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

Do You Qualify for Enhertu Coverage by UnitedHealthcare in Georgia? Decision Tree & Next Steps

Answer Box: Your Path to Enhertu Coverage in Georgia

UnitedHealthcare requires prior authorization for Enhertu (fam-trastuzumab deruxtecan) in Georgia. To qualify, you need documented HER2-positive status, appropriate diagnosis (breast, lung, or gastric cancer), and typically evidence of prior HER2-targeted therapy failure. Submit requests through the UnitedHealthcare Provider Portal with complete clinical documentation. If denied, Georgia residents have 60 days to file an external review with the Georgia Department of Insurance. Start by confirming your HER2 status and gathering prior treatment records today.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Your Approval Checklist
  4. If "Possibly Eligible": Tests and Timeline
  5. If "Not Yet": Alternatives and Exception Requests
  6. If Denied: Georgia Appeal Path
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & How to Fix Them
  9. FAQ: Georgia-Specific Questions

How to Use This Decision Tree

This guide helps Georgia patients and their doctors navigate UnitedHealthcare's requirements for Enhertu (fam-trastuzumab deruxtecan-nxki). Work through each section in order—starting with eligibility triage—to identify your strongest path to coverage.

Before you start, gather:

  • Your UnitedHealthcare member ID and policy details
  • Pathology reports showing HER2 status
  • Complete treatment history (medications tried, dates, outcomes)
  • Recent imaging or lab results
  • Any previous denial letters
Tip: Keep copies of all documents. Georgia's external review process requires comprehensive medical records.

Eligibility Triage: Do You Qualify?

Answer these questions to determine your approval likelihood:

1. Diagnosis Confirmed?

You need ONE of these FDA-approved indications:

  • HER2-positive breast cancer (metastatic, after prior HER2 therapy)
  • HER2-low breast cancer (metastatic, hormone receptor-positive must be endocrine therapy refractory)
  • HER2-mutant non-small cell lung cancer (metastatic)
  • HER2-positive gastric or gastroesophageal junction cancer (metastatic)

2. HER2 Status Documented?

Required biomarker testing varies by cancer type:

  • Breast cancer: IHC 3+ or ISH+ (HER2-positive); IHC 1+ or IHC 2+/ISH- (HER2-low)
  • NSCLC: HER2 (ERBB2) mutation via NGS testing
  • Gastric cancer: HER2 overexpression or gene amplification

3. Prior Therapy Requirements Met?

UnitedHealthcare typically requires step therapy:

  • Breast cancer: Prior trastuzumab-based regimen (with or without pertuzumab)
  • NSCLC: May require prior systemic therapy
  • Gastric cancer: Consider HER2 re-testing after prior trastuzumab

4. ILD Risk Assessment Complete?

Mandatory safety requirements:

  • Baseline pulmonary function assessment
  • No active interstitial lung disease
  • Plan for ongoing respiratory monitoring

If "Likely Eligible": Your Approval Checklist

You qualify if you answered "yes" to questions 1-4 above.

Step-by-Step: Fastest Path to Approval

  1. Confirm Prior Authorization Requirement (Day 1)
  2. Gather Clinical Documentation (Days 1-3)
    • HER2 testing results with specific methodology
    • Pathology reports with ICD-10 codes
    • Treatment history with dates and outcomes
    • Baseline pulmonary assessment
  3. Submit Prior Authorization (Day 4)
    • Use UnitedHealthcare Provider Portal
    • Include medical necessity letter from oncologist
    • Attach all supporting documentation
    • Request expedited review if clinically urgent
  4. Track Your Request (Days 5-30)
    • Standard review: 15 business days
    • Expedited review: 72 hours
    • Check status via provider portal

Medical Necessity Letter Checklist

Your oncologist should include:

  • Problem: Specific diagnosis with staging
  • Prior treatments: Medications tried, duration, response/failure
  • Clinical rationale: Why Enhertu is appropriate now
  • Guidelines: Reference to NCCN guidelines or FDA labeling
  • Monitoring plan: ILD surveillance protocol

If "Possibly Eligible": Tests and Timeline

You may qualify but need additional documentation.

Missing HER2 Testing?

  • Breast cancer: Request HER2 testing on most recent tissue sample
  • NSCLC: Order comprehensive genomic profiling (CGP) or targeted HER2 mutation testing
  • Gastric cancer: Consider HER2 re-testing if prior trastuzumab exposure

Unclear Prior Therapy History?

