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

How to Get Trikafta Covered by Cigna in Ohio: Complete Prior Authorization and Appeals Guide

Answer Box: Quick Path to Trikafta Coverage

To get Trikafta covered by Cigna in Ohio: Submit prior authorization with CFTR genotype documentation (F508del mutation), baseline liver function tests, and prescription from a CF specialist. If denied, file internal appeal within 180 days, then external review through Ohio Department of Insurance. Contact ODI at 800-686-1526 for help. Start today: Gather genetic test results and call your CF clinic to begin the PA process.

Table of Contents

  1. Policy Overview: How Cigna Covers Trikafta
  2. Medical Necessity Requirements
  3. Step Therapy and Exceptions
  4. Quantity Limits and Dispensing Rules
  5. Required Diagnostics and Lab Work
  6. Specialty Pharmacy Requirements
  7. Evidence to Support Your Case
  8. Appeals Process in Ohio
  9. Common Denial Reasons and Solutions
  10. FAQ

Policy Overview: How Cigna Covers Trikafta

Cigna classifies Trikafta as a specialty medication requiring prior authorization across all plan types—HMO, PPO, and Medicare Advantage. The drug is typically managed through Express Scripts and dispensed via Accredo specialty pharmacy.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all plans Cigna PA Policy
Formulary Tier Specialty tier Plan-specific formulary
Step Therapy May apply to CFTR modulators Coverage determination
Quantity Limits 84 tablets/28 days, 56 packets/28 days DQM Policy
Site of Care Accredo specialty pharmacy only PA approval letter
Appeals Deadline 180 days for internal appeal Plan documents

Medical Necessity Requirements

Cigna requires documented proof that Trikafta meets specific clinical criteria. Here's what counts as "medically necessary":

Essential Requirements:

  • Confirmed cystic fibrosis diagnosis with appropriate ICD-10 code
  • CFTR genotype showing at least one F508del mutation or other responsive mutation
  • Prescription from a cystic fibrosis specialist or pulmonologist
  • Age ≥2 years (per FDA labeling)
Tip: If your genotype is unknown, you'll need FDA-cleared CFTR genetic testing before Cigna will consider coverage. Don't skip this step—it's the most common reason for initial denials.

Step Therapy and Exceptions

Cigna may require you to try other CFTR modulators first, depending on your specific mutation and plan. Common step therapy sequences include:

  1. F508del homozygous patients: May need to try Symdeko or document intolerance
  2. Gating mutations: Kalydeco trial may be required first
  3. Other mutations: Case-by-case evaluation

Getting a Step Therapy Exception:

  • Document previous trials and failures with required medications
  • Provide clinical notes showing intolerance or contraindications
  • Include specialist letter explaining why Trikafta is the appropriate first-line choice

Submit exceptions through the same prior authorization process as initial requests.

Quantity Limits and Dispensing Rules

Cigna enforces strict quantity limits through drug quantity management policies:

Standard Limits:

  • Tablets (age 12+): 84 tablets per 28-day supply
  • Oral granules (age 2-5): 56 packets per 28-day supply
  • Mail order: Up to 84-day supplies available

Quantity Limit Exceptions:

  • Required for doses above standard limits
  • Must include clinical justification (hepatic impairment, drug interactions)
  • Submit with original PA or as separate request

Required Diagnostics and Lab Work

Before starting Trikafta, Cigna expects comprehensive baseline testing:

Mandatory Lab Work:

  • Liver function tests: ALT, AST, alkaline phosphatase, total bilirubin
  • CFTR genotype: FDA-cleared testing showing responsive mutations
  • Baseline pulmonary function tests: Including FEV1 percentage predicted

Ongoing Monitoring Requirements:

  • Monthly LFTs for first 6 months
  • Quarterly LFTs for months 6-12
  • Annual LFTs thereafter
  • PFTs every 3-6 months to document response
Note: Keep all lab results organized. You'll need them for initial authorization, appeals, and renewal requests.

