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

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

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

Enhertu (fam-trastuzumab deruxtecan-nxki) requires prior authorization from Aetna CVS Health for all FDA-approved indications. The fastest path to approval: (1) Submit Aetna's Enhertu precertification form (GR-69531 5-24) with HER2 testing results and prior therapy documentation, (2) Include medical necessity letter citing FDA approval and treatment failures, (3) Use Availity portal or fax to 888-267-3277. Standard review takes 30-45 days; expedited decisions within 72 hours if urgent. If denied, Florida residents have 180 days to file internal appeals, then external review through Florida Department of Financial Services.

Table of Contents

Coverage Requirements Overview

Aetna CVS Health covers Enhertu for multiple FDA-approved indications but requires prior authorization for all uses. Here's what you need to know:

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all indications Aetna 2025 Precert List
HER2 Testing IHC 3+ or ISH positive required FDA-approved companion diagnostic
Step Therapy Prior anti-HER2 therapy documented Aetna Medical Policy CPB 966
Site of Care Outpatient infusion center Buy-and-bill with J9358
Formulary Status Specialty tier, non-formulary Plan-specific formulary

Approved Indications

Based on Aetna's medical policy, Enhertu is covered for:

  • HER2-positive breast cancer: Unresectable/metastatic after prior anti-HER2 regimen
  • HER2-low/ultralow breast cancer: Unresectable/metastatic after prior therapy
  • HER2-mutant NSCLC: Subsequent therapy after systemic treatment
  • HER2-positive gastric/GEJ cancer: Advanced disease after prior therapy
  • Other HER2-positive solid tumors: Tumor-agnostic indication per FDA approval

Step-by-Step: Fastest Path to Approval

1. Verify HER2 Status and Prior Therapy

Who does it: Oncologist
Documents needed: Pathology report with HER2 testing (IHC/ISH), treatment history
Timeline: Same day if records available

2. Complete Aetna Enhertu Precertification Form

Who does it: Provider's office
Documents needed: Aetna Enhertu PA form (GR-69531 5-24)
Timeline: 15-30 minutes to complete

3. Gather Supporting Documentation

Who does it: Medical assistant/nurse
Documents needed:

  • ICD-10 diagnosis codes
  • Prior therapy failure/intolerance documentation
  • Weight-based dosing calculation
  • Physician attestation for medical necessity

4. Submit Prior Authorization Request

Who does it: Provider's office
How to submit: Availity portal (preferred) or fax to 888-267-3277
Timeline: Submit at least 2 weeks before planned start date

5. Follow Up and Track Status

Who does it: Provider's office
How: Call 1-866-752-7021 or check Availity portal
Timeline: Standard review 30-45 days; expedited 72 hours if urgent

6. Coordinate Specialty Pharmacy if Approved

Who does it: CVS Specialty Pharmacy
Contact: 1-800-237-2767
Timeline: 3-5 days for enrollment and delivery coordination

7. Appeal if Denied

Who does it: Provider with patient consent
Timeline: 180 days for internal appeal in Florida
Next step: External review through Florida DFS if internal appeal fails

Required Forms and Documentation

Primary Form

Use Aetna's Enhertu Precertification Request Form (2 pages, form GR-69531 5-24). This covers all FDA-approved indications.

Clinical Documentation Checklist

Essential Requirements:

  • ✅ HER2 testing results (pathology report)
  • ✅ ICD-10 diagnosis code
  • ✅ Prior therapy documentation with dates
  • ✅ Evidence of progression or intolerance
  • ✅ Patient weight for dosing calculation
  • ✅ Prescriber DEA and NPI numbers

Medical Necessity Letter Should Include:

  • FDA approval for specific indication
  • HER2 testing methodology and results
  • Prior anti-HER2 therapies tried and failed
  • Contraindications to alternative treatments
  • Expected treatment duration and monitoring plan
Clinician Corner: When documenting prior therapy failures, be specific about dates, duration, and reason for discontinuation (progression vs. intolerance). Aetna's policy requires "prior anti-HER2 regimen" for most indications, so document trastuzumab, pertuzumab, or T-DM1 use clearly.

Submission Methods

  • Fastest processing and real-time status updates
  • Register at Availity.com if not already enrolled
  • Upload all supporting documents directly
  • Automatic confirmation of receipt

Fax Submission

  • Fax number: 888-267-3277
  • Include cover sheet with patient ID and urgency level
  • Send during business hours for fastest processing
  • Follow up by phone to confirm receipt

Phone Support

  • Provider line: 1-866-752-7021 (TTY 711)
  • Member services: Number on back of insurance card
  • Use for status updates and urgent requests

Mail (Slowest Option)

Send to address listed on PA form (verify current address on form as it may change).

CVS Specialty Pharmacy Enrollment

Once Enhertu is approved, CVS Specialty Pharmacy handles dispensing and delivery to infusion centers.

