By Counterforce Health Team in Tagrisso (osimertinib) —

Getting Tagrisso (Osimertinib) Covered by Cigna in New Jersey: Complete Guide to Prior Authorization and Appeals

Quick Answer: How to Get Tagrisso Covered by Cigna in New Jersey

Cigna covers Tagrisso (osimertinib) with prior authorization for EGFR-mutated NSCLC in metastatic, adjuvant, and unresectable stage III settings. No step therapy required under Cigna's national policy. To get approved: (1) Submit PA with EGFR mutation test results showing exon 19 deletion or L858R, (2) Include oncology notes confirming stage and treatment setting, (3) If denied, file internal appeal within 180 days, then external review through New Jersey's IHCAP within 4 months. Start by calling Cigna at the number on your ID card to confirm your plan's specific formulary status.

Table of Contents

  1. Cigna's Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Required Diagnostics and Documentation
  4. Step Therapy and Formulary Exceptions
  5. Quantity Limits and Dosing Rules
  6. Appeals Process for New Jersey
  7. Common Denial Reasons and Solutions
  8. Cost Assistance Options
  9. When to Escalate
  10. FAQ

Cigna's Coverage Policy Overview

Cigna's national oncology policy for Tagrisso applies across commercial, Medicare Advantage, and most employer plans in New Jersey. The drug requires prior authorization but has no step therapy requirement in the policy text.

Coverage at a Glance

Requirement Details Where to Find
Prior Authorization Required for all indications Cigna PA Policy CNF-550
Step Therapy None required by national policy Same policy document
Formulary Tier Specialty (Tier 4-5) typically Plan-specific formulary
Quantity Limits 80mg once daily maximum Cigna DQM Policy CNF-885
Age Requirement 18 years or older PA Policy CNF-550
Note: Individual employer plans may add additional restrictions beyond the national policy. Always verify your specific plan's requirements.

Medical Necessity Requirements

Cigna covers Tagrisso for three specific NSCLC settings, each with distinct criteria:

1. Advanced or Metastatic NSCLC (First-line)

  • Age ≥ 18 years
  • EGFR mutation-positive advanced or metastatic NSCLC
  • Used as monotherapy
  • Approval duration: 1 year

2. Adjuvant Treatment (Post-resection)

  • Completely resected stage IB-IIIA NSCLC
  • EGFR exon 19 deletion or exon 21 (L858R) mutation documented
  • Used after tumor resection
  • Approval duration: Total of 3 years (not renewable cycles)

3. Unresectable Stage III NSCLC

  • Locally advanced, unresectable stage III disease
  • EGFR exon 19 deletion or L858R mutation
  • Approval duration: 1 year

Required Diagnostics and Documentation

EGFR Mutation Testing

All approvals require documented EGFR mutations by an "approved test." Your submission must include:

Molecular pathology report showing:

  • Patient identifiers and specimen details
  • Test name and CLIA-certified lab
  • Specific mutation results (e.g., "EGFR exon 19 deletion positive")
  • Date of testing

Staging and Imaging Documentation

For metastatic disease:

  • CT chest/abdomen/pelvis or PET/CT showing metastatic sites
  • Staging summary (e.g., "Stage IV adenocarcinoma")

For adjuvant use:

  • Surgical pathology confirming complete resection
  • Pathologic TNM staging (IB-IIIA)
  • Pre-operative imaging

For unresectable stage III:

  • Imaging confirming unresectable status
  • Documentation of completed chemoradiation
  • Post-treatment imaging showing no progression
Clinician Corner: Include the most recent radiology report that corresponds to current disease status. This prevents delays from reviewers requesting additional imaging documentation.

Step Therapy and Formulary Exceptions

Good news: Cigna's national Tagrisso policy contains no step therapy requirements. You don't need to fail erlotinib, gefitinib, or other EGFR inhibitors first.

However, some New Jersey employer plans may add step therapy at the formulary level. If your plan requires step therapy:

Medical Exception Process

  1. Document contraindications to required first-line agents
  2. Cite clinical guidelines supporting Tagrisso as first-line (NCCN NSCLC v3.2025)
  3. Request expedited review if treatment delay poses clinical risk

Exception Request Template

"Requesting step therapy waiver for Tagrisso per Cigna PA Policy CNF-550, which authorizes first-line use for EGFR-mutated NSCLC with no step therapy requirement. Patient has [specific EGFR mutation] and meets all medical necessity criteria."

