By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (larotrectinib) Covered by Cigna in California: Complete Guide to Prior Authorization and Appeals

Answer Box: Quick Path to Coverage

Cigna requires prior authorization for Vitrakvi (larotrectinib) in California, with approval typically within 5 business days when complete documentation is submitted. Your oncologist must provide NTRK fusion test results, treatment history, and medical necessity justification. If denied, California's Independent Medical Review (IMR) overturns 55-70% of medical necessity denials for specialty oncology drugs. Start today: Have your oncologist submit the PA via CoverMyMeds or Cigna's provider portal with your molecular pathology report and prior therapy documentation.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all specialty-tier oncology drugs Cigna Formulary PDF
NTRK Fusion Testing Validated assay confirming NTRK gene fusion FDA-approved tests (FoundationOne CDx, others)
Prescriber Oncology specialist preferred Cigna provider directory
Age Limits None (FDA-approved for adults and pediatrics) FDA Label
Duration Initial approval typically 1 year Plan-specific policy
Appeals Deadline 180 days from denial California Health & Safety Code

Step-by-Step: Fastest Path to Approval

1. Confirm Your NTRK Fusion Status

Who: Your oncologist orders the test
What: FDA-approved molecular testing (NGS, FISH, or IHC)
Timeline: 7-14 days for results
Key point: Cigna requires documented NTRK fusion before considering coverage

2. Gather Required Documentation

Who: You and your care team
What you need:

  • Complete molecular pathology report
  • Treatment history and prior therapy failures
  • Staging/imaging showing metastatic or unresectable disease
  • ICD-10 diagnosis codes
  • Current weight/BSA for dosing (pediatric patients)

3. Submit Prior Authorization

Who: Your oncologist's office
How: CoverMyMeds ePA portal or Cigna provider portal
Timeline: Cigna responds within 5 business days for routine requests, 72 hours for urgent cases
Pro tip: Electronic submissions process faster than fax

4. Track Your Request

Who: You or your clinic
How: Cigna member portal or call 1-800-882-4462
What to expect: Approval, denial, or request for additional information

5. If Approved: Coordinate Specialty Pharmacy

Who: Cigna coordinates with Accredo (their specialty pharmacy)
Timeline: 5-7 days from approval to first delivery
Your role: Confirm delivery address and insurance information

California's Unique Protections

California offers stronger patient protections than most states, especially for specialty oncology drugs like Vitrakvi.

Step Therapy Overrides (AB 347)

Under California law, Cigna must grant step therapy exceptions if:

  • You've tried the preferred drug and it failed or caused intolerable side effects
  • The preferred drug is contraindicated based on your medical history
  • Prior therapy attempts from any state count toward California requirements

Independent Medical Review Success Rates

California's Department of Managed Health Care (DMHC) data shows:

  • 55-70% of medical necessity denials are overturned for specialty oncology drugs
  • Additional 10-25% are reversed by plans during the IMR process
  • No cost to patients for filing an IMR

From our advocates: "We've seen multiple NTRK inhibitor denials overturned at IMR when patients included comprehensive molecular testing reports and clear documentation that standard chemotherapy wasn't appropriate. The key is showing this isn't experimental—it's precision medicine based on your tumor's genetics."

Expedited Review Rights

For progressive cancer, California requires:

  • 72-hour decisions for urgent prior authorization requests
  • Expedited IMR within 7 days if internal appeals are denied
  • Automatic approval if Cigna misses response deadlines

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"No NTRK fusion documented" Resubmit with complete pathology report Molecular testing results with fusion partner identified
"Not medically necessary" Provide NCCN guideline citations NCCN Guidelines for your specific tumor type
"Experimental/investigational" Emphasize FDA approval and guideline support FDA label, peer-reviewed studies, treatment center protocols
"Tumor appears resectable" Document unresectability or metastatic disease Current imaging, surgeon consultation notes
"Insufficient prior therapy" Show previous treatments tried and failed Complete treatment history with dates and outcomes

Clinician Corner: Medical Necessity Letter Checklist

For prescribers submitting Vitrakvi prior authorization requests:

Essential elements to include:

  • Patient's specific NTRK fusion type and testing methodology
  • TNM staging and evidence of unresectable/metastatic disease
  • Prior systemic therapies attempted with dates and reasons for discontinuation
  • Current performance status and treatment goals
  • Reference to NCCN Guidelines Category 1 recommendation for NTRK inhibitors
  • Planned monitoring schedule and duration of therapy

Helpful language: "This patient has a confirmed NTRK gene fusion-positive solid tumor as demonstrated by [specific test]. Standard chemotherapy approaches have been exhausted/are inappropriate due to [specific reasons]. NCCN Guidelines provide a Category 1 recommendation for TRK inhibitors in this clinical scenario."

