By Counterforce Health Team in Orkambi (lumacaftor/ivacaftor) —

How to Get Orkambi Covered by Cigna in Florida: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Orkambi Covered by Cigna in Florida

Orkambi (lumacaftor/ivacaftor) requires prior authorization from Cigna, with approval typically taking 5 business days. To get covered in Florida: (1) Your CF specialist submits genetic documentation proving F508del homozygosity, (2) Cigna reviews clinical criteria including age ≥1 year and CF diagnosis, (3) If approved, prescription transfers to Accredo specialty pharmacy. If denied, you have 180 days to file an internal appeal, followed by external review through Florida's Department of Financial Services. Start by ensuring your provider has complete genetic test results and CF documentation ready.

Table of Contents

Is Orkambi Covered by Cigna?

Yes, Orkambi is covered by most Cigna plans in Florida, but requires prior authorization. The medication appears on Cigna's 2025 formularies with step therapy (ST) requirements, meaning you may need to try other treatments first unless specific criteria are met.

Which Plans Cover Orkambi:

  • Commercial Cigna plans (employer-sponsored)
  • Cigna Medicare Advantage plans
  • Individual marketplace plans through Cigna

Key Coverage Requirements:

  • Must be prescribed by or in consultation with a CF specialist
  • Genetic documentation showing F508del homozygosity required
  • Patient must be ≥1 year old
  • Clinical evidence of cystic fibrosis diagnosis
Note: Cigna manages specialty drugs like Orkambi through Express Scripts and Accredo specialty pharmacy. Your prescription will automatically transfer once approved.

Prior Authorization Process

Your CF specialist (not you) submits the prior authorization request to Cigna. Here's exactly what happens:

Step-by-Step: Fastest Path to Approval

  1. Genetic Testing Confirmation (Patient/Clinic)
  2. Clinical Documentation Gathering (Clinic)
    • CF diagnosis evidence (sweat chloride test, clinical symptoms)
    • Prior therapy history and failures/intolerances
    • Current clinical status (FEV1, weight, exacerbations)
    • Timeline: 1-2 days to compile existing records
  3. Prior Authorization Submission (Prescriber)
    • Complete Cigna PA form with all required documentation
    • Submit electronically via provider portal or fax
    • Timeline: Same day submission possible
  4. Cigna Review Process
    • Standard review: 5 business days
    • Expedited review: 72 hours (if urgent)
    • Decision communicated to prescriber and patient
  5. Specialty Pharmacy Setup (If Approved)
    • Prescription automatically transfers to Accredo
    • Accredo contacts patient within 24-48 hours
    • First shipment typically within 3-5 days

Timeline and Urgency

Standard Timeline: 5-10 business days from PA submission to medication delivery

Expedited Process: Available for urgent medical situations

  • Request expedited review through prescriber
  • Decision within 72 hours
  • Call Cigna provider services to escalate: (verify with current provider directory)

When to Request Expedited Review:

  • Patient currently hospitalized
  • Significant clinical deterioration
  • Risk of serious adverse health consequences

Clinical Criteria and Requirements

Cigna requires specific documentation to approve Orkambi. Missing any element typically results in denial.

Required Documentation Checklist

Genetic Requirements:

  • ✓ Laboratory report showing F508del homozygous mutation
  • ✓ Copy of genetic counselor report (if available)

Clinical Requirements:

  • ✓ CF diagnosis confirmed by at least one: positive newborn screen, family history, clinical features
  • ✓ Evidence of abnormal CFTR function (elevated sweat chloride, genetic testing)
  • ✓ Current age ≥1 year documented
  • ✓ Prescriber specializes in CF or pulmonology

Treatment History:

  • ✓ Documentation of prior CF therapies tried
  • ✓ Reasons for failure or intolerance
  • ✓ Current clinical status and treatment goals
Clinician Corner: The medical necessity letter should reference FDA labeling for F508del homozygous patients and include specific clinical indicators like FEV1 measurements, frequency of pulmonary exacerbations, and nutritional status. Cite current CF Foundation guidelines when available.

Understanding Your Costs

Cost varies significantly by plan type and coverage phase:

Commercial Plans

  • Typical copay: $50-$500 per month (varies by tier)
  • Manufacturer assistance: Vertex GPS program can reduce copay to $15/month for eligible patients
  • Maximum annual cost: Usually capped at plan's out-of-pocket maximum

Medicare Advantage Plans

  • Coverage rate: 89% of Medicare Part D plans cover Orkambi
  • Copay in coverage gap: Can reach $3,000+ annually
  • Manufacturer copay cards: NOT eligible for Medicare beneficiaries
  • Alternative assistance: PAN Foundation, HealthWell Foundation may help

Financial Assistance Resources:

When Cigna Says No: Appeals Process

Cigna denies Orkambi requests approximately 21% of the time initially, but appeal success rates are high with proper documentation.

