By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (larotrectinib) Covered by Cigna in Florida: Complete PA Guide and Appeal Process

Answer Box: Getting Vitrakvi Covered by Cigna in Florida

Cigna requires prior authorization for Vitrakvi (larotrectinib) with NTRK fusion confirmation via molecular testing, oncologist prescription, and documentation of metastatic/unresectable disease. Submit through CoverMyMeds or fax to 866-873-8279 using Florida Medical PA Form. Standard approval takes 72 hours; appeals must be filed within 180 days. First step: Verify NTRK fusion testing is complete and request PA form from your oncologist today.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Checklist
  4. Required Documentation Packet
  5. Submission Process
  6. Specialty Pharmacy Setup
  7. After Submission: What to Expect
  8. Appeals Process for Florida
  9. Common Denial Reasons & Solutions
  10. Costs & Patient Assistance
  11. FAQ

Who Should Use This Guide

This guide is for Florida residents with Cigna insurance who need coverage for Vitrakvi (larotrectinib), an oral TRK inhibitor for NTRK fusion-positive solid tumors. You'll find this most helpful if:

  • Your oncologist has recommended Vitrakvi based on NTRK gene fusion testing
  • You have metastatic or unresectable cancer that's progressed on other treatments
  • You're facing a prior authorization requirement or denial from Cigna
  • You need to understand the appeal process specific to Florida insurance law

Expected outcome: With proper documentation, most medically appropriate Vitrakvi requests get approved. Florida's external review process provides additional protection if initial appeals are denied.

Member & Plan Basics

Verify Your Coverage

Before starting the PA process, confirm these basics through myCigna.com or by calling the number on your insurance card:

  • Active prescription coverage: Vitrakvi is covered under pharmacy benefits, not medical
  • Plan type: Fully insured vs. self-funded (affects Florida appeal rights)
  • Specialty pharmacy requirement: Most Cigna plans require Accredo for specialty drugs
  • Formulary status: Check if Vitrakvi is on your plan's formulary and at what tier
Note: Cigna typically covers Vitrakvi as a specialty drug with prior authorization requirements across all plan types.

Clinical Criteria Checklist

Your oncologist must document that you meet these FDA-approved criteria:

Primary Requirements

  • ✅ NTRK gene fusion confirmed by FDA-approved companion diagnostic
  • ✅ Solid tumor (any histology) that is metastatic or unresectable
  • ✅ No satisfactory treatment alternatives or disease progression following treatment
  • ✅ Oncologist prescription (board-certified preferred)

Age-Specific Dosing

  • Adults (BSA ≥1.0 m²): 100 mg twice daily
  • Pediatric: BSA-based dosing using solution or capsules
  • Weight/BSA documentation required for proper dosing approval

Testing Requirements

The molecular pathology report must specify:

  • Gene fusion partner (e.g., "NTRK1-TPM3 fusion")
  • Testing methodology (NGS, FISH, RT-PCR, or IHC)
  • Laboratory certification and date of testing

Required Documentation Packet

Core Documents (Submit All)

  1. Completed Florida Medical Prior Authorization Form
  2. NTRK fusion test report with methodology and fusion partner
  3. Oncology consultation notes documenting:
    • Primary diagnosis with ICD-10 code
    • Disease staging (metastatic/unresectable evidence)
    • Prior treatment history and outcomes
    • Treatment goals and prognosis
  4. Current prescription with strength, dosing, and quantity
  5. Recent imaging showing disease extent/progression

Medical Necessity Letter Components

Your oncologist should include a letter addressing:

  • Clinical rationale: Why Vitrakvi is medically necessary for your specific case
  • FDA approval status: Cite the tumor-agnostic NTRK fusion indication
  • Treatment alternatives: Document why other options are inappropriate or have failed
  • Expected outcomes: Reference clinical trial data showing response rates
  • Monitoring plan: How treatment response will be assessed
Clinician Corner: Include NCCN Guidelines references and cite the pooled efficacy data from SCOUT, NAVIGATE, and CLIMB trials showing overall response rates of 75% across tumor types.

Submission Process

  1. Register for Cigna ePA: Email [email protected] with provider details
  2. Use CoverMyMeds: Submit through www.covermymeds.com/main/prior-authorization-forms/cigna/
  3. Track status: Monitor approval progress through the portal

Alternative Methods

  • Fax: 866-873-8279 (ensure all pages are legible)
  • Phone: 800-244-6224 for urgent cases requiring verbal PA

Timeline Expectations

  • Standard review: 72 hours for complete submissions
  • Urgent/expedited: 24 hours when medically necessary
  • Incomplete submissions: Returned for additional documentation

Specialty Pharmacy Setup

Once approved, Cigna requires Accredo specialty pharmacy for Vitrakvi fulfillment:

