By Counterforce Health Team in Tagrisso (osimertinib) —

UnitedHealthcare's Coverage Criteria for Tagrisso in Ohio: What Counts as "Medically Necessary"?

Answer Box: Getting Tagrisso Covered by UnitedHealthcare in Ohio

UnitedHealthcare requires prior authorization for Tagrisso (osimertinib) based on documented EGFR mutation and NSCLC diagnosis. Your fastest path to approval: 1) Gather EGFR mutation test results from FDA-approved lab, 2) Have oncologist submit PA via UnitedHealthcare Provider Portal, 3) If denied, file internal appeal within 180 days, then request external review through Ohio Department of Insurance. Start today: Contact your oncologist to confirm EGFR testing is complete and initiate the PA process.

Table of Contents

Policy Overview: Plan Types and Coverage Rules

UnitedHealthcare's Tagrisso coverage applies across all Ohio plan types—HMO, PPO, Medicare Advantage, and employer-sponsored plans. The medication is classified as a specialty drug requiring prior authorization through OptumRx, UnitedHealthcare's pharmacy benefit manager.

Key policy features:

  • Prior authorization required for all plan types
  • 12-month approval periods with annual reauthorization
  • Specialty pharmacy dispensing only (typically OptumRx)
  • Medical necessity criteria based on EGFR mutation status and NSCLC diagnosis

Self-funded employer plans may have slight variations, but most follow the standard UnitedHealthcare policy framework. You can find your specific plan's formulary and coverage details through the UnitedHealthcare member portal.

Indication Requirements: FDA Status and Off-Label Use

Tagrisso has FDA approval for specific EGFR-mutant NSCLC indications, which UnitedHealthcare recognizes as the primary coverage criteria:

FDA-approved indications:

  • Metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations (first-line)
  • Metastatic NSCLC with EGFR T790M mutation after progression on EGFR TKI therapy
  • Adjuvant treatment following tumor resection in NSCLC with EGFR exon 19 deletions or L858R mutations

Off-label coverage: UnitedHealthcare may cover off-label use if supported by NCCN Compendium Category 1, 2A, or 2B recommendations for the specific cancer indication.

Note: Off-label requests require additional clinical justification and may face higher scrutiny during the PA review process.

Step Therapy and Medical Exceptions

UnitedHealthcare may require step therapy depending on your specific clinical situation:

First-line treatment: Patients with newly diagnosed EGFR-mutant metastatic NSCLC typically don't face step therapy requirements, as Tagrisso is a preferred first-line option.

Second-line treatment: For T790M-positive disease after progression on first-generation EGFR TKIs (erlotinib, gefitinib), step therapy documentation includes:

  • Prior EGFR TKI therapy with dates
  • Evidence of disease progression (imaging, clinical notes)
  • T790M mutation testing results

Medical exceptions are granted when:

  • Previous EGFR TKIs caused severe adverse reactions
  • Drug interactions contraindicate other options
  • Patient has specific comorbidities making alternatives inappropriate

Document exceptions with detailed clinical notes explaining why standard step therapy isn't suitable.

Quantity Limits and Renewal Requirements

Standard quantity limits:

  • 80mg tablets: 30 tablets per 30-day supply (one daily)
  • 40mg tablets: 30 tablets per 30-day supply (one daily)

Renewal requirements every 12 months:

  • Evidence of continued clinical benefit (stable disease or response)
  • Tolerability assessment
  • Updated staging if applicable
  • Confirmation of ongoing EGFR mutation status

Dose modifications for adverse events require clinical documentation justifying the reduced dose and expected duration.

Required Diagnostics and Documentation

UnitedHealthcare requires comprehensive diagnostic documentation to establish medical necessity:

Essential diagnostics:

  • EGFR mutation testing from FDA-approved laboratory
  • Histologic confirmation of NSCLC (adenocarcinoma preferred)
  • Staging studies (CT chest/abdomen/pelvis, brain MRI if indicated)
  • Performance status assessment

EGFR testing specifications:

  • Must use FDA-approved assay (e.g., cobas® EGFR Mutation Test v2)
  • CLIA-certified laboratory required
  • Tissue sample with ≥30% tumor content preferred
  • Plasma testing acceptable if tissue unavailable

Documentation timing:

  • EGFR testing within 6 months of PA request
  • Staging studies within 3 months
  • Clinical notes within 30 days

Specialty Pharmacy and Site of Care Rules

Dispensing requirements:

Network compliance:

  • Using out-of-network pharmacies results in coverage denial
  • Patients receive specialty pharmacy contact information after PA approval
  • Automatic refill programs available through network pharmacies

For Ohio residents, Counterforce Health helps patients navigate specialty pharmacy requirements and resolves dispensing issues that can delay treatment access.

