By Counterforce Health Team in Turalio (pexidartinib) —

How to Get Turalio (Pexidartinib) Covered by Cigna in North Carolina: Complete Approval Guide and Appeals Process

Quick Answer: Your Path to Turalio Coverage

You likely qualify for Turalio (pexidartinib) coverage by Cigna in North Carolina if you:

  • Have confirmed TGCT diagnosis with imaging/pathology reports
  • Are 18+ years old with surgery contraindicated due to severe morbidity risk
  • Complete REMS program enrollment for hepatotoxicity monitoring

Fastest approval path: Your prescriber submits prior authorization with complete documentation package through Cigna's online portal. Standard review takes 72 hours; expedited urgent cases get 24-hour decisions. If denied, North Carolina's Smart NC external review provides binding independent appeal within 45 days.

Start today: Contact your prescriber to initiate REMS enrollment and gather required TGCT documentation.

Table of Contents

  1. Eligibility Decision Tree
  2. Required Documentation Checklist
  3. REMS Program Enrollment
  4. Submission Process and Timelines
  5. Common Denial Reasons and Solutions
  6. Appeals Process in North Carolina
  7. Cost and Financial Assistance
  8. Frequently Asked Questions

Do You Qualify? Eligibility Decision Tree

Likely Eligible ✅

You meet these criteria:

  • Confirmed TGCT (tenosynovial giant cell tumor) diagnosis with radiology/pathology
  • Age 18 or older
  • Surgery not recommended due to severe morbidity or functional limitation risk
  • Willing to complete REMS program enrollment and liver monitoring

Next step: Proceed to documentation checklist and submit prior authorization.

Possibly Eligible ⚠️

You have some but not all requirements:

  • TGCT diagnosis confirmed but surgical evaluation incomplete
  • Under 18 years old (pediatric use requires additional documentation)
  • Liver function abnormalities that need optimization first

Next step: Work with your oncologist to complete missing evaluations and optimize baseline health status.

Not Yet Eligible ❌

Missing key requirements:

  • No confirmed TGCT diagnosis
  • Surgery remains a viable first-line option
  • Contraindications to REMS monitoring requirements

Next step: Complete diagnostic workup and surgical consultation before considering Turalio.

Required Documentation Checklist

Core Requirements for Cigna Prior Authorization

Patient Demographics:

  • Age verification (≥18 years required)
  • Cigna member ID and policy information
  • ICD-10 diagnosis code (M12.2x series for TGCT)

TGCT Diagnosis Documentation:

  • Radiology reports (MRI/CT scans showing tumor characteristics)
  • Pathology report confirming TGCT/PVNS diagnosis
  • Clinical notes documenting symptoms and functional limitations

Surgical Contraindication Evidence:

  • Surgical consultation note explaining why surgery is not recommended
  • Documentation of severe morbidity risk or functional limitation concerns
  • Multidisciplinary team assessment when available

REMS Program Requirements:

  • Prescriber REMS certification confirmation
  • Patient enrollment form completion
  • Baseline liver function tests (ALT, AST, bilirubin)
  • Pharmacy REMS certification verification
Tip: Cigna processes complete submissions faster. Missing any single document can delay approval by weeks.

REMS Program Enrollment Process

Turalio carries a boxed warning for potentially fatal hepatotoxicity, requiring mandatory REMS participation before Cigna will approve coverage.

Prescriber Requirements

  1. Complete REMS certification at TuralioREMS.com
  2. Enroll patient in monitoring registry
  3. Order baseline liver tests and establish monitoring schedule
  4. Document REMS compliance in prior authorization submission

Patient Requirements

  1. Sign enrollment form acknowledging liver injury risks
  2. Complete baseline liver function tests before treatment
  3. Agree to periodic monitoring throughout treatment
  4. Report symptoms of liver problems immediately

Monitoring Schedule

  • Baseline: Complete liver panel before first dose
  • Ongoing: Monthly liver tests for first 6 months, then as clinically indicated
  • Interruption protocol: If liver injury suspected, immediate testing and possible discontinuation
Critical: REMS non-compliance is a common denial reason. Ensure all parties complete enrollment before submitting to Cigna.

Submission Process and Timelines

How to Submit Prior Authorization

Online Portal (Preferred):

  • Log into Cigna provider portal
  • Complete oncology prior authorization form
  • Upload all required documentation
  • Submit electronically for fastest processing

Alternative Methods:

  • Fax: Use Cigna's specialty pharmacy fax line (verify current number)
  • Phone: Call Cigna prior authorization department for urgent cases

Review Timelines

Review Type Timeline When to Use
Standard 72 hours Routine requests with complete documentation
Expedited 24 hours Life-threatening situations or urgent medical need

What Happens Next

If Approved:

  • Authorization processed in Cigna's system
  • Prescription can be filled at Accredo or designated specialty pharmacy
  • Coverage typically valid for 12 months with renewal requirements

