By Counterforce Health Team in Tagrisso (osimertinib) —

If Tagrisso (Osimertinib) Isn't Approved by Blue Cross Blue Shield in Michigan: Formulary Alternatives & Exception Paths

Answer Box: Getting Tagrisso Alternatives or Exceptions with BCBS Michigan

If BCBS Michigan denies Tagrisso (osimertinib), you have three main paths: try formulary alternatives like erlotinib or gefitinib with prior authorization, request a formulary exception for Tagrisso with medical necessity documentation, or appeal the denial through Michigan's external review process. Recent Michigan cases show successful overturns when EGFR mutations are confirmed and alternatives are contraindicated. First step today: Have your oncologist verify your EGFR testing results and submit either an alternative drug PA or Tagrisso exception request through the BCBS Michigan provider portal.

Table of Contents

  1. When Alternatives Make Sense
  2. EGFR TKI Alternatives on BCBS Michigan Formulary
  3. Pros and Cons of Alternative Options
  4. Formulary Exception Strategy for Tagrisso
  5. Switching Logistics and Coordination
  6. Re-trying for Tagrisso Later
  7. Appeals Process in Michigan
  8. Costs and Patient Assistance
  9. FAQ

When Alternatives Make Sense

Blue Cross Blue Shield of Michigan requires prior authorization for all EGFR tyrosine kinase inhibitors (TKIs) used in non-small cell lung cancer (NSCLC). While Tagrisso appears on the 2025 Clinical Drug List, recent denial cases show strict adherence to coverage criteria.

Alternatives may be appropriate when:

  • You have first-time EGFR-sensitizing mutations (exon 19 deletion or L858R) without T790M resistance
  • Previous TKI therapy hasn't been tried
  • Tagrisso is denied for administrative reasons rather than medical necessity
  • Cost considerations are paramount while establishing EGFR mutation status

Alternatives are NOT appropriate when:

  • You have T790M resistance mutation after prior TKI therapy
  • You've already failed first- or second-generation EGFR TKIs
  • You have CNS metastases (Tagrisso has superior CNS penetration)
  • Your oncologist has documented contraindications to other TKIs
Note: A November 2025 Michigan case shows BCBS Michigan was ordered to cover Tagrisso for EGFR-mutant large cell neuroendocrine carcinoma after external review, demonstrating that denials can be successfully overturned.

EGFR TKI Alternatives on BCBS Michigan Formulary

Based on BCBS Michigan's prior authorization guidelines, these EGFR inhibitors require PA but may have different coverage criteria:

First-Generation EGFR TKIs

  • Erlotinib (Tarceva): Oral daily; FDA-approved for EGFR-mutant metastatic NSCLC
  • Gefitinib (Iressa): Oral daily; first-line for EGFR exon 19 deletion or L858R mutations

Second-Generation EGFR TKIs

  • Afatinib (Gilotrif): Oral daily; FDA-approved for EGFR exon 19 deletion or L858R mutations
  • Dacomitinib (Vizimpro): Oral daily; first-line for metastatic NSCLC with EGFR mutations

Coverage Requirements Table

Drug PA Required Typical Criteria Common Restrictions
Erlotinib Yes EGFR+ NSCLC, appropriate setting May require first-line use documentation
Gefitinib Yes EGFR exon 19 del or L858R Limited to first-line metastatic setting
Afatinib Yes EGFR sensitizing mutations Requires mutation confirmation
Dacomitinib Yes EGFR+ metastatic NSCLC May have quantity limits

Source: BCBS Michigan PA Guidelines

Pros and Cons of Alternative Options

Erlotinib (Tarceva)

Pros: Extensive clinical experience, oral administration, may have fewer coverage restrictions Cons: Higher rate of skin toxicity, less effective against T790M resistance, inferior CNS penetration compared to Tagrisso

Gefitinib (Iressa)

Pros: Generally well-tolerated, effective for EGFR-sensitizing mutations Cons: Not effective against T790M, limited to first-line use, potential for drug interactions

Afatinib (Gilotrif)

Pros: Irreversible EGFR inhibition, effective against some uncommon EGFR mutations Cons: Higher rate of diarrhea and skin toxicity, not effective against T790M

Testing and Monitoring Considerations

All alternatives require:

  • Confirmed EGFR mutation testing via FDA-approved companion diagnostics
  • Regular monitoring for progression
  • Cardiac and pulmonary function assessment
  • Skin toxicity management protocols

Formulary Exception Strategy for Tagrisso

If alternatives aren't appropriate, request a formulary exception for Tagrisso. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying the specific denial basis and drafting point-by-point rebuttals aligned to the plan's own rules.