Appeals Playbook for Cigna in California

Level 1: Internal Appeal

  • Deadline: 180 days from denial
  • How to file: Cigna member portal, phone (1-800-882-4462), or mail
  • Timeline: 15-30 days for decision
  • What to include: Denial letter, medical records, physician statement, clinical evidence

Level 2: Independent Medical Review (IMR)

  • When: After internal appeal denial or 30 days with no response
  • How to file: DMHC online portal or call 888-466-2219
  • Cost: Free to patients
  • Timeline: 45 days standard, 7 days expedited
  • Success rate: 55-70% overturn rate for oncology medical necessity disputes

Scripts for Common Situations

Calling Cigna about PA status: "Hi, I'm calling to check the status of a prior authorization request for Vitrakvi, generic name larotrectinib. The request was submitted on [date] for [patient name], member ID [number]. Can you tell me if any additional information is needed and when I can expect a decision?"

Requesting expedited review: "This is an urgent request for a patient with progressive NTRK fusion-positive cancer. Any delay in treatment could result in disease progression and compromise treatment outcomes. Please process this as an expedited review under California's 72-hour requirement."

Costs & Patient Assistance

Manufacturer Support

Bayer/Loxo Oncology Access Services:

  • Copay assistance program (may reduce costs to $0 for eligible commercial patients)
  • Bridge therapy during appeals process
  • Prior authorization support services
  • Contact: 1-833-VITRAKVI (1-833-848-7258)

Foundation Grants

  • Patient Access Network Foundation
  • The Leukemia & Lymphoma Society
  • CancerCare Co-Payment Assistance Foundation
  • Verify eligibility: many have income limits and cancer-type restrictions

State Programs

California residents may qualify for additional assistance through:

  • Covered California premium subsidies
  • Medi-Cal (California's expanded Medicaid program)
  • County indigent care programs

When to Escalate to State Regulators

Contact the California Department of Managed Health Care (DMHC) if:

  • Cigna misses response deadlines (5 days routine, 72 hours urgent)
  • You suspect the denial wasn't based on medical evidence
  • The plan refuses to follow California step therapy override laws
  • You need help filing an Independent Medical Review

DMHC Help Center: 888-466-2219
Online: healthhelp.ca.gov

The Health Consumer Alliance provides free assistance to California residents appealing health plan denials, including specialty drug coverage disputes. They've successfully overturned cancer treatment denials through DMHC advocacy.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform ingests denial letters and clinical notes to draft point-by-point rebuttals aligned to each plan's specific rules, pulling the right citations for medications like Vitrakvi and weaving them into appeals with required clinical facts and operational details payers expect.

Frequently Asked Questions

How long does Cigna prior authorization take in California? Standard requests: 5 business days. Urgent requests: 72 hours. Cigna processes most specialty drug PAs through Express Scripts, which completes coverage reviews within 2 days of receiving complete information.

What if Vitrakvi is non-formulary on my Cigna plan? You can request a formulary exception. Your oncologist must provide clinical justification for why preferred alternatives aren't appropriate. California law requires plans to have a transparent exception process.

Can I get expedited review if my cancer is progressing? Yes. California requires 72-hour decisions for urgent situations. Your oncologist must certify that delay poses a serious threat to your health.

Does step therapy apply if I failed treatments in another state? Under California's AB 347, prior therapy attempts from any state count toward step therapy requirements. Cigna cannot require you to retry medications that previously failed.

What happens if I move to California mid-treatment? California has continuity-of-care protections. If you're already on Vitrakvi, Cigna generally must continue coverage while evaluating your case under their criteria.

How successful are appeals for NTRK inhibitors? California's IMR data shows 55-70% success rates for medical necessity appeals in oncology. Success is higher when complete molecular testing documentation and guideline support are provided.

Can I use manufacturer copay assistance with Cigna? Yes, for most commercial Cigna plans. Medicare and Medicaid plans may have restrictions. Check with Bayer's TRAK Assist program for current eligibility.

What if Cigna requires me to try entrectinib (Rozlytrek) first? This would be step therapy. Your oncologist can request an override based on clinical factors like drug interactions, CNS involvement, or your specific NTRK fusion type.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and should not replace professional medical or legal advice. Coverage decisions vary by individual plan and medical circumstances. For personalized guidance, consult your healthcare provider and insurance plan directly. Counterforce Health provides specialized support for navigating complex prior authorization and appeal processes.

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