By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (Larotrectinib) Covered by UnitedHealthcare in Florida: 2025 PA Requirements and Appeal Guide

Quick Answer: Getting Vitrakvi Covered by UnitedHealthcare in Florida

UnitedHealthcare requires prior authorization for Vitrakvi (larotrectinib) in Florida. To get approved: (1) Submit a PA request through OptumRx with confirmed NTRK gene fusion testing results, (2) document that your solid tumor is metastatic/unresectable with no satisfactory alternatives, and (3) ensure your oncologist includes prior therapy history. Patients under 19 are automatically approved without PA review. Start the process 3-4 weeks before you need the medication. If denied, you have 180 days to file an internal appeal, followed by external review through Florida's Department of Financial Services.

Table of Contents

  1. UnitedHealthcare's Vitrakvi Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Required Diagnostic Testing
  5. Specialty Pharmacy Requirements
  6. Prior Authorization Process
  7. Appeals Process in Florida
  8. Cost Support Options
  9. Common Denial Reasons and Solutions
  10. FAQ

UnitedHealthcare's Vitrakvi Coverage Policy Overview

UnitedHealthcare covers Vitrakvi (larotrectinib) under its specialty drug benefit with mandatory prior authorization for most patients. The policy applies across commercial plans, Individual & Family Plans, and Medicare Advantage in Florida.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for adults; automatic approval for patients <19 UHC PA Notification
Formulary Status Specialty tier, non-preferred Florida PDL 2025
Step Therapy May require trial of preferred agents first UHC Step Therapy Policy
Specialty Pharmacy Must use OptumRx or approved network pharmacy UHC Specialty Requirements
Authorization Duration Up to 12 months if criteria met UHC PA Notification

Medical Necessity Requirements

UnitedHealthcare defines medical necessity for Vitrakvi based on FDA-approved indications and specific clinical criteria:

Primary Requirements

Diagnosis Criteria:

  • Histologically confirmed solid tumor (any type except blood cancers)
  • Confirmed NTRK gene fusion via FDA-approved testing
  • Tumor is metastatic, locally advanced, or surgical resection would cause severe morbidity
  • No satisfactory alternative treatments available

Patient Eligibility:

  • Performance status 0-2 (ECOG scale)
  • No prior TRK inhibitor therapy
  • Stable brain metastases (if present) on consistent steroid regimen
Clinician Corner: Your medical necessity letter should include: (1) pathology report with NTRK fusion confirmation, (2) staging documentation showing metastatic/unresectable disease, (3) summary of prior therapies and outcomes, (4) current performance status, and (5) treatment goals. Reference FDA labeling and NCCN guidelines to strengthen your case.

Step Therapy and Exception Pathways

UnitedHealthcare may require step therapy for solid tumor treatments before approving Vitrakvi, particularly for Medicare Advantage plans effective 2025.

Step Therapy Requirements

Preferred First-Line Options (varies by tumor type):

  • Standard chemotherapy regimens per NCCN guidelines
  • Other targeted therapies if biomarker-appropriate
  • Immunotherapy when indicated

Exception Criteria:

  • Previous failure or intolerance to preferred agents
  • Medical contraindication to step therapy drugs
  • Prior therapy outside UnitedHealthcare network (with documentation)
  • Clinical urgency requiring immediate TRK inhibition

How to Request Step Therapy Exception

  1. Document Prior Failures: Include treatment dates, dosing, duration, and reason for discontinuation
  2. Medical Contraindications: Provide clinical rationale with supporting lab values or comorbidities
  3. Submit with PA: Include step therapy exception request in initial prior authorization

Required Diagnostic Testing

NTRK fusion testing is mandatory before UnitedHealthcare will consider Vitrakvi coverage. The testing must meet specific criteria:

Testing Requirements

Acceptable Test Methods:

  • Next-generation sequencing (NGS) panels including NTRK1/2/3
  • RNA-based fusion detection assays
  • FDA-approved companion diagnostics

Required Documentation:

  • Laboratory report showing specific NTRK fusion partner
  • Confirmation that fusion retains tyrosine kinase domain
  • Testing performed on adequate tumor tissue (minimum cellularity requirements)
  • No known resistance mutations present

CPT Codes for NTRK Testing:

  • 81445, 81449, 81450, 81451, 0242U (NGS-based panels)
Note: Liquid biopsy may be acceptable if tissue biopsy is medically contraindicated, but requires additional justification per UHC molecular diagnostic policy.

Specialty Pharmacy Requirements

Vitrakvi must be dispensed through UnitedHealthcare's specialty pharmacy network, primarily OptumRx in Florida.

