By Counterforce Health Team in Vitrakvi (larotrectinib) —

Do You Qualify for Vitrakvi (Larotrectinib) Coverage by Aetna (CVS Health) in Ohio? Complete Decision Tree & Appeals Guide

Quick Answer: Your Path to Vitrakvi (Larotrectinib) Coverage in Ohio

To qualify for Vitrakvi (larotrectinib) coverage through Aetna (CVS Health) in Ohio, you need: (1) documented NTRK gene fusion-positive solid tumor, (2) metastatic or unresectable disease, and (3) prescription by an in-network oncologist. Fastest approval path: Submit prior authorization through Aetna's precertification process with complete NTRK testing results and clinical documentation. If denied, Ohio residents have strong appeal rights including external review through the Ohio Department of Insurance within 180 days.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible" - Document Checklist
  4. If "Possibly Eligible" - Tests to Request
  5. If "Not Yet" - Alternative Pathways
  6. If Denied - Ohio Appeal Process
  7. Common Denial Reasons & Fixes
  8. FAQ: Ohio-Specific Questions
  9. Sources & Further Reading

How to Use This Decision Tree

This guide helps patients and clinicians navigate Aetna (CVS Health) prior authorization requirements for Vitrakvi (larotrectinib) in Ohio. Each section includes specific timelines, forms, and appeal rights under Ohio law.

Before you start: Gather your insurance card, recent pathology reports, and oncology notes. Most Aetna plans require prior authorization for Vitrakvi, but the specific criteria depend on whether you have commercial, Medicare, or Medicaid coverage.

Note: This is not medical advice. Always consult your oncology team for treatment decisions.

Eligibility Triage: Do You Qualify?

Likely Eligible ✅

You probably qualify if ALL of these apply:

  • Solid tumor with documented NTRK gene fusion (NTRK1, NTRK2, or NTRK3)
  • Disease is metastatic or unresectable (or surgery would cause severe morbidity)
  • Prescribed by board-certified oncologist or hematologist
  • Prior standard therapies tried, failed, or inappropriate for your tumor type
  • Performance status adequate (ECOG ≤2 or Karnofsky >50%)

Next step: Proceed to Document Checklist

Possibly Eligible ⚠️

You may qualify with additional documentation if:

  • NTRK testing shows "TRK protein positive" but no gene fusion confirmation
  • Tumor is locally advanced but resectability unclear
  • Limited prior therapy history documented
  • Prescribed by non-oncology specialist

Next step: See Tests to Request

Not Yet ❌

Coverage unlikely without changes if:

  • No NTRK testing performed or negative results
  • Tumor is resectable with good surgical outcomes expected
  • No prior systemic therapy when standard options exist
  • Prescribed by non-specialist without oncology consultation

Next step: Review Alternative Pathways

If "Likely Eligible" - Document Checklist

Required Documentation for Aetna Prior Authorization

Document Type What to Include Where to Find It
NTRK Test Report Molecular pathology showing NTRK1/2/3 gene fusion, test methodology (NGS/FISH/RT-PCR), CLIA lab certification Hospital pathology department or reference lab
Oncology Note Diagnosis with ICD-10, staging, prior treatments, rationale for Vitrakvi Treating oncologist's records
Prescription Details Exact dosing (adult: 100mg BID; pediatric: BSA-based), NDC, quantity Oncology clinic
Insurance Verification Member ID, plan type (commercial/Medicare/Medicaid), formulary status Aetna member portal or ID card

Submission Process

Step 1: Verify Network Status

  • Confirm your oncologist is Aetna in-network
  • Check if Vitrakvi requires specialty pharmacy (usually CVS Specialty)

Step 2: Submit Prior Authorization

  • Online: Aetna provider portal (preferred method)
  • Phone: 1-855-582-2025 (commercial plans)
  • Fax: 1-855-330-1716

Step 3: Timeline Expectations

  • Standard review: 72 hours for complete submissions
  • Expedited review: 24 hours if delay could harm health
  • Missing information: Additional 72 hours after documents received
From our advocates: "We've seen Aetna approvals in Ohio happen within 24-48 hours when the NTRK fusion report clearly states the gene fusion partner and the oncologist's note addresses prior therapy appropriateness. The key is submitting complete documentation upfront rather than piecemeal."

