By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (larotrectinib) Covered by UnitedHealthcare in Virginia: Prior Authorization Guide and Appeal Scripts

Answer Box: Getting Vitrakvi Covered by UnitedHealthcare in Virginia

UnitedHealthcare requires prior authorization for Vitrakvi (larotrectinib) with specific criteria: confirmed NTRK gene fusion via validated testing, metastatic or unresectable solid tumor, and no known resistance mutations. Submit through OptumRx portal with molecular pathology report, staging documentation, and oncologist notes. Decisions typically take 7-14 days (24-72 hours if expedited). If denied, Virginia's State Corporation Commission provides external review within 45 days (72 hours for urgent cancer cases). Start today: Gather your NTRK fusion test results and contact your oncologist to initiate the prior authorization process.

Table of Contents

Coverage Requirements at a Glance

Requirement What UnitedHealthcare Needs Where to Find It Timeline
Prior Authorization Required for all ages via OptumRx UHC Provider Portal 7-14 days standard
NTRK Gene Fusion Validated NGS, FISH, or IHC test results Molecular pathology lab report Test takes 7-14 days
Disease Status Metastatic or unresectable solid tumor Staging scans (CT/MRI/PET) + pathology Current within 3 months
Resistance Testing No acquired mutations (G595R, G623R, etc.) Same molecular report Included in fusion testing
Age Categories Pediatric (<19): Auto-approved 12 months Birth certificate or medical records Immediate if under 19
Performance Status ECOG 0-2 documented Oncologist clinical notes At each visit

Step-by-Step: Fastest Path to Approval

1. Order NTRK Fusion Testing (Oncologist, 1-2 weeks)

Your oncologist orders comprehensive genomic profiling through a CLIA-certified laboratory. The test must specifically identify NTRK gene fusions (like ETV6-NTRK3 or TPM3-NTRK1) and screen for resistance mutations.

2. Gather Required Documentation (Patient/Clinic, 2-3 days)

Collect these essential documents:

  • Complete molecular pathology report with fusion details
  • Recent staging scans showing metastatic or unresectable disease
  • Oncologist notes documenting performance status and treatment goals
  • Summary of prior therapies (if applicable)

3. Submit Prior Authorization (Prescriber, Same day)

Your oncologist submits the PA through the OptumRx provider portal or calls 1-800-711-4555. All documentation must be attached to avoid delays.

Tip: Request expedited review if treatment delay could cause harm. UnitedHealthcare processes urgent requests within 24-72 hours.

4. Track Decision Status (Patient, Ongoing)

Monitor your approval status through the UnitedHealthcare member portal or by calling customer service. Approvals are valid for 12 months.

5. Fill at Specialty Pharmacy (Patient, 1-2 days)

Vitrakvi must be dispensed through OptumRx or an approved specialty pharmacy network. Your oncologist will coordinate the prescription transfer.

Clinician Corner: Medical Necessity Letter Checklist

Essential elements for a strong prior authorization:

  • Diagnosis: Specific solid tumor type with ICD-10 code
  • Molecular findings: NTRK fusion partner and testing method
  • Disease staging: Metastatic sites or reasons for inoperability
  • Prior treatments: Previous therapies, response, and discontinuation reasons
  • Clinical rationale: Reference to FDA labeling and NCCN guidelines
  • Monitoring plan: Follow-up schedule and response assessment criteria

Common Denial Reasons & How to Fix Them

Denial Reason Solution Required Documentation
Missing NTRK fusion result Submit complete molecular report NGS/FISH report with specific fusion identified
Tumor appears resectable Provide surgical consultation note Surgeon's assessment of operability and morbidity risk
No prior therapy documented Submit treatment history or contraindication rationale Previous oncology notes, allergy documentation
Non-specialist prescriber Transfer care or obtain oncology consultation Board-certified oncologist evaluation
Resistance mutations present Consider alternative TRK inhibitor or clinical trial Updated molecular testing, trial availability

Appeals Playbook for Virginia

Internal Appeals (First Step)

