CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1036-14

Gilotrif® (afatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Prior authorization/notification criteria for Gilotrif (afatinib) coverage under UnitedHealthcare commercial plans (Colorado Rocky Mountain Health Plans program), including initial and reauthorization criteria for multiple cancer indications and special rules for members <19.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGilotrif® (afatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 1036-14

Change TypeAnnual review (no criteria changes)

Effective DateSep 1, 2025

Next Review Date

Key ActionProviders must obtain prior authorization/notification for Gilotrif; approvals are issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Annual review 6/2025 with no changes to coverage criteria.

Effective date set to 9/1/2025 in program header.

4Covered Indications

12Authorization Duration

2013-2025P&T Review Range

Coverage Summary & Indications

Gilotrif (afatinib) is a kinase inhibitor indicated as first-line treatment for metastatic non-small cell lung cancer (NSCLC) when tumors have non-resistant epidermal growth factor receptor (EGFR) mutations detected by an FDA‑approved test. It is also indicated for treatment of metastatic, squamous NSCLC that progresses after platinum-based chemotherapy. The National Comprehensive Cancer Network (NCCN) additionally recognizes Gilotrif for use in advanced non-nasopharyngeal head and neck cancers with progression on or after platinum-containing chemotherapy and as a single-agent option for brain metastases in patients with EGFR‑sensitizing mutation positive NSCLC. Safety and efficacy of Gilotrif have not been established in tumors with resistant EGFR mutations.

Members under age 19

Gilotrif will be approved based on the following criterion (auto-process for members under 19):

ALL of the following

Patient is less than 19 years of age
Authorization will be issued for 12 months.

Reauthorization — Metastatic NSCLC

Gilotrif will be approved for reauthorization when the following is met:

ALL of the following

Patient does not show evidence of progressive disease while on Gilotrif therapy
Authorization will be issued for 12 months.

Reauthorization — Advanced non-nasopharyngeal head and neck cancer

Gilotrif will be approved for reauthorization when the following is met:

ALL of the following

Patient does not show evidence of progressive disease while on Gilotrif therapy
Authorization will be issued for 12 months.

Reauthorization — Brain metastasis indication

Gilotrif will be approved for reauthorization when the following is met:

ALL of the following

Patient does not show evidence of progressive disease while on Gilotrif therapy
Authorization will be issued for 12 months.

NCCN Recommended Regimens

Approval when the drug is recognized by NCCN with specified categories:

The drug has been recognized for treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Prior Authorization, Documentation & Billing Guidance

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Gilotrif. When criteria are met, approvals are issued for 12 months. Prescriptions for members under age 19 will automatically process without a coverage review.

Documentation Required

Clinical documentation for initial authorization

For initial authorization, clinical documentation must support the requested indication and relevant clinical findings: diagnosis consistent with the covered indication (metastatic NSCLC, advanced non-nasopharyngeal head and neck cancer after platinum chemotherapy, or brain metastases from EGFR‑sensitizing mutation positive NSCLC); tumor EGFR mutation status showing non-resistant (sensitizing) EGFR mutations where applicable; and documentation of progression after prior platinum‑based chemotherapy when required (for squamous NSCLC and for head and neck cancer).

Diagnosis matching the requested indication (metastatic NSCLC, advanced non‑nasopharyngeal head and neck cancer, or brain metastases from EGFR‑sensitizing mutation positive NSCLC).
EGFR mutation testing demonstrating non‑resistant (sensitizing) EGFR mutations when applicable.
Documentation of disease progression after prior platinum‑based chemotherapy when required (e.g., squamous NSCLC and advanced head and neck cancer).
Brain metastasis requests must document EGFR‑sensitizing mutation positive NSCLC as specified.

Documentation Required

Reauthorization documentation

For reauthorization, provide documentation demonstrating the patient does not have evidence of disease progression while receiving Gilotrif therapy.

Billing Rule

Supply limits may apply

The plan may enforce supply limits for Gilotrif as part of utilization management.

Denial Risk

State mandates and benefit plan limits

Coverage in this program may be superseded or modified by applicable state mandates, federal regulatory requirements, and the member's specific benefit plan. In some cases, initial approvals or reauthorizations may be granted automatically based on prior claim/medication history, diagnosis codes, or claim logic.

Evidence & Definitions

Primary references supporting this policy include the Gilotrif package insert (April 2022) and the NCCN Drugs and Biologics Compendium (accessed April 30, 2025). The policy notes NCCN recognition for additional indications (advanced non-nasopharyngeal head and neck cancers and brain metastases in EGFR‑sensitizing mutation positive NSCLC) as cited in those sources.

Non-resistant EGFR mutations: EGFR mutations that are not associated with resistance to afatinib per product labeling; the product labeling notes that safety and efficacy have not been established in patients whose tumors have resistant EGFR mutations.

Background

Gilotrif is a kinase inhibitor with labeled indications that include: first-line treatment of metastatic NSCLC with tumors harboring non-resistant EGFR mutations, and treatment of metastatic, squamous NSCLC that has progressed after platinum-based chemotherapy. The NCCN also recommends Gilotrif for advanced non-nasopharyngeal head and neck cancers after platinum-containing chemotherapy and for brain metastases in EGFR‑sensitizing mutation positive NSCLC. The product labeling includes a limitation of use stating that safety and efficacy were not established in patients whose tumors have resistant EGFR mutations.

Revision History

2025-06-01annual_reviewLatest

Annual review 6/2025 with no changes to coverage criteria

2025-09-01program_effective_date

Effective date set to 9/1/2025 in program header

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGilotrif® (afatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 1036-14

Change TypeAnnual review (no criteria changes)

Effective DateSep 1, 2025

Next Review Date

Key ActionProviders must obtain prior authorization/notification for Gilotrif; approvals are issued for 12 months when criteria are met.

SourceLink

On This Page

OpenPayer

Gilotrif® (afatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Coverage Summary & Indications

Prior Authorization, Documentation & Billing Guidance

Applicable Codes & Program Identifiers

Evidence & Definitions

Background

Revision History