By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (Larotrectinib) Covered by Humana in North Carolina: Complete PA Guide and Appeal Process

Answer Box: Getting Vitrakvi Covered by Humana in North Carolina

Vitrakvi (larotrectinib) requires prior authorization through Humana Medicare Advantage plans in North Carolina. To secure coverage: (1) Confirm NTRK gene fusion with FDA-approved testing, (2) Submit complete PA documentation including pathology report and oncologist letter, (3) Use Humana's designated specialty pharmacy network. If denied, North Carolina offers robust external review through Smart NC with 72-hour expedited decisions for urgent cases. Start the process 3-4 weeks before needed treatment.

First step today: Contact your oncologist to request NTRK fusion testing documentation and begin the prior authorization process through Humana's provider portal.

Table of Contents

  1. Humana's Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Required Diagnostics and Documentation
  5. Specialty Pharmacy Requirements
  6. Step-by-Step: Fastest Path to Approval
  7. Common Denial Reasons and Solutions
  8. Appeals Process for North Carolina
  9. North Carolina External Review Rights
  10. Costs and Patient Assistance
  11. FAQ

Humana's Coverage Policy Overview

Humana classifies Vitrakvi as a specialty oncology medication requiring prior authorization across all plan types—Medicare Advantage, Medicare Part D, and commercial plans. The drug is processed through Humana's Clinical Pharmacy Review team due to its high cost (approximately $394,000 annually at adult dosing) and specific indication requirements.

Plan Types and Coverage Differences

  • Medicare Advantage: Standard PA required with 85% of complete electronic requests receiving decisions within one business day
  • Medicare Part D: Must use approved specialty pharmacy network; 90-day transition coverage may apply for new members with active treatment
  • Commercial Plans: Similar PA requirements with potential step therapy protocols

Official coverage policies are updated annually and available through Humana's prior authorization lists.

Medical Necessity Requirements

Humana requires all of the following criteria to establish medical necessity for Vitrakvi:

Core Eligibility Criteria

Requirement Documentation Needed Source
NTRK Gene Fusion FDA-approved test results (NGS, FISH, or RT-PCR) FDA Label
Solid Tumor Pathology report confirming histologic diagnosis Clinical documentation
Disease Stage Metastatic, locally advanced, or unresectable tumor Oncologist assessment
Treatment History No satisfactory alternatives or progression after prior therapy Medical records
Prescriber Board-certified oncologist Provider credentials
Performance Status ECOG 0-2 documented Clinical notes

Pediatric Considerations

Children under 19 years may receive automatic approval without standard PA review in some Humana plans, but comprehensive documentation is still recommended. The FDA has approved Vitrakvi for pediatric use as young as one month old for NTRK fusion-positive solid tumors.

Step Therapy and Exception Pathways

Humana typically requires evidence that standard therapies per NCCN guidelines have been tried and failed before approving Vitrakvi. This applies especially to Medicare Advantage plans.

Required Prior Therapies

  • Standard chemotherapy regimens appropriate for tumor type
  • Other biomarker-specific targeted agents (when applicable)
  • Immunotherapy (if clinically indicated)

Exception Criteria

You can bypass step therapy requirements by documenting:

  1. Failure of prior standard therapies with specifics (drug, dose, duration, outcome)
  2. Contraindication to standard agents with clinical rationale
  3. Clinical urgency necessitating immediate TRK inhibition
  4. Prior therapies completed outside current plan (requires proof)
Tip: Include step therapy exception requests in your initial PA submission to avoid delays.

Required Diagnostics and Documentation

NTRK Fusion Testing Requirements

FDA-approved methods for confirming NTRK gene fusions include:

  • Next-Generation Sequencing (NGS): Preferred method; FoundationOne CDx qualifies
  • Fluorescence In Situ Hybridization (FISH): Alternative for confirmation
  • RT-PCR: Feasible but less comprehensive than NGS

The pathology report must specify:

  • Type of diagnostic test performed
  • Test result showing NTRK fusion positivity
  • Date of test and laboratory details
  • Fusion partner identification (when available)

Additional Required Documentation

  • Disease staging: Imaging reports confirming metastatic/unresectable status
  • Prior therapy summary: Dates, regimens, outcomes, reasons for discontinuation
  • Current performance status: ECOG score with date assessed
  • Treatment goals: Clearly stated objectives and monitoring plan

Specialty Pharmacy Requirements

Vitrakvi must be dispensed through Humana's approved specialty pharmacy network, typically CenterWell Specialty Pharmacy™. Using out-of-network pharmacies may result in full patient responsibility for costs.

Key Requirements

  • Prior authorization must be approved before dispensing
  • Initial fills typically limited to 30-day supply
  • Refills require ongoing medical necessity documentation
  • Direct communication between specialty pharmacy and prescriber required

Contact Humana's pharmacy services to verify current network requirements.

