CurrentUnitedHealthcarePolicy N/A

Tagrisso (osimertinib) prior authorization

Prior authorization and notification requirements for coverage of Tagrisso (osimertinib) for UnitedHealthcare members, including pediatric, non-small cell lung cancer (NSCLC) with specific EGFR mutations, CNS metastases, and adjuvant or unresectable disease settings.

Policy Summary

PayerUnitedHealthcare

PolicyTagrisso (osimertinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating diagnosis of EGFR mutation–positive NSCLC or CNS involvement and required documentation of qualifying EGFR mutations.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

Exon19, L858R, S768I, L861Q, G719X, T790Mqualifying EGFR mutations

IncludedCNS coverage

2025 P 1174-11program number

Coverage Criteria for Tagrisso (osimertinib)

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Central Nervous System (CNS) Cancer

Covered when ANY of the following are met for initial authorization; reauthorization requires evidence of clinical response

CNS metastases initial: Diagnosis of brain metastases from EGFR mutation-positive NSCLC

Authorization will be issued for 12 months

CNS metastases initial: Diagnosis of leptomeningeal metastases from EGFR mutation-positive NSCLC

Authorization will be issued for 12 months

CNS reauthorization: Documentation of positive clinical response to Tagrisso therapy

Authorization will be issued for 12 months

Non-small cell lung cancer (NSCLC)

Initial authorization: Covered when ALL of the following are met

NSCLC initial - diagnosis: Diagnosis of non-small cell lung cancer (NSCLC)

NSCLC initial - EGFR mutation: Disease is positive for at least one of the following EGFR mutations: Exon 19, Exon 21 L858R, S768I, L861Q, G719X, or T790M

NSCLC initial - disease setting

Adjuvant post-resection: Disease is stage IB, II, IIIA, or IIIB (T3, N2) AND patient has undergone complete resection AND patient has received previous adjuvant chemotherapy or is ineligible for platinum-based chemotherapy
Locally advanced/unresectable post-chemoradiation: Disease is stage II-III AND disease is locally advanced or unresectable AND no disease progression during or following concurrent or sequential chemoradiation
Recurrent/advanced/metastatic: Disease is recurrent, advanced, or metastatic

NSCLC reauthorization: Documentation of positive clinical response to Tagrisso therapy

Authorization will be issued for 12 months

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Tagrisso (osimertinib) will be approved when documentation shows NSCLC with an eligible EGFR mutation and the applicable clinical scenario (adjuvant post-resection, locally advanced/unresectable post-chemoradiation, or recurrent/advanced/metastatic disease). Authorization length: 12 months.

Approval requires documentation of EGFR mutation testing (exon 19, exon 21 L858R, S768I, L861Q, G719X, or T790M).
Authorization may be based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic.
Supply limits may apply.

Step Therapy

Step Therapy Notes

No explicit step-therapy sequence is required for Tagrisso. For the EGFR T790M population, the indication references prior EGFR TKI therapy (disease progressed on or after EGFR TKI therapy) — document prior TKI treatment when applicable.

No required trials of alternate agents prior to approval.
For T790M-positive disease, document progression after prior EGFR TKI therapy.

Documentation Required

Authorization Logic & Documentation Sources

Approval and reauthorization decisions may be made using previous claim/medication history, diagnosis codes (ICD-10), and automated claim logic. Ensure records (pathology/genomic test results, staging, prior treatments, and surgical/adjuvant therapy documentation) are available to support the request.

Authorization may be granted without full chart review when claims data sufficiently document criteria.
Provide EGFR mutation test results and documentation of stage, resection status, chemoradiation response, or metastatic/recurrent disease as applicable.
Supply limits and program-specific automated processes may affect approval.

Denial Risk

Denial Triggers

Failure to meet the coverage criteria will result in denial of coverage. Common denial triggers include missing EGFR mutation documentation, absence of required staging/resection or chemoradiation history for the indicated scenario, or lack of evidence of prior EGFR TKI therapy where T790M indication is claimed.

Missing or undocumented EGFR mutation status.
No documentation of complete resection and prior adjuvant chemotherapy or ineligibility when claiming adjuvant indication.
No documentation of chemoradiation and lack of progression for locally advanced/unresectable indication.
For T790M requests, no evidence of prior EGFR TKI therapy and subsequent progression.

Step	Requirement / Note
T790M indication references prior EGFR TKI therapy per labeled indication	No explicit mandated step-therapy failures are specified in this document; prior TKI therapy is referenced for the T790M population
Documented evidence of prior progression on or after EGFR TKI therapy is required for the T790M‑positive indication (per product labeling)	Prior authorization is required; approval will follow when coverage criteria for the indicated NSCLC or CNS settings and qualifying EGFR mutations are met

Definitions

EGFR mutation-positive NSCLC — key examples

DefinitionEGFR mutation-positive non-small cell lung cancer (examples include Exon 19 deletion, Exon 21 L858R, S768I, L861Q, G719X, T790M)

Actionable testing requirementDisease must be positive for at least one qualifying EGFR mutation listed to meet coverage criteria for Tagrisso

Examples of qualifying mutationsExon 19; Exon 21 L858R; S768I; L861Q; G719X; T790M

Clinical contexts where definition appliesMetastatic disease, adjuvant post-resection in qualifying stages, unresectable stage III post-chemoradiation, brain metastases, and leptomeningeal metastases

Source guidanceNCCN recognizes Tagrisso for limited and extensive brain metastases and leptomeningeal metastases in EGFR mutation-positive NSCLC

Background

Tagrisso (osimertinib) is a kinase inhibitor indicated for multiple EGFR mutation–positive non‑small cell lung cancer (NSCLC) settings, including first‑line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, treatment of T790M mutation–positive NSCLC after progression on prior EGFR TKI therapy, adjuvant therapy following complete resection in adults with qualifying EGFR mutations, and for unresectable stage III disease that has not progressed after chemoradiation. The National Comprehensive Cancer Network (NCCN) also recommends Tagrisso for treatment of limited and extensive brain metastases and leptomeningeal metastases in EGFR mutation–positive NSCLC.

Policy Summary

PayerUnitedHealthcare

PolicyTagrisso (osimertinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating diagnosis of EGFR mutation–positive NSCLC or CNS involvement and required documentation of qualifying EGFR mutations.

SourceLink

On This Page

OpenPayer

Tagrisso (osimertinib) prior authorization

Coverage Criteria for Tagrisso (osimertinib)

Provider Actions, Authorization & Documentation

Initial Therapy Criteria

Reauthorization / Continuation Criteria

Step Therapy / Prior Treatment Notes

Definitions

Background