Enrollment Steps

  1. Prescriber completes: Accredo Prescription & Enrollment Form
  2. Fax to: 888-302-1028
  3. Patient calls: 877-826-7657 to set up delivery preferences
  4. Create account: Register at Accredo.com using prescription number

TRAK Assist Alternative

Bayer's patient support program can facilitate enrollment:

  • Prescriber fax: 1-888-506-8725 with patient authorization
  • Covers: 5-year enrollment, bridge supply during coverage gaps
  • Patient opt-out: 1-844-634-8725 if desired

After Submission: What to Expect

Confirmation and Tracking

  • Record confirmation numbers from electronic submissions
  • Check status every 2-3 business days if no response
  • Contact Cigna at 800-882-4462 for submission verification

If Additional Information Requested

Cigna may request:

  • Updated lab values or imaging
  • Peer-to-peer review with prescribing oncologist
  • Additional prior therapy documentation
  • Clarification of dosing rationale

Response quickly to avoid automatic denials due to incomplete information.

Appeals Process for Florida

Internal Appeal (Required First Step)

If your PA is denied, you have 180 calendar days from the denial notice to file an internal appeal.

Submission Options:

  • Online: Through Cigna provider portal (fastest)
  • Form: Complete Customer Appeal Request
  • Phone: 1-800-882-4462 for immediate discussion

Required Appeal Documents:

  • Copy of denial notice or EOB
  • Enhanced medical necessity letter addressing denial reasons
  • Additional clinical evidence (peer-reviewed studies, guidelines)
  • Updated patient status if condition has worsened

External Review (Florida-Specific Rights)

After internal appeal denial, Florida law provides independent external review rights:

  • Eligibility: Medical necessity denials under fully insured plans
  • Timeline: Request within 4 months of final internal denial
  • Process: Florida Department of Financial Services assigns independent medical reviewer
  • Cost: Free to consumers
  • Decision: Binding on Cigna if overturned

Florida Consumer Assistance: Call 1-877-693-5236 for help navigating the appeals process.

Common Denial Reasons & Solutions

Denial Reason Required Fix Supporting Documents
No NTRK fusion documented Submit molecular pathology report NGS/FISH results with fusion partner
Tumor appears resectable Surgical consultation note Oncology/surgery notes on unresectability
Prior therapies not attempted Document contraindications or failures Treatment history, adverse event notes
Non-oncologist prescriber Transfer prescription Board-certified oncologist credentials
Experimental/investigational Cite FDA approval FDA label, NCCN compendium entry

Costs & Patient Assistance

Insurance Coverage

  • Typical copay: $50-$150/month for specialty tier drugs
  • Deductible: May apply before copay assistance kicks in
  • Annual out-of-pocket max: Provides cost protection for high-cost drugs

Manufacturer Support

Bayer TRAK Assist Program:

  • $0 copay for eligible commercial patients
  • Bridge supply during coverage delays
  • Enrollment: 1-800-288-8374
  • Eligibility verification and prior authorization support

Additional Resources

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies and crafting evidence-based rebuttals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes for specialty medications like Vitrakvi.

FAQ

Q: How long does Cigna prior authorization take for Vitrakvi in Florida? A: Standard review is 72 hours for complete submissions. Urgent cases can be expedited to 24 hours when medically necessary.

Q: What if Vitrakvi is not on my Cigna formulary? A: You can request a formulary exception by demonstrating medical necessity and why formulary alternatives are inappropriate for NTRK-positive tumors.

Q: Can I get an expedited appeal if my condition is worsening? A: Yes, mark your appeal "Expedited" and include documentation of clinical urgency. Expedited appeals have faster review timelines.

Q: Does Florida law provide additional appeal rights beyond federal requirements? A: Yes, Florida requires external review for medical necessity denials under fully insured plans, providing an independent medical opinion that's binding on insurers.

Q: What happens if I miss the 180-day appeal deadline? A: Missing the deadline typically forfeits your appeal rights. Contact Florida's Insurance Consumer Helpline immediately if you're approaching the deadline.

Q: Can my oncologist request a peer-to-peer review? A: Yes, oncologists can request to speak directly with Cigna's medical director to discuss the clinical rationale for Vitrakvi coverage.

From our advocates: "We've seen Vitrakvi appeals succeed when families include the molecular testing report showing the specific NTRK fusion and a clear timeline of prior treatments that failed. The key is demonstrating that this isn't experimental—it's FDA-approved for exactly this patient's tumor profile."

When navigating complex prior authorization requirements, Counterforce Health provides specialized support in analyzing denial letters and crafting targeted appeals that address payer-specific criteria. Their evidence-based approach has helped many patients access critical specialty medications through the appeals process.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and individual circumstances. Always consult with your healthcare provider and insurance company for decisions about your specific situation. For assistance with insurance problems in Florida, contact the state Insurance Consumer Helpline at 1-877-693-5236.

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