By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (Larotrectinib) Covered by Aetna CVS Health in Michigan: Complete Appeals Guide with Templates

Answer Box: Getting Vitrakvi Covered by Aetna CVS Health in Michigan

Aetna CVS Health requires prior authorization for Vitrakvi (larotrectinib) with mandatory NTRK gene fusion testing documentation. The fastest path to approval: 1) Submit PA request through Aetna's provider portal with positive NTRK fusion test results and clinical notes showing unresectable/metastatic disease, 2) Include prior therapy documentation or contraindications to alternatives, 3) If denied, file internal appeal within 180 days. Michigan residents have 127 days for external review through DIFS with binding decisions within 60 days (72 hours for expedited cases).

Table of Contents

Understanding Aetna CVS Health's Vitrakvi Requirements

Vitrakvi (larotrectinib) is a breakthrough oral TRK inhibitor approved by the FDA for adult and pediatric patients with solid tumors harboring NTRK gene fusions. With an annual cost approaching $400,000, Aetna CVS Health maintains strict prior authorization requirements to ensure appropriate use.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Every Vitrakvi prescription must be pre-approved Aetna 2024 Precertification List
NTRK Fusion Testing Positive test via NGS, FISH, or PCR required Molecular pathology report
Oncologist Prescription Must be prescribed by cancer specialist Provider credentials verification
Disease Status Unresectable, metastatic, or surgical morbidity Imaging reports, clinical notes
Prior Therapy Documentation Evidence of failure/intolerance or lack of alternatives Treatment history, physician notes

What Aetna CVS Health Looks For

Aetna's medical reviewers evaluate Vitrakvi requests based on FDA labeling requirements and clinical necessity. The drug is approved for tumor-agnostic use, meaning any solid tumor type qualifies if it has an NTRK gene fusion and meets other criteria.

Key approval factors:

  • Confirmed NTRK gene fusion (not just NTRK expression)
  • Tumor cannot be surgically removed without severe morbidity
  • Disease is metastatic or locally advanced
  • No satisfactory alternative treatments available, or progression after prior therapy

Step-by-Step: Fastest Path to Approval

1. Confirm NTRK Fusion Status (Patient/Physician)

Your oncologist must order comprehensive genomic testing if not already completed. Acceptable methods include next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR). The report must clearly document the fusion partner and confirm retention of the active tyrosine kinase domain.

Timeline: 1-2 weeks for test results
Submit to: Testing laboratory (FoundationOne, Caris, etc.)

2. Gather Required Documentation (Physician/Staff)

Compile all supporting materials before submitting the PA request:

  • NTRK fusion test results
  • Current imaging showing disease extent
  • Treatment history with dates and outcomes
  • ICD-10 diagnosis codes
  • Clinical notes justifying medical necessity

Timeline: 2-3 days
Submit to: Internal medical records team

3. Submit Prior Authorization (Physician)

Complete Aetna's specialty medication precertification form through their provider portal or submit via fax. Include all documentation from step 2.

Timeline: Same day submission
Submit to: Availity portal or CVS Caremark specialty pharmacy

4. Follow Up Within 72 Hours (Physician/Staff)

Contact Aetna to confirm receipt and completeness of your submission. Request expedited review if clinically urgent.

Timeline: 24-72 hours for standard review
Contact: Provider services line on denial letter

5. Address Any Requests for Additional Information (Physician)

Respond promptly to any requests for clarification or additional documentation. Common requests include more detailed treatment history or updated imaging.

Timeline: 24-48 hours response time
Submit to: Same portal/fax as original request

6. Receive Decision and Next Steps (All)

Aetna typically responds within 72 hours for complete submissions. If approved, the prescription can be filled through CVS Specialty Pharmacy. If denied, proceed immediately to appeals process.

Timeline: 1-3 business days
Next step: Appeal if denied (see below)

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
"No NTRK fusion documented" Submit complete molecular pathology report Lab report showing positive NTRK fusion with method and fusion partner
"Experimental/investigational" Cite FDA approval and tissue-agnostic indication FDA approval letter, clinical guidelines
"Tumor is resectable" Provide surgical consultation or imaging interpretation Surgeon's note on morbidity risk or imaging showing unresectability
"No prior therapy documented" Clarify if first-line appropriate or document failures Treatment timeline with dates and response assessments
"Non-specialist prescriber" Transfer prescription to oncologist Oncology consultation note and new prescription
From Our Advocates: We've seen cases where initial denials were overturned simply by resubmitting with a clearer molecular pathology report that explicitly stated "NTRK gene fusion positive" rather than just listing detected mutations. Small details in documentation can make a significant difference in approval rates.

Appeals Playbook for Michigan Residents

Michigan offers robust appeal rights under the Patient's Right to Independent Review Act. Here's your roadmap through each level:

Internal Appeals with Aetna CVS Health

First-Level Appeal:

  • Deadline: 180 days from denial date
  • How to file: Written request via member portal or certified mail
  • Timeline: 30 days for standard, 72 hours for expedited
  • Required: Original denial letter, additional clinical evidence, physician letter

Peer-to-Peer Review: Request a direct conversation between your oncologist and Aetna's medical director. This often resolves denials when clinical nuances need explanation.

  • How to request: Call number on denial letter
  • Preparation: Have NTRK test results, treatment history, and guideline references ready
  • Talking points: Emphasize FDA approval, lack of alternatives for NTRK-positive tumors, and disease progression risk

External Review Through Michigan DIFS

If Aetna upholds the denial after internal appeals, Michigan residents can request an independent external review through the Department of Insurance and Financial Services.