Step-by-Step: Fastest Path to Approval

1. Confirm NTRK Fusion Testing (Week 1)

Who: Oncologist
Action: Order FDA-approved NTRK fusion testing if not already completed
Timeline: 7-14 days for results
Documentation: Ensure pathology report includes test method and fusion details

2. Gather Prior Therapy Documentation (Week 1-2)

Who: Clinical staff
Action: Compile complete treatment history with outcomes
Documents needed: Previous oncology notes, imaging reports, pharmacy records

3. Submit Prior Authorization (Week 2-3)

Who: Prescriber or authorized staff
Action: Submit complete PA through Humana provider portal
Alternative: Fax to 877-486-2621 or call 800-555-2546
Timeline: 85% of electronic requests decided within 1 business day

4. Include Exception Requests (Week 2-3)

Who: Prescriber
Action: Submit step therapy and formulary exceptions simultaneously
Documentation: Medical necessity letter with NCCN guideline references

5. Coordinate with Specialty Pharmacy (Week 3)

Who: Patient/caregiver
Action: Contact CenterWell Specialty Pharmacy once PA approved
Timeline: 2-3 business days for first fill

6. Monitor and Appeal if Denied (Week 3-4)

Who: Prescriber and patient
Action: Submit internal appeal within 65 days if denied
Escalation: External review through Smart NC if internal appeals fail

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
No NTRK fusion documented Submit validated test results FDA-approved assay report with fusion confirmation
Tumor deemed resectable Provide surgical consultation Surgeon's assessment of unresectability/morbidity risk
Insufficient prior therapy Document treatment failures Complete therapy timeline with outcomes
Non-oncologist prescriber Transfer to oncology specialist Board-certified oncologist evaluation
Off-label use concerns Cite FDA tissue-agnostic approval Reference FDA label and NCCN guidelines

Appeals Process for North Carolina

Internal Appeals with Humana

Timeline: 65 days from denial notice
Method: Online, fax (877-486-2621), or phone (800-555-2546)
Required: Original PA documentation plus additional clinical justification

Expedited Appeals

Available for urgent medical situations where delays could jeopardize health:

  • Timeline: 72 hours for decision
  • Criteria: Active disease progression or treatment interruption risk
  • Documentation: Physician attestation of urgency
From our advocates: We've seen Vitrakvi appeals succeed when oncologists include specific NTRK fusion details, cite the FDA's tissue-agnostic approval, and document rapid disease progression. The key is comprehensive initial documentation—missing pathology reports are the most common reason for delays.

North Carolina External Review Rights

If Humana's internal appeals are denied, North Carolina offers robust external review protections through Smart NC.

External Review Process

Eligibility: State-regulated plans (most individual and small group plans)
Timeline: 120 days after final internal denial to request
Authority: Smart NC (NC Department of Insurance)
Phone: 1-855-408-1212

Process Steps

  1. Submit Request: Complete external review form from NC Department of Insurance
  2. Review Assignment: Smart NC assigns Independent Review Organization (IRO)
  3. Decision Timeline: 45 days for standard review, 72 hours for expedited
  4. Binding Decision: IRO ruling is final and binding on Humana

Expedited External Review

Criteria: Delay would seriously jeopardize life or ability to regain function
Timeline: 72 hours (24-72 hours for urgent drug denials)
Special provision: May waive requirement to complete internal appeals first

Key advantage: North Carolina's external review system has successfully overturned many denials for expensive cancer treatments and specialty drugs.

Costs and Patient Assistance

Manufacturer Support Programs

Bayer's TRAK Assist Program provides:

  • Prior authorization and appeals support
  • $0 copay program for eligible commercial patients
  • Bridge supply during appeals process
  • Clinical and reimbursement support

Contact: Bayer TRAK Assist or 1-833-VITRAKVI

Additional Resources

  • Patient Access Network (PAN) Foundation: Copay assistance for qualifying patients
  • CancerCare: Financial assistance and case management
  • North Carolina Cancer Fund: State-specific assistance programs

FAQ

How long does Humana prior authorization take in North Carolina?
85% of complete electronic PA requests receive decisions within one business day. Complex cases may take up to 14 days.

What if Vitrakvi is non-formulary on my Humana plan?
Request a formulary exception by demonstrating medical necessity and providing clinical justification. Include evidence of failure/contraindication to formulary alternatives.

Can I request an expedited appeal in North Carolina?
Yes, both Humana internal appeals and North Carolina external reviews offer expedited processes for urgent medical situations, with decisions in 72 hours or less.

Does step therapy apply if I failed treatments in another state?
Yes, but you must provide documentation of prior therapies completed outside your current Humana plan. Include pharmacy records and physician notes detailing outcomes.

What counts as FDA-approved NTRK fusion testing?
NGS platforms like FoundationOne CDx, FISH, and RT-PCR are acceptable. The key is using a validated laboratory method that can detect NTRK1, NTRK2, and NTRK3 gene fusions.

How does Smart NC help with Vitrakvi appeals?
Smart NC provides free advocacy, helps complete external review forms, and can assist with gathering supporting documentation. Their decisions are binding on Humana.

Getting Additional Support

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Vitrakvi. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, helping patients, clinicians, and specialty pharmacies navigate complex prior authorization processes more effectively.

For immediate assistance with Humana denials in North Carolina, contact Smart NC at 1-855-408-1212 or visit the NC Department of Insurance website for external review forms and guidance.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and should not replace professional medical or legal advice. Coverage policies and requirements may change. Always verify current requirements with Humana and consult with your healthcare provider regarding treatment decisions. For personalized assistance with insurance appeals in North Carolina, contact Smart NC or consider working with organizations like Counterforce Health that specialize in coverage advocacy.

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