By Counterforce Health Team in Trikafta / Kaftrio (elexacaftor/tezacaftor/ivacaftor) —

Cigna's Coverage Criteria for Trikafta in Florida: What Counts as "Medically Necessary"?

Answer Box: Getting Trikafta Covered by Cigna in Florida

Cigna requires prior authorization (PA) for Trikafta in Florida with documented cystic fibrosis diagnosis (ICD-10 E84.0), confirmed CFTR genotype (F508del or responsive mutations), and prescription from a CF specialist. Standard PA review takes 5 business days; expedited review available for urgent cases. First step today: Have your CF specialist download Cigna's Trikafta PA form and submit with complete genetic testing results, clinical documentation, and baseline labs.

Table of Contents

Policy Overview: How Cigna Manages Trikafta Coverage

Cigna covers Trikafta (elexacaftor/tezacaftor/ivacaftor) across its Florida commercial, Medicare, and Medicaid plans, but requires prior authorization regardless of plan type. The medication appears on Cigna's 2024-2025 Florida 4-Tier and 5-Tier Prescription Drug Lists with PA designation.

Key Policy Documents:

Most Cigna plans route Trikafta through Express Scripts specialty pharmacy network, typically Accredo, after PA approval.

FDA Indication Requirements

FDA-Approved Indications for Trikafta:

  • Cystic fibrosis in patients ≥2 years old with at least one F508del mutation in the CFTR gene
  • CF patients with other CFTR mutations responsive to elexacaftor/tezacaftor/ivacaftor based on in vitro data

Cigna's medical necessity criteria align closely with FDA labeling, requiring:

Requirement Documentation Needed Source
Age Patient ≥2 years FDA Label
Diagnosis Confirmed CF diagnosis (ICD-10 E84.0-E84.9) Cigna Policy CNF_356
Genotype F508del homozygous OR F508del + responsive mutation Genetic test report required
Prescriber CF specialist or pulmonologist preferred PA form requirement

Step Therapy & Medical Exceptions

Good news for Florida patients: Cigna typically does not require step therapy for Trikafta when prescribed for FDA-approved indications with proper genotype documentation. However, some plans may have step therapy requirements for certain age groups or off-label uses.

Medical Exception Process: If step therapy applies to your specific plan, exceptions are available when:

  • Previous CFTR modulators caused adverse reactions
  • Patient has contraindications to required step therapy drugs
  • Prior therapy was ineffective despite adequate trial

Exception Timeline: 72 hours for step therapy exceptions, 24 hours for expedited reviews when health conditions may worsen.

Quantity and Frequency Limits

Standard Coverage: Once PA is approved, Cigna covers standard Trikafta dosing without quantity limits:

  • Morning dose: Two tablets (150mg elexacaftor/100mg tezacaftor/75mg ivacaftor)
  • Evening dose: One tablet (150mg elexacaftor/100mg tezacaftor/75mg ivacaftor)
  • Supply: 28-day fills through specialty pharmacy
  • NDC: 78206-0150-28

Renewal Requirements: Annual PA renewal typically required with updated clinical documentation showing continued benefit and tolerability.

Required Diagnostic Documentation

Essential Documentation for PA Approval:

Genetic Testing Requirements

  • FDA-cleared CFTR mutation analysis confirming F508del or responsive mutations
  • Acceptable tests: ACMG-recommended panels, full CFTR sequencing, or targeted mutation analysis
  • Results must specify exact mutations on both alleles

Clinical Documentation

  • Sweat chloride test ≥60 mmol/L (if available)
  • Baseline labs within 90 days: liver function tests (ALT/AST), total bilirubin
  • Pulmonary function tests (FEV1, FVC) when age-appropriate
  • Growth parameters for pediatric patients

Medical History

  • Previous CFTR modulator trials and outcomes
  • Current CF therapies and adherence
  • Recent hospitalizations or exacerbations

Specialty Pharmacy Requirements

Mandatory Specialty Pharmacy Routing: Cigna requires Trikafta fulfillment through Accredo specialty pharmacy for most plans. After PA approval:

  1. Automatic transfer: Prescription routes to Accredo within 24-48 hours
  2. Patient enrollment: Accredo contacts patient to complete enrollment
  3. Shipping: Temperature-controlled delivery, typically monthly
  4. Support: Dedicated CF pharmacists available

Patient Contact: 877-826-7657 for Accredo enrollment questions

Tip: Enroll with Accredo proactively once PA is submitted to avoid delays in first shipment.

