How to Get Turalio (Pexidartinib) Covered by Humana in California: Prior Authorization Guide
Answer Box: Getting Turalio Covered by Humana in California
Turalio (pexidartinib) requires prior authorization from Humana and is typically placed on Tier 5 (specialty tier). To get approved in California:
- Complete REMS enrollment - Both prescriber and patient must enroll in the Turalio REMS Program
- Submit comprehensive PA request - Include TGCT diagnosis with MRI, surgical assessment, baseline liver function tests
- Use Biologics specialty pharmacy - Turalio can only be dispensed through this REMS-certified pharmacy
First step today: Have your prescriber verify their REMS certification and gather your MRI report showing TGCT diagnosis. If denied, California's Independent Medical Review (IMR) process offers strong appeal rights with 50-60% overturn rates.
Table of Contents
- Plan Types & Coverage Implications
- Formulary Status & Tier Placement
- Prior Authorization Requirements
- REMS Program Enrollment
- Specialty Pharmacy Network
- Cost-Sharing Basics
- Submission Process
- Common Approval Patterns
- Appeals Process in California
- When to Escalate
Plan Types & Coverage Implications
Humana operates several plan types in California, each with different coverage pathways for specialty medications like Turalio:
Medicare Advantage Plans: Most common Humana coverage in California. These plans follow Medicare Part D rules for prescription drugs but may have additional utilization management. Prior authorization is standard for specialty tier medications.
Commercial Plans: Less common but available through employers. These plans are subject to California state insurance regulations and may offer different appeal rights through the Department of Managed Health Care (DMHC).
Note: Medicare Advantage appeals follow federal Medicare procedures, while commercial plans may use California's Independent Medical Review (IMR) process.
Your plan type affects which appeals process you'll use if initially denied. Check your insurance card or member portal to confirm your specific plan structure.
Formulary Status & Tier Placement
Turalio is typically placed on Tier 5 (specialty tier) in Humana Medicare Advantage formularies for 2024. This is the highest cost-sharing tier, reserved for complex, high-cost medications.
Coverage at a Glance
| Requirement | Status | Where to Verify | Source |
|---|---|---|---|
| Prior Authorization | Required | Humana formulary search | Humana policy |
| Formulary Tier | Tier 5 (Specialty) | Member portal or formulary | Plan documents |
| Quantity Limits | Likely applies | PA determination | Coverage review |
| Step Therapy | May apply | Clinical review | Medical policy |
| Specialty Pharmacy | Required (Biologics only) | REMS program | FDA REMS |
Alternative medications that insurers may prefer include surgical intervention (when feasible) or off-label use of imatinib or nilotinib, though these have limited evidence for TGCT.
Prior Authorization Requirements
Humana's prior authorization for Turalio focuses on several key criteria:
Medical Necessity Documentation
Diagnosis Requirements:
- Confirmed tenosynovial giant cell tumor (TGCT) diagnosis
- MRI imaging demonstrating characteristic features (blooming artifacts, synovial thickening >5mm, hemosiderin deposits)
- Clear documentation of diffuse-type vs. localized subtype
Clinical Justification:
- Evidence that surgical options are not feasible or have failed
- Documentation of severe morbidity or functional limitations
- Assessment of contraindications to surgery
Safety Requirements:
- Baseline liver function tests (AST, ALT, bilirubin, alkaline phosphatase, GGT)
- Confirmation of no active liver disease or biliary tract disease
- REMS program enrollment completion
Clinician Corner: Medical Necessity Letter Checklist
When preparing your PA request, include:
✓ Problem statement: TGCT diagnosis with ICD-10 code and imaging findings
✓ Prior treatments: Surgical assessment and why surgery isn't appropriate
✓ Clinical rationale: Functional limitations and symptom severity
✓ Guidelines: Reference FDA labeling for approved indication
✓ Safety plan: Baseline labs and monitoring schedule
✓ REMS compliance: Confirmation of prescriber and patient enrollment
REMS Program Enrollment
Turalio is only available through the FDA-mandated REMS program due to serious hepatotoxicity risk. This enrollment is separate from insurance approval but required for coverage.
Enrollment Steps
- Prescriber Certification: Your doctor must complete training at TURALIOREMS.com or call 1-833-887-2546
- Patient Registration: Complete patient enrollment forms and safety education
- Monitoring Plan: Establish schedule for required liver function tests:
- Weekly LFTs for first 8 weeks
- Every 2 weeks for next month
- Every 3 months thereafter
Tip: REMS enrollment typically takes 3-5 business days. Start this process while preparing your PA request to avoid delays.
Humana's REMS Documentation Requirements:
- Completed prescriber certification
- Patient enrollment confirmation
- Baseline liver function test results
- Monitoring plan documentation
Specialty Pharmacy Network
Critical: Turalio can only be dispensed through Biologics specialty pharmacy - not through Humana's CenterWell Specialty, CVS Specialty, or AccredoHealth.
Prescription Process
| Step | Who | Action | Contact |
|---|---|---|---|
| 1 | Prescriber | Send prescription to Biologics | Fax: 1-800-823-4506 |
| 2 | Biologics | Contact patient for shipping | Phone: 1-800-850-4306 |
| 3 | Patient | Provide insurance and shipping info | Work with Biologics team |
| 4 | Biologics | Process PA with Humana | Coordinate with plan |
Patient Enrollment Process:
- Biologics will call you within 24-48 hours of receiving the prescription
- They'll verify insurance benefits and coordinate PA submission
- Medication ships directly to your home once approved
- Financial assistance programs are available through Biologics
Cost-Sharing Basics
As a Tier 5 specialty medication, Turalio typically has the highest cost-sharing in your plan. Cash price ranges around $23,850 for a typical 28-day supply (verify with GoodRx for current pricing).
