By Counterforce Health Team in Enhertu (fam-trastuzumab deruxtecan-nxki) —

How to Get Enhertu (fam-trastuzumab deruxtecan-nxki) Covered by Aetna CVS Health in Virginia: Prior Authorization Guide and Appeals Process

Answer Box: Getting Enhertu Covered by Aetna CVS Health in Virginia

Enhertu requires prior authorization from Aetna CVS Health for all FDA-approved indications. The fastest path to approval: 1) Submit PA request with HER2 testing results and prior therapy documentation via Availity portal, 2) Include evidence of step therapy failure/intolerance, and 3) Allow 30-45 days for standard review or request expedited review for urgent cases (72 hours). If denied, Virginia residents have 180 days to appeal internally and can request external review through the Virginia State Corporation Commission's Bureau of Insurance within 120 days of final denial.

Table of Contents

Coverage Basics

Is Enhertu Covered by Aetna CVS Health?

Yes, Enhertu (fam-trastuzumab deruxtecan-nxki) is covered by Aetna CVS Health plans, but prior authorization is required for all FDA-approved indications. These include HER2-positive breast cancer, HER2-low and HER2-ultralow breast cancer, HER2-mutant non-small cell lung cancer, and HER2-positive gastric/gastroesophageal junction adenocarcinoma.

The medication appears on Aetna's 2025 precertification list, meaning coverage is not automatic and requires clinical review before approval.

Which Aetna Plans Cover Enhertu?

  • Commercial plans (employer-sponsored and individual)
  • Medicare Advantage plans
  • Medicaid managed care plans in Virginia

Coverage details may vary by specific plan type and formulary tier. Check your Summary of Benefits and Coverage or contact Aetna member services at 1-800-872-3862 to confirm your plan's coverage.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Gather Required Documentation (Patient/Clinic)
    • HER2 testing results (pathology report)
    • Complete treatment history with dates
    • Current diagnosis with ICD-10 codes
    • Expected timeline: Same day
  2. Submit PA Request (Prescriber)
  3. Clinical Review (Aetna)
    • Medical necessity evaluation
    • Formulary and step therapy verification
    • Expected timeline: 30-45 days for standard review
  4. Decision Notification (Aetna to Provider/Patient)
    • Approval with authorization number
    • Denial with specific reasons
    • Expected timeline: Within 24-48 hours of decision
  5. CVS Specialty Enrollment (If Approved)
    • Patient contacted for enrollment
    • Coordination with infusion center
    • Expected timeline: 3-5 business days

Timing and Urgency

Standard Review Timeline

  • Initial decision: 30-45 business days
  • Additional information requests: May extend timeline by 14 days
  • Provider notification: Within 24 hours of decision

Expedited Review Process

For urgent medical situations where waiting could jeopardize the patient's health:

  • Timeline: 72 hours for decision
  • How to request: Mark "urgent" on PA form and provide clinical justification
  • Requirements: Physician attestation of medical urgency
Tip: Cancer treatment often qualifies for expedited review. Have your oncologist document why immediate treatment is critical.

Clinical Criteria and Requirements

Coverage Requirements Table

Requirement What It Means Documentation Needed Source
HER2 Testing Confirmed HER2-positive, HER2-low, or HER2-mutant status Pathology report with testing methodology FDA Label
Prior Therapy Evidence of step therapy completion Treatment records showing failure/intolerance Aetna Policy
Diagnosis Documentation Appropriate FDA-approved indication Medical records with ICD-10 codes Aetna PA Form
Prescriber Qualification Oncology specialist or qualified physician Provider credentials verification Aetna Provider Manual

Step Therapy Requirements by Indication

HER2-Positive Breast Cancer:

  • Prior anti-HER2 therapy (trastuzumab, pertuzumab, or T-DM1)
  • Documentation of progression or intolerance

HER2-Mutant NSCLC:

  • Prior systemic therapy for advanced disease
  • HER2 mutation confirmation via NGS or other validated testing

HER2-Positive Gastric Cancer:

  • Prior trastuzumab-based regimen
  • Disease progression documentation

Understanding Your Costs

Enhertu is typically covered under your medical benefit (not pharmacy benefit) since it's an infused medication. Your out-of-pocket costs depend on:

  • Deductible: Applied first if not met
  • Coinsurance: Usually 10-30% after deductible
  • Out-of-pocket maximum: Annual limit on your costs

Estimated costs per treatment: Without insurance, Enhertu costs approximately $2,440 per 100mg vial. Total cycle costs vary by weight and dosing requirements.