Common Denial Reasons & Solutions

Denial Reason How to Fix Required Documentation
Missing genetic testing Submit F508del homozygous results Laboratory genetic report
Age requirements not met Confirm patient ≥1 year old Medical records with birthdate
Not prescribed by specialist Get CF specialist consultation Referral or co-signature
Insufficient clinical justification Provide detailed medical necessity letter Treatment history, clinical goals

Florida Appeals Process

Internal Appeal (First Level):

  • Deadline: 180 days from denial notice
  • Cigna response time: 30 days (standard) or 72 hours (expedited)
  • How to file: Through Cigna member portal or written request
  • Required: Original denial letter, new supporting documentation, prescriber letter

External Review (Second Level):

  • Deadline: 4 months after final internal denial
  • Review time: 30 days (standard) or 72 hours (expedited)
  • How to file: Florida Department of Financial Services
  • Success rate: Approximately 72% for well-documented cases (based on similar state data)
From Our Advocates: "We've seen Orkambi appeals succeed most often when families include a timeline showing how the patient's health declined without CFTR modulators, alongside genetic testing and a detailed letter from their CF center. The key is addressing each specific denial reason point-by-point."

Florida Consumer Assistance:

  • Insurance Consumer Helpline: 1-877-MY-FL-CFO (877-693-5236)
  • File complaint online
  • External review is FREE to consumers in Florida

Renewal Requirements

Orkambi prior authorization typically requires renewal every 12 months. Cigna may request updated clinical documentation to continue coverage.

Renewal Documentation:

  • Current clinical status (FEV1, BMI, exacerbation frequency)
  • Evidence of clinical benefit or stable disease
  • Continued specialist oversight
  • Updated treatment goals

Timeline for Renewal:

  • Start process 30-45 days before current authorization expires
  • Submit through same channels as initial request
  • Avoid coverage gaps by planning ahead

Specialty Pharmacy Transfer

Once approved, your Orkambi prescription automatically transfers to Accredo, Cigna's specialty pharmacy partner.

What to Expect:

  1. Accredo Contact: Patient outreach within 24-48 hours of approval
  2. Insurance Verification: Accredo confirms coverage details and copay
  3. Delivery Setup: Choose delivery schedule and address
  4. Ongoing Support: Access to specialty pharmacists and nursing support

Accredo Services:

  • Free overnight shipping
  • Medication synchronization
  • Adherence monitoring
  • Side effect management support

Contact Accredo: Visit Accredo.com for current contact information and patient portal access.

Troubleshooting Common Issues

PA Status Check:

  • Log into Cigna member portal
  • Call member services number on insurance card
  • Contact prescriber's office for status updates

Missing Documentation:

  • Request genetic test results from original testing facility
  • Obtain CF center records including sweat chloride tests
  • Ask specialist to provide detailed treatment history

Portal or System Issues:

  • Try alternative submission methods (fax vs. electronic)
  • Contact Cigna provider services for technical support
  • Keep copies of all submitted documentation

Urgent Situations:

  • Request expedited review immediately
  • Contact CF center for emergency medication samples
  • Consider hospital-based administration if critically needed

Frequently Asked Questions

How long does Cigna prior authorization take for Orkambi in Florida? Standard review takes 5 business days. Expedited review for urgent cases takes 72 hours. Total time from approval to medication delivery is typically 7-10 days.

What if Orkambi is non-formulary on my Cigna plan? You can request a formulary exception with clinical justification. Success rates are high when proper genetic and clinical documentation supports medical necessity for F508del homozygous patients.

Can I request an expedited appeal in Florida? Yes, both internal appeals and external reviews can be expedited if delays would jeopardize your health. Request expedited processing when filing your appeal.

Does step therapy apply if I've tried other CF medications? Step therapy requirements may be waived if you're already established on Orkambi or have documented failures/intolerances to preferred alternatives. Include this history in your PA request.

What happens if I move from another state to Florida? Cigna plans must provide continuity of care for up to 90 days during transitions. Contact member services immediately to ensure uninterrupted coverage during your move.

Can my CF center help with the appeal process? Yes, CF centers often have dedicated insurance coordinators experienced with Orkambi appeals. They can provide clinical documentation and write detailed medical necessity letters.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for patients, clinicians, and specialty pharmacies. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with payer-specific requirements. For complex cases like Orkambi coverage, we help identify the exact clinical documentation needed and draft point-by-point rebuttals that address each denial reason systematically.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always verify current requirements with your insurance plan and consult healthcare providers for medical decisions. For personalized assistance with insurance appeals, consider consulting with patient advocates or legal professionals familiar with healthcare coverage issues.

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