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

Lowering Out-of-Pocket Costs for Enhertu with UnitedHealthcare in North Carolina: Copay Cards, Tiering Appeals, and Financial Assistance

Answer Box: Enhertu (fam-trastuzumab deruxtecan-nxki) costs $150,000+ annually but UnitedHealthcare commercial patients can reduce out-of-pocket to $0 drug cost plus $100/infusion using the ENHERTU4U copay program. Submit prior authorization via UnitedHealthcare Provider Portal with HER2-positive pathology results and prior therapy documentation. If denied, appeal internally within 180 days, then file external review with Smart NC within 120 days. First step: Call UnitedHealthcare member services to confirm your specialty drug benefits and deductible.

Table of Contents

  1. What Drives Enhertu Costs with UnitedHealthcare
  2. Investigating Your Benefits: Key Questions to Ask
  3. Manufacturer Assistance and Copay Programs
  4. Foundation Grants and Independent Support
  5. Appealing Specialty Tier Placement
  6. Prior Authorization Requirements and Appeals
  7. Smart NC External Review Process
  8. Annual Planning and Renewal Changes
  9. Conversation Scripts for Common Scenarios

What Drives Enhertu Costs with UnitedHealthcare

Enhertu's annual list price exceeds $150,000, with individual cycles costing approximately $9,574 every 21 days. UnitedHealthcare classifies Enhertu as a specialty tier medication, which typically means:

  • Higher out-of-pocket costs: 20-50% coinsurance or $100-$500+ copays per infusion
  • Separate medical deductible: $1,000-$5,000+ before coverage kicks in
  • Prior authorization required: Must prove medical necessity before approval
  • Site-of-care restrictions: May require specific infusion centers

Since Enhertu is administered by IV infusion, it's covered under your medical benefit rather than pharmacy benefit. This means facility fees and administration costs (up to $100+ per visit) are separate from the drug cost.

Coverage Rates and Restrictions

As of September 2025, 79% of commercial plans cover Enhertu for 51.4% of enrollees, but restrictions like prior authorization and step therapy commonly apply.

Investigating Your Benefits: Key Questions to Ask

Before starting Enhertu, call UnitedHealthcare member services (number on your insurance card) and ask these specific questions:

Question Why It Matters What to Record
"What's my specialty drug coinsurance percentage?" Determines your share of the $150K+ annual cost Write down the exact percentage (e.g., 20%, 30%)
"What's my annual medical deductible?" Amount you pay 100% before coinsurance starts Note if it's individual vs. family, in-network amount
"Is prior authorization required for Enhertu?" Delays treatment if not submitted properly Get PA form name/number if available
"Which infusion centers are in-network?" Out-of-network costs can be 2-3x higher Request list of approved facilities near you
"What's my annual out-of-pocket maximum?" Your financial protection ceiling Confirm in-network vs. out-of-network limits
Tip: Ask for your Summary of Benefits and Coverage (SBC) to be mailed or emailed. This document contains all cost-sharing details in writing.

Manufacturer Assistance and Copay Programs

ENHERTU4U Patient Savings Program

For commercially insured patients, Daiichi Sankyo and AstraZeneca offer significant savings:

  • $0 drug copay (no income requirements)
  • Up to $100 per infusion for administration fees
  • Maximum $26,000 annually in assistance
  • Excludes: Medicare, Medicaid, government insurance, Massachusetts and Rhode Island residents

How to enroll: Call 1-833-ENHERTU (1-833-364-3788) or visit ENHERTU4U.com. Note that a new copay portal launches January 12, 2026, requiring existing users to transition.

Patient Assistance Program (Free Drug)

For uninsured, underinsured, or Medicare patients, the manufacturer offers free Enhertu if you:

  • Are a US resident
  • Meet income limits (specific thresholds not publicly detailed)
  • Spend ≥3% of household income on medications
  • Have no other assistance available

Apply through RxAssist or call the ENHERTU4U program directly.

Foundation Grants and Independent Support

When manufacturer assistance isn't enough, these independent organizations may provide additional copay help:

  • CancerCare Co-Pay Assistance Foundation
  • The Assistance Fund
  • Patient Access Network Foundation
  • Good Days (formerly Chronic Disease Fund)

Each foundation has different eligibility criteria, typically requiring commercial insurance with high out-of-pocket costs. Applications often take 2-4 weeks to process.

Appealing Specialty Tier Placement

If Enhertu is placed on a high specialty tier with unaffordable costs, you can request a formulary exception. UnitedHealthcare allows up to three tier changes per year for medical necessity.

When to Request a Tier Exception

  • Your oncologist believes no lower-tier alternatives are appropriate
  • You've tried and failed preferred agents
  • Lower-tier drugs cause unacceptable side effects
  • You're stable on Enhertu and switching would be harmful

Required Documentation

Submit through the UnitedHealthcare Provider Portal with:

  • Medical necessity letter from your oncologist
  • Documentation of failed prior therapies
  • Clinical notes supporting Enhertu's unique benefits
  • Published studies comparing Enhertu to tier-preferred alternatives

Prior Authorization Requirements and Appeals

UnitedHealthcare requires prior authorization for Enhertu with these key criteria:

Required Documentation

  • HER2-positive status: IHC 3+ or ISH-positive pathology report
  • FDA-approved indication: HER2-positive breast, gastric, or lung cancer
  • Prior therapy failure: Documentation of trastuzumab, pertuzumab, or other HER2-targeted agents
  • ILD risk mitigation plan: Baseline pulmonary function and monitoring strategy
  • Prescriber qualification: Oncologist or hematologist-oncologist

Timeline Expectations

  • Standard review: 14-15 business days
  • Expedited review: 72 hours (if delay would jeopardize health)
  • Peer-to-peer review: Available within 5 business days of initial denial
Note: Request expedited review if treatment delays could worsen your cancer or if you're between treatments.

