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

How to Get Enhertu (fam-trastuzumab deruxtecan-nxki) Covered by Cigna in Washington: Appeals Guide with State Protections

Answer Box: Getting Enhertu Covered by Cigna in Washington

Eligibility: Enhertu (fam-trastuzumab deruxtecan-nxki) requires prior authorization through Cigna's Express Scripts/Accredo for HER2-positive cancers. Fastest path: Submit PA with HER2+ test results, prior therapy failures, and oncologist's medical necessity letter. First step today: Call Cigna (number on your ID card) to verify formulary status and PA requirements. If denied, Washington's strong external review process (RCW 48.43.535) provides binding appeals through independent review organizations within 20 days.

Table of Contents

  1. Why Washington State Rules Matter
  2. Prior Authorization Requirements and Turnaround Standards
  3. Step Therapy Protections in Washington
  4. External Review and Complaints Process
  5. Practical Scripts and Sample Language
  6. Common Denial Reasons and How to Fix Them
  7. When to Escalate to State Regulators
  8. Quick Reference Guide

Why Washington State Rules Matter

Washington provides some of the strongest consumer protections in the nation for insurance denials. Unlike many states, Washington requires insurers to follow strict timelines and offers a robust external review process through certified Independent Review Organizations (IROs).

For Enhertu specifically, these protections matter because:

  • High-cost specialty drugs like Enhertu (~$2,440 per 100mg vial) face intensive scrutiny from Cigna's utilization management
  • HER2-positive cancer treatments often require biomarker documentation that may initially be deemed insufficient
  • Washington's external review process has strong overturn rates for oncology drugs when proper evidence is submitted
Note: These protections apply to fully insured Cigna plans. If you have an employer self-funded plan (ERISA), federal rules apply instead, though many large employers voluntarily use similar processes.

Prior Authorization Requirements and Turnaround Standards

Coverage at a Glance

Requirement What It Means Where to Find It Timeline
Prior Authorization Required for Enhertu Cigna formulary 72 hours standard, 24 hours expedited
HER2+ Documentation Biomarker test results Pathology report, oncology notes Submit with initial PA
Step Therapy May require formulary alternatives first Express Scripts PA portal Override possible with medical necessity
Site of Care Infusion center requirements Cigna provider directory Verify before scheduling

Submission Process

Standard Timeline: Cigna must respond within 72 hours of receiving complete PA documentation. For life-threatening conditions, request expedited review (24-hour response).

Required Documentation:

  • HER2-positive test results (IHC 3+ or FISH amplified)
  • Prior therapy history and failures/contraindications
  • Oncologist's medical necessity letter citing NCCN guidelines
  • Current staging and performance status

Submit through:

Step Therapy Protections in Washington

Washington's RCW 48.43.515 requires insurers to grant step therapy exceptions within 72 hours (24 hours expedited) if any of these criteria are met:

Medical Exception Criteria

  • Contraindicated: Required drug likely to cause adverse reaction
  • Ineffective: Required drug won't work for patient's condition
  • Previously failed: Patient tried required drug without success
  • Currently stable: Patient doing well on requested medication

For Cancer Patients

While Washington doesn't categorically exempt cancer drugs from step therapy (unlike some states), the medical exception criteria strongly favor oncology cases:

  • Document disease progression on required alternatives
  • Cite cardiac contraindications (common with HER2+ therapies)
  • Reference NCCN guidelines supporting Enhertu as appropriate choice
  • Include biomarker rationale (HER2+ status, mutation testing)
From our advocates: We've seen step therapy overrides succeed when oncologists clearly document why delaying Enhertu for formulary alternatives could harm outcomes in aggressive HER2+ cancers. The key is connecting patient-specific factors to clinical evidence.

External Review and Complaints Process

If Cigna denies your Enhertu request after internal appeals, Washington's external review process provides a powerful safety net.

Timeline and Process

  1. Internal Appeals First: File within 180 days of denial
    • Level 1: 45 days for Cigna response
    • Level 2: 60 days for response
  2. External Review: File within 120 days of final internal denial

Required Documentation for External Review

  • All denial letters from Cigna
  • Complete medical records
  • Oncologist's detailed clinical rationale
  • Published studies supporting Enhertu for your cancer type
  • NCCN guideline citations (specific page references)

The IRO will assign oncology specialists to review your case independently of Cigna's initial decision.

