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

How to Get Enhertu (fam-trastuzumab deruxtecan-nxki) Covered by Cigna in Pennsylvania: Complete Appeals Guide with Forms & Timelines

Answer Box: Getting Enhertu Covered by Cigna in Pennsylvania

Fastest path to approval: Submit prior authorization through Cigna's provider portal with documented HER2-positive status, prior therapy failures, and NCCN guideline support. If denied, request peer-to-peer review within 7-14 days, then file internal appeals within 180 days. Pennsylvania residents can use the state's Independent External Review Program (50% overturn rate) within 4 months of final denial via pa.gov/reviewmyclaim.

First step today: Gather insurance card, HER2 test results, and prior therapy documentation. Contact your oncologist to initiate the PA process.

Table of Contents

  1. Understanding Cigna's Enhertu Coverage Requirements
  2. Reading Your Denial Letter
  3. Fixing Common Issues Before Appealing
  4. First-Level Appeal Strategy
  5. Peer-to-Peer Review Process
  6. Pennsylvania External Review Program
  7. Medical Necessity Letter Template
  8. Common Denial Reasons & Solutions
  9. Cost Support Options
  10. When to Escalate
  11. Frequently Asked Questions

Understanding Cigna's Enhertu Coverage Requirements

Cigna typically covers Enhertu (fam-trastuzumab deruxtecan-nxki) through its specialty pharmacy benefit managed by Express Scripts, requiring prior authorization for this high-cost oncology drug. Coverage depends on meeting specific medical necessity criteria aligned with FDA labeling and NCCN guidelines.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before dispensing Cigna Provider Portal Cigna PA Policy
HER2 Testing Must document HER2-positive status by approved test Pathology report from CLIA lab Cigna Biomarker Policy
Line of Therapy Usually second-line or later Treatment history notes NCCN Guidelines
Prescriber Oncologist or hematologist-oncologist Provider credentials Standard requirement
Site of Care Outpatient infusion center Treatment plan eviCore guidelines

Key Medical Necessity Criteria

Based on Cigna's oncology policies and NCCN guidelines, Enhertu coverage typically requires:

  • Confirmed HER2-positive tumor (IHC 3+ or ISH-amplified) or HER2-mutant NSCLC
  • Advanced or metastatic disease (unresectable, locally advanced, or stage IV)
  • Prior therapy failure on trastuzumab-based regimens (breast/gastric) or standard therapy (NSCLC)
  • Appropriate dosing: 5.4 mg/kg every 3 weeks (most indications) or 6.4 mg/kg every 3 weeks (gastric cancer)
  • ILD risk mitigation plan documented due to boxed warning
Pennsylvania Advantage: Under Act 39 (effective January 1, 2025), state-regulated plans must cover medically necessary cancer biomarker testing, including HER2 testing, which can help establish eligibility for Enhertu.

Reading Your Denial Letter

When Cigna denies Enhertu, the letter will contain crucial information for your appeal strategy:

Key Elements to Identify

  1. Denial reason code (e.g., "not medically necessary," "step therapy required")
  2. Appeal deadline (usually 180 days for first-level internal appeals)
  3. Required documentation for reconsideration
  4. Benefit type (medical vs. pharmacy benefit)
  5. Reference to specific policy (cite this in your appeal)

Common Denial Language and What It Means

  • "Experimental/investigational": Coverage limited to FDA-approved indications
  • "Step therapy not met": Must try preferred alternatives first
  • "Insufficient documentation": Missing HER2 test results or prior therapy records
  • "Dosing exceeds guidelines": Requested dose above FDA-approved limits

Fixing Common Issues Before Appealing

Before filing a formal appeal, address these fixable problems:

Missing Documentation

  • HER2 test results: Submit pathology report showing IHC 3+ or ISH amplification
  • Prior therapy records: Document dates, responses, and reasons for discontinuation
  • Staging information: Provide imaging confirming advanced/metastatic disease