Evidence to Support Medical Necessity

Key Guidelines and Evidence Sources:

Primary Guidelines

Supporting Literature

When appealing denials, reference peer-reviewed studies demonstrating:

  • Improved lung function (ppFEV1 improvements)
  • Reduced pulmonary exacerbations
  • Enhanced quality of life scores
  • Sweat chloride normalization

Pro tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying the specific denial basis and crafting point-by-point rebuttals aligned with plan policies.

Sample Medical Necessity Narrative

Template for CF Specialist Letter:

"Patient [Name], DOB [Date], has genetically confirmed cystic fibrosis with [specific mutations, e.g., F508del homozygous] documented by [lab name] on [date]. Current clinical status includes [FEV1 value], [recent exacerbation history], and [current therapies]. Trikafta is FDA-approved for this exact genotype and age group. Based on clinical trials and CF Foundation guidelines, this triple-combination therapy addresses the underlying CFTR protein defect and is expected to provide significant clinical benefit including improved lung function and reduced exacerbations. Standard dosing of [morning/evening regimen] is requested with baseline labs demonstrating adequate hepatic function [attach results]. This therapy aligns with evidence-based CF care standards and is medically necessary for this patient's condition."

Special Cases: Pediatric and Comorbidities

Pediatric Considerations (Ages 2-17)

  • Weight-based dosing: May require adjustment for very young patients
  • Growth monitoring: Document height/weight percentiles
  • School impact: Include functional assessments when relevant
  • Caregiver education: Document family understanding and support

Comorbidity Documentation

CF-Related Conditions:

  • Pancreatic insufficiency and enzyme replacement
  • CF-related diabetes management
  • Liver disease considerations
  • Bone health concerns

Escalation Paths:

  • Peer-to-peer review with Cigna medical director
  • External clinical consultation
  • Appeals with subspecialist support letters

Appeals Process for Florida Patients

Internal Appeals (Required First Step)

Timeline: 180 days from denial notice Review Period: 30 days (standard), 72 hours (expedited) Submission Methods:

  • myCigna portal (fastest)
  • Phone: 1-800-244-6224
  • Mail to address on denial letter

External Review (After Internal Appeal)

Florida Department of Financial Services External Review:

  • Timeline: Request within 4 months of final internal denial
  • Cost: Free to patients
  • Contact: Florida DFS Consumer Helpline at 877-693-5236
  • Decision: Binding on Cigna if overturned
Note: Florida's external review process has strong consumer protections and independent medical expert review.

When working with specialists and patients on Trikafta appeals, we've found that comprehensive genetic documentation combined with current CF Foundation guidelines creates the strongest medical necessity case, especially when the initial denial was based on incomplete genotype information or outdated step therapy requirements.

Quick Reference Checklist

Before Starting PA:

  • Confirm patient has Cigna coverage and specialty pharmacy benefits
  • Verify CF diagnosis with ICD-10 code E84.0-E84.9
  • Obtain FDA-cleared CFTR genetic testing results
  • Schedule baseline labs (liver function tests)
  • Download current Cigna Trikafta PA form

PA Submission Requirements:

  • Completed PA form with all required fields
  • Genetic test report showing F508del or responsive mutations
  • Clinical notes documenting CF diagnosis and current status
  • Baseline laboratory results (≤90 days old)
  • Prior therapy history (if applicable)
  • Prescriber DEA/NPI information

Common Errors to Avoid:

  • Incomplete genetic testing (need specific mutations, not just "CF positive")
  • Missing prescriber attestation signatures
  • Outdated lab values (>90 days old)
  • Insufficient clinical documentation of CF severity

FAQ

How long does Cigna PA take for Trikafta in Florida? Standard review is 5 business days. Expedited review (24-72 hours) available when standard timeline would jeopardize patient health.

What if Trikafta is non-formulary on my plan? Cigna offers formulary exception process with physician certification of medical necessity. Review completed within 72 hours.

Does step therapy apply if I've failed CFTR modulators outside Florida? Florida law protects against repeating step therapy from recent prior plans within 90 days. Document previous trials clearly.

Can I request expedited appeals? Yes, expedited internal appeals (72 hours) and external reviews (72 hours) available when standard timelines would jeopardize health.

What if my CF center isn't familiar with Cigna's requirements? Share this guide and Cigna's official PA form. Consider involving Counterforce Health for complex cases requiring targeted appeal strategies.

Are there cost-sharing limits for approved Trikafta? Coverage varies by plan. Check your specific formulary tier and copay/coinsurance. Manufacturer copay assistance may be available.

How often must PA be renewed? Typically annually, with updated clinical documentation showing continued benefit and tolerability.

What happens if I move to another state? PA requirements may differ by state. Contact Cigna to understand new state requirements and transition coverage.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage questions. For assistance with complex coverage issues, contact the Florida Department of Financial Services Consumer Helpline at 877-693-5236.

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