  • Timeline: 180 days from denial notice
  • Process: Submit through UnitedHealthcare member portal or mail to address on denial letter
  • Documents: Enhanced clinical justification, additional supporting evidence
  • Decision time: 30 days standard, 72 hours expedited

External Review Through Virginia SCC

If UnitedHealthcare upholds their denial, Virginia's State Corporation Commission provides independent review:

Standard External Review:

  • Filing deadline: 120 days from final internal denial
  • Process: Submit Form 216-A to SCC Bureau of Insurance
  • Timeline: 45 days for IRO decision
  • Cost: Free to patients

Expedited External Review (Cancer Cases):

  • When to use: Treatment delay could seriously jeopardize health
  • Timeline: 72 hours for IRO decision
  • Special provision: Can skip internal appeals if urgent
Virginia Advantage: The state allows expedited external review for cancer treatment denials without completing internal appeals first—a unique protection for patients needing immediate care.

Contact Virginia SCC Bureau of Insurance:

Costs & Patient Support Programs

Manufacturer Support (Bayer)

  • TRAK Assist Program: Provides coverage support, prior authorization assistance, and potential $0 copay for eligible commercial patients
  • Bridge therapy: Free drug while appeals are pending
  • Contact: 1-833-TRAK-ASS (1-833-872-5277)

Additional Resources

  • Patient Advocate Foundation: Financial assistance for cancer medications
  • CancerCare: Copay assistance and emotional support
  • Virginia Cancer Registry: May provide resource referrals

When Vitrakvi Isn't Available: Alternative Options

Rozlytrek (entrectinib)

Similarities: Also targets NTRK fusions; covers ROS1-positive NSCLC Differences: More intensive cardiac monitoring required; different side effect profile Coverage: Similar PA requirements through UnitedHealthcare

Clinical Trials

If both approved TRK inhibitors are denied or inappropriate:

  • ClinicalTrials.gov: Search for NTRK fusion-positive tumor studies
  • National Cancer Institute: 1-800-4-CANCER for trial matching
  • Local cancer centers: Many participate in investigational drug studies

Exception Requests

When standard alternatives fail or are contraindicated, document:

  • Specific medical reasons other options won't work
  • Unique benefits of Vitrakvi for your situation
  • Supporting literature or case reports

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform helps patients and providers navigate complex prior authorization requirements and appeals processes, significantly improving approval rates for specialty medications like Vitrakvi.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Vitrakvi in Virginia? Standard requests take 7-14 days. Expedited requests (when delay could cause harm) are processed within 24-72 hours. Submit early to avoid treatment delays.

What if my NTRK fusion test is negative? Vitrakvi is only approved for NTRK fusion-positive tumors. If negative, discuss alternative targeted therapies based on other molecular findings with your oncologist.

Can I appeal if UnitedHealthcare says Vitrakvi is experimental? Yes. Vitrakvi has FDA approval for NTRK fusion-positive solid tumors. Reference the FDA label and NCCN guidelines in your appeal.

Does step therapy apply to Vitrakvi? UnitedHealthcare's 2025 policy doesn't specify step therapy requirements for NTRK inhibitors, but document any prior treatments and their outcomes to strengthen your case.

What if I'm under 19 years old? Great news—UnitedHealthcare automatically approves Vitrakvi for pediatric patients under 19 for 12 months without additional review.

Can I get expedited review in Virginia for cancer treatment? Yes. Virginia allows expedited external review for cancer cases where treatment delay could cause serious harm, with decisions in 72 hours.

What happens if my appeal is denied? After exhausting UnitedHealthcare's internal appeals, you can request external review through Virginia's State Corporation Commission. The independent reviewer's decision is binding on the insurance company.

From Our Advocates

"We've seen many Virginia patients successfully obtain Vitrakvi coverage after initial denials by submitting comprehensive molecular reports that clearly document the specific NTRK fusion and demonstrate why the tumor is unresectable. The key is often getting a surgical consultation note that explicitly states the risks of attempted resection outweigh potential benefits."

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan. Always verify current requirements with your insurance company and consult your healthcare provider for medical decisions. For assistance with complex appeals, consider working with coverage advocates like Counterforce Health who specialize in overturning specialty drug denials.

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