Coding Issues

  • Ensure correct ICD-10 diagnosis codes (e.g., C50.911 for metastatic breast cancer)
  • Verify HCPCS code J9358 for billing
  • Match indication to FDA-approved uses

Benefit Confusion

  • Confirm whether Enhertu is covered under medical or pharmacy benefit
  • Check if specialty pharmacy enrollment is required through Express Scripts

First-Level Appeal Strategy

Timeline and Submission

  • Deadline: 180 days from denial date
  • Method: Cigna provider portal or written appeal
  • Decision timeframe: 30-60 days (24 hours for expedited)

What to Include in Your Appeal

  1. Cover letter stating appeal request and member information
  2. Complete medical records supporting medical necessity
  3. Peer-reviewed literature supporting off-label use (if applicable)
  4. NCCN guideline citations showing recommended therapy
  5. Provider letter detailing clinical rationale
Tip: For urgent cases where treatment delay could seriously jeopardize health, request an expedited appeal with physician certification.

Peer-to-Peer Review Process

Scheduling the Call

Contact Cigna Health Services at 1-800-88-Cigna (882-4462) within 7-14 days of denial to request peer-to-peer review.

Physician Talking Points Checklist

Clinical Indication

  • State exact diagnosis with ICD-10 code and staging
  • Reference specific NCCN guideline category (1, 2A, or 2B)
  • Cite FDA-approved indication if applicable

Prior Therapy History

  • Summarize previous regimens with dates and outcomes
  • Emphasize progression on Cigna-preferred alternatives
  • Document contraindications to other options

Patient Status

  • Provide current ECOG performance status (0-1 preferred)
  • Review recent labs showing adequate organ function
  • Address any safety concerns (cardiac function, pulmonary status)

Treatment Plan

  • Confirm dosing matches FDA label or NCCN recommendations
  • Outline ILD monitoring plan per boxed warning
  • Specify treatment duration and response monitoring

Pennsylvania External Review Program

Pennsylvania's Independent External Review Program offers a powerful appeal option after exhausting Cigna's internal process.

Key Statistics and Timeline

Metric Details
Success Rate ~50% of denials overturned (259 of 517 cases in 2024)
Request Deadline 4 months after final denial letter
Standard Decision 45 days from assignment
Expedited Decision 72 hours (with physician certification)
Cost Free to consumers

How to File

  1. Complete Cigna's internal appeals first
  2. Submit request at pa.gov/reviewmyclaim
  3. Upload required documents:
    • Final Adverse Benefit Determination letter
    • Insurance card
    • Supporting medical records
  4. Provide additional information within 15 days if requested

Getting Help

  • Pennsylvania Insurance Department: 1-877-881-6388
  • Pennsylvania Health Law Project: Free assistance for complex cases
  • Pennie Consumer Hotline: For marketplace plan issues

Medical Necessity Letter Template

Essential Components

Patient Information

  • Name, DOB, member ID
  • Diagnosis with ICD-10 code
  • Disease stage and extent

Clinical Rationale

  • HER2 testing methodology and results
  • Prior treatments attempted with outcomes
  • Contraindications to alternatives
  • Expected benefits of Enhertu therapy

Evidence Base

  • NCCN guideline citation with category
  • Peer-reviewed studies supporting use
  • FDA labeling information
  • Professional society recommendations

Safety Monitoring

  • ILD surveillance plan
  • Cardiac function monitoring
  • Laboratory monitoring schedule
  • Patient education documentation
From Our Advocates: In our experience helping patients navigate Enhertu appeals, the most successful cases include detailed documentation of why standard alternatives failed or are contraindicated, coupled with clear evidence that the patient's HER2 status and disease characteristics match established guidelines. This composite approach significantly improves approval chances.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
Missing HER2 Status Submit pathology report with IHC 3+ or ISH amplification from CLIA-certified lab
Step Therapy Required Document prior trastuzumab-based therapy failure or contraindications
Experimental Use Provide NCCN guideline citation showing Category 1 or 2A recommendation
Dosing Concerns Confirm dose matches FDA label: 5.4 mg/kg q3w (most cancers) or 6.4 mg/kg q3w (gastric)
ILD Risk Submit comprehensive monitoring plan and patient education documentation
Site of Care Verify outpatient infusion center meets Cigna network requirements