If "Possibly Eligible" - Tests to Request

Missing NTRK Gene Fusion Confirmation

Problem: IHC showing "TRK positive" without molecular confirmation Solution: Request comprehensive NGS panel or NTRK-specific fusion testing

Tests to order:

  • Next-generation sequencing (NGS) solid tumor panel including NTRK1/2/3
  • FISH for NTRK1/2/3 gene rearrangements
  • RT-PCR for NTRK fusion transcripts

Timeline: 7-14 days for results; resubmit PA immediately after positive confirmation

Unclear Disease Status

Problem: Staging documentation insufficient for "metastatic/unresectable" determination Solution: Request updated imaging and multidisciplinary review

Documentation needed:

  • Recent CT/MRI with radiologist interpretation
  • Surgical consultation note if resectability in question
  • Oncology note confirming metastatic disease or surgical morbidity risk

If "Not Yet" - Alternative Pathways

No NTRK Testing Performed

Immediate action: Order NTRK fusion testing if clinically appropriate

  • Discuss with oncology team whether NTRK testing is indicated for your tumor type
  • Some tumor types have higher NTRK fusion rates (secretory carcinomas, infantile fibrosarcoma)

Standard Therapies Not Yet Tried

Coverage strategy: Document why standard options are inappropriate

  • Medical contraindications to chemotherapy/radiation
  • Prior severe toxicity to standard agents
  • Tumor characteristics suggesting poor response to conventional therapy

Formulary Exception Request

If Vitrakvi is non-formulary on your Aetna plan:

  • Submit medical exception request through Aetna's formulary exception process
  • Include clinical rationale why covered alternatives won't work
  • Timeline: 72 hours standard, 24 hours expedited

If Denied - Ohio Appeal Process

Aetna Internal Appeals

Level 1: Standard Appeal

  • Deadline: Submit within timeframe specified in denial letter (typically 60-180 days)
  • How: Use appeal form in denial notice or call member services
  • Timeline: 30-60 days for decision (varies by plan type)

Level 2: Peer-to-Peer Review

  • Request medical director review with your oncologist
  • Schedule through Aetna's precertification line
  • Prepare clinical summary focusing on medical necessity

Ohio External Review

After exhausting Aetna's internal appeals, Ohio residents can request independent external review:

Eligibility: Final denial involving medical judgment or "experimental/investigational" determination Deadline: 180 days from final Aetna denial letter Process: Submit request through Aetna (not directly to Ohio DOI) Timeline:

  • Standard: 30 days for IRO decision
  • Expedited: 72 hours if delay threatens health

Contact Ohio Department of Insurance:

Tip: Ohio's external review process is binding on insurers. Independent medical experts often overturn denials for FDA-approved orphan drugs like Vitrakvi when proper documentation is provided.

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
"No NTRK fusion documented" Submit complete molecular pathology report NGS/FISH/RT-PCR report showing specific gene fusion
"Not medically necessary" Appeal with oncology letter citing FDA labeling and guidelines NCCN references, peer-reviewed studies, FDA label excerpts
"Experimental/investigational" Document FDA approval for tumor-agnostic indication FDA approval letter, clinical trial data
"Non-oncology prescriber" Transfer prescription to in-network oncologist Board certification documentation
"Resectable tumor" Obtain surgical consultation documenting morbidity risk Surgeon's note explaining why surgery inappropriate

Patient Assistance While Appealing

Manufacturer Support:

Financial Assistance:

  • Patient advocacy organizations may provide grant funding
  • Hospital financial counselors can help identify resources

FAQ: Ohio-Specific Questions

How long does Aetna prior authorization take in Ohio? Standard PA decisions are made within 72 hours of receiving complete documentation. Expedited requests (when delay could harm health) are decided within 24 hours.

What if Vitrakvi is non-formulary on my Aetna plan? You can request a formulary exception with clinical justification. Timeline is 72 hours standard, 24 hours expedited.

Does step therapy apply to Vitrakvi in Ohio? Aetna typically manages Vitrakvi through prior authorization rather than formal step therapy, given its orphan drug status and biomarker-specific indication.

Can I request expedited appeals in Ohio? Yes, if your oncologist certifies that waiting could seriously harm your health. Both Aetna internal appeals and Ohio external reviews offer expedited timelines.

What if my Aetna plan is through my employer (ERISA)? Self-funded employer plans may use federal rather than Ohio appeal processes, but many voluntarily follow Ohio's external review procedures. Check your plan documents or call the number on your ID card.

How do I know if my oncologist is Aetna in-network? Use Aetna's provider directory online or call the member services number on your insurance card to verify network status before submitting PA.

Getting specialized help with insurance appeals can make the difference between approval and denial. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes 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. For complex cases like Vitrakvi appeals, having expert support to navigate payer-specific workflows and cite the right evidence can significantly improve approval odds.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan terms, medical circumstances, and current policies. Always consult your healthcare team for treatment decisions and your plan documents for specific coverage terms. For questions about Ohio insurance regulations, contact the Ohio Department of Insurance directly.

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