By Counterforce Health Team in Turalio (pexidartinib) —

How to Get Turalio (Pexidartinib) Covered by UnitedHealthcare in Ohio: Complete PA and Appeals Guide

Answer Box: Getting Turalio Covered by UnitedHealthcare in Ohio

UnitedHealthcare requires prior authorization for Turalio (pexidartinib) with TGCT diagnosis confirmation, REMS enrollment, and surgical non-feasibility documentation. The fastest path: (1) Complete TURALIO REMS enrollment at turaliorems.com (3-5 days), (2) Gather pathology, imaging, and surgical consult notes, (3) Submit PA via UHC provider portal with baseline liver tests. If denied, Ohio residents can file external review within 180 days through the Ohio Department of Insurance.

First step today: Call UnitedHealthcare at the number on your insurance card to verify coverage and get the current PA form.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. REMS Requirements
  4. Documentation Checklist
  5. Costs and Coverage
  6. Common Denial Reasons
  7. Appeals in Ohio
  8. Renewal Requirements
  9. Specialty Pharmacy
  10. FAQ

Coverage Basics

Is Turalio Covered by UnitedHealthcare?

Yes, UnitedHealthcare covers Turalio (pexidartinib) as a specialty tier medication, but prior authorization is required for all plans. The drug is approved for symptomatic tenosynovial giant cell tumor (TGCT) not amenable to surgery that causes severe morbidity or functional limitations.

Which UnitedHealthcare Plans Cover Turalio?

  • Commercial plans (individual, group, employer-sponsored)
  • Medicare Advantage plans in Ohio
  • Medicaid managed care (where applicable)

All plans require the same PA criteria, though cost-sharing varies by plan type.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Day 1)
    • Call UnitedHealthcare member services (number on insurance card)
    • Confirm Turalio is on formulary and get current PA form
    • Ask about specialty pharmacy requirements
  2. REMS Enrollment (Days 1-5)
    • Prescriber enrolls at turaliorems.com
    • Patient completes enrollment and safety training
    • Obtain baseline liver function tests (ALT, AST, bilirubin)
  3. Gather Documentation (Days 3-7)
    • TGCT pathology report with ICD-10 code
    • MRI or CT imaging showing tumor extent
    • Surgical consultation notes explaining why surgery isn't feasible
    • Prior treatment history and outcomes
  4. Submit PA Request (Day 7)
    • Use UHC provider portal or fax PA form
    • Include medical necessity letter from prescriber
    • Attach all supporting documentation
  5. Follow Up (Days 10-14)
    • Check status via provider portal
    • Respond to any requests for additional information within 48 hours
    • Request expedited review if clinically urgent

Coverage at a Glance

Requirement Details Where to Find
PA Required Yes, all plans UHC PA Policy
Formulary Tier Specialty (Tier 4) Plan formulary document
Step Therapy Not required UHC PA criteria
Age Limit <19 years: automatic approval UHC PA policy
Diagnosis Symptomatic TGCT not amenable to surgery Medical records
REMS Mandatory enrollment turaliorems.com
Approval Duration 12 months initial PA determination letter

REMS Requirements

The FDA requires all patients, prescribers, and pharmacies to enroll in the TURALIO REMS program due to hepatotoxicity risks.

Prescriber Requirements

  • Complete online training and knowledge assessment
  • Submit Prescriber Enrollment Form
  • Verify patient enrollment before prescribing
  • Monitor liver function per protocol

Patient Requirements

  • Review Patient Guide and receive counseling
  • Complete baseline liver function tests
  • Undergo hepatitis B and C screening
  • Sign Patient Enrollment Form with prescriber

Timeline

REMS enrollment typically takes 3-5 business days. Call 1-855-TURALIO (1-855-887-2546) for assistance.

Tip: Incomplete REMS enrollment is the most common reason for automatic PA denial. Ensure all parties are enrolled before submitting your request.

Documentation Checklist

Required Documents for PA Submission

Medical Records:

  • TGCT pathology report with specific ICD-10 code
  • MRI or CT imaging showing tumor location and extent
  • Surgical consultation notes explaining non-feasibility
  • Prior treatment history (medications, therapies tried)

Laboratory Results:

  • Baseline liver function tests (ALT, AST, total bilirubin)
  • Hepatitis B surface antigen and core antibody
  • Hepatitis C antibody
  • HIV testing (if clinically indicated)

REMS Documentation:

  • Prescriber REMS enrollment confirmation
  • Patient REMS enrollment confirmation
  • Pharmacy REMS certification (if known)

Insurance Information:

  • Current UnitedHealthcare ID card
  • Plan formulary or benefit summary
  • Any prior denial letters

