By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (Larotrectinib) Covered by Aetna CVS Health in Illinois: PA Forms, Appeal Scripts & Timeline Guide

Quick Answer: Aetna CVS Health requires prior authorization for Vitrakvi (larotrectinib) with documented NTRK gene fusion testing and evidence of metastatic/unresectable disease. Submit PA via CVS Specialty at 1-888-267-3277 with molecular pathology report, oncologist notes, and prior therapy documentation. If denied, appeal within 180 days using medical necessity letter addressing specific denial reasons. Illinois residents have external review rights within 4 months of final denial.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all specialty oncology drugs including Vitrakvi Aetna 2024-2025 Precertification Lists Aetna PA Lists
NTRK Fusion Testing Documented NTRK1/2/3 gene fusion via targeted testing Clinical Policy Bulletin 0715 Aetna CPB 0715
Tumor Status Metastatic or unresectable solid tumor FDA labeling requirements FDA Approval Letter
Prior Therapy Documentation of standard therapy failure/intolerance Plan-specific oncology policies Verify with plan documents
Prescriber Medical oncologist or qualified specialist Standard specialty drug requirements Contact CVS Specialty
Appeal Deadline (IL) 180 days from denial notice Illinois insurance law Illinois External Review

Step-by-Step: Fastest Path to Approval

1. Confirm NTRK Fusion Status (Patient/Oncologist)

  • Order targeted NTRK1/2/3 fusion testing (not broad NGS panels)
  • Ensure report clearly states "fusion-positive" with specific fusion partner
  • Timeline: 5-10 business days for results

2. Gather Required Documentation (Clinic Staff)

  • Complete molecular pathology report
  • Staging imaging showing metastatic/unresectable disease
  • Prior therapy records with dates, responses, and discontinuation reasons
  • Timeline: 1-2 days to compile

3. Submit Prior Authorization (Prescriber)

  • Fax CVS Specialty: 1-888-267-3277
  • Include PA form, clinical notes, and all supporting documents
  • Timeline: Standard decision within 15 business days

4. Monitor and Follow Up (Clinic/Patient)

  • Track submission via CVS Caremark portal
  • Request expedited review if clinically urgent
  • Timeline: 72 hours for expedited decisions

5. Appeal if Denied (Prescriber/Patient)

  • Submit appeal within 180 days using medical necessity template
  • Address specific denial reasons point-by-point
  • Timeline: 15 business days for standard appeals

Understanding Aetna's NTRK Testing Policy

Aetna's Clinical Policy Bulletin 0715 specifically addresses NTRK testing requirements:

Key Policy Points:NTRK1/2/3 gene fusion testing is "medically necessary for members with solid tumors being considered for treatment with larotrectinib (Vitrakvi)"Aetna explicitly states it "does not consider large NGS panels such as FoundationOne CDx medically necessary for this indication"Targeted NTRK fusion assays are preferred over comprehensive genomic profiling

This policy helps streamline approval by ensuring you order the right test upfront. If your patient already has NTRK fusion results from a broader panel, the fusion result itself can still support the Vitrakvi PA—but Aetna may deny coverage for the panel testing.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing NTRK fusion documentation Submit complete molecular pathology report Lab report with fusion partner, assay method, date
Tumor considered resectable Obtain surgeon's note on unresectability Surgical consultation documenting inoperability/morbidity risk
Insufficient prior therapy Document standard treatment failures Chemotherapy records with dates, responses, toxicity notes
Non-specialist prescriber Transfer care or obtain consultation Medical oncologist evaluation and treatment plan
"Experimental" designation Cite FDA approval and guidelines FDA labeling, NCCN references, peer-reviewed literature
Step therapy not met Document contraindications to preferred agents Allergy records, drug interaction profiles, prior intolerance
From Our Advocates: We've seen Aetna initially deny Vitrakvi cases where the NTRK fusion report was buried in a 40-page genomic analysis. Creating a one-page summary highlighting the specific NTRK fusion finding, tumor stage, and prior therapies dramatically improves first-pass approval rates. This composite experience reflects common documentation issues across multiple cases.

