By Counterforce Health Team in Turalio (pexidartinib) —

The Requirements Checklist to Get Turalio (Pexidartinib) Covered by Aetna (CVS Health) in Florida

Quick Answer: Getting Turalio Covered by Aetna (CVS Health) in Florida

Who qualifies: Patients with symptomatic tenosynovial giant cell tumor (TGCT) not amenable to surgery, causing severe morbidity or functional limitations. Fastest path: Complete Aetna's prior authorization form with REMS enrollment documentation, surgical contraindication evidence, and detailed medical necessity letter. First step today: Contact CVS Specialty Pharmacy at 1-800-237-2767 to obtain the current PA form and confirm REMS program enrollment requirements. Most complete submissions are approved within 14 days.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation Requirements
  5. Required Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Reasons & How to Fix Them
  10. Appeals Process in Florida
  11. Printable Checklist

Who Should Use This Checklist

This guide is designed for patients with TGCT and their healthcare providers seeking Turalio (pexidartinib) coverage through Aetna (CVS Health) in Florida. You'll need this if:

  • Your doctor has recommended Turalio for symptomatic TGCT
  • Surgery isn't an option due to tumor location, patient condition, or risk factors
  • You're experiencing significant pain, swelling, or functional limitations
  • Your case requires prior authorization approval

Expected outcome: When documentation is complete and meets Aetna's criteria, over 95% of straightforward requests are approved, often within 24 hours of submission.

Member & Plan Basics

Coverage Verification Requirements

Requirement Details Where to Check
Active Coverage Verify current Aetna membership and benefits Member ID card, Aetna member portal
Plan Type Commercial, Medicare Advantage, or Medicaid Benefits summary or call member services
Specialty Drug Coverage Confirm Turalio is covered under your plan Aetna formulary lookup
Prior Authorization Required for all Turalio prescriptions CVS Specialty confirmation
Note: Aetna routes most specialty medications, including Turalio, through CVS Specialty Pharmacy. Confirm your plan's specialty pharmacy requirements before starting the approval process.

Clinical Criteria Requirements

FDA-Approved Indication

Turalio is approved for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

Aetna's Medical Necessity Criteria

✅ Required Clinical Elements:

  • Confirmed TGCT diagnosis via imaging and/or pathology
  • Documentation of severe morbidity or functional limitations
  • Evidence that surgery is not feasible or would cause unacceptable morbidity
  • REMS program enrollment for both prescriber and patient
  • Baseline liver function tests within acceptable limits

Step Therapy Requirements

Surgery is considered first-line treatment for TGCT. Turalio approval requires documentation explaining why surgery is not appropriate, such as:

  • Tumor location making resection technically unfeasible
  • High risk of significant loss of joint function
  • Patient not a surgical candidate due to comorbidities
  • Previous surgical failure or recurrence

Coding & Documentation Requirements

ICD-10 Diagnosis Codes

  • M12.2 - Villonodular synovitis (pigmented villonodular synovitis/diffuse TGCT)
  • D48.1 - Neoplasm of uncertain behavior of connective and other soft tissue
  • D21.0-D21.9 - Benign neoplasms of connective and other soft tissue (location-specific)

Drug Identification

  • NDC: 73626-010-01
  • Generic Name: Pexidartinib
  • Strength: 200 mg capsules
  • Typical Dosing: 250 mg twice daily with low-fat meals

Required Documentation Packet

Medical Necessity Letter Components

Your prescriber's letter should include:

  1. Patient Demographics
    • Full name, date of birth, member ID
    • Primary and secondary diagnoses with ICD-10 codes
  2. Clinical Summary
    • Detailed description of symptoms (pain, swelling, functional impairment)
    • Objective measures from imaging or functional assessments
    • Impact on daily activities and quality of life
  3. Surgical Assessment
    • Clear explanation of why surgery is not feasible
    • Specific risks or contraindications to surgical intervention
    • Prior surgical attempts and outcomes (if applicable)
  4. Treatment Rationale
    • Why Turalio is medically necessary for this patient
    • Expected clinical benefits and treatment goals
    • Planned duration of therapy (typically 12 months initially)
  5. Safety Monitoring Plan
    • Baseline liver function test results
    • Commitment to REMS-required monitoring schedule
    • Plan for managing potential adverse effects

Required Attachments

  • Recent imaging reports (MRI, CT, or ultrasound)
  • Pathology reports (if tissue diagnosis available)
  • Operative reports from previous surgeries
  • Current laboratory results (liver function tests)
  • REMS enrollment documentation

Submission Process

Step-by-Step Submission

  1. Obtain Current Forms
    • Call CVS Specialty at 1-800-237-2767
    • Download from Aetna provider portal
    • Verify you have the most recent version
  2. Complete Prior Authorization Form
    • Fill out all required fields completely
    • Include prescriber DEA number and NPI
    • Specify exact dosing and quantity requested
  3. Submit Documentation
    • Fax: 1-855-633-7673 (CVS Specialty)
    • Phone: 1-800-237-2767 for questions
    • Portal: Through Aetna provider portal (if available)
  4. Confirmation
    • Request confirmation number for submission
    • Save all submitted documents
    • Note submission date and method
Tip: Incomplete applications are the top cause of delays. Double-check that all required fields are filled and supporting documents are included before submission.