Evidence to Support Medical Necessity

Strong medical necessity documentation includes multiple evidence sources:

Clinical guidelines:

  • NCCN Guidelines for Non-Small Cell Lung Cancer
  • ASCO Clinical Practice Guidelines
  • FDA prescribing information

Peer-reviewed literature:

  • FLAURA trial data for first-line treatment
  • AURA3 trial results for T790M-positive disease
  • Real-world effectiveness studies

Patient-specific factors:

  • Performance status and life expectancy
  • Comorbidities affecting treatment selection
  • Previous treatment responses and tolerability
  • Quality of life considerations
Clinician Tip: Reference specific guideline recommendations and trial data in your PA request. For example: "Per NCCN Guidelines v2.2024, osimertinib is preferred first-line therapy for EGFR exon 19 deletion-positive metastatic NSCLC."

Sample Medical Necessity Narrative

Template paragraph structure:

"This 65-year-old patient with newly diagnosed metastatic lung adenocarcinoma (ICD-10: C78.00) harbors an EGFR exon 19 deletion mutation confirmed by FDA-approved cobas testing at [Laboratory Name] on [Date]. Per NCCN Guidelines and FDA labeling, osimertinib is the preferred first-line therapy for this molecular subtype, demonstrating superior progression-free survival compared to first-generation EGFR TKIs in the FLAURA trial. The patient has adequate performance status (ECOG 1) and no contraindications to osimertinib therapy. Standard dosing of 80mg daily is planned with routine monitoring for known adverse effects including QTc prolongation and interstitial lung disease."

Edge Cases and Special Situations

Pediatric patients: Limited data exists for pediatric use. Coverage requires:

  • Pediatric oncology consultation
  • Literature review supporting use
  • Institutional review board approval if applicable

Pregnancy considerations: Tagrisso is contraindicated in pregnancy. Documentation should include:

  • Pregnancy test results
  • Contraception counseling notes
  • Risk-benefit discussion documentation

Comorbidity management:

  • Cardiac issues: Baseline ECG and cardiology clearance
  • Pulmonary disease: Baseline pulmonary function tests
  • Drug interactions: Comprehensive medication review

Escalation pathways:

  • Peer-to-peer review requests for complex cases
  • Medical director consultation for unusual circumstances
  • Counterforce Health assistance for persistent denials

Coverage Criteria Quick Reference

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans Provider portal submission UHC PA Policy
EGFR Mutation FDA-approved test showing eligible mutation Lab report from CLIA facility FDA Labeling
NSCLC Diagnosis Histologically confirmed Pathology report UHC PA Policy
Quantity Limit 30 tablets per 30 days Plan formulary UHC Formulary
Specialty Pharmacy OptumRx network only Member portal UHC Provider Site

Appeals Process in Ohio

Internal Appeal Process:

  1. File within 180 days of denial notice
  2. Submit through: UnitedHealthcare member portal or written request
  3. Timeline: 15-30 days for standard review, 72 hours for urgent cases
  4. Required documents: Denial letter, additional clinical evidence, physician letter

External Review in Ohio:

  • Deadline: 180 days after final internal denial
  • Process: Request through Ohio Department of Insurance
  • Timeline: 30 days standard, 72 hours expedited
  • Cost: Free to consumers
  • Contact: Ohio DOI Consumer Hotline: 800-686-1526

The external review process in Ohio provides an independent medical review through certified Independent Review Organizations (IROs). Decisions are binding on UnitedHealthcare if the appeal is successful.

FAQ

How long does UnitedHealthcare PA take in Ohio? Standard review takes up to 15 business days. Expedited review (72 hours) is available for urgent medical situations.

What if Tagrisso isn't on my formulary? Non-formulary drugs can still be covered through the PA process with strong medical necessity documentation. Consider formulary exception requests.

Can I request an expedited appeal? Yes, if delays would seriously jeopardize your health. Document the urgency with clinical notes and physician attestation.

Does step therapy apply if I failed treatments outside Ohio? Previous treatment failures from any location count toward step therapy requirements. Provide complete treatment records.

What happens if my EGFR test was done at a non-FDA approved lab? UnitedHealthcare typically requires FDA-approved testing. You may need repeat testing at an approved facility.

How do I find an in-network specialty pharmacy? Contact UnitedHealthcare member services or check your member portal for contracted specialty pharmacies in Ohio.

This information is for educational purposes only and is not medical advice. Coverage policies may vary by plan. For personalized assistance with UnitedHealthcare coverage appeals and prior authorization requirements, Counterforce Health provides specialized support for patients navigating insurance denials for specialty medications like Tagrisso.

Disclaimer: Insurance policies and state regulations change frequently. Always verify current requirements with UnitedHealthcare member services and the Ohio Department of Insurance before making coverage decisions.

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