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

Get Trikafta Covered by Cigna in North Carolina: Complete Prior Authorization & Appeals Guide

Answer Box: Getting Trikafta Covered by Cigna in North Carolina

Cigna requires prior authorization for Trikafta (elexacaftor/tezacaftor/ivacaftor) with documented cystic fibrosis diagnosis, CFTR genetic testing, and CF specialist prescription. Submit electronically via CoverMyMeds or fax the official Cigna PA form with ICD-10 code E84.0, genetic test results, and medical necessity letter. If denied, appeal internally within 180 days, then request external review through Smart NC within 120 days. Standard review: 5 business days; urgent: 72 hours.

First step today: Confirm your CFTR genotype testing and schedule a CF specialist consultation if needed.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Cystic Fibrosis
  3. Product Coding: NDC, Units, and Billing
  4. Clean Request Anatomy
  5. Frequent Pitfalls to Avoid
  6. Verification with Cigna Resources
  7. Quick Audit Checklist
  8. Appeals Process in North Carolina
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Trikafta falls under Cigna's pharmacy benefit as a specialty tier medication, managed through Express Scripts with dispensing via Accredo specialty pharmacy. Unlike injectable therapies that might qualify for medical benefit coverage, this oral CFTR modulator requires pharmacy benefit prior authorization and follows standard prescription drug pathways.

Note: Some employer plans may have different benefit structures. Verify your specific coverage by calling Cigna at 1-800-244-6224 or checking your myCigna portal.

The annual list price exceeds $369,000, making prior authorization mandatory across all Cigna plans. Express Scripts applies quantity limits and step therapy requirements based on your specific plan design.

ICD-10 Mapping for Cystic Fibrosis

The primary diagnosis code for Trikafta approval is E84.0 (Cystic fibrosis with pulmonary manifestations). This code supports medical necessity when paired with documented CFTR mutations and clinical evidence.

Supported Documentation Language

Your medical records should include specific terminology that aligns with ICD-10 coding:

  • "Cystic fibrosis with chronic pulmonary infection"
  • "CF-related bronchiectasis with recurrent exacerbations"
  • "Pancreatic insufficiency secondary to cystic fibrosis"
  • "CFTR dysfunction confirmed by genetic testing"

Alternative codes like E84.1 (with intestinal manifestations) or E84.8 (with other manifestations) may apply based on your clinical presentation, but E84.0 provides the strongest foundation for Trikafta approval given its pulmonary focus.

Product Coding: NDC, Units, and Billing

Code Type Details
NDC 78206-0150-28 (150mg/100mg/75mg tablets, 28-day supply)
HCPCS Not applicable (oral medication)
J-Code Not applicable (not injectable)
Units 84 tablets per 28-day fill (56 morning + 28 evening)

Dosing Units by Age/Weight

  • Adults & ≥12 years: 2 tablets AM (200/100/150 mg total), 1 tablet PM (150 mg ivacaftor)
  • 6-<12 years, ≥30 kg: Same as adult dosing
  • 6-<12 years, <30 kg: 2 tablets AM (100/50/75 mg total), 1 tablet PM (75 mg ivacaftor)
  • 2-<6 years: Granule formulations with different NDCs

The standard 28-day supply calculation assumes no dose adjustments for hepatic impairment or drug interactions. Vertex prescribing information details specific reductions for CYP3A inhibitors.

Clean Request Anatomy

A complete prior authorization request includes these essential components:

Patient Information Section

  • Insurance ID and group number
  • Date of birth and contact information
  • ICD-10 diagnosis: E84.0 with onset date

Clinical Documentation

  • CFTR genetic testing: FDA-cleared lab report showing F508del or responsive mutations
  • Specialist attestation: Board-certified pulmonologist or CF specialist prescription
  • Baseline labs: AST, ALT, bilirubin within 90 days
  • Medical necessity letter: Addressing CF Foundation guidelines and treatment goals

Prescription Details

  • NDC: 78206-0150-28
  • Quantity: 84 tablets per 28 days
  • Directions: 2 tablets every morning, 1 tablet every evening with fat-containing food
  • Duration: Ongoing chronic therapy
Tip: Submit electronically through CoverMyMeds for fastest processing and real-time status tracking.

Frequent Pitfalls to Avoid

Unit Conversion Errors

The most common billing mistake involves calculating monthly supplies incorrectly. Trikafta requires different tablet counts for morning versus evening doses—don't assume a simple 2-tablets-daily calculation.

