By Counterforce Health Team in Vitrakvi (larotrectinib) —

How Long Does It Take to Get Vitrakvi (larotrectinib) Approved by Aetna CVS Health in Florida? Complete Timeline & Appeal Guide

Answer Box: Getting Vitrakvi Approved by Aetna CVS Health in Florida

Aetna CVS Health requires prior authorization for Vitrakvi (larotrectinib) with a standard 72-hour decision timeline (24 hours for urgent cases). Success depends on complete documentation: validated NTRK gene fusion test results, oncologist prescription, proof of metastatic/unresectable disease, and prior therapy history. Submit through Availity.com or call 1-888-632-3862. If denied, Florida members have 180 days to appeal with external review options available.

First step today: Gather your molecular pathology report showing NTRK fusion and have your oncologist submit the PA request with complete clinical documentation.

Table of Contents

  1. What Affects Vitrakvi Approval Timing
  2. Pre-Submission Preparation (0-2 Days)
  3. Submission to Initial Review (1-3 Days)
  4. Additional Information Requests (1-7 Days)
  5. Decision Window & Outcomes
  6. If Denied: Florida Appeal Rights
  7. Renewal Cycles & Ongoing Authorization
  8. Timeline Visual & Milestones
  9. Time-Saving Tips for Faster Approval

What Affects Vitrakvi Approval Timing

Several factors influence how quickly Aetna CVS Health processes your Vitrakvi (larotrectinib) prior authorization in Florida:

Documentation Completeness is the biggest factor. CVS Caremark requires specific evidence including:

  • Validated NTRK gene fusion test results with specific fusion partner identified
  • Board-certified oncologist prescription and clinical notes
  • Proof of metastatic, unresectable, or advanced solid tumor status
  • Documentation of prior therapies and medical necessity

Benefit Type affects processing speed. Medicare Advantage members may have additional CMS requirements, while commercial plans follow standard Aetna policies.

Clinical Urgency determines whether you qualify for expedited review. Life-threatening conditions or serious health risks from delay can trigger the 24-hour expedited timeline instead of the standard 72-hour review.

Note: Incomplete submissions are the #1 cause of delays. Aetna may request additional information, extending the timeline by 1-7 days.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

Before your oncologist submits the prior authorization, ensure you have:

Required Lab Results:

  • Molecular pathology report confirming NTRK gene fusion
  • Testing methodology specified (NGS, FISH, or IHC)
  • Specific fusion partner identified (e.g., ETV6-NTRK3, TPM3-NTRK1)
  • Lab certification/validation documentation

Clinical Documentation:

  • Oncologist's clinical notes and treatment plan
  • Pathology reports showing tumor type and staging
  • Imaging studies confirming metastatic/unresectable disease
  • Prior therapy history with dates, responses, and failures
  • Performance status assessment (ECOG or Karnofsky score)

Administrative Details:

  • Patient insurance card and member ID
  • Prescriber NPI and DEA numbers
  • ICD-10 diagnosis codes
  • Requested dosing (100 mg BID for adults, BSA-based for pediatrics)

Verification Steps

  1. Confirm NTRK Testing Validity: Ensure your molecular test used an FDA-approved or validated assay method
  2. Check Prescriber Credentials: Vitrakvi must be prescribed by a board-certified oncologist or hematologist
  3. Review Prior Therapies: Document all previous treatments, including dates and reasons for discontinuation

Submission to Initial Review (1-3 Days)

How to Submit Your Prior Authorization

Electronic Submission (Fastest):

  • Availity Provider Portal - recommended method
  • Electronic Medical Record (EMR) integration via EDI
  • Novologix platform for specialty medications

Phone Submission:

  • Commercial plans: 1-888-632-3862 (TTY: 711)
  • Available Monday-Friday, 8 AM - 6 PM EST

Required Timeline Compliance:

  • Standard reviews: 72 hours from complete submission
  • Expedited reviews: 24 hours for urgent medical situations
  • Providers should submit at least 2 weeks before planned treatment start

What Reviewers Check First

Aetna's clinical team follows a structured review process:

  1. Prescriber Verification: Confirms oncologist credentials and specialty
  2. NTRK Fusion Confirmation: Reviews molecular pathology report for specific fusion
  3. Tumor Status Assessment: Verifies metastatic/unresectable disease documentation
  4. Prior Therapy Review: Checks treatment history and medical necessity
  5. Formulary Status: Confirms coverage under member's specific plan
Tip: Electronic submissions through Availity typically process faster than phone or fax submissions.

Additional Information Requests (1-7 Days)

If Aetna requests additional information, respond immediately to avoid delays:

Common Information Requests:

  • Missing or incomplete NTRK fusion test results
  • Additional clinical notes from the oncologist
  • Clarification on prior therapy failures or contraindications
  • Updated imaging studies or pathology reports

How to Respond Quickly:

  1. Same-Day Response: Submit requested documents within 24 hours
  2. Use Electronic Methods: Upload through Availity or secure email
  3. Include Cover Letter: Clearly reference the original PA request number
  4. Follow Up: Call to confirm receipt of additional documentation

Understanding Hold Queues: When additional information is requested, your case enters a "pending" status. The 72-hour clock restarts once Aetna receives complete documentation.

