CurrentCignaPolicy N/A

Oncology - Gilotrif Prior Authorization Policy

Defines Cigna's prior authorization requirements and coverage criteria for Gilotrif (afatinib) for prescription benefit plans, including FDA‑approved NSCLC indications and selected head and neck cancers; affects providers requesting coverage for members under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyOncology - Gilotrif Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 11, 2024

Key ActionObtain prior authorization and document an FDA‑approved EGFR sensitizing mutation or prior platinum-based chemotherapy per indication; approvals are issued for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3covered indications listed (NSCLC EGFR+, NSCLC squamous, Head & Neck)

1 yearstandard approval duration for covered indications

12/11/2024review date

Coverage Criteria for Gilotrif (afatinib)

FDA‑Approved Indication: NSCLC — EGFR mutation‑positive (first‑line)

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FDA‑Approved Indication: NSCLC — Squamous cell carcinoma (post‑platinum)

Approve for 1 year if the patient meets ALL of the following

Metastatic squamous NSCLC criteria: A) Patient is ≥ 18 years of age; AND B) Patient has metastatic squamous cell carcinoma; AND C) Patient has disease progression after treatment with platinum-based chemotherapy.

Other Uses with Supportive Evidence: Head and Neck Cancer (non‑nasopharyngeal)

Approve for 1 year if the patient meets ALL of the following

Head and neck cancer criteria: A) Patient is ≥ 18 years of age; AND B) Patient has non-nasopharyngeal head and neck cancer (examples: lip, oral cavity, oropharynx, hypopharynx, glottis, larynx, supraglottic larynx, ethmoid sinus, maxillary sinus, occult primary); AND C) Patient has disease progression on or after platinum-based chemotherapy.

This is listed as an 'other use with supportive evidence'.

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required — 1‑year approvals when criteria met

Prior authorization is recommended for prescription benefit coverage of Gilotrif; when the patient meets the applicable coverage criteria, approvals are issued for a duration of 1 year.

Step Therapy

Prior chemotherapy requirement — post‑platinum progression required

For the metastatic squamous NSCLC and non‑nasopharyngeal head & neck cancer indications, approval requires documentation of disease progression after treatment with platinum-based chemotherapy as specified in the criteria.

Squamous NSCLC: 'C) Patient has disease progression after treatment with platinum-based chemotherapy.'
Head and neck cancer: 'C) Patient has disease progression on or after platinum-based chemotherapy.'

Documentation Required

Required documentation and plan terms

Providers should document the member's applicable benefit plan and the clinical facts supporting medical necessity, including applicable test results such as an FDA‑approved test demonstrating a sensitizing EGFR mutation when required by the criteria; coverage remains subject to the terms of the member's benefit plan document.

Document the applicable benefit plan terms and any plan exclusions or limitations (per Instructions for Use).
Provide clinical documentation supporting the diagnosis and prior therapies.
When covering first‑line EGFR‑mutant NSCLC, include results from an approved test demonstrating a sensitizing EGFR mutation (examples listed in policy).

Denial Risk

Not covered uses — other indications considered investigational

Requests for Gilotrif for any indication not listed in this policy are considered experimental, investigational or unproven and may be denied.

Background

Gilotrif (afatinib) is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor indicated for EGFR mutation–positive metastatic non–small cell lung cancer (NSCLC) as first‑line therapy and for metastatic squamous NSCLC after platinum‑based chemotherapy; it is included in guideline recommendations for EGFR‑sensitizing mutations and is subject to prior authorization per this policy.

Coverage decisions in this policy require documentation of EGFR sensitizing mutations detected by an approved test for the first‑line metastatic NSCLC indication and adherence to the specified prior‑therapy requirements for post‑platinum squamous NSCLC and selected head and neck cancer uses.

Definitions

Sensitizing EGFR mutations

Exon 19 deletionsAssociated with sensitivity to EGFR TKIs (e.g., afatinib)

Exon 21 (L858R) substitutionKnown sensitizing EGFR mutation responsive to EGFR TKIs

L861QLess common sensitizing EGFR mutation included in guideline recommendations

G719XLess common sensitizing EGFR mutation included in guideline recommendations

S768ILess common sensitizing EGFR mutation included in guideline recommendations

Line of Therapy

first-line

First-line metastatic EGFR+ NSCLC: Requires sensitizing EGFR mutation detected by approved test; patient age ≥ 18; metastatic disease.

second-line

Second-line/salvage for squamous NSCLC or head & neck: Requires metastatic squamous NSCLC or non-nasopharyngeal head & neck cancer with disease progression after platinum-based chemotherapy; patient age ≥ 18.

Revision History

2024-12-11Annual revision / Review dateLatest

Policy reviewed on 12/11/2024 (annual revision); no clinical criteria changes noted in this revision summary.

2023-11-29Annual revision / Review date

Policy reviewed on 11/29/2023 (annual revision); no clinical criteria changes noted in this revision summary.