Specialty Pharmacy Requirements

Turalio dispensing is restricted to CVS Specialty Pharmacy for most Aetna plans. Key requirements:

REMS Program Compliance

  • Prescriber Certification: Must complete REMS training at www.TURALIOREMS.com
  • Patient Enrollment: Complete REMS registry enrollment form
  • Pharmacy Certification: Only REMS-certified pharmacies can dispense

Monitoring Requirements

  • Baseline Testing: AST, ALT, total bilirubin, alkaline phosphatase
  • Ongoing Monitoring: Weekly for first 8 weeks, then every 2 weeks for 4 weeks, then monthly
  • Documentation: All monitoring results must be documented in REMS system

For specialized guidance on navigating complex prior authorizations and appeals, Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements.

After Submission: What to Expect

Timeline Expectations

  • Standard Review: 14 days (often faster for complete submissions)
  • Expedited Review: 72 hours (if urgent medical need documented)
  • Additional Information Requests: May extend timeline by 7-14 days

Status Tracking

  • Call CVS Specialty at 1-800-237-2767
  • Check Aetna member portal
  • Contact prescriber's office for updates

Approval Confirmation

  • Written approval notice with authorization number
  • Coverage duration (typically 12 months)
  • Any quantity limits or restrictions
  • Renewal requirements

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Documentation
Missing TGCT diagnosis Submit imaging reports and pathology MRI/CT scans, biopsy results
Surgical options not addressed Provide detailed surgical contraindication letter Surgeon's assessment, operative risks
REMS enrollment gaps Complete all REMS requirements Enrollment confirmations, training certificates
Insufficient medical necessity Expand clinical documentation Functional assessments, symptom severity
Quantity limits exceeded Justify dosing based on patient factors Weight-based calculations, FDA labeling

Appeals Process in Florida

Internal Appeal (First Level)

  • Deadline: 65 days from denial notice
  • Timeline: 30 days for standard, 72 hours for expedited
  • Submission:
    • Mail: Aetna Medicare Appeals Unit, P.O. Box 14067, Lexington, KY 40512
    • Fax: 1-724-741-4953 (standard) or 1-724-741-4958 (expedited)

External Review (Independent Review)

If internal appeal is denied, Florida law provides access to independent external review:

  • Deadline: 4 months after final internal denial
  • Process: Submit request to Florida Department of Financial Services
  • Cost: No charge to consumer
  • Decision: Binding on insurer if overturned
From our advocates: "We've seen cases where the initial denial cited 'experimental' status, but a well-documented appeal highlighting FDA approval and the patient's specific surgical contraindications led to approval within 48 hours. The key was clearly explaining why surgery wasn't feasible in this particular case."

Florida Consumer Assistance

  • Insurance Consumer Helpline: 1-877-MY-FL-CFO (1-877-693-5236)
  • Online Complaints: Through Florida Department of Financial Services
  • Consumer Advocate: Available for complex cases

For patients facing repeated denials or complex appeals, Counterforce Health specializes in analyzing payer-specific policies and crafting appeals that address each plan's exact criteria, often identifying coverage pathways that weren't initially apparent.

Printable Checklist

Before You Start

□ Verify active Aetna coverage and specialty pharmacy benefits
□ Confirm TGCT diagnosis with appropriate ICD-10 code
□ Document why surgery is not feasible or appropriate
□ Complete REMS enrollment for prescriber and patient
□ Obtain baseline liver function tests

Documentation Packet

□ Completed prior authorization form (current version)
□ Medical necessity letter with all required elements
□ Recent imaging reports (MRI, CT, or ultrasound)
□ Pathology reports (if available)
□ Laboratory results (liver function tests)
□ REMS enrollment confirmations
□ Prior surgical reports or consultant assessments

Submission

□ Double-check all required fields are complete
□ Fax to CVS Specialty: 1-855-633-7673
□ Request and record confirmation number
□ Save copies of all submitted documents
□ Note submission date and method

Follow-Up

□ Track status after 7-10 days
□ Respond promptly to any information requests
□ Prepare appeal documentation if needed
□ Contact Florida DFS if external review becomes necessary

Frequently Asked Questions

Q: How long does Aetna prior authorization take for Turalio in Florida?
A: Most complete submissions receive decisions within 14 days, with over 95% of straightforward cases approved within 24 hours when all documentation is provided.

Q: What if Turalio is not on my Aetna formulary?
A: You can request a formulary exception by demonstrating medical necessity and providing evidence that covered alternatives are inappropriate or contraindicated.

Q: Can I request an expedited appeal if my condition is urgent?
A: Yes, if waiting could harm your health, you can request expedited review with a decision within 72 hours. Your doctor's support strengthens the expedited request.

Q: Does step therapy apply if I've tried treatments outside Florida?
A: Prior treatment history from any state counts toward step therapy requirements, but you'll need documentation from those providers.

Q: What happens if CVS Specialty can't fill my prescription?
A: Due to REMS requirements, only certified specialty pharmacies can dispense Turalio. CVS Specialty will coordinate with other REMS-certified pharmacies if needed.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and medical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For assistance with insurance appeals and coverage issues, contact the Florida Department of Financial Services Consumer Helpline at 1-877-693-5236.

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