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

The Requirements Checklist to Get Enhertu (fam-trastuzumab deruxtecan-nxki) Covered by Blue Cross Blue Shield in New Jersey: Forms, Appeals, and PA Guide

Answer Box: Getting Enhertu Covered by Blue Cross Blue Shield in New Jersey

Eligibility: HER2-positive unresectable/metastatic breast cancer or other FDA-approved HER2-expressing tumors after prior anti-HER2 therapy. Fastest path: Submit prior authorization via Horizon BCBS Provider Portal or MagellanRx (1-800-424-4508) with HER2 pathology report, treatment history, and monitoring plan. First step today: Verify your specific BCBS plan's Enhertu policy and PA requirements using their online PA search tool. If denied, New Jersey's Independent Health Care Appeals Program (IHCAP) provides external review through Maximus Federal Services.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria for Enhertu Coverage
  4. Coding and Billing Requirements
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: What to Expect
  9. Denial Prevention Tips
  10. Appeals Process in New Jersey
  11. Printable Checklist

Who Should Use This Checklist

This guide is designed for patients and their oncology teams seeking coverage for Enhertu (fam-trastuzumab deruxtecan-nxki) through Blue Cross Blue Shield plans in New Jersey. Use this checklist if you have:

  • HER2-positive breast cancer, gastric cancer, or other HER2-expressing solid tumors
  • Failed or cannot tolerate prior HER2-directed therapies
  • A Blue Cross Blue Shield plan (Horizon BCBS, Horizon NJ Health Medicaid, or other BCBS entities)
  • Received a denial that you want to appeal

Expected outcome: Following this checklist significantly improves your chances of approval by ensuring all required documentation is complete and properly submitted.

Member & Plan Basics

Coverage Requirements

Requirement Details Where to Verify
Active Coverage Member must be enrolled and current on premiums Member portal or ID card
Plan Type Commercial, Medicare Advantage, or Medicaid Horizon Provider Portal
Prior Authorization Required for Enhertu (J9358) MagellanRx Management
Formulary Status Medical benefit (buy-and-bill) Plan-specific drug list
Note: Horizon BCBS New Jersey uses MagellanRx Management for HER2-directed biologic reviews. Call 1-800-424-4508 to verify current requirements for your specific plan.

Clinical Criteria for Enhertu Coverage

FDA-Approved Indications

Primary indications that BCBS typically covers:

  • HER2-positive unresectable or metastatic breast cancer
  • HER2-mutant non-small cell lung cancer (NSCLC)
  • HER2-positive gastric or gastroesophageal junction adenocarcinoma
  • HER2-expressing solid tumors (tumor-agnostic indication)

Step Therapy Requirements

Most BCBS plans require documentation of:

  1. Prior HER2-directed therapy in the metastatic setting
  2. Disease progression or intolerance to previous treatments
  3. Adequate performance status (typically ECOG 0-2)
  4. Baseline cardiac function (LVEF assessment)

HER2 Testing Documentation

Test Method Acceptable Results Documentation Needed
IHC 3+ (breast/gastric) or 1+/2+ (HER2-low) Pathology report with percentage
ISH/FISH Amplified (ratio ≥2.0) Lab report with methodology
NGS HER2 mutation (NSCLC) Molecular testing report

Coding and Billing Requirements

Essential Codes

  • HCPCS: J9358 (1 mg units)
  • ICD-10: C50.xx (breast), C34.xx (lung), C16.xx (gastric)
  • NDC: 65597-0406-01 (verify current)
  • Administration: 96413 (initial IV chemo infusion)

Dosing Information

Standard dosing: 5.4 mg/kg IV every 3 weeks for most indications. Calculate total mg per cycle based on patient weight for accurate unit billing.

Documentation Packet Essentials

Core Documents Required

  1. HER2 pathology report (within 2 years)
  2. Treatment history with dates and responses
  3. Current staging and performance status
  4. Baseline cardiac assessment (ECHO/MUGA)
  5. Pulmonary assessment (chest imaging)

Medical Necessity Letter Components

Your oncologist's letter should include:

  • Patient diagnosis with ICD-10 codes
  • HER2 status and testing methodology
  • Prior therapies attempted and reasons for discontinuation
  • Clinical rationale for Enhertu
  • ILD monitoring plan (key for approval)
  • NCCN guideline support
Clinician Tip: Address Enhertu's boxed warning for interstitial lung disease by explicitly stating your monitoring protocol: baseline chest imaging, symptom assessment at each visit, and immediate drug interruption for suspected ILD.