Specialty Pharmacy Requirements

Once approved, Trikafta must be dispensed through Accredo specialty pharmacy. Here's how it works:

Enrollment Process:

  1. Cigna sends approval to Accredo automatically
  2. Accredo contacts patient within 24-48 hours
  3. Patient completes enrollment and insurance verification
  4. First shipment typically arrives within 3-5 business days

Ongoing Shipments:

  • Monthly temperature-controlled delivery
  • Automatic refills 7-10 days before running out
  • Patient portal for tracking and communication

Contact Accredo: 877-826-7657 for enrollment or shipment issues.

Evidence to Support Your Case

Strong clinical documentation significantly improves approval odds. Include these evidence types:

Clinical Guidelines:

Supporting Documentation:

  • Detailed medical necessity letter from CF specialist
  • Recent clinic notes showing disease progression or symptoms
  • Documentation of previous therapy failures or intolerances
  • Quality of life assessments or functional status measures

Sample Medical Necessity Statement: "Patient has cystic fibrosis with confirmed F508del/F508del genotype. Current FEV1 is 65% predicted with recent decline from 72%. Previous trial of Symdeko resulted in minimal improvement and GI intolerance. Trikafta is indicated per FDA labeling and CF Foundation guidelines for this genotype and clinical presentation."

Appeals Process in Ohio

If Cigna denies your Trikafta request, Ohio provides robust appeal rights:

Internal Appeals (Required First Step):

  1. Timeline: 180 days from denial notice
  2. Submission: Write to address on denial letter or use member portal
  3. Documentation: Include all supporting clinical evidence
  4. Decision: 30 days for standard, 72 hours for expedited

External Review (After Internal Appeals):

  1. Eligibility: Medical necessity denials after completing internal appeals
  2. Timeline: Request within 4 months of final internal denial
  3. Process: Ohio Department of Insurance assigns Independent Review Organization
  4. Decision: 30 days standard, 72 hours expedited
  5. Contact: ODI Consumer Services at 800-686-1526
Important: External review decisions are binding on Cigna. If the IRO overturns the denial, Cigna must provide coverage.

Common Denial Reasons and Solutions

Denial Reason Solution
"No documented CFTR genotype" Submit FDA-cleared genetic test results showing F508del or responsive mutation
"Lack of baseline labs" Provide complete LFTs and PFTs from within 30 days
"Not prescribed by specialist" Get prescription from CF center or pulmonologist
"Drug interactions noted" Submit medication reconciliation and safety monitoring plan
"Quantity exceeds limits" Request quantity limit exception with clinical justification
"Step therapy not completed" Document previous trials or request medical exception

From Our Advocates

We've seen many Cigna Trikafta denials overturned when families provide comprehensive genetic documentation and specialist support. One key tip: if your initial genetic testing was done years ago, consider updating it with current FDA-cleared methods, as newer test reports often include more detailed mutation analysis that payers prefer. This approach has helped several families move from denial to approval without lengthy appeals.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters, identifying specific coverage criteria, and drafting point-by-point rebuttals aligned with each payer's policies.

FAQ

How long does Cigna prior authorization take in Ohio? Standard review takes up to 5 business days. Expedited review (for urgent medical needs) takes 72 hours or less.

What if Trikafta isn't on my Cigna formulary? Request a formulary exception through the same prior authorization process. Include clinical justification for why formulary alternatives aren't appropriate.

Can I get an expedited appeal in Ohio? Yes, if delay would seriously jeopardize your health. Your physician must certify the urgent need in writing.

Does step therapy apply if I tried other CFTR modulators outside Ohio? Yes, document any previous trials regardless of where they occurred. Include medical records and specialist notes about outcomes.

What happens if I move from Ohio to another state? Coverage continues under the same Cigna plan, but appeal rights may differ. Check your new state's external review process.

How much does Trikafta cost with Cigna coverage? Costs vary by plan. Specialty tier copays typically range from $50-500 per month. Check with Cigna member services for your specific copay.

Can I use manufacturer copay assistance with Cigna? Yes, Vertex offers copay support for eligible patients. Contact Vertex Connect at 1-877-752-5933 for enrollment.

What if my child needs Trikafta but is under age 2? Coverage for off-label use requires extensive clinical justification and specialist support. Consider working with Counterforce Health for complex cases like this.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always consult with your healthcare provider and insurance plan for the most current information. For additional help with complex appeals, consider consulting with coverage advocacy services.

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