By Counterforce Health Team in Kalydeco (ivacaftor) —

How to Get Kalydeco (ivacaftor) Covered by Cigna in New Jersey: Complete Prior Authorization & Appeals Guide

Answer Box: Getting Kalydeco Covered by Cigna in New Jersey

Kalydeco (ivacaftor) requires prior authorization from Cigna via Express Scripts for cystic fibrosis patients with documented CFTR responsive mutations. Submit genetic test results proving responsive mutations (G551D, R117H, etc.) plus CF specialist's medical necessity letter through CoverMyMeds or fax (855) 840-1678. Standard review takes 5 business days; expedited review available within 72 hours for urgent cases. If denied, you have 180 days to file internal appeals, followed by New Jersey's Independent Health Care Appeals Program (IHCAP) for external review.

Next step: Contact your CF specialist to gather CFTR genetic testing results and initiate the prior authorization process today.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Documentation Requirements
  5. Submission Process
  6. Specialty Pharmacy Transfer
  7. Appeals Process in New Jersey
  8. Common Denial Reasons & Solutions
  9. Cost Assistance Programs
  10. FAQ

Who Should Use This Guide

This guide helps New Jersey residents with Cigna insurance navigate the prior authorization process for Kalydeco (ivacaftor), a CFTR potentiator for cystic fibrosis treatment. You'll need this if:

  • Your doctor prescribed Kalydeco for cystic fibrosis with specific CFTR mutations
  • Cigna denied your initial prescription request
  • You're transferring from another specialty pharmacy to Accredo
  • You received a "prior authorization required" notice from your pharmacy

Expected outcome: With proper documentation, most Kalydeco requests get approved within 5-7 business days. The annual list price is approximately $369,255, but your actual cost depends on your plan's specialty drug benefits and available assistance programs.

Member & Plan Basics

Verify Your Coverage

Before starting the prior authorization process:

  • Check active Cigna coverage through your member portal or call the number on your insurance card
  • Confirm specialty drug benefits are included in your plan
  • Review your deductible status - Kalydeco may be subject to your annual deductible before copay assistance applies
  • Identify your plan type (commercial, Medicare Advantage, or Medicare Part D) as this affects appeal timelines

Formulary Status

Kalydeco appears on most Cigna formularies as a Tier 4 specialty medication with prior authorization requirements. Unlike many high-cost drugs, Cigna does not impose step therapy requirements for Kalydeco - you don't need to try and fail other CFTR modulators first.

Clinical Criteria Requirements

FDA-Approved Indications

Kalydeco is approved for cystic fibrosis patients with specific responsive CFTR mutations, including:

  • Gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R
  • R117H mutation (with additional considerations)
  • Other responsive mutations as listed in the FDA label

Age Requirements

  • 12 months and older for most responsive mutations
  • Specific age requirements may vary by mutation type

Required Clinical Documentation

Your CF specialist must provide:

  • CFTR genetic test results from an FDA-cleared laboratory
  • Sweat chloride test showing ≥60 mmol/L (supporting CF diagnosis)
  • Current clinical status including FEV1, recent hospitalizations, and disease progression
  • Treatment history showing standard CF care is insufficient

Documentation Requirements

Essential Documents Checklist

For the Patient:

  • Active Cigna insurance card
  • CFTR genetic testing results
  • Recent clinic notes (last 6-12 months)
  • Current medication list
  • Any previous Kalydeco approvals or denials

For the Prescriber:

  • Medical necessity letter on clinic letterhead
  • CFTR mutation confirmation
  • CF diagnosis documentation (ICD-10: E84.0-E84.9)
  • Clinical rationale for Kalydeco therapy
  • Monitoring plan

Medical Necessity Letter Components

Your CF specialist's letter should include:

  1. Patient demographics and Cigna member ID
  2. CF diagnosis with supporting test results
  3. Specific CFTR mutation(s) and responsiveness to ivacaftor
  4. Clinical rationale explaining why Kalydeco is medically necessary
  5. Treatment goals and expected outcomes
  6. Monitoring plan for safety and efficacy
Tip: Request your genetic testing results from your CF center's laboratory. These are often stored in the CF Patient Registry but may need to be requested separately for insurance purposes.

