By Counterforce Health Team in Tagrisso (osimertinib) —

UnitedHealthcare's Coverage Criteria for Tagrisso (osimertinib) in Pennsylvania: What Counts as "Medically Necessary"?

Answer Box: Getting Tagrisso Covered by UnitedHealthcare in Pennsylvania

To get Tagrisso (osimertinib) covered by UnitedHealthcare in Pennsylvania, you need: documented EGFR mutation (exon 19 deletion or L858R), confirmed NSCLC diagnosis, and prior authorization approval. Submit through the UHC Provider Portal with pathology reports and staging documentation. If denied, Pennsylvania's new external review program overturns 50% of appealed denials. First step today: Call the number on your insurance card to verify PA requirements for your specific plan.

Table of Contents

Policy Overview: How UnitedHealthcare Covers Tagrisso

UnitedHealthcare requires prior authorization for Tagrisso across most commercial plans through OptumRx. The drug appears on Tier 3 specialty formularies with strict medical necessity criteria tied to EGFR mutation status and disease staging.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all ages 19+ UHC PA Policy 2025 P 1174-11
EGFR Testing Mandatory documentation Pathology/molecular report
Formulary Tier Tier 3 specialty OptumRx formulary
Step Therapy Not required nationally Plan-specific; verify with member services
Specialty Pharmacy Often required Optum Specialty Pharmacy
Pennsylvania Advantage: Since January 2024, Pennsylvania's Independent External Review program has overturned 50% of health plan denials, giving you strong appeal rights after internal processes.

Medical Necessity Requirements

UnitedHealthcare's official policy requires all of the following for approval:

Core Criteria for NSCLC

Diagnosis Requirements:

  • Confirmed non-small cell lung cancer (NSCLC)
  • EGFR mutation-positive disease documented by FDA-approved or CLIA-validated testing

Qualifying EGFR Mutations:

  • Exon 19 deletion
  • Exon 21 L858R substitution
  • T790M (for progression after prior EGFR TKI)
  • S768I, L861Q, G719X (other activating mutations)

Clinical Scenarios (choose one):

  1. Adjuvant therapy: Stage IB-IIIB completely resected NSCLC after or instead of platinum chemotherapy
  2. Locally advanced: Stage II-III unresectable disease with no progression during/after chemoradiation
  3. Metastatic/recurrent: Advanced or metastatic EGFR-mutated NSCLC
  4. CNS involvement: Brain or leptomeningeal metastases from EGFR-positive NSCLC

Evidence Documentation Checklist

✓ Pathology report specifying exact EGFR mutation
✓ Staging documentation (imaging, surgical pathology)
✓ Treatment history (prior therapies, responses, failures)
✓ Oncologist letter citing NCCN guidelines and medical necessity
✓ Performance status and current disease burden

Clinician Corner: Reference NCCN NSCLC guidelines explicitly in your medical necessity letter. Tagrisso is Category 1 preferred for first-line metastatic EGFR-mutated NSCLC and accepted for adjuvant use.

Step Therapy & Exception Pathways

Good news: UnitedHealthcare's national Tagrisso policy does not require step therapy through other EGFR inhibitors (erlotinib, gefitinib, afatinib) for first-line use. However, employer-specific plans may add step edits.

When Step Therapy Applies

  • Plan-specific utilization management (verify with member services)
  • T790M indication: Must document progression on prior EGFR TKI

Medical Exception Documentation

If your plan requires step therapy, document:

  • Contraindications to required drugs (drug interactions, organ dysfunction)
  • Prior failures with specific agents and adverse events
  • Clinical urgency (rapidly progressing disease)

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify coverage (Patient/clinic): Call member services to confirm PA requirements and formulary tier
  2. Gather documentation (Clinic): Collect EGFR testing, pathology, staging reports
  3. Submit PA request (Prescriber): Use UHC Provider Portal with complete clinical package
  4. Request expedited review (Prescriber): Mark urgent for cancer progression risk
  5. Track status (Clinic): Monitor portal for determination (standard: ~15 days; expedited: ~72 hours)
  6. Obtain specialty pharmacy (Patient): Fill at Optum Specialty if approved
  7. Prepare for reauthorization (Clinic): Document clinical response for 12-month renewal
Tip: Request expedited review for cancer cases. UnitedHealthcare typically processes urgent oncology PAs within 72 hours.

