By Counterforce Health Team in Tagrisso (osimertinib) —

Getting Tagrisso (Osimertinib) Covered by Cigna in North Carolina: Complete Prior Authorization and Appeals Guide

Answer Box: Quick Path to Approval

Cigna requires prior authorization for Tagrisso (osimertinib) with documented EGFR mutation testing and oncologist prescribing. Fastest approval path: Submit PA through Express Scripts/Accredo with EGFR mutation results, pathology report, and medical necessity letter. If denied, file internal appeal within 180 days, then request Smart NC external review within 120 days. North Carolina's external review has 40-60% success rates for oncology drugs when proper evidence is provided. Start today: Contact your oncologist to gather EGFR mutation documentation and verify Cigna specialty pharmacy requirements.

Table of Contents

  1. Coverage Requirements Overview
  2. Prior Authorization Process
  3. Medical Necessity Documentation
  4. Common Denial Reasons & Solutions
  5. Appeals Process in North Carolina
  6. Smart NC External Review
  7. Cost Considerations
  8. Frequently Asked Questions

Coverage Requirements Overview

Tagrisso (osimertinib) is a third-generation EGFR tyrosine kinase inhibitor manufactured by AstraZeneca for treating EGFR-mutant non-small cell lung cancer (NSCLC). Cigna classifies Tagrisso as a specialty medication requiring prior authorization and mandates filling through Express Scripts or Accredo specialty pharmacy.

Coverage at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all plans Complete PA form with clinical data Cigna Oncology Policy
EGFR Mutation Positive for del19 or L858R FDA-approved or CLIA-certified lab results Cigna PA Criteria
Specialty Pharmacy Express Scripts/Accredo only Prescription transfer required Cigna Provider Portal
Prescriber Oncologist or consultation Medical license verification Cigna PA Policy
Diagnosis Advanced/metastatic NSCLC Pathology report with staging Cigna Coverage Criteria

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify EGFR Mutation Testing (Patient/Oncologist)
    • Obtain results showing exon 19 deletion or L858R substitution
    • Ensure testing from FDA-approved or CLIA-certified laboratory
    • Timeline: Same day if results available
    • FDA Approved Companion Diagnostics
  2. Gather Clinical Documentation (Oncologist's Office)
    • Complete pathology report with NSCLC diagnosis and staging
    • Treatment history including prior therapies and outcomes
    • Current performance status and treatment goals
    • Timeline: 1-2 business days
    • Submit via: Cigna Provider Portal
  3. Submit Prior Authorization (Prescriber)
    • Complete Cigna PA form with all required fields
    • Include medical necessity letter (see template below)
    • Attach supporting lab results and clinical notes
    • Timeline: Submit within 5 business days of gathering documents
    • Expected response: 72 hours for standard, 24 hours for expedited
  4. Coordinate Specialty Pharmacy (Patient/Clinic)
    • Transfer prescription to Express Scripts or Accredo
    • Verify patient insurance and copay assistance eligibility
    • Timeline: 2-3 business days after PA approval
    • Contact: Express Scripts Specialty or Accredo
Tip: Submit expedited PA requests for patients with rapidly progressing disease or those currently hospitalized. Include "URGENT" in the subject line and provide clinical justification for expedited review.

Medical Necessity Documentation

Clinician Corner: Medical Necessity Letter Checklist

Your medical necessity letter should address these key elements:

Patient-Specific Clinical Information:

  • Confirmed NSCLC diagnosis with pathology report reference
  • EGFR mutation type (exon 19 deletion or L858R) with lab report date
  • Disease stage and current extent of metastatic involvement
  • Performance status (ECOG or Karnofsky scale)

Treatment Rationale:

  • Prior therapies attempted and clinical outcomes
  • Contraindications or intolerances to alternative EGFR inhibitors
  • Specific clinical guidelines supporting osimertinib use
  • Expected treatment goals and monitoring plan

Supporting Evidence:

  • Reference to FDA prescribing information
  • NCCN Guidelines for NSCLC (current version)
  • Published clinical trial data supporting efficacy in your patient's specific mutation type

ICD-10 Coding for NSCLC Documentation

Accurate coding supports medical necessity and reduces denial risk:

Primary Diagnosis Codes:

  • C34.10-C34.92: Malignant neoplasm of bronchus and lung (specify location)
  • C77.1: Secondary malignant neoplasm of intrathoracic lymph nodes
  • C78.00: Secondary malignant neoplasm of unspecified lung

Supporting Codes:

  • Z85.118: Personal history of other malignant neoplasm of bronchus and lung
  • Z51.11: Encounter for antineoplastic chemotherapy
  • Z15.01: Genetic susceptibility to malignant neoplasm (when applicable)

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
No EGFR mutation documented Submit FDA-approved test results CLIA-certified lab report with mutation type
Wrong clinical setting Clarify metastatic vs. adjuvant use Updated staging with imaging reports
Step therapy not completed Request medical exception Prior therapy failure/intolerance documentation
Quantity limits exceeded Submit quantity limit override Clinical rationale for higher dosing
Non-formulary status Request formulary exception Comparative effectiveness evidence

When Step Therapy Applies

Cigna may require trial of first- or second-generation EGFR inhibitors before approving Tagrisso. Request step therapy override by documenting:

  • Prior treatment with erlotinib, gefitinib, or afatinib
  • Clinical progression or intolerable adverse effects
  • T790M mutation development (for second-line use)
  • Medical contraindications to preferred agents

Appeals Process in North Carolina

If Cigna denies your Tagrisso prior authorization, North Carolina provides robust appeal rights through a two-level internal process followed by binding external review.