If Denied:

  • Both patient and prescriber receive written notification
  • Appeal rights begin immediately
  • 180-day window to file internal appeal with Cigna

Common Denial Reasons and Solutions

Denial Reason How to Fix Required Documentation
Missing TGCT diagnosis Submit complete radiology/pathology reports MRI/CT scans, biopsy results, ICD-10 codes
Surgery not addressed Provide surgical consultation Note explaining contraindications to surgery
Incomplete REMS enrollment Complete all REMS requirements Prescriber/patient/pharmacy certifications
Insufficient medical necessity Strengthen clinical rationale Functional assessments, symptom documentation
Missing baseline labs Submit liver function tests ALT, AST, bilirubin results within 30 days

Medical Necessity Letter Template

Your prescriber should include:

  1. Patient presentation: TGCT diagnosis, symptoms, functional limitations
  2. Surgical assessment: Why surgery is contraindicated or inappropriate
  3. Treatment rationale: How Turalio addresses unmet medical need
  4. Monitoring plan: REMS compliance and safety monitoring
  5. Clinical guidelines: Reference FDA approval criteria and oncology guidelines

Appeals Process in North Carolina

Level 1: Internal Appeal with Cigna

Timeline: Submit within 180 days of denial Process:

  • Complete Cigna's appeal form
  • Include additional clinical documentation
  • Request peer-to-peer review if helpful
  • Cigna reviews within 72 hours (24 hours if expedited)

Level 2: Smart NC External Review

If Cigna denies your internal appeal, North Carolina offers binding external review through Smart NC.

Eligibility Requirements:

  • State-regulated Cigna plan (not self-funded employer plan)
  • Exhausted Cigna's internal appeals process
  • Denial based on medical necessity or experimental treatment determination

How to Apply:

  1. Submit request within 120 days of Cigna's final denial
  2. Complete external review form (available at NCDOI website)
  3. Include all documentation: medical records, denial letters, prescriber statements
  4. Call Smart NC at 855-408-1212 for assistance

Timeline:

  • Standard review: Independent Review Organization (IRO) decides within 45 days
  • Expedited review: 72 hours for urgent cases where delay jeopardizes health

Outcome:

  • If overturned: Cigna must provide coverage within 3 business days
  • Decision is binding on Cigna
Note: Smart NC staff can help with your application but cannot serve as your formal representative in the review.

Cost and Financial Assistance

Typical Costs

  • Cash price: Approximately $23,850 for 28-day supply (varies by dose)
  • With insurance: Copay varies by Cigna plan tier and specialty pharmacy benefits

Financial Assistance Options

Manufacturer Support:

  • Daiichi Sankyo patient assistance programs
  • Copay reduction cards for eligible patients
  • Visit manufacturer website for current offerings

Foundation Grants:

  • CancerCare Co-Payment Assistance Foundation
  • Patient Access Network Foundation
  • HealthWell Foundation rare disease programs

State Resources:

  • North Carolina pharmaceutical assistance programs
  • Medicaid expansion (effective 2024) may provide additional coverage options

Frequently Asked Questions

How long does Cigna prior authorization take for Turalio in North Carolina?

Standard reviews take 72 hours with complete documentation. Expedited reviews for urgent cases are completed within 24 hours. Incomplete submissions can add weeks to the process.

What if Turalio is not on Cigna's formulary?

Request a formulary exception through your prescriber. Cigna must review exception requests within 72 hours (24 hours if expedited) and provide clinical rationale if denied.

Can I get expedited review if my condition is urgent?

Yes, if delay would seriously jeopardize your health or ability to regain function. Your prescriber must document the urgency and request expedited processing.

What happens if I move from North Carolina during treatment?

Coverage continues under your existing Cigna plan, but external review rights may change based on your new state's regulations. Contact your new state's insurance department for appeal options.

Does step therapy apply to Turalio?

Typically no, since Turalio is indicated when surgery is contraindicated. However, some plans may require documentation of why other systemic therapies (like imatinib off-label) are inappropriate.

How often do external reviews succeed in North Carolina?

Specific success rates for Cigna specialty drug appeals aren't published, but thorough clinical documentation and guideline support significantly improve overturn chances.

Counterforce Health helps patients navigate complex prior authorization and appeals processes by turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters, identifies specific denial reasons, and drafts point-by-point rebuttals aligned to payer policies, significantly improving approval rates for specialty medications like Turalio.

From Our Advocates: "We've seen TGCT patients succeed with Cigna appeals when they provide comprehensive surgical consultation notes clearly documenting why resection would cause severe functional limitations. The key is specific language about anticipated morbidity, not just general statements about surgical difficulty. This documentation, combined with complete REMS enrollment, creates the strongest case for approval."

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Treatment decisions should be made in consultation with qualified healthcare providers. Coverage policies and requirements may change; always verify current information with your insurer and healthcare team.

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