By Counterforce Health Team in Turalio (pexidartinib) —

How to Get Turalio (Pexidartinib) Covered by Humana in Virginia: Complete Prior Authorization Guide

Answer Box: Getting Turalio Covered by Humana in Virginia

Turalio (pexidartinib) requires prior authorization from Humana and enrollment in the FDA REMS program. Virginia patients have strong appeal rights through the State Corporation Commission if denied.

Fastest path to approval:

  1. Complete REMS enrollment at turaliorems.com (prescriber, patient, pharmacy)
  2. Submit prior authorization with TGCT diagnosis (ICD-10 D48.1), surgical contraindication documentation, and baseline liver tests
  3. Use CenterWell Specialty Pharmacy or Biologics by McKesson for dispensing

First step today: Verify your prescriber is REMS-certified and gather imaging showing inoperable TGCT.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation Essentials
  5. Documentation Packet Checklist
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Reasons & Solutions
  10. Appeals Process in Virginia
  11. Cost Assistance Options
  12. FAQ

Who Should Use This Guide

This guide is for Virginia patients with tenosynovial giant cell tumor (TGCT) seeking Humana coverage for Turalio (pexidartinib), as well as their healthcare providers. You'll need this if:

  • Your TGCT is not amenable to surgery or surgery would cause severe morbidity
  • You have active Humana Medicare Advantage or commercial coverage
  • Your doctor has recommended Turalio as medically necessary
  • You've received a denial and need to appeal

Expected outcome: With proper documentation and REMS compliance, most medically appropriate requests are approved. Virginia's external review process provides additional protection if internal appeals fail.

Member & Plan Basics

Coverage Requirements

  • Active Humana coverage (Medicare Advantage, Medicare Part D, or commercial)
  • Specialty pharmacy benefit must be active
  • Deductible status: Check if you've met your annual deductible, as Turalio costs approximately $23,850 per month

Prior Authorization Status

Turalio requires prior authorization under all Humana plans as of 2024. The drug is typically placed on higher formulary tiers due to cost and safety monitoring requirements.

Note: Humana processes 85% of electronic prior authorization requests within one business day, with plans to reach 95% by 2026.

Clinical Criteria Requirements

FDA-Approved Indication

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

Key Clinical Requirements

  1. Confirmed TGCT diagnosis with imaging (MRI preferred)
  2. Surgical assessment documenting why surgery is:
    • Not feasible due to anatomical location
    • Would result in unacceptable morbidity
    • Has failed previously with recurrence
  3. Symptomatic disease affecting function or quality of life
  4. REMS program eligibility (no active liver disease, ability to comply with monitoring)

Step Therapy Considerations

While not always required, document any prior treatments attempted:

  • Previous surgical interventions and outcomes
  • Conservative management (physical therapy, pain management)
  • Other systemic therapies if tried

Coding & Documentation Essentials

ICD-10 Diagnosis Codes

  • Primary: D48.1 (Neoplasm of uncertain behavior of connective and soft tissue)
  • Alternative: M12.2 (Villonodular synovitis) - older terminology still accepted

Drug Identification

  • NDC: 73626-010-01 (most common strength)
  • Generic name: Pexidartinib
  • Billing: Pharmacy benefit (Part D), not medical benefit

Supporting Codes

Document any relevant complications or symptoms:

  • M25.5- (Pain in joint)
  • M25.3- (Other instability of joint)
  • Z87.891 (Personal history of nicotine dependence) if applicable for surgical risk

Documentation Packet Checklist

Medical Necessity Letter Must Include:

  • Patient demographics and insurance information
  • TGCT diagnosis with ICD-10 code D48.1
  • Imaging results (MRI report showing extent of disease)
  • Surgical consultation explaining why surgery is contraindicated
  • Symptom documentation (pain scores, functional limitations)
  • Treatment history and previous interventions
  • REMS enrollment confirmation for prescriber and patient
  • Baseline liver function tests (ALT, AST, bilirubin, alkaline phosphatase)
  • Monitoring plan for ongoing liver safety

Required Attachments:

  1. Recent imaging reports (within 6 months)
  2. Surgical consultation note or operative report
  3. REMS enrollment confirmations
  4. Laboratory results (baseline LFTs)
  5. Previous treatment records
  6. Functional assessment scores if available

Submission Process

  1. Log into Humana provider portal at provider.humana.com
  2. Navigate to Prior Authorization section
  3. Select "Request for Medicare Prescription Drug Coverage Determination"
  4. Upload all documentation as PDF files
  5. Submit and record confirmation number

Alternative Submission Methods

  • Fax: 877-486-2621
  • Phone: Provider services line for urgent requests
  • Mail: Use address provided in portal (verify current address)

Required Form Fields

  • Patient demographics and Humana ID
  • Prescriber NPI and contact information
  • Drug name (Turalio/pexidartinib) and NDC
  • ICD-10 diagnosis code
  • Clinical justification narrative
  • REMS enrollment status

Specialty Pharmacy Requirements

Turalio can only be dispensed through REMS-certified specialty pharmacies. Humana's preferred vendors are:

CenterWell Specialty Pharmacy

  • Humana's in-house specialty provider
  • Coordinates with REMS program
  • Provides clinical monitoring support
  • Handles financial assistance navigation

Biologics by McKesson

  • Manufacturer's exclusive specialty pharmacy partner
  • REMS program integration
  • Patient support services
  • Nationwide dispensing capability

Transfer Process

If switching from another pharmacy:

  1. Verify REMS certification of new pharmacy
  2. Contact preferred vendor to initiate transfer
  3. Provide prescription and clinical documentation
  4. Confirm prior authorization is still valid
  5. Arrange supply continuity during transition
Important: Initial fills are limited to 30-day supplies for the first three months while monitoring is established.