Decision Window & Outcomes

Typical Approval Scenarios

Full Approval (60-70% of complete submissions):

  • Authorization letter specifies approved duration (typically 6-12 months)
  • Quantity limits and dosing parameters included
  • Pharmacy benefit or medical benefit designation clarified

Conditional Approval:

  • May require specific pharmacy (CVS Specialty)
  • Dosing modifications or monitoring requirements
  • Step therapy completion documentation

Denial Outcomes:

  • Detailed reason codes provided
  • Appeal rights and deadlines specified
  • Alternative treatment suggestions may be included

Reading Your Approval Letter

Key information in Aetna approval letters:

  • Authorization Number: Required for pharmacy claims
  • Valid Dates: Start and end dates for coverage
  • Quantity Limits: Monthly supply limitations
  • Renewal Requirements: When re-authorization is needed

If Denied: Florida Appeal Rights

Florida Aetna members have comprehensive appeal rights with specific timelines:

Internal Appeal Process

Timeline: 180 days from denial notice to file appeal Standard Decision: 30 days for future treatments, 60 days for rendered services Expedited Appeals: 72 hours for urgent medical situations

How to File:

  1. Use the appeal form included in your denial letter
  2. Submit additional clinical documentation supporting medical necessity
  3. Include oncologist's detailed medical necessity letter
  4. Send via Aetna member portal or certified mail

External Review Rights

Eligibility: Available after internal appeal completion or for urgent situations Timeline: 180 days to request external review after final internal denial Cost: No charge to members for external review Decision: Binding on Aetna if reviewer overturns denial

Florida-Specific Process:

For Urgent Cases: You can request expedited external review simultaneously with internal appeals if delay could seriously harm your health.

Getting Help with Appeals

Florida Insurance Consumer Helpline: 1-877-693-5236 Aetna Member Services: Number on your insurance ID card Counterforce Health provides specialized support for prescription drug appeals, helping patients and clinicians turn denials into targeted, evidence-backed appeals with higher success rates.

Renewal Cycles & Ongoing Authorization

When Re-Authorization is Needed

Most Vitrakvi approvals require renewal every 6-12 months:

Standard Renewal Timeline:

  • Submit renewal request 30-45 days before expiration
  • Include updated clinical notes and imaging studies
  • Document ongoing response to treatment and absence of progression

What Speeds Renewals:

  • Demonstrated clinical benefit from current therapy
  • Stable or improved disease status
  • No new treatment alternatives available
  • Continued NTRK fusion-positive status

Renewal Documentation:

  • Updated oncologist assessment
  • Recent imaging or lab results
  • Treatment response evaluation
  • Any new adverse events or tolerance issues

Timeline Visual & Milestones

Phase Timeline Key Actions Expected Outcome
Preparation 0-2 days Gather documentation, verify NTRK testing Complete submission package
Submission Day 1 Submit via Availity or phone Confirmation receipt
Initial Review 1-3 days Aetna clinical review begins Decision or information request
Additional Info 1-7 days Respond to any requests Complete documentation
Final Decision 72 hours Approval or denial issued Coverage determination
Appeal (if needed) 180 days File internal appeal Reconsideration
External Review 45 days Independent reviewer Binding decision
Expedited Timeline: For urgent cases, the entire process from submission to decision can be completed within 24-72 hours.

Time-Saving Tips for Faster Approval

Portal Usage Best Practices

Use Availity Electronic Submission:

  • Fastest processing method available
  • Real-time status updates
  • Automatic confirmation receipts
  • Reduced risk of lost documentation

Bundle Evidence Strategically

Create a Complete Package:

  1. Lead with NTRK Results: Place molecular pathology report first
  2. Include Clinical Summary: One-page oncologist overview
  3. Attach Supporting Studies: Imaging, labs, pathology in chronological order
  4. Add Prior Therapy Timeline: Clear documentation of treatment history

Direct Specialty Routing

Ensure Proper Routing:

  • Mark submissions as "Specialty Oncology"
  • Include oncologist's board certification
  • Reference FDA approval for NTRK fusion-positive tumors
  • Use specific ICD-10 codes for primary tumor type

Clinician Corner: Medical Necessity Letter Checklist

Your oncologist's letter should address:

  • Specific NTRK fusion identified and testing method
  • Tumor histology, stage, and unresectable/metastatic status
  • Prior therapies tried, duration, and reasons for discontinuation
  • Why Vitrakvi is appropriate for this patient's tumor type
  • Treatment goals and expected outcomes
  • Plan for monitoring response and toxicity

Include citations to FDA labeling and relevant oncology guidelines supporting tissue-agnostic use.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing NTRK fusion Submit complete molecular pathology report Validated assay results with fusion partner
Non-oncologist prescriber Transfer prescription to board-certified oncologist Updated prescription with oncologist credentials
Lack of medical necessity Provide detailed clinical rationale Comprehensive medical necessity letter
Alternative treatments available Document prior therapy failures Treatment timeline with outcomes
Experimental/investigational Cite FDA approval and guidelines FDA labeling, NCCN guidelines

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take for Vitrakvi in Florida? Standard decisions take 72 hours from complete submission. Expedited reviews for urgent cases are completed within 24 hours.

What if Vitrakvi is non-formulary on my plan? You can request a formulary exception with clinical justification. Your oncologist must demonstrate medical necessity and lack of suitable alternatives.

Can I get expedited review if I'm already on Vitrakvi? Yes, if there's urgent medical need. Discontinuation of effective cancer therapy often qualifies for expedited processing.

Does step therapy apply to Vitrakvi? Step therapy requirements vary by plan. NTRK fusion-positive tumors often qualify for exceptions due to the targeted nature of the therapy.

What happens if my appeal is denied? Florida members can request binding external review through an independent medical expert. This decision is final and binding on Aetna.

How much does Vitrakvi cost without insurance? The wholesale acquisition cost is approximately $32,800 per month. Bayer's TRAK Assist program offers copay assistance for eligible patients.

Counterforce Health specializes in turning prescription drug denials into successful appeals. Our platform analyzes denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals that significantly improve approval rates. We help patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes more effectively.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For assistance with insurance complaints in Florida, contact the Florida Department of Financial Services at 1-877-693-5236.

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