Medical Necessity Documentation Required

Essential Elements:

  1. EGFR Testing Results: Molecular analysis confirming exon 19 deletion, L858R, or T790M mutations
  2. Disease Staging: Pathology report with NSCLC diagnosis and staging
  3. Prior Therapy Documentation: Records of failed TKIs or contraindications to alternatives
  4. Clinical Urgency: ECOG performance status, CNS involvement, rapid progression

Supporting Evidence to Include:

  • NCCN Guidelines recommending osimertinib for specific EGFR mutations
  • FDA labeling information for on-label use
  • Peer-reviewed studies supporting superiority over alternatives
  • Contraindication documentation for formulary alternatives

Submission Process

  1. Provider Portal: Submit via BCBS Michigan provider portal
  2. CoverMyMeds: Electronic PA submission platform
  3. Phone: Call 1-800-437-3803 for urgent cases
  4. Fax: Use plan-specific fax number (verify current number)

Timeline: Standard review takes 5-15 business days; expedited review available for oncology cases with clinical urgency.

From Our Advocates: "We've seen Michigan BCBS cases succeed when the oncologist clearly documented why first-generation TKIs were inappropriate—whether due to T790M resistance, CNS metastases, or prior intolerance. The key is matching your clinical scenario exactly to FDA labeling and NCCN recommendations."

Switching Logistics and Coordination

Pharmacy Benefits Coordination

  • Specialty Pharmacy: Most EGFR TKIs require specialty pharmacy dispensing
  • 30-Day Supply Limits: Common quantity restriction across all TKIs
  • Prior Authorization Transfer: New PA required when switching between drugs

Provider Coordination Steps

  1. Mutation Re-confirmation: Ensure EGFR testing covers all relevant mutations
  2. Baseline Assessments: Cardiac function, pulmonary function tests
  3. Drug Interaction Review: Check for QT-prolonging medications
  4. Patient Education: Discuss expected timelines and side effect profiles

Insurance Transition Management

  • Bridge Therapy: Michigan law provides 90-day continuity for stable patients
  • Appeal During Treatment: Coverage continues during internal appeals
  • Expedited Review: Available for cancer patients with progression risk

Re-trying for Tagrisso Later

Documentation During Alternative Therapy

Track Carefully:

  • Response to treatment (imaging, tumor markers)
  • Toxicity profiles and dose modifications
  • Quality of life impacts
  • Progression dates and sites

Triggers for Tagrisso Re-request

  • Disease Progression: Documented on alternative TKI
  • T790M Emergence: Resistance testing showing T790M mutation
  • Intolerable Side Effects: Requiring dose reductions or discontinuation
  • CNS Progression: Brain metastases development

Re-submission Strategy

Include all previous therapy documentation, progression evidence, and updated EGFR testing results. Reference the successful Michigan case precedent for off-label EGFR-mutant cancers.

Appeals Process in Michigan

Internal Appeal (Required First Step)

  • Timeline: File within 180 days of denial
  • Response Time: 30 days for PA appeals, 60 days for medical necessity
  • Required Documents: Denial letter, member ID, medical necessity letter, clinical records

External Review Through Michigan DIFS

  • Deadline: 127 days after final internal denial
  • Process: Submit via DIFS online form or paper submission
  • Timeline: Standard 60 days, expedited 72 hours for urgent cases
  • Cost: Free to patients

Contact Information:

The platform offered by Counterforce Health can help navigate these complex appeal processes by producing letters that meet procedural requirements and track deadlines for required documentation.

Costs and Patient Assistance

Manufacturer Support Programs

  • AstraZeneca Access 360: Patient assistance for Tagrisso (verify current eligibility)
  • Genentech Access Solutions: Support for erlotinib
  • Boehringer Ingelheim Cares: Assistance for afatinib

State and Federal Programs

  • Michigan Medicaid: May cover alternatives with different criteria
  • 340B Program: Reduced costs at qualifying hospitals
  • State Pharmaceutical Assistance: Contact Michigan DIFS for current programs

FAQ

How long does BCBS Michigan PA take for EGFR TKIs? Standard review is 5-15 business days; expedited review for oncology cases can be 24-48 hours with clinical urgency documentation.

What if Tagrisso is completely non-formulary? Request a formulary exception with medical necessity documentation. Recent Michigan cases show successful appeals when alternatives are inappropriate.

Can I request expedited appeal for cancer progression? Yes, Michigan offers 72-hour expedited external review for urgent cases with physician documentation of potential harm from delay.

Does step therapy apply if I failed TKIs in another state? Out-of-state medical records are accepted. Document prior failures thoroughly with dates, doses, and reasons for discontinuation.

What's the success rate for EGFR TKI appeals in Michigan? While specific rates vary, Michigan's external review process is binding and independent medical experts consider whether denials align with medical standards.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for the most current coverage policies and medical recommendations. For personalized assistance with insurance appeals and prior authorization requests, contact Michigan DIFS at 877-999-6442 or visit michigan.gov/difs.

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