By Counterforce Health Team in Vitrakvi (larotrectinib) — 09 Oct 2025

Do You Qualify for Vitrakvi (Larotrectinib) Coverage by Humana in New Jersey? Decision Tree & Next Steps

Answer Box: Getting Vitrakvi Covered by Humana in New Jersey

Yes, you can get Vitrakvi (larotrectinib) covered by Humana if you have a confirmed NTRK gene fusion-positive solid tumor and meet medical necessity criteria. Fastest path: Your oncologist submits prior authorization through Humana's provider portal with NTRK fusion lab report, clinical notes showing metastatic/unresectable disease, and documentation of prior treatments. Start today: Gather your pathology report confirming NTRK fusion and schedule an appointment with your oncologist to discuss coverage options.

How to Use This Guide
Eligibility Triage: Do You Qualify?
If "Likely Eligible": Your Action Plan
If "Possibly Eligible": Tests and Timeline
If "Not Yet": Alternative Strategies
If Denied: Appeal Path Chooser
Humana Prior Authorization Requirements
New Jersey External Review Process
Common Denial Reasons & Solutions
FAQ

How to Use This Guide

This decision tree helps patients and clinicians navigate Vitrakvi (larotrectinib) coverage with Humana in New Jersey. Start with the eligibility triage below to determine your approval likelihood, then follow the corresponding action plan.

What you'll need:

Insurance card and member ID
Pathology/lab reports
Current oncologist contact information
List of prior cancer treatments
Recent imaging results

Eligibility Triage: Do You Qualify?

✅ Likely Eligible if ALL apply:

Confirmed NTRK gene fusion by validated molecular testing (NGS or IHC + NGS confirmation)
Solid tumor that is metastatic or surgically unresectable
No satisfactory alternative treatments available OR disease progression after standard therapy
Prescribed by an oncologist or hematologist
No known acquired resistance mutations

⚠️ Possibly Eligible if SOME apply:

NTRK testing ordered but results pending
Tumor potentially resectable but high surgical risk
Limited prior therapy but contraindications to standard treatments exist
Pediatric patient with age-appropriate dosing considerations

❌ Not Yet Eligible if ANY apply:

No NTRK fusion testing performed or negative results
Tumor is completely resectable with good surgical candidacy
Multiple effective standard treatments remain untried
Non-oncology prescriber without specialist consultation

If "Likely Eligible": Your Action Plan

Step 1: Gather Required Documentation

Your oncologist needs these documents for Humana prior authorization:

Essential Documents:

NTRK gene fusion laboratory report (specify NTRK1, NTRK2, or NTRK3)
Pathology report confirming solid tumor diagnosis
Recent imaging demonstrating metastatic or unresectable disease
Clinical notes documenting prior treatment history and outcomes
Current performance status assessment (ECOG or Karnofsky scale)

Step 2: Submit Prior Authorization

Timeline: Humana must respond within 72 hours for standard requests, 24 hours for expedited requests.

Submission methods:

Online: Humana Provider Portal
Phone: Contact Humana Clinical Pharmacy Review (verify current number with provider portal)
Fax: Use payer-specific prior authorization fax number (confirm with portal)

Step 3: Track Your Request

Monitor approval status through the provider portal or by calling member services. If approved, coverage typically begins within 1-2 business days.

Tip: Request expedited review if treatment delays could jeopardize your health or ability to regain maximum function.

If "Possibly Eligible": Tests and Timeline

Missing NTRK Testing?

Next steps:

Request comprehensive molecular profiling (NGS panel including fusion detection)
Alternative: Start with pan-TRK immunohistochemistry, confirm positive results with NGS
Ensure testing uses RNA-based methodology for optimal fusion detection

Timeline: NGS results typically available in 7-14 business days from tissue receipt.

Surgical Consultation Needed?

If tumor resectability is unclear, obtain:

Multidisciplinary tumor board recommendation
Surgical oncology consultation documenting unresectability or excessive surgical risk
Updated staging imaging within 30 days

Re-apply timeline: Submit prior authorization within 30 days of receiving confirmatory documentation.

If "Not Yet": Alternative Strategies

NTRK Testing Negative or Unavailable?

Consider these options:

Broader molecular profiling to identify other targetable mutations
Clinical trial enrollment through ClinicalTrials.gov
Standard chemotherapy or immunotherapy as appropriate
Re-biopsy if original tissue is old or insufficient

Coverage for Compassionate Use

In rare circumstances, work with Counterforce Health to develop exception requests based on:

Contraindications to all standard therapies
Exceptional clinical circumstances
Off-label use supported by medical literature

If Denied: Appeal Path Chooser

Level 1: Internal Appeal (Redetermination)

Timeline: 65 days from denial notice to file appeal Process: Submit through Humana member portal or mail written request

Required documents:

Original denial letter
Updated medical necessity letter from oncologist
Additional clinical evidence addressing denial reasons
Recent imaging or lab results showing ongoing need

Level 2: Peer-to-Peer Review

If internal appeal fails, request peer-to-peer discussion between your oncologist and Humana's medical director. Timeline: Must be requested during or immediately after internal appeal process.

