CurrentUnitedHealthcarePolicy 2024 P 1104-14

Tarceva (erlotinib) prior authorization

Defines UnitedHealthcare prior authorization/notification criteria for Tarceva (erlotinib) for oncology indications, including age-based automatic approvals and state mandate considerations; affects providers prescribing Tarceva to UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyTarceva (erlotinib) prior authorization

Policy CodePolicy 2024 P 1104-14

Change TypeNo material changes

Effective DateFeb 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; authorizations are generally issued for 12 months for approved indications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration for approved uses

age <19automatic processing without coverage review

multiplecovered diagnoses listed

Prior Authprogram type

Coverage Criteria

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inv-02: Initial authorization: NSCLC with EGFR sensitizing mutations

Covered when ALL of the following are met:

NSCLC initial authorization: Diagnosis of non-small cell lung cancer AND disease is recurrent OR advanced OR metastatic AND tumors are positive for EGFR exon 19 deletions OR exon 21 L858R substitution mutations OR a known sensitizing EGFR mutation (e.g., S768I, L861Q, G719X)

Authorization issued for 12 months

inv-05: Initial authorization: CNS metastases from NSCLC

Covered when ALL of the following are met:

Brain/leptomeningeal/spine metastases from NSCLC: Diagnosis of brain, leptomeningeal, or spine metastases from NSCLC AND tumors are positive for EGFR exon 19 deletions OR exon 21 L858R substitution mutations OR a known sensitizing EGFR mutation (e.g., S768I, L861Q, G719X)

Authorization issued for 12 months

Tarceva safety and efficacy have not been established for tumors that harbor other EGFR mutations beyond the specified sensitizing alterations; therefore use outside the listed EGFR alterations is not supported by this policy. The policy also states that Tarceva is not recommended for use in combination with platinum-based chemotherapy.

When considering coverage for tumors with multiple EGFR alterations, the policy requires the presence of a known sensitizing EGFR mutation (for example exon 19 deletions or exon 21 L858R, or other sensitizing variants) for NSCLC-related indications; combinations of mutations that do not include a recognized sensitizing alteration do not meet the documented criteria.

The policy lists specific oncology indications (NSCLC with sensitizing EGFR mutations, pancreatic cancer with gemcitabine, chordoma, CNS metastases from NSCLC, relapsed or stage IV non-clear cell kidney cancer, and vulvar cancer) for which Tarceva may be authorized when the stated criteria are met; uses outside these indications or in unlisted mutation contexts should be considered unsupported by the documented coverage criteria.

Initial Therapy Criteria (by indication)

inv-15: Initial therapy criteria

Initial authorization criteria by indication

Initial approvals summary: See indication-specific nodes for criteria: pediatric auto-approval, pancreatic + gemcitabine, NSCLC with sensitizing EGFR mutations, chordoma, non-clear cell advanced/relapsed kidney cancer, CNS metastases from NSCLC, vulvar cancer

Authorizations typically issued for 12 months

Reauthorization / Continuation Criteria

inv-07: Reauthorization criteria (all indications listed)

Reauthorization is approved when ALL of the following are met:

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

Authorization issued for 12 months

inv-16: Reauthorization / continuation

Reauthorization rules for continuation of therapy

Continuation authorization: Patient does not show evidence of progressive disease while on Tarceva therapy

Authorization issued for 12 months

Provider Actions & Authorization Process

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Tarceva (erlotinib). Authorizations are generally issued for 12 months for approved indications. For members under age 19, prescriptions will automatically process without a coverage review.

Prior authorization required for Tarceva (erlotinib).
Authorizations generally issued for 12 months for approved indications.
Members <19 years: prescription auto-processes without coverage review.

Denial Risk

Denial Triggers

Coverage review is required for members age 19 and older; failure to meet specified diagnosis or mutation criteria (e.g., required NSCLC histology and qualifying EGFR sensitizing mutations, or pancreatic cancer criteria and use with gemcitabine) may result in denial of coverage.

Denial risk if member is ≥19 and does not meet diagnosis criteria.
Denial risk if tumor does not have required EGFR exon 19 deletion, exon 21 L858R substitution, or other specified sensitizing EGFR mutation when indicated.
Denial risk if pancreatic cancer cases do not meet staging or combination therapy requirements.

Documentation Required

Administrative Documentation Rules

Approvals may be based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic. UnitedHealthcare may use automated approval and re-approval processes. Supply limits may apply. Some state-mandated coverage or compendium requirements may supersede policy language when applicable.

Approvals may be issued using previous claims/medication history and diagnosis codes (ICD-10).
Automated approval and re-approval processes may be used and vary by program/therapeutic class.
Supply limits may be enforced.
State mandates or compendium requirements may supersede policy when applicable.

Step Therapy

Step Therapy / Automation

Automated approval and re-approval processes may be used; no specific step therapy sequencing is listed in this policy. Where automation is in place, it may expedite approvals based on prior claims/diagnoses.

No explicit step therapy requirements specified in this policy.
Automated approval/re-approval processes may be utilized and vary by program/therapeutic class.

Definitions

Known sensitizing EGFR mutation — definition and examples

DefinitionEGFR alterations that sensitize tumors to EGFR inhibitors (referred to in this policy as 'known sensitizing EGFR mutations').

Examples (documented in policy)S768I; L861Q; G719X; EGFR exon 19 deletions; EGFR exon 21 L858R substitution mutation.

Context of usePresence of one of these mutations in tumors is an eligibility criterion for Tarceva (erlotinib) coverage in NSCLC and CNS metastases from NSCLC per the policy's initial authorization rules.

Limitations notedThe safety and efficacy of Tarceva has not been established for tumors with other (non-sensitizing) EGFR mutations; policy states Tarceva is not recommended for use with platinum-based chemotherapy.

Source wordingPolicy lists tumors positive for EGFR exon 19 deletions, exon 21 L858R substitution mutations, or a known sensitizing EGFR mutation (e.g., S768I, L861Q, G719X).

Background

Tarceva (erlotinib) is an EGFR tyrosine kinase inhibitor indicated for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and for use as first-line treatment in combination with gemcitabine for locally advanced, unresectable, or metastatic pancreatic cancer.

The National Comprehensive Cancer Network (NCCN) also supports Tarceva for several other tumor sites and settings cited in the policy, including chordoma, brain, leptomeningeal, and spine metastases from NSCLC, relapsed or stage IV non-clear cell kidney cancer, NSCLC with other known sensitizing EGFR mutations, and vulvar cancer.

The policy notes that Tarceva’s safety and efficacy have not been established for NSCLC tumors with other EGFR mutations (i.e., mutations beyond the specified sensitizing alterations) and that Tarceva is not recommended in combination with platinum-based chemotherapy.

Step	Requirement
No explicit step therapy steps specified
Automated approval or re-approval processes and claim-history/medication history, diagnosis code (ICD-10), or claim-logic based approvals may be used per UnitedHealthcare program rules