Prescription Routing

Required Steps:

  1. Prescriber submits PA request through OptumRx portal or by calling 1-800-711-4555
  2. Include clinical documentation with PA submission
  3. OptumRx coordinates with patient for delivery once approved
  4. 30-day supply typically dispensed initially with refills based on approval duration

Alternative Network Pharmacies:

  • Limited in-network specialty pharmacies may be available
  • Verify network status before prescribing
  • Out-of-network pharmacies typically not covered

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Gather Required Documents (1-2 days)
    • NTRK fusion test results
    • Pathology/staging reports
    • Prior treatment summary
    • Current clinical notes
  2. Submit PA Request (Same day)
    • Use OptumRx provider portal
    • Include all clinical documentation
    • Specify medical necessity criteria met
  3. UnitedHealthcare Review (Up to 14 days standard, 72 hours expedited)
    • Clinical review by oncology specialist
    • May request additional information
    • Approval notification sent to prescriber and pharmacy
  4. Prescription Processing (1-2 days post-approval)
    • OptumRx contacts patient for delivery
    • First fill typically ships within 24-48 hours
    • Ongoing refills processed automatically
  5. Patient Receives Medication (1-3 days shipping)
    • Overnight shipping available if urgent
    • Patient education materials included
    • Pharmacy support team available

Expedited Review Criteria

Qualifies for 72-hour review:

  • Life-threatening condition requiring immediate treatment
  • Significant clinical deterioration expected with delay
  • Hospital discharge pending medication approval

Appeals Process in Florida

If UnitedHealthcare denies your Vitrakvi prior authorization, Florida law provides specific appeal rights:

Internal Appeals (Required First Step)

Timeline: 180 days from denial notice to file Process:

  1. Submit written appeal via UnitedHealthcare member portal or mail
  2. Include additional evidence: Updated clinical notes, peer-reviewed studies, guideline references
  3. Request peer-to-peer review if initial appeal denied
  4. Decision timeline: 30 days for prospective, 60 days for retrospective

External Review (After Internal Appeal)

Timeline: 4 months after final internal denial Process:

  1. File request with Florida Department of Financial Services
  2. Independent medical review by oncology specialist
  3. Decision timeline: Standard 45 days, expedited 72 hours for urgent cases
  4. Binding decision: UnitedHealthcare must comply if overturned
From our advocates: We've seen successful appeals when families included a detailed timeline of their cancer journey, emphasizing how delays in accessing targeted therapy could impact outcomes. One family's appeal was approved after they submitted additional peer-reviewed studies showing Vitrakvi's efficacy in their specific NTRK fusion subtype, along with a letter from their oncologist explaining why no other treatments were suitable.

State Consumer Assistance

Florida Insurance Consumer Helpline: 1-877-MY-FL-CFO (1-877-693-5236)

  • Free assistance with insurance problems
  • Help navigating appeal process
  • Can facilitate communication with insurers

Cost Support Options

Manufacturer Support Programs

Bayer TRAK Assist Program:

  • $0 copay for eligible commercial patients
  • Financial assistance for uninsured/underinsured
  • Bridge therapy during PA process
  • Clinical support services

Eligibility Requirements:

  • Commercial insurance (not government plans)
  • Income limits may apply for financial assistance
  • U.S. residency required

Additional Resources

Patient Assistance Foundations:

  • Good Days Foundation
  • Patient Access Network Foundation
  • HealthWell Foundation

State Programs:

  • Florida Medicaid (if eligible)
  • 340B program at qualifying hospitals

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and crafting targeted, evidence-backed appeals. Their platform identifies the specific denial basis and generates point-by-point rebuttals aligned with each payer's own coverage criteria.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing NTRK fusion test Submit molecular pathology report Lab report with specific fusion details
Tumor considered resectable Provide surgical consultation Surgeon's note stating unresectability
Lack of prior therapy Document treatment history Pharmacy records, infusion logs
Non-oncology prescriber Transfer to oncology specialist Oncologist consultation note
Step therapy not completed Request medical exception Prior therapy failure documentation

FAQ

How long does UnitedHealthcare PA take in Florida? Standard review takes up to 14 calendar days. Expedited review for urgent cases takes 72 hours. Submit requests 3-4 weeks before medication is needed.

What if Vitrakvi is non-formulary on my plan? Non-formulary status requires additional justification. Include evidence that formulary alternatives are inappropriate or have failed. Consider requesting formulary exception.

Can I request an expedited appeal? Yes, if you have an urgent medical condition. Expedited appeals must be decided within 72 hours. Submit clinical evidence supporting urgency.

Does step therapy apply if I failed treatments in another state? Yes, prior therapy documentation from any provider counts toward step therapy requirements. Include complete treatment records with dates and outcomes.

What happens if my appeal is denied? After exhausting internal appeals, you can request external review through Florida's Department of Financial Services. This independent review is binding on UnitedHealthcare.

Are there age restrictions for Vitrakvi coverage? Patients under 19 years old receive automatic approval without prior authorization review. Adult patients must meet all PA criteria.

Can I use a local pharmacy instead of OptumRx? No, Vitrakvi must be dispensed through UnitedHealthcare's specialty pharmacy network. Using an out-of-network pharmacy typically results in no coverage.

How often do I need reauthorization? Initial authorizations are typically valid for 12 months. Reauthorization requires documentation of ongoing clinical benefit and stable disease or response to treatment.

When navigating insurance denials becomes overwhelming, services like Counterforce Health can help by turning denial letters into targeted appeals that address each payer's specific coverage criteria, potentially saving weeks in the approval process.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with UnitedHealthcare and consult with your healthcare provider regarding treatment decisions. For assistance with insurance problems in Florida, contact the state Insurance Consumer Helpline at 1-877-MY-FL-CFO.

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