Level 3: New Jersey External Review (IHCAP)

Who qualifies: Fully-insured Humana plans (not Medicare Advantage or self-funded employer plans) Timeline: 4 months (180 days) from final internal denial Process: Submit directly to Maximus Federal Services (New Jersey's Independent Health Care Appeals Program administrator)

Required for IHCAP:

Completed internal appeals with Humana
Medical records supporting medical necessity
Treating physician statement
Copy of plan's final denial letter

Note: IHCAP reviews are free to patients, and carriers must comply with favorable decisions.

Humana Prior Authorization Requirements

Coverage Criteria Checklist

Based on Humana's Clinical Pharmacy Review requirements, Vitrakvi approval requires:

Requirement	Documentation Needed	Source
NTRK gene fusion confirmed	Laboratory report with specific fusion identified	FDA labeling requirements
Solid tumor diagnosis	Pathology report with histologic confirmation	Clinical documentation
Metastatic or unresectable	Imaging reports or surgical consultation notes	Staging documentation
Prior therapy or contraindications	Treatment history and rationale for Vitrakvi	Oncologist clinical notes
Oncologist prescriber	Specialist credentials verification	Provider enrollment

Medical Necessity Letter Template

Your oncologist should include:

Patient identification and diagnosis:

Name, DOB, insurance information
Primary solid tumor type and staging
NTRK fusion details (gene, partner if known, testing methodology)

Clinical justification:

Disease progression or unresectability documentation
Prior treatment history and outcomes
Performance status and functional capacity
Expected clinical benefit from Vitrakvi therapy

Supporting evidence:

Reference to NCCN guidelines for tumor-agnostic NTRK inhibitor use
FDA approval basis for tissue-agnostic indication
Published efficacy data for specific tumor type if available

New Jersey External Review Process

New Jersey's Independent Health Care Appeals Program (IHCAP) provides independent medical review for coverage denials.

IHCAP Eligibility Requirements

Fully-insured commercial or Medicaid plan regulated by New Jersey
Completed required internal appeals with your insurer
Denial based on medical necessity, experimental/investigational determination, or similar coverage restriction
Request filed within 180 days of final internal denial

How to File External Review

Complete internal appeals with Humana first (unless qualified for expedited/parallel review)
Gather documentation:
- Final denial letter from Humana
- Medical records supporting medical necessity
- Treating physician letter explaining why treatment is appropriate
Submit to Maximus: Use IHCAP online portal or mail completed forms
Track your case: Maximus provides case numbers and status updates

Timeline and Costs

Standard review: Decision within 45 days of complete submission
Expedited review: Completed within days/weeks if delay could cause serious harm
Cost: Free to patients; insurers pay all review fees
Binding decision: If IHCAP overturns denial, Humana must provide coverage

From our advocates: "We've seen several successful IHCAP appeals for targeted cancer therapies when patients submitted comprehensive molecular testing reports and detailed oncologist letters explaining why standard treatments weren't appropriate. The key is addressing every point in the insurer's denial letter with specific medical evidence."

Common Denial Reasons & Solutions

Denial Reason	Solution Strategy	Required Documentation
"No NTRK fusion documented"	Submit complete molecular pathology report	NGS report showing specific NTRK1/2/3 fusion
"Tumor is resectable"	Obtain surgical consultation documenting unresectability	Surgical oncology note with staging imaging
"Alternative treatments available"	Document contraindications or prior failures	Treatment history with outcomes and toxicities
"Not prescribed by specialist"	Transfer care to oncologist/hematologist	Specialist consultation and prescriber change
"Experimental/investigational"	Reference FDA approval and guidelines	FDA label and NCCN guideline citations

FAQ

How long does Humana prior authorization take for Vitrakvi in New Jersey? Standard requests: 72 hours; expedited requests: 24 hours from receipt of complete documentation.

What if Vitrakvi is not on Humana's formulary? Submit a formulary exception request with medical necessity documentation. Specialty tier drugs cannot receive tier exceptions but can be covered through formulary exceptions.

Can I request an expedited appeal if denied? Yes, if treatment delays could jeopardize your health. Both internal appeals and external IHCAP reviews offer expedited timelines for urgent cases.

Does step therapy apply to Vitrakvi? Typically no, since Vitrakvi is indicated for specific NTRK fusion-positive tumors where standard therapies have failed or are inappropriate.

What manufacturer support is available? Bayer's TRAK Assist program offers copay assistance, prior authorization support, and temporary supply programs for eligible patients.

How much does Vitrakvi cost without insurance? Approximately $32,800 per 30-day supply at wholesale acquisition cost, though patient out-of-pocket costs vary significantly based on insurance design and assistance programs.

When navigating complex insurance approvals for targeted cancer therapies like Vitrakvi, having expert support can make the difference between approval and denial. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical documentation to create evidence-backed appeals that address payers' specific requirements. Their platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved by identifying denial reasons and crafting targeted rebuttals aligned with each plan's own rules.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances, plan specifics, and current policies. Always consult with your healthcare provider and insurance plan for personalized guidance. For additional help with insurance appeals in New Jersey, contact the NJ Department of Banking and Insurance or consider working with coverage advocates like Counterforce Health.

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