By Counterforce Health Team in Kalydeco (ivacaftor) —

How to Get Kalydeco (ivacaftor) Covered by Cigna in Virginia: Complete Prior Authorization Guide

Quick Answer: Getting Kalydeco (ivacaftor) Covered by Cigna in Virginia

To get Kalydeco approved by Cigna in Virginia, you need: (1) documented CFTR mutation testing showing an eligible variant (not homozygous F508del), (2) cystic fibrosis diagnosis with ICD-10 code E84.0, and (3) prior authorization submission through Cigna's specialty pharmacy network. If denied, Virginia's Bureau of Insurance offers external review within 120 days. Start today: Have your doctor order genetic testing if not done, then submit PA documentation to Cigna's provider portal.

Table of Contents

Who Should Use This Guide

This guide is for Virginia residents with cystic fibrosis who need Kalydeco (ivacaftor) coverage through Cigna insurance. You'll benefit most if you:

  • Have confirmed cystic fibrosis with specific CFTR mutations
  • Are at least 1 month old (per FDA labeling)
  • Need help navigating Cigna's prior authorization process
  • Want to understand Virginia's appeal rights upfront

Expected outcome: With proper documentation, most eligible patients receive approval. Cigna's denial rate for specialty medications averages around 21%, but appeals succeed frequently when clinical criteria are clearly met.

Member & Plan Basics

Coverage Requirements

  • Active Cigna coverage with pharmacy benefits
  • Specialty drug coverage (Kalydeco is typically Tier 4 or specialty tier)
  • Prior authorization required for all patients
  • No deductible exemption (specialty copays apply)

Plan Type Considerations

Most Cigna plans route Kalydeco through Express Scripts/Accredo specialty pharmacy. Confirm your plan's specialty pharmacy network before starting.

Clinical Criteria Requirements

FDA-Approved Indications

Kalydeco is approved for cystic fibrosis patients with specific CFTR mutations that respond to ivacaftor. Cigna requires documentation of:

Eligible Mutations Include:

  • G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R
  • R117H (with specific clinical criteria)
  • Additional mutations listed in FDA labeling

Ineligible Mutations:

  • Homozygous F508del (Kalydeco is not effective for these patients)

Age and Clinical Requirements

Documentation Requirements

Essential Documents Checklist

  • Genetic test results showing eligible CFTR mutation
  • Clinical notes confirming cystic fibrosis diagnosis
  • ICD-10 diagnosis code: E84.0 (Cystic fibrosis with pulmonary manifestations)
  • Prescriber specialty confirmation (pulmonology or CF specialist preferred)
  • Age verification (birth date on file)

Medical Necessity Letter Components

Your doctor should include:

  1. Patient's specific CFTR mutation and test date
  2. Clinical signs/symptoms of cystic fibrosis
  3. Treatment goals and expected outcomes
  4. Dosing rationale based on FDA labeling
  5. Confirmation that patient is not homozygous F508del
Clinician Tip: Reference the FDA prescribing information and include mutation-specific efficacy data when available.

Submission Process

Step-by-Step Submission

  1. Complete Cigna's PA form (verify current version)
  2. Attach all required documentation (genetic testing, clinical notes)
  3. Submit via provider portal or fax (confirm current submission method)
  4. Include NDC number: 51167-312-01 for 150mg tablets
  5. Request expedited review if clinically urgent

Coding Information

  • ICD-10: E84.0 (Cystic fibrosis with pulmonary manifestations)
  • HCPCS: J8499 (Prescription drug, oral, non-chemotherapeutic, NOS)
  • NDC: 51167-312-01 (150mg tablets, bottle of 56)

Specialty Pharmacy Transfer

Cigna typically requires Kalydeco to be dispensed through Accredo specialty pharmacy. Here's how to transfer:

Transfer Options

  1. Electronic transfer: Log into myCigna.com → Prescriptions → My Medications
  2. Doctor contact: Have your CF clinic send prescription directly to Accredo
  3. Phone transfer: Call Express Scripts at 800-835-3784

Accredo Contact Information

  • Phone: 877-826-7657
  • Hours: Monday-Friday 7am-10pm CST, Saturday 7am-4pm CST
  • Services: 24/7 pharmacist access, home delivery, refill reminders

After Submission: Next Steps

Timeline Expectations

  • Standard review: 3-5 business days
  • Expedited review: 24-72 hours (with clinical urgency documentation)
  • Approval duration: Typically 1 year

Status Monitoring

  • Check approval status through Cigna member portal
  • Record confirmation numbers and case references
  • Set calendar reminders for reauthorization (typically 10-11 months)

Appeals Process in Virginia

If Cigna denies your Kalydeco request, Virginia provides robust appeal rights through the State Corporation Commission Bureau of Insurance.

Internal Appeals (First Step)

  • Timeline: File within 180 days of denial
  • Process: Submit through Cigna's standard appeal process
  • Documentation: Include new clinical information if available

External Review (Virginia State Process)

  • Eligibility: After completing internal appeals
  • Timeline: File within 120 days of final Cigna denial
  • Forms: Form 216-A (External Review Request)
  • Cost: Free to patients
  • Decision timeline: 45 days standard, 72 hours expedited

Virginia Bureau of Insurance Contact

Virginia Advantage: The state's external review process has helped many patients overturn wrongful denials, with independent medical reviewers specifically trained in rare disease treatments.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing genetic testing Submit CFTR mutation results FDA-cleared CF mutation test results
Age requirements Verify patient ≥1 month old Birth certificate or medical records
Non-responsive mutation Confirm mutation is FDA-approved Cross-reference FDA labeling
Incomplete clinical notes Provide comprehensive CF diagnosis Sweat chloride test, clinical symptoms
Homozygous F508del Kalydeco not indicated Consider alternative CFTR modulators

FAQ

How long does Cigna prior authorization take for Kalydeco in Virginia? Standard review takes 3-5 business days. Expedited review (with clinical urgency) takes 24-72 hours.

What if Kalydeco is not on Cigna's formulary? Request a formulary exception with clinical justification. Cigna has processes for non-formulary medications when medically necessary.

Can I request expedited review? Yes, if your doctor certifies that delays could harm your health. Include clinical urgency documentation with your PA request.

Does Virginia have special protections for rare disease coverage? Virginia's external review process includes independent specialists familiar with rare diseases, providing strong appeal options for CF patients.

What happens if I'm denied after external review? The external review decision is binding on Cigna. If upheld, consider consulting a healthcare attorney or exploring manufacturer assistance programs.

About Counterforce Health: Counterforce Health helps patients and clinicians navigate complex prior authorization processes by turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and drafts point-by-point rebuttals aligned with payer policies, making the appeals process more efficient for rare disease treatments like Kalydeco.

When dealing with Kalydeco denials, having expert support can make the difference between approval and continued delays. Counterforce Health's specialized approach to CFTR modulator appeals has helped many cystic fibrosis patients access their prescribed therapies faster.

From Our Advocates: One common success strategy we see is submitting genetic testing results alongside detailed clinical notes that explicitly address each PA criterion. Patients who include mutation-specific efficacy data and clear treatment rationale tend to receive faster approvals, especially when their CF specialists emphasize the patient's specific clinical needs in the medical necessity letter.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider about treatment decisions and contact Virginia's Bureau of Insurance for official guidance on appeals processes.

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