Appeals Playbook for Illinois

Illinois provides robust appeal rights through the Health Carrier External Review Act:

Internal Appeal Process

  • Deadline: 180 days from denial notice
  • Standard Timeline: 15 business days for decision
  • Expedited Timeline: 24 hours for urgent cases
  • Submission: Follow Aetna's appeal instructions in denial letter

External Review (After Internal Denial)

  • Deadline: 4 months from final adverse determination
  • Cost: Free to consumers
  • Timeline: 45 days maximum (5 days for urgent cases)
  • Contact: Illinois Department of Insurance

Illinois Consumer Resources

  • IDOI Consumer Helpline: 1-877-527-9431
  • Illinois Attorney General Health Care Helpline: 1-877-305-5145
  • External Review Forms: Available at IDOI website

The Illinois Department of Insurance can help you understand your rights, complete external review forms, and navigate the appeal process specifically for oncology drug denials.

Medical Necessity Letter Template

When appealing a Vitrakvi denial, your oncologist should address these key elements:

Patient Information & Diagnosis

  • Full name, DOB, Aetna member ID
  • Primary malignancy with stage and metastatic sites
  • Performance status and current disease burden

NTRK Fusion Documentation

  • Specific fusion identified (e.g., ETV6-NTRK3)
  • Testing methodology and certified laboratory
  • Date of molecular analysis

Prior Therapy History

  • Complete list of previous treatments with dates
  • Best response achieved and reason for discontinuation
  • Documentation of progression or intolerance

Medical Necessity Justification

  • FDA-approved indication alignment
  • Lack of satisfactory alternative treatments
  • Expected clinical benefit and treatment goals
  • Risk of delay in initiating targeted therapy

Clinical Evidence

  • NCCN guideline support for TRK inhibitors
  • Peer-reviewed literature on NTRK fusion-positive tumors
  • Tumor-agnostic efficacy data for larotrectinib

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to the plan's own rules.

Cost Savings & Patient Support

Manufacturer Support Programs

  • Bayer Access Services/TRAK Assist: Provides PA support, appeal assistance, and bridge supply
  • Copay Program: $0 copay for eligible commercial patients
  • Contact: Available through prescriber or Bayer patient services

Financial Assistance Options

  • Patient Access Network Foundation: Grants for cancer patients
  • CancerCare Co-Payment Assistance: Income-based support
  • Illinois Medicaid: Expanded coverage for eligible patients

CVS Specialty Pharmacy Services

  • Dedicated Oncology Support: Clinical pharmacists specialized in cancer care
  • Prior Authorization Assistance: Help with documentation and appeals
  • Contact: 1-888-267-3277

When to Escalate: Illinois Department of Insurance

Contact the Illinois Department of Insurance if:

  • Your internal appeal is taking longer than 15 business days
  • Aetna requests additional documentation repeatedly without clear justification
  • You believe the denial violates Illinois insurance law
  • You need help filing an external review

Illinois IDOI Office of Consumer Health Insurance:

  • Phone: 1-877-527-9431 (toll-free in Illinois)
  • Address: 320 W. Washington Street, Springfield, IL 62767
  • Services: Appeal assistance, external review guidance, consumer education

The IDOI can provide personalized guidance on your specific situation and help ensure your appeal receives proper consideration under Illinois law.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take for Vitrakvi in Illinois? Standard PA decisions are made within 15 business days. Expedited reviews for urgent cases are completed within 72 hours. Submit complete documentation to avoid delays.

What if Vitrakvi is non-formulary on my Aetna plan? Request a formulary exception with medical necessity documentation. Emphasize that NTRK fusion-positive tumors represent a rare, biomarker-defined subset requiring targeted therapy.

Can I request an expedited appeal for Vitrakvi? Yes, if delay would seriously jeopardize your life or health. Document the urgency with your oncologist and specify this in your appeal request.

Does Illinois step therapy apply if I failed treatments in another state? Yes, prior therapy documentation from any state counts toward step therapy requirements. Provide complete records with dates and outcomes.

What happens if my external review is approved? The decision is binding on Aetna. They must provide coverage for Vitrakvi according to the external reviewer's determination.

How much does external review cost in Illinois? External review is free for consumers. The Illinois Department of Insurance covers all costs associated with the independent review process.

Can my oncologist help with the appeal? Absolutely. Physician-written medical necessity letters significantly strengthen appeals. Your oncologist can also request peer-to-peer reviews with Aetna's medical directors.

What if I'm on Illinois Medicaid instead of commercial insurance? Illinois Medicaid has separate appeal processes. Contact the Illinois Department of Healthcare and Family Services for Medicaid-specific guidance.

This guide provides educational information and should not be considered medical or legal advice. For personalized assistance with your specific situation, consult with your healthcare provider and consider contacting the Illinois Department of Insurance consumer helpline. Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeal processes by creating evidence-backed submissions that align with payer requirements.

Sources & Further Reading

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