  • Obtain complete treatment records from all providers
  • Document specific failure criteria (progression, intolerance)
  • Include dates and duration of each therapy

Timeline to Re-apply

  • HER2 testing results: 1-2 weeks
  • Medical records collection: 2-4 weeks
  • Resubmit PA: Within 30 days of receiving new documentation

If "Not Yet": Alternatives and Exception Requests

You don't meet standard criteria but may still get coverage.

Discuss These Alternatives

  • Trastuzumab + pertuzumab (if not previously tried)
  • T-DM1 (Kadcyla) for HER2-positive breast cancer
  • Clinical trials through ClinicalTrials.gov

Prepare Exception Requests

  • Document contraindications to preferred alternatives
  • Gather peer-reviewed literature supporting off-label use
  • Consider peer-to-peer review with UnitedHealthcare medical director
Note: Exception requests have lower approval rates but may succeed with compelling clinical evidence.

If Denied: Georgia Appeal Path

Georgia residents have strong appeal rights with specific timelines.

Level 1: Internal Appeal (Required First)

  • Timeline: File within 180 days of denial
  • Process: Submit through UnitedHealthcare member portal or mail
  • Documentation: Include all clinical records and medical necessity letter
  • Decision: 30 days (72 hours for urgent cases)

Level 2: External Review (Georgia Department of Insurance)

  • Timeline: File within 60 days of final internal denial
  • Cost: Free to patients
  • Process: Submit external review form to Georgia DOI
  • Decision: 45 days standard (72 hours expedited)
  • Outcome: Binding on UnitedHealthcare

When to Request Peer-to-Peer Review

Consider requesting before or during appeals:

  • Complex clinical situations
  • Off-label use with strong evidence
  • Prior therapy intolerance issues

Call UnitedHealthcare at 866-889-8054 (commercial) or 877-842-3210 (Medicare Advantage).

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans UnitedHealthcare formulary Provider Portal
HER2 Testing Must document appropriate biomarker Pathology report FDA Companion Diagnostics
Step Therapy Typically requires prior HER2 therapy Treatment history UHC Clinical Guidelines
ILD Monitoring Baseline and ongoing assessment Pulmonary function tests FDA Label
Site of Care Typically outpatient infusion Provider certification UHC Network Directory

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"Missing HER2 status" Submit pathology report with specific IHC/ISH results
"Step therapy not met" Document prior trastuzumab/pertuzumab failure or contraindication
"Not medically necessary" Provide medical necessity letter citing NCCN guidelines
"Experimental/investigational" Reference FDA approval and indication-specific labeling
"Quantity/dosing exceeds guidelines" Justify weight-based dosing with BSA calculation

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps identify denial reasons and draft point-by-point rebuttals aligned to each plan's specific requirements, potentially improving your chances of approval.

FAQ: Georgia-Specific Questions

How long does UnitedHealthcare prior authorization take in Georgia? Standard review is 15 business days; expedited review is 72 hours for urgent cases. Timeline starts when UnitedHealthcare receives complete documentation.

What if Enhertu is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Non-formulary drugs may be covered at higher cost-sharing tiers.

Can I request expedited appeal in Georgia? Yes, if delay would jeopardize your health. Both UnitedHealthcare internal appeals and Georgia external reviews offer expedited timelines (72 hours).

Does Georgia's external review cost anything? No, external review through the Georgia Department of Insurance is free for patients. The insurer pays all administrative costs.

What happens if I miss the 60-day external review deadline? Georgia's deadline is strict. However, you may still file a complaint with the Georgia DOI Consumer Services at 1-800-656-2298 for assistance.

Can I get help with my appeal in Georgia? Yes, contact Georgians for a Healthy Future for consumer assistance or the Georgia Legal Services Program for complex cases.

Do I need a lawyer for appeals? No, most appeals can be handled without legal representation. Counterforce Health and similar services can help prepare documentation and appeal letters.

What if UnitedHealthcare approves but limits quantity? Quantity limits may be appealed separately. Document medical necessity for the prescribed dosing frequency and duration.

This guide is for informational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on your specific plan terms and clinical circumstances. For personalized assistance, consult your healthcare provider and contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

Sources & Further Reading

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