By Counterforce Health Team in Tagrisso (osimertinib) —

How to Get Tagrisso (Osimertinib) Covered by UnitedHealthcare in Michigan: Appeals Guide & Formulary Alternatives

Quick Answer: Getting Tagrisso Covered by UnitedHealthcare in Michigan

UnitedHealthcare typically covers Tagrisso (osimertinib) as a Tier 3 specialty drug requiring prior authorization for EGFR-mutant NSCLC. First step: Have your oncologist submit PA documentation including EGFR mutation test results, staging, and medical necessity letter through the UnitedHealthcare provider portal. If denied, you have 180 days for internal appeals, then 127 days for Michigan DIFS external review. Success requires documented EGFR mutation (exon 19 deletion or L858R for first-line; T790M for post-TKI progression) and alignment with FDA labeling.

Table of Contents

  1. When Formulary Alternatives Make Sense
  2. Typical EGFR TKI Alternatives
  3. Pros and Cons Overview
  4. Exception Strategy for Tagrisso
  5. Switching Logistics
  6. Re-trying for Tagrisso Later
  7. Michigan Appeals Process
  8. Cost Assistance Programs
  9. FAQ

When Formulary Alternatives Make Sense

Before pursuing appeals for Tagrisso, consider whether UnitedHealthcare's formulary alternatives might be appropriate for your situation. This approach makes sense when:

  • Step therapy is required and you haven't tried first-generation EGFR TKIs
  • Urgent treatment is needed while appealing Tagrisso denial
  • Cost considerations make alternatives more accessible
  • Clinical contraindications to Tagrisso exist (severe cardiac disease, QT prolongation risk)
Note: Contemporary guidelines favor osimertinib (Tagrisso) as first-line therapy for EGFR-mutant NSCLC, but older EGFR TKIs remain viable options with proven efficacy.

UnitedHealthcare Coverage Criteria

UnitedHealthcare's Tagrisso PA policy requires:

  • Confirmed EGFR mutation-positive NSCLC
  • FDA-approved or CLIA-validated testing
  • Appropriate line of therapy (first-line metastatic, adjuvant, or T790M-positive post-TKI)
  • Oncologist prescriber

Michigan-specific protection: Under a January 2024 DIFS bulletin, insurers cannot exclude FDA-approved cancer therapies when statutory criteria are met.

Typical EGFR TKI Alternatives

When UnitedHealthcare requires step therapy before approving Tagrisso, these alternatives are typically required:

First-Generation EGFR TKIs

Erlotinib (Tarceva)

  • Mechanism: Reversible EGFR tyrosine kinase inhibitor
  • Typical formulary tier: 2-3
  • Common side effects: Rash, diarrhea, fatigue
  • Key considerations: Take on empty stomach; drug interactions with acid reducers

Gefitinib (Iressa)

  • Mechanism: Reversible EGFR tyrosine kinase inhibitor
  • Typical formulary tier: 2-3
  • Common side effects: Liver enzyme elevation, rash, diarrhea
  • Key considerations: Less severe rash than erlotinib; higher hepatotoxicity risk

Second-Generation EGFR TKIs

Afatinib (Gilotrif)

  • Mechanism: Irreversible ErbB family blocker
  • Typical formulary tier: 3
  • Common side effects: Severe diarrhea, skin toxicity, stomatitis
  • Key considerations: Superior PFS vs. first-generation TKIs; requires aggressive toxicity management

Pros and Cons Overview

Drug Access Advantages Clinical Benefits Drawbacks Monitoring Needs
Erlotinib Often preferred tier; established PA pathways Proven efficacy; extensive safety data More drug interactions; moderate rash LFTs q4 weeks; empty stomach dosing
Gefitinib Good tolerability profile Lower rash rates vs. erlotinib Higher hepatotoxicity risk LFTs q4 weeks initially; closer liver monitoring
Afatinib Superior efficacy vs. 1st-gen TKIs Longer PFS; lower T790M rates Severe GI/skin toxicity Frequent early visits; proactive diarrhea management
Tagrisso Preferred by guidelines CNS activity; better tolerability Higher cost; complex PA EKG monitoring; less frequent visits

Exception Strategy for Tagrisso

When to Request Step Therapy Exceptions

Request exceptions when alternatives are inappropriate due to:

  • CNS metastases (Tagrisso has superior CNS penetration)
  • Prior TKI intolerance or contraindications
  • Cardiac comorbidities where QT monitoring is challenging
  • Performance status concerns with more toxic alternatives

Building Your Exception Request

Medical necessity documentation should include:

  1. EGFR mutation report (FDA-approved or CLIA-validated test)
  2. Staging documentation (imaging, pathology)
  3. Prior therapy history and outcomes
  4. Clinical rationale citing NCCN/ASCO guidelines
  5. Contraindications to step therapy alternatives
Clinician Corner: The medical necessity letter should explicitly reference Tagrisso's FDA labeling language and include specific mutation details (exon 19 deletion vs. L858R for first-line; T790M for post-TKI progression).