Enrollment Process

  1. Complete CVS Specialty enrollment form (oncology-specific)
  2. Submit insurance verification (front/back of cards)
  3. Coordinate delivery logistics with infusion center
  4. Set up patient benefits verification

Contact Information:

  • Phone: 1-800-237-2767
  • Fax referrals with completed enrollment form
  • Allow 3-5 business days for initial setup

Required Information

  • Patient demographics and contact information
  • Prescriber details (DEA, NPI, state license)
  • Insurance information (primary and secondary)
  • Infusion center delivery address
  • Dosing schedule and administration plan

Appeals Process for Florida Residents

If your Enhertu prior authorization is denied, Florida law provides specific appeal rights.

Internal Appeal (Required First Step)

  • Deadline: 180 days from denial notice
  • Timeline: Aetna must respond within 30-60 days
  • How to file: Written appeal with supporting documentation
  • Include: Medical necessity letter, additional clinical evidence, peer-reviewed studies

Expedited Appeals

Available for urgent medical situations:

  • Timeline: 72 hours for decision
  • Criteria: Delay would seriously jeopardize health
  • How to request: Mark appeal as "urgent" and provide physician attestation

External Review (After Internal Denial)

Florida residents can request independent external review:

  • Agency: Florida Department of Financial Services
  • Deadline: 4 months after final internal denial
  • Cost: Free to consumer
  • Process: Independent medical expert reviews case
  • Decision: Binding on insurer if overturned

Florida Consumer Assistance:

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing HER2 testing Submit pathology report IHC 3+ or ISH positive results
No prior therapy documented Provide treatment history Dates, drugs, duration, outcome
Not FDA-approved indication Cite FDA label FDA approval letter and clinical guidelines
Step therapy not met Document failures/intolerance Medical records showing progression or adverse events
Experimental/investigational Provide FDA approval proof Official FDA labeling and approval date

Sample Appeal Language

"Enhertu (fam-trastuzumab deruxtecan-nxki) received FDA approval for [specific indication] on [date]. The patient has documented HER2-positive disease confirmed by [testing method] and has failed prior therapy with [specific agents]. This treatment is medically necessary and consistent with FDA-approved labeling."

Cost and Financial Assistance

Manufacturer Support

  • ENHERTU4U Program: Copay assistance for commercial insurance
  • Eligibility: Not available for Medicare/Medicaid patients
  • Potential savings: Significant reduction in out-of-pocket costs
  • Apply: Through prescriber or ENHERTU4U website

Additional Resources

  • Patient advocacy organizations for specific cancer types
  • Hospital financial assistance programs
  • State pharmaceutical assistance programs (verify Florida-specific options)
Note: Copay assistance programs cannot be used with government insurance (Medicare, Medicaid, TRICARE).

When to Get Help

Contact Counterforce Health if you need assistance with:

  • Complex prior authorization denials
  • Appeal letter preparation
  • Evidence gathering and medical necessity documentation
  • Payer-specific workflow navigation

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to create point-by-point rebuttals aligned with each payer's specific requirements.

From Our Advocates: "We've seen Enhertu denials overturned most successfully when the appeal includes specific HER2 testing methodology, clear documentation of prior therapy timelines, and citations to both FDA labeling and relevant clinical guidelines. The key is matching your clinical evidence to the payer's exact coverage criteria." (Composite guidance based on advocacy experience; individual results may vary.)

FAQ

How long does Aetna CVS Health prior authorization take for Enhertu in Florida? Standard reviews take 30-45 business days. Expedited reviews for urgent cases are completed within 72 hours. Submit requests at least 2 weeks before planned treatment start.

What if Enhertu is non-formulary on my Aetna plan? You can request a formulary exception by submitting medical necessity documentation showing why preferred alternatives are inappropriate. This requires additional clinical justification.

Can I request an expedited appeal in Florida? Yes, if delay would seriously jeopardize your health. Mark appeals as "urgent" and include physician attestation. Expedited appeals must be decided within 72 hours.

Does step therapy apply if I failed HER2 therapies outside Florida? Yes, prior therapy documentation from any state is acceptable. Provide complete treatment records including dates, dosing, and reason for discontinuation.

What happens if my appeal is denied by Aetna? Florida residents can request external review through the Department of Financial Services at no cost. This provides an independent medical expert review with a binding decision.

Can my oncologist do a peer-to-peer review? Yes, request peer-to-peer review during the PA process or appeal. This allows your oncologist to speak directly with Aetna's medical director about your case.

Is Enhertu covered for off-label uses? Aetna typically covers only FDA-approved indications. Off-label use requires exceptional medical necessity documentation and is rarely approved.

How do I transfer my prescription to CVS Specialty Pharmacy? CVS Specialty will coordinate the transfer once PA is approved. Call 1-800-237-2767 with your approval confirmation and current pharmacy information.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan details. Always consult your healthcare provider and insurance plan documents for specific guidance. For additional support with insurance appeals and prior authorization challenges, visit Counterforce Health for specialized assistance with evidence-backed appeal strategies.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.