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

How to Get Enhertu (Fam-Trastuzumab Deruxtecan-nxki) Covered by Cigna in California: Appeal Guide & Templates

Answer Box: Getting Enhertu Covered by Cigna in California

Cigna requires prior authorization for Enhertu with documented HER2 biomarker testing per ASCO/CAP guidelines, diagnosis details, and prior therapy records. Submit via Cigna's oncology PA form or eviCore system. If denied, California's Independent Medical Review (IMR) overturns 55-68% of medical necessity denials for oncology drugs. Start with your oncologist gathering HER2 pathology reports and treatment history today.

Table of Contents

  1. Understanding Cigna's Enhertu Coverage Requirements
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Playbook for California
  5. Medical Necessity Letter Checklist
  6. California Independent Medical Review (IMR)
  7. Cost Assistance and Patient Support
  8. Frequently Asked Questions

Understanding Cigna's Enhertu Coverage Requirements

Enhertu (fam-trastuzumab deruxtecan-nxki) is a high-cost HER2-targeted therapy averaging $2,440 per 100mg vial with total cycle costs varying by weight. Cigna manages it as a specialty oncology drug requiring prior authorization through Express Scripts/eviCore pathways.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Enhertu prescriptions Cigna PA Form Cigna Policy
HER2 Testing ASCO/CAP guideline-compliant biomarker documentation Pathology reports from CLIA-certified labs FDA Label
Line of Therapy FDA-approved indications with prior therapy documentation Treatment notes showing failures/contraindications Cigna Oncology Policy
Site of Care Buy-and-bill infusion (J9358) Oncology clinic or hospital outpatient CMS HCPCS
ILD Monitoring Baseline pulmonary assessment and monitoring plan Chest imaging, PFTs if indicated FDA Boxed Warning

Step-by-Step: Fastest Path to Approval

1. Confirm HER2 Status Documentation

Who: Oncologist or pathologist
What: ASCO/CAP-compliant HER2 testing results
Timeline: Same day if available
Submit: Include with PA form

Gather pathology reports showing:

  • HER2 IHC score (0, 1+, 2+, 3+)
  • ISH/FISH results if performed
  • Clear classification (HER2-positive, HER2-low, or HER2-ultralow per indication)

2. Document Prior Therapies and Failures

Who: Medical team
What: Complete treatment history with dates and outcomes
Timeline: 1-2 business days to compile
Submit: Attach to PA submission

Include all prior HER2-directed therapies, standard chemotherapy regimens, and reasons for discontinuation (progression, toxicity, contraindications).

3. Submit Prior Authorization

Who: Prescriber or clinic staff
What: Cigna Enhertu PA form with supporting documents
Timeline: Submit within 1-2 days of decision to prescribe
Submit: Fax, mail, or electronic PA system

4. Monitor PA Status

Who: Clinic staff
What: Track submission through Cigna provider portal
Timeline: Standard review 1-2 business days; expedited 24 hours
Follow-up: Call if no response within stated timeframe

5. Request Peer-to-Peer if Needed

Who: Prescribing oncologist
What: Direct discussion with Cigna medical director
Timeline: Usually within 72 hours of request
Outcome: Often resolves clinical questions before formal denial

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing HER2 biomarker data Submit ASCO/CAP-compliant pathology report HER2 testing guidelines with IHC/ISH results
Non-formulary status Request formulary exception with medical necessity Exception criteria form
Incorrect line of therapy Clarify FDA indication alignment Treatment timeline showing appropriate sequencing
ILD risk concerns Address monitoring plan Baseline chest imaging, pulmonary consultation if needed
Site of care restriction Justify infusion center necessity J9358 billing rationale, administration requirements
From Our Advocates: We've seen cases where initial denials for "experimental" use were overturned by clearly citing the specific FDA indication and providing NCCN guideline references. The key is matching your patient's exact diagnosis and prior therapy sequence to the approved label language.

