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

How to Get Enhertu Covered by Humana in Ohio: Complete Prior Authorization and Appeal Guide

Answer Box: Getting Enhertu Covered by Humana in Ohio

Humana requires prior authorization for Enhertu (fam-trastuzumab deruxtecan-nxki) across all indications. The fastest path to approval: 1) Your oncologist submits a complete prior authorization through Humana's provider portal with HER2 biomarker results, prior therapy documentation, and ILD monitoring plan. 2) If denied, appeal within 65 days using Humana's redetermination process. 3) For final denials, file external review with Ohio Department of Insurance within 180 days. Start today: Call Humana at the number on your insurance card to confirm current PA requirements and forms.

Table of Contents

  1. Patient Profile: Who Qualifies for Enhertu
  2. Pre-Authorization Preparation
  3. Submitting Your Request
  4. Initial Outcome: Approval or Denial
  5. The Appeal Process
  6. External Review in Ohio
  7. What We'd Do Differently: Key Lessons
  8. Templates and Checklists
  9. FAQ
  10. Sources and Further Reading

Patient Profile: Who Qualifies for Enhertu

Enhertu (fam-trastuzumab deruxtecan-nxki) is approved for multiple HER2-positive and HER2-low solid tumors. To qualify for Humana coverage, you'll need:

Biomarker Requirements:

  • HER2-positive breast cancer: IHC 3+ or ISH positive
  • HER2-low breast cancer: IHC 1+ or IHC 2+/ISH negative
  • HER2-mutant NSCLC: Confirmed HER2/ERBB2 mutation by NGS
  • HER2-positive gastric cancer: HER2 overexpression or gene amplification

Prior Therapy Requirements:

  • Failed or progressed on appropriate prior systemic therapy
  • For breast cancer: typically requires prior trastuzumab-based treatment
  • Documentation of treatment history with dates and outcomes

Safety Requirements:

  • No active interstitial lung disease (ILD)
  • Baseline pulmonary function assessment completed
  • Plan for ongoing ILD monitoring during treatment
Note: The VENTANA HER2 (4B5) assay is now approved for detecting HER2-low and ultra-low expressors, expanding eligibility.

Pre-Authorization Preparation

Before submitting your PA request, gather these essential documents:

Required Clinical Documentation

Document Type Specific Requirements Where to Obtain
Pathology Report HER2 status with testing methodology Hospital/lab that performed biopsy
Treatment History Prior therapies, dates, outcomes Oncology clinic records
ILD Assessment Baseline PFT, chest imaging, no active ILD Pulmonology or oncology notes
Medical Necessity Letter Clinical rationale, guidelines cited Treating oncologist

Medical Necessity Letter Checklist

Your oncologist should include:

  • Diagnosis: ICD-10 coded with staging
  • Biomarker results: Specific HER2 testing methodology and results
  • Prior treatments: Medications tried, duration, response, reason for discontinuation
  • Clinical rationale: Why Enhertu is appropriate now
  • Safety assessment: ILD risk evaluation and monitoring plan
  • Guideline support: Reference to NCCN guidelines or FDA labeling

Submitting Your Request

Step-by-Step Submission Process

  1. Confirm PA requirement: Call Humana member services or check the prior authorization search tool
  2. Complete PA forms: Your provider uses Humana's prior authorization forms specific to oncology medications
  3. Submit electronically: Through Humana's provider portal for fastest processing (goal: 95% of complete requests decided within one business day by 2026)
  4. Include all documentation: Attach pathology reports, treatment history, medical necessity letter, and ILD assessment
  5. Request expedited review if urgent: For immediate clinical need, request 24-hour expedited review

Timeline Expectations

  • Standard review: 72 hours from complete submission
  • Expedited review: 24 hours for urgent cases
  • Incomplete submissions: May delay decision by 7-14 days

Initial Outcome: Approval or Denial

If Approved

  • Coverage determination letter will specify:
    • Approved indication and dosing
    • Duration of approval
    • Any ongoing requirements (monitoring, reporting)
    • Site of care restrictions if applicable

If Denied: Common Reasons

  • Missing biomarker documentation: HER2 status not clearly documented with companion diagnostic
  • Insufficient prior therapy: Haven't tried or documented failure of required prior treatments
  • ILD concerns: Baseline assessment incomplete or active lung disease present
  • Non-formulary status: Drug not on preferred formulary tier