After Submission: What to Expect

Timeline for Decision

  • Standard requests: 14 days maximum
  • Electronic submissions: Often within 1-2 business days
  • Expedited requests: 72 hours for urgent cases

Confirmation and Tracking

  1. Record confirmation number from submission
  2. Check portal status every 2-3 business days
  3. Follow up if no decision within expected timeframe
  4. Review determination letter carefully for any conditions

If Approved

  • Approval will specify quantity limits and duration
  • Specialty pharmacy will contact patient for delivery coordination
  • REMS monitoring requirements remain in effect
  • Regular reauthorization may be required

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing TGCT diagnosis Submit imaging reports and pathology MRI showing TGCT, biopsy if available
Surgery not addressed Provide surgical consultation Note explaining why surgery is contraindicated
REMS non-compliance Complete enrollment process REMS confirmation for all parties
Insufficient liver monitoring Submit baseline labs and monitoring plan LFTs within 30 days, ongoing schedule
Prior therapy not documented Provide treatment history Records of previous interventions

Appeals Process in Virginia

If your initial request is denied, Virginia provides robust appeal rights:

Internal Appeals (First Step)

  1. File within 60 days of denial notice
  2. Submit additional clinical information addressing denial reasons
  3. Request peer-to-peer review if appropriate
  4. Standard timeline: 30 days for decision

Virginia External Review

After exhausting internal appeals, Virginia residents can request external review through the State Corporation Commission Bureau of Insurance:

Timeline and Process

  • File within 120 days of final internal denial
  • Standard review: 45 days for decision
  • Expedited review: 72 hours for urgent cases
  • Contact: [email protected] or (877) 310-6560

Required Forms

  • Virginia External Review Request Form (Form 216-A)
  • All denial letters and medical documentation
  • Prescriber statement supporting medical necessity
Virginia Advantage: The state's external review process has helped many patients obtain coverage for specialty medications when internal appeals failed.

Cost Assistance Options

Manufacturer Support

  • Daiichi Sankyo patient assistance programs
  • Copay cards for eligible commercial insurance patients
  • Financial hardship programs for qualifying patients

Foundation Grants

  • Patient Advocate Foundation
  • CancerCare Patient Financial Assistance
  • Rare disease-specific foundations

State Resources

Virginia expanded Medicaid may provide coverage for eligible patients not covered by other programs.

From Our Advocates

"We've seen Virginia patients succeed with Turalio appeals by focusing on two key elements: comprehensive surgical contraindication documentation and complete REMS compliance upfront. When prescribers clearly explain why surgery would cause unacceptable morbidity and all REMS requirements are met before submission, approval rates are significantly higher. Don't wait for a denial to get these pieces right."

FAQ

How long does Humana prior authorization take for Turalio in Virginia? Standard requests are processed within 14 days, but electronic submissions through the provider portal often receive decisions within 1-2 business days.

What if Turalio is not on Humana's formulary? You can request a formulary exception as part of the prior authorization process. Include strong medical necessity justification and evidence that covered alternatives are inappropriate.

Can I request an expedited appeal in Virginia? Yes, if your doctor certifies that delays could seriously jeopardize your health. Expedited internal appeals are decided within 72 hours, and Virginia's external review offers 72-hour expedited decisions for urgent cases.

Does REMS enrollment guarantee coverage approval? No, REMS compliance is necessary but not sufficient. You still need prior authorization approval based on medical necessity and plan criteria.

What happens if I can't afford the copay even with insurance? Explore manufacturer patient assistance programs, foundation grants, and discuss payment plans with your specialty pharmacy. Some programs can reduce out-of-pocket costs significantly.

How often do I need reauthorization for Turalio? This varies by plan, but typically requires reauthorization every 6-12 months with updated clinical documentation and ongoing monitoring results.

When You Need Expert Help

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed responses. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes, particularly for specialty medications like Turalio that require extensive documentation and regulatory compliance.

For patients facing denials or complex coverage challenges, Counterforce Health's platform can help identify the specific denial basis and draft point-by-point rebuttals aligned to your plan's requirements, potentially saving months of back-and-forth with your insurer.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current requirements with your insurer and consult your healthcare provider for medical decisions. For personalized assistance with Virginia insurance appeals, contact the State Corporation Commission Bureau of Insurance at (877) 310-6560.

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