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

How to Get Enhertu (fam-trastuzumab deruxtecan-nxki) Covered by Humana in Florida: Prior Authorization, Appeals, and Medical Necessity Requirements

Quick Answer: Getting Enhertu Covered by Humana in Florida

To get Enhertu (fam-trastuzumab deruxtecan-nxki) covered by Humana in Florida, you'll need prior authorization with HER2 testing results and documented treatment history. Submit through your oncologist via Humana's provider portal with clinical notes showing medical necessity. If denied, you have 65 days to appeal, and Florida offers external review through the Department of Financial Services. Start by calling Humana member services at the number on your ID card to verify your specific plan requirements and formulary status.

Table of Contents

  1. Humana Coverage Policy Overview
  2. FDA Indication Requirements
  3. Step Therapy & Medical Exceptions
  4. Required Diagnostics & Documentation
  5. Specialty Pharmacy & Site of Care
  6. Medical Necessity Evidence
  7. Prior Authorization Process
  8. Appeals Process in Florida
  9. Common Denial Reasons & Solutions
  10. Cost Support Options
  11. FAQ

Humana Coverage Policy Overview

Humana covers Enhertu primarily through Medicare Advantage plans in Florida, with all plans requiring prior authorization for this high-cost specialty oncology medication. The drug must be dispensed through Humana's specialty pharmacy network and administered at approved infusion centers.

Plan Types and Coverage:

  • Medicare Advantage: Covered under Part B with prior authorization
  • Medicare Part D: Limited coverage; most infused oncology drugs fall under Part B
  • Medicaid Managed Care: Coverage varies by specific plan
Note: Humana's Medicare Advantage denial rate is approximately 3.5% (2023), among the lowest of major insurers, but denials often stem from incomplete documentation rather than medical necessity disputes.

FDA Indication Requirements

Enhertu has multiple FDA-approved indications that Humana recognizes for coverage:

Approved Indications:

  • HER2-positive breast cancer (metastatic, after prior HER2-directed therapy)
  • HER2-low breast cancer (metastatic, after chemotherapy)
  • HER2-positive gastric or gastroesophageal junction adenocarcinoma
  • HER2-mutant non-small cell lung cancer (NSCLC) after prior systemic therapy
  • HER2-positive solid tumors (tumor-agnostic indication)

Required Documentation:

  • FDA-approved companion diagnostic test results showing HER2 status
  • Pathology reports with ICD-10 diagnosis codes
  • Staging documentation confirming metastatic or unresectable disease
Tip: The Oncomine Dx Target Test is an FDA-approved companion diagnostic that demonstrates superior accuracy (11% false negative rate vs. 25% for non-approved tests).

Step Therapy & Medical Exceptions

Humana typically requires documentation of prior therapies before approving Enhertu, though specific step therapy requirements vary by indication.

Breast Cancer Step Therapy:

  • Prior trastuzumab-based therapy (unless contraindicated)
  • Documentation of disease progression
  • Previous chemotherapy regimens tried and failed

Medical Exception Pathways:

  • Contraindications to required prior therapies
  • Documented intolerance with specific adverse events
  • Disease progression requiring immediate targeted therapy
  • Clinical scenarios where delay would cause harm

Documentation Requirements:

  • Physician attestation of medical necessity
  • Chart notes detailing prior treatment failures
  • Laboratory or imaging evidence of progression
  • Contraindication documentation with clinical rationale

Required Diagnostics & Documentation

HER2 Testing Requirements

Mandatory Testing:

  • HER2 immunohistochemistry (IHC) or in situ hybridization (ISH)
  • Results must be from FDA-approved companion diagnostic
  • Testing performed within 6 months of treatment initiation
  • Clear documentation of HER2-positive, HER2-low, or HER2-mutant status

Baseline Safety Assessments

Before Enhertu approval, Humana requires documentation of:

Pulmonary Assessment (ILD Risk):

  • High-resolution CT scan of chest ruling out interstitial lung disease
  • Baseline oxygen saturation (SpO2) measurements
  • Pulmonary function tests if clinically indicated
  • No history of pneumonitis or significant lung disease

Other Required Labs:

  • Complete blood count with differential
  • Comprehensive metabolic panel
  • Liver function tests
  • ECOG performance status documentation

Specialty Pharmacy & Site of Care

Enhertu must be obtained through Humana's specialty pharmacy network and administered at approved facilities.

