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

How to Get Enhertu (Fam-Trastuzumab Deruxtecan-nxki) Approved by Humana in Virginia: Timeline, Forms & Appeal Process

Answer Box: Your Path to Enhertu Coverage

Getting Enhertu (fam-trastuzumab deruxtecan-nxki) covered by Humana in Virginia requires prior authorization with HER2 testing documentation and medical necessity justification. Standard decisions take 7-14 days; expedited reviews complete within 72 hours if your health is at serious risk. Start by having your oncologist submit a complete prior authorization request through Humana's provider portal or by calling 866-488-5995. If denied, you have 65 days to appeal and can request Virginia's external review process through the State Corporation Commission Bureau of Insurance for additional protection.

Table of Contents

What Affects Approval Timing

Several factors influence how quickly Humana processes your Enhertu prior authorization in Virginia:

Benefit Type: Enhertu is typically covered under your medical benefit (Part C for Medicare Advantage) rather than prescription drug coverage, which can affect processing pathways and timelines.

Documentation Completeness: Humana requires specific clinical documentation including HER2 testing results, prior treatment history, and medical necessity justification. Complete submissions process faster than those requiring follow-up.

Clinical Complexity: Enhertu has multiple FDA-approved indications (HER2-positive breast cancer, HER2-low breast cancer, HER2-mutant NSCLC, and others). Clear documentation matching your specific indication streamlines review.

Urgency Level: Standard prior authorizations follow CMS timelines, but expedited reviews are available when delays could seriously harm your health.

Note: Starting January 1, 2026, CMS will require Medicare Advantage plans to decide standard prior authorizations within 7 calendar days (down from the current 14 days), with Humana committing to 1-business-day decisions for 95% of complete electronic requests.

Pre-Submission Preparation (0-2 Days)

Before your oncologist submits the prior authorization, gather these essential documents:

Required Documentation Checklist

  • HER2 Testing Results: IHC and/or ISH results from FDA-approved testing showing HER2-positive, HER2-low, or HER2-mutant status
  • Pathology Report: Confirming cancer type, stage, and hormone receptor status
  • Prior Treatment History: Detailed list of previous therapies, dates, responses, and reasons for discontinuation
  • Current Clinical Status: Recent oncology notes, performance status (ECOG), and imaging results
  • Insurance Information: Current Humana member ID, group number, and plan details

Medical Necessity Elements

Your oncologist's prior authorization request must demonstrate that Enhertu meets Humana's medical necessity criteria, typically including:

  1. Appropriate Indication: Matches FDA-approved uses for your specific cancer type and HER2 status
  2. Line of Therapy: Meets requirements for prior treatment (e.g., previous anti-HER2 therapy for HER2-positive breast cancer)
  3. Safety Monitoring Plan: Documentation of baseline assessments and monitoring for interstitial lung disease (ILD) and cardiac function
  4. Contraindication Documentation: Evidence that preferred formulary alternatives are inappropriate

Submission to Initial Review (1-7 Days)

How to Submit

Provider Portal (Fastest): Humana's Availity Essentials portal for electronic submission

Phone: 866-488-5995 (providers); 866-773-5959 (members)

Fax: 800-594-5309

What Reviewers Check First

Humana's clinical reviewers prioritize these elements:

  1. Formulary Status: Whether Enhertu requires prior authorization for your specific plan
  2. FDA Indication Match: Alignment between your diagnosis/HER2 status and approved uses
  3. Documentation Completeness: All required clinical information included
  4. Provider Credentials: Prescription from qualified oncology specialist
Tip: Electronic submissions through the provider portal typically process fastest and provide real-time status updates.

Additional Information Requests (1-7 Days)

If Humana requests additional information, respond promptly to avoid delays:

Common Information Requests

  • Missing HER2 Testing: Specific IHC scores or ISH results
  • Prior Therapy Details: Exact regimens, duration, and response documentation
  • Baseline Safety Labs: Cardiac function (LVEF) and pulmonary assessment
  • Guideline Support: NCCN or other professional society recommendations

How to Respond Quickly

  • Same-Day Response: Fax additional documents to 800-594-5309 with original case number
  • Provider Portal: Upload documents directly to pending prior authorization
  • Phone Follow-up: Call 866-488-5995 to confirm receipt of additional information

Counterforce Health specializes in helping patients and clinicians navigate these information requests by identifying exactly what documentation payers need and ensuring submissions are complete the first time.