The Appeal Process

Internal Appeals with Humana

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

How to Appeal:

  1. Request redetermination: Use Humana's appeal forms or call member services
  2. Provide additional evidence: New clinical information, peer-reviewed studies, updated guidelines
  3. Request peer-to-peer review: Direct discussion between Humana's clinical reviewer and your oncologist

Peer-to-Peer Review Strategy

During the peer-to-peer call, your oncologist should emphasize:

  • Specific FDA-approved indication match
  • Failed alternatives and reasons why
  • Unique clinical circumstances requiring Enhertu
  • Safety monitoring plan for ILD risk
  • Reference to current treatment guidelines
From our advocates: "We've seen successful appeals when oncologists come prepared with specific prior therapy dates and clearly articulate why standard alternatives won't work. The peer-to-peer review is often the turning point."

External Review in Ohio

If Humana upholds the denial, Ohio law provides an independent external review option.

Ohio External Review Process

Deadline: 180 days from final internal denial to request external review

How to File:

  1. Submit written request to Ohio Department of Insurance
  2. Include all medical records and supporting documentation
  3. Ohio DOI assigns case to Independent Review Organization (IRO)

Timeline:

  • Standard review: 30 days for IRO decision
  • Expedited review: 72 hours for urgent cases

Contact for Help: Ohio Department of Insurance Consumer Hotline: 1-800-686-1526

What Makes External Reviews Successful

  • Complete medical record: All treatment history, imaging, labs
  • Updated clinical evidence: Recent studies supporting Enhertu use
  • Clear medical necessity: Why no other treatment option is suitable
  • Safety documentation: Comprehensive ILD monitoring plan

What We'd Do Differently: Key Lessons

Based on successful Enhertu appeals, here's what works:

Do This First

  • Get complete biomarker testing: Use FDA-approved companion diagnostics
  • Document everything: Every prior treatment with specific dates and outcomes
  • Address ILD upfront: Complete baseline assessment before PA submission

Avoid These Mistakes

  • Incomplete treatment history: Vague references to "failed prior therapy"
  • Missing safety documentation: No ILD assessment or monitoring plan
  • Generic medical necessity letters: Not specific to Humana's criteria

Timing Strategy

  • Start PA early: Don't wait until current treatment fails
  • Use expedited process: For urgent clinical situations
  • Appeal quickly: Don't wait until the 65-day deadline approaches

Templates and Checklists

Patient Phone Script for Humana

"I'm calling about prior authorization for Enhertu for my [cancer type]. My member ID is [number]. Can you confirm current PA requirements and send me the appropriate forms? I also need to know if this requires expedited review given my clinical situation."

Pre-Submission Checklist

  • HER2 biomarker results with testing methodology
  • Complete prior treatment history with dates
  • Baseline pulmonary function assessment
  • Medical necessity letter citing guidelines
  • ICD-10 diagnosis codes
  • Current imaging and lab results
  • Humana PA forms completed by provider

FAQ

How long does Humana prior authorization take for Enhertu? Standard review takes 72 hours; expedited review takes 24 hours. Electronic submissions through the provider portal are processed fastest.

What if Enhertu isn't on Humana's formulary? You can request a formulary exception with medical necessity documentation. Your oncologist must demonstrate that covered alternatives are ineffective or harmful.

Can I get an expedited appeal in Ohio? Yes, both Humana internal appeals and Ohio external reviews offer expedited options (24-72 hours) if delay would seriously jeopardize your health.

Does step therapy apply to Enhertu? Often yes - Humana typically requires trying other HER2-targeted therapies first unless contraindicated or previously failed.

What's the cost if approved? Costs vary by plan. Check with Humana about your specific copay. The manufacturer offers patient assistance programs that may help.

Who can help with appeals in Ohio? Contact the Ohio Department of Insurance at 1-800-686-1526, or organizations like UHCAN Ohio for patient advocacy support.

Getting insurance approval for complex cancer treatments shouldn't feel impossible. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to create compelling appeals that speak directly to payer requirements, improving approval rates for critical medications like Enhertu.

Whether you're navigating prior authorization requirements or preparing for an appeal, having the right documentation and strategy makes all the difference. For additional support with your Humana appeal in Ohio, consider working with experienced advocates who understand both the clinical requirements and the insurance landscape.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For official Ohio insurance regulations and consumer rights, visit the Ohio Department of Insurance website.

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