Cost Support Options

Manufacturer Assistance

  • Daiichi Sankyo Patient Support: Financial assistance programs
  • AstraZeneca Access 360: Copay support and patient assistance programs

Foundation Grants

  • Patient Access Network Foundation: Cancer-specific grants
  • CancerCare: Financial assistance and copay help
  • Leukemia & Lymphoma Society: Patient aid program

State Programs

  • Pennsylvania's expanded Medicaid may cover Enhertu under Act 39 biomarker testing provisions

When to Escalate

File a Complaint with Pennsylvania Regulators

Contact the Pennsylvania Insurance Department if:

  • Cigna fails to meet appeal deadlines
  • Inappropriate denial reasons are given
  • Process violations occur

Required Documentation:

  • All denial and appeal correspondence
  • Timeline of events
  • Policy information
  • Medical records supporting your case

Additional Resources

  • Pennsylvania Health Law Project: Legal assistance for complex cases
  • Patient advocate organizations: Disease-specific support groups

Frequently Asked Questions

How long does Cigna prior authorization take in Pennsylvania? Standard PA decisions are made within 1-5 business days. Expedited reviews for urgent cases are completed within 24 hours when treatment delay could seriously jeopardize health.

What if Enhertu is non-formulary on my Cigna plan? Request a formulary exception through the standard PA process. Provide medical necessity documentation and evidence that formulary alternatives are inappropriate or contraindicated.

Can I request an expedited appeal? Yes, if treatment delay poses serious risk to life or health. Your physician must certify the urgency, and Cigna must decide within 24-72 hours.

Does step therapy apply if I failed treatments outside Pennsylvania? Prior therapy records from any location count toward step therapy requirements. Submit complete treatment history with dates and outcomes.

What happens if my external review is successful? Cigna must immediately provide coverage, including retroactive coverage if you paid out-of-pocket during the appeal process.

How much does Enhertu cost without insurance? Directional pricing shows approximately $2,440 per 100mg vial, with total cycle costs depending on patient weight and dosing schedule. Most patients require multiple vials per cycle.

Can I get help with the appeals process? Yes. Contact the Pennsylvania Insurance Department at 1-877-881-6388 or the Pennsylvania Health Law Project for free assistance with complex appeals.

What if I have a self-funded employer plan? Self-funded ERISA plans may not be subject to Pennsylvania's external review program. However, you can still use Cigna's internal appeals process and may have access to federal external review options.

Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies navigate complex insurance denials for high-cost medications like Enhertu. Our platform analyzes denial letters, identifies the specific basis for denial, and generates targeted, evidence-backed appeals that align with each payer's own policies and procedures. By combining clinical expertise with payer-specific workflows, we help transform denials into approvals while reducing the administrative burden on healthcare providers.

Whether you're facing a medical necessity challenge, step therapy requirement, or formulary restriction, having the right documentation and appeal strategy can make the difference between approval and denial. The appeals process may seem daunting, but with proper preparation and understanding of Cigna's requirements, many patients successfully obtain coverage for Enhertu therapy.

For additional support navigating your specific situation, consider working with Counterforce Health to develop a comprehensive appeal strategy tailored to your case and Cigna's policies.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance appeals and should not be considered medical or legal advice. Treatment decisions should be made in consultation with qualified healthcare providers. Insurance policies and appeal processes may vary. Always consult your specific plan documents and contact your insurance company directly for the most current information about coverage requirements and appeal procedures.

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