Sample Exception Language

"Patient has metastatic EGFR exon 19 deletion-positive NSCLC with CNS metastases. NCCN guidelines recommend osimertinib as preferred first-line therapy due to superior CNS activity compared to erlotinib/gefitinib. Step therapy with first-generation TKIs would delay optimal treatment and potentially compromise neurologic outcomes."

Switching Logistics

Provider Coordination

Before switching from alternatives to Tagrisso:

  1. Document progression on current EGFR TKI (imaging, clinical notes)
  2. Obtain T790M testing if switching post-progression
  3. Plan washout period (typically 0-7 days unless toxicity concerns)
  4. Coordinate pharmacy to avoid treatment gaps

Pharmacy Requirements

Most UnitedHealthcare plans require:

  • Optum Specialty Pharmacy for Tagrisso fills
  • Quantity limits (1 tablet daily)
  • Prior authorization transfer documentation

Counterforce Health helps patients navigate these complex pharmacy transitions by automating the documentation process and ensuring all required clinical information reaches the right decision-makers at UnitedHealthcare.

Monitoring During Transition

  • Baseline assessments: CBC, CMP, LFTs, EKG
  • Early follow-up: 2-4 weeks post-switch
  • Toxicity management: Have protocols ready for common Tagrisso side effects

Re-trying for Tagrisso Later

What to Document During Alternative Trials

If starting with formulary alternatives, document:

Efficacy outcomes:

  • Response rates and duration
  • Progression-free survival
  • Quality of life impacts

Toxicity profiles:

  • Grade and frequency of adverse events
  • Dose modifications required
  • Treatment interruptions

Resistance patterns:

  • T790M emergence (if tested at progression)
  • Alternative resistance mechanisms

Timing Your Tagrisso Request

Optimal timing for re-submission:

  • At progression on first/second-generation TKIs
  • With T790M documentation (tissue or plasma)
  • After toxicity-related discontinuation of alternatives
  • With updated guidelines supporting first-line osimertinib

Michigan Appeals Process

Internal Appeals with UnitedHealthcare

Timeline: 180 days from denial notice Process: Submit through provider portal or mail Required documentation:

  • Complete medical records
  • EGFR mutation testing
  • Oncologist letter with clinical justification
  • Guideline citations (NCCN, ASCO)

Michigan DIFS External Review

If internal appeals fail, Michigan's Patient's Right to Independent Review Act provides:

Timeline: 127 days after final internal denial Process: File with Michigan DIFS Decision: Binding on insurer if approved Expedited review: 72 hours for urgent cases

Michigan Advantage: DIFS explicitly protects cancer patients' access to FDA-approved therapies, giving strong grounds for EGFR inhibitor appeals.

When to Request Expedited Review

Request expedited processing when:

  • Disease progression threatens life or function
  • Current therapy has failed or caused severe toxicity
  • Delay would compromise treatment outcomes

Cost Assistance Programs

AstraZeneca Patient Support

AZ&Me Prescription Savings Program:

  • Eligible patients may pay $0-$25 per month
  • Income-based assistance available
  • Apply at astrazeneca-us.com

Foundation Grants

Patient Advocate Foundation: Copay assistance for qualifying patients CancerCare: Financial assistance and copay relief programs Leukemia & Lymphoma Society: Copay assistance for blood cancer patients (some lung cancer coverage)

FAQ

How long does UnitedHealthcare PA take in Michigan? Standard PA decisions: 15 business days. Expedited requests (urgent medical need): 72 hours.

What if Tagrisso is non-formulary? Request formulary exception with medical necessity documentation. Michigan law protects access to FDA-approved cancer therapies when criteria are met.

Can I request peer-to-peer review? Yes. Have your oncologist request direct discussion with UnitedHealthcare medical director to explain clinical rationale.

Does step therapy apply if I failed EGFR TKIs outside Michigan? Prior therapy history should transfer. Provide documentation of previous treatments and outcomes from all providers.

What if I have Medicare Advantage through UnitedHealthcare? Similar PA requirements apply, but appeal rights may differ. Check your Evidence of Coverage for specific procedures.

How do I file a complaint with Michigan DIFS? Call 877-999-6442 or visit michigan.gov/difs for complaint forms and guidance.

When Counterforce Health Can Help

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to craft targeted, evidence-backed responses. Our platform identifies specific denial reasons—whether PA criteria, step therapy, or "not medically necessary" determinations—and drafts point-by-point rebuttals aligned with UnitedHealthcare's own coverage rules.

For EGFR inhibitor denials, we pull the right clinical evidence (FDA labeling, NCCN guidelines, peer-reviewed studies) and weave them into appeals with required documentation like EGFR mutation results, staging, and treatment history. This systematic approach helps patients, clinicians, and specialty pharmacies get prescription drugs approved more efficiently.

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 personalized guidance. For additional help with insurance appeals in Michigan, contact the Department of Insurance and Financial Services at 877-999-6442.

Sources & Further Reading:

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