Specialty Pharmacy Options:

Site of Care Requirements:

  • Outpatient infusion centers (hospital-based or freestanding)
  • Oncology clinics with infusion capabilities
  • Home administration not typically covered
  • Must be in Humana's provider network

Administration Details:

  • Intravenous infusion every 3 weeks
  • Weight-based dosing (5.4 mg/kg)
  • Requires ILD monitoring protocols
  • J-code: J9358 for billing

Medical Necessity Evidence

Clinical Guidelines Support

Recognized Guidelines:

  • FDA prescribing information for approved indications
  • NCCN Guidelines for breast, gastric, and lung cancers
  • ASCO clinical practice guidelines
  • Tumor-agnostic HER2-positive solid tumor guidance

Supporting Evidence for Appeals

Peer-Reviewed Literature:

  • Clinical trial data (DESTINY-Breast04, DESTINY-Gastric01, DESTINY-Lung02)
  • Real-world effectiveness studies
  • Comparative effectiveness vs. alternatives
  • Safety and monitoring protocols

Clinical Rationale Elements:

  • Patient-specific factors favoring Enhertu
  • Prior therapy failures with documented progression
  • Contraindications to alternative treatments
  • Expected clinical benefit based on biomarker status

Prior Authorization Process

Step-by-Step Submission

  1. Verify Coverage - Call Humana member services to confirm plan benefits
  2. Gather Documentation - Collect HER2 testing, imaging, prior therapy records
  3. Complete PA Form - Physician submits via Humana provider portal
  4. Clinical Review - Humana reviews within 7 calendar days (standard)
  5. Approval/Denial - Written notification sent to prescriber and patient

Required PA Information:

  • Patient demographics and insurance information
  • Diagnosis with ICD-10 codes
  • HER2 testing results and dates
  • Prior therapy history with dates and outcomes
  • Prescriber attestation of medical necessity
  • Proposed treatment plan and monitoring

Timeline Expectations:

  • Standard review: 7 calendar days
  • Expedited review: 72 hours (if delay could harm health)
  • Additional information requests may extend timeline

Appeals Process in Florida

Internal Appeal (Redetermination)

Timeline: You have 65 days from denial notice to file an internal appeal.

Submission Methods:

  • Online through Humana member portal
  • Mail or fax using Request for Redetermination form
  • Phone call to member services number on ID card

Required Elements:

  • Written appeal statement
  • Additional clinical documentation
  • Physician support letter
  • Relevant medical literature (if applicable)

External Review in Florida

If Humana denies your internal appeal, Florida law provides external review rights.

Process:

External Review Contact: Florida Division of Consumer Services Insurance Consumer Helpline: 1-877-693-5236

Timeline:

  • Standard external review: 45 days
  • Expedited external review: 72 hours (urgent cases)
  • Decision is binding on Humana

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
Missing HER2 testing Submit companion diagnostic results FDA-approved test report with clear HER2 status
Insufficient prior therapy Document treatment history Chart notes showing progression on prior treatments
ILD risk concerns Provide safety monitoring plan Baseline chest CT, pulmonary function tests
Non-formulary status Request formulary exception Medical necessity letter citing lack of alternatives
Site of care restriction Verify network status Confirm infusion center is in-network

Medical Necessity Letter Template

Your oncologist should include these elements:

Patient History:

  • Diagnosis with staging and biomarker status
  • Prior treatments tried with dates and outcomes
  • Current disease status and progression

Clinical Rationale:

  • Why Enhertu is medically necessary
  • Contraindications or failures of alternatives
  • Expected clinical benefit
  • Monitoring plan for ILD risk

Supporting Evidence:

  • FDA label indication match
  • Guideline recommendations
  • Relevant clinical studies

Cost Support Options

Manufacturer Assistance

Daiichi Sankyo Patient Assistance:

Foundation Grants

  • Patient Access Network Foundation
  • HealthWell Foundation
  • CancerCare Financial Assistance
  • Leukemia & Lymphoma Society

State Programs

Florida residents may qualify for additional support through state cancer programs and charity care at hospitals.

When Treatment is Urgent

For urgent cases where delay could cause serious harm:

  1. Request expedited review (72-hour timeline)
  2. Contact Humana utilization management directly
  3. Consider peer-to-peer review with medical director
  4. File simultaneous external review if internal appeal fails
  5. Document urgency with physician letter
From our advocates: We've seen cases where submitting comprehensive ILD monitoring protocols upfront prevented denials related to safety concerns. Including baseline chest imaging and a detailed pulmonary assessment plan demonstrates proactive risk management that payers value.

FAQ

How long does Humana prior authorization take for Enhertu? Standard review is 7 calendar days, with expedited review available in 72 hours for urgent cases.

What if Enhertu is not on my Humana formulary? You can request a formulary exception by demonstrating medical necessity and lack of suitable alternatives on the formulary.

Can I appeal a Humana denial in Florida? Yes, you have 65 days to file an internal appeal, followed by external review through Florida's Department of Financial Services if needed.

Does step therapy apply if I've failed treatments outside Florida? Yes, prior treatment failures from any location count toward meeting step therapy requirements if properly documented.

What ILD monitoring is required for Humana coverage? Baseline chest CT scan, ongoing pulmonary function monitoring, and regular clinical assessments per FDA guidelines.

How do I find a Humana in-network infusion center in Florida? Use Humana's provider directory online or call member services to verify network status before scheduling.

Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Enhertu. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to draft targeted, evidence-backed appeals that align with payer-specific criteria.

If you're facing a denial or need help with the prior authorization process, Counterforce Health can help streamline your appeal with the right clinical documentation and evidence citations that insurance companies require for approval.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your specific Humana plan and consult your healthcare provider for medical decisions. For assistance with insurance issues in Florida, contact the Division of Consumer Services at 1-877-693-5236.

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