Appeals Playbook for Pennsylvania

Pennsylvania residents have exceptional appeal rights thanks to the new state-run external review program launched in 2024.

Internal Appeals with UnitedHealthcare

Timeline: Must file within 180 days of denial
Process: Submit via UHC member portal or by mail
Documents needed:

  • Original denial letter
  • Medical records and EGFR testing
  • Oncologist appeal letter
  • NCCN guideline excerpts

Standard review: 30 days
Expedited review: 72 hours (for urgent medical needs)

Pennsylvania External Review (Game-Changer)

If UnitedHealthcare upholds the denial, Pennsylvania's Independent External Review offers a binding second opinion.

Key Stats: 50% of appeals are overturned in patients' favor
Timeline: 45 days for standard review; 72 hours for expedited
Cost: Free to patients
Deadline: 4 months after final internal denial

How to file:

  1. Complete UnitedHealthcare's internal appeals first
  2. Obtain Final Adverse Benefit Determination letter
  3. Submit request at pa.gov external review portal
  4. Include all medical records and supporting literature
Pennsylvania residents: You have 4 months to request external review after your final UnitedHealthcare denial. The Independent Review Organization's decision is binding on your insurer.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"No documented EGFR mutation" Submit complete pathology report Molecular testing results with specific mutation identified
"Not medically necessary" Cite NCCN guidelines and FDA labeling Oncologist letter referencing Category 1 evidence
"Step therapy not completed" Request medical exception Document contraindications or prior failures
"Quantity limits exceeded" Justify dosing regimen NCCN dosing recommendations, patient weight/BSA
"Experimental/investigational" Establish FDA approval status FDA label, NCCN compendium listing

Sample Appeal Points

  • "Tagrisso is FDA-approved and NCCN Category 1 preferred for EGFR exon 19 deletion metastatic NSCLC"
  • "Delays in EGFR-targeted therapy risk disease progression and reduced survival outcomes"
  • "Patient's T790M mutation specifically requires osimertinib per resistance patterns"

Costs & Patient Assistance

List price: Tagrisso costs over $15,000 per month without insurance coverage.

Financial Support Options

  • AstraZeneca patient assistance: AZCares program for eligible uninsured/underinsured patients
  • Copay assistance: Up to $25,000 annually for commercially insured patients
  • Pennsylvania pharmaceutical assistance: Check state programs for seniors and disabled residents
  • Foundation grants: CancerCare, Patient Access Network Foundation, others
Note: Pennsylvania has strengthened oral cancer drug parity laws. Some UnitedHealthcare plans may have $0 copays for oral oncology medications.

FAQ

Q: How long does UnitedHealthcare prior authorization take in Pennsylvania?
A: Standard reviews take up to 15 business days; expedited cancer cases typically resolve within 72 hours.

Q: What if Tagrisso isn't on my formulary?
A: Request a formulary exception with medical necessity documentation. Pennsylvania's external review covers formulary denials.

Q: Can I get Tagrisso while appealing a denial?
A: Ask your oncologist about "continuity of care" provisions or emergency supplies while appeals are pending.

Q: Does step therapy apply if I failed other EGFR drugs outside Pennsylvania?
A: Document prior treatment failures thoroughly. UnitedHealthcare should accept out-of-state medical history.

Q: What's the success rate for Tagrisso appeals in Pennsylvania?
A: Pennsylvania's external review program overturns 50% of denials overall. Cancer drug appeals often have higher success rates with proper documentation.

Q: Can I appeal to Pennsylvania if my plan is through my employer?
A: Only if your employer plan is fully insured (state-regulated). Self-funded ERISA plans use federal external review instead.

From our advocates: "We've seen complex Tagrisso cases turn around when families gathered complete EGFR testing documentation and worked with their oncologist to reference specific NCCN guideline sections. Pennsylvania's new external review process has been particularly effective for specialty cancer drugs when internal appeals fail."

Getting Tagrisso covered by UnitedHealthcare in Pennsylvania requires understanding both the insurer's specific EGFR mutation requirements and your state's powerful new appeal rights. With proper documentation and Pennsylvania's 50% external review success rate, patients have multiple pathways to coverage.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific coverage criteria, and drafts point-by-point rebuttals aligned to each plan's requirements—making the complex prior authorization and appeals process more manageable for families facing expensive specialty drug denials.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your insurer and consult your healthcare team for medical decisions. For personalized assistance with Pennsylvania insurance appeals, contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388.

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