CurrentCignaPolicy N/A

Gefitinib (Iressa) prior authorization for NSCLC coverage criteria

Prior authorization requirements for gefitinib (Iressa) tablets for treatment of non-small cell lung cancer in Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyGefitinib (Iressa) prior authorization for NSCLC coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateSep 3, 2025

Key ActionObtain prior authorization and document age, metastatic NSCLC status, and EGFR mutation detected by an FDA-approved test; approvals are for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yeartypical approval duration

Adults ≥18minimum patient age in criteria

EGFR exon 19 or exon 21primary mutations listed

Not med. necessaryexplicit exclusion stance

NCCNguideline source cited

Coverage Criteria for Gefitinib (Iressa)

FDA-Approved Indication (Initial approval)

Covered when ALL of the following are met for the FDA-approved NSCLC indication (approve for 1 year):

FDA-Approved Indication - NSCLC: Patient is ≥ 18 years of age; AND patient has advanced or metastatic disease; AND patient has EGFR mutation-positive disease; AND the mutation was detected by an approved test.

Examples of EGFR mutation-positive non-small cell lung cancer include exon 19 deletions, exon 21 (L858R) substitution mutations, L861Q, G719X, and S768I.

Gefitinib (Iressa) is not medically necessary for any uses outside the specified FDA‑approved indication for EGFR mutation‑positive advanced or metastatic non‑small cell lung cancer. Requests for coverage for indications not listed in this policy will be denied as not medically necessary.

Use of Iressa (gefitinib) for any indication not explicitly listed as covered in this policy is considered not medically necessary. Coverage criteria are limited to the FDA‑approved NSCLC indication and will be updated if new published data change the policy.

Regimen	Indication	Coverage status	Approval duration / notes
Gefitinib monotherapy (Iressa)	EGFR mutation-positive metastatic non-small cell lung cancer (first-line) — patients with sensitizing EGFR mutations such as exon 19 deletions or exon 21 (L858R); other sensitive mutations include L861Q, G719X, S768I.	Covered with criteria	Prior authorization required; approve for 1 year when ALL coverage criteria are met (age ≥18, advanced/metastatic disease, EGFR mutation detected by an FDA‑approved test).

Policy Summary

PayerCigna

PolicyGefitinib (Iressa) prior authorization for NSCLC coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateSep 3, 2025

Key ActionObtain prior authorization and document age, metastatic NSCLC status, and EGFR mutation detected by an FDA-approved test; approvals are for 1 year when criteria are met.

SourceLink

On This Page

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Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for gefitinib. Approvals are provided for 1 year when criteria met.

Affected product: Iressa® (gefitinib tablets) and generics
Approval duration: 1 year when criteria met

Step Therapy

Step Therapy / Sequencing

No explicit step therapy sequence is specified in this policy. NCCN lists osimertinib (Tagrisso®) as the preferred first-line therapy (category 1); gefitinib and other EGFR TKIs are listed under "Useful in Certain Circumstances" (category 1) and gefitinib is "Other Recommended" (category 2A) for certain less common mutations (L861Q, G719X, S768I). Clinicians should follow NCCN guidance for sequencing when selecting first-line EGFR TKI therapy.

NCCN recommends testing for sensitizing EGFR mutations in metastatic NSCLC
Preferred first-line per NCCN: osimertinib (Tagrisso®)
Gefitinib categorized as "Useful in Certain Circumstances" or "Other Recommended" for some mutations

Documentation Required

Required Clinical Documentation

Documentation must support the criteria for approval. Provide clinical information demonstrating age, disease stage, and EGFR mutation–positive status.

Patient age (≥ 18 years)
Evidence of advanced or metastatic NSCLC
Documentation of EGFR mutation–positive disease (examples: exon 19 deletions, exon 21 L858R, L861Q, G719X, S768I)
Test report showing the mutation was detected by an FDA-approved/validated test

Denial Risk

Non‑Covered Uses / Denial Risk

Requests for gefitinib for indications other than the FDA-approved NSCLC indication (first-line treatment of metastatic NSCLC with sensitizing EGFR mutations) will be denied as not medically necessary unless supportive evidence for another use is added to the criteria.

Policy considers gefitinib not medically necessary for all other uses; criteria will be updated as new data become available

Biomarker and Mutation Requirements

EGFR mutation requirements (biomarker list)

Required EGFR mutationsExon 19 deletion; exon 21 (L858R) substitution; L861Q; G719X; S768I

Detection methodMutation must be detected by an FDA‑approved test (the mutation was detected by an approved test).

Clinical contextThese are considered sensitizing EGFR mutations associated with response to EGFR tyrosine kinase inhibitors in metastatic NSCLC.

Common vs less commonExon 19 deletions and exon 21 (L858R) are the most common; L861Q, G719X, and S768I are less common but also sensitive to EGFR TKIs.

Definition — EGFR mutation‑positive disease

Definition of EGFR mutation‑positive diseasePresence of sensitizing EGFR mutations such as exon 19 deletions, exon 21 (L858R), L861Q, G719X, or S768I detected by an FDA‑approved test.

Guideline recommendationNCCN recommends testing for sensitizing EGFR mutations in metastatic NSCLC.

Therapeutic implicationPatients with these mutations have significantly better responses to EGFR tyrosine kinase inhibitors.

Examples provided in policyPolicy examples explicitly list exon 19 deletions, exon 21 (L858R), L861Q, G719X, and S768I as EGFR mutation‑positive disease.

OpenPayer

Gefitinib (Iressa) prior authorization for NSCLC coverage criteria

Coverage Criteria for Gefitinib (Iressa)

Provider Requirements and Prior Authorization

Line of Therapy

Biomarker and Mutation Requirements

Background

Covered Regimens and Dosing