Decision Window & Outcomes

Standard Timeline

  • Current Standard: 14 calendar days for non-urgent requests
  • 2026 Update: 7 calendar days for standard decisions
  • Expedited: 72 hours when health is at serious risk

Possible Outcomes

Approval: Full coverage authorized for specified duration and dosing Partial Approval: Coverage with restrictions (dose limits, site of care requirements) Denial: Coverage declined with specific reason codes

Reading Your Approval Letter

Approved prior authorizations specify:

  • Authorization Number: Required for billing
  • Valid Dates: Coverage period (typically 3-6 months for oncology drugs)
  • Quantity Limits: Approved doses per cycle
  • Site of Care: Where treatment can be administered

If Denied: Appeal Process

Humana Internal Appeals

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

Standard Appeal: Decision within 30 days Expedited Appeal: Decision within 72 hours for urgent cases

How to Appeal

  1. Call Member Services: 866-773-5959 to request appeal forms
  2. Online: Submit through Humana member portal
  3. Written Request: Mail to address on denial letter

Appeal Documentation

Include with your appeal:

  • Original denial letter
  • Additional medical records supporting medical necessity
  • Peer-reviewed literature or guidelines supporting Enhertu use
  • Updated physician letter addressing specific denial reasons

Virginia-Specific Appeal Rights

Virginia provides additional protections through the State Corporation Commission Bureau of Insurance:

External Review Process

After exhausting Humana's internal appeals, you can request external review:

  • Timeline: 120 days from final internal denial
  • Cost: Free to consumers
  • Decision Time: 45 days (standard); 72 hours (expedited)
  • Binding: Decision is final and binding on Humana

How to File External Review

  1. Contact the Bureau: Call 1-877-310-6560 for guidance
  2. Submit Form 216-A: External Review Request form
  3. Include Documentation: All medical records, denial letters, and appeal correspondence
Virginia Advantage: Virginia allows expedited external review for cancer treatment denials without requiring completion of internal appeals first—a special provision recognizing the urgency of oncology care.

Timeline Visual & Milestones

Stage Timeline Key Actions Expected Outcome
Preparation 0-2 days Gather HER2 testing, treatment history Complete documentation package
Submission Day 1 Provider submits PA via portal/phone Acknowledgment within 24 hours
Initial Review Days 2-7 Clinical review of indication/necessity Approval or information request
Additional Info Days 8-14 Respond to any documentation requests Final determination
Decision Day 14 (current) / Day 7 (2026) Approval, partial approval, or denial Coverage authorization or denial letter
Appeal Days 15-79 File internal appeal if denied Appeal decision within 30 days
External Review Days 80-124 File Virginia external review Independent decision within 45 days

Time-Saving Tips

Portal Optimization

  • Electronic Submission: Use Humana's provider portal for fastest processing
  • Complete Documentation: Include all required elements in initial submission
  • Status Tracking: Monitor progress through online portal

Specialty Routing

  • Oncology Fast Track: Requests from certified oncologists may receive priority review
  • Expedited Processing: Request urgent review when delays risk patient safety

Bundled Evidence

Submit comprehensive packages including:

  • Clinical notes with clear medical necessity rationale
  • HER2 testing results with laboratory certification
  • Treatment timeline showing prior therapy failures
  • Safety monitoring plan addressing ILD risk

Counterforce Health's platform helps clinicians prepare these comprehensive submissions by automatically identifying required documentation and drafting evidence-based medical necessity letters tailored to specific payer requirements.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing HER2 Testing Submit complete biomarker results IHC/ISH report from FDA-approved test
Insufficient Prior Therapy Document previous treatment failures Detailed regimen list with dates and outcomes
Site of Care Restriction Request exception or find approved facility Provider network verification
Non-Formulary Status File formulary exception Medical necessity letter citing contraindications to alternatives
Experimental/Investigational Provide FDA approval documentation Current prescribing information and indication

Medical Necessity Letter Elements

Your oncologist's letter should address:

  • Specific FDA indication that applies to your case
  • HER2 testing methodology and results
  • Prior treatment history and reasons for failure/intolerance
  • Clinical rationale for Enhertu over alternatives
  • Safety monitoring plan especially for ILD risk
  • Professional guidelines supporting use (NCCN, ASCO)

FAQ

How long does Humana prior authorization take for Enhertu in Virginia? Standard decisions take up to 14 days currently (7 days starting in 2026). Expedited reviews complete within 72 hours when medically urgent.

What if Enhertu is non-formulary on my Humana plan? You can request a formulary exception with prescriber documentation that formulary alternatives are medically inappropriate.

Can I request expedited review for cancer treatment? Yes, both Humana and Virginia's external review process offer expedited timelines when delays could seriously jeopardize your health.

Does Virginia have special protections for cancer drug appeals? Yes, Virginia allows expedited external review for cancer treatment denials without requiring completion of internal appeals first.

What happens if both Humana and external review deny coverage? You retain rights to pursue other options including legal action, though the external review decision is binding on the insurance plan.

How much does external review cost in Virginia? External review through Virginia's Bureau of Insurance is completely free to consumers.

Renewal Cycles & Reauthorization

Enhertu prior authorizations typically require renewal every 3-6 months. For faster reauthorization:

Required for Renewal

  • Clinical Response Documentation: Imaging showing stable disease or response
  • Toxicity Assessment: Confirmation of acceptable side effect profile
  • Continued Medical Necessity: Ongoing indication for treatment

Expedited Renewal Process

  • Submit renewal requests 2-3 weeks before expiration
  • Include updated oncology notes documenting clinical benefit
  • Reference original authorization number for faster processing

This guide provides educational information about insurance coverage processes and should not be considered medical advice. For personalized guidance about your specific situation, consult with your healthcare team and insurance plan directly.

Sources & Further Reading

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