CurrentUnitedHealthcarePolicy 2025 P 1161-11

Iressa (gefitinib) prior authorization

Prior authorization and notification criteria for coverage of Iressa (gefitinib) for UnitedHealthcare members, including initial and reauthorization rules and special pediatric handling. Applies to pharmacy benefit management for covered members.

Policy Summary

PayerUnitedHealthcare

PolicyIressa (gefitinib) prior authorization

Policy CodePolicy 2025 P 1161-11

Change TypeCoverage criteria added/updated (material)

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization documentation showing diagnosis and molecular testing confirming a sensitizing EGFR mutation; prescriptions for patients <19 process automatically without coverage review.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for recurrent or advanced NSCLC per NCCN recommendations and updated reauthorization wording.

Updated background to include NCCN-recommended additional EGFR mutations (S768I, L861Q, G719X) and mention of brain metastases.

Effective date set to 1/1/2026 and program number published as 2025 P 1161-11.

12 monthsauthorization duration typically issued

auto-processPatients <19

EGFR ex19/21primary sensitizing mutations required

Category 1/2A/2BNCCN recognition

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Coverage Criteria for Iressa (gefitinib)

Initial Therapy (NSCLC)

Covered when ALL of the following are met

Initial Authorization (NSCLC): (1) Diagnosis of non-small cell lung cancer (NSCLC) AND (2) Disease is recurrent, advanced, or metastatic (recurrent OR advanced OR metastatic) AND (3) One of the following tumor genotypes: EGFR exon 19 deletion OR EGFR exon 21 (L858R) substitution OR a known sensitizing EGFR mutation (e.g., exon 20 S768I, exon 18 G719X, exon 21 L861Q)

Authorization issued for 12 months.

Reauthorization (NSCLC)

Covered when ALL of the following are met

Reauthorization (NSCLC): Patient does not show evidence of progressive disease while on Iressa therapy

Authorization duration: 12 months.

Initial Therapy (CNS metastases)

Covered when ALL of the following are met

Initial Authorization (CNS metastases): (1) Diagnosis of central nervous system (CNS) cancer with metastatic lesions AND (2) Iressa is active against the primary (NSCLC) tumor which harbors a known EGFR sensitizing mutation

Authorization issued for 12 months.

Reauthorization (CNS metastases)

Covered when ALL of the following are met

Reauthorization (CNS metastases): Patient does not show evidence of progressive disease while on Iressa therapy

Authorization duration: 12 months.

Pediatric (under 19)

Patients <19 years: Patient is less than 19 years of age (prescription processes automatically without coverage review).

Authorization issued for 12 months.

Some state mandates and member benefit plans may affect coverage for off‑label uses of Iressa. Where a state law or mandate requires coverage for an off‑label indication or specifies use of a particular compendium, that requirement supersedes the language in this policy. Additionally, member benefit plan terms may further restrict or expand coverage beyond the criteria described here; providers should verify state‑specific mandates and the applicable member benefit plan before submitting an authorization request.

For continuation (reauthorization) of Iressa, coverage is contingent on the patient not showing evidence of progressive disease while on Iressa therapy. If a patient demonstrates disease progression while receiving Iressa, continued therapy may be considered not medically necessary and reauthorization can be denied.

Initial Therapy

Initial therapy

Initial authorization criteria

Initial (NSCLC or CNS): See criteria: diagnosis of NSCLC (recurrent, advanced, or metastatic) with required EGFR sensitizing mutation OR CNS metastatic lesions when Iressa is active against the primary NSCLC tumor with a known EGFR sensitizing mutation

Authorization issued for 12 months.

Continuation / Reauthorization Criteria

Continuation therapy

Reauthorization rule

Reauthorization: Patient does not show evidence of progressive disease while on Iressa therapy

Authorization issued for 12 months.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Iressa except for members under age 19, who process automatically without coverage review. Authorization for patients < 19 years will be issued for 12 months.

Prior authorization required for Iressa (Iressa will be approved for members < 19 years automatically for 12 months).
Automated approval pathways may be used based on program rules; see utilization management notes.

Denial Risk

Denial Risk for Insufficient Diagnosis or Molecular Evidence

Denial risk if documentation does not support the required diagnosis or molecular testing. Specifically, requests may be denied when the patient does not have a diagnosis of non-small cell lung cancer (NSCLC) with recurrent, advanced, or metastatic disease, or when there is no documentation of a tumor positive for a qualifying EGFR sensitizing mutation.

Key Definitions

Sensitizing EGFR mutation (definition)

DefinitionSensitizing EGFR mutation: EGFR exon 19 deletions, exon 21 (L858R) substitution, and other NCCN‑recognized mutations such as S768I (exon 20), G719X (exon 18), and L861Q (exon 21).

Clinical relevanceThese mutations indicate tumor sensitivity to EGFR tyrosine kinase inhibitors, including Iressa (gefitinib), and support use as first‑line therapy for metastatic NSCLC.

Inclusion for brain metastasesNCCN recommends Iressa for patients with a known sensitizing EGFR mutation and associated brain metastases.

Document sourceBackground and initial authorization criteria require molecular testing demonstrating one of these sensitizing EGFR mutations for coverage.

Background

Iressa (gefitinib) is a tyrosine kinase inhibitor indicated as first‑line treatment for metastatic non‑small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) substitution. NCCN also recognizes additional sensitizing EGFR mutations (for example, S768I, G719X, L861Q) and supports use in patients with a known sensitizing EGFR mutation and associated brain metastases. Prior authorization is required for most members; authorizations are typically issued for 12 months, and prescriptions for members under age 19 process automatically without coverage review.

Step Therapy

Step	Description
No explicit step therapy sequence specified in this document	Other utilization management programs may apply; UnitedHealthcare may approve initial and reauthorization based solely on prior claim/medication history, diagnosis codes, and/or claim logic. Supply limits may be in place.

Quantity Limits

Iressa (gefitinib) — quantity limits and utilization notes

Quantity managementSupply limits may be in place for Iressa (gefitinib).

Automated processesUnitedHealthcare may use automated approval or re‑approval processes based on claim/medication history, diagnosis codes (ICD‑10), and/or claim logic; this may interact with supply limits.

Program variabilityUse of automated approval and re‑approval processes and any limits varies by program and/or therapeutic class.

Site of Care

Note

No site-of-care restrictions specified

No site-of-care restrictions are specified in this policy. However, utilization management programs and automated approval processes may vary by program and could affect how requests are processed depending on the setting.

Revision History

2026-01-01policy_effectiveLatest

Policy effective date set to January 1, 2026; program published as 2025 P 1161-11.

2025-10annual_review_material_change

Annual review: added coverage criteria for recurrent or advanced NSCLC per NCCN recommendations and updated reauthorization wording.

2024-10annual_review

Annual review: updated background and list of examples of sensitizing EGFR mutations per NCCN recommendations and updated references.