By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (Larotrectinib) Covered by UnitedHealthcare in California: Prior Authorization Guide and Appeal Scripts

Answer Box: Getting Vitrakvi Covered by UnitedHealthcare in California

Vitrakvi (larotrectinib) requires prior authorization through OptumRx for UnitedHealthcare members in California. To get approved: (1) Submit NTRK fusion test results via the UHC provider portal, (2) document prior therapies or contraindications for step therapy exception, and (3) include oncologist notes confirming metastatic/unresectable disease. If denied, California's Independent Medical Review (IMR) through the DMHC has a 50-61% overturn rate for specialty oncology drugs. Start your PA request 3-4 weeks before you need the medication.

Table of Contents

  1. Before You Start: Plan Verification
  2. Coverage Requirements at a Glance
  3. Step-by-Step: Fastest Path to Approval
  4. Gather Required Documentation
  5. Common Denial Reasons & How to Fix Them
  6. Appeals Playbook for California
  7. Patient Support and Cost Savings
  8. Frequently Asked Questions

Before You Start: Plan Verification

First, confirm your UnitedHealthcare plan details:

  • Plan Type: Commercial, Medicare Advantage, or Medicaid (Medi-Cal)
  • Formulary Status: Vitrakvi is typically Tier 3 or Tier 4 specialty
  • Specialty Pharmacy Required: Must be filled through UHC-approved specialty pharmacy
  • Benefit Type: Covered under pharmacy benefit, not medical benefit
Tip: Use the PreCheck MyScript® app or call the number on your insurance card to verify current formulary placement and copay amounts.

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Must get approval before dispensing Complete PA form with clinical notes UHC PA Requirements
NTRK Fusion Testing Confirmed positive fusion via validated test NGS sequencing report with fusion details UHC Vitrakvi Policy
Age Exception Patients under 19 get automatic approval Birth certificate or medical record UHC Vitrakvi Policy
Step Therapy Must try preferred treatments first Documentation of failures/contraindications UHC Step Therapy
Disease Status Metastatic or unresectable solid tumor Staging reports and imaging Clinical documentation

Step-by-Step: Fastest Path to Approval

1. Confirm NTRK Fusion Status

Who does it: Oncologist orders testing
Document needed: NGS sequencing report showing specific fusion partners
Timeline: 7-14 days for results
Submit to: Include with PA request

2. Document Step Therapy Exception (if applicable)

Who does it: Treating physician
Document needed: Prior therapy summary with dates, doses, outcomes
Timeline: Gather within 1-2 days
Submit to: OptumRx PA portal

3. Complete Prior Authorization Form

Who does it: Prescriber or clinic staff
Document needed: UHC PA form
Timeline: Submit 3-4 weeks before needed
Submit to: UnitedHealthcare Provider Portal or OptumRx

4. Include Clinical Justification

Who does it: Oncologist
Document needed: Medical necessity letter with FDA labeling references
Timeline: 1-2 days to prepare
Submit to: Attach to PA request

5. Submit Complete Package

Who does it: Clinic staff
Document needed: All forms plus supporting documentation
Timeline: Same day submission
Submit to: Provider portal (preferred) or fax

6. Track Decision Timeline

Who does it: Patient or clinic
Expected timeline: 15 business days for standard review
Follow-up: Call after 10 days if no response
Expedited: 72 hours for urgent cases

7. Prepare for Specialty Pharmacy

Who does it: Patient
Document needed: Approval letter and prescription
Timeline: 2-3 days for first fill
Specialty pharmacy: UHC-approved network only

Gather Required Documentation

Clinical Documentation Checklist

Essential Items:

  • NTRK fusion test report (NGS preferred)
  • Pathology report confirming solid tumor diagnosis
  • Staging documentation (CT, MRI, or PET scans)
  • ECOG performance status (0-2 required)
  • Prior therapy summary with specific details:
    • Drug names and doses
    • Treatment dates and duration
    • Reason for discontinuation
    • Response or progression evidence

Step Therapy Exception Documentation:

  • Previous treatment failures with medical records
  • Contraindications with supporting lab values
  • Intolerance reactions with clinical notes
  • Rationale for immediate TRK inhibitor need
Clinician Corner: Your medical necessity letter should reference the FDA labeling for tumor-agnostic approval and include specific NTRK fusion details from the molecular pathology report.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
No NTRK fusion documented Submit validated test results NGS report with fusion partners identified
Step therapy not met Request exception with clinical justification Prior therapy failures or contraindications
Tumor resectable Provide surgical consultation Surgeon's note on unresectability
Non-specialist prescriber Transfer to oncology Oncologist prescription and evaluation
Missing staging information Submit current imaging Radiology reports showing metastatic disease
Lack of prior therapy Document treatment history Chemotherapy records or exception rationale

Appeals Playbook for California

Internal Appeals (First Level)

Timeline: 180 days from denial date
How to file: UnitedHealthcare member portal or mail
Required documents:

  • Denial letter
  • Medical necessity letter from oncologist
  • Updated clinical documentation
  • Peer-reviewed literature supporting use

Expedited appeals: Available for urgent cases (72-hour decision)

California Independent Medical Review (IMR)

California offers one of the strongest external review processes in the nation through the Department of Managed Health Care (DMHC).

When to use: After internal appeal denial or 30-day delay
Success rate: 50-61% overturn rate for specialty oncology drugs
Cost: Free to patients
Timeline: 45 days standard, 7 days expedited

How to file IMR:

  1. Call DMHC Help Center: 888-466-2219
  2. Submit online at healthhelp.ca.gov
  3. Include all medical records and denial correspondence
Note: IMR decisions are binding on UnitedHealthcare. If overturned, they must provide coverage.

Patient Phone Script for Appeals

"I'm calling to file an internal appeal for my denied prior authorization for Vitrakvi (larotrectinib). My member ID is [number]. The denial was dated [date], and I have additional clinical documentation from my oncologist that supports medical necessity. Can you help me submit this appeal and provide the reference number for tracking?"

Patient Support and Cost Savings

Manufacturer Support Programs

Bayer Access Services/TRAK Assist:

  • Prior authorization support
  • $0 copay program for eligible commercial patients
  • Bridge supply during appeals
  • Contact: 1-833-VITRAKVI

Financial Assistance Options

  • Commercial insurance: Copay cards may reduce out-of-pocket to $0-$10
  • Medicare patients: Foundation grants through CancerCare or Patient Advocate Foundation
  • Uninsured/underinsured: Bayer patient assistance program

When navigating complex insurance appeals for specialty oncology drugs like Vitrakvi, having expert support can make the difference between approval and denial. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer requirements.

Frequently Asked Questions

How long does UnitedHealthcare PA take in California?
Standard review is 15 business days. Urgent cases qualify for expedited review within 72 hours. Submit requests 3-4 weeks before needed.

What if Vitrakvi is non-formulary on my plan?
Request a formulary exception with your PA. Include medical necessity documentation and evidence that preferred alternatives are inappropriate.

Can I request an expedited appeal in California?
Yes, if delay would seriously jeopardize your health. Both UnitedHealthcare internal appeals and California IMR offer expedited timelines.

Does step therapy apply if I failed treatments outside California?
Yes, document all prior therapies regardless of location. Include medical records showing treatment dates, doses, and outcomes.

What happens if my oncologist isn't in UnitedHealthcare's network?
You may need a referral to an in-network oncologist for the PA, or request an out-of-network exception based on specialty expertise.

How much will Vitrakvi cost with UnitedHealthcare?
As a Tier 3/4 specialty drug, expect 25-40% coinsurance. Use manufacturer copay programs to reduce out-of-pocket costs significantly.

Can I appeal directly to California if UnitedHealthcare denies my request?
You must complete at least one internal appeal first, then you can file an IMR with the DMHC within 180 days of the final internal denial.

What if UnitedHealthcare delays my appeal decision?
In California, you can contact the DMHC Help Center at 888-466-2219 to report delays and request intervention.

From our advocates: We've seen patients successfully overturn initial Vitrakvi denials by submitting comprehensive NGS fusion reports alongside detailed prior therapy documentation. The key is demonstrating both the molecular basis for treatment and the clinical necessity through previous treatment failures or contraindications. California's IMR process has been particularly effective for complex oncology cases when internal appeals fail.

For additional support with your Vitrakvi appeal, Counterforce Health specializes in transforming insurance denials into successful approvals through evidence-based appeal strategies tailored to specific payer policies and state regulations.

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions and insurance coverage options.

Sources & Further Reading

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