By Counterforce Health Team in Vitrakvi (larotrectinib) —

Aetna CVS Health's Coverage Criteria for Vitrakvi (Larotrectinib) in Virginia: What Counts as "Medically Necessary"?

Answer Box: Getting Vitrakvi (Larotrectinib) Covered by Aetna CVS Health in Virginia

Aetna CVS Health requires prior authorization for Vitrakvi with three key requirements: confirmed NTRK gene fusion via validated testing, metastatic/unresectable solid tumor status, and documented failure or unsuitability of standard therapies. The fastest path to approval: (1) Order NTRK fusion testing via RNA-based NGS, (2) compile prior treatment records, and (3) submit PA through CVS Specialty Pharmacy with complete molecular pathology report. If denied, Virginia offers external review through the State Corporation Commission within 120 days.

Table of Contents

  1. Policy Overview
  2. Indication Requirements
  3. Step Therapy & Exceptions
  4. Quantity and Frequency Limits
  5. Required Diagnostics
  6. Site of Care & Specialty Pharmacy
  7. Evidence to Support Medical Necessity
  8. Sample "Meets Criteria" Narrative
  9. Edge Cases
  10. Quick Reference Table
  11. Appeals Playbook for Virginia
  12. FAQ

Policy Overview

Aetna CVS Health treats Vitrakvi (larotrectinib) as a specialty oncology medication requiring prior authorization across all plan types - Commercial PPO/HMO, Medicare Advantage, and Medicaid managed care products. The drug is distributed exclusively through CVS Specialty Pharmacy under their oncology oral solids tumor program.

Plan Type Coverage Variations:

  • Commercial plans: Standard PA with 72-hour decision timeline
  • Medicare Advantage: Additional Part D formulary restrictions may apply
  • Aetna Better Health (Medicaid): State-specific criteria with expedited review options

Policy documents are housed in Aetna's precertification database, with drug-specific criteria accessible through the CVS Caremark provider portal.

Indication Requirements

Aetna's coverage criteria closely mirror the FDA's tumor-agnostic approval for Vitrakvi. The medication is considered medically necessary when prescribed for:

FDA-Approved Indication:

  • Adult and pediatric patients with solid tumors harboring NTRK gene fusions
  • Metastatic or surgically unresectable disease
  • No satisfactory alternative treatment options, OR
  • Disease progression following treatment

Documentation Must Include:

  • Histologically confirmed solid tumor (any primary site)
  • Staging studies confirming metastatic or unresectable status
  • NTRK fusion testing results from validated laboratory
  • Treatment history demonstrating standard therapy failure or unsuitability
Note: Aetna does not restrict coverage to specific tumor types, aligning with the FDA's tissue-agnostic approval.

Step Therapy & Exceptions

Unlike many targeted therapies, Vitrakvi typically doesn't face rigid step therapy requirements due to its unique NTRK fusion-positive indication. However, Aetna requires documentation of prior treatment attempts or clinical rationale for first-line use.

Medical Exception Pathways:

  • Prior Treatment Failure: Document specific therapies tried, duration, and reason for discontinuation
  • Contraindications: Provide clinical evidence why standard treatments are unsuitable
  • Tumor Biology: NTRK fusion status may supersede typical sequencing requirements

Virginia-Specific Protections: Virginia insurance regulations provide additional step therapy override protections for cancer patients, requiring expedited review (72 hours) when delay could jeopardize health outcomes.

Quantity and Frequency Limits

Standard Quantity Limits:

  • Adults: 60 capsules per 30-day supply (100mg twice daily)
  • Pediatrics: Variable based on BSA calculation and formulation (capsule vs. solution)
  • Initial fills: Often limited to 30-day supply pending tolerance assessment

Renewal Requirements:

  • Clinical response documentation every 3-6 months
  • Imaging studies showing stable disease or response
  • Toxicity assessment and dose modification rationale

Override Requests: Submit quantity limit exceptions through the CVS Caremark PA portal with clinical justification for dose adjustments or extended supplies.

Required Diagnostics

NTRK Gene Fusion Testing - Critical Requirement:

Aetna requires explicit documentation of NTRK1, NTRK2, or NTRK3 gene fusion via validated testing methods:

Testing Method Acceptability Documentation Needed
RNA-based NGS Preferred Full laboratory report with fusion partner identification
FISH Acceptable Positive result with methodology details
Pan-TRK IHC + Confirmation Conditional IHC screening MUST be confirmed by molecular testing

Laboratory Report Requirements:

  • CLIA-certified or CAP-accredited laboratory
  • Specimen adequacy (minimum 10% tumor content)
  • Specific fusion identification (e.g., ETV6-NTRK3)
  • Testing methodology clearly stated

Clinical Staging Documentation:

  • CT or MRI confirming metastatic/unresectable disease
  • Performance status assessment (ECOG 0-2 typically required)
  • Baseline organ function studies

Site of Care & Specialty Pharmacy

CVS Specialty Pharmacy Requirement: Vitrakvi is distributed exclusively through CVS Specialty Pharmacy for Aetna members. No site-of-care restrictions apply since it's an oral medication for home administration.

