By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (larotrectinib) Covered by Aetna (CVS Health) in Pennsylvania: Forms, Appeals, and Alternative Options

Quick Answer: Getting Vitrakvi (larotrectinib) Covered by Aetna (CVS Health) in Pennsylvania

Vitrakvi requires prior authorization from Aetna (CVS Health) in Pennsylvania. To get approval: (1) Submit NTRK gene fusion test results confirming tumor positivity, (2) provide clinical documentation showing metastatic/unresectable disease, and (3) include records of prior therapies if required by step therapy. If denied, Pennsylvania's new external review program has overturned roughly 53% of appealed denials in 2024. Start by calling Aetna's precertification line at 1-800-624-0756 and requesting the specialty drug prior authorization forms.

Table of Contents

  1. When Formulary Alternatives Make Sense
  2. Typical Alternatives to Vitrakvi
  3. Pros and Cons Overview
  4. Exception Strategy for Vitrakvi
  5. Switching Logistics
  6. Re-trying for Vitrakvi Later
  7. Coverage Requirements at a Glance
  8. Appeals Playbook for Pennsylvania
  9. Common Denial Reasons & Solutions
  10. Frequently Asked Questions

When Formulary Alternatives Make Sense

If Aetna (CVS Health) denies Vitrakvi (larotrectinib) coverage, considering alternatives may be appropriate in specific situations. Formulary alternatives make sense when:

  • Initial denial is based on non-formulary status rather than medical necessity
  • Step therapy requirements mandate trying other NTRK inhibitors first
  • Patient has specific contraindications to larotrectinib (drug interactions, liver dysfunction)
  • Urgent treatment is needed while appealing the Vitrakvi denial

However, alternatives should only be considered with oncologist guidance, as NTRK fusion-positive cancers are rare and treatment options are limited.

Note: According to Aetna's 2025 specialty drug list, Vitrakvi requires prior authorization but is covered when criteria are met.

Typical Alternatives to Vitrakvi

FDA-Approved NTRK Inhibitors

Rozlytrek (entrectinib) is the primary alternative to Vitrakvi for NTRK fusion-positive solid tumors:

  • Also targets ROS1 fusions in non-small cell lung cancer
  • Better CNS penetration than larotrectinib
  • Requires the same NTRK fusion testing documentation
  • Similar prior authorization requirements with Aetna

Augtyro (repotrectinib) is a newer option:

  • FDA-approved for NTRK fusion-positive solid tumors
  • Also covers ROS1-positive NSCLC
  • May be non-formulary on some Aetna plans, requiring exceptions

Off-Label Considerations

In rare cases, oncologists may consider broader-spectrum kinase inhibitors, though these are not NTRK-specific and generally less effective. These would require extensive clinical justification for coverage.

Pros and Cons Overview

Alternative Coverage Pros Coverage Cons Clinical Considerations
Rozlytrek (entrectinib) Established formulary status; NCCN preferred Same PA requirements as Vitrakvi Better for CNS metastases; similar efficacy
Augtyro (repotrectinib) Newer option with high response rates May require formulary exception Limited long-term data; resistance profile unclear
Off-label options Potentially lower cost Extensive justification required Generally less effective for NTRK fusions

Exception Strategy for Vitrakvi

When requesting a formulary exception for Vitrakvi from Aetna (CVS Health), focus on these key elements:

Medical Necessity Documentation

Your oncologist should include:

  • NTRK fusion test results from an FDA-approved assay
  • Tumor staging confirming metastatic or unresectable disease
  • Prior treatment history and documented failures/intolerances
  • Clinical rationale citing FDA labeling and NCCN guidelines
  • Contraindications to formulary alternatives (if applicable)

Submission Process

  1. Complete Aetna's specialty drug PA form (available through CVS Specialty)
  2. Fax to 1-888-267-3277 or submit via Availity portal
  3. Request expedited review if treatment delay poses health risks
  4. Follow up within 48 hours to confirm receipt
Tip: According to Aetna's policies, prior authorization requests are typically reviewed within 24 hours once complete documentation is received.