Potential Cost-Sharing Structure
- Deductible: May apply before coverage begins
- Coinsurance: Often 25-33% for specialty tier
- Out-of-pocket maximum: Provides annual cost protection
Financial Assistance Options:
- Manufacturer copay assistance (check eligibility requirements)
- Patient foundation grants for rare diseases
- State pharmaceutical assistance programs
Note: This is educational information only. Consult your plan documents for specific cost-sharing details.
Submission Process
Step-by-Step: Fastest Path to Approval
- Gather Documentation (Patient/Clinic)
- Insurance cards and member ID
- MRI report with TGCT findings
- Baseline liver function tests
- Surgical consultation notes
- Complete REMS Enrollment (Prescriber)
- Register at TURALIOREMS.com
- Complete certification training
- Submit patient enrollment forms
- Submit PA Request (Prescriber)
- Use Humana provider portal or fax
- Include all medical necessity documentation
- Reference REMS enrollment completion
- Coordinate with Biologics (Patient)
- Provide prescription to Biologics pharmacy
- Complete patient intake process
- Verify shipping information
- Track Decision (Patient/Clinic)
- Standard PA decisions: ~7-14 days
- Expedited reviews available for urgent cases
- Follow up if no response within timeframe
Common Approval Patterns
Strong Turalio PA submissions typically include:
Diagnostic Evidence:
- High-quality MRI with radiologist interpretation
- Clear description of TGCT subtype and extent
- Documentation of characteristic imaging features
Clinical Justification:
- Orthopedic or surgical consultation
- Functional assessment scores or quality of life measures
- Failed conservative management documentation
Safety Compliance:
- Normal baseline liver function tests
- REMS enrollment confirmation
- Monitoring plan establishment
Common Denial Reasons & Fixes
| Denial Reason | How to Overturn |
|---|---|
| Missing TGCT diagnosis | Submit MRI report with clear radiological findings |
| Surgical options not addressed | Include surgical consultation showing inoperability |
| REMS enrollment incomplete | Complete all REMS requirements before resubmission |
| Insufficient medical necessity | Add functional assessments and symptom documentation |
Appeals Process in California
If your initial PA request is denied, California offers robust appeal rights, though the process depends on your plan type.
Internal Appeals (All Plans)
Timeline: 30 days for standard appeals, 72 hours for expedited
How to File: Humana member portal or member services
Required: Copy of denial letter, additional medical records, prescriber statement
External Review Options
Medicare Advantage Plans:
- Follow Medicare's federal reconsideration process
- Independent review entity assigned by CMS
- Binding decisions when overturned
Commercial Plans:
- May be eligible for California Independent Medical Review (IMR)
- File through DMHC for HMOs or CDI for other plans
- Success rate: 50-60% of specialty drug appeals are overturned
From our advocates: "We've seen patients successfully appeal Turalio denials by emphasizing the functional limitations and including detailed imaging reports. The key is demonstrating that surgery truly isn't an option and that conservative management has failed. Strong appeals often include a peer-reviewed study supporting off-label use when relevant."
California IMR Process
- Complete internal appeal with your plan (required first step)
- File IMR application within 6 months of final denial
- Submit medical records supporting medical necessity
- Wait for decision (30 days standard, 7 days expedited)
- Plan must comply with favorable IMR decisions (binding)
Contact for Help:
- DMHC Help Center: 888-466-2219
- CDI Consumer Hotline: 800-927-4357
When to Escalate
Consider escalating to state regulators if:
- Humana fails to respond within required timeframes
- Multiple denials despite complete documentation
- Plan refuses to honor favorable appeal decisions
- REMS-related delays affecting patient safety
California Department of Managed Health Care: Handles most HMO complaints
California Department of Insurance: Covers PPO and other commercial plans
Medicare: For Medicare Advantage plan issues
Frequently Asked Questions
How long does Humana PA take in California?
Standard prior authorization decisions are typically made within 7-14 days. Expedited reviews for urgent medical situations can be completed within 72 hours.
What if Turalio is non-formulary on my plan?
You can request a formulary exception through the same PA process. Include additional justification for why formulary alternatives aren't appropriate.
Can I request an expedited appeal?
Yes, if your condition is urgent or if delays could seriously jeopardize your health. Your prescriber must support the expedited request.
Does step therapy apply to Turalio?
Step therapy requirements vary by plan, but surgical consultation is typically required to demonstrate that less invasive options aren't feasible.
What happens if I move out of California during treatment?
Notify Humana immediately. Coverage may continue, but appeal rights will follow the rules of your new state.
Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes, then identifies the denial basis and drafts point-by-point rebuttals aligned to the plan's own rules. For more information about streamlining your appeals process, visit www.counterforcehealth.org.
When dealing with complex prior authorization requirements like those for Turalio, having the right documentation and understanding payer-specific workflows can make the difference between approval and denial. Counterforce Health specializes in creating these targeted, evidence-backed appeals that speak directly to plan policies and medical necessity criteria.
Sources & Further Reading
- Humana Medicare Drug Formulary Search
- Turalio REMS Program Official Site
- FDA Turalio Prescribing Information
- California Department of Managed Health Care
- California Department of Insurance
- Biologics Specialty Pharmacy
- Humana Provider Portal
Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage determinations. Coverage policies and requirements may change; verify current information with official sources.
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