Enrollment Process:

  1. Prescriber completes CVS Specialty enrollment form
  2. CVS Specialty initiates PA process
  3. Patient counseling and delivery coordination
  4. Ongoing adherence monitoring and refill management

Out-of-Network Considerations: Using non-CVS specialty pharmacies may result in coverage denial or significantly higher out-of-pocket costs.

Evidence to Support Medical Necessity

Clinical Guidelines to Reference:

  • FDA prescribing information for tumor-agnostic indication
  • NCCN Guidelines supporting NTRK inhibitor use in fusion-positive tumors
  • Peer-reviewed efficacy data from registrational trials

Documentation Strategy: Include concise references to published response rates (overall response rate ~75% across tumor types) and duration of response data supporting Vitrakvi's clinical benefit in NTRK fusion-positive cancers.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying the specific denial basis and crafting point-by-point rebuttals aligned to each plan's own coverage criteria. Their platform pulls the right clinical citations and weaves them into appeals with all required documentation.

Sample "Meets Criteria" Narrative

"Patient is a [age]-year-old with histologically confirmed [tumor type], metastatic disease documented by [imaging date/findings]. NTRK gene fusion testing performed at [laboratory name] on [date] demonstrates [specific fusion, e.g., ETV6-NTRK3] via RNA-based next-generation sequencing. Prior systemic therapies include [list treatments, dates, responses]. Standard treatment options are [exhausted/contraindicated] due to [specific reasons]. ECOG performance status is [0-2]. Vitrakvi (larotrectinib) 100mg twice daily is requested per FDA-approved indication for NTRK fusion-positive solid tumors. Treatment aligns with NCCN recommendations for targeted therapy in biomarker-selected patients."

Edge Cases

Pediatric Considerations:

  • BSA-based dosing calculations required
  • Liquid formulation may be necessary for younger patients
  • Additional safety monitoring protocols

Pregnancy/Reproductive Health:

  • Contraception requirements for patients of childbearing potential
  • Pregnancy testing documentation
  • Risk-benefit assessment in reproductive-age patients

Comorbidity Management:

  • Drug interaction screening with hepatic metabolism considerations
  • Dose modifications for organ dysfunction
  • Concurrent medication review

Escalation Paths: For complex cases, request peer-to-peer review with Aetna's medical director or consider external review through Virginia's State Corporation Commission if standard appeals are unsuccessful.

Quick Reference Table

Requirement Documentation Needed Common Errors Source
NTRK Fusion RNA-NGS or FISH report from certified lab IHC-only testing, unclear fusion status Testing Guidelines
Disease Status Imaging confirming metastatic/unresectable Missing staging, resectable disease FDA Label
Prior Therapy Treatment history with dates/responses Incomplete records, missing failures PA Form
Prescriber Medical oncologist or specialist Primary care prescriber Aetna Policy
Pharmacy CVS Specialty enrollment Attempting retail pharmacy fill CVS Specialty

Appeals Playbook for Virginia

Internal Appeals Timeline:

  • Standard: 30-45 days for decision
  • Expedited: 72 hours if delay jeopardizes health
  • Deadline: 180 days from denial notice

External Review Process: Virginia's State Corporation Commission Bureau of Insurance offers binding external review for medical necessity denials.

Steps for External Review:

  1. Complete internal appeals first (except urgent cases)
  2. File Form 216-A within 120 days of final denial
  3. SCC assigns Independent Review Organization (IRO)
  4. IRO decision within 45 days (72 hours if expedited)
  5. Binding decision on insurer

Virginia-Specific Advantages:

  • No cost for external review
  • Expedited process for cancer treatment denials
  • Managed Care Ombudsman support available

For patients navigating complex appeals, Counterforce Health provides specialized support in crafting evidence-backed appeals that address specific payer criteria and procedural requirements.

FAQ

How long does Aetna CVS Health PA take for Vitrakvi in Virginia? Standard decisions within 72 hours; expedited reviews within 24 hours for urgent cases.

What if Vitrakvi is non-formulary on my plan? Submit formulary exception request with clinical justification and NTRK fusion documentation.

Can I request expedited appeal if denied? Yes, if your oncologist certifies that delay would jeopardize your health or ability to regain function.

Does step therapy apply if I failed treatments outside Virginia? Treatment history from any location counts; provide complete records with dates and outcomes.

What happens if CVS Specialty denies enrollment? Contact Aetna member services and request alternative specialty pharmacy authorization.

How do I get help with the appeals process in Virginia? Contact the Virginia SCC Consumer Services at 1-877-310-6560 or the Managed Care Ombudsman.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on individual plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For personalized assistance with insurance appeals and prior authorization, visit Counterforce Health.

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