Switching Logistics

If you need to start an alternative while appealing for Vitrakvi:

Coordination Steps

  1. Confirm NTRK testing results apply to the alternative drug
  2. Submit separate PA request for the alternative (Rozlytrek/Augtyro)
  3. Coordinate with CVS Specialty Pharmacy for dispensing
  4. Maintain appeal timeline for Vitrakvi during alternative treatment
  5. Document response/tolerability to support future Vitrakvi requests

Pharmacy Network Requirements

Aetna requires specialty oncology drugs to be dispensed through approved networks:

  • CVS Specialty Pharmacy is the primary network
  • Limited distribution may require specific specialty pharmacies
  • 30-day supplies are typical, with prior authorization renewal required

Re-trying for Vitrakvi Later

If you start with an alternative, you can request Vitrakvi coverage later by documenting:

Failure or Intolerance Evidence

  • Disease progression on the alternative (imaging, biomarkers)
  • Adverse effects requiring discontinuation
  • Drug interactions preventing optimal dosing
  • Quality of life impacts affecting treatment adherence

Clinical Documentation

Your oncologist should provide:

  • Treatment timeline showing alternative trial duration
  • Response assessment with objective measures
  • Rationale for switching based on clinical guidelines
  • Updated staging and disease status

Counterforce Health specializes in helping patients navigate these complex coverage scenarios by analyzing denial patterns and crafting targeted appeals that align with payer-specific requirements.

Coverage Requirements at a Glance

Requirement Details Documentation Source
Prior Authorization Required for all NTRK inhibitors Aetna 2025 Precertification List
NTRK Fusion Testing FDA-approved assay results required Clinical lab report
Disease Status Metastatic or unresectable tumors Oncology notes, imaging
Specialist Prescriber Oncologist or hematologist DEA/NPI verification
Specialty Pharmacy CVS Specialty network required CVS Specialty enrollment
Review Timeline 24-48 hours standard; 72 hours expedited Aetna policy

Appeals Playbook for Pennsylvania

Internal Appeal Process

Timeline: 180 days from denial to file; 30-45 days for standard review

Required Documents:

  • Original denial letter
  • Updated medical necessity letter
  • Additional clinical evidence
  • Aetna redetermination request form

Submission: Fax to number on denial letter or submit via member portal

Pennsylvania External Review

Pennsylvania's Independent External Review Program launched in January 2024 offers binding appeals after internal processes are exhausted.

Success Rate: Approximately 53% of appealed denials were overturned in the program's first six months.

Timeline:

  • 4 months to file after final internal denial
  • 45 days for standard review
  • 72 hours for expedited/urgent cases

Cost: Free to consumers

How to File: Online at pa.gov or call 1-877-881-6388

From our advocates: We've seen Pennsylvania patients succeed in external reviews by submitting comprehensive molecular pathology reports alongside detailed treatment histories. The independent review organizations particularly value peer-reviewed evidence supporting tumor-agnostic approvals for rare cancers—documentation that many initial denials lack.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"Not medically necessary" Submit FDA labeling, NCCN guidelines, and molecular test results
"Experimental/investigational" Cite FDA approval date and indication-specific studies
"Non-formulary drug" Request formulary exception with clinical justification
"Step therapy required" Document contraindications or failures of preferred agents
"Inadequate documentation" Provide complete molecular pathology report and staging

Frequently Asked Questions

How long does Aetna (CVS Health) prior authorization take in Pennsylvania? Standard review takes 24-48 hours once complete documentation is submitted. Expedited reviews for urgent cases are completed within 72 hours.

What if Vitrakvi is non-formulary on my Aetna plan? Request a formulary exception with clinical documentation showing medical necessity and lack of suitable alternatives.

Can I request an expedited appeal if treatment is urgent? Yes. Both Aetna's internal appeals and Pennsylvania's external review offer expedited timelines (72 hours) when delay would jeopardize health.

Does step therapy apply if I've failed other treatments outside Pennsylvania? Step therapy requirements typically accept documented failures from other states if properly documented in medical records.

What molecular tests does Aetna accept for NTRK fusion confirmation? FDA-approved companion diagnostics and validated next-generation sequencing panels that can detect NTRK gene fusions are generally accepted.

How much does Vitrakvi cost without insurance coverage? The wholesale acquisition cost is approximately $32,800 per 30-day supply, though Bayer's TRAK Assist program offers copay support for eligible patients.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always consult with your healthcare provider and insurance plan for current information specific to your situation. Counterforce Health provides specialized support for navigating insurance coverage challenges for complex medications, turning denials into targeted, evidence-backed appeals that align with payer-specific requirements.

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