Internal Appeals Timeline

First-Level Internal Appeal:

  • Deadline: 180 days from denial notice
  • Review time: 30 days (15 days for urgent cases)
  • How to file: Cigna Appeals Portal or fax completed form
  • Required: Denial letter, additional clinical evidence, physician statement

Second-Level Internal Appeal:

  • Deadline: 60 days from first-level denial
  • Review time: 30 days (15 days for urgent cases)
  • Process: Automatic escalation or separate request
  • Decision: Final internal determination
Note: For life-threatening conditions, request expedited review at each level. Include documentation that delay would "seriously jeopardize life or ability to regain function."

Required Appeal Documentation

  • Original denial letter with reason codes
  • Complete medical records supporting medical necessity
  • Updated clinical notes showing disease progression
  • Peer-reviewed literature supporting osimertinib use
  • Physician attestation of medical necessity

Smart NC External Review

North Carolina's external review program offers binding decisions that can overturn Cigna denials. Success rates for oncology drugs range from 40-60% when comprehensive clinical evidence is provided.

External Review Process

Eligibility Requirements:

  • State-regulated health plan (not self-funded employer plans)
  • Completed Cigna's internal appeals or qualify for expedited review
  • Denial based on medical necessity or experimental treatment determination

How to File:

Review Timeline:

  • Standard Review: 45 days from complete application
  • Expedited Review: 72 hours for urgent oncology cases
  • Decision: Binding on Cigna; coverage required within 3 business days if approved

Smart NC Success Factors

Based on documented outcomes, external reviews succeed when they include:

  • FDA-approved indication documentation
  • Failure of or contraindication to covered alternatives
  • Peer-reviewed clinical evidence specific to patient's mutation type
  • Clear articulation of life-threatening consequences of denial

From our advocates: We've seen numerous Tagrisso denials overturned through Smart NC when oncologists provide comprehensive mutation testing documentation and explain why alternative EGFR inhibitors are inappropriate. The key is presenting a complete clinical picture rather than just submitting the denial letter.

Counterforce Health specializes in helping patients and clinicians prepare evidence-based appeals for specialty drug denials, including detailed guidance on North Carolina's external review process and success strategies for oncology medications.

Cost Considerations

Out-of-Pocket Costs

Even with Cigna approval, Tagrisso typically carries specialty tier copays of $100-500+ per month depending on your specific plan design. List price exceeds $15,000 per 30-day supply.

Financial Assistance Options

  • AstraZeneca Patient Assistance: AZ&Me Prescription Savings Program
  • Foundation Support: The Patient Access Network Foundation, CancerCare Co-Payment Assistance
  • State Programs: North Carolina's expanded Medicaid (effective 2024) may provide additional coverage options

Specialty Pharmacy Coordination

Work directly with Express Scripts or Accredo to:

  • Verify copay assistance program eligibility
  • Coordinate delivery and refill scheduling
  • Access clinical support services and adherence programs

Frequently Asked Questions

How long does Cigna prior authorization take in North Carolina? Standard PA decisions are made within 72 hours of complete submission. Expedited requests for urgent cases are decided within 24 hours.

What if Tagrisso is non-formulary on my Cigna plan? Request a formulary exception by demonstrating medical necessity and why covered alternatives are inappropriate. Include comparative effectiveness data and clinical guidelines.

Can I request an expedited appeal if my cancer is progressing? Yes. Document that delay would seriously jeopardize your life or ability to regain function. Both internal appeals and Smart NC external review offer expedited timelines.

Does step therapy apply if I failed prior EGFR inhibitors outside North Carolina? Yes, but document the prior therapies, duration of treatment, and reasons for discontinuation. Out-of-state treatment records are valid for step therapy requirements.

What happens if Smart NC overturns Cigna's denial? The decision is binding. Cigna must provide coverage within 3 business days and cannot appeal the external review decision.

How much does external review cost in North Carolina? External review through Smart NC is completely free to patients and their families.

Can I get help preparing my appeal? Yes. Smart NC provides free assistance at 855-408-1212. Counterforce Health also offers specialized support for complex oncology drug appeals.

What if my employer plan is self-funded? Self-funded ERISA plans are not subject to North Carolina's external review law. However, they typically have their own independent review processes outlined in your plan documents.

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 documents for specific coverage decisions. For personalized assistance with North Carolina insurance appeals, contact Smart NC at 855-408-1212 or visit the North Carolina Department of Insurance website.

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