Costs and Coverage

Typical Cost-Sharing in Ohio

Without insurance, Turalio costs approximately $23,850 for a 28-day supply. With UnitedHealthcare coverage:

Plan Type Estimated Monthly Cost
Commercial $50-$200 copay or 20-40% coinsurance
Medicare Advantage Varies by plan; check Summary of Benefits
After Out-of-Pocket Max $0 (varies by plan)

Financial Assistance Options

  • Turalio Copay Program: May reduce out-of-pocket costs for eligible patients
  • Daiichi Sankyo Patient Assistance: Income-based support programs
  • State pharmaceutical assistance: Check Ohio Department of Aging resources

Call 1-855-TURALIO for current assistance program details.

Common Denial Reasons

Denial Reason How to Overturn
Missing TGCT diagnosis Submit pathology report with specific ICD-10 code
Surgery not addressed Include surgical consultation explaining non-feasibility
Incomplete REMS Verify all parties enrolled; submit confirmation
Missing baseline labs Complete and submit required liver function tests
Insufficient documentation Provide comprehensive medical necessity letter

Medical Necessity Letter Components

Your prescriber should include:

  • Specific TGCT diagnosis with supporting pathology
  • Why surgery is not an option (location, recurrence, patient factors)
  • Prior treatments attempted and outcomes
  • Expected benefits of Turalio therapy
  • Monitoring plan for liver function
  • References to FDA labeling and clinical guidelines

Appeals in Ohio

Internal Appeals with UnitedHealthcare

If your PA is denied, you have 180 days to file an internal appeal:

  1. First Level Appeal
    • Submit within 180 days of denial notice
    • Include new supporting documentation
    • Decision within 30 days (72 hours if expedited)
  2. Second Level Appeal (if applicable)
    • Available for some plan types
    • Same timeline and documentation requirements

Ohio External Review Process

After exhausting internal appeals, Ohio residents can request external review:

Timeline: Within 180 days of final internal denial

Process:

  1. Submit written request to UnitedHealthcare
  2. UHC forwards to Ohio Department of Insurance
  3. Independent Review Organization (IRO) assigned
  4. Decision within 30 days (72 hours if expedited)

Contact: Ohio Department of Insurance Consumer Services

Note: External review decisions are binding on the insurer. If approved, UnitedHealthcare must cover the treatment.

Renewal Requirements

Reauthorization Process

Turalio PA approvals are valid for 12 months. For renewal:

Required Documentation:

  • Updated medical records showing continued need
  • Evidence of no disease progression
  • Ongoing REMS compliance
  • Current liver function tests

Timeline: Submit renewal request 30 days before current authorization expires.

Specialty Pharmacy

Why Specialty Pharmacy is Required

Turalio must be dispensed through REMS-certified specialty pharmacies due to safety monitoring requirements. UnitedHealthcare typically uses OptumRx for specialty medications.

OptumRx Contact: 1-800-711-4555

What to Expect

  • 30-day supplies initially
  • Direct shipping to patient
  • Coordination with REMS monitoring
  • Prior authorization assistance

FAQ

Q: How long does UnitedHealthcare PA take for Turalio in Ohio? A: Standard PA decisions are made within 15 business days. Expedited reviews (for urgent cases) are completed within 72 hours.

Q: What if Turalio is not on my plan's formulary? A: Even non-formulary drugs can be covered with prior authorization. Submit a medical necessity request with comprehensive documentation.

Q: Can I request an expedited appeal in Ohio? A: Yes, if a delay would seriously jeopardize your health or ability to regain maximum function. Both internal and external reviews offer expedited timelines.

Q: Does step therapy apply if I tried treatments in another state? A: UnitedHealthcare's Turalio policy doesn't require step therapy, but document any prior treatments attempted anywhere to strengthen your case.

Q: What if my prescriber isn't enrolled in REMS yet? A: REMS enrollment is mandatory before PA approval. Your prescriber must complete enrollment at turaliorems.com, which takes 3-5 business days.

Q: How do I check my PA status? A: Use the UnitedHealthcare provider portal, call member services, or contact OptumRx directly if using their specialty pharmacy.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to craft compelling appeals that align with payer-specific criteria.

When dealing with specialty medications like Turalio, having the right documentation and understanding payer-specific workflows can make the difference between approval and denial. Counterforce Health provides the tools and expertise to streamline this process, reducing the administrative burden on healthcare providers while improving patient access to essential treatments.

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 UnitedHealthcare and consult with your healthcare provider for medical decisions. For assistance with appeals or questions about Ohio insurance regulations, contact the Ohio Department of Insurance at 1-800-686-1526.

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