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

How to Get Enhertu (fam-trastuzumab deruxtecan-nxki) Covered by Aetna CVS Health in New Jersey: Complete Appeals Guide with Forms and Timelines

Answer Box: Getting Enhertu Covered by Aetna CVS Health in New Jersey

Enhertu (fam-trastuzumab deruxtecan-nxki) requires prior authorization from Aetna CVS Health for all FDA-approved indications. The fastest path to approval: 1) Submit complete PA request with HER2 biomarker testing, prior therapy documentation, and ILD monitoring plan via Aetna provider portal; 2) If denied, file internal appeal within 180 days; 3) Use New Jersey's Independent Health Care Appeals Program (IHCAP) for external review. Start today: Contact your oncology team to gather HER2 pathology reports and treatment history for the PA submission.

Table of Contents

  1. Understanding Aetna's Enhertu Coverage Requirements
  2. Step-by-Step: Prior Authorization Process
  3. Reading Your Denial Letter
  4. First-Level Internal Appeal
  5. Peer-to-Peer Review Strategy
  6. New Jersey External Review Process
  7. Appeal Templates and Scripts
  8. Cost Assistance Options
  9. When to Escalate to Regulators

Understanding Aetna's Enhertu Coverage Requirements

Enhertu is classified as a non-formulary specialty medication requiring prior authorization for all indications, including HER2-positive breast cancer, HER2-mutant NSCLC, and HER2-positive gastric adenocarcinoma.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before treatment Aetna provider portal PA List
HER2 Testing IHC/FISH confirmation Pathology report FDA Label
Prior Therapy Step therapy documentation Medical records Aetna Policy
ILD Monitoring Safety protocol required Treatment plan FDA REMS
Appeal Deadline 180 days from denial Denial letter Member Rights

Key Coverage Criteria by Indication

HER2-Positive Breast Cancer:

  • Unresectable or metastatic disease
  • Prior anti-HER2 therapy (trastuzumab, pertuzumab, or T-DM1)
  • HER2 positivity confirmed by IHC 3+ or FISH-positive

HER2-Mutant NSCLC:

  • Documented HER2 mutations via validated testing
  • Prior systemic therapy including platinum-based chemotherapy
  • Unresectable or metastatic disease

HER2-Positive Gastric/GEJ:

  • Advanced or metastatic HER2-positive adenocarcinoma
  • Prior trastuzumab-based regimen documentation

Step-by-Step: Prior Authorization Process

Step 1: Gather Required Documentation (Patient/Clinic)

  • HER2 pathology report from CLIA-certified lab
  • Complete treatment history with dates and outcomes
  • Current staging and performance status (ECOG 0-2)
  • ILD monitoring protocol
  • Timeline: 2-3 days to collect

Step 2: Submit PA Request (Clinic)

  • Use Aetna provider portal or call 1-855-240-0535
  • Include completed precertification form with original signature
  • Attach all supporting documentation
  • Timeline: Same-day submission possible

Step 3: Await Decision (Aetna)

  • Standard review: 30-45 days
  • Expedited review: 72 hours for urgent cases
  • Timeline: Most complete submissions decided within 24 hours
Tip: Submit PA requests at least 2 weeks before planned treatment start to allow for potential appeals.

Reading Your Denial Letter

When Enhertu is denied, decode the specific reason to target your appeal:

Common Denial Codes & Fixes

Denial Reason How to Overturn Required Documents
Missing HER2 status Submit pathology report IHC/FISH results from CLIA lab
Step therapy not met Document prior failures Treatment records with dates/outcomes
Non-formulary drug Request formulary exception Medical necessity letter
ILD risk not addressed Submit monitoring plan Pulmonary assessment protocol
Experimental/investigational Cite FDA approval FDA label and indication

First-Level Internal Appeal

File your internal appeal within 180 days of the denial date. Aetna requires comprehensive documentation addressing the specific denial reason.

Medical Necessity Letter Checklist

Your oncologist should include:

  • Clinical problem: Specific cancer type, stage, and HER2 status
  • Prior treatments: All previous therapies with dates, duration, and reasons for discontinuation
  • Clinical rationale: Why Enhertu is medically necessary for this patient
  • Guideline support: FDA labeling and NCCN guideline citations
  • Safety monitoring: Detailed ILD surveillance plan
  • Treatment goals: Expected outcomes and monitoring parameters

Appeal Submission Methods

  • Phone: 1-866-814-5506 (specialty drugs)
  • Fax: 1-888-267-3277
  • Mail: CVS Caremark, 1300 East Campbell Road, Richardson, TX 75081

Peer-to-Peer Review Strategy

Request a peer-to-peer call with Aetna's medical director when your appeal needs clinical discussion.