Smart NC External Review Process

North Carolina provides robust external review rights through the Smart NC program when UnitedHealthcare denials persist after internal appeals.

Eligibility Requirements

  • Plan type: State-regulated plans (individual, small group; self-funded employer plans may not qualify)
  • Denial basis: Medical necessity or experimental treatment determination
  • Internal appeals: Must complete UnitedHealthcare's two-level internal appeals process
  • Timeline: File within 120 days of final internal denial

How to Request External Review

Step Action Timeline
1. Gather documents Final UHC denial letter, medical records, signed patient release Immediately after final denial
2. Download form NC DOI external review request form Within 120 days
3. Submit request Mail to: N.C. Dept. of Insurance, 1201 Mail Service Center, Raleigh, NC 27699-1201 Within 120 days
4. Decision Independent Review Organization (IRO) issues binding decision 45 days (standard) or 4 business days (expedited)

Success Rates and Outcomes

Smart NC accepts approximately 61% of requests that include complete documentation. The IRO's decision is binding on UnitedHealthcare—if they approve coverage, the insurer must provide it within 3 business days.

Free assistance: Call Smart NC at 1-855-408-1212 for help completing forms and gathering evidence.

Annual Planning and Renewal Changes

UnitedHealthcare can modify Enhertu's coverage annually during plan renewals. Key changes to monitor:

What Can Change

  • Tier placement: Higher specialty tiers with increased cost-sharing
  • Prior authorization criteria: More restrictive requirements
  • Site-of-care limitations: Preferred infusion center networks
  • Step therapy additions: Requirements to try cheaper alternatives first

Planning Strategies

  • Review Summary of Benefits: Compare current vs. new year coverage in October-November
  • Grandfather protection: Patients stable on Enhertu often qualify for continued coverage under previous terms
  • Alternative plan evaluation: Consider switching during open enrollment if current plan becomes unaffordable

At Counterforce Health, we help patients and providers navigate these complex coverage changes by analyzing denial letters and crafting targeted appeals that align with each plan's specific criteria. Our platform identifies the exact reasons for coverage denials and provides evidence-backed rebuttals to maximize approval chances.

Conversation Scripts for Common Scenarios

Calling UnitedHealthcare Member Services

"Hi, I need to verify coverage for a specialty medication called Enhertu, generic name fam-trastuzumab deruxtecan-nxki. Can you tell me:

  1. Is prior authorization required?
  2. What's my specialty drug coinsurance percentage?
  3. What's my current deductible balance?
  4. Which infusion centers near [your zip code] are in-network?
  5. Can you email me the prior authorization form?"

Requesting Peer-to-Peer Review (For Clinic Staff)

"I'm calling to request a peer-to-peer review for [patient name], member ID [number]. UnitedHealthcare denied prior authorization for Enhertu on [date]. The prescribing oncologist Dr. [name] needs to speak with your medical director about the clinical necessity. When is the earliest available appointment?"

Appealing to Smart NC

"I'm requesting an external review of UnitedHealthcare's denial for Enhertu cancer treatment. I've completed both levels of internal appeals. The denial was based on medical necessity, but my oncologist believes this medication is essential for my HER2-positive cancer. I have all required documentation ready to submit."

Clinician Corner: Medical Necessity Documentation

Healthcare providers can strengthen Enhertu prior authorizations by including:

Essential Elements

  • HER2 testing methodology: Specify IHC, FISH, or NGS results with exact scores
  • Prior therapy timeline: Dates, drugs, doses, duration, and reason for discontinuation
  • Disease progression evidence: Imaging, tumor markers, or clinical deterioration
  • Contraindications to alternatives: Why other HER2-targeted therapies aren't appropriate
  • ILD monitoring plan: Baseline pulmonary function, scheduled follow-ups

Supporting Guidelines

  • FDA prescribing information for approved indications
  • NCCN Clinical Practice Guidelines for specific cancer types
  • ASCO treatment recommendations for HER2-positive cancers
From our advocates: "We've seen Enhertu approvals improve significantly when oncologists include specific HER2 testing methodology and quantify prior therapy failures. One patient's appeal succeeded after the provider clarified that trastuzumab was discontinued due to cardiac toxicity, not disease progression—this distinction made UnitedHealthcare's medical director recognize Enhertu as the appropriate next step rather than retreating with the same agent."

Common Denial Reasons and Solutions

Denial Reason Required Fix Documentation Needed
"HER2 status not documented" Submit pathology report IHC 3+ or ISH-positive results with methodology
"Prior therapy not attempted" Prove previous HER2-targeted treatment Pharmacy records, infusion logs, or clinic notes
"Not FDA-approved indication" Clarify cancer type and stage Pathology report with histology and staging
"ILD risk not addressed" Include monitoring plan Baseline CT chest, PFTs, monitoring schedule
"Site of care not appropriate" Request exception or find in-network facility Medical necessity for specific infusion center

When to Escalate Beyond UnitedHealthcare

If Smart NC external review fails or you encounter procedural violations, contact:

  • North Carolina Department of Insurance Consumer Services: 1-855-408-1212
  • File a complaint: NC DOI online complaint system
  • Medicare beneficiaries: 1-800-MEDICARE for additional federal protections

Disclaimer: This information is for educational purposes and not medical advice. Always consult your healthcare provider and insurance company for specific coverage decisions. Treatment decisions should be made in consultation with qualified medical professionals.

Sources and Further Reading

For personalized assistance with Enhertu coverage appeals and prior authorization, Counterforce Health provides evidence-backed appeal services that turn insurance denials into targeted rebuttals aligned with each payer's specific criteria.

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