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

How to Get Enhertu (fam-trastuzumab deruxtecan-nxki) Covered by Blue Cross Blue Shield in Virginia: Appeals, Forms & Timeline

Quick Answer: Your Path to Enhertu Coverage in Virginia

Enhertu (fam-trastuzumab deruxtecan-nxki) requires prior authorization from Blue Cross Blue Shield Virginia, typically placed on specialty tier 4 formularies. Your oncologist must submit HER2 testing results, prior treatment documentation, and clinical justification. If denied, Virginia's external review process through the State Corporation Commission provides independent oversight within 45 days (72 hours for urgent cases). Start by verifying your specialty pharmacy network and gathering HER2 status documentation today.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Setup
  5. Common Denial Reasons & Solutions
  6. Appeals Process in Virginia
  7. Cost-Share Considerations
  8. Submission Checklist
  9. When to Escalate
  10. FAQ

Plan Types & Coverage Implications

Blue Cross Blue Shield Virginia (Anthem) operates different plan structures that affect your Enhertu access:

Commercial Plans (Employer-Sponsored)

  • HMO plans may require oncology referrals
  • PPO plans typically allow direct specialist access
  • All plans require prior authorization for specialty oncology drugs

Medicare Advantage

  • Follow Medicare Part B coverage rules for infused drugs
  • May have different formulary tiers than commercial plans
  • Often use Anthem's specialty pharmacy network

Medicaid (Virginia Medallion)

  • Expanded coverage since 2019 includes specialty oncology drugs
  • May have additional state-specific requirements
  • Fee-for-service vs. managed care distinctions apply
Note: Self-funded employer plans may opt into Virginia's external review process but aren't required to—verify this with your HR department if appealing a denial.

Formulary Status & Tier Placement

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all indications Anthem Provider Portal Clinical Criteria Updates
Formulary Tier Specialty Tier 4 (highest cost-share) Plan formulary documents Member portal
Step Therapy May apply for breast cancer Clinical guidelines Provider News Updates
Quantity Limits 600-700 mg every 21 days Medical policy Coverage guidelines
Site of Care Specialty pharmacy or buy-and-bill Network directory Pharmacy benefits

Formulary Alternatives by Indication:

  • HER2+ Breast Cancer: Trastuzumab + pertuzumab, T-DM1 (Kadcyla)
  • HER2+ Gastric Cancer: Trastuzumab-based regimens
  • HER2-mutant NSCLC: Tucatinib combinations, chemotherapy

Prior Authorization Requirements

Step-by-Step: Fastest Path to Approval

  1. Verify HER2 Status (Oncologist)
    • Submit IHC/ISH testing results showing HER2 overexpression (3+) or amplification
    • For NSCLC: provide genomic testing confirming HER2 mutation
    • Timeline: Results typically available within 3-5 business days
  2. Document Prior Therapies (Clinic Staff)
    • List all previous anti-HER2 treatments with dates, doses, outcomes
    • Include reasons for discontinuation (progression, toxicity, intolerance)
    • Attach clinical notes and imaging showing disease progression
  3. Submit PA Request (Provider)
    • Use Anthem's electronic portal or designated forms
    • Include diagnosis codes (C50.x for breast, C16.x for gastric, C78.x for lung mets)
    • Reference NCCN guidelines supporting Enhertu use
  4. Specialty Pharmacy Coordination (Patient/Clinic)
    • Enroll with Anthem's preferred specialty pharmacy network
    • Complete financial assistance screening
    • Schedule infusion appointments pending approval
  5. Follow Up (All Parties)
    • Standard PA decisions: 72 hours after complete submission
    • Urgent requests: 24 hours for life-threatening situations
    • Track status through provider portal or member services

Medical Necessity Documentation

Your oncologist's letter should include:

Clinical Rationale Checklist:

  • ✓ Confirmed HER2-positive status with specific test results
  • ✓ Disease stage (locally advanced/metastatic) with imaging dates
  • ✓ Prior anti-HER2 therapy failures with specific agents and timelines
  • ✓ Current performance status and treatment goals
  • ✓ Reference to FDA labeling and NCCN Category 1 recommendations
  • ✓ Planned monitoring for interstitial lung disease (ILD)

Specialty Pharmacy Setup

Anthem's Preferred Network: Enhertu must be dispensed through designated specialty pharmacies or administered via buy-and-bill at approved infusion centers.

Patient Setup Steps:

  1. Enrollment: Contact Anthem specialty pharmacy services at the number on your insurance card
  2. Financial Screening: Complete copay assistance applications
  3. Delivery Coordination: Arrange shipment to infusion center
  4. Monitoring Setup: Establish regular check-ins for side effect management
Tip: Start specialty pharmacy enrollment immediately after PA submission—approval can happen quickly, and you want to avoid treatment delays.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Missing HER2 testing" Submit complete pathology report IHC 3+ or ISH amplified results
"Inadequate prior therapy" Document specific failures Treatment timelines, progression notes
"Not FDA-approved indication" Cite specific FDA labeling Reference accelerated approval dates
"Alternative available" Request step therapy override Medical contraindications to alternatives
"Experimental/investigational" Provide FDA approval evidence Current prescribing information

Step Therapy Override Process

If BCBS requires you to try other HER2-targeted therapies first, your oncologist can request an override by documenting:

  • Contraindications to required first-line agents
  • Previous failures of the same drug class
  • Clinical urgency making delays inappropriate
  • Patient-specific factors (comorbidities, prior toxicities)

Submit override requests through the same PA portal with supporting clinical notes.