Mismatched Codes

Using outdated NDCs or incorrect diagnosis codes triggers automatic denials. Always verify current product codes through Cigna's formulary database before submission.

Missing Start Dates

Cigna's system requires specific therapy start dates for utilization management tracking. Vague entries like "ASAP" or "when approved" delay processing.

Incomplete Genetic Documentation

Submitting genetic counselor summaries instead of full laboratory reports often results in requests for additional information. Include the complete FDA-cleared CFTR analysis with mutation details.

Verification with Cigna Resources

Before submitting your prior authorization, cross-check these Cigna resources:

Call Express Scripts at 1-800-282-2881 to confirm specialty pharmacy requirements and Accredo enrollment procedures.

Quick Audit Checklist

Before submission, verify:

☐ ICD-10 E84.0 with documented onset date
☐ Current CFTR genetic testing report attached
☐ CF specialist prescription and medical necessity letter
☐ Baseline laboratory values (AST, ALT, bilirubin) within 90 days
☐ Correct NDC (78206-0150-28) and quantity (84 tablets/28 days)
☐ Patient demographics match insurance card exactly
☐ Prior therapy documentation if applicable
☐ Electronic submission via CoverMyMeds or official Cigna PA form

Appeals Process in North Carolina

Internal Appeals with Cigna

If your initial request is denied, you have 180 days to file an internal appeal. Submit additional documentation addressing the specific denial reasons through your myCigna portal or by calling 1-800-244-6224.

Required for appeal:

  • Original denial letter
  • Updated medical necessity letter addressing denial reasons
  • Additional clinical documentation (recent PFTs, treatment response data)
  • CF specialist peer-to-peer review request if appropriate

Timeline: 15-30 days for standard review; 72 hours for expedited appeals when delay could seriously jeopardize your health.

External Review Through Smart NC

North Carolina offers robust external review rights through the Smart NC program. After exhausting Cigna's internal appeals, you have 120 days to request an independent review.

How to file:

  • Call Smart NC at 1-855-408-1212 for free assistance
  • Submit online at the NC Department of Insurance portal
  • Mail completed external review form with supporting documents

Timeline: 45 days for standard review; 72 hours for expedited cases. The Independent Review Organization's decision is binding on Cigna.

From our advocates: "We've seen several North Carolina Trikafta denials overturned through Smart NC external review, particularly when families provided comprehensive genetic testing documentation and CF specialist letters citing specific FDA-approved indications. The key is addressing every denial reason systematically with clinical evidence."

Success factors for external review:

  • Complete CFTR mutation analysis showing F508del or responsive variants
  • CF Foundation care guidelines supporting Trikafta use
  • Documentation of disease progression or inadequate response to alternatives
  • Age-appropriate dosing justification per FDA labeling

FAQ

How long does Cigna prior authorization take for Trikafta in North Carolina? Standard review takes up to 5 business days; expedited review for urgent cases takes 72 hours. Electronic submissions through CoverMyMeds typically process faster than fax submissions.

What if Trikafta is non-formulary on my Cigna plan? Request a formulary exception by demonstrating that formulary alternatives are ineffective or inappropriate based on your CFTR genotype. Include genetic testing and specialist attestation that other CFTR modulators won't work for your specific mutations.

Can I request an expedited appeal if my condition is worsening? Yes. If delays in accessing Trikafta could seriously jeopardize your health or ability to regain function, request expedited review. Your CF specialist must attest to the urgent medical need.

Does step therapy apply if I've tried other CFTR modulators outside North Carolina? Document all prior CFTR modulator use (Kalydeco, Orkambi, Symdeko) with treatment dates, outcomes, and reasons for discontinuation. This history often satisfies step therapy requirements regardless of where treatment occurred.

What happens after Trikafta is approved? Cigna will coordinate with Accredo specialty pharmacy for dispensing. Enroll at Accredo.com or call 1-877-622-3362. Set up automatic refills and monitoring for liver function tests as required.

How much will I pay out-of-pocket? Specialty tier copays vary by plan but can be substantial. Apply for Vertex Pathways patient assistance at VertexPathways.com—the program covers copays exceeding $10,000 annually for eligible patients.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Trikafta. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals that address payer requirements point-by-point. For North Carolina families navigating Cigna's prior authorization process, we provide the clinical documentation and procedural expertise that increases approval rates for life-changing therapies.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult your healthcare provider and insurance company for specific coverage determinations. For personalized assistance with Cigna appeals in North Carolina, contact Counterforce Health or Smart NC at 1-855-408-1212.

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