Preparation Checklist

  • Patient summary: 2-3 sentence case overview
  • Key talking points: HER2 status, prior failures, contraindications to alternatives
  • Guidelines ready: FDA label sections, NCCN recommendations
  • Safety plan: ILD monitoring protocol details

Sample Script for Peer-to-Peer

"This is Dr. [Name] requesting peer-to-peer review for [Patient] regarding Enhertu coverage. The patient has HER2-positive metastatic breast cancer with progression on prior trastuzumab and pertuzumab. HER2 testing shows 3+ by IHC. We have a comprehensive ILD monitoring protocol in place per FDA labeling. The patient meets all FDA-approved indication criteria."

New Jersey External Review Process

If Aetna upholds the denial after internal appeals, New Jersey's Independent Health Care Appeals Program (IHCAP) provides binding external review.

IHCAP Process Overview

New Jersey contracts with Maximus Federal Services to administer external reviews. This program gives you a fighting chance—about half of external appeals nationwide favor consumers.

Eligibility Requirements

  • Completed Aetna's internal appeal process
  • Filed within 4 months (180 days) of final internal denial
  • Denial based on medical necessity or coverage determination
  • NJ-regulated insurance plan

How to File External Appeal

  1. Online: Maximus IHCAP Portal
  2. Phone: 1-888-866-6205 for technical support
  3. Required documents:
    • All internal appeal denial letters
    • Medical records supporting necessity
    • Signed consent forms

Timeline and Process

  • Preliminary review: 5 business days to confirm eligibility
  • Full review: 45 days maximum for standard appeals
  • Expedited review: 72 hours for urgent cases where delay could cause serious harm
  • Cost: Free to patients (insurers pay all fees)

The Independent Utilization Review Organization (IURO) assigns physician reviewers with oncology expertise to evaluate your case. Their decision is binding—if they overturn Aetna's denial, the company must provide coverage.

Note: Providers can file external appeals on behalf of patients with proper consent forms.

Appeal Templates and Scripts

Patient Phone Script for Aetna

"Hello, I'm calling about a denial for Enhertu (fam-trastuzumab deruxtecan-nxki). My member ID is [number]. I received a denial letter dated [date] with reference number [number]. I'd like to file an internal appeal and request all necessary forms. Can you also tell me the specific medical criteria that weren't met so my doctor can address them directly?"

Email Template for Medical Records

Subject: Urgent: Medical Records Needed for Enhertu Appeal - [Patient Name]

"Dear [Provider Name],

I need the following records for my Aetna appeal for Enhertu coverage:

  • HER2 pathology report with IHC/FISH results
  • Complete treatment history from [date] to present
  • Documentation of treatment failures or intolerance
  • Current staging and performance status assessment

Please fax to [number] or email securely by [date]. Thank you for your assistance with this time-sensitive appeal."

Cost Assistance Options

While appealing, explore these financial support programs:

Manufacturer Support

  • Enhertu Co-pay Program: May reduce out-of-pocket costs for eligible commercially insured patients
  • Patient Assistance Program: Income-based free drug program
  • Contact: Visit EnhertuHCP.com or call manufacturer directly

Additional Resources

  • CancerCare Financial Assistance: Grants for treatment-related costs
  • Patient Access Network Foundation: Copay assistance for specialty oncology drugs
  • New Jersey Cancer Education and Early Detection Program: State resources for cancer patients

At Counterforce Health, we help patients and clinicians turn insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals aligned to each plan's specific rules, pulling the right citations and clinical evidence to strengthen your case.

When to Escalate to Regulators

If Aetna fails to follow proper procedures or violates New Jersey insurance laws, contact state regulators:

New Jersey Department of Banking and Insurance

File a Complaint When:

  • Appeals deadlines aren't met
  • Required forms aren't provided
  • Medical records aren't properly reviewed
  • External review decisions aren't honored

Include copies of all denial letters, appeal submissions, and correspondence in your complaint.

From our advocates: "We've seen cases where insurers initially denied Enhertu for 'experimental' use, even for FDA-approved indications. A well-documented appeal citing the specific FDA label indication and NCCN guidelines often resolves these denials quickly. The key is addressing the exact denial reason with targeted clinical evidence."

Frequently Asked Questions

How long does Aetna prior authorization take in New Jersey? Most complete submissions receive decisions within 24 hours, though standard review can take 30-45 days. Expedited reviews for urgent cases are completed within 72 hours.

What if Enhertu is non-formulary on my plan? Request a formulary exception by submitting clinical documentation showing medical necessity. Your doctor must demonstrate why formulary alternatives aren't appropriate.

Can I request an expedited appeal? Yes, if treatment delay could seriously jeopardize your health. Your oncologist must document the urgency and potential harm from delay.

Does step therapy apply if I failed treatments outside New Jersey? Yes, Aetna accepts documentation of prior treatment failures regardless of where they occurred, as long as medical records clearly show the attempts and outcomes.

What happens if I start treatment before approval? Aetna may deny coverage for services already provided. However, you can appeal retroactive denials using the same process, especially if treatment was urgent.

How often do external appeals succeed in New Jersey? While specific statistics aren't published, national data shows external appeals favor consumers in approximately 50% of cases, particularly for specialty oncology drugs with strong clinical evidence.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Coverage policies and procedures may change—verify current requirements with official sources before proceeding with appeals.

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