-by-point rebuttal of denial reasons
  4. Include supporting clinical evidence
  5. Request immediate reconsideration and approval

When to Escalate to State Regulators

Contact Illinois regulators if:

  • Cigna fails to respond within required timeframes
  • You suspect discriminatory coverage practices
  • The company violates Illinois insurance laws
  • External review process is improperly handled

Illinois Department of Insurance:

Document all interactions with Cigna, including dates, representatives spoken with, and outcomes. This information will be valuable if regulatory intervention becomes necessary.

Cost Assistance Options

Even with insurance coverage, Kalydeco can involve significant out-of-pocket costs:

Vertex Patient Assistance:

  • CF Compass program provides financial and insurance support
  • Phone: (877) 752-5933
  • Website: cfcompass.com

Foundation Support:

  • Cystic Fibrosis Foundation Emergency Fund
  • HealthWell Foundation CF grants
  • Patient Access Network Foundation

State Programs:

  • Illinois pharmaceutical assistance programs
  • Medicaid coverage for eligible patients

When working with Counterforce Health, patients and specialty pharmacies get cleaner submissions that reduce back-and-forth with insurers while tracking deadlines and required documentation throughout the appeals process.

Frequently Asked Questions

How long does Cigna prior authorization take for Kalydeco in Illinois? Standard review takes 5 business days. Expedited review for urgent cases takes 72 hours. Call (800) 882-4462 for expedited requests.

What if Kalydeco is not on my Cigna formulary? Request a formulary exception with clinical documentation showing why covered alternatives are inappropriate. Decision timeline is 72 hours for standard requests, 24 hours for expedited.

Can I get emergency Kalydeco while waiting for approval? Some plans allow 30-day emergency fills during PA review. Check with your pharmacy and Cigna member services to confirm availability.

Does Illinois require step therapy for Kalydeco? No universal step therapy requirement exists for Kalydeco, though individual plan variations may apply. Cigna's policy focuses on genetic documentation rather than prior medication trials.

What mutations qualify for Kalydeco coverage? FDA-approved responsive mutations include G551D, G1244E, G1349D, G178R, G551S, G970R, G1244E, S1251N, S1255P, and S549R, among others. Your genetic test must show at least one responsive variant.

How much does Kalydeco cost with Cigna coverage? Costs vary by plan tier and coverage details. List price is approximately $369,000 annually, but patient costs depend on copays, deductibles, and assistance programs.

Can my pediatric pulmonologist prescribe Kalydeco? Yes, if they're board-certified in pulmonology or affiliated with a CF Foundation-accredited care center. General pediatricians typically cannot prescribe without specialist consultation.

What happens if my external review is denied? External review decisions are final and binding. However, you may be able to reapply if new clinical information becomes available or if your condition changes.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for specific guidance regarding your situation.

Sources & Further Reading:

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