Denials and Appeals Process

Common Denial Reasons & How to Address Them

Denial Reason How to Overturn Required Documentation
Missing HER2 testing Submit pathology report Complete biomarker testing results
Step therapy not met Document prior failures Treatment records with dates and outcomes
Not medically necessary Provide clinical justification Physician letter with guideline citations
Non-formulary status Request formulary exception Medical necessity letter

Virginia Appeals Timeline

  1. Internal Appeal (First Level)
  2. Expedited Appeal (If Applicable)
    • Decision time: 72 hours
    • Criteria: Urgent medical necessity
    • Documentation: Physician attestation of urgency
  3. External Review (Virginia State Level)
    • Deadline: 120 days from final internal denial
    • Contact: Virginia State Corporation Commission Bureau of Insurance
    • Phone: 1-877-310-6560
    • Decision time: 45 days (standard) or 72 hours (expedited)

Peer-to-Peer Review Script for Providers

"I'm requesting a peer-to-peer review for [patient name] regarding Enhertu coverage. The patient has [specific HER2 status] and has failed [list prior therapies with dates]. Current treatment guidelines from [NCCN/ASCO] support Enhertu as appropriate therapy. The patient's condition requires immediate treatment to prevent disease progression."

Renewal Requirements

When to Reauthorize

  • Standard renewal: Every 6-12 months
  • Trigger events: Plan changes, dose adjustments, indication changes

What Changes Require New PA

  • Different indication
  • Dose increase beyond approved amount
  • Switch from one Aetna plan to another
  • Change in prescribing physician

CVS Specialty Pharmacy Coordination

Once approved, Enhertu is typically dispensed through CVS Specialty Pharmacy, which coordinates with your infusion center.

Enrollment Process

  1. CVS Specialty contacts you within 24-48 hours of approval
  2. Complete enrollment forms and insurance verification
  3. Schedule delivery coordination with infusion site
  4. Receive medication tracking information

Contact CVS Specialty: 1-800-237-2767

Troubleshooting Common Issues

Portal Problems

  • Availity portal down: Call Aetna provider services at 1-800-872-3862
  • Missing forms: Download from Aetna provider forms page
  • Submission errors: Verify all required fields completed

Communication Issues

  • No response from Aetna: Follow up after 5 business days
  • Missing documentation: Check fax confirmation or portal submission status
  • Patient questions: Direct to Aetna member services at 1-800-872-3862

Virginia External Review Rights

Virginia residents have strong external review rights through the State Corporation Commission's Bureau of Insurance. This independent review can overturn Aetna's denial decisions.

How to Request External Review

  1. Complete Internal Appeals First (required in most cases)
  2. File Within 120 Days of final internal denial
  3. Use Form 216-A available at Virginia SCC website
  4. Submit to: Virginia State Corporation Commission Bureau of Insurance P.O. Box 1157 Richmond, VA 23218

External Review Timeline

  • Standard cases: 45 days for decision
  • Expedited cases: 72 hours (urgent medical necessity)
  • Cancer treatment: May qualify for expedited review without completing internal appeals

The external review decision is binding on Aetna and free to Virginia residents.

Patient Financial Support

ENHERTU4U Copay Program

Eligible patients with commercial insurance may pay $0 out-of-pocket up to $26,000 per calendar year, plus up to $100 per infusion administration.

  • Eligibility: Commercial insurance (like Aetna), no income requirements
  • Enrollment: Call 1-833-ENHERTU (1-833-364-3788) or visit ENHERTU4U.com
  • Process: Provider completes enrollment form

Additional Support Options

  • Independent foundations: Patient Access Network, HealthWell Foundation
  • Manufacturer assistance: For uninsured or underinsured patients
  • State programs: Virginia may offer additional cancer support programs

Frequently Asked Questions

Q: How long does Aetna CVS Health PA take in Virginia? A: Standard prior authorization decisions take 30-45 business days. Expedited reviews for urgent cases are completed within 72 hours.

Q: What if Enhertu is non-formulary on my plan? A: You can request a formulary exception by submitting a medical necessity letter documenting why covered alternatives are inappropriate or ineffective.

Q: Can I request an expedited appeal in Virginia? A: Yes, if your physician certifies that waiting for a standard appeal could seriously jeopardize your health. Expedited appeals are decided within 72 hours.

Q: Does step therapy apply if I failed treatments in another state? A: Yes, prior therapy failures are recognized regardless of where treatment occurred. Provide complete treatment records with dates and outcomes.

Q: What happens if my appeal is denied? A: Virginia residents can request external review through the State Corporation Commission Bureau of Insurance. This independent review can overturn Aetna's decision and is binding.

Q: Is genetic testing required for coverage? A: HER2 testing is required, but the specific method (IHC, FISH, NGS) may vary by indication. Your pathology report must clearly document HER2 status.

Q: Can I use the copay card with Aetna? A: Yes, the ENHERTU4U copay program is available for patients with commercial Aetna plans. Government insurance (Medicare, Medicaid) is not eligible.

Q: What if I need to switch infusion centers? A: Contact CVS Specialty Pharmacy to coordinate delivery to your new infusion site. No new prior authorization is typically required for location changes.

From our advocates: We've seen many Virginia patients successfully obtain Enhertu coverage by ensuring their HER2 testing documentation is complete and clearly stated in pathology reports. Taking time to gather comprehensive prior therapy records upfront often prevents delays and additional information requests. This is a composite example based on common successful approaches.

For complex cases requiring targeted appeals and evidence-backed documentation, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful approvals by drafting point-by-point rebuttals aligned to each payer's specific requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical advice. Coverage decisions depend on your specific plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For questions about Virginia insurance regulations, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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