Practical Scripts and Sample Language

Calling Cigna for PA Status

"I'm calling about prior authorization for Enhertu, generic name fam-trastuzumab deruxtecan-nxki, for my HER2-positive [cancer type]. Can you confirm the formulary status and PA requirements? I'd also like to request expedited review due to the aggressive nature of my cancer."

Medical Necessity Letter Key Points

Your oncologist should include:

  • Diagnosis: "Patient has HER2-positive [cancer type] confirmed by [test method] showing [specific results]"
  • Prior treatments: "Patient previously received [list treatments] with [outcomes/failures]"
  • Clinical rationale: "Per NCCN Guidelines v.[year], page [#], Enhertu is recommended for [specific indication]"
  • Urgency: "Delay in treatment could result in disease progression given [specific clinical factors]"

Appeal Letter Template

Re: Appeal for [Patient Name] - Denial of Enhertu (fam-trastuzumab deruxtecan-nxki)
Policy #[number], Group #[number]

This letter appeals Cigna's denial dated [date] for Enhertu treatment. The denial was based on [quote exact reason]. Coverage is medically necessary for the following reasons:

1. Patient has HER2-positive [cancer type] confirmed by [test details]
2. NCCN Guidelines v.[year], Category 1 recommendation supports Enhertu for this indication
3. Prior therapies [list] were ineffective/contraindicated due to [reasons]
4. FDA approval and clinical trials demonstrate efficacy for this patient population

Request immediate reversal and authorization for treatment.

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Cite NCCN guidelines, FDA label Medical necessity letter, guidelines excerpt
"Experimental/investigational" Reference FDA approval, compendia FDA approval letter, NCCN Compendium listing
Missing biomarker data Submit HER2+ test results Pathology report, IHC/FISH results
Step therapy required Request medical exception Prior therapy failure documentation
Quantity limits exceeded Justify weight-based dosing Dosing calculation, body surface area
Site of care restrictions Document infusion requirements Facility certification, administration plan

When to Escalate to State Regulators

Contact the Washington Office of Insurance Commissioner if:

  • Cigna misses response deadlines (72 hours standard, 24 expedited)
  • Appeals process isn't followed properly
  • You suspect discriminatory practices
  • External review decision isn't implemented

Contact Information:

  • Phone: 1-800-562-6900
  • Website: insurance.wa.gov
  • File complaints online through their consumer portal

Quick Reference Guide

Key Deadlines (Washington)

  • PA Response: 72 hours (24 expedited)
  • Internal Appeal Filing: 180 days from denial
  • External Review Filing: 120 days from final internal denial
  • IRO Decision: 20 days (72 hours expedited)

Essential Documents Checklist

  • ☐ Insurance card and policy information
  • ☐ HER2+ biomarker test results
  • ☐ Complete oncology treatment history
  • ☐ Current staging and imaging
  • ☐ Oncologist's medical necessity letter
  • ☐ NCCN guideline references
  • ☐ Prior authorization forms

Emergency Contacts

  • Cigna Member Services: Number on your ID card
  • Express Scripts PA: 800-753-2851
  • WA Insurance Commissioner: 1-800-562-6900
  • Enhertu Patient Support: 1-844-368-4378

Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific denial basis and crafting evidence-backed rebuttals aligned to each plan's own rules. The platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements for high-cost medications like Enhertu.

FAQ

How long does Cigna take to approve Enhertu in Washington? Standard prior authorization decisions are required within 72 hours. Expedited reviews for urgent cases must be completed within 24 hours.

What if Enhertu isn't on Cigna's formulary? You can request a formulary exception by documenting medical necessity and why formulary alternatives are inappropriate for your case.

Can I appeal if step therapy is required? Yes, Washington law requires insurers to grant step therapy exceptions within 72 hours if you meet medical criteria like prior failures or contraindications.

What's the success rate for external reviews in Washington? While specific rates for Enhertu aren't published, oncology drug appeals have historically strong success rates when proper clinical evidence is submitted to Independent Review Organizations.

Does this apply to Medicare Advantage plans? Cigna Medicare Advantage follows federal rules, but many protections are similar. Contact 1-800-MEDICARE for MA-specific guidance.

What if my employer plan is self-funded? Self-funded ERISA plans aren't subject to Washington state insurance laws, but many voluntarily follow similar processes. Check with your HR department.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and appeals processes. It is not medical or legal advice. Always consult with your healthcare provider about treatment decisions and consider consulting a qualified attorney for complex appeals. Coverage decisions depend on individual plan terms and medical circumstances.

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