Appeals Process in Virginia

Internal Appeals Timeline

Standard Internal Appeal:

  • File within 30 days of denial notice
  • BCBS has 30 days to respond for pre-service requests
  • 60 days for post-service (reimbursement) claims

Expedited Internal Appeal:

  • Available when delays could jeopardize health
  • Decision required within 72 hours
  • Can file simultaneously with standard appeal

Virginia External Review

If internal appeals fail, Virginia's State Corporation Commission Bureau of Insurance provides independent review:

Eligibility:

  • Must complete BCBS internal appeals first
  • File within 120 days of final internal denial
  • Applies to medical necessity determinations

Timeline:

  • Standard: 45 days for IRO decision
  • Expedited: 72 hours for urgent medical situations
  • Cancer-specific: Virginia allows expedited review for cancer treatment denials

Submission Process:

  1. Complete Form 216-A (External Review Request)
  2. Include all denial letters and appeal responses
  3. Submit physician documentation supporting medical necessity
  4. Mail to: State Corporation Commission, Bureau of Insurance, P.O. Box 1157, Richmond, VA 23218
  5. Or fax to: (804) 371-9944
Important: Virginia's external review is free and conducted by independent medical experts, not BCBS employees.

Cost-Share Considerations

Typical Member Responsibility:

  • Specialty Tier 4: 25-40% coinsurance after deductible
  • Annual out-of-pocket maximums apply ($9,450 for individual ACA plans in 2025)

Financial Assistance Options:

  • Manufacturer Support: Daiichi Sankyo patient assistance programs
  • Copay Cards: May reduce member cost-share to $5-25 per treatment
  • Foundation Grants: Cancer-specific charitable organizations
  • Virginia Programs: Limited income-based assistance through state resources

Note: This information is educational only and not financial advice. Consult with your insurance benefits coordinator for plan-specific details.

Submission Checklist

What to Gather Before Starting

Patient Information:

  • ✓ Insurance card with member ID
  • ✓ Policy documents or benefits summary
  • ✓ Prior authorization form (if provided by BCBS)

Clinical Documentation:

  • ✓ Pathology report with HER2 testing results
  • ✓ Imaging studies showing disease extent
  • ✓ Complete treatment history with dates and outcomes
  • ✓ Current oncology consultation notes
  • ✓ Laboratory values (CBC, comprehensive metabolic panel)

Provider Requirements:

  • ✓ NPI number and practice information
  • ✓ DEA registration for controlled substances (if applicable)
  • ✓ Access to Anthem provider portal or PA submission system

When to Escalate

Contact Virginia Regulators When:

  • BCBS doesn't respond to appeals within required timeframes
  • You suspect unfair claims practices
  • External review decisions aren't implemented promptly

Virginia State Corporation Commission Bureau of Insurance:

  • Phone: (877) 310-6560 (Consumer Services)
  • Website: scc.virginia.gov
  • Managed Care Ombudsman available for HMO issues

Additional Resources:

  • Virginia Poverty Law Center Health Assistance Program
  • Patient advocacy organizations specific to your cancer type
  • Legal aid societies for complex insurance disputes

FAQ

How long does BCBS prior authorization take in Virginia? Standard PA requests receive decisions within 72 hours of complete submission. Urgent requests are processed within 24 hours.

What if Enhertu is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and providing clinical documentation that preferred alternatives are inappropriate.

Can I request an expedited appeal for cancer treatment? Yes. Virginia allows expedited appeals when treatment delays could seriously jeopardize your health, with decisions required within 72 hours.

Does step therapy apply if I've failed treatments outside Virginia? Treatment history from any location counts toward step therapy requirements, as long as you provide adequate documentation of prior failures.

What happens if my employer plan is self-funded? Self-funded plans may opt into Virginia's external review process. If not, you may have federal external review options through HHS.

How much will Enhertu cost with BCBS coverage? Costs vary by plan, but specialty tier drugs typically require 25-40% coinsurance. Manufacturer copay assistance programs may significantly reduce your out-of-pocket costs.

Getting your cancer treatment approved shouldn't be a battle you fight alone. Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific approval criteria, and drafts point-by-point rebuttals using the right medical evidence and clinical facts. From prior authorization submissions to external review appeals, we help ensure your treatment decisions are based on medicine, not insurance bureaucracy.

If you're facing a denial for Enhertu or any specialty cancer treatment, Counterforce Health can help streamline your appeal with payer-specific workflows and deadline tracking, giving you more time to focus on your health while we handle the paperwork.

Sources & Further Reading

This article is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance benefits coordinator for personalized guidance. Coverage policies and requirements may change—verify current information with your specific BCBS plan.

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