Submission Process

Step-by-Step Submission

  1. Verify PA requirement using Horizon's PA search tool
  2. Complete appropriate form (varies by plan type)
  3. Submit via portal or call MagellanRx at 1-800-424-4508
  4. Include all documentation from checklist above
  5. Request expedited review if clinically urgent
  6. Document submission with confirmation number
  7. Follow up within 5-7 business days

Submission Channels by Plan Type

Plan Type Primary Method Contact
Horizon Commercial Provider portal + MagellanRx 1-800-424-4508
Horizon NJ Health Plan-specific PA process Plan customer service
Medicare Advantage Medical policy review Plan utilization management

Specialty Pharmacy Routing

Enhertu typically follows a buy-and-bill model through oncology practices. However, some plans may require:

  • Contracted specialty pharmacy for drug sourcing
  • Prior approval before first dose ordering
  • Site of care restrictions (hospital outpatient vs. office)

Verify your plan's specific requirements during PA submission to avoid delays.

After Submission: What to Expect

Timeline Expectations

  • Routine PA: 5-7 business days
  • Expedited PA: 24-48 hours (oncology urgency)
  • Additional information requests: 3-5 days to respond

Status Monitoring

  1. Record confirmation number from submission
  2. Check status every 3-5 days via portal
  3. Prepare for peer-to-peer if requested
  4. Document all communications for potential appeals

Denial Prevention Tips

Five Common Pitfalls and Solutions

  1. Missing HER2 documentation
    • Fix: Include complete pathology report with methodology and percentage
  2. Incomplete treatment history
    • Fix: List all prior regimens with dates, responses, and discontinuation reasons
  3. Dosing outside FDA label
    • Fix: Use standard 5.4 mg/kg dosing or provide strong clinical justification
  4. No ILD monitoring plan
    • Fix: Explicitly address pulmonary monitoring in medical necessity letter
  5. Wrong submission channel
    • Fix: Verify plan-specific PA requirements before submitting

Appeals Process in New Jersey

If your initial PA is denied, New Jersey offers robust appeal rights:

Internal Appeals

  1. File with BCBS within plan-specified timeframe (typically 60 days)
  2. Include additional documentation addressing denial reasons
  3. Request peer-to-peer review with medical director
  4. Escalate to second-level internal appeal if denied

External Review (IHCAP)

New Jersey's Independent Health Care Appeals Program provides independent medical review:

  • Administrator: Maximus Federal Services
  • Phone: 1-888-866-6205
  • Timeline: File within 120 days of final internal denial
  • Cost: Free to patients
  • Decision: Binding on insurance plan

Expedited Appeals

For urgent oncology situations:

  • Standard: Decision within 48 hours
  • Requirements: Physician attestation of clinical urgency
  • Submission: Fax to expedited review line (verify current number)

Printable Checklist

Before Submitting PA

  • Verify active BCBS coverage
  • Confirm Enhertu PA requirement for specific plan
  • Obtain HER2 pathology report (within 2 years)
  • Document all prior HER2-directed therapies
  • Complete baseline cardiac assessment
  • Perform baseline pulmonary evaluation
  • Calculate correct dosing (5.4 mg/kg q3 weeks)

Documentation Packet

  • Completed PA form (plan-specific)
  • Medical necessity letter with ILD monitoring plan
  • HER2 testing results with methodology
  • Treatment history with dates and responses
  • Current staging and imaging reports
  • ECHO/MUGA results
  • Chest imaging (baseline)
  • NCCN guideline citations

Submission

  • Submit via correct channel (portal/MagellanRx)
  • Request expedited review if urgent
  • Record confirmation number
  • Schedule follow-up in 5-7 days
  • Prepare for potential peer-to-peer review

At Counterforce Health, we help patients and providers navigate complex prior authorization requirements by turning insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals using the right clinical evidence and payer-specific workflows.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance plan for personalized guidance. For additional help with New Jersey insurance appeals, contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467.

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