By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (Larotrectinib) Covered by Humana in Michigan: Complete PA Guide and Appeal Process

Quick Answer: Vitrakvi (larotrectinib) requires prior authorization from Humana in Michigan as a Tier 5 specialty drug. Submit the Medicare Prescription Drug Coverage Determination form with NTRK fusion test results, oncologist notes, and prior therapy documentation to fax 877-486-2621. Standard approval takes 72 hours; expedited requests are decided in 24 hours. If denied, you have 65 days to appeal and can request Michigan DIFS external review within 127 days of final denial.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timeline Expectations
  6. Common Denial Reasons and Solutions
  7. Appeals Process in Michigan
  8. Renewal and Re-Authorization
  9. Cost Assistance Programs
  10. FAQ

What This Guide Covers

This comprehensive guide helps Michigan patients and their healthcare providers navigate Humana's prior authorization process for Vitrakvi (larotrectinib), a targeted therapy for solid tumors with NTRK gene fusions. Whether you have Humana Medicare Advantage, commercial coverage, or are facing a denial, we'll walk you through each step to maximize your chances of approval.

Vitrakvi is FDA-approved for adult and pediatric patients with solid tumors that have NTRK gene fusions, are metastatic or unresectable, and have no satisfactory treatment alternatives. With an annual cost of approximately $394,000, securing insurance coverage is crucial for most patients.

Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, payer-specific submissions. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and craft targeted appeals that address each plan's specific criteria.

Before You Start: Verify Your Coverage

Check Your Plan Type and Formulary Status

First, confirm your specific Humana plan type, as requirements vary:

  • Humana Medicare Advantage Part D: Most common in Michigan; covers ~20 different plan options
  • Humana Commercial: Employer-sponsored plans
  • Humana Medicaid: Dual-eligible special needs plans

Vitrakvi is typically placed on Tier 5 (specialty) across Humana formularies, requiring the highest copay/coinsurance and prior authorization. Use Humana's drug search tool to confirm your specific plan's coverage.

Verify Network Status

Ensure your oncologist participates in your Humana network. Non-network prescribers face additional scrutiny and delays. Vitrakvi must be dispensed through CenterWell Specialty Pharmacy, Humana's preferred specialty pharmacy network.

Gather Required Documentation

Essential Clinical Documentation

NTRK Fusion Testing Results

  • CLIA-certified laboratory report documenting specific NTRK gene fusion
  • Acceptable methods: NGS panels, FDA-approved companion diagnostics
  • Must identify fusion partner (e.g., ETV6-NTRK3) and confirm intact kinase domain

Pathology and Staging

  • Primary tumor pathology report with histology
  • Imaging studies confirming metastatic or unresectable disease
  • Surgical consultation notes (if applicable) documenting inoperability

Treatment History

  • Complete prior therapy timeline with dates, responses, and discontinuation reasons
  • Documentation of treatment failures or intolerances
  • Rationale for first-line use if no prior therapies attempted

Administrative Requirements

  • Current Humana member ID and plan details
  • Correct ICD-10 diagnosis codes for primary malignancy
  • Patient weight and BSA (for pediatric dosing)
  • Prescriber DEA and NPI numbers

Submit Your Prior Authorization Request

Submission Methods

Electronic Submission (Fastest)

  • Use Humana's provider portal or standard ePA platforms
  • Typical processing: 24-72 hours for complete submissions

Fax Submission

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all Humana plans Humana PA List
Formulary Tier Tier 5 (Specialty) Drug Guide
Prescriber Oncology specialist preferred Clinical best practice
NTRK Testing Mandatory fusion documentation FDA labeling requirement
Dispensing CenterWell Specialty Pharmacy Specialty network

Follow-Up and Timeline Expectations

Standard Processing Times

  • Standard PA: 72 hours from complete submission
  • Expedited PA: 24 hours with medical urgency documentation
  • Incomplete submissions: Additional 3-7 days for information requests

Follow-Up Best Practices

Call Humana's Clinical Pharmacy Review team at 800-555-2546 (Monday-Friday, 8am-6pm ET) to:

  • Confirm receipt of your submission
  • Check processing status
  • Provide additional information if requested
  • Request expedited review for urgent cases
Tip: Keep detailed records of all reference numbers, representative names, and conversation summaries. This documentation proves invaluable if appeals become necessary.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing NTRK fusion report Submit complete molecular pathology results CLIA lab report with specific fusion details
Non-oncology prescriber Transfer prescription to oncologist Board-certified hematology/oncology specialist
Tumor considered resectable Provide surgical consultation Note documenting unresectability or prohibitive morbidity
Insufficient prior therapy Document treatment history Complete timeline of prior regimens and outcomes
Off-label use concerns Submit guideline support NCCN guidelines or peer-reviewed literature

Appeals Process in Michigan

Internal Appeals (Humana)

If your initial request is denied, you have 65 days from the denial notice to file an internal appeal:

  1. File redetermination request via Humana appeals portal or phone (800-867-6601)
  2. Include strengthened documentation addressing specific denial reasons
  3. Request expedited review if waiting poses serious health risks
  4. Receive decision within 7 days (standard) or 24 hours (expedited)

Michigan External Review Process

Michigan offers robust external review rights under the Patient's Right to Independent Review Act, administered by the Department of Insurance and Financial Services (DIFS):

Timeline: 127 days from final Humana denial to file external review Process: DIFS assigns case to Independent Review Organization (IRO) Decision time: 60 days maximum (72 hours for expedited cases) Cost: No fee to patients

To file external review:

  • Use DIFS online External Review Request form
  • Include denial letters, medical records, and physician support letter
  • Call DIFS at 877-999-6442 for assistance
From our advocates: "We've seen Michigan patients successfully overturn Humana denials by working closely with their oncologists to document the urgency of treatment. One key strategy is having the prescriber clearly articulate why surgical options aren't viable and why Vitrakvi represents the best available therapy based on the patient's specific NTRK fusion type."

Renewal and Re-Authorization

Typical Approval Patterns

  • Initial approval: 3-6 months
  • Subsequent renewals: 6-12 months
  • Renewal requirements: Evidence of clinical benefit, tolerability assessment, absence of disease progression

Renewal Timeline

Submit renewal requests 30 days before current authorization expires to prevent treatment interruption. Renewals typically process within 24-48 hours when clinical response is well-documented.

When working with Counterforce Health, our platform automatically tracks renewal deadlines and prepares documentation packages that align with Humana's specific requirements, significantly reducing the risk of coverage gaps.

Cost Assistance Programs

Manufacturer Support

Bayer TRAK Assist Program

  • Phone: 1-844-275-2360
  • Services: PA support, appeals assistance, bridge therapy
  • Copay program: $0 copay for eligible commercial patients

Specialty Pharmacy Benefits

CenterWell Specialty Pharmacy offers:

  • Financial assistance coordination
  • Clinical support and monitoring
  • Expedited shipping in unmarked packaging
  • Contact: 1-800-486-2668

FAQ

How long does Humana prior authorization take for Vitrakvi in Michigan? Standard PA requests are processed within 72 hours of complete submission. Expedited requests for urgent medical situations are decided within 24 hours.

What if Vitrakvi is not on my Humana formulary? You can request a formulary exception by submitting the same PA documentation. Humana must respond within 72 hours for standard requests.

Can I request an expedited appeal in Michigan? Yes, both Humana internal appeals and Michigan DIFS external reviews offer expedited processes when waiting would seriously jeopardize your health.

Does step therapy apply to Vitrakvi? Given Vitrakvi's tumor-agnostic indication for NTRK fusion-positive cancers, step therapy requirements are typically waived when proper molecular testing confirms eligibility.

What happens if Humana denies my appeal? You can escalate to Michigan's external review process through DIFS within 127 days of the final denial. This independent medical review is binding on Humana.

How do I find my specific Humana plan's formulary? Log into your MyHumana account or use the drug search tool with your ZIP code to access your plan-specific formulary.

Checklist: Before You Start

  • Insurance card with member ID and plan type
  • NTRK gene fusion test results from CLIA-certified lab
  • Pathology report confirming solid tumor diagnosis
  • Imaging studies showing metastatic/unresectable disease
  • Complete prior therapy documentation
  • Oncologist treatment notes and rationale
  • Patient weight and BSA (for dosing calculations)
  • ICD-10 diagnosis codes

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage policies, forms, and contact information may change. Always verify current requirements with Humana and consult your healthcare provider for medical decisions. For assistance with complex prior authorization cases, consider consulting with coverage specialists like Counterforce Health who can provide personalized guidance based on your specific situation.

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