Submission Process

Step-by-Step Prior Authorization

  1. Gather documentation (see checklist above)
  2. Submit via preferred method:
    • CoverMyMeds portal (recommended for fastest processing)
    • Fax: (855) 840-1678
    • Phone: (800) 882-4462 for urgent cases
  3. Include all required documents in initial submission
  4. Request confirmation of receipt and tracking number
  5. Follow up if no response within 5 business days

Review Timelines

  • Standard review: 5 business days
  • Expedited review: 72 hours (for urgent medical situations)
  • Incomplete submissions: May take longer due to additional information requests

When dealing with complex prior authorization requirements, Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific rules.

Specialty Pharmacy Transfer

Cigna's Preferred Network

Cigna requires Kalydeco to be dispensed through Accredo specialty pharmacy. If you're currently using another specialty pharmacy:

  1. Contact Accredo at their main number to begin enrollment
  2. Request prescription transfer from your current pharmacy
  3. Provide Accredo's contact information to your current pharmacy
  4. Verify insurance coverage transfers correctly
  5. Schedule delivery to your preferred address

Accredo Services

  • Fast shipping at no extra cost
  • Special handling for refrigerated medications
  • 24/7 access to specialty-trained pharmacists
  • Online order tracking through myCigna app

Appeals Process in New Jersey

Internal Appeals Timeline

Level Filing Deadline Review Time How to Submit
Level 1 180 days from denial 30 days (standard) / 72 hours (expedited) myCigna portal, fax (866) 593-4482, or mail
Level 2 60 days from Level 1 denial 45-60 days Same methods as Level 1

New Jersey External Review (IHCAP)

After exhausting internal appeals, New Jersey offers the Independent Health Care Appeals Program (IHCAP) through Maximus Federal Services:

  • Filing deadline: 180 days from final internal denial
  • Cost: Free to patients
  • Review time: 45 days for standard, expedited available for urgent cases
  • Success rate: Approximately 50% of external appeals favor consumers
  • Contact: 1-888-393-1062 for IHCAP assistance

Appeal Submission Tips

  • Include all original documentation plus any new supporting evidence
  • Address the specific denial reason in your appeal letter
  • Request peer-to-peer review with Cigna medical director
  • Mark urgent appeals clearly if delay would cause serious harm
  • Keep detailed records of all communications and deadlines

Common Denial Reasons & Solutions

Denial Reason Solution
Missing CFTR mutation documentation Submit complete genetic testing report from FDA-cleared laboratory
Insufficient clinical history Provide detailed CF specialist notes showing disease progression
Non-responsive mutation Verify mutation is on FDA-approved list; consider genetic counseling
Missing specialist signature Ensure CF pulmonologist signs all forms and letters
Incomplete prior authorization form Double-check all required fields are completed
From our advocates: We've seen cases where patients received denials for "non-responsive mutations" when the genetic test actually showed responsive variants. Always request a copy of how Cigna interpreted your genetic results and compare it to the FDA label. Sometimes a simple clarification call resolves the issue without a formal appeal.

Cost Assistance Programs

Manufacturer Support

Vertex Patient Services offers:

  • Copay assistance for eligible commercial insurance patients
  • Free drug programs for uninsured/underinsured patients
  • Insurance navigation support
  • Contact: 1-877-752-5933

Additional Resources

  • CF Foundation Compass Program: Insurance navigation and financial assistance
  • HealthWell Foundation: Grants for CF medications
  • New Jersey Pharmaceutical Assistance Program: State-specific prescription help

FAQ

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

What if Kalydeco is non-formulary on my Cigna plan? Submit a formulary exception request with clinical documentation showing why alternatives are inappropriate. Cigna must respond within 72 hours for exception requests.

Can I get an emergency supply while waiting for approval? Some Cigna plans allow a 30-day emergency fill during prior authorization review. Check with your pharmacy and plan benefits.

Does step therapy apply to Kalydeco? No, Cigna does not require step therapy for Kalydeco. You don't need to try and fail other CFTR modulators first.

What happens if my appeal is denied in New Jersey? You can file for external review through New Jersey's IHCAP program within 180 days of the final internal denial. This review is free and conducted by independent medical experts.

How do I expedite an appeal if my condition is worsening? Call Cigna immediately at 1-800-88-CIGNA, explain the urgent medical situation, and request expedited appeal processing. Fax your appeal marked "EXPEDITED - URGENT" with documentation of potential harm from delay.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific insurance plan and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance.

For additional help with New Jersey insurance appeals, contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 or the IHCAP hotline at 1-888-393-1062.

Sources & Further Reading

Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeals processes by creating targeted, evidence-backed responses that align with each insurer's specific requirements and policies.

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