Quantity Limits and Dosing Rules

Cigna's Drug Quantity Management policy limits Tagrisso to FDA-labeled dosing:

  • Standard dose: 80mg once daily
  • Quantity per fill: 30 tablets for 30 days (or 90 for 90 days)
  • 40mg tablets: No quantity overrides recommended

If you need dose reductions due to toxicity, document the clinical rationale clearly in your PA request.

Appeals Process for New Jersey

Step-by-Step Appeals Timeline

1. Internal Appeal (Required First Step)

  • Deadline: 180 days from denial notice
  • Decision time: 72 hours for standard oncology PA
  • Submit to: Cigna member services or provider portal

2. Second Internal Level (If Required)

  • Some NJ HMO/PPO plans require two internal levels
  • Same 180-day deadline from original denial

3. External Review (New Jersey IHCAP)

  • Deadline: 4 months from final internal denial
  • Administrator: Maximus Federal Services
  • Cost: $25 filing fee (waivable for hardship)
  • Decision time: 45 days standard, 48 hours expedited

Required Documents for IHCAP External Review

  • Completed IHCAP external appeal application
  • All Cigna denial and internal appeal letters
  • Signed consent forms for medical record release
  • Complete medical records relevant to the drug request
  • Supporting clinical guidelines and literature
From our advocates: We've seen that external appeals in New Jersey succeed more often when the submission includes specific NCCN guideline citations and clear documentation of why the denial contradicts established medical standards. The key is showing that Cigna's decision conflicts with recognized medical practice.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Documentation Needed
No EGFR mutation documented Submit molecular pathology report Lab report with specific mutation
Wrong treatment setting Clarify indication in appeal Oncology note confirming stage/setting
Experimental/investigational Cite FDA approval and NCCN guidelines FDA label and guideline excerpts
Quantity limit exceeded Request medical exception Clinical note justifying dose/quantity
Not medically necessary Provide comprehensive clinical rationale Complete treatment history and guidelines

Cost Assistance Options

While pursuing coverage approval, consider these financial assistance programs:

Manufacturer Support

  • AstraZeneca Patient Assistance Program
  • Income-based eligibility
  • Can provide free drug during appeals process

Foundation Grants

  • CancerCare Co-Payment Assistance Foundation
  • Patient Access Network Foundation
  • Income and diagnosis requirements vary
Tip: Apply for patient assistance programs while your appeal is pending. Many programs can provide temporary coverage during the review process.

When to Escalate

Contact New Jersey regulators if you experience:

  • Cigna missing appeal deadlines
  • Denial without proper clinical review
  • Procedural violations during the appeals process

New Jersey Department of Banking and Insurance

FAQ

How long does Cigna PA take in New Jersey? Standard decisions within 72 hours for oncology drugs; expedited within 24 hours if delay could jeopardize health.

What if Tagrisso is non-formulary on my plan? Request a formulary exception through Cigna's coverage determination process, providing clinical necessity documentation.

Can I request an expedited appeal? Yes, if treatment delay would seriously jeopardize your health. Mark all submissions as "urgent" and provide clinical justification.

Does step therapy apply if I failed other EGFR inhibitors outside New Jersey? No, Cigna's policy has no step therapy requirement regardless of prior treatment location.

What happens if IHCAP overturns Cigna's denial? The decision is binding on Cigna. They must cover the service and report compliance to New Jersey regulators within 10 business days.

How much does Tagrisso cost without insurance? List prices typically exceed $15,000 per 30-day supply. Patient assistance programs can significantly reduce out-of-pocket costs.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes to identify the denial basis and draft point-by-point rebuttals aligned to each plan's specific requirements.

If your initial PA request is denied, Counterforce Health can help analyze the denial reason and develop a comprehensive appeal strategy that addresses Cigna's specific concerns while highlighting the medical necessity for Tagrisso in your clinical situation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific insurance plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For official appeals procedures and current forms, refer to your plan documents and the linked official sources above.

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