Standard External Review:

  • Deadline: 127 days from final internal denial
  • How to file: Online form or paper submission
  • Timeline: 60 days maximum (often faster)
  • Cost: Free to patient
  • Decision: Binding on Aetna

Expedited External Review:

  • Eligibility: Urgent medical condition where delay would harm patient
  • Timeline: 72 hours from complete submission
  • Required: Physician letter certifying medical urgency
  • Contact: DIFS at 877-999-6442

Medical Necessity Letter Template

When appealing a Vitrakvi denial, your oncologist's letter should address these key points:

[Date]

Re: Appeal for Vitrakvi (larotrectinib) Coverage
Patient: [Name], DOB: [Date], Policy #: [Number]
Denial Reference: [Number and Date]

To Whom It May Concern:

I am writing to appeal the denial of Vitrakvi (larotrectinib) for my patient [Name], who has [tumor type] with a confirmed NTRK gene fusion.

CLINICAL JUSTIFICATION:
- Patient has histologically confirmed [tumor type] with NTRK gene fusion detected by [testing method] (see attached report)
- Disease is [unresectable/metastatic] based on [imaging/surgical consultation] dated [date]
- Prior therapies include [list treatments with dates and outcomes]
- Vitrakvi is FDA-approved for this exact indication regardless of tumor origin

MEDICAL NECESSITY:
NTRK gene fusions occur in <1% of solid tumors but predict exceptional response to TRK inhibitors. Standard chemotherapy has limited efficacy in NTRK-positive tumors. Delay in appropriate targeted therapy risks disease progression and loss of performance status.

SUPPORTING EVIDENCE:
- FDA approval based on 75% overall response rate across tumor types
- NCCN Guidelines recommend TRK inhibitors as preferred therapy for NTRK-positive tumors
- No contraindications to larotrectinib in this patient

I respectfully request immediate reconsideration and approval of this medically necessary treatment.

Sincerely,
[Physician Name, Credentials]
[Contact Information]

Costs & Patient Assistance Programs

Even with insurance approval, Vitrakvi's high cost can create affordability challenges. Multiple assistance programs can help:

Manufacturer Support Programs

TRAK Assist Program (Bayer):

  • $0 copay for eligible commercial insurance patients
  • Bridge supply during appeals process
  • Prior authorization support
  • Contact: 1-833-VITRAKVI (1-833-848-7258)

Foundation Assistance

  • Patient Access Network (PAN) Foundation: Grants for underinsured patients
  • CancerCare Co-Payment Assistance: Financial aid for treatment costs
  • Leukemia & Lymphoma Society: Patient aid program

State-Specific Resources

Michigan residents may qualify for additional support through:

  • Michigan Department of Health and Human Services: Medicaid expansion programs
  • Priority Health: Community benefit programs for underinsured patients

Counterforce Health helps patients navigate these complex assistance programs while simultaneously working on insurance appeals, ensuring no gaps in access to critical medications.

When to Escalate to Michigan DIFS

Consider filing a complaint with Michigan DIFS if you experience:

  • Delayed responses: Aetna exceeding regulatory timelines (72 hours for expedited, 30 days for standard)
  • Inappropriate denials: Rejection despite meeting FDA-approved criteria
  • Procedural violations: Failure to provide proper appeal information or forms

How to file a complaint:

  • Online: DIFS complaint portal
  • Phone: 877-999-6442 (toll-free consumer hotline)
  • Mail: Michigan DIFS, Consumer Services Division, P.O. Box 30220, Lansing, MI 48909

Include your denial letters, appeal responses, and timeline documentation. DIFS investigates insurance company practices and can order corrective action.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in Michigan? Standard requests: 72 hours for complete submissions. Expedited requests (urgent medical need): 24 hours. Incomplete submissions may take longer while additional information is gathered.

What if Vitrakvi is non-formulary on my Aetna plan? Request a formulary exception through CVS Caremark. Provide clinical justification for why formulary alternatives are inappropriate for NTRK-positive tumors.

Can I request an expedited appeal in Michigan? Yes, if your physician certifies that delaying treatment would seriously jeopardize your health. Both Aetna internal appeals and DIFS external reviews offer expedited options with 72-hour decision timelines.

Does step therapy apply if I've failed treatments outside Michigan? Treatment history from any state counts toward step therapy requirements. Provide documentation of prior therapies and outcomes regardless of where treatment occurred.

What happens if DIFS rules against me? DIFS external review decisions are binding, but you can seek judicial review in Michigan circuit court within 60 days if you believe the decision was legally flawed.

How much does Vitrakvi cost without insurance? The wholesale acquisition cost is approximately $32,800 per month ($394,000 annually). Patient assistance programs can significantly reduce out-of-pocket costs for eligible patients.

Can my family doctor prescribe Vitrakvi? Aetna typically requires prescription by an oncology specialist. If your primary care physician is managing your cancer care, they may need to provide additional documentation of their expertise in oncology.

What if I need Vitrakvi for a pediatric patient? The same approval criteria apply to pediatric patients. Dosing is based on body surface area, and a liquid formulation is available for children who cannot swallow capsules.

This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance company's official channels for coverage determinations.

For personalized assistance with Vitrakvi appeals and prior authorization support, Counterforce Health specializes in turning insurance denials into evidence-backed approvals for specialty medications.

Sources & Further Reading

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