Appeals Playbook for California

Internal Appeals with Cigna

First-Level Internal Appeal

  • Timeline: 180 days from denial to file
  • Review period: 30 days for standard; 72 hours for expedited
  • Submit to: Address on denial letter or Cigna member portal
  • Required: Written request, clinical documentation, prescriber letter

Second-Level Internal Appeal

  • When: After first-level denial
  • Timeline: Additional 30 days for review
  • Who reviews: Different medical director than first level

Expedited Appeals

Request expedited review if:

  • Standard timeframe could jeopardize life or health
  • Patient currently receiving non-formulary treatment
  • Serious deterioration of condition expected

Timeline: 24-72 hours for decision

Medical Necessity Letter Checklist

Your oncologist's letter should include:

Clinical Foundation

  • Patient's specific cancer type and stage
  • HER2 status with exact IHC/ISH results
  • Performance status (ECOG/Karnofsky)
  • Relevant comorbidities

Treatment Rationale

  • Complete prior therapy history with dates
  • Specific reasons each prior treatment failed
  • Why Enhertu is medically necessary now
  • Expected treatment duration and monitoring plan

Evidence Base

  • FDA indication citation matching patient's case
  • NCCN guideline reference (if applicable)
  • Key clinical trial data (DESTINY trials)
  • Contraindications to alternative therapies

ILD Risk Mitigation

  • Baseline pulmonary assessment results
  • Monitoring schedule for symptoms/imaging
  • Plan for dose modifications if needed

Counterforce Health specializes in crafting evidence-backed appeals that align with payer requirements. Their platform can help structure medical necessity arguments using the specific language and criteria that Cigna reviewers expect to see.

California Independent Medical Review (IMR)

If Cigna upholds their denial after internal appeals, California's IMR process offers strong patient protections with 55-68% overturn rates for oncology denials.

Eligibility Requirements

  • Completed Cigna's internal appeal process
  • Denial based on medical necessity, experimental/investigational, or coverage exclusion
  • Plan regulated by California DMHC (most HMOs and managed care)

How to File IMR

  1. Online: DMHC website
  2. Phone: 888-466-2219 (DMHC Help Center)
  3. Mail: Submit application with supporting documents

Timeline

  • Standard IMR: 45 days from complete application
  • Expedited IMR: 72 hours for urgent cases
  • No cost to patient: DMHC covers all review fees

Required Documents

  • All denial letters from Cigna
  • Medical records supporting Enhertu necessity
  • Oncologist's detailed letter of medical necessity
  • HER2 testing reports
  • Prior therapy documentation

Success Factors

Based on California IMR data, successful appeals typically include:

  • Clear FDA indication alignment
  • NCCN guideline support
  • Documented failure of standard alternatives
  • Expert oncologist attestation
  • Complete HER2 biomarker documentation

Cost Assistance and Patient Support

Manufacturer Programs

  • ENHERTU Access Program: Patient assistance for eligible uninsured/underinsured patients
  • Co-pay assistance: Up to $25,000 annually for commercially insured patients
  • Contact: 1-833-ENHERTU or manufacturer website

Foundation Support

  • Patient Advocate Foundation: Co-pay relief programs
  • CancerCare: Financial assistance and case management
  • Leukemia & Lymphoma Society: Patient aid programs

Frequently Asked Questions

Q: How long does Cigna prior authorization take for Enhertu in California? A: Standard PA reviews take 1-2 business days. Expedited reviews for urgent cases are completed within 24 hours.

Q: What if Enhertu is non-formulary on my Cigna plan? A: Request a formulary exception demonstrating medical necessity or contraindications to formulary alternatives.

Q: Can I request an expedited appeal if my condition is worsening? A: Yes, if standard review timeframes could jeopardize your health or if you're currently receiving the medication.

Q: Does step therapy apply if I failed treatments with a previous insurer? A: Document prior failures thoroughly. Cigna may accept previous treatment history, but clear documentation is essential.

Q: What's the success rate for Enhertu appeals in California? A: California IMR data shows 55-68% success rates for oncology medical necessity appeals, particularly when supported by strong clinical evidence.

Q: Who can help me prepare an appeal in California? A: Counterforce Health offers specialized insurance appeal support, or contact the DMHC Help Center at 888-466-2219 for guidance.

When to Escalate

Contact California regulators if:

  • Cigna doesn't respond within stated timeframes
  • You need help filing an IMR
  • You believe the denial violates state insurance laws

DMHC Help Center: 888-466-2219
DMHC Website: healthhelp.ca.gov
CDI Consumer Hotline: 800-927-4357 (for CDI-regulated plans)

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies may change; verify current requirements with Cigna and California regulators.

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